Supporting Statement for a Generic Information Collection Request (ICR)
                    Under the Paperwork Reduction Act (PRA)
EXECUTIVE SUMMARY
 Identification of the Information Collection  -  Title and Numbers
      Title: Revision: Generic Clearance for TSCA Section 4 Test Rules, Test Orders, Enforceable Consent Agreements (ECAs), Voluntary Data Submissions, and Exemptions from Testing Requirements
	ICR Numbers: EPA ICR No.: 2697.01,
	OMB Control No.: 2070-0215
	Docket ID No.: EPA-HQ-OPPT-2015-0436

 Abstract
This generic ICR covers the information collection activities associated with the submission of information to EPA pursuant to TSCA section 4 regulatory actions. (15 U.S.C. 2603). The updates in this generic ICR were conducted to include the authorities provided to EPA under TSCA, as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (hereinafter the "Lautenberg Act"). Under TSCA, EPA has the authority to issue regulatory actions designed to gather or develop health and safety information and exposure information on chemical substances and mixtures, and to control unreasonable risks associated with new and existing chemical substances. TSCA section 4 authorities allow EPA to require the development of information related to chemicals and the use of prescribed "protocols and methodologies" in order to inform EPA and other federal agencies about chemical risks, which in turn will inform decision makers for purposes of prioritization for risk evaluation, risk evaluation and risk management of those chemicals as necessary.
Supporting Statement
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 information collection activities covered by this ICR and imposed on the respondents as part of the TSCA section 4 testing program, as established by 53 USC 2603, allow EPA to ensure that the necessary information will be developed, that the results meet basic scientific standards of acceptability and adequacy, that unforeseen complications or issues can be addressed, and that any required testing is progressing on schedule. The information collection activities would be required if certain statutory determinations are made that indicate the development of information under TSCA section 4 is necessary. TSCA section 4 requires manufacturers and processors of chemical substances and mixtures to conduct testing if it finds that the manufacture, distribution, processing, use or disposal of a chemical substance or a mixture may present an unreasonable risk to human health or the environment [TSCA Sections 4(a)(1)]. The rationale for establishing the necessity for issuing a TSCA section 4 regulatory action would be presented under the findings and/or statement of need, along with an indication of the underlying evidence, in the specific action.
TSCA section 2(b)(1) states that it is the policy of the United States that "adequate information should be developed with respect to the effect of chemical substances and mixtures on health and the environment and that the development of such information should be the responsibility of those who manufacture [which is defined by statute to include import] and those who process such chemical substances and mixtures."
The Lautenberg Act expanded EPA's explicit statutory authority to require the development of information under TSCA section 4. In addition to the statutory testing authority previously provided under TSCA section 4, the Lautenberg Act amended TSCA to explicitly provide authority to issue orders. TSCA section 4(a)(2) now explicitly authorizes EPA to promulgate rules, issue orders, or enter into consent agreements to require testing to develop information that is necessary:
       To review a notice submitted under TSCA section 5 or to perform a risk evaluation under TSCA section 6(b);
       To implement a requirement imposed in a rule, order, or consent agreement under TSCA section 5(e) or (f), or in a rule promulgated under section 6(a);
       At the request of a Federal implementing authority under another Federal law, to meet the regulatory testing needs of that authority with regard to toxicity and exposure;
       To determine if a chemical substance or mixture manufactured, processed, or distributed in commerce solely for export presents an unreasonable risk of injury to health or the environment in the U.S., pursuant to TSCA section 12(a)(2); and
       To prioritize a chemical substance under TSCA section 6(b) (subject to certain limitations).

