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

Table of Contents
1.EXECUTIVE SUMMARY4
1(a).Identification of the Information Collection  -  Title and Numbers4
1(b).Docket Information4
1(c).ICR Status4
1(d).Abstract5
2.NECESSITY OF THE INFORMATION COLLECTION6
2(a).Related Legal and/or Administrative Requirements6
2(b).Necessity of the Information Collection9
2(c).Uses, Users, and Purpose of the Information Collection9
3.NON-DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA10
3(a).Non-Duplication10
3(b).Consultations and Public Comments10
3(c).Effects of Less Frequent Collection12
3(d).Small Entity Flexibility13
3(e).General PRA Related Guidelines13
3(f).Confidentiality14
3(g).Sensitive Questions14
4.AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT14
4(a).Agency Activities14
4(b).Estimating Agency Burden and Cost15
4(b)(i).Unit Burden for Agency Activities15
4(b)(ii).Total Agency Burden and Cost16
4(b)(iii).Collection Schedule17
4(b)(iv).Use of Technology to Facilitate Collection Activities18
5.THE RESPONDENTS AND INFORMATION COLLECTION ACTIVITIES18
5(a).Methodology for Estimating Respondent Burden and Costs19
5(a)(i).Respondent Activities19
5(b).Estimating the Respondent Burden and Costs21
5(b)(i).CDX Registration for e-Reporting24
5(b)(ii).Initial Response, Test Rules24
5(b)(iii).Study Plan, Test Rules25
5(b)(iv).Test Results, Test Rules26
5(b)(v).Initial Response, Test Orders26
5(b)(vi).Study Plan, Test Orders27
5(b)(vii).Test Results, Test Orders28
5(b)(viii).Voluntary Initial Contact, ECAs29
5(b)(ix).Study Plan, ECAs29
5(b)(x).Test Results, ECAs30
5(b)(xi).Voluntary Robust Summaries for Test Rules, Test Orders, and ECAs31
5(b)(xii).Voluntary Data Submissions31
5(b)(xiii).Testing Costs (Non-Labor Costs)32
5(c).Respondent Universe, Total, and Bottom Line Burden Hours and Costs33
5(c)(i).CDX Registration for e-Reporting  -  Total Respondent Burden and Costs35
5(c)(ii).Initial Response, Test Rules  -  Total Respondent Burden and Costs35
5(c)(iii).Study Plan, Test Rules  -  Total Respondent Burden and Costs36
5(c)(iv).Test Results, Test Rules  -  Total Respondent Burden and Costs37
5(c)(v).Initial Response, Test Orders  -  Total Respondent Burden and Costs37
5(c)(vi).Study Plan, Test Orders  -  Total Respondent Burden and Costs38
5(c)(vii).Test Results, Test Orders  -  Total Respondent Burden and Costs38
5(c)(viii).Voluntary Initial Contact, ECAs  -  Total Respondent Burden and Costs39
5(c)(ix).Study Plan, ECAs39
5(c)(x).Test Results, ECAs40
5(c)(xi).Voluntary Robust Summaries for Test Rules, Test Orders, and ECAs40
5(c)(xii).Voluntary Data Submissions41
5(c)(xiii).Testing Costs (Non-Labor Costs)  -  Total Respondent Burden and Costs41
6.ESTIMATING BURDEN AND COST OF THIS COLLECTION42
6(a).Total Estimated Respondent Annual Burden and Costs42
6(b).PRA Burden Statement45
6(c).Changes in the Estimates45
6(d).Reference Tables46
7.References and Attachments to the Supporting Statement50
Appendix A: Specific Legacy Assumptions Converted to Standardized Assumptions52
Appendix B: Overlap Model53
Appendix C: Derivation of Program Input Information56
Appendix D: ICs for TSCA Section 4 Actions Under a Generic ICR57
Appendix E: Additional Information on Methodology57
Appendix F: Specific Data Items Requested62



EXECUTIVE SUMMARY
Identification of the Information Collection  -  Title and Numbers
      Title: Generic Clearance for TSCA Section 4 Test Rules, Test Orders, Enforceable Consent Agreements (ECAs), Voluntary Data Submissions, and Exemptions from Testing Requirement
ICR Numbers: EPA ICR No.: 1139.12, OMB Control No.: 2070-0033
Docket ID No.: EPA-HQ-OPPT-2015-0436

Docket Information
The information collection request (ICR) that explains the information collection activities and related burden and cost estimates, as well as other supporting documents related to the ICR, are available in the docket established for this ICR. The Environmental Protection Agency (EPA) maintains an official record for all activities conducted under Toxic Substances Control Act (TSCA) section 4. The official record consists of the documents referenced in a specific activity, any public comments received during an applicable comment period, any information developed (including letters of intent to conduct testing, exemption letters, study plans, progress reports and the final study report) under an applicable section 4 action, and other information related to the activity, including information claimed as confidential business information (CBI). The official record includes the documents that are physically located in the docket, as well as documents that are referenced in those documents. 
The Agency has established a public docket for this ICR under Docket ID No. EPA-HQ-OPPT-2015-0436, which is available for online viewing at www.regulations.gov, or in person viewing at the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution Ave., NW, Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is (202) 566-1744, and the telephone number for the Pollution Prevention and Toxics Docket is (202) 566-0280. You may submit comments regarding the Agency's need for this information, the accuracy of the provided burden estimates and any suggested methods for minimizing respondent burden, including the use of automated collection techniques.
ICR Status
Under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information, unless it displays a currently valid control number issued by the Office of Management and Budget (OMB). The OMB control numbers are displayed either by publication in the Federal Register or by other appropriate means, such as on the related collection instrument or form, if applicable. The display of OMB control numbers for certain EPA regulations is consolidated in 40 CFR part 9.
Before submitting an ICR to OMB for review and approval under the PRA, an agency must solicit comments pursuant to PRA §3506(c)(2)(A) and 5 CFR 1320.8(d)(1). After considering comments received on the draft ICR, the agency must submit the ICR to OMB for review and approval according to the procedures prescribed in 5 CFR 1320.12. In announcing the submission of the final ICR to OMB for review and approval, the agency must provide another opportunity for public review and comments on the revised ICR pursuant to 5 CFR 1320.12(c).
This is a revision to an existing ICR for EPA ICR No. 1139.11; OMB Control No. 2070-0033; entitled "TSCA Section 4 Test Rules, Consent Orders, Enforceable Consent Agreements, Voluntary Testing Agreements, Voluntary Data Submissions, and Exemptions from Testing Requirements (Reinstatement)"; approved through October 31, 2021. 
Abstract
This generic ICR covers the information collection activities associated with the submission of information to EPA, developed 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.
Legal authority: Under TSCA section 4, EPA has the authority to promulgate rules, issue orders, and enter into consent agreements requiring manufacturers and processors to develop information on chemical substances and mixtures. More details are provided in Unit 2(a) of this Supporting Statement. 
Respondents/affected entities: Entities potentially affected by the ICR include chemical manufacturers (hereinafter including importers) and processors. 
Respondents' obligation to respond: Responses are mandatory under TSCA.
Confidentiality of responses: Respondents may claim all or part of a document 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 and 40 CFR part 2, 40 CFR 790, and any other specific requirements as described in individual test rules, orders, or consent agreements. TSCA section 14 also requires an entity claiming information as confidential to substantiate and certify those claims unless the information is otherwise exempt from those requirements. 
Estimated total number of potential respondents: 175.
Frequency of response: On occasion. See Appendix B for discussion of reporting frequency considerations for modeling respondent burden.
Estimated total annual burden: 32,147 hours. Burden is defined at 5 CFR 1320.3(b).
Estimated total annual costs: $7,650,663, includes no annualized capital investment or maintenance and operational costs.
Changes in the estimates: There is an overall increase of 29,020 hours in the total respondent burden that is currently approved by OMB for this ICR. This increase reflects changes in the number of actions, CBI substantiation requirements, and methodological updates. However, there is a reduction in annual cost estimates due to a change in the assumed battery of tests that may be required for this three-year period under potential testing actions. The assumption is based on statutory changes under the Lautenberg Act, such as the mandated tiered testing approach. Further details about these changes are included in this ICR supporting statement. 
NECESSITY OF THE INFORMATION COLLECTION
Related Legal and/or Administrative Requirements
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."
TSCA section 4(a)(1) mandates that EPA require manufacturers and processors of chemical substances and mixtures to conduct testing if it finds that:
      "(A)(i) (I) the manufacture, distribution in commerce, processing, use, or disposal of a chemical substance or mixture, or that any combination of such activities, may present an unreasonable risk of injury to health or the environment,
            (II) there is insufficient information and experience upon which the effects of such 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 
            
            (III) testing of such substance or mixture with respect to such effects is necessary to develop such information; or
            
             (ii)(I) a chemical substance or mixture is or will be produced in substantial quantities, and (aa) it enters or may reasonably be anticipated to enter the environment in substantial quantities or (bb) there is or may be significant or substantial human exposure to such substance or mixture,
            
            (II) 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 any combination of such activities on health or the environment can reasonably be determined or predicted, and
            
            (III) testing of such substance or mixture with respect to such effects is necessary to develop such information; and 
      
      (B) in the case of a mixture, the effects which the mixture's manufacture, distribution in commerce, processing, use, or disposal or any combination of such activities may have on health or the environment may not be reasonably and more efficiently determined or predicted by testing the chemical substances which comprise the mixture[.]"
      
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. This approach is explained in more detail in EPA's statement of policy for making findings under TSCA section 4(a)(1)(B) in the Federal Register of May 14, 1993 (58 FR 28736, 28738-39; FRL-4059-9). Note that the TSCA sections that were previously enumerated as 4(a)(1)(A) and (B) are now enumerated as 4(a)(1)(A)(i) and 4(a)(1)(A)(ii), respectively.
The specific requirements and procedures governing testing consent agreements, test rules, and exemptions from test rules are found in 40 CFR part 790. The requirements regarding Good Laboratory Practice standards (GLPs) are found in 40 CFR part 792, the various test guidelines that are incorporated into the individual test rules are in 40 CFR parts 795 through 798, and Subparts E and H of 40 CFR part 799, and the chemical specific testing requirements are in Subparts B, C, and D of 40 CFR part 799. Certain regulations are currently undergoing revisions to more closely conform with the language and authorities under the Lautenberg Act, including TSCA section 4(c) reimbursement process regulations at 40 CFR part 791 and EPA's GLP regulations relevant to TSCA section 4 information development, at 40 CFR part 792.
Testing pursuant to TSCA section 4 also requires the use of prescribed protocols and methodologies. The term "protocols and methodologies" is defined under TSCA section 3 as "a prescription of the health and environmental effects, and information relating to toxicity, persistence, and other characteristics which affect health and the environment, for which information for a chemical substance or mixture are to be developed and any analysis that is to be performed on such information, and to the extent necessary to assure that respecting such effect and characteristics are reliable and adequate  -  the manner in which such information [is] to be developed, the specification of any test protocol or methodology to be employed in the development of such information, and such other requirements as are necessary to provide such assurance." TSCA section 4 allows for the prescription of protocols and methodologies for the development of information on health and environmental effects including carcinogenesis, mutagenesis, teratogenesis, behavioral disorders, cumulative or synergistic effects, and any other effect which may present an unreasonable risk of injury to health or the environment. TSCA also allows for the prescription of protocols and methodologies for the assessment of exposure potential to humans and the environment. TSCA allows for protocols and methodologies to be prescribed for chemical characteristics including persistence, acute toxicity, subacute toxicity, chronic toxicity, and any other characteristic which may present such a risk. The methodologies that may be prescribed include serial or tiered testing, in vitro tests, whole animal tests, and epidemiologic studies, with the stipulation that EPA consult with the National Institute for Occupational Safety and Health prior to prescribing epidemiologic studies of employees.
Necessity of the Information Collection
The information collection activities covered by this ICR and imposed on the respondents as part of the TSCA section 4 testing program 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. 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.
Uses, Users, and Purpose of the Information Collection
EPA's Office of Pollution Prevention and Toxics (OPPT), other EPA Offices and/or other Federal agencies will generally be the primary groups for which information will be collected. However, to the extent that reported information is not considered to be CBI, environmental groups, environmental justice advocates, industry, state and local government entities and other members of the public may have access to this information for their own use.
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 uses the information collected to prioritize chemicals for risk evaluation, evaluate risks associated with the manufacture, processing, distribution, use or disposal of a chemical, and may support further regulatory designation or action as needed with respect to that chemical pursuant to TSCA section 6 requirements. 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). TSCA established the ITC as an independent advisory committee to identify chemicals regulated by TSCA for which there are suspicions of toxicity or exposure and for which there is little, if any, ecological effects, environmental fate or health effects testing information. 
NON-DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA
Non-Duplication
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.

