August 29, 2000

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 Existing Chemical Test Rules, Consent Orders, Test Rule

Exemptions, and Voluntary Test Data Submissions

ICR Nos.: EPA ICR #1139.06; OMB Control # 2070-0033

1(b) Short Characterization

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 to which there is substantial exposure or

release. Section 4 of the Toxic Substances Control Act (TSCA) provides the authority for

collecting this test data, and is intended to assure 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.

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

resource intensive than formal TSCA rulemaking and allows 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 which

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. 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 publically 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/opptintr/chemtest/index.htm.)

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

identified by OPPT, EPA may also develop such actions to meet the information needs of
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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) 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, the National Institute of Health and Safety, and the Organization

for Economic Cooperation and Development (OECD).

The Agency 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

Enforceable Consent Agreement (ECA), or (3) through commitments from industry as

Voluntary Testing Agreements (VTAs).

The testing specified in a rule or consent order issued under TSCA section 4, or

any testing identified in the voluntary Challenge Programs, 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), while response to a consent order issued

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

VTA is voluntary. The export notification provisions 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 TSCA

Nonconfidential Information Center, Rm. NE B-67, 401 M St., SW., Washington, D.C. The

Center is open from noon - 4:00 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

Section 2(b)(1) of TSCA, 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
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unanswered questions about the effects of the chemical substance. EPA need not limit the

scope of testing required to the factual basis for the 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 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 an Interagency Testing Committee (ITC) places on its TSCA §4(e) "Priority Testing

List." The ITC is an independent advisory committee to the EPA Administrator that

includes 15 U.S. Government organizations. The ITC was created under TSCA §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 go to: http://www.epa.gov/opptintr/itc/.)

Although the Agency may not have yet made the 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 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 publically 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(b) Use/Users of the Data

Data collected under the Chemical Testing Program is used 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 toxicologic and health effects data, ecological effects data, and

environmental fate data, will be used by scientists, professional industrial hygienists, other

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

purposes, including Material Safety Data Sheets, and product labels. Additionally, data

developed for chemicals used or produced in particular work sites will be useful in
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developing 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 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 section 4 rule, the

data collected may be used by other agencies, and interested parties. 

Since 1979, approximately 540 of the 15,000 chemical sub-set of the TSCA

Inventory have been the subject of testing actions within the OPPT Existing Chemicals

Testing Program. Virtually all of the 540 chemicals are "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 Voluntary Testing Agreements. More than 50% of

these testing actions have been taken in the last several years and have focussed on

chemicals with clearly identified data "needs" (as opposed to simply data gaps). 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

3(a)(1) 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, 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.
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3(a)(2) 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.

3(a)(3) HPV and Children’s Health Voluntary Challenge Programs

EPA has searched the publicly available scientific data bases for chemicals

embraced by the High Production Volume (HPV) and Children’s Health Voluntary

Challenge Programs and held meetings with public interest groups and industry.

The data that are developed and/or submitted as a result of the program is unlikely

to be duplicative.

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

In proposing to renew this ICR, EPA provided a 60-day public notice and comment

period that ended on September 27, 1999 (64 FR 40865, July 28, 1999). EPA received

comments from the Chemical Manufacturers Association (CMA). These comments are

addressed in Attachment 6 to this ICR.

3(c) Consultations

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

exemption process (10/84 and 5/85) and one procedural rule on the consent order

process (6/86) 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 Chemical Manufacturers Association (CMA) and the Natural Resources

Defense Council (NRDC) 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.

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.

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 and study plans before beginning testing, and a
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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 exceeds 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 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, for purposes of the HPV

Challenge Program, 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

then CBI, which is discussed above.

3(h) Electronic Reporting 

In a process that began in 1996, OPPT has been working with representatives from

various offices within EPA, OMB, DOJ, GSA, and the regulated community to develop a

user-friendly electronic reporting process for the information that is submitted to EPA

under sections 4, 5, 8, and 12(b) of TSCA. EPA is expected to announce the availability of

the electronic reporting option for these submissions under TSCA by the end of 2000.
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Although the TSCA electronic submission project has not been implemented yet,

participants in the voluntary HPV Challenge Program will submit the information

electronically to allow for it to be promptly posted on the internet (See

http://www.epa.gov/chemrtk/elecsubm.htm). Since as many as 14,389 responses of the

total 17,299 annual responses estimated for this ICR (see Table 7) are in response to the

voluntary HPV Challenge Program, the Agency estimates that as much as 83% of the

responses under this ICR will be collected electronically.

4 THE RESPONDENTS AND THE INFORMATION REQUESTED

4(a) Respondents/SIC Codes

 Respondents affected by the collection activity may include, but are not limited to: 

 

Type of Entity NAICS Examples 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.

The North American Industrial Classification System (NAICS) codes have been

provided to assist you and others in determining whether this information collection activity

might affect certain entities. This listing is not intended to be exhaustive, but rather

provides a guide for readers regarding entities likely to be affected by this information

collection activity. Please note that previous ICRs identified the following Standard

Industrial Classification (SIC) codes: 

2819 Industrial organic chemicals

2891 Adhesives and sealants

2851 Paints and allied products

2299 Textile goods

5172 Petroleum products

NAICS has replaced SIC as the standard classification system for industry. 

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
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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 GLPs are found in 40 CFR part 792, the various test guidelines that are

incorporated into the individual test rules are in 40 CFR parts 795 through 798, and 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 Good Laboratory

Practice standards (GLPs) requirements 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 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 which of these representative substances their

chemical is equivalent to. The type of data needed may vary with the chemical being

tested, and will be described in detail in each individual test rule. 

HPV and Children’s Health Voluntary Challenge Programs - The HPV Challenge

Program is a voluntary initiative under which manufacturers of HPV chemicals will

voluntarily develop and or submit certain Organization for Economic Cooperation and

Development (OECD) screening level studies for the chemicals they manufacture. 

Similarly, the Children’s Health Challenge Program is a voluntary initiative under which
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manufacturers of chemicals with identified children's health concerns agree to submit

available data or conduct any needed testing for the chemicals they manufacture. Although

the data submissions are voluntary, EPA believes that the development and/or submission

of such data represents costs and burdens not captured in existing information collections. 

4(b)(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 file search for relevant existing data. If existing data is found:

- Prepare and review summary of existing data.

- Submit summary and 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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HPV and Children’s Health Voluntary Challenge Program. Exemption

applications are not necessary for chemicals being tested under the HPV or Children’s

Health Voluntary Challenge Programs. However, companies may submit relevant

information pertaining to the production volume for chemicals that EPA believes are

produced or imported in substantial amounts. Based on this information, EPA may delist

a chemical. That is to say, companies may submit information that indicates that specific

chemicals are not produced in substantial quantities and therefore, testing of these

chemicals is not necessary. Based on a review of the information submitted, EPA may

remove a chemical from the list of HPV chemicals or list of children’s health chemicals.

5 THE INFORMATION COLLECTION - AGENCY ACTIVITIES, COLLECTION

METHODOLOGY, AND INFORMATION MANAGEMENT

5(a) Agency Activities

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

Office of Pollution Prevention and Toxics, Chemical Control Division, Chemical Testing

and Information Branch, where they are reviewed for completeness and then routed to

biologists, chemists, toxicologists, and wildlife scientists within the Office of Pollution

Prevention and Toxics to determine whether the subject chemicals are likely to present an

unreasonable risk to human health or the environment. Similarly, data received under the

HPV and Children’s Health Challenge Programs will be reviewed as described above for

purposes of developing preliminary hazard and risk characterizations for those chemicals. 

If the data indicate that such risk may exist they are forwarded to other EPA staff who use

them in support of possible regulatory 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 letter 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;

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.
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5(b) Collection Methodology and Management

For each chemical identified for testing as part of the TSCA Chemical Testing

Program, the specific data requested, the testing necessary to generate that data - along

with the guideline requirements for conducting the tests, the timeframe for completing the

testing, and the date by which the requested data must be submitted to the Agency are

established in the Test Rule, Consent Order or as part of the VTAs. OPPT has used the

Master Testing List (MTL) since 1990 to establish its TSCA Existing Chemical Testing

Program agenda. The MTL presents a consolidated listing of OPPT's existing chemical

testing priorities, as well as those of other EPA Program Offices, other Federal agencies,

the TSCA Interagency Testing Committee, and international organizations such as the

Organization for Economic Cooperation and Development (OECD).

The main purposes of the MTL are to (1) identify chemical testing needs of the

Federal Government (including EPA) and relevant international organizations (e.g.,

OECD), (2) focus limited EPA resources on the highest priority chemical testing needs, (3)

publicize the testing priorities for industrial chemicals, (4) obtain broad public input on

OPPT's TSCA Chemical Testing Program and its priorities, and (5) encourage voluntary

initiatives by the U.S. chemical industry to fill the priority data needs that are identified on

the MTL.

EPA believes that companies with product stewardship programs will recognize the

importance of promptly filling the data needs identified via the MTL because they know a

database that is inadequate to support risk assessment deprives people who are exposed

to a chemical of their right to know about the hazards/risks that may be posed by that

chemical substance. The identification of testing needs on the MTL provides an

opportunity for responsible companies to initiate voluntary activities to develop the needed

data for their own MTL-listed chemicals. In those instances in which companies decline to

take this opportunity, EPA may initiate appropriate actions to address the needs

identified, including rulemakings under TSCA Section 4. 