TSCA section 4(a)(3) was also established by the Lautenberg Act. According to TSCA section 4(a)(3), rules, orders, and consent agreements pursuant to TSCA section 4(a)(2) must include a "Statement of Need," which requires EPA to identify the need for the development of new information, describe how information reasonably available to EPA informed the decision to require new information, explain the basis for requiring any testing of vertebrate animals, and, as applicable, explain why issuance of an order is warranted instead of promulgating a rule or entering into a consent agreement.
TSCA section 4(a)(4) established that when requiring the development of new information under TSCA section 4(a), EPA must employ a tiered screening and testing process, under which the results of screening tests or assessments of available information inform the decision whether to require more advanced testing. It is therefore assumed, for the purposes of estimating burden for this three-year period, that testing would consist primarily of screening-level tests. If other types of testing are required in the future, the burden estimates will be modified as needed at that time.
TSCA section 4(h) was also established by the Lautenberg Act and requires EPA to take specified steps to reduce and replace vertebrate animal testing to the extent practicable, scientifically justified, and consistent with policies of Title I of TSCA. Also, voluntary testing developed for submission under Title 1 of TSCA, and not pursuant to a request or requirement by EPA, must first be attempted by means of an alternative test method or strategy identified by EPA pursuant to TSCA section 4(h)(2)(C) and for the development of such information before conducting new vertebrate animal testing.
EPA may require any type of health or environmental effects testing necessary to address unanswered questions about the effects of the chemical. Regarding testing pursuant to TSCA section 4(a)(1), EPA need not limit the scope of testing required to the factual basis for the TSCA section 4(a)(1)(A)(i) or 4(a)(1)(A)(ii) findings, as long as EPA finds that there is insufficient information and experience upon which the effects of the manufacture, distribution in commerce, processing, use, or disposal of such substance or mixture or of any combination of such activities on health or the environment can reasonably be determined or predicted, and that testing is necessary to develop the information.
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's Office of Pollution Prevention and Toxics (OPPT) within the Office of Chemical Safety and Pollution Prevention (OCSPP), other EPA Offices and/or other Federal agencies will be the primary groups for which information will be collected. However, to the extent that reported information is not considered to be CBI, the public may have access to this information.
The information required under TSCA section 4 may be used to provide EPA with the necessary information on health effects, ecological effects, and environmental fate to predict the effects of chemicals on human health or the environment. EPA's statutory authority under TSCA sections 4(a)(1) or 4(a)(2) may be used to ensure the safety of existing chemicals in the marketplace by applying a three-step statutory and regulatory approach that includes prioritizing, evaluating, and managing risks of chemicals under TSCA section 6. EPA may also need to develop information under TSCA section 4 pursuant to other authorities provided under TSCA section 4(a)(2), including pursuant to TSCA section 5. Also, EPA may be required to develop a testing action under TSCA section 4 in response to a recommendation received from the TSCA Interagency Testing Committee (ITC).
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.
On December 4, 2013, EPA finalized a rule to require electronic reporting of certain information submitted to the Agency under TSCA sections 4, 5, 8(a) and 8(d). The rule became effective in March 2014. Submitters are now required to use EPA's Central Data Exchange (CDX; https://cdx.epa.gov/), the Agency's electronic reporting site to make submissions in response to TSCA section 4. Submitters must register to use EPA's Agency-wide CDX portal for submitting information in a secure manner, select the Chemical Safety and Pesticide Programs (CSPP) portion of the site, access a Web-based TSCA reporting tool called the Chemical Information Submission System (CISS), and select the TSCA section 4 option for transmitting information as exhibited in the CDX/Manage Toxic Substances Section 4 User Guides. (Note: Users who have previously registered with CDX are able to add "Submission for Chemical Safety and Pesticide Program (CSPP)" to their current registration.) This reporting tool is compatible with Windows, Mac, Linux, and UNIX based computers, and uses "Extensible Markup Language" (XML) specifications for efficient data transmission across the Internet. Two test rules that were issued before the electronic reporting rule went into effect in March 2014 are still active. Submissions for these two test rules have been made by using the U.S. Mail and by electronic submission. Any information collection activities pursuant to new test rules, test orders, or consent agreements will be made electronically.
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.
 In general, the activities associated with collecting test information for chemicals subject to TSCA are not duplicated by any other agency or office within EPA. TSCA is the only applicable authority to allow for such information collection, and TSCA specifically assigns that authority to EPA. In addition, EPA takes several steps to ensure that its requests for information do not result in duplicative efforts by those responding, including:
       A single submission of the information will satisfy the request.
       Prior to proposing a test rule, issuing a test order, or entering into a testing agreement, EPA searches the scientific literature, holds public information gathering meetings if deemed appropriate, and has discussions with industry representatives and other government agencies to determine what types of information have already been obtained about the chemical under consideration.
       EPA proposes a test rule, issues a test order, or enters into a consent agreement only after it has determined that necessary tests have not yet been conducted.
       Exemption applicants are not required to supply information that EPA can obtain by other existing processes.
       Where appropriate, equivalence data on a similar chemical may be accepted by EPA in place of conducting new studies.
If the collection of information impacts small businesses or other small entities, describe the methods used to minimize burden.
 Test rules and orders both offer the options of joining a testing consortium or requesting an exemption. Although these options are available to both large and small entities, they are of particular value to small entities as they relieve the small entity (which often has fewer resources) of the direct responsibility for collecting or submitting the required information.
 Some relief associated with reimbursement of testing costs is provided to small entities under TSCA section 4(c)(3)(A), which requires that all relevant factors be considered including the effect on the competitive position of the person required to provide reimbursement in relation to the person to be reimbursed and the share of the market of the person required to provide reimbursement in relation to the share of such market of the person to be reimbursed. In most cases, this requirement would serve to benefit the small entity.
 Decisions relating to how the cost of testing is to be divided among companies are decided by the manufacturers subject to the test rule, test order, or consent agreement. Generally, small businesses are assigned a portion of the costs that is proportionate to their market share. However, if any party believes a particular reimbursement arrangement is unfair, TSCA directs the Administrator of EPA to assist in resolving the conflict and EPA will consider the special needs of small businesses if such action becomes necessary. To date, no party has requested that EPA assist in reimbursement decisions.
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.
EPA believes that test rules, test orders, and consent agreements require the minimal submissions to assure necessary oversight and tracking of the test information necessary to prioritize, evaluate, and manage chemical risks. Less frequent collection would mean that EPA would not have information sufficient to carry out its statutory mandates. Regulatory actions pursuant to TSCA section 4 may require the test sponsor to submit to EPA: 1) a letter of intent to test that identifies who will be conducting the testing, 2) study plans before beginning testing, and 3) a final report that contains the study results. Each party subject to a test rule or order that wants to request an exemption from testing is required to submit an exemption application to EPA.
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.
 The information retention requirements for test rules, test orders, and consent agreements exceed one of the PRA guidelines contained in 5 CFR 1320.5. Documentation records, raw data, and specimens pertaining to a test rule or consent agreement study are required to be retained for ten years from the effective date of the applicable test rule or publication date of the consent agreement. These recordkeeping requirements are codified in 40 CFR 792.195. These requirements are necessary to permit sufficient time to review results, carry out prioritization efforts, perform appropriate risk evaluations and, when necessary, to institute appropriate risk management actions. Long-term studies may take five years from the effective date of the final test rule, test order, or consent agreement to perform and submit to EPA; assessment of study results may require an additional one to two years of internal and external peer review; institution of risk management regulatory controls and legal challenges may require an additional two to four years before final resolution of issues. All studies, both short and long-term, are relevant to assessing the potential risk of the chemical and therefore must be retained during the ten-year period. In those regulatory cases where either EPA's action or the information upon which it is based are challenged, it is imperative that all records, raw information, and specimens be available for further review or investigation. Applicable record retention requirements will be prescribed in orders and/or updates to applicable recordkeeping regulations and will likely cover the same ten-year period as set forth in the regulations regarding rules and consent agreements.
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 reported.
   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) in proposing to renew this ICR, EPA will publish a notice in the Federal Register that will provide a 60-day public comment period. The comments received and any additional public comment for this action will be posted in the docket.
As required under 5 CFR 1320.8(d)(1), in addition to the public notice, EPA staff will contact appropriate stakeholders and ask them for their assessment of the regulatory burden estimates expressed by the Agency in this ICR. A summary of these consultations will be provided in the supporting statement during the second comment period.
Explain any decision to provide any payment or gift to respondents, other than remuneration of contractors or grantees.
Not applicable.
 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.
Information submitted to EPA in response to test rules, test orders, and consent agreements, is, in most cases, non-confidential. Respondents may claim all or part of a document submitted to be confidential. 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, 40 CFR part 2, 40 CFR 790, and any specific confidentiality requirements under a particular testing action. TSCA, as amended by the Lautenberg Act, establishes additional requirements for respondents claiming CBI. These requirements include the submitter substantiating a CBI claim as well as certifying the claim, when applicable. TSCA section 14(c)(2) exempts certain types of information claimed CBI from CBI substantiation requirements. Certain information required pursuant to TSCA section 4 that is not exempt under section 14(c)(2) may require substantiation if claimed CBI. Certain information collection activities may require specific substantiation information. However, if there are no requirements to answer specific questions in substantiating confidentiality claims, respondents may refer to EPA's website for sample substantiation questions and guidance at https://www.epa.gov/tsca-cbi/what-include-cbi-substantiations.
 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 information of a sensitive or private nature is requested in conjunction with these information collection activities, and these information collection activities comply with the provisions of the Privacy Act of 1974 and OMB Circular A-108.
 12. Provide estimates of the hour burden of the collection of information. The statement should:
 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.
   b) If this request for approval covers more than one form, provide separate hour burden estimates for each form and aggregate the hour burdens.
   c) 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'.
Methodology revisions and additional estimates are necessary to incorporate considerations of the Lautenberg Act provisions. The methodology changes in this ICR revision build upon key improvements implemented in the previous ICR that are designed to minimize redundant calculations, thereby avoiding errors, and reducing cost for production and quality control (EPA, 2018a; see also Nielsen & Day, 2018). Additionally, EPA reviewed and considered the workflow of TSCA section 4 actions under TSCA, as amended by Lautenberg Act. EPA's methodology objectives include:
   Objective 1: Reflect the nature of the information collection according to action in a transparent manner, with continued attention to efficiency and communication,
   Objective 2: Provide ease in future updates based on anticipated load projections for TSCA section 4 actions, and
   Objective 3: Enable minimal changes during the ICR period (i.e., via worksheet corrections) by providing burden estimates at sufficiently high levels to cover the three-year period.
For each type of activity covered by this generic ICR, this section of the ICR describes the respondents, the information collection activities, and related estimates for burden and costs associated with those activities. Additional information regarding the overall methodology, as well as specific considerations for particular ICs, are available in Appendix F.
Respondents affected by the collection activity may include, but are not limited to, entities identified by the North American Industrial Classification System (NAICS) codes within the following industry categories:
                                Type of Entity
                                     NAICS
                   Example of Potentially Affected Entities
Chemical Manufacturers (including Importers)
                                   325, 324
Persons who manufacture (defined by statute to include import) one or more of the subject chemical substances.
Processors
                                   325, 324
Persons who process one or more of the subject chemical substances.