Consultations and Public Comments
Under 5 CFR 1320.8(d)(1) OMB requires agencies to consult with potential ICR respondents and data users about specific aspects of ICRs before submitting an original or renewal ICR to OMB for review and approval. In accordance with this regulation, EPA submitted questions to nine parties via e-mail. The individuals contacted were:
Mike Walls, Vice President
Regulatory and Technical Affairs
American Chemistry Council Inc.
700 2nd Street N.E.
Washington, D.C. 20002
E-mail: mike_walls@americanchemistry.com 

Matthew Moedritzer, Manager
Legal and Governmental Relations 
Society of Chemical Manufacturers and Affiliates (SOCMA)
1400 Crystal Drive, Suite 630
Arlington, VA 22202
E-mail: moedritzerm@socma.com

Steve Bennet, Vice President
Scientific Affairs 
Household and Commercial Products Association  
1667 K Street N.W., Suite 300
Washington, D.C. 20006
E-mail: Steve.bennett@thehcpa.org 

Derek Swick, Senior Policy Advisor
Regulatory and Scientific Affairs
American Petroleum Institute
1220 L Street N.W.
Washington, D.C. 20005-4070
E-mail: swickd@api.org

Melissa Scanlan
Co-Founder and Director, New Economy Law Center
Professor of Law
Environmental Law Center, Vermont Law School
164 Chelsea St, PO Box 96
South Royalton, VT 05068
E-mail: MSCANLAN@vermontlaw.edu  

Marie Gargas, Senior Technical Director
Regulatory Affairs
Plastics Industry Association  
1425 K Street NW., Suite 500 
Washington, DC 20005
E-mail: mgargas@plasticsindustry.org

Sharyn Stein
Environmental Defense Fund
Media contact
1875 Connecticut Ave, NW
Washington, DC 20009
E-mail: sstein@edf.org 

Ken Cook
President and Co-Founder
Environmental Working Group
500 Washington, St. 
San Francisco, CA 94111
E-mail: ken@ewg.org 

David Goldston
Director, Government Affairs 
Natural Resources Defense Council
1152 15th Street, NW
Washington, DC 20005
E-mail: michihara@nrdc.org

EPA did not receive any direct responses to its solicitation for consultations. SOCMA, EDF, and ACC, however, did submit comments to the docket during the public comment period. A copy of EPA's consultation e-mail to the above potential respondents is included in Attachment 4. 
In proposing to revise this ICR, EPA provided a 60-day public notice and comment period that ended on July 31, 2020 (85 FR 33151, June 1, 2020). During the comment period, EPA received comments from the Center for Specialty Chemical Science, LLC (CSCS), a subsidiary of the Society of Chemical Manufacturers & Affiliates (SOCMA); the Environmental Defense Fund (EDF); and the American Chemistry Council. A copy of the comments and of EPA's response to the comments are included as Attachments 5, 6, 7, and 8, respectively.
Effects of Less Frequent Collection
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. 
Small Entity Flexibility
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.
General PRA Related Guidelines
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.
Confidentiality
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. 
Sensitive Questions
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.
AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT
Agency Activities
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.

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.
Estimating Agency Burden and Cost
      The cost and burden to the Agency to process, review, and analyze the information collected under TSCA section 4 test rules, test orders, ECAs, and voluntary data submissions are discussed below. 
Unit Burden for Agency Activities
      The estimated unit burden for processing initial response (one hour) study plans (four hours), progress reports (one hour) is the same as from the previous ICRs and is believed to be reflective of current conditions. The estimated unit burden for final reports, including those from testing/studies, and from voluntary submissions is estimated at seven hours, as revised to reflect current conditions. The estimated unit burden for the Agency to process and review each exemption application is estimated at three hours, as revised to reflect current conditions. Table 1 derives Agency total unit burden and costs per chemical undergoing testing annually (see Table 38 for wage rate information).
      
Table 1. Agency Unit Burden and Cost Estimates (2018$) - 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 Response (not including Exemption Applications)
1
  $74.34 
Study Plans
4
  $297.36 
Final Reports
7
  $520.38 
Robust Summaries
1
  $74.34 
Exemption Applications
3
  $223.02 
Voluntary Data Submissions
7
  $520.38 
Subtotal; Collection, Processing and Review
N/A
  $1,709.82 
Review of Confidentiality Claims 
   Chemical Identity1
1.5
  $126.39 
   Other2
0.2
  $16.85 
Subtotal; Confidentiality Claims
N/A
  $143.24 
Total
N/A
$1,853.06
Footnotes:
1 Obtained from proposed rule for chemID CBI claims for active chemicals on the TSCA Inventory (EPA, 2019a)
2 Drawn from the burden and cost report for the final TSCA Inventory Notification Requirements rule (EPA, 2017a) with adjustments for number of applicable data elements

Total Agency Burden and Cost
      Table 2 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 19.

Table 2. 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 Response (Letter of Intent)
3.50
70.00
3.50
 
25.64
Initial Response (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
0.35
 
2.56
Total Number of Responses Received
17.85
357.00
14.35
24.50
312.20
      
Based on the unit burden for Agency activities as presented in Table 1, as well as the estimated number of responses in Table 2, the total annual Agency burden and cost estimates are presented in Table 3. 
Table 3. Annual Agency Burden and Cost Estimates (2018$)
Collection Activity
Unit Burden (hours)
Total Number of Documents Handled Annually
Overlap Factor
Total Burden (hours)
Average Wage Rate
Unit Cost
Total Costs
Collection, Processing and Review
Initial Repsonse (not including Exemption Applications)
1
  25.64
  2.80
  72
  $74.34 
  $74.34 
  $5,352 
Study Plans
4
  25.64
  2.80
  287
  $74.34 
  $297.36 
  $21,336 
Final Reports
7
  179.64
  2.80
  3,521
  $74.34 
  $520.38 
  $261,751 
Robust Summaries
1
  2.56
  2.80
  7
  $74.34 
  $74.34 
  $520 
Exemption Applications
3
  73.50
  2.80
  617
  $74.34 
  $223.02 
  $45,868 
Voluntary Data Submissions
7
  24.50
  2.80
  480
  $74.34 
  $520.38 
  $35,683 
Subtotal; Collection, Processing and Review
  331.49
  2.80
  4,984
  $74.34 
  N/A
  $370,511 
Review of Confidentiality Claims 
   Chemical Identity1
1.5
  25.64
  2.80
  108
  $84.26 
  $126.39 
  $9,100 
   Other2
0.200
  25.64
  2.80
  14
  $84.26 
  $16.85 
  $1,180 
Subtotal; Confidentiality Claims
  51.28
  2.80
  122
  $84.26 
N/A
  $10,280 
Total, Agency
  382.77
  2.80
  5,106
N/A
N/A
  $380,791 
1 Obtained from previous ICR estimates (EPA, 2018a).
2 Drawn from the burden and cost report for the final TSCA Inventory Notification Requirements rule (EPA, 2017a) with adjustments for number of applicable data elements.

Collection Schedule
This information collection activity does not have a calendar-based schedule. The testing period is defined by the individual test rule, test order, or ECA. The time required to conduct the test, based on testing guidelines, is in accord with the timeline established in the approved test plan, or timing otherwise established by the Agency. Required testing is conducted only once, and each related activity occurs on a one-time basis. For the reasons described above, the collection is considered an "on occasion" collection. Also note that in this ICR revision, the definition of a response (i.e., submission) is changed to include all testing activities associated with a chemical. As in previous ICRs, the typical time period for testing may vary from less than a year to three years, although it can be longer and varies according to the chemical and the testing required. 
For each chemical identified for testing within EPA's TSCA Chemical Testing Program, the specific information requested, the testing necessary to generate that information, along with the test protocols, the time frame for completing the testing, and the date by which the requested information is to be submitted to the Agency, are established in the TSCA section 4 test rule, test order, or ECA. 
Test information submitted to the Agency under the TSCA Chemical Testing Program is reviewed by scientists to determine whether the information developed is adequate for the purposes for which it was gathered. In addition to being housed in an appropriate EPA TSCA docket, non-confidential version of this information deemed adequate by the Agency will also be made publicly available in the TSCA online database, ChemView (https://chemview.epa.gov/chemview). The information can be used in conjunction with published material and is a valuable source along with or in the absence of published data. The information is used by federal and state agencies, researchers, toxicologists, risk assessors, the regulated industry, attorneys, trade and professional associations, and non-governmental organizations, as well as the public at large.
Use of Technology to Facilitate Collection Activities
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), 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 the new requirement of electronic submission. Any information collection activities pursuant to new test rules, test orders, or consent agreements will be made electronically.
THE RESPONDENTS AND INFORMATION COLLECTION ACTIVITIES
This introductory section provides an overview of methodology considerations and developments for the burden and cost estimates used for this generic ICR revision. Additional information is available in Appendix E.
The burden and cost estimates cover TSCA section 4 actions, including test rules, test orders, and ECAs, as well as exemption applications pertaining to test rules and test orders. Additionally, the burden and cost estimates include voluntary data submissions. The burden levels in this ICR revision are expected to increase compared to the previous ICR due to implementation of certain provisions of the Lautenberg Act. The Lautenberg Act amended TSCA, the nation's primary chemicals management law. The Lautenberg Act includes improvements such as: (1) Mandatory requirement for EPA to evaluate existing chemicals with clear and enforceable deadlines; (2) Risk-based chemical assessments; (3) Increased public transparency for chemical information; and (4) Consistent source of funding for EPA to carry out the responsibilities under the new law (EPA, 2019b). Specific to TSCA section 4, EPA can initiate testing via test orders in addition to test rules and ECAs.    
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. 
Methodology for Estimating Respondent Burden and Costs
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.

  Respondent Activities
       Electronic Submission Activities
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.
       Document Preparation Activities
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. 

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. An exemption applicant may request an exemption from information development requirements if another entity has agreed to conduct the information development or the applicant believes that equivalence data are otherwise available in lieu of developing the required information under the rule or order. Equivalence data is defined at 40 CFR 790.3 as chemical data or biological test data intended to show that two substances or mixtures are equivalent and equivalent is defined there to mean a chemical substance or mixture is able to represent or substitute for another in a test or series of tests, and that the data from one substance can be used to make scientific and regulatory decisions concerning the other substance. Equivalence data are often CBI and only the manufacturer or processor of the chemical has this information. 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. In most cases, the manufacturer is required to give only its identity, address, a technical contact and a list of the tests for which an exemption is being requested. When equivalence data are needed because more than one representative substance is being tested, the Agency will limit the information required by giving minimum chemical specific requirements in the individual test rules. This approach was devised in response to comments by industry that applying the broad equivalence data requirements to all exemptions candidates would, in some cases, result in submission of unnecessary information. The exemption process for test orders is expected to be similar to that for test rules.
Exemption applications are not necessary for chemicals being tested under an ECA because of the inherent nature of the related agreement process itself. For the same reason, an exemption application would not be submitted by someone who is voluntarily submitting information, because an exemption is never necessary when there is no requirement.
Estimating the Respondent Burden and Costs
This section presents the relevant unit burdens of the information collection activities to respondents in terms of the time required by companies to perform the activities as outlined in the introductory section of this document. Unless otherwise stated, assumptions presented in section 5 use information from the previous ICR (EPA, 2018a). As an initial step to organize information according to the submission's response unit of per chemical, activities are bundled according to the chemical being tested. In this presentation EPA explains, from the respondents' point of view, all the activities associated with a TSCA section 4 submission (generically) for test rules, test orders, and ECAs. Thereafter, estimates are derived and presented according to those types of activities. 
From the average respondent's perspective, any given TSCA section 4 action may require a variety of activities, depending on the specifics of the action with regard to the chemical to be tested, tests required, and timing of the tests. The collection of these activities per chemical constitutes the definition of a submission for purposes of analysis in this document. Table 4 presents a generic version of the collection of activities per chemical tested. For the seven tests under each action, some activities occur in the initial year, and some are spread out throughout the three-year period. Table 5 presents the annual burden and cost for a single chemical tested in a generic standardized TSCA section 4 action. Note that the result of Table 5 is used in reporting average respondent burden. In the following sections, unit burdens by collection activity type are presented in Section 5(b), with associated universe information and total burdens presented in Section 5(c). For a comprehensive list of activity-level burdens with applicable labor categories used to construct Table 4 and the tables in Section 5(b), see Table 36 in Section 6.

Table 4. TSCA Section 4 Actions  -  Activities per Chemical Undergoing Testing Over Three Years and Annually
Activity2
TSCA Section 4 Action1

Total Counts Three Year Period
Year 1
Year 2
Year 3
 Average Per Year4
Initial ResponseLetter of Intent
OR
Voluntary Request to Negotiate a Consent Agreement for ECAs
1
1


0.333
Interim Reports




 
  Study Plans
1
1


  0.333
  CBI Substantiation
1
1


  0.333
Final Reports




 
  Studies
7
2
2
3
  2.333
  Laboratory Review
7
2
2
3
  2.333
  Recordkeeping
7
2
2
3
  2.333
(Voluntary) Robust Summaries
1


1
  0.333
General Note:
This information is presented as an overview and for use in Section 5. Note that the activities listed above include a mix of required and voluntary activities. Certain activities are not included in this table because they are not relevant to the core bundle of activities associated with a testing submission. Excluded activities are associated with: CDX, Exemption Applications, Voluntary Submissions, and Testing Costs (Non-Labor Costs).
Footnotes:
1 Additional detail is provided in Table 36 in Section 6, which lists detailed activities and applicable labor categories (i.e., managerial, technical, clerical).
2 Note that a response is defined as the collection of related activities involving a battery of seven tests all of which pertain to a chemical undergoing testing. 
4 Averages per year are rounded as shown for use in calculations in subsequent burden tables.


