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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, Consent Orders, and Test Rule 

Exemptions

EPA ICR No.: 1139.08 OMB Control No.: 2070-0033

1(b) Short Characterization/Abstract

This data collection program is designed to provide the Environmental Protection Agency

(EPA) with necessary test 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. Section 4 of the Toxic Substances Control Act (TSCA) provides the 

authority for collecting these test data, and is intended to ensure that chemicals that may pose 

serious risks to human health or the environment undergo testing by manufacturers or processors, 

and that the results of such testing are made available to EPA. 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. 

(TSCA is available on the Internet at http://epw.senate.gov/tsca.pdf.) 

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 consent

orders and Voluntary Testing Agreements (VTAs). ECAs and VTAs are usually less resource

intensive 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 about the

Chemical Testing Program, go to: http://www.epa.gov/oppt/chemtest/index.html.)

In addition to developing actions under TSCA section 4 that meet specific needs

identified by OPPT, EPA may also develop such actions to meet the information needs of other
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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). At the present time, EPA anticipates that data

gathered by activities conducted during this ICR renewal period will be used, in addition to those

above, by other agencies, including the Occupational Safety and Health Administration (OSHA)

and the Organization for Economic Cooperation and Development (OECD).

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 consent order 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 3), while response to a consent order issued 

under TSCA section 4 is only mandatory for participants in the ECA. Participating in a VTA is 

voluntary. The export notification provisions of TSCA section 12 apply to any exporter of a 

chemical subject to a rule or consent order 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 (rulemaking, ECA, VTA), 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.
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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 “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) mandates that EPA

require manufacturers and processors of chemical substances and mixtures to conduct testing if it

finds that:

“(1)(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) (frequently described as

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 Interagency Testing Committee (ITC) places on the TSCA section 4(e) “Priority Testing 

List.” The ITC is an independent advisory committee to the EPA Administrator that includes 16 

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/opptintr/itc/.)

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 consent order 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 scientists, professional industrial hygienists, other 

occupational health professionals and workers for hazard communication and right-to-know 

purposes, including Material Safety Data Sheets (MSDSs), and product labels.

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

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
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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 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 section 4 Enforceable Consent 

Agreements, and Negotiated Testing Agreements. In addition, almost 250 formal TSCA section 

4 “Decisions Not to Test” (DNTs) have been issued by EPA to date. Screening efforts to identify

priorities and determine testing needs for other chemicals are currently underway in OPPT.

3 NON-DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION

CRITERIA

3(a) Non-Duplication

Test Rules and Consent Orders

Prior to proposing a test rule or issuing a consent order, 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 Agency proposes a test rule or issues

a consent order only after it has determined that necessary tests have not yet been conducted.

Exemptions

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.
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3(b) Public Notice Required Prior to ICR Submission to OMB

Prior to submission to OMB, this ICR will be made available to the public for comment

through a Federal Register notice. The public will have 60 days to provide comments. Any

comments received will be given consideration when completing the supporting statement that is

submitted to OMB.

3(c) Consultations

The Agency has issued two procedural rules on the test rule development and exemption

process (October 1984 and May 1985) and one procedural rule on the consent order process

(June 1986) that describe the information collection requirements for test rules and consent

orders. Of particular note, the Agency held a series of public meetings at the request of the

American Chemistry Council (formerly the Chemical Manufacturers Association (CMA)) and

Environmental Defense (ED) (formerly the Environmental Defense Fund) during the spring and

summer of 1985 to develop the consent order process. In addition to the procedural rules, each

individual test rule solicits comment on the information collection requirements.

Previous commenters on EPA’s information gathering requirements under test rules,

consent orders, and the exemption process have included numerous representatives of the

chemical industry, environmental groups and the public at large. A number of issues were

discussed including the schedule for the test rule and consent order process, what constitutes

confidential information, how EPA should provide guidance for submission of equivalence data,

how the Agency will provide standards for development of test data, enforceability of consent

orders, and how to make consent orders equivalent to test rules.