Prior to transmitting TSCA section 4 reports and other key correspondence, new submitters must register with CDX. In addition, these respondents must complete an Electronic Signature Agreement form, including signature and date, and then submit the form electronically back to EPA.
Respondents may undertake one or more of the following activities:
   (a)	Review rulemaking  or order and/or participate in ECA discussions.
   (b)	Conduct searches for relevant existing information. If information is found:
      i.	Determine whether the information is relevant; and
      ii.	Submit information to EPA if equivalent to testing action requirements.
   (c)	Submit "Letter of Intent" to conduct testing (or, for ECA, a "Request to Negotiate a Consent Agreement" or complete and submit testing exemption application to EPA.
   (d)	Plan necessary activities, e.g., consortia, arrange for conduct of studies, etc.
   (e)	Prepare and submit periodic progress reports, if applicable.
   (f)	Record and prepare information for submission (includes QA/QC reviews).
   (g)	Prepare, review, and submit final report.
   (h)	Review submission for CBI and provide substantiation for confidentiality claims.
   (i)	Maintain information and final report in records.
   (j) 	Review guidance documents.
   (k)	Engage in pre-issuance outreach.
These activities may vary based on the category under which the activity may occur:
Test Rules and Orders  -  Test rules and orders require manufacturers (including importers) of the subject chemical to submit a letter identifying who is sponsoring the required testing; a study plan before testing begins; semi-annual progress reports, as applicable, during the conduct of the testing; and a final report of the test results. Since information is typically required on a chemical basis  -  as opposed to a manufacturer basis, test sponsors typically form consortia to satisfy the testing requirements.
Enforceable Consent Agreement (ECAs)  -  Signatories to an ECA commit to provide information on the subject chemical, and typically adopt the same approach as that used for test rules. As such, one of the ECA participants would take the lead to submit a letter identifying who is sponsoring the required testing and a study plan before testing begins, semi-annual progress reports during the conduct of the testing, and a final report of the test results.
Voluntary Submissions  -  This activity is not prompted by any rule or agreement. As a result, it only involves the submission of a test's final reports and may include a Robust Summary of the test results.
Testing Exemption Applications  -  If an entity determines that they are subject to a testing requirement, but qualify for an exemption, the entity would submit a completed application to EPA requesting to be exempt from conducting the required testing and providing an appropriate rationale. Exemption applicants are not required to supply information that the Agency can obtain by other existing processes. In general, test rules reduce the burden associated with preparing exemption applications to a minimum by restricting the information required to that absolutely necessary to determine if the applicant is eligible for an exemption. The exemption process for test orders is expected to be similar to that for test rules.
The respondent universe for test rules, test orders, ECAs, and Voluntary Data Submissions, Exemption Applications and Robust Summaries are presented in Table 1.
Three-year to one-year scaling considerations for activities associated with Testing Exemption Applications, Voluntary Submissions, and CDR Registrations are handled slightly differently than the scaling for bundled activities, as depicted in Table G-1. With the durations short and the activities themselves separate from the bundle associated with a chemical being tested, EPA assumes no need to apportion the activity over there years in the unit burden, but instead takes one third of the incidence rate to determine the counts in Table 1.
For Testing Exemption Applications, EPA revises the assumption from previous ICRs to a basis that three exemptions (yielding one annually) per chemical undergoing testing occur for Test Rules and Test Orders. The basis for this assumption uses information in the previous ICR (EPA, 2018a) stating that during Testing of Certain High Production Volume Chemicals; Second Group of Chemicals (76 FR 1067), 52 exemption applications were received for 19 chemicals subject to the test rule. Taking the ratio of exemption applications at 52 over 19 yields a factor of 2.8 exemption applications per chemical, rounded up to 3 exemption applications per chemical with each application assumed to involve one chemical. EPA also assumes that all tests are exempted in the exemption application. The newly structured assumption based on chemical testing provides ease of future maintenance as the number of exemptions is expected to vary according to the number of chemicals tested in actions.
Similarly, for Voluntary Data Submissions, EPA revises the assumption from previous ICRs to a basis that one submission (yielding one-third annually) per chemical tested occur for Test Rules and Test Orders. The newly structured assumption based on chemical testing provides ease of future maintenance as the number of exemptions is expected to vary according to number of chemicals tested in actions. The resultant number of submissions totals 24.5 for 77 chemicals tested, compared to a total of 10 for 92 chemicals reflecting HPV conditions (EPA, 2013). The newly structured assumption based on chemical testing provides ease of future maintenance as the number of exemptions is expected to vary according to number of chemicals tested in actions.
For CDX registrations, EPA assumes that 40 percent of sponsors, plus all exemption applicants, will produce new registrations.
In the sections that follow, the total burden of each type of information collection activity is estimated using universe information in Table 1. Additional unit burden information can be found in Appendix G.
Table 1. Universe Information for this ICR Period
                                Type of Action
                                Program Input
                          Annual Number of Responses
                              Generic Assumptions

                             New Actions per Year
                        Associated Number of Chemicals

            (Standardized for All Types of TSCA Section 4 Actions)
Test Rule
                                      0.5
                                       7
                                      3.5
1 sponsor per chemical

2.8 overlap factor

7 tests per chemical undergoing testing

3 years testing duration overall
Test Order
                                      10
                                       7
                                      70

Enforceable Consent Agreement
                                      0.5
                                       7
                                      3.5

                                Inferred Inputs
                                  Assumptions
Exemption Application, Test Rule

                                      3.5
3 exemption applications per chemical undergoing testing in Test Rules and Test Orders

Duration of 1 year or less but occurs throughout the 3-year period

All tests exempted for a chemical exempted

2.8 overlap factor
Exemption Application, Test Order

                                     70.0
Same as above
Voluntary Data Submissions

                                     24.5
1 voluntary data submission involving one chemical per chemical undergoing testing in Test Rules and Test Orders

Duration of 1 year or less but occurs throughout the 3-year period
CDX Registration

                                     10.7
40% of sponsors plus exemption applicants produce registrations

Duration of 1 year or less but occurs throughout the 3-year period

2.8 overlap factor
General Note:
For Inputs with "duration of one year or less" the value per chemical is divided by three because the event can occur anytime in the three year period and does not need to be allocated across the three years, in contrast to activities that are part of the bundle presented in Table G-2.

Based on the unit burden estimates presented in Table G-3, as well as the estimated number of responses presented in Table 1, the total respondent burden and costs for CDX registration for e-Reporting are presented in Table 2 EPA assumes that some respondents are already registered in CDX, and only 40 percent of respondents would be required to register for CDX under this ICR. These respondents may be employees from sponsor companies that are new to EPA e-reporting or they may be employees new to e-reporting due to turnover within a company that has prior experience with e-reporting.
Table 2. CDX Registration for e-Reporting  -  Annual Total Respondent Burden and Costs (2020$)
                                   Activity
                         Unit Burden per Registration
                    Number of Registrations/Registrants[1]
                                Overlap Factor
                             Total Burden (Hours)
                               Total Labor Cost
                             Total Non-Labor Cost
                                  Total Cost
CDX Registration
                                                                          0.180
                                                                           10.7
                                                                            2.8
                                                                          5.393
                                                                       $434.12
                                                                         $0.00
                                                                       $434.12
CDX Electronic Signature
                                                                          0.350
                                                                           10.7
                                                                            2.8
                                                                         10.486
                                                                       $844.27
                                                                         $0.00
                                                                       $844.27
Total, Reporting
                                                                          0.530
                                                                           10.7
                                                                            2.8
                                                                         15.879
                                                                     $1,278.39
                                                                         $0.00
                                                                     $1,278.39
Total, Recordkeeping
                                                                          0.000
                                                                            0.0

                                                                          0.000
                                                                         $0.00
                                                                         $0.00
                                                                         $0.00
Total, CDX Registration and e-Reporting and Recordkeeping
                                                                          0.530
                                                                           10.7
                                                                            2.8
                                                                         15.879
                                                                     $1,278.39
                                                                         $0.00
                                                                     $1,278.39
1 Number of registrations is assumed to be 40 percent of the total number of sponsors for test rules, test orders, ECAs, and exemption applications assuming one sponsor per chemical.