The MTL contains over 500 individual existing chemicals and more than 10 existing

chemical categories and presents EPA's TSCA Chemical Testing Program priorities for

1996-1998. Testing actions are currently being developed on more than 200 chemicals

listed on the MTL while testing is currently underway on almost 300 chemicals identified on

the MTL. In addition, more than 100 chemicals are being removed from the MTL at this

time, over 70 of those because their testing programs have been completed. 

It is also important to note that the Chemical Testing Program and the MTL are

integral components 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 environmental concerns have been and continue to be

identified and refined through various existing chemical screening activities within OPPT.
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Test data submitted to the Agency under the TSCA Chemical Testing Program is

reviewed by scientists to determine whether or not the data developed is adequate for the

purposes for which it was gathered and determining whether or not further regulatory action

is necessary. The data are then entered into the TSCA Test Submission Database

(TSCATS). TSCATS is an online index to unpublished, nonconfidential studies covering

chemical testing results and adverse effects of chemicals on health and ecological

systems. TSCATS was developed in 1985 to make ongoing and completed chemical

testing studies available to the public and includes chemical exposure studies,

epidemiology, environmental fate, monitoring, episodic incidents, such as spills and case

reports. There are four types of documents in the database: Section 4 chemical testing

results, Section 8(d) health and safety studies, Section 8(e) substantial risk of injury to

health or the environment notices, and voluntary documents submitted to EPA known as a

For Your Information (FYI) notice. There are 81,000 studies on 6,700 unique chemical

substances contained in 23,000 documents. The titles of these 23,000 unpublished

reports can be searched directly on the National Technical Information Service’s (NTIS)

web site. Microfiche copies of the full-text documents of the unpublished reports

referenced by TSCATS are directly available from NTIS and from the Chemical Information

Systems (CIS).

 

 Studies are indexed 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. The

index is available through a variety of electronic formats. 

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.
August 29, 2000

14

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 onetime 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 3 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 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 on the potential number of consent

orders, and the anticipated industry participation in the voluntary children’s health testing

program and the voluntary HPV Challenge Program, all of which may result in industry

submitting existing data or conducting the necessary testing to provide the requested data

during the next three year ICR approval period. Although the Agency anticipates the need

to issue test rules for those HPV chemicals that have identified data gaps that remain

unaddressed by the voluntary program, this ICR assumes that most of the HPV chemicals

will be captured by the voluntary program. If, in the context of a rulemaking, the Agency

determines that the total annual burden covered by this ICR needs to be increased, it will

submit an Information Correction Worksheet (ICW) to increase the total annual burden in

the OMB inventory.

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. Attachment 5 provides a detailed discussion of the derivation of the loaded

wage rates that are used in these estimates.

Assumptions

The estimated burden and costs to the Federal Government and to the respondents

is based on the following assumptions. These assumptions are based on historical

experience with the TSCA testing program, as well as projections for the testing program
August 29, 2000

 

1

 HPV chemicals are those with annual production and/or importation volumes above 1 million pounds.

 

2

 The HPV program covers 2,089 chemicals. Thus, to calculate the annual number of affected chemicals, EPA

divided 2,089 by three years (i.e., the ICR approval period).

 

3

 In most instances, test sponsors will form a “Panel” or “Task Force”, through a common trade organization (e.g.,

Chemical Manufacturers Association, Synthetic Organic Chemical Manufacturers Association), to coordinate

testing and reporting under section 4 of TSCA. Therefore, it is likely that for any Test Rule or Consent Order and

Enforceable Consent Agreement, there will be one submitter representing the respondents.

 

4

 The assumption of 1 sponsor for every 7 HPV chemicals is derived from EPA’s evaluation of the current status

of the HPV Testing Program. In August 2000, EPA estimated that 161 panels or sponsors, representing 442 firms,

had agreed to participate in the HPV Challenge Program. To account for possible redundancy of firms among the

15

over the next three years. These assumptions are reflected in the estimated burden and

costs that are presented in Tables 1 and 3.

Assumptions (line numbers refer to line numbers in Table 1):

1) Three average test rules and eight consent orders will be issued per year

(line a). Both the average test rules and consent orders average one to five

chemicals per rule/order (five chemicals are assumed in this ICR) (line b). 

2) In addition, this ICR incorporates estimates of the burdens and costs

associated with voluntary testing programs, including a program targeting

chemicals of concern for children’s health, and the voluntary component of

the high production volume (HPV) chemicals1 testing program. A total of 52

chemicals have been identified for potential inclusion in the children’s health

voluntary chemical program, although only 22 chemicals are expected to be

included in the initial program, and involve annual information collection

activities covered by this ICR over the next three years (line b). EPA

assumes that industry participation in the voluntary HPV Challenge program

will result in the completion of testing for 697 HPV chemicals annually over

the next three years (line b).2 Since those HPV chemicals not enrolled in the

voluntary HPV Challenge program may become subject to a rulemaking in

the future, any additional burden associated with the HPV Initiative will be

added to the OMB Inventory for this ICR through the OMB ICR burden

correction process (i.e., if necessary, an ICW will be submitted to increase

the OMB Inventory to account for any additional burden that may result from

rulemakings issued under the HPV Initiative).

3) Groups of chemicals may be represented by one sponsor or a panel

representing multiple sponsors.3 The following ratios are assumed: one

sponsor per five chemicals for all average test rules and consent orders, one

sponsor per 11 children’s health testing program chemicals, and one

sponsor per seven HPV testing program chemicals (line d).4 Thus, it is
August 29, 2000

panels (i.e., one firm belonging to more than one panel), EPA subtracted the number of panels from the number of

firms to get 281 distinct firms. EPA then divided this estimate into the 2,089 chemicals covered by the HPV Challenge.

The estimate of 7.4 chemicals per sponsor was rounded to 7. 

16

estimated that 1 test sponsor responds to an average test rule or consent

order, 2 sponsors respond to the children’s health testing program, and 100

sponsors respond to the HPV testing program (line e).

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

“long-term studies” are concluded within three years.

 5) For chemicals subject to the “Standard” testing battery (i.e., average test rule

and consent decree chemicals), 11 studies per chemical (7 short term, 4

long term) are required. For chemicals subject to the “SIDS Tier I” testing

battery (i.e., voluntary HPV Challenge program chemicals), 13 short-term

studies are required for each chemical. Sixteen studies per chemical (ten

short term, six long term) are required for the “children’s health” testing

battery (lines i and k). Details on the testing batteries are found in Table 2.

 6) In total, 9,666 short-term studies and 352 long-term studies will be

performed per year (lines j and l), for a total of 10,018 studies (line n).

 7) Each test sponsor must submit one letter of intent and one set of study plans

for each study (line g); five semi-annual progress reports for each long-term

study (line o); and one final report for each study (line q). (Note that for

chemicals contained in a proposed rulemaking, the rulemaking itself serves

as the study plan, so sponsors would not have to do their own study plans -

although EPA’s estimate here assumes that they do.) Although the

proposed ICR indicated that semi-annual reports would be required for all

studies, this ICR has dropped the semi-annual progress reports for the short

term studies. All 13 studies required for each chemical under the HPV

Challenge Program can be completed within a year and therefore would not

require a progress report. The expected total number of reports is therefore

11,891, including 468 for average test rules, 1,248 for consent orders, 1,014

related to the children’s health testing program, and 9,161 related to the

HPV testing program (line s). 

 8) For each sponsor of average test rules, there will be an estimated five

companies applying for an exemption. Exemptions are not relevant for

ECAs or for VTAs like the voluntary children’s health program, or the

voluntary HPV Challenge Program. The total number of estimated annual

exemptions is 15 (line y).

 9) Assuming that each report is considered a separate response, the total

number of estimated responses is 11,906 (11,891 reports + 15 exemptions)

(line z).
August 29, 2000

 

5

 Guidance on Searching for Chemical Information and Data, May 1999

(http://www.epa.gov/opptintr/chemrtk/srchsuid.htm).

17

 10) The total number of respondents is 128 (113 sponsors + 15 exemption

applicants) (line bb).

 11) In conducting any test that will be submitted to EPA under TSCA, the

respondent must comply with Good Laboratory Practices (GLPs). Since the

GLPs represent basic standard practices used by laboratories, any burden

and costs related to GLPs are fully captured in the laboratory cost and

burden estimates provided in Table 3.

 12) Although the actual distribution of respondents by activity may vary from that

shown in Table 1 (i.e., the data may alternatively be submitted under a test

rule, consent order, or voluntary program), the estimated overall number of

submissions is likely to remain the same. If the Agency determines that the

total annual burden covered by this ICR needs to be increased to

accommodate additional activities that exceed the estimated overall number

of submissions currently anticipated, it will submit an ICW to increase the

total annual burden in the OMB Inventory.

Additional Assumptions Related to the Voluntary Challenge Programs

The “Challenge” programs established for the children’s health and HPV chemicals

are voluntary initiatives under which manufacturers of chemicals targeted for testing will

voluntarily submit data on hazard endpoints. EPA would exclude any chemicals enrolled in

these Challenge programs from its planned section 4 test rules and would provide

recognition to Challenge participants for their voluntary actions.

For purposes of this ICR, EPA estimates that participants in the voluntary children’s

health or HPV Challenge programs would incur the same costs and burdens that they

would incur if the chemicals were subject to a section 4 rule, i.e., requirements to prepare

study plans, conduct testing, and report on testing results. In addition, to determine which

endpoints need to be tested, Challenge program participants would most likely undertake

a search for any existing studies for each chemical, and submit any studies to EPA.5 The

costs and burden associated with these data searches are included as reporting costs

and are described below under “Reporting Costs and Burdens.”