Table 5. Generic TSCA Section 4 Action Annual Comprehensive Unit Burden and Unit Cost (2018$) for Test Rules, Test Orders, and ECAs
 
Frequency of Occurrence (Average Per Year)
Unit Burden per Chemical (hours)
Unit Cost per Chemical
Initial Response
Letter of Intent
  0.333
  0.333
  $25.41 
OR



Voluntary Request to Negotiate a Consent Agreement for ECAs



Interim Reports
Study Plans
  0.333
  12.987
$991.17 
CBI Substantiation1
  0.333
  1.215
$94.22 
Final Reports
Studies, including Corporate Review
  2.333
  107.318
$8,243.28 
Laboratory Review
  2.333
  13.998
$1,068.33 
Voluntary Robust Summaries
  0.033
  0.400
$30.50 
Total, Reporting
   
  136.251
$10,452.91 
Total, Recordkeeping (Final Reports)
  2.333
  1.167
$57.49 
TOTAL, Test Rules, Test Orders, ECAs
 
  137.418
$10,493.15 
Notes:1. This information is presented as an overview and for use in Section 5. Note that the activities listed above include a mix of required and voluntary activities. Certain activities are not included in this table because they are not relevant to the core bundle of activities associated with testing. Excluded activities are associated with: CDX, Exemption Applications, Voluntary Submissions, and Testing Costs (Non-Labor Costs).2. Table 36 lists detailed associated activities and applicable labor categories (i.e., managerial, technical, clerical); Table 37 provides wage rates. Costs listed in this table are all labor costs.Footnotes:1 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 and the list of substantiation questions.




CDX Registration for e-Reporting
Respondents incur burden and costs in activities associated with e-reporting. Activities that are needed to facilitate electronic submission include CDX registration and CDX electronic signature; the unit burden for each of these activities is 0.180 hours and 0.350 hours of technical burden, respectively, as shown in Table 6.   
Table 6. CDX Registration Annual Unit Burden and Cost (2018$)
Activity
Unit Burden
Unit Cost

Managerial Burden (hours)
Technical Burden (hours)
Clerical Burden (hours)
Unit Burden (hours)
Labor Unit Cost 1
Non-Labor Costs
Unit Cost
CDX Registration
0.000
0.180
0.000
0.180
$13.74 
$0.00 
$13.74 
CDX Electronic Signature
0.000
0.350
0.000
0.350
$26.71 
$0.00 
$26.71 
Total, Reporting
0.000
0.530
0.000
0.530
$40.45 
$0.00 
$40.45 
Total, Recordkeeping
0.000
0.000
0.000
0.000
$0.00 
$0.00 
$0.00 
Total, CDX Registration and e-Reporting and Recordkeeping
0.000
0.530
0.000
0.530
$40.45 
$0.00 
$40.45 
Footnotes:
1 Unit costs are estimated by multiplying the clerical, technical, and managerial burdens by the corresponding wage rates in Table 37.


Initial Response, Test Rules 
The letter of intent is an initial response made by respondents after EPA promulgates a test rule and it formally acknowledges that the respondent intends to sponsor required testing under the rule. An entity subject to a test rule may apply for an exemption from one or all of the testing requirements imposed in a test rule if that testing will be, or has been, performed by another entity subject to the rule. 
It is difficult to predict how many exemption applications might be submitted to EPA in any one year. EPA changes this assumption to a per-chemical basis at three per chemical undergoing testing, or one annually. The new assumption is incorporated for ease of future maintenance as the number of exemptions is expected to vary according to the number of chemicals tested in actions (see also Table 4). EPA also assumes that each application would request exemption from all tests. 

Table 7. Initial Response, Test Rules - Annual Per Chemical Unit Burden and Cost (2018$)
Activity
Unit Burden
 

Managerial Burden (hours)
Technical Burden (hours)
Clerical Burden (hours)
Unit Burden (hours)
Frequency of Occurrence (Average Per Year)
Adjusted Unit Burden (hours)
Labor Unit Cost 1
Non-Labor Cost
Unit Cost
Letter of Intent
0.000
1.000
0.000
1.000
0.333
0.333
$25.41 
$0.00 
$25.41 
Total, Reporting
0.000
1.000
0.000
1.000
0.333
0.333
$25.41 
$0.00 
$25.41 
Total, Recordkeeping
0.000
0.000
0.000
0.000
0.000
0.000
$0.00 
$0.00 
$0.00 
Total, Letter of Intent, Test Rules
0.000
1.000
0.000
1.000
0.333
0.333
$25.41 
$0.00 
$25.41 
OR
 
Prepare Exemption Application
0.000
2.000
0.000
2.000
1.000
2.000
$152.64 
$0.00 
$152.64 
Corporate Review
6.000
0.000
0.000
6.000
1.000
6.000
$480.54 
$0.00 
$480.54 
Total, Reporting
6.000
2.000
0.000
8.000
1.000
8.000
$633.18 
$0.00 
$633.18 
Total, Recordkeeping
0.000
0.000
0.500
0.000
1.000
0.500
$17.25 
$0.00 
$17.25 
Total, Exemption Application, Test Rules 
6.000
2.000
0.500
8.500
1.000
8.500
$650.43 
$0.00 
$650.43 
Footnotes:
1 Unit costs are estimated by multiplying the clerical, technical, and managerial burdens by the corresponding wage rates in Table 37.

Study Plan, Test Rules
After the initial response has occurred, test sponsor respondents must provide a study plan to EPA. The study plan includes documents detailing the different types of tests, protocols to be followed, health effects, and endpoints to be covered in each chemical report. One study plan for each chemical is required at the beginning of the testing period. 
CBI substantiation to support confidentiality claims for relevant data elements for the overall submission throughout the testing period (see list of transactions in Table 4) must be provided in conjunction with the study plan transmittal. The CBI substantiations address chemical identity (chemID) and other data elements. 

Table 8. Study Plan, Test Rules  -  Annual Per Chemical Unit Burden and Cost (2018$)
Activity
Unit Burden
 

Managerial Burden (hours)
Technical Burden (hours)
Clerical Burden (hours)
Unit Burden (hours)
Frequency of Occurrence (Average Per Year)
Adjusted Unit Burden (hours)
Labor Unit Cost1
Non-Labor Cost
Unit Cost
Study Plan
0.000
39.000
0.000
39.000
0.333
12.987
$991.17 
$0.00 
$991.17 
CBI Substantiation2
1.184
2.465
0.000
3.649
0.333
1.215
$94.22 
$0.00 
$94.22 
Total, Reporting
1.184
41.465
0.000
42.649
0.333
14.202
$1,085.39 
$0.00 
$1,085.39 
Total, Recordkeeping
0.000
0.000
0.000
0.000
0.000
0.000
$0.00 
$0.00 
$0.00 
Total, Study Plan, Test Rules
1.184
41.465
0.000
42.649
0.333
14.202
$1,085.39 
$0.00 
$1,085.39 
Footnotes:1 Unit costs are estimated by multiplying the clerical, technical, and managerial burdens by the corresponding wage rates in Table 37.2 Drawn from the burden and cost report for the final TSCA Inventory Notification Requirements rule (EPA, 2017a) with adjustments for number of applicable data elements and the list of substantiation questions. For CBI substantiation questions see What to Include in CBI Substantiations - Sample substantiation templates (EPA, 2017b).
     
Test Results, Test Rules
At the conclusion of each test, respondents are required to provide a final report, which must also undergo both corporate and laboratory review. Recordkeeping is also required for all final report transmittals. 
Table 9. Test Results, Test Rules  -  Annual Per Chemical Unit Burden and Cost (2018$)
Activity
Unit Burden
 

Managerial Burden (hours)
Technical Burden (hours)
Clerical Burden (hours)
Unit Burden (hours)
Frequency of Occurrence (Average Per Year)
Adjusted Unit Burden (hours)
Labor Unit Cost1
Non-Labor Cost
Unit Cost
Study Final Report
0.000
40.000
0.000
40.000
2.333
93.320
$7,122.18 
$0.00 
$7,122.18 
Study Corporate Review
6.000
0.000
0.000
6.000
2.333
13.998
$1,121.10 
$0.00 
$1,121.10 
Laboratory Review
0.000
6.000
0.000
6.000
2.333
19.998
$1,068.33 
$0.00 
$1,068.33 
Total, Reporting
6.000
46.000
0.000
52.000
 
121.316
$9,311.61 
$0.00 
$9,311.61 
Total, Recordkeeping
0.000
0.000
0.500
0.500
2.333
1.167
$40.24 
$0.00 
$40.24 
Total, Test Results, Test Rules
6.000
46.000
0.500
52.500
 
122.483
$9,351.85 
$0.00 
$9,351.85 
Footnotes:
1 Unit costs are estimated by multiplying the clerical, technical, and managerial burdens by the corresponding wage rates in Table 37.

Initial Response, Test Orders
As with test rules, the letter of intent is an initial response made by respondents in response to test orders and it formally acknowledges that the respondent intends to sponsor required testing under the order. An entity subject to a test order may apply for an exemption from one or all of the testing requirements imposed in a test order if that testing will be, or has been, performed by another entity subject to the order. 
In either case, it is difficult to predict how many exemption applications might be submitted to EPA in any one year. EPA changes this assumption to a per-chemical basis at three per chemical undergoing testing, or one annually. The new assumption is incorporated in order to ease the consolidation of activities involved with an initial response (see Table 19). EPA also assumes that each application would request the exemption from all of the testing.
Table 10. Initial Response, Test Orders - Annual Per Chemical Unit Burden and Cost (2018$)
Activity
Unit Burden
 

Managerial Burden (hours)
Technical Burden (hours)
Clerical Burden (hours)
Unit Burden (hours)
Frequency of Occurrence (Average Per Year)
Adjusted Unit Burden (hours)
Labor Unit Cost1
Non-Labor Cost
Unit Cost
Letter of Intent
0.000
1.000
0.000
1.000
0.333
0.333
$25.41 
$0.00 
$25.41 
Total, Reporting
0.000
1.000
0.000
1.000
0.333
0.333
$25.41 
$0.00 
$25.41 
Total, Recordkeeping
0.000
0.000
0.000
0.000
0.000
0.000
$0.00 
$0.00 
$0.00 
Total, Letter of Intent, Test Orders
0.000
1.000
0.000
1.000
0.333
0.333
$25.41 
$0.00 
$25.41 
OR
Prepare Exemption Application
0.000
2.000
0.000
2.000
1.000
2.000
$152.64 
$0.00 
$152.64 
Corporate Review
6.000
0.000
0.000
6.000
1.000
6.000
$480.54 
$0.00 
$480.54 
Total, Reporting
6.000
2.000
0.000
8.000
1.000
8.000
$633.18 
$0.00 
$633.18 
Total, Recordkeeping
0.000
0.000
0.500
0.500
1.000
0.500
$17.25 
$0.00 
$17.25 
Total, Exemption Application, Test Orders 
6.000
2.000
0.500
8.500
1.000
8.500
$650.43 
$0.00 
$650.43 
Footnotes:
1 Unit costs are estimated by multiplying the clerical, technical, and managerial burdens by the corresponding wage rates in Table 37.

Study Plan, Test Orders
After the initial response has occurred, respondents must provide a study plan to EPA. The study plan includes documents detailing the different types of tests, health effects, and endpoints covered in each chemical report. One study plan for each chemical is required at the beginning of the testing period. 
CBI substantiation to support confidentiality claims for relevant data elements throughout the testing period (see list of transactions in Table 4) must be provided in conjunction with the study plan transmittal. The CBI substantiations address chemID and other data elements.
Table 11. Study Plan, Test Orders  -  Annual Per Chemical Unit Burden and Cost (2018$)
Activity
Unit Burden
 

Managerial Burden (hours)
Technical Burden (hours)
Clerical Burden (hours)
Unit Burden (hours)
Frequency of Occurrence (Average Per Year)
Adjusted Unit Burden (hours)
Labor Unit Cost 1
Non-Labor Cost
Unit Cost
Study Plan
0.000
39.000
0.000
39.000
0.333
12.987
$991.17 
$0.00 
$991.17 
CBI Substantiation2
1.184
2.465
0.000
3.649
0.333
1.215
$94.22 
$0.00 
$94.22 
Total, Reporting
1.184
41.465
0.000
42.649
0.333
14.202
$1,085.39 
$0.00 
$1,085.39 
Total, Recordkeeping
0.000
0.000
0.000
0.000
0.000
0.000
$0.00 
$0.00 
$0.00 
Total, Study Plan, Test Orders
1.184
41.465
0.000
42.649
0.333
14.202
$1,085.39 
$0.00 
$1,085.39 
Footnotes:
1 Unit costs are estimated by multiplying the clerical, technical, and managerial burdens by the corresponding wage rates in Table 37.
2 Drawn from the burden and cost report for the final TSCA Inventory Notification Requirements rule (EPA, 2017a) with adjustments for number of applicable data elements and the list of substantiation questions. For CBI substantiation questions see What to Include in CBI Substantiations - Sample substantiation templates (EPA, 2017b).