Based on the unit burden estimates presented in Table G-4, as well as the estimated number of responses in Table 1, the total respondent burden and costs for initial response under test rules are presented below in Table 3.
Table 3. Initial Response, Test Rules  -  Annual Total Respondent Burden and Costs (2020$)
                                   Activity
                         Adjusted Unit Burden (hours)
                     Number of Respondents (Sponsors) [1]
            Number of Responses (Chemicals Tested within an Action)
                                Overlap Factor
                             Total Burden (hours)
                               Total Labor Cost
                             Total Non-Labor Cost
                                  Total Cost
Letter of Intent
                                                                          0.333
                                                                           3.50
                                                                           3.50
                                                                            2.8
                                                                          3.263
                                                                       $262.74
                                                                         $0.00
                                                                       $262.74
Subtotal, Letter of Intent Total
                                                                          0.333
                                                                           3.50
                                                                           3.50
                                                                            2.8
                                                                          3.263
                                                                       $262.74
                                                                         $0.00
                                                                       $262.74
OR

Prepare Exemption Application
                                                                          2.000
                                                                           3.50
                                                                           3.50
                                                                            2.8
                                                                         19.600
                                                                     $1,577.80
                                                                         $0.00
                                                                     $1,577.80
Corporate Review
                                                                          6.000
                                                                           3.50
                                                                           3.50
                                                                            2.8
                                                                         58.800
                                                                     $5,558.95
                                                                         $0.00
                                                                     $5,558.95
Subtotal, Exemption Application Reporting
                                                                          8.000
                                                                           3.50
                                                                           3.50
                                                                            2.8
                                                                         78.400
                                                                     $7,136.75
                                                                         $0.00
                                                                     $7,136.75
Subtotal, Recordkeeping
                                                                          0.500
                                                                           3.50
                                                                           3.50
                                                                            2.8
                                                                          4.900
                                                                       $179.24
                                                                         $0.00
                                                                       $179.24
Subtotal, Exemption Application
                                                                            8.5
                                                                           3.50
                                                                           3.50
                                                                            2.8
                                                                         83.300
                                                                     $7,315.99
                                                                         $0.00
                                                                     $7,315.99
Overall Total, Initial Contact including Exemption Applications Reporting
                                                                          4.166
                                                                           7.00
                                                                           7.00
                                                                            2.8
                                                                         81.663
                                                                     $7,399.49
                                                                         $0.00
                                                                     $7,399.49
Overall Recordkeeping
                                                                          0.500
                                                                           3.50
                                                                           3.50
                                                                            2.8
                                                                          4.900
                                                                       $179.24
                                                                         $0.00
                                                                       $179.24
Overall Total, Initial Contact including Exemption Applications
                                                                          4.416
                                                                            7.0
                                                                            7.0
                                                                            2.8
                                                                         86.563
                                                                     $7,578.73
                                                                         $0.00
                                                                     $7,578.73
[1] Assumes one sponsor per chemical per year.

Based on the unit burden estimates presented in Table G-5, as well as the estimated number of responses in Table 1, the total respondent burden and costs for study plans under test rules are presented below in Table 4.
Table 4. Study Plan, Test Rules  -  Annual Total Respondent Burden and Costs (2020$)
                                   Activity
                         Adjusted Unit Burden (hours)
                     Number of Respondents (Sponsors) [1]
            Number of Responses (Chemicals Tested within an Action)
                                Overlap Factor
                             Total Burden (hours)
                               Total Labor Cost
                             Total Non-Labor Cost
                                  Total Cost
Study Plan
                                                                         12.987
                                                                           3.50
                                                                           3.50
                                                                           2.80
                                                                         127.27
                                                                    $10,245.41
                                                                         $0.00
                                                                    $10,245.41
CBI Substantiation
                                                                          1.215
                                                                           3.50
                                                                           3.50
                                                                           2.80
                                                                          11.91
                                                                     $1,012.83
                                                                         $0.00
                                                                     $1,012.83
Total, Reporting
                                                                         14.202
                                                                           3.50
                                                                           3.50
                                                                           2.80
                                                                         139.18
                                                                    $11,258.24
                                                                         $0.00
                                                                    $11,258.24
Total, Recordkeeping
                                                                          0.000
                                                                           0.00
                                                                           0.00

                                                                           0.00
                                                                         $0.00
                                                                         $0.00
                                                                         $0.00
Total, Study Plan, Test Rules
                                                                         14.202
                                                                           3.50
                                                                           3.50
                                                                           2.80
                                                                         139.18
                                                                    $11,258.24
                                                                         $0.00
                                                                    $11,258.24
[1] Assumes one sponsor per chemical.

Based on the unit burden estimates presented in Table G-6, as well as the estimated number of responses in Table 1, the total respondent burden and costs for test results under test rules are presented below in Table 5.

Table 5. Test Results, Test Rules  -  Annual Total Respondent Burden and Costs (2020$)
                                   Activity
                         Adjusted Unit Burden (hours)
                     Number of Respondents (Sponsors) [1]
            Number of Responses (Chemicals Tested within an Action)
                                Overlap Factor
                             Total Burden (hours)
                               Total Labor Cost
                             Total Non-Labor Cost
                                  Total Cost
Study Final Report
                                                                         93.320
                                                                           3.50
                                                                           3.50
                                                                           2.80
                                                                         914.54
                                                                    $73,620.15
                                                                         $0.00
                                                                    $73,620.15
Study Corporate Review
                                                                         13.998
                                                                           3.50
                                                                           3.50
                                                                           2.80
                                                                         137.18
                                                                    $12,969.03
                                                                         $0.00
                                                                    $12,969.03
Laboratory Review
                                                                         13.998
                                                                           3.50
                                                                           3.50
                                                                           2.80
                                                                         137.18
                                                                    $11,043.03
                                                                         $0.00
                                                                    $11,043.03
Total, Reporting
                                                                        121.316
                                                                           3.50
                                                                           3.50
                                                                           2.80
                                                                       1,188.90
                                                                    $97,632.21
                                                                         $0.00
                                                                    $97,632.21
Total, Recordkeeping
                                                                          1.167
                                                                           3.50
                                                                           3.50
                                                                           2.80
                                                                          11.44
                                                                       $418.17
                                                                         $0.00
                                                                       $418.17
Total, Test Results, Test Rules
                                                                        122.483
                                                                           3.50
                                                                           3.50
                                                                           2.80
                                                                       1,200.33
                                                                    $98,050.38
                                                                         $0.00
                                                                    $98,050.38
[1] Assumes one sponsor per chemical.