In addition to the public notice and comment period required by the OMB regulations

that implement the Paperwork Reduction Act (see Section 0) of this Supporting Statement), the

OMB regulations, 5 CFR 1320.8(d)(1), also require agencies to consult with potential ICR

respondents and data users about specific aspects of an ICR before the agency submits the ICR to

OMB for review and approval. In accordance with this regulation and based on OPPTS

Regulatory Coordination Staff guidance, EPA will solicit comments from no more than nine

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

3(d) Effects of Less Frequent Collection

Test rules and consent orders require the test sponsor to submit a letter notifying EPA

who will be conducting the testing, study plans before beginning testing, and a final report of the

study results. Each exemption applicant is required to submit an exemption application. Less

frequent information collection would jeopardize EPA’s ability to ensure that testing is being

conducted in accordance with the rules and consent orders, and to grant exemptions from test

rules.

3(e) General Guidelines

The data retention requirements for test rules and consent orders exceed one of the

Paperwork Reduction Act guidelines contained in 5 CFR 1320.6. Documentation records, raw

data, and specimens pertaining to a test rule or consent order study are required to be retained for
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ten years from the effective date of the applicable test rule or publication date of the consent

order. 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

consent order 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 the Agency’s action may be challenged, it is imperative that all records, raw data, and

specimens be available to support the Agency’s decision.

3(f) Confidentiality

Information submitted to EPA in response to test rules and consent orders and in

exemption applications is, in most cases, non-confidential. EPA has also discouraged the 

submission of CBI material. If respondents wish to claim information submitted in response to a 

test rule or consent order 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

The information requested does not include information of a sensitive nature other than

CBI, which is discussed above.

3(i) Electronic Reporting

A description of data collection/management activities, including electronic reporting of 

data is presented in section 5(b).

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

facilities within the following industry categories:

Type of Entity NAICS Example of Potentially Affected Entities

Chemical 

Manufacturers and 

Importers

325, 32411 Persons who manufacture (defined by statute to include 

import) one or more of the subject chemical substances.

Processors 325, 32411 Persons who process one or more of the subject chemical 

substances.
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4(b) Information Requested

(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).

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 consent orders, 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 And Consent Orders - EPA promulgates a rule or consent order describing 

what type of testing must be performed on the chemical and specifying specific test guidelines 

that have been published by the EPA or alternative methods proposed by industry and approved 

by EPA as 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.

Exemptions - Information collection authorized by section 4(c) of TSCA is designed to 

reduce the burden of duplicative testing under test rules. Test rules generally require testing of 

only a single representative chemical substance and all chemicals subject to the test rule are 

assumed equivalent to it. Exemption applicants are required to submit only that information 

necessary to establish the identity of the applicant and the test requirements from which the 

exemption is being requested. In those few cases in which more than one representative 

substance is to be tested under a test rule, exemption applicants will also be required to submit 

data showing to which of these representative substances their chemical is equivalent. The type 

of data needed may vary with the chemical being tested, and will be described in detail in each 

individual test rule.
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(ii) Respondent 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 or an application for an exemption.

(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.

These activities may vary based on the type of activity:

Test Rules and Consent Orders - Test rules and consent orders require test sponsors 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.

Exemptions - Test Rules. 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, the rule 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.

Consent Orders. Exemption applications are not necessary for chemicals being tested

under consent orders because the consent order process inherently eliminates duplicative testing.
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5 THE INFORMATION COLLECTION - AGENCY ACTIVITIES, COLLECTION

METHODOLOGY, AND INFORMATION MANAGEMENT

5(a) Agency Activities

Data collected under TSCA section 4 test rules and consent orders are received by the

Office of Pollution Prevention and Toxics (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 Inventory Rule Update Amendments (IURA) 

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.