Test Results, Test Orders
As with test rules, at the conclusion of each test, respondents are required to provide a final report, which must also undergo both corporate and laboratory review. Recordkeeping is also required for all final report transmittals. 
Table 12. Test Results, Test Orders  -  Annual Per Chemical Unit Burden and Cost (2018$)
Activity
Unit Burden
 

Managerial Burden (hours)
Technical Burden (hours)
Clerical Burden (hours)
Unit Burden (hours)
Frequency of Occurrence (Average Per Year)
Adjusted Unit Burden (hours)
Labor Unit Cost1
Non-Labor Cost
Unit Cost
Study Final Report
0.000
40.000
0.000
40.000
2.333
93.320
$7,122.18 
$0.00 
$7,122.18 
Study Corporate Review
6.000
0.000
0.000
6.000
2.333
13.998
$1,121.10 
$0.00 
$1,121.10 
Laboratory Review
0.000
6.000
0.000
6.000
2.333
13.998
$1,068.33 
$0.00 
$1,068.33 
Total, Reporting
6.000
46.000
0.000
52.000
 
121.316
$9,311.61 
$0.00 
$9,311.61 
Total, Recordkeeping
0.000
0.000
0.500
0.500
2.333
1.167
$40.24 
$0.00 
$40.24 
Total, Test Results, Test Orders
6.000
46.000
0.500
52.500
 
122.483
$9,351.85 
$0.00 
$9,311.61 
Footnotes:
1 Unit costs are estimated by multiplying the clerical, technical, and managerial burdens by the corresponding wage rates in Table 37.

Voluntary Initial Contact, ECAs
The request to negotiate a consent agreement is an initial contact made by respondents interested in participating in negotiations for an Enforceable Consent Agreement. The request consists of a letter notifying EPA of the party's intent to participate. 
Table 13. Voluntary Initial Contact, ECAs  -  Annual Per Chemical Unit Burden and Cost (2018$)
Activity
Unit Burden
 

Managerial Burden (hours)
Technical Burden (hours)
Clerical Burden (hours)
Unit Burden (hours)
Frequency of Occurrence (Average Per Year)
Adjusted Unit Burden (hours)
Labor Unit Cost1
Non-Labor Cost
Unit Cost
Request to Negotiate
0.000
1.000
0.000
1.000
0.333
0.333
$25.41 
$0.00 
$25.41 
Total, Reporting
0.000
1.000
0.000
1.000
0.333
0.333
$25.41 
$0.00 
$25.41 
Total, Recordkeeping
0.000
0.000
0.000
0.000
0.000
0.000
$0.00 
$0.00 
$0.00 
Total, Voluntary Initial Contact, ECAs
0.000
1.000
0.000
1.000
0.333
0.333
$25.41 
$0.00 
$25.41 
Footnotes:
1 Unit costs are estimated by multiplying the clerical, technical, and managerial burdens by the corresponding wage rates in Table 37.

Study Plan, ECAs
After the voluntary initial contact has occurred, respondents must then provide a study plan to EPA. The study plan includes documents detailing the different types of tests, health effects, and endpoints covered in each chemical report. One study plan for each chemical is required at the beginning of the testing period. 
CBI substantiation to support confidentiality claims for relevant data elements throughout the testing period (see list of transactions in Table 4) must be provided in conjunction with the study plan transmittal. The CBI substantiations, address chemID and other data elements.
Table 14. Study Plan, ECAs  -  Annual Per Chemical Unit Burden and Cost (2018$)
Activity
Unit Burden
 

Managerial Burden (hours)
Technical Burden (hours)
Clerical Burden (hours)
Unit Burden (hours)
Frequency of Occurrence (Average Per Year)
Adjusted Unit Burden (hours)
Labor Unit Cost1
Non-Labor Cost
Unit Cost
Study Plan
0.000
39.000
0.000
39.000
0.333
12.987
$991.17 
$0.00 
$991.17 
CBI Substantiation2
1.184
2.465
0.000
3.649
0.333
1.215
$94.22 
$0.00 
$94.22 
Total, Reporting
1.184
41.465
0.000
42.649
0.333
14.202
$1,085.39 
$0.00 
$1,085.39 
Total, Recordkeeping
0.000
0.000
0.000
0.000
0.000
0.000
$0.00 
$0.00 
$0.00 
Total, Study Plan, ECA
1.184
41.465
0.000
42.649
0.333
14.202
$1,085.39 
$0.00 
$1,085.39 
Footnotes:
1 Unit costs are estimated by multiplying the clerical, technical, and managerial burdens by the corresponding wage rates in Table 37.
2 Drawn from the burden and cost report for the final TSCA Inventory Notification Requirements rule (EPA, 2017a) with adjustments for number of applicable data elements and the list of substantiation questions. For CBI substantiation questions see What to Include in CBI Substantiations - Sample substantiation templates (EPA, 2017b).

Test Results, ECAs
As with test rules and test orders, at the conclusion of each test, ECA respondents are required to provide a final report, which must also undergo both corporate and laboratory review. Recordkeeping is also required for all final report transmittals. 
Table 15. Test Results, ECAs  -  Annual Per Chemical Unit Burden and Cost (2018$)
Activity
Unit Burden
 

Managerial Burden (hours)
Technical Burden (hours)
Clerical Burden (hours)
Unit Burden (hours)
Frequency of Occurrence (Average Per Year)
Adjusted Unit Burden (hours)
Labor Unit Cost1
Non-Labor Cost
Unit Cost
Study Final Report
0.000
40.000
0.000
40.000
2.333
93.320
$7,122.18 
$0.00 
$7,122.18 
Study Corporate Review
6.000
0.000
0.000
6.000
2.333
13.998
$1,121.10 
$0.00 
$1,121.10 
Laboratory Review
0.000
6.000
0.000
6.000
2.333
13.998
$1,068.33 
$0.00 
$1,068.33 
Total, Reporting
6.000
46.000
0.000
52.000
 
121.316
$9,311.61 
$0.00 
$9,311.61 
Total, Recordkeeping
0.000
0.000
0.500
0.500
2.333
1.167
$40.24 
$0.00 
$40.24 
Total, Test Results, Test Orders
6.000
46.000
0.500
52.500
 
122.483
$9,351.85 
$0.00 
$9,351.85 
Footnotes:
1 Unit costs are estimated by multiplying the clerical, technical, and managerial burdens by the corresponding wage rates in Table 37.
Voluntary Robust Summaries for Test Rules, Test Orders, and ECAs
EPA estimates that ten percent of the studies completed for TSCA Section 4 testing actions will be accompanied by a robust summary, yielding one robust summary per chemical each year. 
      
Table 16.  Voluntary Robust Summaries for Test Rules, Test Orders, and ECAs  -  Annual Per Chemical Unit Burden and Cost (2018$)
Activity
Unit Burden
 

Managerial Burden (hours)
Technical Burden (hours)
Clerical Burden (hours)
Total Unit Burden (hours)
Frequency of Occurrence (Average Per Year)
Adjusted Unit Burden (hours)
Total Labor Unit Cost 1
Total Non-Labor Cost
Total Unit Cost
Robust Summary
0.000
12.000
0.000
12.000
0.033
0.400
$30.50 
$0.00 
$30.50 
Total, Reporting
0.000
12.000
0.000
12.000
0.033
0.400
$30.50 
$0.00 
$30.50 
Total, Recordkeeping
0.000
0.000
0.000
0.000
0.000
0.000
$0.00 
$0.00 
$0.00 
Total, Robust Summaries (Voluntary)
0.000
12.000
0.000
12.000
0.033
0.400
$30.50 
$0.00 
$30.50 
Footnotes:
1 Unit costs are estimated by multiplying the clerical, technical, and managerial burdens by the corresponding wage rates in Table 37.

Voluntary Data Submissions
EPA conservatively assumes that a voluntary submission consists of a final report for one chemical, as shown in Table 17. The description of this assumption is slightly revised from previous ICRs for simplification purposes.

Table 17. Voluntary Data Submissions  -  Annual Per Chemical Unit Burden and Cost (2018$)
Activity
Unit Burden
 

Managerial Burden (hours)
Technical Burden (hours)
Clerical Burden (hours)
Unit Burden (hours)
Frequency of Occurrence (Average Per Year)
Adjusted Unit Burden (hours)
Labor Unit Cost1
Non-Labor Costs
Unit Cost
Paper Submission of Final Reports
0.000
0.000
10.000
10.000
1.000
10.000
$345.00 
$14.62 
$359.62 
Total, Reporting
0.000
0.000
10.000
10.000
1.000
10.000
$345.00 
$14.62 
$359.62 
Total, Recordkeeping
0.000
0.000
1.000
1.000
1.000
1.000
$34.50 
$0.00 
$34.50 
Total, Voluntary Data Submissions
0.000
0.000
11.000
11.000
1.000
11.000
$379.50 
$14.62 
$394.12 
Footnotes:
1 Unit costs are estimated by multiplying the clerical, technical, and managerial burdens by the corresponding wage rates in Table 37.

Testing Costs (Non-Labor Costs)
Testing costs include laboratory costs and administrative costs. For purposes of this ICR, as in past ICRs, EPA assumes that the tests specified in a standard testing battery of seven tests are all likely to be performed on each chemical, although the specific tests actually performed could differ depending on specific circumstances and testing needs. Estimates include non-labor costs for analytical chemistry method development and validation where it was judged that such method development would be necessary to conform to good laboratory practices. Tests are assigned costs based on typical costs cited by industry experts and compiled by EPA. The overall laboratory costs of the "standard" testing battery (per chemical) is estimated at $58,177, (see Appendix A for further detail). 
In addition to laboratory costs, there are also costs for consortium management and costs for technical experts. Consortium management costs, which includes activities such as identifying manufacturers, meetings, organizing payment for testing, developing contracts for testing, and employing toxicologists who may be hired to provide technical expertise, are estimated at 15 percent of total laboratory costs. Costs for technical experts working for the consortium by providing study review and site visits to the laboratory are estimated at 10 percent of total laboratory costs. 

Table 18. Testing Costs (Non-Labor Costs)  -  Annual Per Chemical Unit Burden and Cost (2018$)
Activity
Unit Burden
 

Managerial Burden (hours)
Technical Burden (hours)
Clerical Burden (hours)
Total Unit Burden (hours)
Frequency of Occurrence (Average Per Year)
Adjusted Unit Burden (hours)
Total Labor Unit Cost 1
Total Non-Labor Cost
Total Unit Cost
Laboratory Costs
0.000
0.000
0.000
0.000
0.333
0.000
$0.00 
$19,392.33 
$19,392.33 
Consortium Management
0.000
0.000
0.000
0.000
0.333
0.000
$0.00 
$2,908.85 
$2,908.85 
Technical Experts
0.000
0.000
0.000
0.000
0.333
0.000
$0.00 
$1,939.23 
$1,939.23 
Total, Testing Costs (Non-Labor Costs)
0.000
0.000
0.000
0.000
0.333
0.000
$0.00 
$24,240.41 
$24,240.41 
Footnote:
1 Unit costs are estimated by multiplying the clerical, technical, and managerial burdens by the corresponding wage rates in Table 37.

Respondent Universe, Total, and Bottom Line Burden Hours and Costs
The respondent universe for test rules, test orders, ECAs, and Voluntary Data Submissions, Exemption Applications and Robust Summaries are presented in Table 19 below. 
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 4. 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 19.
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 19 and the unit burdens presented in Section 5(b).
Table 19. 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 5.

CDX Registration for e-Reporting  -  Total Respondent Burden and Costs
Based on the unit burden estimates presented in Table 6, as well as the estimated number of responses presented in Table 19, the total respondent burden and costs for CDX registration for e-Reporting are presented below in Table 20. 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 20. CDX Registration for e-Reporting  -  Annual Total Respondent Burden and Costs (2018$)
Activity
Unit Burden per Registration
Number of Registrations/Registrants1
Overlap Factor
Total Burden (Hours)
Total Labor Cost
Total Non-Labor Cost
Total Cost
CDX Registration
0.180
10.7
2.8
5.393
$411.65 
$0.00 
$411.65 
CDX Electronic Signature
0.350
10.7
2.8
10.486
$800.23 
$0.00 
$800.23 
Total, Reporting
0.530
10.7
2.8
15.879
$1,211.88 
$0.00 
$1,211.88 
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
$1,211.88 
$0.00 
$1,211.88 
Footnotes:
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.

Initial Response, Test Rules  -  Total Respondent Burden and Costs
Based on the unit burden estimates presented in Table 7, as well as the estimated number of responses in Table 19, the total respondent burden and costs for initial response under test rules are presented below in Table 21.
Table 21. Initial Response, Test Rules  -  Annual Total Respondent Burden and Costs (2018$)
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
$249.02 
$0.00 
$249.02 
Subtotal, Letter of Intent Total
0.333
3.50
3.50
2.8
3.263
$249.02 
$0.00 
$249.02 
OR
 
 
 
 
 
 
 
 
Prepare Exemption Application
2.000
3.50
3.50
2.8
19.600
$1,495.87 
$0.00 
$1,495.87 
Corporate Review
6.000
3.50
3.50
2.8
58.800
$4,709.29 
$0.00 
$4,709.29 
Subtotal, Exemption Application Reporting
8.000
3.50
3.50
2.8
78.400
$6,205.16 
$0.00 
$6,205.16 
Subtotal, Recordkeeping
0.500
3.50
3.50
2.8
4.900
$169.05 
$0.00 
$169.05 
Subtotal, Exemption Application
8.5
3.50
3.50
2.8
83.300
$6,374.21 
$0.00 
$6,374.21 
Overall Total, Initial Response including Exemption Applications Reporting
4.166
7.00
7.00
2.8
81.663
$6,454.18 
$0.00 
$6,454.18 
Overall Recordkeeping
0.500
3.50
3.50
2.8
4.900
$169.05 
$0.00 
$169.05 
Overall Total, Initial Response including Exemption Applications
4.416
7.0
7.0
2.8
85.563
$6,323.23 
$0.00 
$6,623.23 
Footnotes:
1 Assumes one sponsor per chemical.

