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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 submission 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 

specific 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 Collection 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 Section 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 manufacture 

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 by rule require testing after 

finding that (1) a chemical 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 ICR is designed to provide EPA with the necessary data on 

health effects, ecological effects and environmental fate to predict the probable impacts 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 necessary 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 

types 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 properly assess and manage health and environmental risks that may be posed by

existing and new chemicals covered by 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 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. (For more information go to: 

http://www.epa.gov/assessing-and-managing-chemicals-under-tsca/data-development-andinformation-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 been 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 Occupational 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 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 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 initiate proceeding under TSCA section 4(a) or to provide reasons for 

not doing so. 
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In general, when the need for data is identified by EPA, EPA may obtain the needed test 

data (1) by issuing a test rule through notice and comment rulemaking, (2) through negotiation 

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 by 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 testing requirement if that testing will be or has been 

performed by 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 entered 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 only 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, ECAs, and VTAs). The official record consists of the documents referenced in a 

specific activity, any public comments received during an applicable comment period, any test 

data developed (including letters of intent to conduct testing, exemption letters, study 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 

physically 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 Prevention 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 

holidays.

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 that 
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“adequate data should be developed with respect to the effect of chemical 

substances and mixtures on health and the environment and that the development 

of such data 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.”

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 reasonably 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 order 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 environment.

Once the Agency has made a finding under TSCA section 4(a)(1), EPA may require any

type 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 testing 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, distribution 
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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 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 ITC places on the TSCA section 4(e) “Priority Testing List.” The ITC 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-andmanaging-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 of 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 properly assess and 

manage health and environmental risks that may be posed by existing and new chemicals 

covered by 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-toknow purposes, including Safety Data Sheets (SDSs) and product labels required under OSHA 

regulations.

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. Local, state and county governments rely on the Agency’s ability to set health and 
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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 developed, 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 activities 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 addition, almost 250 formal 

TSCA section 4 “Decisions Not to Test” (DNTs) have been issued by EPA to date. EPA 

maintains a listing on its website that identifies the TSCA chemicals for which testing data has 

been received by EPA under TSCA section 4, along with basic 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 specifically 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, holds 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.
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Agency proposes a test rule or 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 ICR, EPA will 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 ICR 

respondents and data users about specific aspects of ICRs before submitting an ICR 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 ICR respondents 

and data users with respect to the renewal of this ICR.

3(d) Effects of Less Frequent 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 is required to submit an exemption 

application to EPA. In either case, each submission is intended to be a one-time submission to 

EPA. Less 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. Documentation records, raw data, and specimens 

pertaining to a test rule or ECA study are required to be retained for ten years from the effective 

date of the applicable test rule or publication date of the ECA. These recordkeeping requirements 

are codified in 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. Long-term studies may take five years from the effective 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 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 the Agency’s action or the data upon which it is based are challenged, it is 
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imperative that all records, raw data, and specimens be available for further review or 

investigation.

3(f) Confidentiality

Information 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 EPA 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 requested 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 rule 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 register to use EPA’s Agencywide 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 

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, 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

new test rules will be made by electronic submission alone.

4 THE RESPONDENTS AND THE INFORMATION REQUESTED

4(a) Respondents/NAICS Codes

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:

 

3 Docket reference EPA-HQ-OPPT-2011-0519
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Type of Entity NAICS Example of Potentially Affected Entities

Chemical 

Manufacturers and 

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.

4(b) Information Requested

4(b)(i) Data Items

EPA may require any type 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 

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 

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 FR 28736, 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 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 TSCAmandated standards (TSCA section 4(d)) for development of adequate and reliable data. Records 

concerning data 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

 

4 Also available at http://www.epa.gov/oppt/chemtest/pubs/sct4rule.html
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require testing of only 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 testing and submit the data to EPA. The ECA or VTA 

describes what type 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 wrapping up the HPV Challenge 

Program5that was covered in previous ICRs 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 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 data. Records concerning data 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 and 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 by another party. Any manufacturer or processor subject to a test rule may submit an 

application to EPA for an exemption from performing any or all of the tests 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 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. Should 

they decide to do so, EPA simply asks that they follow the same procedures for preparing their 

package and completing their submission. 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. 