In order to sustain this program, the EPA must undertake the following applicable

activities:

a) Review letters of intent and study plans for completeness;

b) Review progress reports;

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 ECAs and VTAs.

In addition to the activities cited above the Agency maintains a facility inspection and test

data audit program to ensure testing is done in compliance with GLPs, and may also participate

in other activities related to this program, e.g., other voluntary efforts to identify data gaps and

develop test data, efforts to establish test guidelines or standards that may be used in the

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, TSCA Section 4

ECA or VTA. 

It is also important to note that the TSCA Chemical Testing Program is an integral

component of OPPT’s TSCA existing and new chemicals programs. These programs are

responsible for assessing and managing 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
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environmental concerns have been and continue to be identified and refined through various

existing chemical screening activities within OPPT.

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

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 consent orders, 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 consent order. 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.
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5(d) Collection Schedule

This information collection activity does not involve more than one submission per

activity. Required testing is conducted only once, and each related submission is a one-time on

occasion submission. The testing period is based on the individual rule, consent order, or VTA,

the standard time required to conduct the required test according to the testing guidelines,

according to the timing established in the approved test plan, or timing otherwise established by

the Agency.

The time period for screening level testing, like that conducted under the HPV Initiative,

is usually less than a year. The typical time period for other types of testing is around three years, 

although it can be longer and varies according to the chemical and the test required.

6 ESTIMATING THE BURDEN AND COST OF THE COLLECTION

Overview

The methodology used in estimating the annual burden and costs to industry resulting

from TSCA section 4 test rules, consent orders and agreements, and voluntary submissions over

the next three years is based on EPA’s most recent cost and burden estimates. These have been

combined with current information concerning the number and type of TSCA section 4 test rules

under development, estimates of the potential number of consent orders and agreements, 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.

Individual actions covered by this ICR may impact industry over most or all of the three

year ICR period. In these cases, the impacts of the action have been converted to an annual basis

by assuming, for example, that one-third of the chemicals covered by the action would be

addressed in each of the three years.

Additional data collection efforts beyond those identified in this ICR may be conducted

during the three year ICR period, but the extent of such activities cannot be projected at this

time. 

The following sections explain the assumptions and methods that were used to estimate

the burden and costs for this ICR, along with a summary of the cost and burden calculations.

6(a)-(b) Estimating Total Respondent Burden and Cost

Consent Orders and Enforceable Consent Agreements

Based on historical experience with the TSCA testing program and expected consent

order activity over the three year ICR period, EPA assumes that one consent order or enforceable

consent agreement (ECA) will be issued per year for a total of three consent orders/agreements
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issued during the ICR period. Past consent orders and agreements have covered an average of

one to five chemicals. For this ICR, EPA assumes five chemicals will be covered by each

order/agreement.

The testing required under future consent orders or agreements cannot be predicted and

will be determined on a case by case basis. For purposes of the ICR, EPA assumes as in past

ICRs that each chemical will be evaluated by performing the tests specified in a “Standard”

testing battery (see 
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Table 1). The test battery includes 10 studies per chemical (7 short term, 3 long term).1

Each test sponsor must submit one letter of intent and one set of study plans for each chemical; 

five semi-annual progress reports for each long-term study; and one final report for each study. 

EPA estimates that 10 percent of the studies completed will be accompanied by a robust 

summary. These assumptions are used to estimate the costs and are recorded in 

 

1

“Short-term studies” are tests that can be concluded in the year they begin; “long-term studies” are concluded

within three years.
15

Table 2.

EPA generates and maintains a listing of the laboratory cost and burden data for

numerous TSCA and OECD test protocols. Test cost estimates were adjusted to end-of-year

2010 dollars using the Bureau of Labor Statistics’ Employment Cost Index (ECI) and are shown

in Table 1. The mean cost of the “Standard” battery is $1,465,985.

