1 **Supporting Statement for a Request for OMB Review under**

**The Paperwork Reduction Act**
**1 IDENTIFICATION OF THE INFORMATION COLLECTION**  **1(a) Title of the Information Collection**  **Title: TSCA Section 4 Test Rules, Enforceable Consent Agreements (ECAs),**  **Voluntary Testing Agreements (VTAs), Voluntary Data Submissions, and Exemptions from Testing Requirement**  **EPA ICR No.: 1139. 11**  **OMB Control No.: 2070 -**  **0033 1(b)**  **Short Characterization/Abstract** This information collection request (ICR) covers the submiss ion of test data to the Environmental Protection Agency (EPA) to support the decision making process for an industrial chemical under the Toxic Substances Control Act (TSCA) (15 U.S.C. 2601). 1 Under TSCA, EPA has the authority to issue regulations designed to gather health/safety and exposure information on, require testing of, and control exposure to chemical substances and mixtures. Drugs, cosmetics, foods, food additives, pesticides, and nuclear materials are exempt from TSCA. EPA's TSCA Inventory

currently contains over 70,000 existing chemicals. The TSCA Inventory is a compilation of the names of all existing chemical substances along with their respective Chemical Abstract Service (CAS) Registry numbers, production/importation volume ranges, and specif ic sites of production/importation. Chemicals produced in annual volumes above 1 million pounds are considered High Production Volume or "HPV" chemicals. This subset of 3,000

- 4,000 HPV chemicals is the main focus of OPPT's Existing Chemicals Data Collectio n and Data Development (Testing) activities. Data on chemicals that are collected or developed are made accessible to the public and are intended to provide input for efforts to evaluate potential risk from exposures to these chemicals. As stated in Secti on 2 of TSCA, "It is the policy of the United States that adequate data should be developed with respect to the effect of chemical substances and mixtures on health and the environment and development of such data be the responsibility of those who manufac ture and those who process such chemicals and mixtures." Section 4 of TSCA gives EPA the authority to require chemical manufacturers and processors to test existing chemicals. Under Section 4, EPA can b y rule require testing after finding that (1) a chemi cal may present an unreasonable risk of injury to human health or the environment, and/or the chemical is produced in substantial quantities that could result in significant or substantial human or environmental exposure, (2) the available data to evaluate the chemical are inadequate, and (3) testing is needed to develop the needed data.

1 See also Attachment 1.2

The data collected under this I CR is designed to provide EPA with the necessary data on health effects, ecological effects and environmental fate to predict the probable i mpacts on human health or the environment of chemicals that may present an unreasonable risk. EPA uses the information collected to assess risks associated with the manufacture, processing, distribution, use or disposal of a chemical, and to support any ne cessary

regulatory

action with respect to that chemical. The Chemical Testing Program in EPA’s Office of Pollution Prevention and Toxics (OPPT) also works with members of the U.S. chemical industry and other interested parties to develop needed data via TSCA Section 4 Enforceable Consent Agreements (ECAs) and Voluntary

Testing Agreements (VTAs). ECAs and VTAs are usually less burdensome than formal TSCA rulemaking and allow EPA to consider agreed

- upon pollution prevention and other ty pes of product stewardship initiatives by the chemical industry

as a possible substitute for or adjunct to certain types of needed testing. The Chemical Testing Program requires the development of test data that provide critical information on health effects, ecological effects and environmental fate that enables EPA and others to properl y assess and manage health and environmental risks that may be posed by existing and new chemicals covered b y TSCA. The “universe” of existing chemicals on the TSCA Chemical Substances Inventory that may present the greatest potential health and/or environmental concerns have been and continue to be identified and refined through various existing chemical screening activities within OPPT. EPA also makes the testing data publicl y available to help the public understand the risks posed by exposure to chemicals and to facilitate the public’s involvement in environm ental decision

- making. (For more information go to: http://www.epa.gov/assessing

- and

- managing

- chemicals

- under

- tsca/data

- development

- and

information

- collection

- assess - risks .) In addition to developing test rules under TSCA section 4 that meet specific needs identified by

OPPT, EPA may

also develop such actions to meet the information needs of other offices within EPA and other agencies. For example, test data in the past have b een developed for EPA’s Office of Solid Waste and Emergency Response (OSWER), Office of Air and Radiation (OAR), and Office of Water (OW). EPA has also developed test rules to collect data that would also be used by other agencies, including the Occupation al Safety and Health Administration (OSHA), the Agency for Toxic Substances and Disease Registry (ATSDR), and the Organization for Economic Cooperation and Development (OECD), to name a few. OPPT may

also be required to develop a test rule under TSCA se ction 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 b y TSCA for which there are suspicions of toxicity or exposure and for which there are few, if any, ecological effects, environmental fate or health effects testing data. When the ITC designates chemicals for testing, EPA is required under TSCA section 4(e)(1)(B) to publish Federal Register notices either to initiat e proceeding under TSCA section 4(a) or to provide reasons for not doing so.3

In general, when the need for data is identified b y EPA, EPA may obtain the needed test data (1) b y issuing a test rule through notice and comment rulemaking, (2) through negoti ation with industry

and issuing an ECA, or (3) through commitments from industry as VTAs. The testing specified in a rule or ECA issued under TSCA section 4 only needs to be conducted once for each specified chemical. As such, only one of the entities that manufacture, import or process the specified chemical, or a consortia formed b y these entities, will conduct the specified testing and report the results of that testing to EPA. An entity subject to a test rule may also apply

for an exemption from the te sting requirement if that testing will be or has been performed b y another party

. Responses to the collection of information specified in a rule issued under TSCA section 4 are mandatory

(see 40 CFR part 790, Attachment 2), while responses to an ECA enter ed into under TSCA section 4 is only mandatory

for participants in the ECA. In contrast, participating in a VTA, or otherwise submitting data without a requirement, is completely voluntary

. The export notification provisions of TSCA section 12 apply to any exporter of a chemical subject to a rule or an ECA issued under TSCA section 4, regardless of their participation in the ECA or any related testing consortia. Respondents may

claim all or part of a document confidential. EPA will disclose information that is covered by a claim of confidentiality onl y to the extent permitted by, and in accordance with, the procedures in TSCA section 14 and 40 CFR part 2. EPA maintains an official record for all activities conducted under TSCA section 4 (rulemakings, ECA s, and VTAs). The official record consists of the documents referenced in a specific activity , an y public comments received during an applicable comment period, any test data developed (including letters of intent to conduct testing, exemption letters, stu dy plans, progress reports and the final study report), and other information related to the activity , including information claimed as CBI. The official record includes the documents that are phy sicall y located in the docket, as well as the documents that are referenced in those documents. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the Office of Pollution Preventio n and Toxics (OPPT) Docket, EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution Ave., NW, Washington, D.C. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holiday s.
**2 NEED FOR AND USE OF**  **THE COLLECTION 2(a)**  **Need/Authority for the Collection** TSCA section 2(b)(1) states that it is the policy of the United States that4 “adequate data should be developed with respect to the effect of chemical substances and mixtures on health and the enviro nment and that the development of such data should be the responsibility of those who manufacture [which is defined b y statute to include import] and those who process such chemical substances and mixtures.” To implement this policy , 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) 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 are insufficient data 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 data; or (B )(i) a chemical substance or mixture is or will be produced in substantial quantities, and (I) it enters or may reasonabl y be anticipated to enter the environment in substantial quantities or (II) there is or may be significant or substantial human exposure to such substance or mixture, (ii) there are insufficient data 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 data [.]” If EPA makes these findings for a chemical substance or mixture, the Agency must require that testing be conducted on that chemical substance or mixture. The purpose of the testing would be to develop data about the substance or mixture’s health and environmental effects where there is an insufficiency of data and experience in ord er to support a determination that the manufacture, distribution in commerce, processing, use or disposal of the substance or mixture, or any combination of such activities, does or does not present an unreasonable risk of injury to health or the environme nt. Once the Agency

has made a finding under TSCA section 4(a)(1), EPA may require any ty pe of health or environmental effects testing necessary to address unanswered questions about the effects of the chemical substance. EPA need not limit the scope of t esting required to the factual basis for the TSCA section 4(a)(1)(A)(i) or (B)(i) findings, as long as EPA finds that there are insufficient data and experience upon which the effects of the manufacture, distribution5

in commerce, processing, use, or dispos al of such substance or mixture or of any combination of such activities on health or the environment can reasonabl y be determined or predicted, and that testing is necessary

to develop the data. This approach is explained in more detail in EPA’s statement of policy

for making findings under TSCA section 4(a)(1)(B) (a.k.a. the “B” policy) in the Federal Register of May 14, 1993 (58 FR 28736, 28738