 

For some HPV Challenge chemicals, sponsors may prepare and submit a delisting

request. The delisting request would be accompanied by documentation supporting a

sponsor's claim that a chemical is not a high production volume chemical. For this ICR,

EPA assumes that the cost and burden of preparing such documentation, which would

include information on the production status of the chemical and identification of

manufacturers and importers, would be similar to the cost and burden of performing the

search described above. 
August 29, 2000

18

To the extent any delisting requests are accepted by EPA, such chemicals would

not be required to undergo testing under the Challenge programs. At this time, EPA

cannot estimate the number of delisting requests that will be submitted, nor the number that

would be accepted. The number accepted is expected to be small, however, since the

identification of a chemical as an HPV chemical is based on manufacturers’ and

importers’ own submissions to the TSCA Inventory. For this reason, EPA has not made

any adjustments to the estimates in this ICR of the costs and burdens incurred by

manufacturers of HPV chemicals to account for possible delisting requests.

These assumptions are used to estimate the cost and burden factors (or multipliers)

in Tables 1 and 3, and are also discussed in the remainder of this ICR.

Table 1. TSCA Section 4 ICR Assumptions

TSCA Section 4 ICR Assumptions

Test

Rule

Consent

Order

Children’s

Health HPV TOTALS

a No. of rules/orders issued 3 8 1 1 13

b Chemicals per rule/order 5 5 22 697 -

c Total no. of chemicals (a × b) 15 40 22 697 774

d No. of chemicals per sponsor 5 5 11 7 -

e No. of sponsors per rule or order (b ÷ d) 1 1 2 100 -

f Total no. of sponsors (a × e) 3 8 2 100 113

g Letters of intent per sponsor 1 1 1 1 -

h Total letters of intent (f × g) 3 8 2 100 113

i No. of short-term studies per chemical 7 7 10 13 -

j Total no. of short-term studies (c × i) 105 280 220 9,061 9,666

k No. of long-term studies per chemical 4 4 6 0 -

l Total no. of long-term studies (c × k) 60 160 132 0 352

m Total no. of studies per chemical (i + k) 11 11 16 13 -

n Total no. of studies (j + l) 165 440 352 9,061 10,018

o No. of semi-annual progress reports per

 Short-term study

 Long-term study/1

5

0

5

5

0

5

5

0

5

0

0

0

-

-

-

p Total no. of semi-annual progress reports 

 Short-term studies (o × j)

 Long-term studies (o × l)

300

0

300

800

0

800

660

0

660

0

0

0

1,760

0

1,760

q No. of final reports per study 1 1 1 1 -

r Total no. of final reports (n × q) 165 440 352 9,061 10,018

s Total no. of reports (h + p + r) 468 1,248 1,014 9,161 11,891

t Total reports per sponsor (s ÷ f) 156 156 507 92 -

u Total reports per rule/order (s ÷ a) 156 156 1,014 9,161 -

v Total reports per chemical (s ÷ c) 31 31 46 13 -

w No of exemptions per sponsor 5 0 0 0 -

x No. of exemptions per rule/order (e × w) 5 0 0 0 -

y Total no. of exemptions (a × x) 15 0 0 0 -

z Total no. of responses (s + y) 483 1,248 1,014 9,161 11,906

aa No. of responses per rule/order (e + x) 6 1 2 100 -

bb Total no. of respondents (a × aa) 18 8 2 100 128

/2 No reports for short-term studies since they can be completed in one year and five reports at 6, 12, 18, 24, and 30 months

for long-term studies.
August 29, 2000

 

6

 The laboratory cost is considered part of the sponsor’s overall cost, but the laboratory burden is not. The

laboratory burden is estimated here because it is used to derive an estimate of the burden incurred by the sponsor to

administer the testing program. See section 6(a) for more details.

 

7

 For one of the tests included in the “children’s health” battery (870.5100) test costs have not been developed. 

To provide a cost estimate, the cost for an older but similar test protocol (798.5265) was used and inflated to end-ofyear 1997 dollars according to the method described in the text.

19

Test Protocols and Costs

Each chemical covered by an average test rule or consent order must be evaluated

by performing the tests specified in the “Standard” testing battery. The test protocols and

associated cost and burden data for the “Standard” testing battery are depicted in Table 2. 

For the “children’s health” testing battery, only SIDS Tier I and SIDS Tier II tests will be

performed during the time period for an approved ICR (i.e., three years). This excludes test

numbers 2, 8, and 12 (all SIDS Tier III tests) from the “children’s health” testing costs.

Finally, the “SIDS Tier I” testing battery will be conducted for each chemical listed in the

HPV testing program. The cost and burden details of the “children’s health” and “SIDS

Tier I” testing batteries are presented in Table 2.

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

numerous TSCA and OECD test protocols. Any test protocols listed in Table 2 for which

cost and burden data were estimated prior to 1994 were adjusted to end-of-year 1997

dollars using the Bureau of Labor Statistics’ Employment Cost Indices (ECIs) (see

Attachment 5). When cost and burden data for a specific test protocol were available for

multiple species and routes of administration, the average cost and burden of all available

species and routes of administration was calculated and utilized for this report.

As shown in Table 2, the mean cost of the “Standard” battery is $982,002 and the

average laboratory burden associated with this testing is 11,555 hours.6 The mean cost of

the “children’s health” battery is $1,986,643 and the associated laboratory burden is

23,128 hours.7 For purposes of this ICR, however, only SIDS Tier I and SIDS Tier II tests

will be conducted for the “children’s health” battery. Thus, the “children’s health” testing cost

for this ICR is $902,696 and the burden for this ICR is 9,872 hours. The mean cost of the

“SIDS Tier I” battery is $177,168 and the associated laboratory burden is 1,857 hours.
August 29, 2000

20

Table 2. TSCA Section 4 ICR Test Batteries

Protocol Name

Protocol

Number

Date of

Estimate

Mean

Cost Estimate

Lab Burden

(hours)

“STANDARD” TESTING BATTERY

1. Algal Acute Toxicity \1 797.1050 08/03/90 $7,547 57

2. Daphnid Acute Toxicity 797.1300 04/25/96 $7,230 54

3. Fish Acute Toxicity 797.1400 04/25/96 $10,950 65

4. Gene Mutations in Somatic Cells 798.5300 08/16/94 $15,190 144

5. Subchronic Oral Toxicity 870.3100 09/03/96 $118,742 882

6. Prenatal Developmental Tox. (2 species) 870.3700 08/27/96 $199,690 2,314

7. Reproduction/Fertility Effects 870.3800 08/27/96 $458,708 6,086

8. Salmonella Reverse Mutation Assay 870.5265 09/16/96 $5,905 48

9. In vivo Bone Marrow Cytogenetics 870.5395 02/27/97 $12,785 125

10. Developmental Neurotoxicity 870.6300 08/27/96 $145,255 1,780

“STANDARD” - GRAND TOTAL $982,002 11,555

“CHILDREN’S HEALTH” TESTING BATTERY

1. Metabolism and pharmacokinetics 870.7485 12/02/96 $28,449 330

2. Neurotoxicity screening battery 870.6200 09/25/96 $145,296 1,522

3. Immunotoxicity 870.7800 12/02/96 $54,838 387

4. Bacterial reverse mutation assays \2 870.5100 08/17/94 $5,942 44

5. In vitro mammalian cytogenetics 870.5375 09/23/96 $14,960 149

6. Prenatal developmental toxicity study 870.3700 05/23/95 $95,995 1,074

7. Reproduction and fertility effects 870.3800 09/01/95 $495,804 6,086

8. Developmental neurotoxicity study 870.6300 08/27/96 $151,681 1,780

9. 90-day oral subchronic in rodents OR 870.3100 09/14/96 $123,995 882

90-day dermal subchronic in rodents OR 870.3250 02/02/97 $116,056 1,004

90-day inhalation subchronic in rodents 870.3465 12/02/96 $84,075 2,458

SUBTOTAL(AVERAGE) $174,709 1,448

10. Acute oral OR 870.1100 08/27/96 $2,966 44

acute dermal OR 870.1200 08/27/96 $3,874 45

acute inhalation 870.1300 08/27/96 $14,880 200

SUBTOTAL(AVERAGE) $7,240 96

11. Mammalian bone marrow chromosomal

aberrations OR

870.5385 09/25/96 $36,360 394

Mammalian erythrocyte micronucleus 870.5395 02/27/97 $13,160 125

SUBTOTAL(AVERAGE) $24,760 259

12. Combined chronic/carcinogenicity OR 870.4300 04/04/97 $879,061 10,864

Carcinogenicity 870.4200 04/04/97 $691,122 9,053

SUBTOTAL(AVERAGE) $785,092 9,959

“CHILDREN’S HEALTH” - GRAND TOTAL $1,986,643 23,128

“CHILDREN’S HEALTH” - ICR TOTAL \3 $902,696 9,872

“SIDS TIER I” (HPV) TESTING BATTERY

1. Melting Point OECD 102 04/20/98 $1,200 13

2. Boiling Point OECD 103 04/20/98 $1,250 14

3. Vapor Pressure OECD 104 06/11/98 $12,570 118
August 29, 2000

Table 2. TSCA Section 4 ICR Test Batteries

Protocol Name

Protocol

Number

Date of

Estimate

Mean

Cost Estimate

Lab Burden

(hours)