2

EPA has also included 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. Method development and validation is typically performed to determine the

effectiveness of an analytical method to determine the levels of the chemical in the dosing matrix

in toxicity studies. Short term and long-term studies are assigned a cost of $3,835 and $9,314

respectively, based on typical costs cited by industry experts (Piccirillo, 2004). Total validation

costs for the testing battery are $54,787, resulting in a total laboratory cost of $1,465,985.

Exemption applications are not necessary for chemicals being tested under consent orders

because the consent order process inherently eliminates duplicative testing.

 

2

The laboratory cost is considered part of the sponsor’s overall cost.
16

Table 1: TSCA Section 4 “Standard” Testing Battery Costs

Test Protocol Name Protocol 

Number

Date of 

Estimate

Mean Cost 

Estimate 

(2010$)1

Validation 

Costs (2010$)

Algal Acute Toxicity 797.1050 8/3/1990 $28,986.83 $3,835.11

Daphnid Acute 

Toxicity 797.1300 4/25/1996 $11,232.48 $3,835.11

Fish Acute Toxicity 797.1400 4/25/1996 $22,806.83 $3,835.11

Gene Mutations in 

Somatic Cells 798.5300 8/16/1994 $25,160.49 $3,835.11

Subchronic Oral 

Toxicity 870.3100 9/3/1996 $186,149.49 $3,835.11

Prenatal 

Developmental Tox. 

(2 species)

870.3700 8/27/1996 $142,943.18 $9,313.83

Reproduction/Fertility

Effects 870.3800 8/27/1996 $737,572.04 $9,313.83

Salmonella Reverse 

Mutation Assay 870.5265 9/16/1996 $9,256.85 $3,835.11

In vivo Bone Marrow 

Cytogenetics 870.5395 2/27/1997 $19,376.05 $3,835.11

Developmental 

Neurotoxicity 870.6300 8/27/1996 $227,713.28 $9,313.83

Subtotal $1,411,198 $54,787

Total $1,465,985

1 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 test costs updated to 2010 dollars.

Source: U.S. EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branch.

Based upon the assumptions and testing batteries discussed above, various factors can be

derived that are employed to estimate total costs and burdens for the respondents. These factors

are summarized in
17

Table 2.
18

Table 2: Assumptions Used in Estimating Annual Costs and Burdens

TSCA Section 4 ICR Assumptions Total1

a Number of Orders/Agreements Issued 1

b Chemicals Per Order/Agreement 5

c Total no. of chemicals (a × b) 5

d No. of Chemicals per sponsor 5

e No. of sponsors per rule or order (b ÷ d) 1

f Total no. of sponsors (a × e) 1

g Letters of intent/study plans per sponsor 1

h Total letters of intent/study plans (f × g) 1

i No. of short-term studies per chemical 9

j Total no. of short-term studies (c × i) 47

k No. of long term studies per chemical 4

l Total no. of long-term studies (c × k) 20

m Total no. of studies per chemical (i + k) 13

n Total no. of studies (j + l) 67

o No. of semi-annual progress reports per 

short term study 0

long term study 5

p Total no. of semi-annual progress reports

short term studies (o x j) 0

long term studies (o x l) 100

q No. of final reports per study 1

r Total no. of final reports (n × q) 67

s No. of robust summaries26.7

t Total no. of reports (h + p + r + s) 174.7

u Total reports per sponsor (t ÷ f) 174.7

v Total reports per rule/order (t ÷ a) 174.7

w Total reports per chemical (t ÷ c) 35

x No. of exemptions per sponsor 0

y No. of exemptions per rule/order 0

z Total no. of exemptions 0

aa Total no. of responses (t + z) 173

bb No. of responses per rule/order (e + y) 1

cc Total no. of respondents (f + z) 1

1 Numbers are rounded - calculations may not appear exact.

2 For consent orders, only 10 percent of studies are expected to be accompanied by robust summaries.

Total Number of Respondents

The Agency assumes that on an annual basis there will be one respondent to an

enforceable consent order or agreement annually (
19

Table 2, line f). This respondent is expected to provide reporting with no third party 

disclosures associated with these activities. Exemption applications are not necessary for 

chemicals under the test rule so there are no exemption applicants counted among the 

respondents (
20

Table 2, line y).
21

Total Number of Reports

Over the course of the testing period, a total of 174.7 reports will be submitted (
22

Table 2, line t). This may include, but is not limited to: letter of intent and set of study

plans, semi-annual progress reports for long-term studies, and the final reports for each study.