Study Plan, Test Rules  -  Total Respondent Burden and Costs
Based on the unit burden estimates presented in Table 8, as well as the estimated number of responses in Table 19, the total respondent burden and costs for study plans under test rules are presented below in Table 22.
Table 22. Study Plan, Test Rules  -  Annual Total Respondent Burden and Costs (2018$)
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
$9,713.47 
$0.00 
$9,713.47 
CBI Substantiation
1.215
3.50
3.50
2.80
11.91
$923.36 
$0.00 
$923.36 
Total, Reporting
14.202
3.50
3.50
2.80
139.18
$10,636.83 
$0.00 
$10,636.83 
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
$10,636.83 
$0.00 
$10,636.83 
Footnotes:
1 Assumes one sponsor per chemical.

Test Results, Test Rules  -  Total Respondent Burden and Costs
Based on the unit burden estimates presented in Table 9, as well as the estimated number of responses in Table 19, the total respondent burden and costs for test results under test rules are presented below in Table 23.
Table 23. Test Results, Test Rules  -  Annual Total Respondent Burden and Costs (2018$)
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
$69,797.36 
$0.00 
$69,797.36 
Study Corporate Review
13.998
3.50
3.50
2.80
137.18
$10,986.78 
$0.00 
$10,986.78 
Laboratory Review
13.998
3.50
3.50
2.80
137.18
$10,469.63 
$0.00 
$10,986.78 
Total, Reporting
121.316
3.50
3.50
2.80
1,188.90
$91,253.77 
$0.00 
$91,253.77 
Total, Recordkeeping
1.167
3.50
3.50
2.80
11.44
$394.35 
$0.00 
$394.35 
Total, Test Results, Test Rules
122.483
3.50
3.50
2.80
1,200.33
$91,648.12 
$0.00 
$91,648.12 
Footnotes:
1 Assumes one sponsor per chemical.

Initial Response, Test Orders  -  Total Respondent Burden and Costs
Based on the unit burden estimates presented in Table 10, as well as the estimated number of responses in Table 19, the total respondent burden and costs for initial response under test orders are presented below in Table 24.
Table 24. Initial Response, Test Orders  -  Annual Total Respondent Burden and Costs (2018$)
Activity
Adjusted Unit Burden (hours)
Number of Respondents (Sponsors) 1
Number of Responses (Chemicals Tested within an Action)
Overlap Factor
Total Burden (hours)
Total Labor Cost (2018$)
Total Non-Labor Cost (2018$)
Total Cost (2018$)
Letter of Intent
0.333
70.00
70.00
2.80
65.268
$4,980.36 
$0.00 
$4,980.36 
Subtotal, Letter of Intent Total
0.333
70.00
70.00
2.80
65.268
$4,980.36 
$0.00 
$4,980.36 
OR
 
 
 
 
 
 
 
 
Prepare Exemption Application
2.000
70.00
70.00
2.80
392.000
$29,917.44 
$0.00 
$29,917.44 
Corporate Review
6.000
70.00
70.00
2.80
1,176.000
$94,185.84 
$0.00 
$94,185.84 
Subtotal, Exemption Application Reporting
8.000
70.00
70.00
2.80
1,568.000
$124,103.28 
$0.00 
$124,103.28 
Subtotal, Recordkeeping
0.500
70.00
70.00
2.80
98.000
$3, 381.00 
$0.00 
$3,381.00 
Subtotal, Exemption Application
8.000
70.00
70.00
2.80
1,666.000
$127,484.28 
$0.00 
$124,103.28 
Overall Total, Initial Response including Exemption Applications Reporting
4.167
140.00
140.00
2.80
1,633.268
$129,083.64 
$0.00 
$127,484.28 
Overall Recordkeeping
0.500
70.00
70.00
2.80
98.000
$3,381.00 
$0.00 
$3,381.00 
Overall Total, Initial Response including Exemption Applications
4.417
140.00
140.00
2.80
1,731.268
$132,464.64 
$0.00 
$132,464.64 
Footnotes:
1 Assumes one sponsor per chemical.

Study Plan, Test Orders  -  Total Respondent Burden and Costs
Based on the unit burden estimates presented in Table 11, as well as the estimated number of responses in Table 19, the total respondent burden and costs for study plans under test orders are presented below in Table 25.
Table 25. Study Plan, Test Orders  -  Annual Total Respondent Burden and Costs (2018$)
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
$194,269.32 
$0.00 
$194,269.32 
CBI Substantiation
1.215
70.00
70.00
2.80
238.14
$18,467.12 
$0.00 
$18,467.12 
Total, Reporting
14.202
70.00
70.00
2.80
2,783.59
$212,736.44 
$0.00 
$212,736.44 
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
$212,736.44 
$0.00 
$212,736.44 
Footnotes:
1 Assumes one sponsor per chemical.

Test Results, Test Orders  -  Total Respondent Burden and Costs
Based on the unit burden estimates presented in Table 12, as well as the estimated number of responses in Table 19, the total respondent burden and costs for test results under test orders are presented below in Table 26.
Table 26. Test Results, Test Orders  -  Annual Total Respondent Burden and Costs (2018$)
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
$1,395,947.28 
$0.00 
$1,395,947.28 
Study Corporate Review
13.998
70.00
70.00
2.80
2,743.61
$219,735.60 
$0.00 
$219,735.60 
Laboratory Review
13.998
70.00
70.00
2.80
2,743.61
$209,392.68 
$0.00 
$209,392.68 
Total, Reporting
121.316
70.00
70.00
2.80
23,777.94
$1,825,075.56 
$0.00 
$1,825,075.56 
Total, Recordkeeping
1.167
70.00
70.00
2.80
228.73
$7,887.04 
$0.00 
$7,887.04 
Total, Test Results, Test Orders
121.316
70.00
70.00
2.80
24,006.67
$1,832,962.60 
$0.00 
$1,832,962.60 
Footnotes:
1 Assumes one sponsor per chemical.

 Voluntary Initial Contact, ECAs  -  Total Respondent Burden and Costs
Based on the unit burden estimates presented in Table 13, as well as the estimated number of responses in Table 19, the total respondent burden and costs for voluntary initial contact under ECAs are presented below in Table 27.
Table 27. Voluntary Initial Contact, ECAs  -  Annual Total Respondent Burden and Costs (2018$)
Activity
Adjusted Unit Burden (hours)
Number of Respondents (Sponsors)1
Number of Responses (Chemicals Tested within an Action)
Overlap Factor
Total Burden (hours)
Total Labor Cost (2018$)
Total Non-Labor Cost (2018$)
Total Cost (2018$)
Request to Negotiate
0.333
3.50
3.50
2.80
3.263
$249.02 
$0.00 
$249.02 
Total, Reporting
0.333
3.50
3.50
2.80
3.263
$249.02 
$0.00 
$249.02 
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
$249.02 
$0.00 
$249.02 
Footnotes:
1 Assumes one sponsor per chemical.

Study Plan, ECAs
Based on the unit burden estimates presented in Table 14, as well as the estimated number of responses in Table 19, the total respondent burden and costs for study plans under ECAs are presented below in Table 28.

Table 28. Study Plan, ECAs  -  Annual Total Respondent Burden and Costs (2018$)
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
$9,713.47 
$0.00 
$9,713.47 
CBI Substantiation
1.215
3.50
3.50
2.80
11.907
$923.36 
$0.00 
$923.36 
Total, Reporting
14.202
3.50
3.50
2.80
139.180
$10,636.83 
$0.00 
$10,636.83 
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
$10,636.83 
$0.00 
$10,636.83 
Footnotes:
1 Assumes one sponsor per chemical.

Test Results, ECAs
Based on the unit burden estimates presented in Table 15, as well as the estimated number of responses in Table 19, the total respondent burden and costs for test results under ECAs are presented below in Table 29.
Table 29. Test Results, ECAs  -  Annual Total Respondent Burden and Costs 
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
$69,797.36 
$0.00 
$69,797.36 
Study Corporate Review
13.998
3.50
3.50
2.80
137.180
$10,986.78 
$0.00 
$10,986.78 
Laboratory Review
13.998
3.50
3.50
2.80
137.180
$10,469.63 
$0.00 
$10,469.63 
Total, Reporting
121.316
3.50
3.50
2.80
1,188.896
$91,253.77 
$0.00 
$91,253.77 
Total, Recordkeeping
1.167
3.50
3.50
2.80
11.437
$394.35 
$0.00 
$394.35 
Total, Test Results,  ECAs
122.483
3.50
3.50
2.80
1,200.333
$91,648.12 
$0.00 
$91,648.12 
Footnotes:
1 Assumes one sponsor per chemical.

Voluntary Robust Summaries for Test Rules, Test Orders, and ECAs
Based on the unit burden estimates presented in Table 16, as well as the estimated number of responses in Table 19, the total respondent burden and costs for robust summaries are presented below in Table 30.

Table 30. Voluntary Robust Summaries for Test Rules, Test Orders, and ECAs  -  Annual Total Respondent Burden and Costs (2018$)
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
$6,575.80 
$0.00 
$6,575.80 
Total, Reporting
0.400
77.00
77.00
2.80
86.240
$6,575.80 
$0.00 
$6,575.80 
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
$6,575.80 
$0.00 
$6,575.80 
Footnotes:
1 Assumes one sponsor per chemical.

Voluntary Data Submissions
Based on the unit burden estimates presented in Table 17, 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 31.
Table 31. Voluntary Data Submissions - Annual Total Respondent Burden and Costs (2018$)
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
$23,667.00 
$1,002.93 
$24,669.93 
Total, Reporting
10.000
24.50
24.50
2.80
686.000
$23,667.00 
$1,002.93 
$24,669.93 
Total, Recordkeeping
1.000
24.50
24.50
2.80
68.600
$2,366.70 
$0.00 
$2,366.70 
Total, Voluntary Data Submissions
11.000
24.50
24.50
2.80
754.600
$26,033.70 
$1,002.93 
$27,036.63 
Footnotes:
1 Assumes one sponsor per chemical.

  Testing Costs (Non-Labor Costs)  -  Total Respondent Burden and Costs
Based on the unit non-labor cost estimates presented in Table 18, as well as the estimated number of responses in Table 19, the total respondent non-labor costs for testing costs are presented below in Table 32.
Table 32. Testing Costs (Non-Labor Costs)  -  Annual Total Respondent Burden and Costs (2018$)
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 
$4,180,986.35 
$4,180,986.35 
Consortium Management
0.000
77.00
77.00
2.80
0.0000
$0.00 
$627,148.06 
$627,148.06 
Technical Experts
0.000
77.00
77.00
2.80
0.0000
$0.00 
$418,097.99 
$418,097.99 
Total, Testing Costs (Non-Labor Costs)
0.000
77.00
77.00
2.80
0.0000
$0.00 
$5,226,232.40 
$5,226,232.40 
Footnotes:
1 Assumes one sponsor per chemical.

ESTIMATING BURDEN AND COST OF THIS COLLECTION
Total Estimated Respondent Annual Burden and Costs
Table 33 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 34. 
With respect to reporting burden and cost, EPA estimates that this ICR will impose a total of 32,147 burden hours annually with an annual average respondent burden for a TSCA Section 4 action estimated at about 137 hours for test rules, test orders, or ECAs (response is on a per-chemical, or submission basis). For CDX registrations, the average annual respondent burden is 0.53 hours per registration.






Table 33. Summary of Annual Total Respondent Burden and Cost (2018$), By Type of Information Collection Activity
Type of Information Collection Activity
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
$1,211.88 
$0.00 
$1,211.88 
Test Rules
Initial Response, Test Rules
4.416
7
7
2.8
86.56
$6,623.23 
$0.00 
$6,623.23 
Study Plan, Test Rules
14.202
3.5
3.5
2.8
139.18
$10,636.83 
$0.00 
$10,636.83 
Test Results, Test Rules
122.483
3.5
3.5
2.8
1,200.33
$91,648.12 
$0.00 
$91,648.12 
Test Orders
Initial Response, Test Orders
4.417
140
140
2.8
1,731.77
$132,464.64 
$0.00 
$132,464.64 
Study Plan, Test Orders
14.202
70
70
2.8
2,783.59
$212,736.44 
$0.00 
$212,736.44 
Test Results, Test Orders
122.483
70
70
2.8
24,006.67
$1,832,962.60 
$0.00 
$1,832,962.60 
Enforceable Consent Agreements (ECAs)
Voluntary Initial Contact, ECAs
0.333
3.5
3.5
2.8
3.26
$249.02 
$0.00 
$249.02 
Study Plan, ECAs
14.202
3.5
3.5
2.8
139.18
$10,636.83 
$0.00 
$10,636.83 
Test Results, ECAs
122.483
3.5
3.5
2.8
1,200.33
$91,648.12 
$0.00 
$91,648.12 
Voluntary  -  Other
Robust Summaries (Voluntary) for Test Rules, Test Orders, and ECAs
0.400
77.0
77.0
2.8
86.24
$6,575.80 
$0.00 
$6,575.80 
Voluntary Data Submission
11.000
24.5
24.5
2.8
754.60
$26,033.70 
$1,002.93 
$27,036.63 
Testing
Laboratory Costs (Non-Labor Costs)
0.00
77
77
2.8
0.00
$0.00 
$5,226,232.40 
$5,226,232.40 
Total
 
175
262.7
2.8
32,147
$2,423,427 
$5,227,235 
$7,650,663 
Notes: All ICs listed above include recordkeeping costs, where applicable
1 Assumes one sponsor per chemical.