21

4. Water Solubility OECD 105 04/20/98 $4,930 53

5. Partition Coefficient (shake flask) OECD 107 04/20/98 $5,630 50

SUBTOTAL $25,580 248

6. Inherent Biodegradation OECD 302 04/20/98 $14,670 175

7. Genetic Toxicity (Salmonella) OECD 471 03/23/98 $5,930 44

8. Acute Toxicity to Aquatic Plants OECD 201 05/12/98 $7,360 62

SUBTOTAL $27,960 281

9. Acute Toxicity to Fish OECD 203 04/16/98 $8,300 56

10. Acute Toxicity to Daphnia OR OECD

202(I)

04/20/98 $6,390 40

Chronic Toxicity to Daphnia 850.1300 01/18/97 $26,400 173

SUBTOTAL (AVERAGE) $20,545 135

11. Acute Oral Toxicity OR OECD 401 03/21/98 $2,840 41

Acute Dermal Toxicity OR OECD 402 03/22/98 $3,833 43

Acute Inhalation Toxicity OECD 403 04/20/98 $13,650 184

SUBTOTAL (AVERAGE) $6,774 89

12. Chromosomal Aberration, in vitro OR OECD 473 04/20/98 $16,730 159

Chromosomal Aberration, in vivo OECD 474 04/23/98 $13,068 130

SUBTOTAL (AVERAGE) $14,899 145

13. Combined Repeated Dose with

Repro./Devel. Toxicity Screen OR

OECD 422 12/08/94 $83,260 1,146

Repeated Dose Oral Toxicity AND OECD 407 02/15/97 $36,400 328

Repro./Devel. Toxicity Screening Test OECD 421 04/01/97 $43,160 445

SUBTOTAL (AVERAGE) $81,410 960

“SIDS TIER I” - GRAND TOTAL $177,168 1,857

Notes:

\1 Cost adjusted from 1990 to end-of-year 1997 using a factor of 1.261, which is the ratio of ECI 1997:ECI 1990 (or,

135.2/107.2 = 1.261). See Attachment 5.

\2 Cost estimate for this protocol not available. Cost of 798.5265 was used instead.

\3 This total excludes Tier III tests (i.e., numbers 2, 8, and 12).

6(a) Respondent Cost and Burden

For purposes of calculating the PRA related burden and costs for this ICR, the

Agency assumed that the respondents will incur both laboratory testing costs and

administrative costs and burden when complying with the anticipated test rules, ECAs and

VTAs. The laboratory testing costs were used to calculate the potential costs associated

with administering the testing, and the the administrative costs were divided into reporting

costs and non-reporting costs. These are described in more detail later in this section.
August 29, 2000

22

The unit burden for each activity is based upon previous Section 4 ICRs and EPA’s

best estimates of the burdens that will be incurred under TSCA Section 4 test rules over

the next three year period. The unit wage rates used to monetize these burdens are

derived in Attachment 5 and are summarized as follows:

INDUSTRY LABOR

CATEGORY

LOADED

HOURLY RATE ($1998)

 Managerial

 Technical

 Secretarial

$86.86

$64.30

$25.63

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 below based on data presented in Table 1.

Number of Respondents

The Agency’s estimates assume that there will be an average of six respondents

per average test rule, one respondent as testing sponsor and five others who apply for

exemptions (See Table 1, line aa). The Agency assumes that there will be one respondent

(i.e., the test sponsor) per consent order, and for the children’s health and HPV testing

programs, that there will be 2 and 100 sponsors per rule, respectively. The estimated

annual total number of respondents for this ICR is 128 (i.e., 113 sponsors and 15

exemption applicants) (Table 1, line bb). 

Number of Reports

Over the course of the testing period, each test sponsor, or a common

representative of the test sponsors, will submit, on average, 93 reports (i.e., 11,891 reports

÷ 128 sponsors = 92.9). This will 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 that will be undertaken in response to TSCA

section 4 test rules. Table 3 presents estimates of the laboratory and administrative costs

and burden. These are discussed in detail below.

Laboratory Costs and Burdens

The costs and burdens incurred by sponsors performing laboratory testing are

presented in Table 3, and were calculated in order to derive estimates of the respondent’s

administrative burdens. The burden estimates associated with the paperwork related to
August 29, 2000

 

8

 Laboratory costs per study are: $89,273 for average test rules and consent orders, $56,419 for the children’s

health test rule, and $13,628 for the HPV program.

23

testing are captured in this ICR as administrative burden. The figures in Table 3 are based

on the estimated costs of the tests and the estimated lab burdens presented in Table 2. 

Total laboratory costs of the ICR are estimated to be $197.4 million ($14.7 million

for average test rules; $39.3 million for consent orders; $19.9 million for the children’s

health testing program; and $123.5 million for the HPV testing program). With a projected

total of 10,018 studies to be conducted annually (Table 3, line d), the average laboratory

cost is $19,700 per study (Table 3, line i).8

Administrative Costs and Burdens

EPA’s experience in test rule development has shown the administrative costs and

burdens associated with testing programs to be approximately 25 percent of the laboratory

costs and burdens. EPA has applied this 25 percent factor to estimate the administrative

costs and burden associated with test rules, consent orders, and the voluntary children’s

health program. For the voluntary HPV Challenge program, however, EPA assumed that

the administrative costs and burdens were equal to 100 percent of the laboratory costs

and burdens, instead of 25 percent. EPA used 100 percent for the voluntary HPV

Challenge program because of the relatively large number of tests (see Table 1, line j), and

the associated recordkeeping and reporting burden for each test.

Following the assumptions described above, the total administrative cost is

estimated to be $142.0 million annually (Table 3, line g) and the total administrative burden

is 1,507,390 hours (Table 3, line o). These administrative costs and burdens are assumed

to be incurred through reporting and non-reporting activities.

Administrative Reporting Costs and Burdens. Part of the administrative costs and

burdens associated with this ICR are derived from reporting activities undertaken by

respondents. These include activities such as: 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. Reporting

estimates also include the data search and reviews conducted for the voluntary children’s

health and HPV Challenge programs.

The respondents’ annual cost and burden estimates associated with each reporting

activity are detailed in Table 4 (more detailed tables for each type of activity are included

as Attachment 7). The unit wage rate information is explained in Attachment 5. The unit

labor hours are derived from previous information collection requests and are believed to
August 29, 2000

 

9

 Estimates of the burden and cost associated with the Children’s Health and HPV Challenge Programs (searching

for and submitting existing studies of the health and ecological effects of each chemical) are based on the TSCA

Section 8(d) ICR. For each chemical, 6.5 manufacturers are assumed to spend 18 hours each determining which sites

may have relevant studies, performing the search, developing a list of studies found, and making copies of studies

for submittal to EPA. Each manufacturer is assumed to copy 48 pages (3 studies × 16 pages per study). For the

external search, one sponsor per chemical are assumed to spend 60 hours searching electronic and other databases,

and copy and submit a total of 160 pages to EPA (10 studies × 16 pages per study). 

 

10 Economic Analysis for Renewed Information Collection Request for the TSCA Section 8(d )Health and Safety

Data Reporting Rule, U.S. Environmental Protection Agency, OPPT/EETD/EPAB, October 1995.

24

be reflective of the annual amount of time required for each activity over the next three year

period.9

To estimate the cost and burden of performing data searches for the voluntary

programs, EPA assumes that 6.5 firms per chemical would search their internal records

and one sponsor per chemical would perform an external search of the literature. The

assumption of 6.5 firms per chemical is based on the estimates made in the economic

analysis prepared in support of the ICR for the TSCA Section 8(d) Health and Safety Data

Reporting Rule.10 Based on this, 143 searches by firms (6.5 × 22) and 22 searches by

sponsors are assumed for the children’s health test program annually. Similarly, 4,531

searches by firms (6.5 × 697) and 697 searches by sponsors are assumed for the HPV

testing program annually. Each year there will be an estimated total of 4,674 searches

conducted by manufacturers (143 + 4,531) and 719 searches conducted by sponsors (22

+ 697) for the children’s health and HPV testing programs. 

The total annual respondent cost and burden for reporting activities is $51.0 million

and 1,182,574 hours (Table 4).

Non-reporting Administrative Costs and Burdens. Non-reporting administrative

activities include the effort of respondents to organize a testing program, obtain and review

bids from laboratories who would conduct the testing, and prepare and submit samples to

the laboratory for testing. For this ICR, EPA has calculated the costs and burdens of these

activities as the difference between the total administrative costs and burdens and the

reporting costs and burdens derived above. Based on this calculation, non-reporting

activities associated with laboratory testing are estimated to cost $90.9 million annually

and impose a burden of 324,816 hours annually (Table 3, lines g and o). Since these

activities are only undertaken at the discretion of the individual respondent and are not part

of the Agency’s testing program, these estimates are only being provided for

completeness, and are not attributable as burden and costs for the purposes of this ICR.
August 29, 2000