Types of Costs and Burdens

The following discussion presents estimates of the costs and burdens of each of the main

categories of collection activities covered in this ICR. Table 3 presents estimates of the

laboratory and administrative costs, and administrative burdens, and is discussed in detail below.

Laboratory Costs

The costs incurred by sponsors performing laboratory testing are presented in Table 3.

Total laboratory costs associated with activities covered by this ICR are estimated to be $7.3 

million per year (Table 3, line f). With a projected total of 67 studies to be conducted (Table 3, 

line d), the average laboratory cost is $109,409 per study3(Table 3, line i).

 

3

Some long-term tests assumed to be conducted under consent order may take more than a year to complete. For 

purposes of the ICR EPA assumes the full cost and burden of completing the testing is incurred during each year.
23

Table 3: Annual Laboratory Cost and Burden Estimates

TSCA Section 4 Factors Consent Orders & Agreements (2010$)

a Total no. of rules/order 1

b Total no. of chemicals 5

c Total no. of sponsors 1

d Total no. of studies 67

e Laboratory cost per chemical $1,466,084

f Total laboratory costs $7,330,422

g Administrative Reporting costs $373,531

Administrative non-reporting costs $1,832,606

Total Administrative costs a$2,206,136

h Total laboratory and administrative costs 

(f + g) $9,536,559

i Laboratory costs per study (f÷d) $109,409

j Administrative costs per study (g÷d) $32,927.41

k Total testing costs per study (i + j) $142,337

l Total testing costs per sponsor (h÷c) $9,536,558.56

m Administrative Reporting burden b6,951

Administrative non-reporting burden c32,282

Total admin. Burden 39,233

n Administrative burden per study (m÷d) 586

o Total administrative burden per sponsor (m÷c) 39,233

Numbers throughout table have been rounded

a Administrative non-reporting costs and burdens are assumed to equal 25% of laboratory costs and burdens.

b The reporting burdens are derived in Table 5.

c The non-reporting administrative burden is estimated by dividing the administrative cost by $56.77, which 

represents the weighted average wage rate. The weighted average wage reflects an assumed 20/60/20 mix of 

managerial/technical/clerical labor.

Administrative Costs

Administrative costs are assumed to comprise both reporting and non-reporting activities

and are explained in detail below. The average administrative cost is calculated based on the

average lab cost per study of $109,409 (Table 3, line i), and is equal to $32,927 (Table 3, line j).

The average administrative cost is divided by the weighted average hourly labor rate of 

$56.77 per hour to result in an average burden of 586 hours per chemical (Table 3, line n). The

weighted average hourly labor rate is based on a labor mix that is 20 percent managerial, 60

percent technical, and 20 percent clerical. The total administrative cost is estimated to be $2.2

million annually (Table 3, line g).
24

Reporting Costs and Burdens

Part of the administrative costs associated with this ICR is derived from reporting

activities undertaken by respondents. These activities include: preparing letters of intent and

study plans; preparing progress reports; preparing test results for submission to EPA; recording

test results; conducting laboratory or corporate reviews; performing associated clerical work for

final report preparation; record keeping; conducting administrative activities to preparing for and

oversee the testing program; and applying for exemptions. The burden estimates and unit supply

costs associated with these activities are reported in Table 4 and are based on estimates provided 

in the prior ICR.