Based on the unit burden estimates presented in Table G-7, as well as the estimated number of responses in Table 1, the total respondent burden and costs for initial response under test orders are presented below in Table 6.
Table 6. Initial Response, Test Orders  -  Annual Total Respondent Burden and Costs (2020$)
                                   Activity
                         Adjusted Unit Burden (hours)
                     Number of Respondents (Sponsors) [1]
            Number of Responses (Chemicals Tested within an Action)
                                Overlap Factor
                             Total Burden (hours)
                               Total Labor Cost
                             Total Non-Labor Cost
                                  Total Cost
Letter of Intent
                                                                          0.333
                                                                          70.00
                                                                          70.00
                                                                           2.80
                                                                         65.268
                                                                     $5,254.76
                                                                         $0.00
                                                                     $5,254.76
Subtotal, Letter of Intent Total
                                                                          0.333
                                                                          70.00
                                                                          70.00
                                                                           2.80
                                                                         65.268
                                                                     $5,254.76
                                                                         $0.00
                                                                     $5,254.76
OR

Prepare Exemption Application
                                                                          2.000
                                                                          70.00
                                                                          70.00
                                                                           2.80
                                                                        392.000
                                                                    $31,556.00
                                                                         $0.00
                                                                    $31,556.00
Corporate Review
                                                                          6.000
                                                                          70.00
                                                                          70.00
                                                                           2.80
                                                                      1,176.000
                                                                   $111,179.04
                                                                         $0.00
                                                                   $111,179.04
Subtotal, Exemption Application Reporting
                                                                          8.000
                                                                          70.00
                                                                          70.00
                                                                           2.80
                                                                      1,568.000
                                                                   $142,735.04
                                                                         $0.00
                                                                   $142,735.04
Subtotal, Recordkeeping
                                                                          0.500
                                                                          70.00
                                                                          70.00
                                                                           2.80
                                                                         98.000
                                                                     $3,584.84
                                                                         $0.00
                                                                     $3,584.84
Subtotal, Exemption Application
                                                                          8.000
                                                                          70.00
                                                                          70.00
                                                                           2.80
                                                                      1,666.000
                                                                   $146,319.88
                                                                         $0.00
                                                                   $146,319.88
Overall Total, Initial Contact including Exemption Applications Reporting
                                                                          4.167
                                                                         140.00
                                                                         140.00
                                                                           2.80
                                                                      1,633.268
                                                                   $147,989.80
                                                                         $0.00
                                                                   $147,989.80
Overall Recordkeeping
                                                                          0.500
                                                                          70.00
                                                                          70.00
                                                                           2.80
                                                                         98.000
                                                                     $3,584.84
                                                                         $0.00
                                                                     $3,584.84
Overall Total, Initial Contact including Exemption Applications
                                                                          4.417
                                                                         140.00
                                                                         140.00
                                                                           2.80
                                                                      1,731.268
                                                                   $151,574.64
                                                                         $0.00
                                                                   $151,574.64
[1] Assumes one sponsor per chemical.

Based on the unit burden estimates presented in Table G-8, as well as the estimated number of responses in Table 1, the total respondent burden and costs for study plans under test orders are presented below in Table 7.
Table 7. Study Plan, Test Orders  -  Annual Total Respondent Burden and Costs (2020$)
                                   Activity
                         Adjusted Unit Burden (hours)
                     Number of Respondents (Sponsors) [1]
            Number of Responses (Chemicals Tested within an Action)
                                Overlap Factor
                             Total Burden (hours)
                               Total Labor Cost
                             Total Non-Labor Cost
                                  Total Cost
Study Plan
                                                                         12.987
                                                                          70.00
                                                                          70.00
                                                                           2.80
                                                                       2,545.45
                                                                   $204,908.20
                                                                         $0.00
                                                                   $204,908.20
CBI Substantiation
                                                                          1.215
                                                                          70.00
                                                                          70.00
                                                                           2.80
                                                                         238.14
                                                                    $20,256.60
                                                                         $0.00
                                                                    $20,256.60
Total, Reporting
                                                                         14.202
                                                                          70.00
                                                                          70.00
                                                                           2.80
                                                                       2,783.59
                                                                   $225,164.80
                                                                         $0.00
                                                                   $225,164.80
Total, Recordkeeping
                                                                          0.000
                                                                           0.00
                                                                           0.00
                                                                           2.80
                                                                           0.00
                                                                         $0.00
                                                                         $0.00
                                                                         $0.00
Total, Study Plan, Test Orders
                                                                         14.202
                                                                          70.00
                                                                          70.00
                                                                           2.80
                                                                       2,783.59
                                                                   $225,164.80
                                                                         $0.00
                                                                   $225,164.80
[1] Assumes one sponsor per chemical.

Based on the unit burden estimates presented in Table G-9, as well as the estimated number of responses in Table 1, the total respondent burden and costs for test results under test orders are presented below in Table 8.
Table 8. Test Results, Test Orders  -  Annual Total Respondent Burden and Costs (2020$)
                                   Activity
                         Adjusted Unit Burden (hours)
                      Number of Respondents (Sponsors)[1]
            Number of Responses (Chemicals Tested within an Action)
                                Overlap Factor
                             Total Burden (hours)
                               Total Labor Cost
                             Total Non-Labor Cost
                                  Total Cost
Study Final Report
                                                                         93.320
                                                                          70.00
                                                                          70.00
                                                                           2.80
                                                                      18,290.72
                                                                 $1,472,402.96
                                                                         $0.00
                                                                 $1,472,402.96
Study Corporate Review
                                                                         13.998
                                                                          70.00
                                                                          70.00
                                                                           2.80
                                                                       2,743.61
                                                                   $259,380.52
                                                                         $0.00
                                                                   $259,380.52
Laboratory Review
                                                                         13.998
                                                                          70.00
                                                                          70.00
                                                                           2.80
                                                                       2,743.61
                                                                   $220,860.64
                                                                         $0.00
                                                                   $220,860.64
Total, Reporting
                                                                        121.316
                                                                          70.00
                                                                          70.00
                                                                           2.80
                                                                      23,777.94
                                                                 $1,952,644.12
                                                                         $0.00
                                                                 $1,952,644.12
Total, Recordkeeping
                                                                          1.167
                                                                          70.00
                                                                          70.00
                                                                           2.80
                                                                         228.73
                                                                     $8,363.32
                                                                         $0.00
                                                                     $8,363.32
Total, Test Results, Test Orders
                                                                        122.483
                                                                          70.00
                                                                          70.00
                                                                           2.80
                                                                      24,006.67
                                                                 $1,961,007.44
                                                                         $0.00
                                                                 $1,961,007.44
[1] Assumes one sponsor per chemical.

Table 9. Review Guidance Documents and Pre-Issuance Outreach, Test Orders  -  Annual Total Respondent Burden and Costs (2020$)
                                   Activity
                         Adjusted Unit Burden (hours)
                     Number of Respondents (Sponsors) [1]
            Number of Responses (Chemicals Tested within an Action)
                                Overlap Factor
                             Total Burden (hours)
                               Total Labor Cost
                             Total Non-Labor Cost
                                  Total Cost
Review Guidance Documents
                                                                          0.483
                                                                          70.00
                                                                          70.00
                                                                           2.80
                                                                        94.6680
                                                                     $8,516.20
                                                                         $0.00
                                                                     $8,516.20
Pre-Issuance Outreach
                                                                          1.000
                                                                          70.00
                                                                          70.00
                                                                           2.80
                                                                       196.0000
                                                                    $16,695.28
                                                                         $0.00
                                                                    $16,695.28
Total, Review Documents and Pre-Issuance Outreach
                                                                          1.483
                                                                          70.00
                                                                          70.00
                                                                           2.80
                                                                       290.6680
                                                                    $25,211.48
                                                                         $0.00
                                                                    $25,211.48
[1] Assumes one sponsor per chemical.