Table 34. Summary of Annual Total Burden and Costs (2018$), 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 
$102,832.87 
$0.00 
$102,832.87 
Test Orders 2
137.418
70.0
70.0
2.8
                26,933.93 
$2,056,657.40 
$0.00 
$2,056,657.40 
Enforceable Consent Agreements (ECAs) 3
137,418
3.5
3.5
2.8
                    1,346.70 
$102,832.87 
$0.00 
$102,832.87 
Voluntary Data Submissions 4
11.000
24.5
24.5
2.8
                       754.60 
$26,033.70 
$1,002.93 
$27,036.36 
Testing Costs, Non-Labor (Test Rules, Test Orders, ECAs) 5
 
77.00
77.0
2.8
0.00
$0.00 
$5,226,232.40 
$5,226,232.40 
Subtotal, Testing
 
101.5
178.5
2.8
30,381.93
$2,288,356.84 
$5,227,235.33 
$7,515,592.17 
Section 4 Exemption Applicants
Subtotal, Exemption Applications
8.500
73.5
73.5
2.8
                    1,749.30 
$133,858.49 
$0.00 
$132,858.49 
CDX Registrants
Subtotal, CDX Registration and e-Signature
0.530
10.7
10.7
2.8
                         15.88 
$1,211.88 
$0.00 
$1,211.88 
Total 6
 
175.0
262.7
2.8
32,147 
$2,423,427 
$5,227,235 
$7,650,663 
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.
Footnotes:
1 Includes Initial Response, Study Plan, Test Results, Voluntary Robust Summaries
2 Includes Initial Response, 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.



PRA Burden Statement
Under the PRA, burden is defined at 5 CFR 1320.3(b).
The annual public burden for this collection of information, which is approved under OMB Control No. 2070-0033, is estimated about 137 hours for the average response for a TSCA section 4 action on a per-chemical basis, not including CDX registration, and 0.53 hours per CDX registration. Burden is defined in 5 CFR 1320.3(b). An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a current and valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR part 9 and included on the related collection instrument or form, if applicable.

Changes in the Estimates

This request represents an increase of 29,020 hours from that currently in the OMB inventory (from 3,127 to 32,147 hours). As shown in Table 21, this increase is due to
Changes in the number of actions
CBI substantiation
Methodological updates
            
Table 35. Summary of Changes in ICR Estimates
Type of Burden Estimate
Previous ICR
Changes
ICR Renewal


Changes in Number of Chemicals Tested within TSCA Section 4 Actions1 
CBI Substantiation
Methodology2


Unit
Total
Δ Unit
Δ Total
Δ Unit
Δ Total
Δ Unit
Δ Total
Unit
Total
A. CDX Registration
0.53
4.45
0.00
1.22
0.00
0.00
0.00
10.21
0.53
15.88
B. Test Rules, including Robust Summaries, excluding Exemption Applications
248.66
2,486.60
0.00
-1,616.29
1.22
4.25
-112.46
472.14
137.42
1,346.70
C. Test Orders, including Robust Summaries, excluding Exemption Applications
248.66
0.00
0.00
17,406.20
1.22
85.05
-112.46
9,442.68
137.42
26,933.93
D. ECAs, including Robust Summaries
248.66
497.32
0.00
372.99
1.22
4.25
-112.46
472.14
137.42
1,346.70
E. Voluntary Data Submissions3
11.00
122.00
0.00
258.50
0.00
0.00
0.00
347.10
11.00
754.60
F. Exemption Applications
8.50
17.00
0.00
607.75
0.00
0.00
0.00
1,124.55
8.50
1,749.30
TOTAL
3,127.37
17,030.37
93.56
11,895.82
32,147
Footnotes:
1 Calculated according to methodology in previous ICR2 This ICR's methodology accounts for overlap and better captures the comprehensive view of the number of chemicals tested per year3 Previous ICR reports 122 hours as the unit burden. The corrected number is 11 hours.

Reference Tables
      The tables in this section are provided for reference, as they contain supporting information for the analyses of Sections 4  -  5.
      
Table 36. Activity-Level Unit Burdens and Costs (2018$) by Activity and Type of Action
Activity
Unit of Analysis
Managerial Burden
(hours)
Technical Burden
(hours)
Clerical Burden
(hours)
Activity-Level Unit Burden
(hours)
Average Wage Rate
Labor Costs
Per-Activity Non-Labor Costs
Total per-Activity Cost


a
b
c
d = a + b + c
e
f = d x e
g
h = f + g
CDX




CDX Registration
Registration
0.000
0.180
0.000
0.180
$76.33 
$13.74 
$0.00 
$13.74 
CDX Electronic Signature
Registration
0.000
0.350
0.000
0.350
$76.31 
$26.71 
$0.00 
$26.71 
Initial Response (Test Rules, Test Orders, ECAs)
Letter of Intent
Chemical
0.000
1.000
0.000
1.000
$76.32 
$76.32 
$0.00 
$76.32 
Request to Negotiate
Chemical
0.000
1.000
0.000
1.000
$76.32 
$76.32 
$0.00 
$76.32 
Alternate Initial Response (Test Rules, Test Orders)




Prepare Exemption Application
Application
0.000
2.000
0.000
2.000
$76.32 
$152.64 
$0.00 
$152.64 
Corporate Review
Review
6.000
0.000
0.000
6.000
$80.09 
$480.54 
$0.00 
$480.54 
Recordkeeping
Record
0.000
0.000
0.500
0.500
$34.50 
$17.25 
$0.00 
$17.25 
Standardized Core Activities (Test Rules, Test Orders, ECAs)
Study Plan (ten tests)1
Chemical
0.000
39.000
0.000
39.000
$76.32 
$2,976.48 
$0.00 
$2,976.48 
CBI Substantiation2
Substantiation
1.184
2.465
0.000
3.649
$77.54 
$282.96 
$0.00 
$282.96 
Biannual Progress Report 
(Long Duration Studies)
Report
0.000
8.000
0.000
8.000
$76.32 
$610.56 
$0.00 
$610.56 
Final Report
(Short Duration Studies)
Report
0.000
40.000
0.000
40.000
$76.32 
$3,052.80 
$0.00 
$3,052.80 
Final Report
(Long Duration Studies)
Report
0.000
80.000
0.000
80.000
$76.32 
$6,105.60 
$0.00 
$6,105.60 
Corporate Review
(Short Duration Studies)
Review
6.000
0.000
0.000
6.000
$80.09 
$480.54 
$0.00 
$480.54 
Corporate Review
(Long Duration Studies)
Review
9.000
0.000
0.000
9.000
$80.09 
$720.81 
$0.00 
$720.81 
Laboratory Review
Review
0.000
6.000
0.000
6.000
$76.32 
$457.92 
$0.00 
$457.92 
Recordkeeping
Record
0.000
0.000
0.500
0.500
$34.50 
$17.25 
$0.00 
$17.25 
Voluntary Robust Summaries (Test Rules, Test Orders, ECAs, Voluntary Data Submissions)
Robust Summary
Chemical
0.000
12.000
0.000
12.000
$76.32 
$915.84 
$0.00 
$915.84 
Voluntary Data Submission3
Paper Submission of Final Reports
Chemical
0.000
0.000
10.000
10.000
$34.50 
$345.00 
$14.62 
$359.62
Recordkeeping
Record
0.000
0.000
1.000
1.000
$34.50 
$34.50 
$0.00 
$34.50 
Testing Costs (ten tests) 4
Laboratory Costs
Chemical
0.000
0.000
0.000
0.000
-
$0.00 
$1,663,397.00 
$1,663,397.00 
Consortium Management
Chemical
0.000
0.000
0.000
0.000
-
$0.00 
$249,509.55 
$249,509.55 
Technical Experts
Chemical
0.000
0.000
0.000
0.000
-
$0.00 
$166,339.70 
$166,339.70 
Footnotes:
1 For test rules or orders and testing agreements, the estimates of this ICR Revision are developed for a battery of ten tests per chemical (see Table A-1 for list of tests; see Table 4 for activity frequencies per chemical). For labor costs, with the exception of the activity "Study Plans," the activity-level burdens of this table are unaffected by the number of tests. However, for the activity, "Study Plans" involving different test counts, the activity-level (and chemical-level) unit burden estimate for "Study Plans" is obtained by multiplying the number of tests by 3.9 hours per test-per chemical to obtain hours per chemical.
2 Drawn from the burden and cost report for the final TSCA Inventory Notification Requirements rule (EPA, 2017a) with adjustments for number of applicable data elements and the list of substantiation questions
3 Voluntary Submissions are the only type of TSCA Section 4 submission that are not required to be submitted electronically. Paper and postage costs for final reports and robust summaries are estimated under "Per-Activity Supply Cost." These costs assumed that a voluntary submission contains: ten final reports averaging 35 pages, plus a cover letter and robust summary, totaling 352 pages. Paper costs at $0.0112 per page total $3.94 (Staples, 2019). Postage via 2-day FedEx Ground for the 0.4 lb package totals $10.68 (FedEx, 2019). 
4 For test rules or orders and testing agreements, the estimates of this ICR Revision are developed for a battery of ten tests per chemical (see Table A-1 for list of tests). For testing costs, the activity-level (and chemical-level) unit burden is obtained based on the laboratory costs. Consortium management is estimated as 15 percent of laboratory costs, and technical experts is estimated as 10 percent of laboratory costs.
   
   
      Estimation of industry unit cost per submission involves combining the activity-level unit burdens identified in Section 5 with wage data for December 2018 (Bureau of Labor Statistics (BLS), 2019) from BLS, as converted from raw wage rate and benefit data to loaded wage rates. Table 37 presents the resultant loaded wage rates for managerial, professional/technical, and clerical staff.
Table 37. Industry Wage Rates (2018$)
Labor Category
Data Series a
Date
Wage
Fringe Benefit
Fringes as % Wage
Overhead % wage b
Fringe + Overhead Factor c
Hourly Loaded Wages d 



(a)
(b)
(c) =(b)/(a)
(d)
(e)= (c)+(d)+1
(f)=(a)x(e)
Managerial
BLS ECEC, Private Manufacturing industries, "Mgt, Business, and Financial"
Dec-18
$48.73 
$23.08 
47%
17%
1.64
$80.09 
Professional / Technical
BLS ECEC, Private Manufacturing industries, "Professional and related"
Dec-18
$44.35 
$24.43 
55%
17%
1.72
$76.32 
Clerical
BLS ECEC, Private Manufacturing industries, "Office and Administrative Support"
Dec-18
$20.77 
$10.20 
49%
17%
1.66
$34.50 
Footnotes:
a Source: Employer Costs for Employee Compensation Historical Supplementary Tables: December 2006  -  March 2019. All rates are rounded to the nearest cent.
b An overhead rate of 17 percent is used based on assumptions in Wage Rates for Economic Analysis of the Toxics Release Inventory Program (Rice, 2002), and the Revised Economic Analysis for the Amended Inventory Update Rule: Final Report (EPA, 2002).
c The inflation factor of "1" in the formula for calculating the fringe + overhead factor means wage data are not escalated to reflect inflation.
d Wage data are rounded to the closest cent in this analysis.

      Agency costs are based on the assumption that the Agency collection procedures are accomplished, on average, by a GS-13, Step 1 employee for EPA Program Staff and a GS-13, Step 5 employee for EPA CBI Review Staff.
Table 38. Agency Wage Rate (2018$)
Labor Category
Data Source for Wage Information
Wage ($/hour)
Fringe Benefit
Fringes as % Wage
Overhead as % wage b
Fringe + Overhead Factor c
Hourly Loaded Wages 


(a)
(b)
(c) =(b)/(a)
(d)
(e)= (c)+(d)+1
(f)=(a)x(e)
EPA Program Staff
Annual federal staff cost: OPM Washington-Baltimore-Northern Virginia, DC-MD-PA-VA-WV area, GS-13 Step 1 pay rates a
$46.46
Included in 60% overhead
N/A
60% b
1.6
$74.34
EPA CBI Review Staff
Annual federal staff cost: OPM Washington-Baltimore-Northern Virginia, DC-MD-PA-VA-WV area, GS-13 Step 5 pay rates a
$52.66
Included in 60% overhead
N/A
60% b
1.6
$84.26
Footnotes:
a Source: U.S. Office of Personnel Management. (2018). Salary Table 2018-DCB. Retrieved March 26, 2018 from Pay & Leave: Salaries & Wages: https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/18Tables/html/DCB_h.aspx.
b The 60 percent fringes-and-overhead rate is from an EPA guide, Instructions for Preparing ICRs (EPA, 2009).
c Wage data are rounded to the closest cent in this analysis. 