Estimates of the respondents’ annual reporting costs and the burden associated with each

reporting activity are detailed in Table 4. The unit wage rate information is explained in the 

Appendix. The unit labor hours are derived from previous information collection requests and 

are believed to be reflective of the annual amount of time required for each activity over the next 

three year period.

For the seven sponsors who have not yet submitted test plans and the one sponsor for the

consent order, EPA assumes that there is a 40-hour administrative burden assigned for

submission of the test plans, and letter of intent in the case of the consent order. The total annual

respondent cost and burden for reporting activities is $2.2 million and 39,233 hours (for

reporting costs see Table 3, line g; for reporting burdens see Table 3, line m; for total reporting

costs and burdens see Table 4).

Non-reporting Administrative Costs and Burdens

EPA’s experience in test rule development has shown the non-reporting administrative

costs associated with testing programs to total approximately 25 percent of the laboratory costs,

and is divided as follows. Non-reporting administrative activities include the effort of

respondents to organize a testing program, obtain and review bids from laboratories that would

conduct the testing, and prepare and submit samples to the laboratory for testing. EPA has

included a burden equal to 15 percent of the test cost to account for management of the

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. An additional 10 percent of the testing cost

will be added to cover the costs of technical 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 for burden

associated with administering the testing consortium and testing. In some cases, the actual

burden of these activities may be 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.

Based on these assumptions, non-reporting activities associated with laboratory testing

are estimated to cost $1.8 million annually (Table 3, line g). These costs are translated into

burden estimates using a weighted average labor cost of $56.77 per hour, which is based on a

labor mix that is 20 percent managerial, 60 percent technical, and 20 percent clerical. The

estimated non-reporting administrative burden based on this approach is 32,282 hours annually

(Table 3, line m).
25

Table 4: Total Annual Respondent Cost and Burden for Reporting Activities

Collection Activity

Unit Labor Unit 

Supply 

Costs

Total 

Annual 

Items

Grand Total

Type a Hours Rate Cost Hours Costs

INTERIM 

REPORTS

Letter of Intent and 

Study Plans T 40 $61.71 $2,468.32 $21.91 1 40 $2,490.24

Prepare Progress 

Report T 8 $61.71 $493.66 $5.48 100 800 $49,371.96 

Subtotal 48 $2,961.99 101 840 $51,862.20 

FINAL REPORTS

Short-term Studies

Record and Prepare 

Test for Submission

T

40 $61.71 $2,468.32 - 47 1,880 $116,011.23 

Laboratory Review T 6 $61.71 $370.25 - 47 282 $17,401.68 

Corporate Review M 6

$69.74 $418.44 - 47 282 $19,666.51 

Type and Print 

Results S 20 $28.98 $579.62 - 47 940 $27,242.33 

Recordkeeping S 1

$28.98 $28.98 $5.48 47 47 $1,367.60 

Subtotal 73 $3,865.61 - -- 3,431 $181,689.35 

Long-term Studies

Record and Prepare 

Test for Submission

T

80 $61.71 $4,936.65 - 20 1,600 $98,732.96 

Corporate Review M 9

$69.74 $627.65 - 20 180 $12,553.09 

Type and Print 

Results S 40 $28.98 $1,159.25 - 20 800 $23,184.96 

Recordkeeping S 1 $28.98 $28.98 $5.48 20 20 $585.10 

Subtotal T 130 $61.71 $6,752.53 - -- 2,600 $135,056.11 

Robust Summaries T 12 $61.71 $740.50 - 7

80 $4,961.33 

FINAL REPORTS 

SUBTOTAL 215 $11,358.64 74 6,111 $321,706.79 

EXEMPTION 

REQUESTIONS T 2 $61.71 $123.42 - 0

0 - 

TOTAL 265 $14,444.05 175 6,951 $373,568.99 

a Labor Type Codes are as follows: T = Technical; M = Managerial; S =Secretarial
26

6(c) Estimating Agency Burden and Cost

The cost and burden to the Agency to process, review, and analyze the information 

collected under section 4 test rules, consent orders and agreements, and voluntary testing 

programs are discussed below and detailed in Table 5.