- 39; FRL

- 4059

- 9). The statute also specifies that EPA should give priority consideration to chemicals that the TSCA I TC places on the TSCA section 4(e) “Priority Testing List.” The I TC is an independent advisory

committee to the EPA Administrator that includes 14 U.S. Government organizations. The ITC was created under TSCA section 4(e) to: 1) review chemicals regulated by TSCA, 2) determine which chemicals need ecological effects, environmental fate or health effects test data and 3) add those chemicals with test data needs to the Priority Testing List and recommend them for testing or information reporting in May and November Reports to the EPA Administrator. (For more information about the ITC, see: http://www.epa.gov/assessing

- and

managing

- chemicals

- under

- tsca/interagency

- testing

- committee .) Although the Agency

may not have yet made the TSCA section 4(a) finding for a particular chemical substance, EPA may still cooperate with industry or others to identify

data gaps and develop testing plans to fill some or all of these gaps. These voluntary efforts help provide additional information about the many chemicals on the TSCA Inventory , and can be used to assess the potential risks associated with the manufacture, processing, distribution, use or disposal of the chemical, as well as allowing the Agency to establish a regulatory

agenda that focuses on those chemicals o f greater concern. The information collected through the Chemical Testing Program, whether submitted pursuant to a rule or ECA or voluntarily , provides critical information on health effects, ecological effects and environmental fate that enables EPA and others to properl y assess and manage health and environmental risks that may be posed by

existing and new chemicals covered b y TSCA. This information is also made publicly available to help the public understand the risks posed by

exposure to chemicals and to facilitate the public’s involvement in environmental decision

- making. **2(c) Practical Utility/Users of the Data**  Data collected under the Chemical Testing Program are used, in conjunction with exposure information, by EPA scientists to determine whether the subject chemicals are likely to present an unreasonable risk to human health or the environment. Furthermore, such information, considered in conjunction with toxicological and health effects data, ecological effects data, and environmental fate data , will be used by non - EPA scientists, professional industrial hygienists, other occupational health professionals and workers for hazard communication and right

- to
know purposes, including Safety Data Sheets (SDSs) and product labels required under OSHA re gulations. Additionally , data developed for chemicals used or produced in particular work sites will be useful in developing and/or maintaining comprehensive safety and health programs at those facilities. L ocal, state and county governments rely

on the A gency ’s ability to set health and6

environmental standards, as do other national governments. The paperwork related requirements imposed on the respondents as part of the Chemical Testing Program allow EPA to ensure that the necessary

testing data will be d eveloped, that the results meet basic scientific standards of acceptability

and adequacy , that unforeseen complications or issues can be addressed, and that the testing is progressing on schedule. If the test data submitted indicate that potentially unreasonable risks may exist, the data will be used by

EPA and the manufacturer to determine the appropriate action necessary to avoid or mitigate the risks. To date, EPA has used collected data to perform the necessary assessments that support such activi ties as the development of water quality criteria, hazardous waste listings, chemical advisories, and reduction of workplace exposures. EPA has also used the resulting assessments to identify

chemicals that may

not warrant additional regulation or concern, or should otherwise be treated as a low priority for further consideration. In addition, since EPA is required under TSCA section 4(d) of TSCA to publish a Federal Register notice announcing the receipt of test data developed under a TSCA section 4 rule, the data collected may

be used by

other agencies and interested parties. Since 1979, approximately 230 of the 15,000 chemicals on the TSCA Inventory that are, or have been, produced in quantities greater than 10,000 pounds per year have been the subject of testing actions within the OPPT Existing Chemicals Testing Program. Virtually all of the 230 chemicals are “High Production Volume (HPV) chemicals.” The testing actions taken to date include a mix of formal TSCA section 4 Test Rules and ECAs. In additio n, almost 250 formal TSCA section 4 “Decisions Not to Test” (DNTs) have been issued b y EPA to date. EPA maintains a listing on its website that identifies the TSCA chemicals for which testing data has been received b y EPA under TSCA section 4, along with b asic background information about the chemical, and available summaries of the testing results. 2

**3. NON**  **- DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION**  **CRITERIA 3(a)**  **Non -**  **Duplication** In general, the activities associated with collecting test data for chemicals regulated under TSCA is not duplicated by any other Agency

or office within EPA. TSCA is the only applicable authority to allow for such data collection, and TSCA specificall y assigns that authority to EPA. In addition, EPA takes several steps to ensure that its requests for data do not result in duplicative efforts by

those responding:

• A single submission of the data will satisfy the request.

• Prior to proposing a test rule or entering into an ECA, EPA searches the scientific literature, ho lds public information gathering meetings if deemed appropriate, and has discussions with industry representatives in order to determine what types of data have already been obtained about the chemical under consideration. The

2 Go to: http://www.epa.gov/oppt/chemtest/pubs/sumindex.html.7 Agency proposes a test rule o r enters into an ECA only after it has determined that necessary

tests have not yet been conducted.

• Exemption applicants are not required to supply information that the Agency can obtain by other existing processes. The equivalence information required provides verification that a chemical is the same. Often this information is CBI and only the manufacturer or processor of the chemical has this information. **3(b) Public Notice Required Prior to ICR Submission to OMB**  In proposing to renew this I CR, EPA w ill provide a 60

- day public notice and comment period. **3(c) Consultations**  Under 5 CFR 1320.8(d)(1), OMB requires agencies to consult with potential I CR respondents and data users about specific aspects of I CRs before submitting an I CR to OMB for review and approval. In accordance with this regulation and based on OCSPP Regulatory Coordination Staff guidance, EPA will submit questions by e - mail to potential I CR respondents and data users with respect to the renewal of this ICR. **3(d) Effects of Less Freq**  **uent Collection** Test rules and ECAs require the test sponsor to submit to EPA a letter that identifies who will be conducting the testing, study plans before beginning testing, and a final report that contains the study

results. Each exemption applicant i s required to submit an exemption application to EPA. In either case, each submission is intended to be a one

- time submission to EPA. L ess frequent collection would equate to no collection and could jeopardize EPA’s ability to ensure that testing is being conducted in accordance with the rules and ECAs, and to grant timely exemptions from test rules. **3(e) General Guidelines under the PRA**  The data retention requirements for test rules and ECAs exceed one of the PRA guidelines contained in 5 CFR 1320.6. Doc umentation records, raw data, and specimens pertaining to a test rule or ECA study are required to be retained for ten ye ars from the effective date of the applicable test rule or publication date of the ECA. These recordkeeping requirements are codified i n 40 CFR 792.195. This requirement is necessary to permit sufficient time to review results, perform appropriate risk assessments and, when necessary , to institute appropriate regulatory

control responses. L ong - term studies may take five years from the eff ective date of the final test rule or ECA to perform and submit to the Agency ; assessment of study results may require an additional one to two years of internal and external peer review; institution of regulatory

controls and legal challenges may require an additional two to three ye ars 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 ye ar period. In those regulatory cases whe re either the Agency ’s action or the data upon which it is based are challenged, it is8

imperative that all records, raw data, and specimens be available for f urther review or investigation. **3(f) Confidentiality**  In formation submitted to EPA in response to test rules and ECAs and in exemption applications is, in most cases, non

- confidential. If respondents wish to claim information submitted in response to a test rule or ECA to be confidential, they may do so. These claims will be handled according to the E PA procedures described in 40 CFR part 2 and the TSCA Confidential Business Information Security Manual, which call for careful protection of confidential business information. **3(g) Sensitive Questions**  No information of a sensitive or private nature is r equested in conjunction with this information collection activity , and this information collection activity complies with the provisions of the Privacy Act of 1974 and OMB Circular A

- 108. **3(h) Electronic Submissions**  On December 4, 2013, EPA finalized a r ule to require electronic reporting of certain information submitted to the Agency under TSCA sections 4, 5, 8(a) and 8(d). 3 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, including test rules and ECAs. Submitters must regis ter 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 (C ISS), and select the TSCA section 4 option for submitting test rule and ECA data. (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, L inux, 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 b y using the U.S. Mail and by the new requirement of electronic submission. Any new test rules will be made by electronic submission alone.
**4 THE RESPOND**  **ENTS AND THE INFORMATION REQUESTED 4(a)**  **Respondents/NAICS Codes** Respondents affected b y the collection activity may include, but are not limited to entities identified by

the North American Industrial Classification Sy stem (NAICS) codes within the following industry

categories:

3 Docket reference EPA

- HQ

- OPPT

- 2011

- 05199

**Type of Entity NAICS**  **Example of Potentially Affected Entities** Chemical Manufacturers and Importers 325, 324 Persons who manufacture (defined b y 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. **4(b) Information Requested**  **4(b)(i) Data Items**  EPA may require any

ty pe of health effects, ecological effects and environmental fate testing necessary

to address unanswered questions about the effects of a chemical substance. EPA need not limit the scope of testing required to the factual basis for the TSCA section 4(a)(1)(A)(i) or (B)(i) findings, as long as EPA also finds that there are insufficient data and expe rience upon which the effects of the manufacture, distribution in commerce, processing, use, or disposal of such substance or mixture or of an y combination of such activities on health or the environment can reasonably be determined or predicted, and that testing is necessary to develop such data. This approach is explained in more detail in EPA’s statement of policy for making findings under TSCA section 4(a)(1)(B) (frequently described as the “B” policy) in the Federal Register of May