25

Table 3. TSCA Section 4 ICR Laboratory Cost and Burden Estimates

TSCA Section 4 ICR Factors Test

Rule

Consent

Order

Children’s

Health HPV TOTALS /1

a Total no. of rules/orders /1 3 8 1 1 13

b Total no. of chemicals /1 15 40 22 697 774

c Total no. of sponsors /1 3 8 2 100 113

d Total no. of studies /1 165 440 352 9,061 10,018

e Lab. cost per chemical /2 $982,002 $982,002 $902,696 $177,168 $254,982

f Total lab. costs (b × e) $14,730,030 $39,280,080 $19,589,312 $123,486,096 $197,355,750

g Administrative Reporting costs

Administrative Non-reporting costs

Total administrative costs /3

$1,039,542

$2,642,965

$3,682,508

$2,772,112

$7,047,908

$9,820,020

$2,484,534

$2,480,294

$4,964,828

$44,742,225

$78,744,103

$123,486,096

$51,040,343

$90,913,341

$141,953,684

h Total lab. and admin. costs (f + g) $18,412,538 $49,100,100 $24,824,140 $246,972,192 $339,309,434

i Lab. costs per study (f ÷ d) $89,273 $89,273 $56,419 $13,628 $19,700

j Admin. costs per study (g ÷ d) $16,006 $16,006 $7,046 $8,690 $9,075

k Total testing costs per study (i + j) $125,279 $105,279 $63,465 $22,319 $28,775

l Total testing costs per sponsor (h ÷ c) $6,137,513 $6,137,513 $12,412,070 $2,469,727 $3,002,738

m Lab. burden per chemical /2 11,555 11,555 9,872 1,857 2,774

n Total lab. burden (b × m) 173,325 462,200 217,184 1,294,329 2,146,922

o Administrative Reporting burden

Administrative Non-reporting burden

Total administrative burden /3

18,525

24,776

43,331

49,400

66,150

115,550

52,295

2,001

54,296

1,062,325

231,888

1,294,329

1,182,574

324,816

1,507,390

p Lab. burden per study (n ÷ d) 1,050 1,051 617 143 214

q Admin. burden per study (o ÷ d) 263 263 154 143 150

r Total administrative burden per sponsor (o ÷ c) 14,444 14,444 27,148 12,942 13,340
August 29, 2000

Table 3. TSCA Section 4 ICR Laboratory Cost and Burden Estimates

TSCA Section 4 ICR Factors Test

Rule

Consent

Order

Children’s

Health HPV TOTALS /1

26

/1 See Table 1.

/2 See Table 2.

/3 For average test rules, consent orders, and the children’s health program, administrative costs and burdens are assumed to equal 25 percent of laboratory costs and

burdens; for the HPV rule administrative costs and burdens are assumed to equal 100 percent of laboratory costs and burdens.
August 29, 2000

27

Table 4. Total Annual Respondent Cost and Burden Estimates for Reporting

COLLECTION ACTIVITY

UNIT LABOR UNIT

SUPPLY

COSTS

ANNUAL

ITEMS

GRAND TOTAL

TYPE /1 HOURS RATE COST HOURS COSTS

INTERIM REPORTS

 Letter of Intent and Study Plans T 40 $64.30 $2,572.00 $20.00 113 4,520 $292,896

 Prepare Progress Report T 8 $64.30 $514.40 $5.00 1,760 14,080 $914,144

 INTERIM REPORTS SUBTOTAL 18,600 $1,207,040

FINAL REPORTS

Short-term Studies

 Record and Prepare Test for Submission T 40 $64.30 $2,572.00 $0.00 9,666 386,640 $24,860,952

 Laboratory Review T 6 $64.30 $385.80 $0.00 9,666 57,996 $3,729,143

 Corporate Review M 6 $86.86 $521.16 $0.00 9,666 57,996 $5,037,533

 Type and Print Results S 20 $25.63 $512.60 $0.00 9,666 193,320 $4,954,792

 Record Keeping S 1 $25.63 $25.63 $5.00 9,666 9,666 $296,070

 Short-term Subtotal 705,618 $38,878,489

Long-term Studies

 Record and Prepare Test for Submission T 80 $64.30 $5,144.00 $0.00 352 28,160 $1,810,688

 Laboratory Review T 9 $64.30 $578.70 $0.00 352 3,168 $203,702

 Corporate Review M 9 $86.86 $781.74 $0.00 352 3,168 $275,172

 Type and Print Results S 40 $25.63 $1,025.20 $0.00 352 14,080 $360,870

 Record Keeping S 1 $25.63 $25.63 $5.00 352 352 $10,782

 Long-term Subtotal 48,928 $2,661,215

FINAL REPORTS SUBTOTAL 754,546 $41,539,704
August 29, 2000

COLLECTION ACTIVITY

UNIT LABOR UNIT

SUPPLY

COSTS

ANNUAL

ITEMS

GRAND TOTAL

TYPE /1 HOURS RATE COST HOURS COSTS

28

 EXEMPTION REQUESTS T 2 $64.30 $128.60 $0.00 15 30 $1,929

EXISTING TEST DATA SEARCH

(CHILDREN’S HEALTH AND HPV CHALLENGE

PROGRAMS)

 Manufacturer

 Corporate review M 3 $86.86 $260.58 $0.00 4,674 14,021 $1,217,821

 File search T 9 $64.30 $578.70 $0.00 4,674 42,062 $2,704,554

 Summary sheet S 1 $25.63 $25.63 $0.00 4,674 4,674 $119,782

 Reproduction S 1.8 $25.63 $46.13 $3.36 4,674 8,412 $231,310

 CBI review M 3 $86.86 $260.58 $0.00 4,674 14,021 $1,217,821

 Manufacturer Subtotal 83,188 $5,491,288

Sponsor

 External search T 60 $64.30 $3,858.00 $11.20 719 110,295 $2,781,955

 Summary sheet S 1 $25.63 $25.63 $0.00 719 215,916 $18,428

 Sponsor Subtotal 326,210 $2,800,383

 DATA SEARCH SUBTOTAL 409,398 $8,291,670

 GRAND TOTALS /2 1,182,574 $51,040,343

/1 Labor Type – T = Technical; M = Managerial; S = Secretarial

/2 A break-out of the total reporting costs by type of activity are provided in Attachment 7.
August 29, 2000

29

Total Cost and Burden. 

Table 5 summarizes the costs and burdens associated with the TSCA Section 4

testing program. The total costs include laboratory costs, administrative reporting costs 

(letters of intent, interim reports, final reports, exclusion requests, and existing data

searches), and non-reporting administrative costs. In calculating paperwork burdens and

paperwork costs, EPA excludes laboratory costs and non-reporting administrative costs

since neither impose paperwork burdens. As shown in Table 5, the combined cost of all

TSCA section 4-related information collection for this ICR is $51.0 million annually with a

combined burden estimate is 1.2 million hours annually. This is equivalent to $65,944 and

1,528 hours per chemical, or $451,684 and 10,465 hours per sponsor, taking into account

774 chemicals and 113 sponsors. 

Table 5. Summary of Respondent Cost and Burden Estimates

ACTIVITY

TOTAL ANNUAL RESPONDENT COST AND BURDEN

Burden 

Hours

Paperwork

Costs

Other 

Costs

Laboratory Testing /1 n/a n/a $197,355,750

Letters of Intent /2 4,520 $292,896 $0

Progress reports /2 14,080 $914,144 $0

Final Reports /2 754,546 $41,539,704 $0

Exemption Requests /2 30 $1,929 $0

Existing Data Search /2 409,398 $8,291,670 $0

Non-reporting administrative /1 n/a n/a $90,913,341

ANNUAL TOTAL 1,182,574 $51,040,343 $288,269,091

Note: totals may not add due to rounding.

/1 The laboratory testing burden and non-reporting administrative costs represent costs incurred by affected entities, but

are not classified as paperwork burdens under the PRA and are only presented here for completeness.

/2 Each of the collection activities is classified as “administrative reporting”.

6(b) Agency Cost and Burden

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

collected under Section 4 test rules and consent orders is discussed below and detailed in

Table 6.

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

by a GS-12, Step 1, employee. The annual 1998 loaded cost of a full-time equivalent

(FTE) for this level employee is $75,306. This includes a base wage of $47,066 plus 60

percent for overhead and benefits (i.e., $28,240). Dividing this value by 2,080 (i.e., the
August 29, 2000

30

number of hours in a work year) equals an hourly wage rate of $36.20 (see Attachment 5

for the derivation of these factors).

AGENCY LABOR

CATEGORY

LOADED

HOURLY RATE ($1998)

 GS-12, Step 1 $36.20

The estimated unit Agency burden of processing letters of intent and study plans (3

hours), progress reports (1 hour), and final reports (5 hours) is derived from the previous

information collection requests and is presented in Table 6. It takes approximately one

hour for the Agency to process and review each exemption application. The total annual

Agency costs and burden for processing letters and reports is $1.9 million and 52,189

hours. The Agency’s annual exemption processing costs and burden is $543 and 15

hours.

Table 6. Annual Agency Cost and Burden Estimates

COLLECTION ACTIVITY

UNIT LABOR UNIT

SUPPLY

COSTS

ANNUAL

ITEMS

GRAND TOTAL

HOURS RATE COST HOURS COSTS

Letter of Intent and Study

Plans

3 $36.20 $108.60 $0.00 113 339 $12,272

Progress Reports 1 $36.20 $36.20 $0.00 1,760 1,760 $63,712

Final Reports 5 $36.20 $181.00 $0.00 10,018 50,090 $1,813,258

 SUBTOTAL 11,891 52,189 $1,889,242

Exemptions 1 $36.20 $36.20 $0.00 15 15 $543

 GRAND TOTAL 11,906 52,204 $1,889,785

6(c) Bottom Line Annual Burden Hours and Costs – Master Tables

6(c)(i) Respondent Tally

Table 7 summarizes the annual average burden per response. EPA estimates that

this ICR will impose 1.2 million burden hours on respondents annually. This total burden

covers 17,299 responses annually for an average of 68.36 hours per response.
August 29, 2000

31

Table 7. Average Burden Hours Per Response

COLLECTION

ACTIVITY

ANNUAL RESPONDENT BURDEN PER RESPONSE 

TOTAL

HOURS

TOTAL

ITEMS

HOURS

PER RESPONSE

Letters of Intent 4,520 113 40.00

Progress reports 14,080 1,760 8.00

Final Reports 754,546 10,018 75.32

Exemption Requests 30 15 2.00

Existing Data Search 409,398 5,393 75.91

TOTAL (all responses) 1,182,574 17,299 68.36

The total burden hours and costs for respondents have been calculated above in

Table 5. Table 8 summarizes these estimated annual burden hours and costs.