The Agency collection procedures are estimated to be accomplished, on average, by a 

GS-13, Step 1 employee. The annual 2010 loaded cost of a full-time equivalent (FTE) for this 

level employee is $142,453. This includes a base wage of $89,033 plus 60 percent for overhead 

and benefits (i.e., $53,420). Dividing this value by 2,080 (i.e., the number of hours in a work 

year) results in an hourly wage rate of $68.48 (see the Appendix for the derivation of these 

figures).

AGENCY LABOR CATEGORY LOADED HOURLY RATE ($2010)

GS-13, Step 1 $68.48

The estimated unit Agency burden of processing letters of intent and study plans (three 

hours), progress reports (one hour), and final reports (five hours) is derived from the previous 

ICRs and is believed to be reflective of the time required for each activity. This information is 

presented in Table 6. It takes approximately one hour for the Agency to process and review each 

exemption application and 16 hours for the Agency to enter study plans and results into the HPV 

Information System (HPVIS). The total annual Agency costs and burden for processing letters 

and reports is $175,298.48 and 2,560 hours, or approximately 1.2 FTEs per year, where one FTE 

is equivalent to 2,080 hours per year. There are no exemptions associated with these actions and 

therefore no associated cost or burden.

Table 5: Annual Agency Cost and Burden Estimates

Collection 

Activity

Unit Labor Unit 

Supply 

Costs

Total 

Annual 

Items

Grand Total

Hours Rate Cost Hours Costs

Letter of 

Intent and 

Study Plans

3 $68.48 $205.44 0 1 3 $205.44 

Progress 

Reports 1 $68.48 $68.48 0 100 100 $6,848.00 

Final Reports 5 $68.48 $342.4 0 67 103 $22,940.80 

HPVIS Data 

Entry 16 $68.48 $1095.68 0 7 112 $7,669.76 

Robust 

Summary 1 $68.48 $68.48 0 7 7 $458.82 

SUBTOTAL 182 557 $38,122.82

Exemptions 1 $68.48 $68.48 0 0 0 $0

TOTAL 182 557 $38,122.82
27

6(d) Bottom Line Burden Hours and Costs

Respondent Annual Hours and Costs

Table 6 summarizes the average annual burden per response. EPA estimates that this ICR 

will impose 39,233 burden hours on respondents annually with an average of 224 hours per 

response.

Table 6: Average Annual Respondent Burden Hours per Response

Collection Activity

Respondent Burden Per Response

Total Hours Total Items Hours Per 

Response

Reporting Activities

Letters of Intent/Study

Plans 40 1 40

Progress Reports 800 100 8

Final Reports 6,111 74 83

Exemption Requests 0 0 0

Subtotal (all responses) 6,951 175 40

Non- reporting activities 32,282 175 184

TOTAL 39,233 175 224

The total annual burden hours and costs for respondents were derived in Table 4, above, 

and are summarized below in Table 7.

Table 7: Summary of Annual Respondent Burden and Costs Estimates

Collection Activity Total

Hours Cost

Reporting Activities

Letters of Intent/Study Plans 40 $2,490

Progress Reports 800 $49,372

Final Reports 6,111 $321,707

Exemption Requests 0 $0

Subtotal (all responses) 6,951 $373,569

Non-reporting activities 32,282 $1,832,606

TOTAL 39,233 $2,206,175

Agency Annual Hours and Costs

The total annual burden hours and costs for the government were derived in Table 5 and 