14, 1993 (58 F R 2873 6, 28738

- 39; FRL

- 4059

- 9). 4 In addition to submitting the specified test data 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 eac h typ e of activity : Test Rules

– EPA may

promulgate a rule describing what ty pe of testing must be performed on the chemical and specifying specific test guidelines that have been published by the EPA or alternative methods proposed b y industry and approv ed b y 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 data. Records concerning data developed according to these st andards must be retained for a minimum of ten ye ars, 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

4 Also available at http://www.epa.gov/oppt/chemtest/pubs/sct4rule.html10

require testing of onl y a single representative chemical substance and all chemicals subject to the test rule are assumed to be equivalent to it. Testing Agreements: ECAs and VTAs

– EPA may negotiate an ECA or VTA under which manufacturers agree to conduct specific testin g and submit the data to EPA. The ECA or VTA describes what ty

pe of testing is to be performed on the chemical and which test guidelines need to be followed to generate the data sought. Although EPA is wrappin g up the HPV Challenge Program 5 that was cove red in previous I CRs and employed the use of VTAs, EPA may still enter into individual VTAs in the future. As with test rules, the test guidelines have either been published b y EPA or another organization (e.g., OECD), or involve alternative methods propo sed b y industry and approved b y 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 data. Records concerning data devel oped 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 an d ECAs generally require testing of only

a single representative chemical substance and all chemicals subject to the ECA or VTA are assumed to be equivalent to it. Testing Exemption Applications

– TSCA section 4 allows an entity subject to a test rule to apply for an exemption from the testing requirement if that testing will be, or has been, conducted b y another party . An y manufacturer or processor subject to a test rule may submit an application to EPA for an exemption from performing any or all of the t ests required under the test rule. The exemption application process and requirements are set out in 40 CFR Part 790, Subpart E. The exemption application, which generall y must be filed within thirty days after the effective date of the test rule, must ide ntify 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 th e exemption request. An exemption application will generall y 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 an y t est rule or other testing requirement or agreement, chemical manufacturers may voluntarily

submit data to EPA at any time. Should they decide to do so, EPA simply asks that they

follow the same procedures for preparing their package and completin g their submission. Since such data submissions are entirely voluntary and based on decisions in which EPA is not a participant, EPA can onl y provide a general estimate of potential burden and costs associated with such submissions, guided generally by pa st 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.

5 A voluntary initiative under which manufacturers of HPV chemicals volunteered to develop and/or submit certain Organization for Economic Cooperation and Develop ment (OECD) screening level studies for the chemicals they manufacture. Additional information about this program is available at http://www.epa.gov/chemrtk/.11

**4(b)(ii) Respondent Activities**  **(1) 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 submi t the form electronicall y back to EPA. **(2) Document Preparation Activities**  Respondents may

undertake one or more of the following activities: (a) Review rulemaking and/or participate in ECA or VTA discussions. (b) Conduct searches for relevant existing data. If data are found: a. Determine whether the data are relevant; b. Prepare and review summary of existing data; and c. Submit summary

of existing data to EPA. (c) Submit “Letter of Intent” to EPA. (d) Plan necessary

activities, e.g., consortia, arran ge for conduct of studies, etc. (e) Prepare and submit periodic progress reports. (f) Record and prepare test data for submission (includes QA/QC reviews). (g) Prepare and review final report. (h) Review submission for CBI. (i) Submit final report with tes t data to EPA. (j) Maintain test data and final report in records. (k) Complete and submit testing exemption application, when applicable These activities may

vary based on the category

under which the activity

may occur: Test Rules

– Test rules require manufacturers/importers of the subject chemical substance to submit a letter identifying who is sponsoring the required testing and study plans before testing begins, semi

- annual progress reports, as applicable, during the conduct of the testing, and a fi nal report of the test results. Since data is ty pically required on a chemical basis

– as opposed to a manufacturer basis, test sponsors ty pically join forces to satisfy

the testing requirements. Testing Agreements : ECAs and VTAs

– Signatories to an ECA or VTA commit to provide data for the subject chemical substance, and ty pically adopt the same approach as that used for test rules. As such, one of the participants would take the lead to submit a letter identifyingwho is sponsoring the required testing and study plans 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 final reports and a Robust Summary of the test results.12

Testing Exemption Applications

– If an entity determines that they are subject to a testing requirement, but qualify

for an exemption, they

would submit a completed exemption application to EPA that requested the exemption and provided an appropriate rationale. Exemption applicants are not required to supply information that the Agency can obtain by other existing processes. Equivalence data are often confidential business information (CBI) and onl y the manufacturer or processor of the chemical has this information. In general, test rules reduces the burden associated with preparing exe mption 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 onl y its identity , address, a technical co ntact 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 data 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 data. Exemption app lications are not necessary for chemicals being tested under an ECA or VTA 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 submittin g data, because an exemption is never necessary when there is no requirement.
**5 THE INFORMATION COLLECTION**  **- AGENCY ACTIVITIES, COLLECTION**  **METHODOLOGY, AND INFORMATION MANAGEMENT 5(a)**  **Agency Activities** Data submitted under TSCA section 4 test rules, ECAs, or voluntarily are received b y OPPT, Chemical Control Division (CCD), Chemical Information and Testing Branch (CITB), where they

are reviewed for completeness and then routed to biologists, chemists, toxicologists, and wildlife scientists within OPPT to determine whether the subject chemicals are likel y to present an unreasonable risk to human health or the environment. If the data indicate that potential hazards may

exist, then these data

– coupled with exposure and use information received under the Chemical Information Reporting rule (CDR) and other information sources

– will be reviewed b y EPA staff. Once reviewed, these data may support possible risk management action. To date, EPA has collected data that have 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 Chemical Testing Program covered by this ICR, EPA must undertake the following activities: a) Review letters o f intent and study plans for completeness; b) Review progress reports;13

c) Review final reports for completeness, accuracy , adherence to test rule guidelines and GLPs; d) Process and review exemption applications; and e) Facilitate development of test rules , ECAs and VTAs, as appropriate. Related to the activities cited in (c) above, the Agency maintains a facility

inspection and test data audit program to ensure testing is done in compliance with GLPs. 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 test data, efforts to establish test guidelines or standards that may be used in the TSCA Chemical Testing Program, and international efforts relate d to chemical testing and associated testing issues. **5(b) Collection Methodology and Management**  For each chemical identified for testing within EPA’s TSCA Chemical Testing Program, the specific data requested, the testing necessary to generate those data , along with the test protocols, the time frame for completing the testing, and the date b y which the requested data are to be submitted to the Agency , are established in the TSCA section 4 Test Rule, ECA or VTA. Test data submitted to the Agency under the TSCA Chemical Testing Program are reviewed b y s cientists to determine whether or not the data developed are adequate for the purposes for which they

were gathered and to determine whether or not further regulatory action is necessary . In addition to bei ng housed in an appropriate EPA TSCA docket, references to the data are entered into the TSCA Test Submission Database (TSCATS). TSCATS is a publicly available, online index to unpublished, non

- confidential studies covering chemical testing results and oth er submitted studies on the possible effects of chemicals on health and ecological sy stems. Submitted studies are indexed in TSCATS under three broad categories: health effects, ecological effects and environmental fate. TSCATS contains information that is pertinent to risk assessment and hazard evaluation processes. 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 data are used b y federal and state agencies, rese archers, toxicologists, risk assessors, the regulated industry , attorney s, trade and professional associations as well as the public at large. TSCATS was developed by EPA in 1985 to make the results of ongoing and completed chemical testing available to th e public and includes chemical exposure studies, epidemiology , environmental fate, monitoring, episodic incidents, such as spills and case reports. There are four primary

types of documents referenced in the TSCATS database: TSCA section 4 chemical testi ng results, TSCA section 8(d) health and safety studies, TSCA section 8(e) substantial risk of injury to health or the environment notices, and voluntary documents submitted to EPA known as For Your Information (FYI) submissions. TSCATS is available through a number of electronic sources; the studies referenced in TSCATS can be viewed in EPA’s public TSCA docket located at EPA’s Headquarters in Washington, D.C., or, alternativel y, via microfiche copies that are available through the National Technical Infor mation Service (NT IS ). **5(c) Small Entity Flexibility** 14

The test rule process minimizes the burden on small businesses by giving them the option of fulfilling their responsibilities under a test rule by either joining a testing consortium or by applying for a test rule exemption. Participation in a testing consortium relieves the small business of direct responsibility for collecting or submitting test information as well as appl yi ng for an exemption. Under ECAs, small businesses are not required to participate, but if they do, they would participate as part of a consortium. Small businesses are also apportioned a smaller proportion of the cost of testing than their larger counterparts. The decision as to how the cost of testing is to be divided among these firms has, to date, been decided by the manufacturers subject to the rule or ECA. Generally , small businesses are assigned a proportion of the costs that is proportionate to their size and market share. However, if any party believes a particular reimburs ement arrangement is unfair, TSCA directs the Administrator of EPA to assist in resolving the conflict and the Agency will certainly consider the special needs of small businesses if such action becomes necessary . To date, no party has requested that the A genc y assist in reimbursement decisions. **5(d) Collection Schedule**  This information collection activity does not have a calendar