 

5 A voluntary initiative under which manufacturers of HPV chemicals volunteered to develop and/or submit certain 

Organization for Economic Cooperation and Development (OECD) screening level studies for the chemicals they 

manufacture. Additional information about this program is available at http://www.epa.gov/chemrtk/.
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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 submit the form electronically 

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, arrange 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 test 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 final report of the test results. Since data is typically required on a chemical basis – as opposed 

to a manufacturer basis, test sponsors typically 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 typically adopt the same approach as that used for 

test rules. As such, one of the participants would take the lead to submit a letter identifying who 

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. 
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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 only the 

manufacturer or processor of the chemical has this information. In general, test rules reduces 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 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 applications 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 submitting 

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 by 

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 likely 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 by 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 of 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 related 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 by 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 by scientists 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 being 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 other submitted studies on the possible effects of chemicals on health and ecological 

systems. 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 by federal and state agencies, researchers, toxicologists, risk assessors, the 

regulated industry, attorneys, 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 the 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 testing 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, 

alternatively, via microfiche copies that are available through the National Technical Information 

Service (NTIS).

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 applying 

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 reimbursement 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 Agency assist in reimbursement decisions.

5(d) Collection Schedule

This information collection activity does not have a calendar-based schedule. The testing 

period is defined by 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 reasons described above, the collection 

is considered an “on occasion” collection. Also note that in this ICR 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 revised methodology and Table 3 for a summary of typical activities per 

chemical over a three year 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 ICR renewal. Two key

changes are implemented. First, the response definition is changed from “per-activity” to a “perchemical” 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 testing agreements, the annual rate for 

activities is rigorously calculated (i.e., prorated) to accurately reflect the assumption that longterm studies are three years in duration.7

 The resultant unit burdens are in units of annual 

responses per chemical and are readily 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 supply 

cost 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 respondent 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

Methodology

Respondent reporting (i.e., paperwork) burden and costs are derived herein. In addition to 

reporting burden, this analysis provides estimates for certain non-reporting costs. 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.

(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 

TSCA 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

 Under 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 associated supply costs are listed in Table A of 

Attachment 3. These estimates are based on estimates in the prior ICR, as updated for ereporting. 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 reporting 

burden are subsequently presented in Sections 6(b)(i)-(v) for CDX registration, test rules, for 

testing agreements, voluntary submissions, and testing exemption applications, respectively.

(2) Non-reporting Costs

Non-reporting cost estimates are based 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 ICRs, EPA assumes that each 

chemical is likely to perform 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 year that they are initiated, and three of these studies are designated as longterm 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 analytical 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 by 

industry experts (Piccirillo, 2004).9 Both labor and non-labor test costs were adjusted to end-ofyear 2014 dollars using an employment cost index (ECI via 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 determine 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 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 Effectsb870.38 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 Neurotoxicityb870.63 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 Analysis 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 

payment for testing, developing contracts for testing, and employing toxicologists 

who may be hired to provide technical expertise for the testing.

• 10 percent of 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 be 
18

undertaken by an organization or individual contracted by the respondent and would be included 

as a cost. However, because respondents may undertake some or all of these activities 

themselves, the burden is included in this analysis. 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 costs.10 Based on conditions reported later is this analysis, 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$)

Information Collection

Number of 

Respondentsa

Number of 

Responses, each 

involving a 10-

test study

Administrative and Laboratory 

Costsb

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 firsttime e-reporting. Submitters are required to register with CDX and complete the electronic 

signature agreement.

For purposes of this ICR, and consistent with most recent information on e-reporting 

(EPA 2015), EPA assumes that 40% of respondents are new CDX submitters, yielding 8.4 

responses 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 chemical substance subject to testing.12 In cases where there is more than one 

 

10 In the previous ICR, this estimate also included administrative 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 response 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%. This 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 companies 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 renewal, 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 information will participate in a consortium that is managed by the test 

sponsor. 

Based on experience, EPA retains the same assumption that was used in past ICRs. 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 one robust summary.

13

Table 3 summarizes the activities overall for a three year period and derives the average 

annual frequency to use in ICR estimates. For test rules, EPA assumes that conditions for the 

next ICR period will amount to the equivalent levels of burden and cost for two rules per year 

with each involving five chemicals. For testing agreements, EPA assumes that there will be one 

agreement per year involving one chemical.

 

13 Historically, robust summaries have been developed in order to standardize how the technical information is 

presented and summarized. 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 

-ORTesting 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., managerial, 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 ICRs, 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 submissions and therefore no e-reporting is assumed. Also in the same 

manner as in previous ICRs, each submission includes:

• ten final reports; and

• one robust summary (10%, as discussed above). 