are summarized below in 
28

Table 8.
29

Table 8: Summary of Annual Agency Burden and Costs Estimates

Collection Activity Total Agency Burden and Costs

Hours Cost

Reporting Activities

Letters of Intent/Study Plans 3 $205

Progress Reports 100 $6,848

Final Reports 335 $22,941

HPVIS Data Entry 112 $7,670

Exemptions 0 $0

TOTAL 550 $37,664

6(e) Reasons for Change in Burden

This request represents a decrease of 112,729 hours (from 151,962 hours to 39,233 hours) 

from that currently in the OMB inventory. This decrease reflects a decrease in the estimated 

number of items to be received from respondents. In the previous ICR, EPA estimated 602 total 

items to be received from respondents. For this ICR, EPA estimates a total of 175 items. Due to a 

smaller reporting universe and the end of the HPV Challenge Program, EPA expects the overall 

burden for respondents to decrease. This change is an adjustment. In addition to these changes, 

the Agency has adjusted all unit costs to reflect the latest available labor wage rates.

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 average about 224 hours per response (see 

Table 6). 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-2010-1010, 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-2010-1010 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.
30

Appendix

Table 9 presents the derivation of the industry wages for 2010 used in this ICR.

Table 9: Industry Wage Rates (December 2010)

Labor 

Category

Wage 

($/hour)1

Fringe 

Benefits 

($/hour)1

Fringes 

as % 

Wage

Overhead 

% Wage2

Fringe + 

Overhead 

Factor

Loaded 

Wages 

($/hour)

(a) (b) (c) = 

(b)/(a) (d) (e)=(1)+(c)+(d) (f) = (a) 

x (e)

Managerial $42.82 $19.64 45.87% 17% 1.63 $69.74 

Technical $36.93 $18.50 50.09% 17% 1.67 $61.71 

Clerical $17.36 $8.67 49.94% 17% 1.67 $28. 98 

Weighted 

Average3 -- -- -- -- -- $56.77

Notes:

1Employer Costs for Employee Compensation Supplementary Tables: December 2010, US Bureau of Labor 

Statistics, March 9, 2011 (BLS, 2011a)

2An overhead rate of 17 percent was estimated based on industry data gathered for the Revised Economic 

Analysis for the Amended Inventory Update Rule: Final Report (EPA, 2002a)

3 The weighted average wage reflects an assumed 20/60/20 mix of managerial/technical/clerical labor.
31

Table 10 presents the derivation of the Agency wage rates for 2010 used in this ICR.

Table 10: Agency Wage Rate for GS-13 Step 1 (January 2010)

Labor 

Categor

y

Data 

Source for 

Wage 

Informatio

n

Dat

e

Wage 

($)

Fringe 

Benefi

t

Fringes 

as % 

wage

Overhea

d as % 

wage

Fringe + 

overhea

d factor

Loaded 

Wage 

($)

(a) (b) (c) = (b) 

/ (a) (d) (e) = (c) + (d) + 1

(f) = (a) 

* (e)

EPA

staff 

FTE

Annual 

federal staff 

cost: OPM 

Washington

-BaltimoreNorthern 

Virginia, 

DC-MDPA-VAWV area, 

GS-14 Step 

5 pay rates a

Jan10$89,03

3 

(annual

)

-- [Include

d in 60% 

overhead

]

60% b1.6 $142,45

3 

(annual)

$42.80 

(hourly

)

$68.48 

(hourly)

Notes:

aThe Agency salary is the unloaded federal GS-13 Step 1 salary ($89,033 for 2010), from the OPM salary table for

the Washington-Baltimore-Northern Virginia Locality Pay Area (OPM, 2010). Hourly rates are based on annual 

salary divided by 2,080 hours.

bThe 60 percent fringes-and-overhead rate is from an EPA guide, Instructions for Preparing ICRs (EPA, 1992).
32

(40 CFR part 790 is available on the Internet at http://ecfr.gpoaccess.gov/cgi/t/text/textidx?c=ecfr&tpl=/ecfrbrowse/Title40/40cfr790_main_02.tpl.)