- based schedule. The testing period is defined b y the individual test rule, ECA, or VTA. 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 reason s described above, the collection is considered an “on occasion” collection. Also note that in this I CR renewal, the definition of a response (i.e., submission) is changed to include all testing activities associated with a chemical. See Section 6(a) for r evised methodology and Table 3 for a summary of ty pical activities per chemical over a three ye ar period, and on average annually

. **6 ESTIMATING THE BURDEN AND COST OF THE COLLECTION**  **6(a) Methodology and Assumptions**  The methodology

used to estimate the annual burden and costs to industry resulting from TSCA section 4 test rules, testing agreements, exemption applications, and voluntary submissions over the next three years has been revised starting with this I CR renewal. Two key changes are implemented . First, the response definition is changed from “per

- activity” to a “per

chemical” metric. A response is now defined as the collection of activities pertaining to the “standard” testing battery of ten tests (seven short

- term; three long

- term), all of which are performed on one specified chemical. This response definition provides the necessary structure for accurate and transparent scaling according to conditions for “number of chemicals” (e.g.,15

involved in a test rule). 6 Second, for test rules and t esting agreements, the annual rate for activities is rigorousl y calculated (i.e., prorated) to accuratel y reflect the assumption that long

term studies are three ye ars in duration. 7 The resultant unit burdens are in units of annual responses per chemical and are readil y used with revisions to conditions for test rules, testing agreements, voluntary

submissions, and exemption applications. Additionally , electronic reporting was implemented during the previous ICR period, requiring unit burden and suppl y cos t revisions. 8 The revised unit burden and cost estimates are combined with information on current conditions concerning the number and type (i.e., number of chemicals involved) of TSCA section 4 test rules, testing agreements, and voluntary submissions, all of which may result in industry submitting existing data or conducting new testing to provide EPA with information necessary to evaluate chemicals under its TSCA section 4 mandate. These assumptions are discussed in detail below. For reference, the re spondent burdens are organized according to OMB

- designated information collection (ICs) as follows:

• CDX Registrations for e

- Reporting

• Test Rules

• Testing Agreements: ECAs, and VTAs

• Voluntary

Submissions

• Testing Exemption Applications **Methodol ogy**  Respondent reporting (i.e., paperwork) burden and costs are derived herein. In addition to reporting burden, this analy sis provides estimates for certain non

- reporting costs. Note that a response is defined as the collection of related activities inv olving a battery of ten test s (seven short

- term; three long

- term), all of which pertain to one specified chemical. **(1) Reporting Burden and Costs**  Reporting burden and costs are based on the following activities: CDX registration, preparing letters of intent and study plans; preparing progress reports; preparing test results in final reports; preparing robust summaries; recording test results; conducting laboratory and/or corporate reviews; and recordkeeping.

6 In previous ICR renewals, the response unit was per activity (e.g., submit robust summary). As activities vary with respect to timing and relative weight (based on burden hours), the new definition provides a more coherent response definition. This was determined to be important under current conditions of very low counts of chemicals subject to TS CA section 4 test rules. However, for future reference the new method is robust to a wide variety of ICR conditions and easily applied to conditions of higher rule and chemical counts. 7 Un der the prior methodology, long

- term study activities were being counted every year thereby generating an “over count” (relative to short

- term studies) by a factor of three for the activity

- level burdens of long

- term studies. 8 The primary effects of the e

- reporting rule on burden estimates involve cutting recordkeeping burden to half its paper - based value, eliminating clerical burden in other activities, and adding an activity to account for electronic registration (see EPA 2013b). Additionally non

- labor costs are eliminated due to reductions in paper and postage costs. See Table D in Attachment 3 for a comparison of activity level burdens before and after e

- reporting.16

The burden estimates by

activity , and assoc iated supply costs are listed in Table A of Attachment 3. These estimates are based on estimates in the prior ICR, as updated for e

reporting. The wage rate information by type of labor (i.e., managerial, technical, clerical) is presented in Table B of Attachment 3. Detailed calculations provided in Sections 6(b)(i) through 6(b)(v) are based on these tables. The next section presents the estimates for non

- paperwork burden and costs for use in final summary tables (Section 6(d)(i)). The estimates for report ing burden are subsequentl y presented in Sections 6(b)(i)

- (v) for CDX registration, test rules, for testing agreements, voluntary submissions, and testing exemption applications, respectivel y. **(2) Non**  **- reporting Costs**  Non

- reporting cost estimates are bas ed on the following activities: organizing the testing program, obtaining and reviewing bids from laboratories, and submitting samples to the laboratory

for testing. For purposes of this ICR, as in past I CRs, EPA assumes that each chemical is likely

to per form the tests specified in a “standard” testing battery of ten tests. As shown in Table 1, seven of these studies are designated as short

- term as they are expected to conclude within the ye ar that they are initiated, and three of these studies are designated as long

term as they

will take three years to conclude. The costs presented in Table 1 are drawn from an EPA

- maintained listing of the laboratory

cost data for numerous TSCA and OECD test protocols (EPA 2013a). Estimates include non

- labor costs for anal yt ical chemistry method development and validation where it was judged that such method development would be necessary to conform to good laboratory practices. Short

- term and long

- term studies are assigned costs based on typical costs cited b y industry experts (Piccirillo, 2004). 9 Both labor and non

- labor test costs were adjusted to end

- of

ye ar 2014 dollars using an employ ment cost index (ECIvia US BLS 2014). The overall cost of the “standard” testing battery (per chemical) is estimated at $1,663,397.

9 Testing providers typically perform method development and validation in order to determine the effectiveness of an analytical method, as well as to det ermine the levels of the chemical in the dosing matrix in toxicity studies. Estimates were originally provided in 2004 dollars as $3,835 and $9,314 for short

- term and long

- term

studies, respectively.17

**Table 1: TSCA Section 4 “Standard” Testing Battery Costs (2014$), Per Chemical**

**Test Protocol Nam e**  **Protocol Number**  **Date of**

**Estimate Me**  **an 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 Effects b 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 Neurotoxicity b 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

- term" 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 An alysis Branch. Filename: Standard Nano Test Costs 9

- 01

- 2013.xls. 3. Piccirillo 2004. Vincent Piccirillo, personal communication. September 20, 2004. Based on experience, EPA assumes that the non

- reporting administrative costs associated with testing programs total approximately 25 percent of the laboratory costs, with the following components:
**• 15 percent of the test cost accounts for management of a**  **consortium.** This includes activities such as identifying manufacturers, meetings, organizing pay ment for testing, developing contracts for testing, and employing toxicologists who may be hired to provide technical expertise for the testing.
**• 10 percent o**  **f the test cost is used to cover the costs of technical experts.** These experts that may

work for the consortium and covers study review and site visits to the laboratory

. This amounts to a total of 25 percent of the test cost used to account for administering the testing consortium and the testing. In some cases, the actual burden of these activities may be18

undertaken b y an organization or individual contracted by the respondent and would be included as a cost. However, because respondents may und ertake some or all of these activities themselves, the burden is included in this analy sis. Applying these assumptions to the total reported laboratory

costs of $1,663,397 (as presented in Table 1), yields an estimate of $2,079,246 per chemical annual cost s. 10 Based on conditions reported later is this analy sis, the resultant total costs are presented in Table 2 at $27,030,195. **Table 2: TSCA Section 4 Total Laboratory and Non -**  **reporting Administrative Costs (2014$)** 

**Inform ation Collection**  **Number of Responde**  **nts a**  **Number of**

**Responses, each involving a 10**  **- test study**  **Administrative and Laboratory Costs**  **b** Section 4 Test Rules 10 10 $20,792,457.63 Testing Agreements 2 2 $4,158,491.53 Voluntary Submissions 1 1 $2,079,245.76 **TOTAL $27,030,195**  Footnotes: a See later sections (e.g. 6(b)(ii) for test rules) for discussion of assumptions regarding conditions for this ICR period. b Administrative non

- reporting costs are assumed to equal 25% of laboratory costs. **6(a)(ii) Assumptions: Respondents and**  **Activities in the Per -**  **Chemical Response** With the exception of voluntary submissions, electronic submissions are required. Therefore, estimates are made to assess burden and cost for respondents who are setting up first

time e

- reporting. Submitters are required to register with CDX and complete the electronic signature agreement. For purposes of this I CR, and consistent with most recent information on e

- reporting (EPA 2015), EPA assumes that 40% of respondents are new CDX submitters, yielding 8.4 respon ses annually

. 11 These respondents may be from firms that are new to EPA e

- reporting or they may be employees new to e
- reporting due to turnover within a firm that has prior experience with e