Table 8. Summary of Respondent Burden and Costs Estimates

COLLECTION

ACTIVITY

Total Annual

Hours Cost

Letters of Intent 4,520 $292,896

Progress reports 14,080 $914,144

Final Reports 754,546 $41,539,704

Exemption Requests 30 $1,929

Existing Data Search 409,398 $8,291,670

TOTAL (all responses) 1,182,574 $51,040,343

6(c)(ii) Agency Tally

The burden hours and costs for the government have been calculated above in

Table 6. These estimates are summarized below in Table 9.

Table 9. Summary of Agency Burden and Costs Estimates

COLLECTION

ACTIVITY

TOTAL ANNUAL AGENCY BURDEN AND COSTS

BURDEN (Hours) COSTS

Letter of Intent and Study Plans 339 $12,272

Progress Reports 1,760 $63,712

Final Reports 50,090 $1,813,258

Exemptions 15 $543
August 29, 2000

32

TOTAL 52,204 $1,889,785

6(d) Reasons for Changes in Burden

The major change from the previous ICR is an increase of 1,106,124 hours in the

estimated total annual burden for this ICR, from 76,450 hours currently in the OMB

inventory to 1,182,574 hours requested in this ICR. This increase, and the corresponding

increase in the costs, are the result of a program change. Specifically, the Agency has

initiated two major new VTAs, the voluntary HPV Challenge Program and the voluntary

children’s health testing program. The inclusion of the estimated burden and costs

associated with these two programs has resulted in a significant increase in the total

number of chemicals covered by the Testing Program, and a corresponding increase in

the reporting and recordkeeping burden related to the program. The voluntary children’s

health testing program will initially involve approximately 22 chemicals each year and is

estimated to result in 1,014 total responses each year. The voluntary HPV Challenge

program is currently expected to include 2,089 chemicals over the three year period for the

ICR, or approximately 697 chemicals each year, and is estimated to result in 9,161 total

responses each year. 

In the previous ICR, the Agency’s estimated burden was based on the assumption

that it would issue 2 average test rules, 4 ECAs, and 1 multi-chemical test rule each year. 

For this ICR, the burden is based on the Agency’s expectation that, on average, it will issue

3 average test rules, and 8 ECAs each year for the next three years. This increase reflects

current Agency testing program activities as reflected in the Agency’s Regulatory Agenda. 

In addition, the Agency has adjusted the costs to reflect an update in the labor rates,

and more recent laboratory testing costs. These cost related changes are adjustments.

6(e) Burden Statement

The annual public burden for this collection of information, which is approved under

OMB Control No. 2070-0033, is estimated to average 68.36 hours per response. 

According to the PRA, “burden” means the total time, effort, or financial resources

expended by persons to generate, maintain, retain, or disclose or provide information to or

for a Federal agency. For this collection it includes the time needed to review instructions;

develop, acquire, install, and utilize technology and systems for the purposes of collecting,

validating, and verifying information, processing and maintaining information, and

disclosing and providing information; adjust the existing ways to comply with any previously

applicable instructions and requirements; train personnel to be able to respond to a

collection of information; search data sources; complete and review the collection of

information; and transmit or otherwise disclose the information. An agency may not

conduct or sponsor, and a person is not required to respond to, a collection of information

unless it displays a currently valid OMB control number. The OMB control number for this

information collection appears above. In addition, the OMB control numbers for EPA's
August 29, 2000

33

regulations, after initial display in the Federal Register, are listed in 40 CFR part 9, as well

as in any applicable collection instrument.

Send comments on the Agency's need for this information, the accuracy of the

provided burden estimates, and any suggested methods for minimizing respondent

burden, including through the use of automated collection techniques to the Director,

Collection Strategies Division (2822), U.S. Environmental Protection Agency, 1200

Pennsylvania Ave, NW, Washington, D.C. 20460. Include the OMB control number in any

correspondence, but do not submit the requested information to this address. The

requested information should be submitted in accordance with the instructions

accompanying the form, or as specified in the corresponding regulation.

ATTACHMENTS:

[NOTE: Unless otherwise noted, an electronic version of the listed attachment appears in

the electronic file for the ICR, following the main text of the Supporting Statement.]

Attachment 1 - Toxic Substances Control Act Section 4 (15 USC 2603) (For an electronic

copy of this law go to http://www.epa.gov/opptsfrs/home/rules.htm.)

Attachment 2 - 40 CFR 790 - Procedures Governing Testing Consent Agreements and

Test Rules (For an electronic copy of this regulation go to

http://www.epa.gov/opptsfrs/home/rules.htm.)

Attachment 3 - OPPT TSCA Test Guidelines Cost Summary (This document is not

available electronically. Please contact EPA for a copy).

Attachment 4 - Public Notice Required Prior to ICR Submission to OMB, 64 FR 40865,

July 28, 1999. (For an electronic copy of this FR document go to

http://www.epa.gov/fedrgstr/EPA-TOX/1999/July/Day-28/t19274.htm).

Attachment 5 - Wage Rates Estimation

Attachment 6 - Response to Comments

Attachment 7 - Supplemental Break-outs for Table 4
August 29, 2000

ATTACHMENT 1

Toxic Substances Control Act Section 4

15 USC 2603
August 29, 2000

ATTACHMENT 2

40 CFR 790

Procedures Governing Testing Consent Agreements and Test Rules
August 29, 2000

ATTACHMENT 3

OPPT TSCA Test Guidelines Cost Summary

(This document is not available electronically. Please contact EPA for a copy).
August 9, 2000

ATTACHMENT 4

Public Notice Required Prior to ICR Submission to OMB

64 FR 40865, July 28, 1999

(For an electronic copy of this FR document go to

http://www.epa.gov/fedrgstr/EPA-TOX/1999/July/Day-28/t19274.htm).
August 9, 2000

 

11Centaur Associates, Inc., Response Times and Labor Costs Final Data Element List Comprehensive Assessment

Information Rule, prepared for the U.S. Environmental Protection Agency under Contract No. 68-02-3980, Washington, D.C.,

April 30, 1985, pp. 94-106.

 

12William Silagi, Wage Rates for Economic analyses of Rulemakings Under EPCRA Section 313, U.S. Environmental

Protection Agency/OPPT/EETD/RIB, Washington, D.C., November 12, 1993, Appendix A.

1

ATTACHMENT 5

WAGE RATES ESTIMATION

A. Overview

Wage rates including fringe benefits and overhead for government labor and three

broad industry categories of labor (managerial, technical, and secretarial) were used in this

cost analysis. The labor categories and loaded wage rates were developed during previous

studies. The basic methodology for estimating wage rates was developed for the

Comprehensive AssessmentInformationRule (CAIR).11 Updated wage rate estimates were

developed by EPA, using the CAIR methodology, for a 1993 economic analysis of

rulemakings under EPCRA Section313.12 The methodology used in developing wage rates

is summarized below.

LABOR CATEGORY LOADED HOURLY RATE

Government

 GS-12, Step 1 $36.20

Industry

 Managerial

 Technical

 Secretarial

$86.86

$64.30

$25.63

B. Government

The Federal government collection activity procedures described in this report are

expected to be accomplished by a GS-12, Step 1, Federal full-time equivalent (FTE)

employee. One FTE is equivalent to 2,080 hours per year. The 1998 cost of a full time

equivalent employee (FTE) was provided by the Office of Personnel Management’s 1998

GeneralSchedule LocalityRatesofPayforWashington-Baltimore,DC-MD-VA-WV (effective

January 1998).

The annual costs per FTE are derived by multiplying the annual pay rate by 1.6 (the

benefits multiplicationfactor). The multiplication factor used is recommended in EPA's Office

of Policy, Planning, and Evaluation's Instructions for Preparing Information Collection

Requests (ICRs) (June 1, 1992). An EPA internal phone call between Carol Rawie

(OPPT/EETD/RIB) and Carl Koch (OPPE/RMD/IMB) onMay 3, 1994, indicated that the 1.6

factor included not only benefits but also overhead. 
August 9, 2000

 

13 Bureau of Labor Statistics, Occupational Compensation Survey, National Summary, 1996, U.S. Department of Labor,

Washington, D.C., Bulletin 2497, March 1998, Tables D-1 and D-3.

2

An annual pay rate of $47,066 is used and reflects a GS-12 (step 1) salary as of

January, 1,1998. This GS-12, Step 1, assumption was recommended by EPA (via an internal

EPA phone call between Carol Rawie (OPPT/EETD/RIB) and Ron Carlson (OPPT/OPME)

on April 25, 1994). Thus, the annual, fully-loaded cost per FTE is $75,306 (i.e., $47,066 ×

1.6), or $36.20 per hour (i.e., $75, 306 ÷ 2,080 hours).

C. Industry

Industry wage data used in developing the basic wage rates for this analysis were

derived from wage information published by the Bureau of Labor Statistics (BLS) for all

goods-producing,private industries.13 The wage rates for four BLS labor categories by level

(i.e., Accountant, Attorney, Engineer, and Secretary) are presented in Table 1. The BLS

wages do not include either fringe benefits or overhead.