References and Attachments to the Supporting Statement
Bureau of Labor Statistics (BLS). (2014, July). Employment Cost Index Historical Listing - Volume V. Series: All Private Workers Total Compensation (not seasonally adjusted).
Bureau of Labor Statistics (BLS). (2019, June 18). Employer Costs for Employee Compensation Historical Supplementary Tables: December 2006 - March 2019. Retrieved August 5, 2019, from http://www.bls.gov/ncs/ect/sp/ecsuphst.pdf
Environmental Protection Agency (EPA). (2002). Revised Economic Analysis for the Amended Inventory Update Rule: Final Report. Retrieved from https://www.regulations.gov/document?D=EPA-HQ-OPPT-2014-0650-0011
EPA. (2009). ICR Handbook: EPA's Guide to Writing Information Collection Requests under the Paperwork Reduction Act of 1995. Retrieved from https://www.pdffiller.com/10247637--ICR-Handbook---Environmental-Protection-Agency-
EPA. (2013a). Supporting Statement for a Request for OMB Review under the Paperwork Reduction Act: TSCA Section 4 Test Rules, Consent Orders, Enforceable Consent Agreements, Voluntary Testing Agreements, Voluntary Data Submissions, and Exemptions from Testing Requirement. Retrieved from https://www.reginfo.gov/public/do/DownloadDocument?objectID=31908502
EPA. (2013b, September 1). Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branch. Filename: Standard Nano Test Costs 9-01-2013.xls.
EPA. (2016, June 30). Supporting Statement for a Request for OMB Review under the Paperwork Reduction Act: TSCA Section 4 Test Rules, Enforceable Consent Agreements (ECAs), Voluntary Testing Agreements (VTAs), Voluntary Data Submissions, and Exemptions from Testing Requirement. Retrieved from https://www.regulations.gov/document?D=EPA-HQ-OPPT-2015-0436-0007
EPA. (2017a). Burden and Cost Report for the Final Rule: TSCA Inventory Notification Requirements. Docket Number EPA-HQ-OPPT-2016-0426 (August 11, 2017).
EPA. (2017b, February 22). General Substantiation Questions to Support CBI Claims. Retrieved September 16, 2019, from https://www.epa.gov/tsca-cbi/general-substantiation-questions-support-cbi-claims
EPA. (2018a). Supporting Statement for a Request for OMB Review under the Paperwork Reduction Act: TSCA Section 4 Test Rules, Enforceable Consent Agreements (ECAs), Voluntary Testing Agreements (VTAs), Voluntary Data Submissions, and Exemptions from Testing Requirement. Retrieved from https://www.reginfo.gov/public/do/DownloadDocument?objectID=80611002
EPA. (2018b, February 26). Technical Background Document TSCA User Fees NPRM.
EPA. (2018c, September 25). Economic Analysis of the Final Rule for Fees for the Administration of the Toxic Substances Control Act, EPA-HQ-OPPT-2017-0401; RIN 2070-AK27.
EPA. (2019a). Economic Analysis for the Proposed Rule: Procedures for Review of CBI Claims for the Identity of Chemicals on the TSCA Inventory.
EPA. (2019b, August 14). The Frank R. Lautenberg Chemical Safety for the 21st Century Act (EPA website). Retrieved from https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/frank-r-lautenberg-chemical-safety-21st-century-act
FedEx. (2019). Postage based on 0.4 lb package shipped 3-day business rate from Kansas City MO to Washington DC. Retrieved September 5, 2019, from https://www.fedex.com/ratefinder/home?cc=US&language=en&locId=express
Fees for the Administration of the Toxic Substances Control Act. , 40 CFR § 700, 720, 723, 725, 790, and 791 (2018).
Frank R. Lautenberg Chemical Safety for the 21st Century. , 40 CFR § 790-799 (2016).
Nielsen, L., & Day, S. (2018, March). Smart Math Saves Time and Improves Communication.
Office of Personnel Management (OPM). (2018). Pay & Leave: Salaries & Wages: Salary Table 2018-DCB. Retrieved from www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/18Tables/html/DCB_h.aspx
Piccirillo, V. (2004, September 20). Vincent Piccirillo, personal communication.
Rice, C. (2002). Wage Rates for Economic Analysis of the Toxics Release Inventory Program. Retrieved from https://www.regulations.gov/document?D=EPA-HQ-OPPT-2014-0650-0005
Staples. (2019). Staples 8.5" x 11" Copy Paper. Retrieved September 5, 2019, from https://www.staples.com/Staples-Copy-Paper-8-1-2-x-11-Case/product_135848

Attachments:
Attachments to the supporting statement are available in the public docket established for this ICR under docket identification number EPA-HQ-OPPT-2015-0436. These attachments are available for online viewing at www.regulations.gov or otherwise accessed as described in the following listing. 
Attachment 1:
Toxic Substances Control Act (TSCA) Section 4 - 15 USC 2603
Attachment 2:
Procedures Governing Testing Consent Agreements and Test Rules, 40 CFR 790
Attachment 3
TSCA Section 4 e-Reporting Screenshots
Attachment 4
Consultations Message Sent by EPA to Potential Respondents
Attachment 5
Center for Specialty Chemical Science, LLC (CSCS) Comment
Attachment 6
Environmental Defense Fund (EDF) Comment
Attachment 7
American Chemistry Council (ACC) Comment
Attachment 8
EPA's Response to Public Comments
Attachment 9
Example of a Section 4 Test Order
Appendix A: Specific Legacy Assumptions Converted to Standardized Assumptions
Table A-1 depicts a detailed table of tests that has been historically part of ICR renewal methodology. In this revision, the assumption is simplified to a generic set of ten tests, with total costs at $1.6 million (Bureau of Labor Statistics (BLS), 2014; EPA, 2013b; Piccirillo, 2004). Of the ten tests in Table A-1, three tests are of long duration and seven are of short duration
In this ICR revision, the assumption is simplified to a generic set of seven screening-level tests, including five physiochemical tests, one environmental fate and degradation test, and one aquatic toxicity test, with a total cost of $58,177. These tests are listed in Table A-2 and the costs were estimated using test costs developed for OPPT's New Chemical Program, and are meant to serve as seven generic tests that may be performed at any point during the three-year period. Future ICR renewals can take into account the actual duration of tests and build a new generic frequency distribution accordingly. 
Table A-1 Legacy TSCA Section 4 "Standard" Testing Battery Laboratory Costs (2014$), Per Chemical
Test Protocol Name
Protocol Number
Date of Estimate
Mean Cost Estimate (2014$)a
Validation Costs (2014$)
Algal Acute Toxicity
  797.105
  8/3/1990
  $12,132.58 
  $4,398.95 
Daphnid Acute Toxicity
  797.13
  4/25/1996
  $11,965.05 
  $4,398.95 
Fish Acute Toxicity
  797.14
  4/25/1996
  $18,285.73 
  $4,398.95 
Gene Mutations in Somatic Cells
  798.53
  8/16/1994
  $25,366.24 
  $4,398.95 
Subchronic Oral Toxicity
  870.31
  9/3/2005
  $167,921.14 
  $4,398.95 
Prenatal Developmental Tox. (2 species)b
  870.37
  1/1/2010
  $152,450.48 
  $10,683.16 
Reproduction/Fertility Effectsb
  870.38
  1/1/2010
  $422,689.97 
  $10,683.16 
Salmonella Reverse Mutation Assay
  870.5265
  9/16/1996
  $9,792.46 
  $4,398.95 
In vivo Bone Marrow Cytogenetics
  870.5395
  2/27/2005
  $24,968.83 
  $4,398.95 
Developmental Neurotoxicityb
  870.63
  1/1/2010
  $754,982.00 
  $10,683.16 
Subtotal
  $1,600,554.48 
  $62,842.13 
Total 
$1,663,397 
Footnotes:
a Where multiple versions of a test have been assessed by EPA (e.g., covering different species or routes of exposure), the mean cost estimate is used. All testing costs are updated to 2014 dollars.
b Designated as "long duration" studies.



 
Sources: 
1. U.S. Bureau of Labor Statistics. July 2014, Employment Cost Index Historical Listing - Volume V. Series: All Private Workers Total Compensation (not seasonally adjusted).
2. U.S. EPA. 2013. Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branch. Filename: Standard Nano Test Costs 9-01-2013.xls.
3. Piccirillo 2004. Vincent Piccirillo, personal communication. September 20, 2004.

Table A-2 Updated TSCA Section 4 "Standard" Testing Battery Laboratory Costs (2018$), Per Chemical
Test Type
Corresponding EPA Guideline or Test ID
Test Cost (2018$)
Physicochemical Screening Tests
Melting Point
830.7200
$1,600
Boiling Point
830.7550
$1,012
Vapor Pressure 
796.1220
$3,065
log Kow
796.1950
$8,500
Water Solubility
830.7840
$11,800
Environmental Fate and Pathways
Ready Biodegradation
835.3110
$9,900
Aquatic Toxicity
Acute Toxicity to Daphnia
850.1010
$22,300
Total
$58,177

Appendix B: Overlap Model
In previous ICRs, estimates assumed that new actions occurred chronologically without consideration of overlap as shown in Figure 1. As a method to model such effects, EPA considers a scenario in which activities are run in sequence, compared to a scenario in which activities running with overlap. In conjunction with the change to the input value of "number of actions initiated each year" instead of a lumped input variable that contains overlap as well, the overlap model is developed as a factor to apply to the new input value which is the ratio of the overlap burden to the sequential burden (see the top panel of Figure 1). The purpose of the overlap factor is to account for burden from actions proceeding asynchronously and in parallel. Additionally, burden from actions with activities from previous ICR periods (carry-over activities) are captured. This appendix provides the details of developing the standardized overlap factor to apply in ICR burden estimation. Future ICR renewals can take into account the actual overlap and revise the model accordingly.
The overlap factor incorporated into this revised model is the ratio of burden that incorporates overlap considerations to the burden of that considers sequential implementation of the actions (see the bottom panel of Figure 1). The factor's numerator and denominator are modeled considering that certain activities for the action fall in certain years over the time span of the action, depending on the assumptions. For example, for three rules occurring in sequence, there is one study plan in years one, three, and six. But for the model considering overlap, there is one study plan in years one, two, and three. An overlap factor greater than one accounts for the fact that the actions are proceeding asynchronously with activities for each contributing action overlapping, even though action initiations are staggered.
Previous ICR estimates model did not account for this overlap as a separate factor, and the model presented in Figure 1 provides a standardized method to be used with a simplified load variable for "number of actions initiated each year." This generic model is based on assumptions of 1 rule with 1 chemical and 1 sponsor. After accounting for the burden associated with each type of activity under the nominal framework described in Section 5, the overlap factor (burden with overlap accounting divided by burden without overlap) is equal to 2.8. 
For each chemical, the unit burden and cost estimates from the previous ICR remain the same under the revised model. These estimates are then adjusted by the overlap factor, as well as any other additional factors to consider such as the number of chemicals per action (see Table C-1 for assumptions) to estimate total burden and costs. In sum, the overlap model facilitates scaling up or down any of the unit-level burden and cost estimates based on changes to program inputs for "number of actions initiated per year."
Figure 1. Overlap Factor Model to Account for Asynchronous, Parallel Activities under Separate Actions


Appendix C: Derivation of Program Input Information
The Fees for the Administration of the Toxic Substances Control Act rule (2018) basis for "number of expected actions under full implementation" for TSCA section 4 are derived using data from TSCA High Production Volume (HPV) TSCA section 4 actions (EPA, 2018b, 2018c). The metrics of ICR renewals are not as specific as the metrics of the Fees rule, as they reflect prospective generic assumptions to be used in ICR renewals every three years. Updating the standardized assumptions of the ICR revision based on experience, and mapping results to the conditions of the Fees rule produces the results in Table C-1. The structure of the assumptions in the ICR differ from those of the Fees rule, but on balance provide overstated burden estimates. The assumption that the testing is conducted over three years (instead of two years for rules and ECAs, or one year for test orders) understates the burden. However, other assumptions more than compensate, leaving the estimates overstated:
One sponsor per chemical (instead of four)
10 tests per chemical (instead of seven)
Overlap Factor of 2.8 (derived based on three years with each new action staggered by one year)
Table C-1: Translating Fees Rule information to ICR Bases
Type of Action
Fees Rule
ICR

Number of Actions Initiated Per Year (New Actions)
Associated Number of Chemicals1
Number of Sponsors per Chemical Tested
Notes on Overlap, Action Duration, and Tests Per Chemical
New Actions per Year
Associated Number of Chemicals
Duration; Overlap Factor2
Simplifying Assumptions(Standardized for all types of actions)
Test Rule
0.5
7
4
One new action every other year and 2 year durations per action; 7 tests per chemical
0.5
7
3 years 2.8 overlap factor
1 sponsor per chemical 
7 tests per chemical tested 
Test Order
10
7
4
No overlap, as duration is one year or less; 7 tests per chemical
10
7
3 years2.8 overlap factor

Enforceable Consent Agreement
0.5
7
4
One new action every other year and 2-year durations per action; 7 tests per chemical
0.5
7
3 years2.8 overlap factor

Footnotes:
1 The assumption of 7 chemicals per action is used in several calculations in the Fees Rule EA, including the section 4 industry opportunity costs (Section 5.1.2) and the number of small businesses (Section 3.4.2.A). However, the justification for the program cost estimates states that each TSCA section 4 action covers one to five chemicals (Section 3.2.2).
2 See Figure 1 for a visual rendering. 
   