- reporting. With respect to test rules and testing agreements, EPA assumes that there will be one test sponsor for each chemic al substance subject to testing. 12 Incases where there is more than one

10 In the previous ICR, this estimate also included admin istrative reporting costs (4% of the total costs). For ease of presentation and accounting of non

- reporting versus reporting costs, this component is neglected. 11 In the ICR Renewal for Section 5 notices, 392 CDX registrations are reported (with one respon se per respondent) out of a total of 1,000 notices for PMN, SNUN, TME, LVE /LoREX, MCAN, TERA,Tier I and II notices (EPA 2015), EPA assumes that a similar percentage of respondents will register for CDX for purposes of TSCA section 4 submissions at 40%. T his assumption is made for simplification purposes. A precise accounting of submitters pertaining to TSCA section 4 CDX registration is implausible due to the fact that com panies may have already registered with CDX for purposes of submissions under other EPA programs e

- PMN, e

- CDR, or TRI

- ME web. 12 Under the previous ICR, EPA assumed that a given sponsor would manage chemical testing for five chemicals. In this ICR rene wal, with much lower counts for rules and chemicals per rule, EPA assumes that a given sponsor will manage chemical testing for one chemical. This change has no effect on estimates for total number of responses.19

manufacturer of the chemical subject to testing, it is assumed that the other manufacturers subject to the request for i nformation will participate in a consortium that is managed b y the test sponsor. Based on experience, EPA retains the same assumption that was used in past I CRs. For a specified chemical, each sponsor is expected to submit:

• one letter of intent and one set of study plans;

• five semi

- annual progress reports per long

- term study ; and

• one final report for each long

- term and short

- term study

. EPA estimates that 10 percent of the studies completed will be accompanied by a robust summary , yielding on e robust summary

. 13 Table 3 summarizes the activities overall for a three year period and derives the average annual frequency

to use in I CR estimates. For test rules, EPA assumes that conditions for the next I CR period will amount to the equivalent levels of burden and cost for two rules per ye ar with each involving five chemicals. For testing agreements, EPA assumes that there will be one agreement per ye ar involving one chemical.

13 Historically, r obust summaries have been developed in order to standardize how the technical information is presented and summari zed. Robust summaries have been adopted voluntarily and used by data submitters outside EPA programs.20

**Table 3: Test Rules and Testing Agreements Activities per Chemical Annually**

**Activity Section 4 Test Rule** 

**- OR** **** **Testing Agreement (CO, ECA, VTA) Total Counts**  **Three Year Period**  **Year 1 Year 2**  **Year 3 Average**  **Per Year Interim Reports**  Letter of Intent/Study Plans 1 1 0.33 Prepare Progress Report (for long

- term studies) 5 2 2 1 1.67 **Final Reports** Short

- term

Studies 7 2 2 3 2.33 Long

- term

Studies 3 3 1.00
**Robust Summaries** 1 1 0.33 Notes: 1. Note that a response is defined as the collection of related activities involving a battery of ten tests (seven short

- term ; three long

- term) all of which pertain to one specified chemical. See Table 1 for additional detail. 2. Additional detail is provided in Attachment 3. Table A lists detailed activities and applicable labor categories (i.e., manage rial, technical, clerical); Table B provides wage rates. 3. Long

- term studies are completed in three years; short

- term studies are completed in one year. 4. Averages per year are rounded for presentation purposes but are not rounded for calculations of total burden. For voluntary

submissions, given that the submission is unrelated to any agreement or other testing requirement, the related activities are more generic, involving final reports and the associated recordkeeping. Although the nature and frequency of such submissions cannot be predicted, EPA conservatively assumes, as in previous I CRs, that there will be one submission per year involving one chemical. Although submitters may use e

- reporting, at this time there have been no voluntary

submis sions and therefore no e

- reporting is assumed. Also in the same manner as in previous I CRs, each submission includes:

• ten final reports; and

• one robust summary (10%, as discussed above). For testing exemption applications, EPA assumes, as in previ ous ICRs, that two applications per ye ar, each involving one chemical will be submitted. Table 4 summarizes the assumptions on respondents and responses, b y typ e of information collection (I C).21

**Table 4: Respondents and Responses Summary**

**Information Collection:**  **CDX Registration**  **Test**

**Rules Testing** 

**Agreem ents:**  **COs, ETAs, and VCAs**  **Voluntary**

**Submissions Testing** 

**Exe mption**  **Applications** Number of Respondents 8.4 10 2 1 2 Number of Responses per Respondent 1 1 1 1 1 Number of Responses Total **8.4 10**  **2 1**  **2** Note: A response is defined as the collection of related activities pertaining to one specified chemical. **6(b) Estimating Respondent Burden and Cost**  To mirror the designated information collections (ICs) in the sy stem used for submitting the I CRs to OMB for approval, the burden and cost estimates are grouped as follows:

• CDX Registrations for e

- Reporting

• Test Rules

• Testing Agreements: COs, ECAs and VTAs

• Voluntary

Submissions

• Testing Exemption Applications The burden and cost estimates, unit labor costs, and unit supply costs 14 are listed according to detailed activity in Table A of Attachment 3. The wage rate information by typ e of labor (i.e., managerial, technical, clerical) is provided in Table B of Attachment 3. Detailed calculations that are presented in Sections 6(b)(i) through 6(b)(v) draw information from these tables. **6(b)(i) CDX Registration for e**  **- Reporting**  As a result of the final electronic reporting rule of 2013, and as of March 2014, respondents incur a small amount of additional burden and costs in carrying out the additional paperwork activities associated with e

- reporting. Activities that are needed to facilitate electronic submission include: CDX registration and CDX electronic signature. Table A in Attachment 3 provides unit burden and cost estimates based on the most recent on e

- reporting information as reported in the Section 5 ICR renewal supporting statement (EPA 2015). For purposes of this ICR, EPA assumes that 8.4 new submitters register annuall y for purposes of TSC A section 4 e

reporting. 15 These respondents may be from firms that are new to EPA e

- reporting or they may be employees new to e
- reporting due to turnover within a firm that has prior experience with e

reporting. Table 5 presents unit and total burdens/cos ts. The information presented in Table 5 is used to complete the IC entry for this group of collection activities under this I CR, as shown in Table 6.

14 Unit supply costs are only applicable to voluntary submissions, as all other submissions require electronic reporting. 15 See detailed footnote in Section 6(a)(ii).22

**Table 5: CDX Registration for e -**  **Reporting Respondent Unit and Total Burden/Cost (2014$)**  **Respondent Activities**  **Unit Burden per Registrant**  **(hours) Total** 

**Burden Unit Cost**  **Total Costs**  CDX Registration 0.180 1.512 $13.00 $109.20 CDX Electronic Signature 0.350 2.940 $25.28 $212.35 CDX Registration and e

- Signature t otal **0.530 4.452**  **$38.28 $321.55**  Notes: 1. Additional detail is provided in Attachment 3. Table A lists detailed activities and applicable labor categories (i.e., managerial, technical, clerical); Table B provides wage rates. Costs listed in this table are all labor costs. 2. Totals are obtained for 8.4 new registrations annually. **Table 6: IC Entry: CDX Registration IC Field:**  **EPA’s Estimates: a**  **1. Responses:** Total Number of Respondents 8.4 Number of Responses (chemicals) per Respondent 1.0 Time Period for Each Response Annual, on occasion Annual Frequency (times per year, per respondent) 1.0 **Annual Number of Responses b**  **8.4 2. Burden Hours:**  **Activities Time per**  **Response Hour per** 

**Response Annual Hour** 

**Burden** Reporting 0.530 0.530 4.452 Recordkeeping 0.000 0.000 0.000 Third

- party Disclosure

- 0

- - 0

- - **Total Burden Hours: 0.530**  **0.530 4.452** 23

**3. Capital and O&M Costs ( this does NOT include labor costs**  **): Activities**  **Cost per Response**  **Annual Cost** Reporting $0.00 $0.00 Recordkeeping $0.00 $0.00 Third

- party Disclosure

- 0

- - 0

- **Total Capital and O&M Costs: $0.00**  **$0.00 4. Annual Responses and Burdens:**  **Annual Totals Total Requested**  Annual Responses 8.400 Annual Hour Burden 4.452 Annual Cost (Non

- Labor) $0.00
a Based on details provided in the Tables presented earlier in this section. b The system uses this number as a multiplier to calculate the Annual Burden hours and costs. **6(b)(ii) T**  **est Rules** In this ICR TSCA section 4 test rule activity is anticipated from rules promulgated prior to this I CR period. Such test rules are still generating responses from sponsors because testing projects can have protracted timelines and/or can encounter delay s. Additionally , potential new rules promulgated in the next three years are considered as part of this ICR’s scope. For purposes of estimates for this ICR period, EPA assumes that both effects amount to the equivalent activity of issuing two rules annually with five chemicals per rule. Activities are as described in S ection 6(a)(ii), plus recordkeeping. Each chemical is evaluated b y performing the tests specified in the “standard” testing battery with seven short