At the managerial and technical levels, wage rates are composites of BLS wages for

several labor categories/levels. The wage rate for managerial personnel is a composite of

average BLS wages for three labor categories/levels: Accountant (levels V-VI); Attorney

(levels IV-VI); and Engineer (levels VI-VIII). The wage rate for technical personnel is a

composite ofaverage BLS wage rates fortwo laborcategories/levels:Accountant(levels II-VI)

and Engineer (levels III-VIII). The wage rate for secretarial personnel is based on the average

BLS wage rate for a single labor category (levels I-V), namely, Secretarial.

Table 1. Average Annual Salary in All Goods-Producing Industries, June 1996

Occupation

Level

Labor Category Annual Salaries /1

Accountant Attorney Engineer Secretarial

I $28,392 $43,732 $35,828 $22,724

II $33,644 $59,644 $42,172 $26,416

III $43,264 $80,496 $49,816 $30,316

IV $55,796 $94,224 $60,788 $35,620

V $71,552 $113,464 $73,944 $42,432

VI $92,508 $141,076 $87,724 na

VII na na $104,156 na

VIII na na $123,032 na

/1 Salary data are reported as weeklypay. The annual salaries are derived by multiplying published weekly pay

rates by 52

weeks.

Source: Occupational Compensation Survey, National Summary, 1996. USDL, BLS, Bulletin 2497, March

1998, Tables A-1, D-3.
August 9, 2000

3

Toderive the composite salaries, the BLS salaries for eachofthe laborcategories that

make upeitherthe managerialortechnicallaborcategoriesused in this analysis are weighted

based on the typical fraction of totalreporting effort thatis accounted for by thatspecific BLS

labor category. The weighting factors are based on information provided by the chemical

industry and chemical industry trade associations. For example, as shown in Table 3,

engineers typicallyaccountfor10/17(orroughly59percent)ofthe managerialeffort expended

in responding to EPA reporting rules. The weighted salaries for each of the BLS labor

categories are then added to derive the base salaries of the broad, composite labor

categories used in this analysis. 

The composite annualsalaryestimates were adjusted to current dollars, if necessary,

using the BLS Employment Cost Index(ECI). The adjusted, composite salary for each of the

three labor categories was thenmultiplied by the sum of the benefits and overhead factors to

estimate a loaded annual salary. This loaded annual salary was divided by 2,080 hours (i.e.,

the average annual number of hours worked per year by a full-time employee) to derive the

basic, loaded hourly wage rate for the three labor categories used in this analysis.

The ECI data and the benefits loading factors are presented inTable 2. Detailed ECI

data for white-collar occupations in the goods-producing,private industries are notavailable

at the same level of detail as the BLS wage data; therefore, ECI data for white-collar

occupations in for all private industries were used to adjust the wages in each BLS labor

category. Detailed benefits data for white-collar occupations in the goods-producing, private

industriesare available,however, and were utilized for this adjustment. Based on information

providedbythe chemical industryand chemicalindustrytradeassociations,itwasdetermined

that overhead for employees in the chemical industry average about 17 percent of the basic

hourly wage.

The loaded hourly wage rates used in the analysis are presented in Table 3. Unit

burdenestimates are converted to unit cost estimates by multiplying the unitburdenhours by

the appropriate wage rates in Table 3.
August 9, 2000

4

Table 2. Bureau of Labor Statistics (BLS) Employment Cost Index (ECI) Wage and Salary and Benefit Estimates

BLS

Labor

Category

BLS ECI

Occupational Category

ECI Wage and Salary

Private Industry /1

March 1997

% of

Compensation /2

Ratio of

%

Benefit

s

to

%

Wages

1996

June

1998

March

ECI Ratio

06/96:03/9

8 Wages

Benefit

s

Managerial Executive, Administrative, and

Managerial Occupations

126.8 137.8 1.087 71.2% 28.8% 0.404

Technical Professional Specialty and

Technical Occupations

128.8 135.9 1.055 71.0% 29.0% 0.408

Secretarial Administrative Support incl Clerical

Occupations

127.3 135.3 1.063 70.3% 29.7% 0.422

/1 Employment cost index (wages and salaries only), all private industry workers by occupation and industry group for white-collar

occupations.

/2 Percent of all workers, all private, goods-producing industries, white-collar occupations.

Source: Bureau of Labor Statistics, Employment Cost Index, Historical Listing, January 27, 1998, Table 6.

 Bureau of Labor Statistics, Employer Costs for Employee Compensation - March 1997, USDL Bulletin: 97-371, October 21, 1997,

Table 11.
August 9, 2000

5

Table 3. Estimated Loaded Hourly Wage Rates by Labor Category

a b c d e f g h i j k

Labor

Category

Occupation

(levels)

Weightin

g

Factor

1996

Composite

Salary

(c × average

salaries

from Table

1)

ECI Ratio

06/96:04/9

8

(from

Table 2)

1998

Adjusted

Salary

(d × e)

Benefits

(% Salary)

(from

Table 2)

Overhead

(% Salary)

Benefits

and

Overhead

Factor

(1+g+h)

1998

Loaded

Annual

Salary

(f × i)

1998

Loaded

Hourly

Rate

(j ÷

2,080)

Managerial Accountant (V-VI)

Attorney (IV-VI)

Engineer (VI-VIII)

 2/17

 5/17

10/17

 9,651

 34,193

 61,747

Composite Salary 17/17 $105,591 1.087 $114,777 40.4% 17.0% 1.574 $180,662 $86.86

Technical Accountant (III-VI)

Engineer (III-VIII)

1/6

5/6

 10,963

 69,369

Composite Salary 6/6 $80,332 1.055 $ 84,750 40.8% 17.0% 1.578 $133,736 $64.30

Secretarial Secretarial (I-V) 1/1 31,502

Composite Salary 1/1 $31,502 1.063 $ 33,487 42.2% 17.0% 1.592 $53,311 $25.63

Source: USEPA, Silagi memo (11/93).

 Occupational Compensation Survey, National Summary, 1996. USDL, BLS, Bulletin 2497, March 1998, Tables A-1, D-3.

 Bureau of Labor Statistics, Employment Cost Index, Historical Listing, January 27, 1998, Table 6.

 Bureau of Labor Statistics, Employment Cost Index - March 1998, USDL Bulletin: 98-170, April 30, 1998, Table 6.

 Bureau of Labor Statistics, Employer Costs for Employee Compensation - March 1997, USDL Bulletin: 97-371, October 21, 1997, Table 11.
August 9, 2000

ATTACHMENT 6

Response to Comments

December 7, 1999

MEMORANDUM

SUBJECT: Responseto Comments Received onthe TSCA Existing ChemicalTestRules,

ConsentOrders, Test Rule Exemptions, and VoluntaryTestData Submissions;

Information Collection Request Renewal (1139)

FROM: Charles M. Auer, Director //s//

Chemical Control Division (7405)

TO: Angela Hoffman, Director

Regulatory Coordination Staff (7101)

BACKGROUND

Section 4 of the Toxic Substances ControlAct (TSCA), (40 CFR 790) was designed

to assure that those chemicals which may pose serious risks to human health or the

environment are tested by manufacturers and processors. If this collection activity were not

carried out after having determined that data was needed to assess risks associated with

manufacture, processing, or disposal of a chemical, EPA would not have enough data to

support necessary regulatory action and would be violating the requirements of section 4 of

TSCA.

One commentor (The ChemicalManufacturersAssociation) respondedto theFederal

Register notice (64 FR 40865, July 28, 1999) announcing EPA’s intent to submit the ICR

for the TSCA section 4 program to OMB. The comments and EPA’s response to OMB for

those comments are contained herein. Both comment and response have beenprepared in

a question and answer Plain Language format.

COMMENTS/RESPONSES

1. Q. What is the scope of the ICR?

A. The burden estimates described in the ICR renewal request is based on 3 test

rules, 8 enforceable consent agreements (ECAs), data collection/development of screeninglevel data for 2,089 chemicals volunteered under the High Production Volume Challenge

Program, and 22 chemicals volunteered under the Voluntary Children’s Health Chemical

Testing Program. For further clarification, the burden associated with the High Production

Volume Test Rules(s) have notbeenincluded inthis ICRrenewalrequest. A burden estimate

will be developed for the HPV Test Rule(s) and submitted as anamendment to this ICRwhen

the HPV Rule(s) is finalized.
August 9, 2000

7

2. Q. Does this ICR provide an estimate of the cumulative burden of other TSCA-related

testing, whether voluntary or pursuant to test orders or enforceable consent agreements

(ECAs)?

A. The estimates in the ICR burden statement are for those which are likely to be

incurred during the 3 year time period covered by the ICR. It does not include estimates of the

burden of other rules, ECAs, etc., before or after that time period. 

3. Q. What is the impact of the HPV testing on laboratory capacity?

A. EPA recognizes that the availability of laboratory capacity could potentially affect

the burdens and costs associated with testing requirements. The Agency recently evaluated

laboratory capacity and found that a variety of factors affect the availability of testing

laboratories including: expansion of laboratory capacity, use of laboratories outside of the

United States, the types of testing in demand, and current amount of available capacity for

particular tests. Given the many factors involved, the Agency does not believe it can

accurately predict what, if any, impact on costs or burdens will result from the test rules

covered by the ICR. Although CMA comments that costs are expected to rise “quickly and

soon,” it has not provided any information that EPA can use to revise its estimates.

4. Q. Has EPA accurately estimated the potential number of respondents for the first

year of the ICR for all anticipated test rules, consent orders, and Children/HPV

programs?