Based on the unit burden estimates presented in Table G-10, as well as the estimated number of responses in Table 1, the total respondent burden and costs for voluntary initial contact under ECAs are presented below in Table 10.
Table 10. Voluntary Initial Contact, ECAs  -  Annual Total Respondent Burden and Costs (2020$)
                                   Activity
                         Adjusted Unit Burden (hours)
                      Number of Respondents (Sponsors)[1]
            Number of Responses (Chemicals Tested within an Action)
                                Overlap Factor
                             Total Burden (hours)
                               Total Labor Cost
                             Total Non-Labor Cost
                                  Total Cost
Request to Negotiate
                                                                          0.333
                                                                            3.5
                                                                            3.5
                                                                           2.80
                                                                          3.263
                                                                       $262.74
                                                                         $0.00
                                                                       $262.74
Total, Reporting
                                                                          0.333
                                                                            3.5
                                                                            3.5
                                                                           2.80
                                                                          3.263
                                                                       $262.74
                                                                         $0.00
                                                                       $262.74
Total, Recordkeeping
                                                                          0.000
                                                                           0.00
                                                                           0.00
                                                                           2.80
                                                                           0.00
                                                                         $0.00
                                                                         $0.00
                                                                         $0.00
Total, Voluntary Initial Contact, ECAs
                                                                          0.333
                                                                           3.50
                                                                           3.50
                                                                           2.80
                                                                          3.263
                                                                       $262.74
                                                                         $0.00
                                                                       $262.74
[1] Assumes one sponsor per chemical.

Based on the unit burden estimates presented in Table G-11, as well as the estimated number of responses in Table 1, the total respondent burden and costs for study plans under ECAs are presented below in Table 11.
Table 11. Study Plan, ECAs  -  Annual Total Respondent Burden and Costs (2020$)
                                   Activity
                         Adjusted Unit Burden (hours)
                      Number of Respondents (Sponsors)[1]
            Number of Responses (Chemicals Tested within an Action)
                                Overlap Factor
                             Total Burden (hours)
                               Total Labor Cost
                             Total Non-Labor Cost
                                  Total Cost
Study Plan
                                                                         12.987
                                                                           3.50
                                                                           3.50
                                                                           2.80
                                                                        127.273
                                                                    $10,245.41
                                                                         $0.00
                                                                    $10,245.41
CBI Substantiation
                                                                          1.215
                                                                           3.50
                                                                           3.50
                                                                           2.80
                                                                         11.907
                                                                     $1,012.83
                                                                         $0.00
                                                                     $1,012.83
Total, Reporting
                                                                         14.202
                                                                           3.50
                                                                           3.50
                                                                           2.80
                                                                        139.180
                                                                    $11,258.24
                                                                         $0.00
                                                                    $11,258.24
Total, Recordkeeping
                                                                          0.000
                                                                           0.00
                                                                           0.00
                                                                           2.80
                                                                          0.000
                                                                         $0.00
                                                                         $0.00
                                                                         $0.00
Total, Study Plan, ECAs
                                                                         14.202
                                                                           3.50
                                                                           3.50
                                                                           2.80
                                                                        139.180
                                                                    $11,258.24
                                                                         $0.00
                                                                    $11,258.24
[1] Assumes one sponsor per chemical.

Based on the unit burden estimates presented in Table G-12, as well as the estimated number of responses in Table 1, the total respondent burden and costs for test results under ECAs are presented below in Table 12.
Table 12. Test Results, ECAs  -  Annual Total Respondent Burden and Costs (2020$)
                                   Activity
                         Adjusted Unit Burden (hours)
                     Number of Respondents (Sponsors) [1]
            Number of Responses (Chemicals Tested within an Action)
                                Overlap Factor
                             Total Burden (hours)
                               Total Labor Cost
                             Total Non-Labor Cost
                                  Total Cost
Study Final Report
                                                                         93.320
                                                                           3.50
                                                                           3.50
                                                                           2.80
                                                                        914.536
                                                                    $73,620.15
                                                                         $0.00
                                                                    $73,620.15
Study Corporate Review
                                                                         13.998
                                                                           3.50
                                                                           3.50
                                                                           2.80
                                                                        137.180
                                                                    $12,969.03
                                                                         $0.00
                                                                    $12,969.03
Laboratory Review
                                                                         13.998
                                                                           3.50
                                                                           3.50
                                                                           2.80
                                                                        137.180
                                                                    $11,043.03
                                                                         $0.00
                                                                    $11,043.03
Total, Reporting
                                                                        121.316
                                                                           3.50
                                                                           3.50
                                                                           2.80
                                                                      1,188.896
                                                                    $97,632.21
                                                                         $0.00
                                                                    $97,632.21
Total, Recordkeeping
                                                                          1.167
                                                                           3.50
                                                                           3.50
                                                                           2.80
                                                                         11.437
                                                                       $418.17
                                                                         $0.00
                                                                       $418.17
Total, Test Results,  ECAs
                                                                        122.483
                                                                           3.50
                                                                           3.50
                                                                           2.80
                                                                      1,200.333
                                                                    $98,050.38
                                                                         $0.00
                                                                    $98,050.38
[1] Assumes one sponsor per chemical.

Based on the unit burden estimates presented in Table G-13, as well as the estimated number of responses in Table 1, the total respondent burden and costs for robust summaries are presented below in Table 13.
Table 13. Voluntary Robust Summaries for Test Rules, Test Orders, and ECAs  -  Annual Total Respondent Burden and Costs (2020$)
                                   Activity
                         Adjusted Unit Burden (hours)
                     Number of Respondents (Sponsors) [1]
            Number of Responses (Chemicals Tested within an Action)
                                Overlap Factor
                             Total Burden (hours)
                               Total Labor Cost
                             Total Non-Labor Cost
                                  Total Cost
Robust Summary
                                                                          0.400
                                                                          77.00
                                                                          77.00
                                                                           2.80
                                                                         86.240
                                                                     $6,935.85
                                                                         $0.00
                                                                     $6,935.85
Total, Reporting
                                                                          0.400
                                                                          77.00
                                                                          77.00
                                                                           2.80
                                                                         86.240
                                                                     $6,935.85
                                                                         $0.00
                                                                     $6,935.85
Total, Recordkeeping
                                                                          0.000
                                                                           0.00
                                                                           0.00
                                                                           2.80
                                                                          0.000
                                                                         $0.00
                                                                         $0.00
                                                                         $0.00
Total, Robust Summaries (Voluntary)
                                                                          0.400
                                                                          77.00
                                                                          77.00
                                                                           2.80
                                                                         86.240
                                                                     $6,935.85
                                                                         $0.00
                                                                     $6,935.85
[1] Assumes one sponsor per chemical.

Based on the unit burden estimates presented in Table G-14, as well as the assumption that there is one voluntary data submission for one chemical each year, the total respondent burden and costs for voluntary data submissions are presented below in Table 14.
Table 14. Voluntary Data Submissions - Annual Total Respondent Burden and Costs (2020$)
                                   Activity
                         Adjusted Unit Burden (hours)
                             Number of Respondents
            Number of Responses (Chemicals Tested within an Action)
                                Overlap Factor
                             Total Burden (hours)
                               Total Labor Cost
                             Total Non-Labor Cost
                                  Total Cost
Paper Submission of Final Reports
                                                                         10.000
                                                                          24.50
                                                                          24.50
                                                                           2.80
                                                                        686.000
                                                                    $25,093.88
                                                                     $1,002.93
                                                                    $26,096.81
Total, Reporting
                                                                         10.000
                                                                          24.50
                                                                          24.50
                                                                           2.80
                                                                        686.000
                                                                    $25,093.88
                                                                     $1,002.93
                                                                    $26,096.81
Total, Recordkeeping
                                                                          1.000
                                                                          24.50
                                                                          24.50
                                                                           2.80
                                                                         68.600
                                                                     $2,509.39
                                                                         $0.00
                                                                     $2,509.39
Total, Voluntary Data Submissions
                                                                         11.000
                                                                          24.50
                                                                          24.50
                                                                           2.80
                                                                        754.600
                                                                    $27,603.27
                                                                     $1,002.93
                                                                    $28,606.20
[1] Assumes one sponsor per chemical.