- term and three long

- term tests, as portrayed in Table 1. The list of activities is the same for test rules and testing agreements with annual frequencies drawn from Table 3. Activity

- level and per

- chemical unit burdens reflect updates due to e

reporting (see Tables A and D in Attachment 3 for reference). **(1) Estimated Annual Respondent Burdens and Costs** 

**– Tes**  **t Rules** This section presents test rules unit burdens and costs, followed by total burden and cost. Table 7 presents components of unit burdens and unit costs for test rules (note these are the same for test rules and testing agreements). Given the unit values from Table 7, and appl yi ng the conditions of two rules per year and five chemicals per rule yi elds total burden and cost results presented in Table 8.24

**Table 7: Test Rules/Testing Agreements Respondent Annual Unit Burden and Cost ,**  **per Chemical (2014$)**  **Respondent Activities Average**  **per Year Burden per** 

**Activity (hours)**  **Unit**

**Burden (hours)**  **Cost per Activity Unit Cost per**  **Che mi**  **cal Interim Reports**  Letter of Intent/Study Plans 0.33 40.00 13.33 $2,888.80 $962.93 Prepare Progress Report 1.67 8.00 13.33 $577.76 $962.93 **Final Reports Short**  **- term** **Studies** 2.33 52.00 121.33 $3,803.44 $8,874.69 Recordkeeping 2.33 0.50 1.17 $15.63 $36.47 **Long -**  **term Studies**  1.00 89.00 89.00 $6,499.58 $6,499.58 Recordkeeping 1.00 0.50 0.50 $15.63 $15.63 **Robust Summaries** 0.33 12.00 4.00 $866.64 $288.88
**Totals 242.66**  **$17,641.11** Notes: 1. See Table 3 for derivation of activity "average per year." 2. Additional detail is provided in Attachment 3. Table A lists detailed activities and applicable labor categories (i.e., managerial, technical, clerical); Table B provides wage rates. Costs listed in this table are all labor costs. **Table 8: Test Rules Respondent Annual Total Burden and Cost (2014$)**
**Respondent Activities Unit Burden**  **per Chemical (hours)**  **Total Burden Unit Cost**  **per Chemical**  **Total Costs**
**Interim Reports** Letter of Intent/Study Plans 13.33 133.30 $962.93 $9,629.30 Prepare Progress Report 13.33 133.30 $962.93 $9,629.30 **Final Reports Short**  **- term** **Studies** 121.33 1,213.30 $8,874.69 $88,746.90 Recordkeeping 1.17 11.70 $36.47 $364.70 **Long -**  **term Studies**  89.00 890.00 $6,499.58 $64,995.80 Recordkeeping 0.50 5.00 $15.63 $156.30 **Robust Summaries** 4.00 40.00 $288.88 $2,888.80
**Totals** 242.66 **2,426.60** $17,641.11 $176,411.10 Notes: 1. Additional detail is provided in Attachment 3. Table A lists activities in greater detail and applicable labor categories (i.e., managerial, technical, clerical); Table B provides wage rates. Costs listed in this table are all labor costs. 2. Totals are obtained for two rules involving five chemicals each annually.25

**(2) IC Entry for Test Rules**  The information presented in Table 8 is used to complete the I C entry for this group of collection activities under this I CR, as shown in Table 9. **Table 9 IC Entry: Test Rules IC Field:**  **EPA’s Estimates: a**  **1. Responses:** Total Number of Respondents 10 Number of Responses (chemicals) per Respondent 1 Time Period for Each Response Annual, on occasion Annual Frequency (times per year, per respondent) 1 **Annual Number of Responses b**  **10 2. Burden Hours:**  **Activities Time per**  **Response Hour per** 

**Response Annual Hour** 

**Burden** Reporting 240.99 240.99 2409.90 Recordkeeping 1.67 1.67 16.70 Third

- party Disclosure

- 0

- - 0

- - **Total Burden Hours: 242.66**  **242.66 2426.60**  **3. Capital and O&M Costs ( this does NOT include labor costs**  **): Activities**  **Cost per Response**  **Annual Cost** Reporting $0.00 $0.00 Recordkeeping $0.00 $0.00 Third

- party Disclosure

- 0

- - 0

- **Total Capital and O&M Costs: $0.00**  **$0.00 4. Annual Responses and Burdens:**  **Annual Totals Total Requested**  Annual Responses 10 Annual Hour Burden 2,427 Annual Cost (Non

- Labor) $0.00

a Based on details provided in the Tables presented earlier in this section. b The system uses this number as a multiplier to calculate the Annual Burden hours and costs.26

**6(b)(iii) Testing Agreements: Enforceable Consent Agreements (ECAs) and** 

**Voluntary Testing Agreements (VTAs)** The specific testing required under future ECAs/VTAs cannot be predicted at this time because it is determined on a case

- by

- case basis. EPA assumes, as in previous I CRs, that there will be two agreements per year, each involving one chemical. Activities are as described in Section 6(a)(ii), including recordkeeping. Each chemical is evaluated b y performing the tests specified in the “standard” testing battery in Table 1. The test battery includes 10 studies per chemical (7 short

- term, 3 long

- term). The list of activities is the same for test rules and testing agreements with annual frequencies drawn from Table 3. **(1) Estimated Annual Respondent Burdens and Costs** 

**– Testing Agreements**  This section presents testing agr eement total burden and cost (see Table 7 for components of unit burdens and unit costs). Given the unit values from Table 7, and applying the conditions of two testing agreements per year and one chemicals per agreement yi elds total burden and cost result s presented in Table 10. **Table 10: Testing Agreements Respondent Annual Total Burden and Costs (2014$)**
**Respondent Activities Unit Burden**  **per Chemical (hours)**  **Total**

**Burden Unit Cost per** 

**Chemical Total Costs** 
**Interim Reports** Letter of Intent/Study Plans 13.33 26.66 $962.93 $1,925.86 Prepare Progress Report 13.33 26.66 $962.93 $1,925.86 **Final Reports** Short

- term

Studies 121.33 242.66 $8,874.69 $17,749.38 Recordkeeping 1.17 2.34 $36.47 $72.94 Long

- term

Studies 89.00 178.00 $6,499.58 $12,999.16 Recordkeeping 0.50 1.00 $15.63 $31.26 **Robust Summaries** 4.00 8.00 $288.88 $577.76
**Totals** 242.66 **485.32** $17,641.11 **$35,282.22** Notes: 1. Additional detail is provided in Attachment 3. Table A lists activities in greater detail and applicable labor categories (i.e., managerial, technical, clerical); Table B provides wage rates. Costs listed in this table are all labor costs. 2. Totals are obtained for two testing agreements involving one chemical each annually. **(2) IC Entry for Testing Agreements**  The information presented in Table 10 is used to complete the I C entry for this group of collection activities under this I CR, as shown in Table 11.27

**Table 11: IC Entry: Testing Agreements IC Field:**  **EPA’s Estimates:**  **a 1. Responses:**  Total Number of Respondents 2 Number of Responses (chemicals) per Respondent 1 Time Period for Each Response Annual, on occasion Annual Frequency (times per year, per respondent) 1 **Annual Number of Responses b**  **2 2. Burden**  **Hours: Activities**  **Time per Response**  **Hour per**

**Response Annual** 

**Hour Burden**  Reporting 240.99 240.99 481.98 Recordkeeping 1.67 1.67 3.34 Third

- party Disclosure

- 0

- - 0

- - 0

- **Total Burden Hours: 242.66**  **242.66 485.32**  **3. Capital and O&M Costs (this does NOT**  **include labor costs) :**  **Activities Cost per**  **Response Annual** 

**Cost Burden**  Reporting $0.00 $0.00 Recordkeeping $0.00 $0.00 Third

- party Disclosure 0 $0.00 **Total Capital and O&M Costs: $0.00**  **$0.00 4. Annual Responses and Burdens:**  **Annual Totals Total Requested**  Annual Responses 2 Annual Hour Burden 485.32 Annual Cost (Non

- Labor) Burden $0.00

a Based on details provided in the Tables presented earlier in this section. b The system uses this number as a multiplier to calculate the Annual Burden hours and costs. **6(b)(iv) Voluntary Submission**  EPA is unable to predict potential voluntary submissions, given none have been received to date. EPA conservatively assumes, as in previous, I CRs, that there will be one voluntary submission for one chemical annuall y. Activities are as listed in Section 6(a)(ii) plus associated recordkeeping.28

**(1) Estimated Annual Respondent Burdens and Costs** 

**– Voluntary Submissions**  This sect ion presents voluntary submission unit burdens and costs, followed by total burden and cost. Table 12 presents components of unit burdens and unit costs for voluntary submissions. Given the unit values from Table 12, and appl yi ng the conditions of two agre ements per year each involving one chemical, yields total burden and cost results presented in Table 13. **Table 12: Voluntary Submission Respondent Unit Burden and Cost (2014$), per Chemical Respondent**  **Activities Average** 