A. In order to estimate the number of chemicals represented per panel, EPA

investigated the current number of committed panels to the HPV Challenge Program. This

information was available at http://www.epa.gov/opptintr/smrestbl.htm and was last updated

on October 12, 1999. EPA identified the panels as either individual companies or a group

of companies (e.g., a consortia) that have committed to submit data for the chemicals

produced. A single company may be part of more than one panel. A panel may cover

anywhere from one chemical to as many as 355 chemicals (e.g., The American Petroleum

Institute (API) Petroleum HPV Testing Group). EPA considers panels to be respondent to the

rules. However, to develop a complete estimate of respondents, EPA also includes estimates

of the number of exemption requests (in the case of the HPV Challenge Program and

Children’s programs there were 0 exemptions).

The ICR burden analysis has been adjusted to assume an average of 7 chemicals

represented per panel(sponsor) for the HPV. This would result in 100 panels (697 chemicals

divided by 7 chemicals per sponsor) for the HPV challenge. 

In regards to the Children’s Initiative, the estimate of chemicals per panel may be

premature, but it is the most reasonable estimate that EPA could come up with given the

status of the initiative.
August 9, 2000

8

5. Q. Has EPA, in developing the burden estimate, calculated the burden for each

member ofthe panel, as eachcompany will searchits own files, sign commitment forms, and

equally share in the work?

A. EPA included an estimate of the costs and burdens for administering the laboratory

testing programs for the rules and voluntaryportions of the ICR. This estimate was 25 percent

of the laboratorycosts for the non-HPV portions of the ICR and 100 percent of the laboratory

costs for the HPV initiative. These estimates do cover all administrative costs of the

programs, including the costs to all members of the panels.

6. Q. Is EPA’s ICR estimate for the SIDS battery of tests accurate?

A. EPA believes that its estimates of testing costs are reasonable. The commenter

has provided no basis for its estimates ofcosts. In addition, CMA has provided an estimate

of the costs of the SIDS battery that is higher than estimates previously submitted to EPA

without an explanation of the reason for the changes in their cost estimates. In response to

the commentor, EPA did, however, review the costs and estimates provided by EPA and

compared them to its own estimates. The bulk of the difference in EPA’s and CMA’s cost

estimates for the SIDS battery can be attributed to the cost estimates of a few tests and to

CMA’s inclusion of the cost of dossier preparation to its estimate of test costs. The tests for

which CMA and EPA cost estimates differed significantly are:

o OECD 407: Repeated Dose 28-day Oral Toxicity in Rodents

o OECD 421: Reproductive Developmental Toxicity Screening

o OECD 422: Combined Repeated Dose Study with Reproductive/ Developmental

Toxicity Screen

EPA contacted six U.S. laboratories that conducted these tests to compare its

estimates of test costs with the cost charged to clients. Table 1 below presents the ranges

and averages oftestcostsforOECD 407,421,422,and any modifications or variations (e.g.,

in route of administration or testing period) to these tests that have been identified in EPA’s

current test cost estimates or by laboratory contacts. Tests, or any of their modifications or

variations, may not be conducted at every laboratory. For example, only one laboratory

contact said their lab performs OECD 421 on rats via inhalation.

In reviewof the responses in table 1, EPA determined that its estimates are withinthe

range of costs charged by laboratories with the exception of OECD 407 for which the EPA’s

estimate is high.

EPA has also included the cost of dossier preparationin itsestimate of administrative

costs so it is included as part of the cost of the collection.

7. Q. Is EPA’s estimation of the cost of the Children’s Health Test Battery reasonable?
August 9, 2000

9

A. EPA used the most reliable data on the costs of the selected tests for the Children’s

test battery. CMA has provided no documentation supporting their estimates that costs range

from $3 - $10 million per chemical. It should also be noted thatCMA’s comments that“many

of the chemicals that EPA had in mind for a children’s health test rule were already data rich

and would undergo only approximately half of the tests in the battery” implies that EPA’s

assumption that conducting the full test battery for all Children’s chemicals is a vast

overestimate of the costs.

8. Q. Did EPA include the cost of searching for existing data for the Children’s rule

included in the ICR burden analysis?

A. Estimates of data search of testing for the Children’s initiative was included in the

ICR, however, was not explained clearly in the burdenanalysis. The cost of the external data

search were described in the section “Administrative Reporting Costs and Burdens” and

Table 4 of the ICR. The number ofannualitems for the data search was estimated at 5,393,

whichincludesestimatesforboth the HPV (5,048 items) and Children’s data test search(165

items), however the section listed the items as HPV challenge items. The 5,393 items

estimate wasderivedbymultiplying 6.5 firms per chemicalplus one sponsorperchemicalthat

were assumed to search for data by the number of HPV and Children’s chemicals per year

(697 and 22). A clarification of these costs will be added to the ICR.
August 9, 2000

ATTACHMENT 7

Supplemental Break-outs for Table 4

Annual Respondent Burden Estimates for Reporting - By Program

COLLECTION ACTIVITY

UNIT

Programs

Test Rule Consent Order Children’s Health HPV GRAND TOTAL

Hrs # hrs # hrs # hrs # hrs # HRS

INTERIM REPORTS

 Letter of Intent and Study Plans 40 3 120 8 320 2 80 100 4,000 113 4,520

 Prepare Progress Report 8 300 2,400 800 6,400 660 5,280 0 0 1,760 14,080

 INTERIM REPORTS Subtotal 2,520 6,720 5,360 4,000 18,600

FINAL REPORTS

Short-term Studies

 Record and Prepare Test for Submission 40 105 4,200 280 11,200 220 8,800 9,061 362,440 9,666 386,640

 Laboratory Review 6 105 630 280 1,680 220 1,320 9,061 54,366 9,666 57,996

 Corporate Review 6 105 630 280 1,680 220 1,320 9,061 54,366 9,666 57,996

 Type and Print Results 20 105 2,100 280 5,600 220 4,400 9,061 181,220 9,666 193,320

 Record Keeping 1 105 105 280 280 220 220 9,061 9,061 9,666 9,666

 Short-term Subtotal 7,665 20,440 16,060 661,453 705,618
August 9, 2000

COLLECTION ACTIVITY

UNIT

Programs

Test Rule Consent Order Children’s Health HPV GRAND TOTAL

Hrs # hrs # hrs # hrs # hrs # HRS

2

Long-term Studies

 Record and Prepare Test for Submission 80 60 4,800 160 12,800 132 10,560 0 0 352 28,160

 Laboratory Review 9 60 540 160 1,440 132 1,188 0 0 352 3,168

 Corporate Review 9 60 540 160 1,440 132 1,188 0 0 352 3,168

 Type and Print Results 40 60 2,400 160 6,400 132 5,280 0 0 352 14,080

 Record Keeping 1 60 60 160 160 132 132 0 0 352 352

 Long-term Subtotal 8,340 22,240 18,348 0 48,928

FINAL REPORTS SUBTOTAL 16,005 42,680 34,408 661,453 754,546

Total 18,525 49,400 39,768 665,453 773,146
August 9, 2000

3

Annual Respondent Cost Estimates for Reporting - By Program

COLLECTION

ACTIVITY

UNIT Test Rules Consent Orders Children’s Health HPV GRAND TOTAL

Hrs$ Supply # $ # $ # $ # $ # COSTS

INTERIM REPORTS

 Letter of Intent and

Study Plans

$2,572 $20 3 $7,776 8 $20,736 2 $5,184 100 $259,200 113 $292,896

 Prepare Progress

Report

$514 $5 300 $155,820 800 $415,520 660 $342,804 0 $0 1,760 $914,144

Interim Reports

Subtotal

$163,596 $436,256 $347,988 $259,200 $1,207,040

FINAL REPORTS

Short-term Studies

 Record and Prepare

Test for Submission

$2,572 $0 105 $270,060 280 $720,160 220 $565,840 9,061 $23,304,892 9,666 $24,860,952

 Laboratory Review $386 $0 105 $40,509 280 $108,024 220 $84,876 9,061 $3,495,734 9,666 $3,729,143

 Corporate Review $521 $0 105 $54,722 280 $145,925 220 $114,655 9,061 $4,722,231 9,666 $5,037,533

 Type and Print Results $513 $0 105 $53,823 280 $143,528 220 $112,772 9,061 $4,644,669 9,666 $4,954,792

 Record Keeping $26 $5 105 $3,216 280 $8,576 220 $6,739 9,061 $277,538 9,666 $296,070

 Short-term

Subtotal

$422,330 $1,126,213 $884,882 $36,445,064 $38,878,489

Long-term Studies

 Record and Prepare

Test for Submission

$5,144 $0 60 $308,640 160 $823,040 132 $679,008 0 $0 352 $1,810,688

 Laboratory Review $579 $0 60 $34,722 160 $95,592 132 $76,388 0 $0 352 $203,702

 Corporate Review $782 $0 60 $46,904 160 $125,078 132 $103,190 0 $0 352 $275,172

 Type and Print Results $1,025 $0 60 $61,512 160 $164,032 132 $135,326 0 $0 352 $360,870

 Record Keeping $26 $5 60 $1,838 160 $4,901 132 $4,043 0 $0 352 $10,782

 Long-term

Subtotal

$453,616 $1,209,643 $997,956 $0 $2,661,215

Final Reports

Subtotal

$875,946 $2,338,856 $1,882,837 $36,445,064 $41,539,704
August 9, 2000

COLLECTION

ACTIVITY

UNIT Test Rules Consent Orders Children’s Health HPV GRAND TOTAL

Hrs$ Supply # $ # $ # $ # $ # COSTS

4

Total $1,039,542 $2,775,112 $2,230,825 $36,704,264 $42,746,744