Appendix D: ICs for TSCA Section 4 Actions Under a Generic ICR
Note that this is a generic ICR, and as such, EPA is requesting generic clearance for the types of activities discussed in this ICR. EPA intends to submit to OMB for review and approval individual Information Collections (ICs) for specific collections of information. For more information about generic ICRs, see OMB's website on Federal Collection of Information: https://www.whitehouse.gov/omb/information-regulatory-affairs/federal-collection-information/
Appendix E: Additional Information on Methodology
Note that it is particularly challenging to design the burden estimate calculations for TSCA section 4 ICR revisions. Any given action contains its own unique set of testing specifications. There may be one or more chemicals -- or even a family of chemicals involved. The tests are specific to the chemical(s) and action, with highly varied counts of tests, test durations, and cost per test. 
New issues addressed in this ICR revision are workflow effects and updates in ICR renewals to reflect regulatory conditions. EPA reviewed workflow during an ICR period and considered the nature of the workflow effects on burden for TSCA section 4 actions. Workflow effects include:
       The nature of burden incidence for respondents to TSCA section 4 actions is intermittent and irregular. 
       Activities do not occur on a set calendar schedule, but rather on an incidental basis, depending on the details of the particular action. 
       Once an action is initiated, a number of activities of differing frequencies follow. 
       The timeline for a single action's related activities can stretch out over multiple years, as tests can be conducted over an extended period of time. 
The overall magnitude of the burden for the ICR is determined by the sum effect of all actions' requirements with associated activities. However, for purposes of this methodology discussion, only one type of action is considered  -  test rules.  Figure 2 presents the nature of burden incidence in real time (top section) compared to levels of burden estimated in ICR renewals (bottom section). Note that at the times that a larger than anticipated burden is incurred, EPA program staff must prepare and submit a worksheet correction to OMB, as depicted for two incidents in  between Years 3 and 6. Although worksheet corrections are a standard procedure for updating the OMB inventory, to the extent that known effects for TSCA section 4 actions can be anticipated in the ICR revision, EPA believes such effects should be included in the ICR revision's burden and cost estimates. 
Figure 2. Comparison of Actual Burden to ICR Estimates for One Type of TSCA Section 4 Action (Test Rules)

EPA also reviewed the issue of updating burden estimates to reflect anticipated regulatory conditions for the upcoming ICR renewal period. Historically, EPA has taken a "placeholder" approach in which a set of generic assumptions are used for calculations, with the understanding that actual conditions can appreciably differ. Periodically -- typically during ICR Renewals -- updates to counts for number of actions and number of chemicals tested per action (or simply "number of chemicals tested within a type of action") are applied to estimates to reflect the intensity of the regulatory conditions. For purposes of this methodology discussion, these updates are referred to as "load projections," which differ from methodology changes to standardized estimates and generic assumptions.
In this stage of the methodology evolution, EPA makes changes to methodology to address the two of overlap estimation and load projections. EPA implements a new standardized estimate for overlap, the overlap model. The model constitutes a new standardized estimate designed to capture the activity patterns shown in Figure 1, as applicable to the requirements of TSCA section 4 actions. EPA is also revising the definition for load projection updates to the number of chemicals undergoing testing in new actions initiated annually. Further details are provided below.
As an overview of methodology components, the standardized estimates and generic assumptions of ICR estimates (defined to meet Objective 1 -- reflect the nature of the information collection) must be highly inclusive of the considerations in Figure 1, including the complexity of multiple activities of varying frequencies associated with activities per single chemical tested, as well as the complexity of multiple actions (of the same type) in effect asynchronously. To better address Objective 2 -- provide ease in future updates, the dynamics of carry-over and overlap on total burden are separated from load projection for the ICR period and handled in a standardized overlap model. The new definition for load projection as number of new rules initiated per year with an average of number of chemicals undergoing testing or more simply, chemicals newly tested in TSCA section 4 actions. This change in methodology replaces the complex load projection that requires EPA program staff to consider both factors (load projection and overlap) lumped together. The next section provides a comprehensive summary of methodology features by objective.
Objective 1 -- reflect the nature of the information collection -- is met by extending work from previous ICR renewals to improve upon the standardized estimate. The key estimate is a standardized unit burden that is generic for test rules, test orders, and ECAs. The unit burden contains activities bundled according to a chemical undergoing testing in a TSCA section 4 action. The unit of analysis for this unit burden chemical tested is a TSCA section 4 action pertaining to the overall submission from a sponsor for the rule, order, or ECA. Prior to this ICR revision (EPA, 2016, 2018a), key features include:
Define response unit as "per chemical tested within an action (e.g., test rules, test orders, ECAs)." Bundling activities to a basis of "per chemical" combines activities of irregular occurrence and differing frequencies to a single metric. This feature shifts the analytical focus away from individual activities and considers a sponsor's overall submission as a bundle of activities, providing a roll-up for the submission. The bundled approach has several advantages. In bundling activities, the irregular frequencies are appropriately weighted across the whole submission. Analysts do not have to repeatedly revisit calculations activity-by-activity. The method minimizes sources of error and document production costs. Additionally, the resultant unit burden estimates are useful for communication purposes, as shown, for example in Table 2's total burden estimate. 
Apply the standardized unit burdens per submission for use in multiple types of actions (rules, orders, ECAs).
Simplify with the standardized unit burden with generic assumptions: 
One sponsor per chemical, and
Battery of seven tests per chemical with an associated cost at $58,177 (see details in Appendix A)
As a new enhancement in this ICR revision, EPA employs a model for overlap to account for carry-over burden from previous ICR periods plus the additive effect of concurrent actions' burden effects on the total burden (see illustration in ). EPA is using a standardized estimate for overlap derived based on three years' duration per action with each new action staggered by one year, which leads to an overlap factor of 2.8 (see details in Appendix B). When the factor is applied, for example, the number of chemicals tested in a TSCA section 4 action is multiplied by 2.8 to account for the effect of staggered intermittent burden as portrayed in Figure 2. Use of this new model adds to the list of key features above:
Account for carry-over and overlap effects separately from new action initiations/load projections.
Objective 2 -- provide ease in future updates -- is related to the new model for overlap described above. Historically, load projections for the ICR required the program staff to consider overlap dynamics as part of the specification set for "number of actions (i.e., rules) per year" and "number of chemicals per action." The input is rather subjective, requiring a knowledge of specific rules in progress at the same time as considering potential future rules and probability of implementation. In this ICR revision, the input metric is simplified, for example, to "number of rules initiated each year" and "average number of chemicals per (new) rule" without need to consider carry-over and overlap which is handled via a standard overlap model. 
Objective 3 -- enable minimal changes during the ICR period -- is accomplished by making the estimate comprehensive and sufficiently inclusive of all known considerations for the three-year ICR renewal period. The continued implementation of key principles employed in previous ICR renewals, plus accounting for overlap specifically (as described for Objective 1), the use of concise metrics for updating load projections work in concert to assure that Objective 3 is met.   
The revised methodology of this ICR revision reflects a continued shift to standardized estimates and generic assumptions in recognition that the estimates are being used to provide a placeholder function in the OMB burden inventory pending possible further revision based on data from TSCA section 4 actions. In future ICR renewals, when loads projections are updated, the standardized estimates and generic assumptions can be revised (i.e., calibrated) to better reflect the actual conditions and EPA experience (e.g. number of tests per chemical undergoing testing, test durations, and test costs). In this plan for continued methodology revisions with updates to standardized estimates and generic assumptions, EPA provides accurate burden estimates, but avoids conveying a false sense of precision in ICR estimates themselves.
Beyond methodology enhancements, this ICR revision contains analyses for purposes specific to changes anticipated in the upcoming ICR period:
   Analysis of the conditions used for the Fees for the Administration of the Toxic Substances Control Act rule (2018) and translation to load projections for this ICR (provided in Appendix C)
   Incorporation of new activities related to the Lautenberg Act requirements
      Respondent substantiation of confidentiality claims
      Agency reviews of confidentiality claims
For reference, the respondent burden estimates are organized in this section according to the following types of information collection activities:
   CDX Registration for e-Reporting
   Initial Response, Test Rules
   Study Plan, Test Rules
   Test Results, Test Rules
   Initial Response, Test Orders
   Study Plan, Test Orders
   Test Results, Test Orders
   Voluntary Initial Contact, ECAs
   Study Plan, ECAs
   Test Results, ECAs
   Voluntary Robust Summaries for Test Rules, Test Orders
   Voluntary Data Submissions
   Testing Costs (Non-Labor Costs)
Appendix F: Specific Data Items Requested
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. This approach is explained in more detail in EPA's statement of policy for making findings under TSCA section 4(a)(1)(B) in the Federal Register of May 14, 1993 (58 FR 28736, 28738-39; FRL-4059-9). Note that the TSCA sections that were previously enumerated as 4(a)(1)(A) and (B) are now enumerated as 4(a)(1)(A)(i) and 4(a)(1)(A)(ii), respectively.
In addition to submitting the specified information to EPA, respondents may also need to submit a letter of intent, study plans and progress reports, or an exemption application. Respondents must also maintain certain records related to the testing.
The specific requirements and procedures governing testing ECAs, test rules, and exemption from test rules are found in 40 CFR part 790. The requirements regarding Good Laboratory Practice standards (GLPs) are found in 40 CFR part 792, the various test guidelines that are incorporated into the individual test rules are in 40 CFR parts 795 through 799, and the chemical specific testing requirements are in 40 CFR part 799.
The following is an overview of the specific requirements for each type of activity:
Test Rules  -  EPA may promulgate a rule describing what type of testing must be performed on the chemical and specifying specific test guidelines that have been published by the EPA or alternative methods proposed by industry and approved by EPA as test methods. In combination with the GLPs requirements, these guidelines or methods provide the TSCA-mandated standards (TSCA section 4(d)) for development of adequate and reliable information. Records concerning information developed according to these standards must be retained for a minimum of ten years, as described in GLP standards. Information collections under TSCA section 4(c) are designed to reduce the burden of duplicative testing under test rules. As such, test rules generally require testing of only a single representative chemical and all chemicals subject to the test rule are assumed to be equivalent to it.
Test Orders  -  EPA may promulgate an order describing what type of testing must be performed on the chemical and specifying specific test guidelines that have been published by the EPA or alternative methods proposed by industry and approved by EPA as test methods. In combination with the GLPs requirements, these guidelines or methods provide the TSCA-mandated standards (TSCA section 4(d)) for development of adequate and reliable information. Records concerning information developed according to these standards must be retained for a minimum of ten years, as described in GLP standards. Information collections under TSCA section 4(c) are designed to reduce the burden of duplicative testing. As such, test orders generally require testing of only a single representative chemical and all chemicals subject to the test order are assumed to be equivalent to it.
Enforceable Consent Agreements (ECAs) -  EPA may negotiate an ECA under which manufacturers agree to conduct specific testing and submit the information to EPA. The ECA describes what type of testing is to be performed on the chemical and which test guidelines need to be followed to generate the information sought. 
As with test rules, the test guidelines have either been published by EPA or another organization (e.g., OECD), or involve alternative methods proposed by industry and approved by EPA as test methods. In combination with the GLPs requirements, these guidelines or methods provide the TSCA-mandated standards (TSCA section 4(d)) for development of adequate and reliable information. Records concerning information developed according to these standards must be retained for a minimum of ten years, as described in GLP standards. Information collections under TSCA section 4(c) are designed to reduce the burden of duplicative testing. As such, test rules and ECAs generally require testing of only a single representative chemical and all chemicals subject to the ECA are assumed to be equivalent to it.
Testing Exemption Applications  -  TSCA section 4 allows an entity subject to a test rule or test order to apply for an exemption from the testing requirement if that testing will be, or has been, conducted by another party. Any manufacturer or processor subject to a test rule or order may submit an application to EPA for an exemption from performing any or all of the tests required under the test rule or order. The exemption application process and requirements for test rules are set out in 40 CFR Part 790, Subpart E. The exemption application, which generally must be filed within thirty days after the effective date of the test rule, must identify the test rule, the chemical, and the Chemical Abstract Service Registration Number (CASRN) of the test substance on which the application is based, and the specific testing requirement(s) from which an exemption is sought, along with the basis for the exemption request. An exemption application will generally be approved if a letter of intent to conduct the testing has been received from another party; if a study plan submitted by another party has been approved; or if the data needs identified in the test rule have been satisfied by another party. A procedure is provided for the appeal and hearing of the denial of an exemption application. Exemptions are also only relevant for testing requirements in test rules.
Voluntary Data Submissions  -  Unrelated to any test rule or other testing requirement or agreement, chemical manufacturers may voluntarily submit data to EPA at any time. Historically, voluntary data submissions have been provided as paper submissions. However, these submissions may be provided electronically through CDX, and it is anticipated that such submissions would be provided electronically in the future when applicable. Should submitters decide to do so, EPA simply asks that submitters follow the same procedures for preparing their package and completing their submission as test rule respondents. Since such data submissions are entirely voluntary and based on decisions in which EPA is not a participant, EPA can only provide a general estimate of potential burden and costs associated with such submissions, guided generally by past such submissions, which have been rare. In doing so, EPA believes that the potential costs and burdens for such voluntary submissions are captured in this information collection request. 