**per Year**  **Burden**

**per Activity**  **(hours) Unit** 

**Burden (hours)**  **Cost per Activity Unit Cost per Chemical** 

**Labor Cost**  **Unit**

**Supply Cost**  **Labor Cost Unit**  **Supply Cost**  **Cost Rob**  **ust Summaries** 1 12 12 $866.64 $0.00 $866.64 $0.00 $866.64 **Voluntary Submission Final**  **Reports** 10 10 100 $312.60 $8.41 $3,126.00 $84.10 $3,210. 10 Recordkeeping 10 1 10 $31.26 $0.00 $312.60 $0.00 $312.60 **Totals 122**  $4,305.24 $84.10 **$4,389. 34**  Note: Addi tional detail is provided in Attachment 3. Table A lists detailed activities and applicable labor categories (i.e., managerial, technical, clerical); Table B provides wage rates. **Table 13: Voluntary Submission Respondent Total Burden and Cost (2014$)**
**Respondent Activities Unit**  **Burden per**  **Chemical (hours)**  **Total**

**Burden Unit Cost per** 

**Chemical Total Costs** 

**Labor Cost**  **Unit**

**Supply Cost**  **Labor**

**Cost Unit** 

**Supply Cost**  **Total**
**Robust Summaries** 12 12 $866.64 $0.00 $866.64 $0.00 $866.64 **Voluntary Submission Final**  **Reports** 100 100 $3,126.00 $84.10 $3,126.00 $84.10 $3,210.10 Recordkeeping 10 10 $312.60 $0.00 $312.60 $0.00 $312.60 **Totals** 122 **122** $4,305.24 $84.10 $4,305.24 $84.10 **$4,389.34** Notes: 1. Additional detail is provided in attachment 3. Table A lists activities in greater detail and applicable labor categories (i.e., managerial, technical, clerical); Table B provides wage rates. 2. Totals are obtained for one voluntary submission involving one chemical annually. **(2) IC Entry for Testing Agreements**  The information presented in Table 13 is used to complete the I C entry for this group of collection activities under this I CR, as shown in Table 14.29

**Table 14: IC Entry: Voluntary Submissions IC Field:**  **EPA’s Estimates: a**  **1. Responses:** Total Number of Respondents 1 Number of Responses (chemicals) per Respondent 1 Time Period for Each Response On occasion Annual Frequency (times per year, per respondent) 1 **Annual Number of Responses b**  1 **2. Burden Hours: Activities**  **Time per Response**  **Hour per**

**Response Annual Hour** 

**Burden** Reporting 112 112 112 Recordkeeping 10 10 10 Third

- party Disclosure 0 0 0 **Total Burden Hours: 122**  **122 122**  **3. Capital and O&M Costs (this does NOT include labor costs)**  **: Activities**  **Cost per Response**  **Annual Cost**

**Burden** Reporting 84.10 84.10 Recordkeeping $0.00 $0.00 Third

- party Disclosure 0 0 **Total Capital and O&M Costs: $84.10**  **$84.10 4. Annual Responses and Burdens:**  **Annual Totals Total Requested**  Annual Responses 1 Annual Hour Burden 122 Annual Cost (Non

- Labor) Burden $84.10

a Based on details provided in the Tables presented earlier in this section. b The system uses this number as a multiplier to calculate the Annual Burden hours and costs. **6(b)(v) Testing Exemption Applications**  As indicated previousl y, an entity subject to a test rule may appl y 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 b y another party . There are basically two different scenarios under wh ich a chemical manufacturer might prepare and submit an application to be exempt from a testing requirement imposed by

a test rule. The first scenario involves a company who manufacturers the specified chemical for TSCA uses, but who will not be submitting the data because, for example, they joined a consortium that is expected to submit the data. The second scenario involves a company who manufacturers the covered chemical, but only for uses that are not covered by TSCA.30

In either case, it is difficult to predict how many exemption applications might be submitted to EPA in any

one year. EPA assumes, as in previous, I CRs, that there will be two applications annually , each involving one chemical. EPA also assumes that each application would request the exemp tion from all of the testing. Activities related to an exemption application are as listed in Section 6(a)(ii) plus associated recordkeeping. **(1) Estimated Annual Respondent Burdens and Costs** 

**– Testing Exemption**  **Applications** This section presents ex emption application unit burdens and costs, followed by total burden and cost. Table 15 presents components of unit burdens and unit costs for testing exemption applications. Given the unit values from Table 15, and appl yi ng the conditions of two exemption applications per year, each involving one chemical, yields total burden and cost results presented in Table 16. **Table 15: Testing Exemption Application Respondent Unit Burden and Cost (2014$), per Chemical**  **Respondent Activities Average**  **per Year Burden** 

**per Activity**  **(hours) Unit** 

**Burden per Chemical**  **(hours) Cost per** 

**Activity Unit Cost** 

**per Chemical**  **Exe mption Application**  1.00 8.00 8.00 $625.76 $625.76

Recordkeeping 1.00 0.50 0.50 $15.63 $15.63 **Totals 8.50**  **$641.39** Note: Additional detail is provided in Attachment 3. Table A lists detailed activities and applicable labor categories (i.e., managerial, technical, clerical); Table B provides wage rates. Costs listed in this table are all labor costs. **Table 16: Testing Exemption Application Respondent Total Burden and Cost (2014$)** 
**Respondent Activities Unit Burden**  **per Chemical**  **(hours) Total** 

**Burden Unit Cost per** 

**Chemical Total Costs** 

**Exe mption Application**  8.00 16.00 $625.76 $1,251.52

Recordkeeping 0.50 1.00 $15.63 $31.26 **Totals** 8.50 **17.00** $641.39 **$1,282.78** Notes: 1. Additional detail is provided in Attachment 3. Table A lists activities in greater detail and applicable labor categories (i.e., managerial, technical, clerical); Table B provides wage rates. Costs listed in this table are all labor costs. 2. Totals are obtained for two testing exemption applications involving one chemical annually. **(2) IC Entry for Testing Exemption Applications**  The information presented in Table 16 is used to complete the I C entry for this group of collection activities under this I CR, as shown in Table 17.31

**Table 17: IC Entry: Testing Exemptions Applications IC Field:**  **EPA’s Estimates: a**  **1. Responses:** Total Number of Respondents 2 Number of Responses (chemicals) per Respondent 1 Time Period for Each Response Annual, on occasion Annual Frequency (times per year, per respondent) 1 **Annual Number of Responses b**  **2 2. Burden Hours:**  **Activities Time per**  **Response Hour per** 

**Response Annual** 

**Burden** Reporting 8.00 8.00 16.00 Recordkeeping 0.50 0.50 1.00 Third

- party Disclosure 0.00 0.00 0.00 **Total Burden Hours: 8.50**  **8.50 17.00**  **3. Capital and O&M Costs (this does Not include labor costs)**  **: Activities**  **Cost per Response**  **Annual**

**Cost** Reporting $0.00 $0.00 Recordkeeping $0.00 $0.00 Third

- party Disclosure $0.00 $0.00 **Total Capital and O&M Costs: $0.00**  **$0.00 4. Annual Responses and Burdens:**  **Annual Totals Total Requested**  Annual Responses 2 Annual Hour Burden 17 Annual Cost (Non

- Labor) Burden $0.00

a Based on details provided in the Tables presented earlier in this section. b The system uses this number as a multiplier to calculate the Annual Burden hours and costs. **6(c) Estimating Agency Burden and Cost**  The cost and burden to the Agency to process, review, and anal yz e the information collected under TSCA section 4 test rules, testing agreements, voluntary testing programs, and testing exemption applications are discussed below and detailed in Tables 18 an d 19. Table 18 lists the documents submitted to the agency (same counts as provided earlier in industry respondent burden and cost sections). Table 19 derives unit and total Agency burden and costs. Costs are based on the assumption that the Agency collection procedures are accomplished, on average, b y a GS

- 13, Step 1 employee (see Table C in Attachment 3 for wage rate information).32

The estimated unit burden for processing letters of intent and study plans (three hours), progress reports (one hour) is the same as from the previous I CRs and is believed to be reflective of current conditions. The estimated unit burden for final reports, including thos e from short

term studies, long

- term studies, and from voluntary submissions is estimated at ten hours, as re vised to reflect current conditions. The estimated unit burden for the Agency to process and review each exemption application is estimated at six hours, as revised to reflect current conditions. The total annual Agency burden and costs is estimated at 554 hours and $38,553. **Table 18: Summary of Reports and Exemption Applications Received by the Agency Annually**

**Information Collection: Test**  **Rules Testing** 

**Agreem ents:**  **COs, ETAs, and VCAs**  **Voluntary**

**Submissions Testing** 

**Exe mption**  **Applications Total Number** 

**of Reports**  **Industry Number of Respondents** 10 2 1 2 **Industry Number of Responses per Respondent**  1 1 1 1 **Industry Number of Responses Total 10**  **2 1**  **2 Interim Reports**  Letter of Intent and Study Plans 3.33 0.67 4 Prepare Progress Report 16.67 3.33 20 **Final Reports Short**  **- term** **Studies Final Report** 23.33 4.67 28 **Long -**  **term Studies Final Report**  10.00 2.00 12 **Robust Summaries** 3.33 3.33 1.00 8 **Voluntary Submission Final Reports** 10.00 10 **Testing Exemption Applications** 2.00 2 **Total Number of Reports to the Agency 84**  Notes 1. See Table 3 for further explanation on test rule and testing agreement per