Based on the unit non-labor cost estimates presented in Table G-15, as well as the estimated number of responses in Table 1, the total respondent non-labor costs for testing costs are presented below in Table 15.
Table 15. Testing Costs (Non-Labor Costs)  -  Annual Total Respondent Burden and Costs (2020$)
                                   Activity
                         Adjusted Unit Burden (hours)
                     Number of Respondents (Sponsors) [1]
            Number of Responses (Chemicals Tested within an Action)
                                Overlap Factor
                             Total Burden (hours)
                               Total Labor Cost
                             Total Non-Labor Cost
                                  Total Cost
Laboratory Costs
                                                                          0.000
                                                                          77.00
                                                                          77.00
                                                                           2.80
                                                                         0.0000
                                                                         $0.00
                                                                 $4,357,293.25
                                                                 $4,357,293.25
Consortium Management
                                                                          0.000
                                                                          77.00
                                                                          77.00
                                                                           2.80
                                                                         0.0000
                                                                         $0.00
                                                                   $653,593.56
                                                                   $653,593.56
Technical Experts
                                                                          0.000
                                                                          77.00
                                                                          77.00
                                                                           2.80
                                                                         0.0000
                                                                         $0.00
                                                                   $435,729.76
                                                                   $435,729.76
Total, Testing Costs (Non-Labor Costs)
                                                                          0.000
                                                                          77.00
                                                                          77.00
                                                                           2.80
                                                                         0.0000
                                                                         $0.00
                                                                 $5,446,616.57
                                                                 $5,446,616.57
[1] Assumes one sponsor per chemical.

 13. Provide an estimate for the total annual cost burden to respondents or recordkeepers resulting from the collection of information.(Do not include the cost of any hour burden already reflected on the burden worksheet).
     a) 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.

     b) 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.
      c) 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.
Table 16 summarizes the estimated total reporting burden and cost according to ICs on an annual basis. Similarly, the total burden and cost according to actions are summarized in Table 17.
With respect to reporting burden and cost, EPA estimates that this ICR will impose a total of 32,435 burden hours annually with an annual average respondent burden for a TSCA Section 4 action estimated at about 137 hours for test rules or ECAs and about 139 hours for test orders (response is on a per-chemical, or submission basis). For CDX registrations, the average annual respondent burden is 0.53 hours per registration.
Section 4 generic ICR will be $90 million dollars. The $90 million dollars was estimated by assuming one batch of Test Orders each year of approximately $30 million dollars each (see Appendix D.)
Table 16. Summary of Annual Total Respondent Burden and Cost (2020$), By Type of Information Collection Activity
                          Information Collection (IC)
                         Adjusted Unit Burden (Hours)
                     Number of Respondents (Sponsors) [1]
            Number of Responses (Chemicals Tested within an Action)
                                Overlap Factor
                          Total Annual Burden (Hours)
                           Total Annual Labor Costs
                         Total Annual Non-Labor Costs
                              Total Annual Costs
CDX Registration
                                                                          0.530
                                                                          10.70
                                                                          10.70
                                                                            2.8
                                                                          15.88
                                                                     $1,278.39
                                                                         $0.00
                                                                     $1,278.39
                                  Test Rules
Initial Contact, Test Rules
                                                                          4.416
                                                                              7
                                                                              7
                                                                            2.8
                                                                          86.56
                                                                     $7,578.73
                                                                         $0.00
                                                                     $7,578.73
Study Plan, Test Rules
                                                                         14.202
                                                                            3.5
                                                                            3.5
                                                                            2.8
                                                                         139.18
                                                                    $11,258.24
                                                                         $0.00
                                                                    $11,258.24
Test Results, Test Rules
                                                                        122.483
                                                                            3.5
                                                                            3.5
                                                                            2.8
                                                                       1,200.33
                                                                    $98,050.38
                                                                         $0.00
                                                                    $98,050.38
                                  Test Orders
Initial Contact, Test Orders
                                                                          4.417
                                                                            140
                                                                            140
                                                                            2.8
                                                                       1,731.27
                                                                   $151,574.64
                                                                         $0.00
                                                                   $151,574.64
Study Plan, Test Orders
                                                                         14.202
                                                                             70
                                                                             70
                                                                            2.8
                                                                       2,783.59
                                                                   $225,164.80
                                                                         $0.00
                                                                   $225,164.80
Test Results, Test Orders
                                                                        122.483
                                                                             70
                                                                             70
                                                                            2.8
                                                                      24,006.67
                                                                 $1,961,007.44
                                                                         $0.00
                                                                 $1,961,007.44
Review Guidance Documents, Test Orders
                                                                          0.483
                                                                             70
                                                                             70
                                                                            2.8
                                                                          94.67
                                                                     $8,516.20
                                                                         $0.00
                                                                     $8,516.20
Pre-Issuance Outreach, Test Orders
                                                                          1.000
                                                                             70
                                                                             70
                                                                            2.8
                                                                         196.00
                                                                    $16,695.28
                                                                         $0.00
                                                                    $16,695.28
                     Enforceable Consent Agreements (ECAs)
Voluntary Initial Contact, ECAs
                                                                          0.333
                                                                            3.5
                                                                            3.5
                                                                            2.8
                                                                           3.26
                                                                       $262.74
                                                                         $0.00
                                                                       $262.74
Study Plan, ECAs
                                                                         14.202
                                                                            3.5
                                                                            3.5
                                                                            2.8
                                                                         139.18
                                                                    $11,258.24
                                                                         $0.00
                                                                    $11,258.24
Test Results, ECAs
                                                                        122.483
                                                                            3.5
                                                                            3.5
                                                                            2.8
                                                                       1,200.33
                                                                    $98,050.38
                                                                         $0.00
                                                                    $98,050.38
                               Voluntary - Other
Robust Summaries (Voluntary) for Test Rules, Test Orders, and ECAs
                                                                          0.400
                                                                           77.0
                                                                           77.0
                                                                            2.8
                                                                          86.24
                                                                     $6,935.85
                                                                         $0.00
                                                                     $6,935.85
Voluntary Data Submission
                                                                         11.000
                                                                           24.5
                                                                           24.5
                                                                            2.8
                                                                         754.60
                                                                    $27,603.27
                                                                     $1,002.93
                                                                    $28,606.20
                                    Testing
Laboratory Costs (Non-Labor Costs)
                                                                           0.00
                                                                             77
                                                                             77
                                                                            2.8
                                                                           0.00
                                                                         $0.00
                                                                 $5,446,616.57
                                                                 $5,446,616.57
Total

                                                                            175
                                                                          262.7
                                                                            2.8
                                                                         32,438
                                                                    $2,625,235
                                                                    $5,447,620
                                                                    $8,072,854
General Notes:
1. All ICs listed above include recordkeeping costs, where applicable.
2. Totals in Table 16 and Table 17 may not be equal due to rounding.