For testing exemption applications, EPA assumes, as in previous ICRs, that two 

applications per year, each involving one chemical will be submitted. Table 4 summarizes the 

assumptions on respondents and responses, by type of information collection (IC).
21

Table 4: Respondents and Responses Summary 

Information Collection:

CDX 

Registration

Test 

Rules

Testing 

Agreements: 

COs, ETAs, 

and VCAs

Voluntary 

Submissions

Testing 

Exemption 

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 system used for submitting 

the ICRs 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 costs14 are listed 

according to detailed activity in Table A of Attachment 3. The wage rate information by type 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 annually for purposes of TSCA section 4 ereporting.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 ereporting. Table 5 presents unit and total burdens/costs. The information presented in Table 5 is 

used to complete the IC entry for this group of collection activities under this ICR, 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 total 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 Responsesb8.4

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) Test Rules

In this ICR TSCA section 4 test rule activity is anticipated from rules promulgated prior 

to this ICR period. Such test rules are still generating responses from sponsors because testing 

projects can have protracted timelines and/or can encounter delays. 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 Section 

6(a)(ii), plus recordkeeping. Each chemical is evaluated by 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 ereporting (see Tables A and D in Attachment 3 for reference).

(1) Estimated Annual Respondent Burdens and Costs – Test 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 applying the 

conditions of two rules per year and five chemicals per rule yields 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 

Chemical

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 IC entry for this group of 

collection activities under this ICR, 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 Responsesb10

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 ICRs, 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 by 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 agreement 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 yields total burden and cost 

results 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 IC entry for this group of 

collection activities under this ICR, 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 Responsesb2

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, ICRs, that there will be one voluntary

submission for one chemical annually. Activities are as listed in Section 6(a)(ii) plus associated 

recordkeeping. 
28

(1) Estimated Annual Respondent Burdens and Costs – Voluntary Submissions

This section 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 applying the conditions of two 

agreements 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

Robust 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: 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.

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 IC entry for this group of 

collection activities under this ICR, 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 Responsesb

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 previously, 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 party. There are basically two different scenarios under which 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, ICRs, that there will be two applications 

annually, each involving one chemical. EPA also assumes that each application would request 

the exemption 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 exemption 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 applying 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

Exemption 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

Exemption 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 IC entry for this group of

collection activities under this ICR, 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 Responsesb2

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 analyze 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 and 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, by 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 ICRs and is believed to be reflective 

of current conditions. The estimated unit burden for final reports, including those from shortterm studies, long-term studies, and from voluntary submissions is estimated at ten hours, as 

revised 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 

Agreements: 

COs, ETAs, 

and VCAs

Voluntary 

Submissions

Testing 

Exemption 

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-year for a three year 

period. Averages per year are rounded for presentation purposes but are not rounded for calculations of total reports per year received 

by the Agency.

2. Number of reports for test rules and testing agreements is obtained by separately multiplying 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 Document 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 OMBdesignated information collections, along with the laboratory cost estimate. With respect to 

reporting burden and cost, EPA estimates that this ICR 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 yields 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, respectively). 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). Additionally, e-reporting 

produced burden reductions (-1,617 hours). Last, methodological corrections and updates 

produced newly 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

Information Collection

Previous ICR 

(as reported in 

reginfo.gov 

Supporting 

Statement)

Previous ICR 

Corrected

Calculationsa

Changes

ICR Renewal

1) Calculation 

corrections to 

previous ICR 

estimates

2) Reduction 

in Section 4 

Test Rulesb

3) Program

Change of 

e-Reportingc

4) Methodology 

Correction and 

Updatesd

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 263 620,191 263 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 9,431 263 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 -1.00 122.00 122.00

Testing Exemption Applications 9 18 9 18 0 0 0 0 -0.50 -1.00 0.00 0.00 8.50 17.00

TOTAL 629,893 95,833 -531,665 -82,960 -1,617 -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 involving an average of 5 chemicals. Also, in the previous ICR it is assumed that each sponsor would support testing for 5 chemicals (10 responses).

c 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. 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 ten 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 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.

The Agency has established a public docket for this ICR under Docket ID No. EPA-HQOPPT-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.

Submit your comments, referencing Docket ID No. EPA-HQ-OPPT-2015-0436 and 

OMB Control No. 2070-0033, to (1) EPA online using www.regulations.gov (our preferred 

method), or by mail to: Document Control Office (DCO), Office of Pollution Prevention and 

Toxics (OPPT), Environmental Protection Agency, Mail Code: 7407T, 1200 Pennsylvania Ave., 

NW, Washington, D.C. 20460, and (2) OMB by 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 ICR under Docket ID No. EPA-HQ-OPPT-2015-0436. These attachments are available for 

online viewing at www.regulations.gov or otherwise accessed as described below.

Attachment 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 Analysis Tables
38

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