- chemical reporting activities, year

- by

- ye ar for a three year period. Averages per year are rounded for presentation purposes but are not rounded for calculations of total reports per yea r received by the Agency. 2. Number of reports for test rules and testing agreements is obtained by separately mu ltiplying the number of rules/agreements times the number of chemicals involved. A similar approach is taken for voluntary submissions and exemption applications.33

**Table 19: Annual Agency Burden and Cost Estimates (2015$)**

**Collection Activity Unit Burden and Cost**  **per Docum ent**  **Total Burden and Cost Unit**  **Burden (hours)**  **Rate Cost**  **Total Number of**  **Documents Total** 

**Burden (hours)**  **Total Costs**
Letter of Intent and Study Plans 5 $69.63 $348.16 4 20 $1,392.64 Progress Reports 1 $69.63 $69.63 20 20 $1,392.60 Final Reports 10 $69.63 $696.32 50 500 $34,816.00 Robust Summaries 1 $69.63 $69.63 8 8 $533.83 **SUBTOTAL 82**  **548 $38,135.07**  Exemption Applications 3 $69.63 $208.90 2 6 $417.79 **TOTAL 84**  **554 $38,552.86**  **6(d) Bottom Line Burden Hours**  **and Costs 6(d)(i)**  **Total Respondent Annual Hours and Costs** Table 20 summarizes the estimated annual reporting burden and cost according to OMB

designated information collections, along with the laboratory cost estimate. With respect to reporting burden and cost, EPA estimates that this I CR will impose a total of 3,156 burden hours annually with a per response burden hour between 8.5 and 243 hours per chemical (not including CDX registrations). The associated total estimated costs are $26,920, with a per response cost between $641 and $17,641 per chemical (not including CDX registrations). Adding CDX Registrations yi elds total reporting burden and cost of 3,055 hours and $27,242 (includes CDX per registration burden and cost at 0.53 hours and $38.28, resp ectivel y). Beyond the total reporting cost an additional $27 million is estimated for non

- reporting costs from laboratory testing.34

**Table 20: Estimated Total Annual Respondent Burden Hours and Costs (2014$) Total**  **Burden (hours)**  **Costs**

**Labor Non**  **- Labor**  **Total Test Rules**  Reporting 2,409.90 $17,589.01 $0.00 $17,589.01 Recordkeeping 16.70 $52.10 $0.00 $52.10 **+ Subtotal 2,426.60**  **$17,641.11 $0.00**  **$17,641.11 Testing Agreements**  Reporting 481.98 $35,178.02 $0.00 $35,178.02 Recordkeeping 3.34 $104.20 $0.00 $104.20 **+ Subtotal 485.32**  **$35,282.22 $0.00**  **$35,282.22 Voluntary Testing Submissions**  Reporting 112.00 $3,992.64 $84.10 $4,076.74 Recordkeeping 10.00 $312.60 $0.00 $312.60 **+ Subtotal 122.00**  **$4,305.24 $84.10**  **$4,389.34 Testing**  **Exemptions Applications** Reporting 16.00 $1,251.52 $0.00 $1,251.52 Recordkeeping 1.00 $31.26 $0.00 $31.26 **+ Subtotal 17.00**  **$1,282.78 $0.00**  **$1,282.78 Total Reporting**  **Burden/Cost 3,050.92**  **$58,511.35 $84.10**  **$58,595.45 CDX Registration**  Registration **4.452 $321.55**  **$0.00 $321.55**  **Laboratory Costs $27,030,194.92**  **TOTAL $27,089,112**  **6(d)(ii) Total Agency Annual Hours and Costs**  The total annual burden hours and costs for the government as detailed in Table 19, is estimated at 554 hours and $38,553. **6(e) Reasons for Change in Burden**  This request represents a decrease of 626,838 hours from that currently in the OMB inventory (from 629,893 to 3,055 hours). As shown in Table 21, this decrease is due mainly to corrections to the previous renewal of this collection, plus reduced levels of activity in test rules given the decrease from 90 responses to 10 responses (

- 82,960 hours). Additi onally , e - reporting produced burden reductions (

- 1,6 17 hours). Last, methodological corrections and updates produced newl y defined unit burdens and adjustments to total burden (

- 8,201 hours). The change associated with e

- reporting is a program change; the rest of the change is an adjustment.35

**Table 21: Reasons for the Change in Burden**

**Inform ation Collection**  **Previous ICR (as reported in**  **reginfo.gov Supporting**  **Statem ent)**  **Previous ICR**

**Correct ed**  **Calculations a**  **Changes ICR Renewal** 

**1) Calculation corrections to**  **previous ICR estim**  **ates 2) Reduction** 

**in Section 4 Test Rules**  **b 3) Program** 

**Change of e**  **- Reporting**  **c 4) Methodology** 

**Correction and Updates**  **d**

**Unit Total**  **Unit Total**  **Unit Total**  **Unit Total**  **Unit Total**  **Unit Total**  **Unit Total**  CDX Registration 0.53 4.45 0.00 0.00 0.53 4.45 Test Rules 263 6 20 , 1 91 263 93,690 0

- 524,106 0

- 82,960

- 31.00

- 1,350.00 10.66

- 6,953.40 242.66 2 , 426.60 Testing Agreements: COs, ETAs, and VCAs 263 9,4 31 263 2,002 0

- 7,429 0 0

- 31.00

- 270.00 10.66

- 1,246.68 242.66 485.32 Voluntary Submissions 23 253 23 123 0

- 130 0 0 0.00 0.00 99.00

- 1.00 122.00 122.0 0 Testing Exemption Applications 9 18 9 18 0 0 0 0

- 0.50

- 1.00 0.00 0.00 8.50 17.00
TO TAL 62 9 , 893 95,833

- 531,665

- 82,960

- 1,6 17

- 8,201 3,055 Footnotes: a Verification of totals from detailed calculations versus totals in IC Entry Tables confirmed that calculation errors occurred (US EPA 2013c).
b In the previous ICR, the conditions include six rules annually, each involving an average of 15 chemicals (90 responses). In this ICR renewal, conditions include two rules annually, each involv ing an average of 5 chemicals. Also, in the previous ICR it is assumed that each sponsor would support testing for 5 chemical s (10 responses).
c The primary effects of the e

- reporting rule on burden estimates involve cutting recordkeeping burden to half i ts paper
- based value, eliminating clerical burden in other activities, and adding an activity to account for electronic registration. Additionally non

- labor costs are eliminated due to reductions in paper and postage costs. See Table D in Attachment x. d Two key changes are implemented in the methodology update. First, the response definition is changed from a per

- activity to a per

- chemical metric. A response is now defined as the collection of activities pertaining to the “standard” testing battery of te n tests (seven short

- term; three long

- term), all of which are performed on one specified chemical. Second, for test rules and testing agreements, the annual rate for activities is rigorously calculated (i.e., prorated) to accurately reflect the assumption that long

- term studies are three years in duration. Additionally, for voluntary submissions, recordkeeping is reduced by 1 hour for consistency with test rules and voluntary agreements.36

**6(f) Burden Statement**  The annual public burden for this collection of information, which is approved under OMB Control No. 2070

- 0033, is estimated to range between 8.5 and 243 hours per response, not including CDX registration, and 0 .53 hours per CDX registration. Burden is defined in 5 CFR 1320.3(b). An a gency

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. The Agency

has established a public docket for this I CR 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 holiday s. 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, th e accuracy of the provided burden estimates and any suggested methods for minimizing respondent burden, including the use of automated collection techniques. Submit your comments, referencing Docket ID No. EPA

- HQ

- OPPT

- 2015

- 0436 and OMB Control No. 2070

- 00 33, to (1) EPA online using www.regulations.gov (our preferred method), or b y mail to: Document Control Office (DCO), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency , Mail Code: 7407T, 1200 Pennsylvania Ave., NW, Washingt on, D.C. 20460, and (2) OMB b y mail to: Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street, NW, Washington, DC 20503.37

**ATTACHMENTS TO THE SUPPORTING STATEMENT** Attachments to the supporting statement are available in the public docket established for this I CR under Docket ID No. EPA

- HQ

- OPPT

- 201 5

- 0436 . These attachments are available for online viewing at www.regulations.gov or otherwise accessed as described below. **Attach ment 1:**  15 U.S.C. 2603, Toxic Substances Control Act (TSCA), Section 4 **Attachment 2:** 40 CFR 790, Procedures Governing Testing Consent Agreements and Test

Rules **Attachment 3:** Economic Anal ys is Tables38

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- 01

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- HQ

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