Footnotes:
[1] Assumes one sponsor per chemical

Table 17. Summary of Annual Total Burden and Costs (2020$), by Action

                   Adjusted Unit Burden per Response (Hours)
                             Number of Respondents
          Number of Responses (e.g., Chemicals Tested for an Action)
                                Overlap Factor
                          Total Annual Burden (Hours)
                           Total Annual Labor Costs
                         Total Annual Non-Labor Costs
                              Total Annual Costs
                            Section 4 Test Sponsors
Test Rules [1]
                                                                        137.418
                                                                            3.5
                                                                            3.5
                                                                            2.8
                                                                      1,346.70
                                                                   $109,886.62
                                                                         $0.00
                                                                   $109,886.62
Test Orders [2]
                                                                        138.887
                                                                           70.0
                                                                           70.0
                                                                            2.8
                                                                     27,221.85
                                                                 $2,222,690.96
                                                                         $0.00
                                                                 $2,222,690.96
Enforceable Consent Agreements (ECAs) 3
                                                                        137.418
                                                                            3.5
                                                                            3.5
                                                                            2.8
                                                                      1,346.70
                                                                   $109,886.62
                                                                         $0.00
                                                                   $109,886.62
Voluntary Data Submissions 4
                                                                         11.000
                                                                           24.5
                                                                           24.5
                                                                            2.8
                                                                        754.60
                                                                    $27,603.27
                                                                     $1,002.93
                                                                    $28,606.20
Testing Costs, Non-Labor (Test Rules, Test Orders, ECAs)

                                                                          77.00
                                                                           77.0
                                                                            2.8
                                                                           0.00
                                                                         $0.00
                                                                 $5,446,616.57
                                                                 $5,446,616.57
Subtotal, Testing

                                                                          101.5
                                                                          178.5
                                                                            2.8
                                                                      30,669.85
                                                                 $2,470,067.47
                                                                 $5,447,619.50
                                                                 $7,917,686.97
                        Section 4 Exemption Applicants
Subtotal, Exemption Applications
                                                                          8.500
                                                                           73.5
                                                                           73.5
                                                                            2.8
                                                                      1,749.30
                                                                   $153,635.87
                                                                         $0.00
                                                                   $153,635.87
                                CDX Registrants
Subtotal, CDX Registration and e-Signature
                                                                          0.530
                                                                           10.7
                                                                           10.7
                                                                            2.8
                                                                         15.88
                                                                     $1,278.39
                                                                         $0.00
                                                                     $1,278.39
Total 5

                                                                          175.0
                                                                          262.7
                                                                            2.8
                                                                        32,435
                                                                    $2,624,982
                                                                    $5,447,620
                                                                    $8,072,601
                                   Universe
                          Total Number of Respondents
Total Number of Responses (Test Rules, Test Orders, ECAs, Voluntary Data Submissions, Exemption Applications, CDX)
                    Total Number of Chemicals Newly Tested
                                     175.0
                                     262.7
                                     101.5
General Notes:

1. All items listed above include recordkeeping activities where applicable. Non-labor costs are not included.
2. Contributing sets of activities for each TSCA Section 4 Action are mapped as described in footnotes.
3. The totals in Table 16 and Table 17 may not be equal due to rounding.

Footnotes:

[1] Includes Initial Contact, Study Plan, Test Results, Voluntary Robust Summaries

[2] Includes Initial Contact, Study Plan, and Test Results,  Voluntary Robust Summaries

3 Includes Voluntary Initial Contact, Study Plan, and Test Results, Voluntary Robust Summaries

[4] Includes Voluntary Data Submission (final reports)

[5] Testing costs are incurred by the same respondents that are considered in test rules, test orders, and ECAs
[6] Note that the CDX Respondent count is not included in total respondent count because there are non-unique and already counted in other lines above.

 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.
Information submitted under TSCA section 4 test rules, test orders, consent agreements, or not pursuant to a particular section 4 testing action is received by OPPT, where it is reviewed for completeness and then routed to biologists, chemists, toxicologists, and wildlife scientists within OPPT to determine whether the subject chemicals are likely to present an unreasonable risk to human health or the environment. If the information indicates that potential hazards may exist, then this information  -  coupled with additional exposure and use information received under the Chemical Data Reporting rule (CDR) and other information sources  -  will be reviewed by EPA staff. Once reviewed, this information may support prioritization for evaluation efforts, risk evaluations and risk management actions. To date, EPA has collected information that has been used to support such activities as the development of water quality criteria, hazardous waste listings, chemical advisories, and reduction of workplace exposures.
For the TSCA section 4 Chemical Testing Program covered by this ICR, EPA may undertake the following activities:
       Review and process initial response (not including Exemption Applications).
       Review and process study plans;
       Review CBI claims and substantiations, when applicable;
       Review and process progress reports, when applicable;
       Review and process final reports for completeness, accuracy, adherence to testing protocols and methodologies, guidelines, and GLPs;
       Review and process exemption applications, and
       Review and process robust summaries.
       Conduct pre-issuance outreach.
EPA may also participate in other activities related to the TSCA Chemical Testing Program, e.g., other voluntary efforts to identify data needs and develop that information, international efforts related to chemical testing and associated testing issues, and other activities that may arise.
Unit Burden for Agency Activities
The estimated unit burden for processing initial response (one hour), study plans (four hours), progress reports (one hour), final reports (seven hours), robust summaries (one hour), exemption applications (three hours), voluntary data submissions (seven hours) is the same as from the previous ICRs and is believed to be reflective of current conditions. The table below shows the addition of pre-issuance outreach (0.5 hour). Agency total unit burden and costs per chemical undergoing testing annually are shown below in Table 18 (see Appendix X for wage rate information).
Table 18. Agency Unit Burden and Cost Estimates (2020$) - Per Document Handled by the Agency
                              Collection Activity
            Unit Burden and Cost per Document Handled by the Agency

                          Activity-Level Unit Burden
                           Activity-Level Unit Cost
Collection, Processing and Review
Initial Contact (not including Exemption Applications)
                                                                              1
                                                                        $96.75
Study Plans
                                                                              4
                                                                       $387.00
Progress Reports
                                                                              1
                                                                        $96.75
Final Reports
                                                                              7
                                                                       $677.25
Robust Summaries
                                                                              1
                                                                        $96.75
Exemption Applications
                                                                              3
                                                                       $290.25
Voluntary Data Submissions
                                                                              7
                                                                       $677.25
Pre-Issuance Outreach
                                                                            0.5
                                                                        $48.38
Subtotal; Collection, Processing and Review
                                                                            N/A
                                                                     $2,370.38
Review of Confidentiality Claims
Chemical Identity[1]
                                                                            1.5
                                                                       $164.48
Other[2]
                                                                            0.2
                                                                        $21.93
Subtotal; Confidentiality Claims
                                                                            N/A
                                                                       $186.41
Total
                                                                            N/A
                                                                     $2,556.79
[1] Obtained from previous ICR estimates (EPA, 2019a)
2 Drawn from the burden and cost report for the final TSCA Inventory Notification Requirements rule (EPA, 2017) with adjustments for number of applicable data elements

Total Agency Burden and Cost
Table 19 lists the number of responses received per chemical undergoing testing annually based on different categories of information collection activities, to provide context for the types and numbers of responses the Agency anticipates receiving due to TSCA Section 4 actions. The number of responses is based on universe information provided in Table 1.
Table 19. Annual Number of Responses Received by the Agency, by Type of Information Collection
                            Information Collection
                                    Action
                           Voluntary Data Submissions
         Total Number of Documents in Document Group Received Annually

                                  Test Rules
                                  Test Orders
                                     ECAs

Initial Contact (Letter of Intent)
                                                                           3.50
                                                                          70.00
                                                                           3.50

                                                                          25.64
Initial Contact (Exemption Application)
                                                                           3.50
                                                                          70.00
                                                                           0.00

                                                                          73.50
Study Plans (including Review of Confidentiality Claims)
                                                                           3.50
                                                                          70.00
                                                                           3.50

                                                                          25.64
Final Reports
                                                                           3.50
                                                                          70.00
                                                                           3.50
                                                                          24.50
                                                                         179.64
Voluntary Robust Summaries
                                                                           0.35
                                                                           7.00