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 ofAugust 29, 2000

2 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.August 29, 2000

3 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 addressAugust 29, 2000

4 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 inAugust 29, 2000

5 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.August 29, 2000

6 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 aAugust 29, 2000

7 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.August 29, 2000

8 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 theAugust 29, 2000

9 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 whichAugust 29, 2000

10 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.August 29, 2000

11 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.August 29, 2000

12 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.August 29, 2000

13 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 peractivity. 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 programAugust 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) chemicals 1 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 isAugust 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 118August 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 toAugust 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 toAugust 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 13,340August 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 $41,539,704August 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., theAugust 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 $543August 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'sAugust 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 4August 29, 2000

ATTACHMENT 1

Toxic Substances Control Act Section 4

15 USC 2603August 29, 2000

ATTACHMENT 2

40 CFR 790
Procedures Governing Testing Consent Agreements and Test RulesAugust 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

11 Centaur 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.

12 William 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 labo r 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 Assessment Information Rule (CAIR). 11 Updated wage rate estimates were developed by EPA, u sing the CAIR methodology, for a 1993 economic analysis of rulemakings under EPCRA Section 313. 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 gov

ernment collection activity procedures described in this report are expected to be accomplished by a G S-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 Personne l Management’s 1998 General Schedule Locality Rates of Pay for Washington-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 multiplication factor). The multiplication factor used is recommended in EPA's Office of Policy, Planning, and Evaluation's Instructions for Prepa ring Information Collection Requests (ICRs) (June 1, 1992). An EPA internal phone call between Carol Rawie (OPPT/EETD/RIB) and Carl Koch (OPPE/RMD/IMB) on May 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 u sed in developing the basic wage rates for this analysis were derived from wa ge 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 Secret ary) 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 of average BLS wage rates for two labor categories/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 weekly pay. 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 To derive the composite salaries, the BLS salaries for each of the labor categories that make up either the managerial or technical labor categories used in this analysis are weighted based on the typical fraction of total reporting effort that is accounted for by that specific BLS labor category. The weighting factors are based on information provided by the chemical industry a nd chemical industry trade associations. For example, as shown in Table 3, engineers typically account for 10/17 (or roughly 59 percent) of the managerial effort 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 annual salary estimates 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 then multiplied 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 in Table 2. Detailed ECI data for white-collar occupations in the goods-producing, private industries are not available at the same level of detail as the BL S wage data; therefore, ECI data for white-collar occupations in for all private industr ies were used to adjust the wages in each BLS labor category. Detailed benefits data for white-collar occupations in the goods-producing, private industries are available, however, and were utilized for this adjustment. Based on information provided by the chemical industry and chemical industry trade associations, it was determined 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 pres ented in Table 3. Unit burden estimates are converted to unit cost estimates by multiplying the unit burden hours 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

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

Technical Accountant (III-VI)

Engineer (III-VIII) 1/6 5/6 10,963

69,369

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

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

1.063 $ 33,487 42.2% 17.0% 1.592 $53,311 $25.63

Composite Salary 1/1 $31,502 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: Response to Comments Received on the TSCA Existing Chemical Test Rules,

Consent Orders, Test Rule Exemptions, and Voluntary Test Data 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 Control Act (TSCA), (40 CFR 790) was designed to assure that those chemicals which may pose serious risks t o 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 Chemical Manufacturers Association) responded to the Federal 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 been prepared 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 Product ion Volume Challenge Program, an d 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 not been included in this ICR renewal request. A burden estimate will be developed for the HPV Test Rule(s) and submitted as an amendment to this ICR when 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 pursuan t 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 o n 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 produc e d. 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 num ber of exemption requests (in the case of the HPV Challenge Program and Children’s programs there were 0 exemptions).

The ICR burden analysis has be en 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 of the panel, as each company will search its 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 voluntary portions of the ICR. This estimate was 25 percent of the laboratory costs 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 of costs. 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 t he commentor, EPA did, however, review the costs and estimates provided by EPA a n d 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 of test costs for OECD 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 review of the responses in table 1, EPA determined that its estimates are within the 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 preparation in its estimate 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 that CMA’s comments that “many of the chemicals that EPA had in mind for a children’s health test rule were already data rich
a nd 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 burden analysis. The cost of the external data search were de scribed in the section “Administrative Reporting Costs and Burdens” and Table 4 of the ICR. The number of annual items for the data search was estimated at 5,393, which includes estimates for both 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 was derived by multiplying 6.5 firms per chemical plus one sponsor per chemical that 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

GRAND TOTAL Test Rule Consent Order Children’s Health HPV

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 16,060 661,453 705,618August 9, 2000

COLLECTION ACTIVITY UNIT Programs

GRAND TOTAL Test Rule Consent Order Children’s Health HPV

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 39,768 665,453 773,146August 9, 2000

3 Annual Respondent Cost Estimates for Reporting - By Program

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

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 $41,539,704August 9, 2000

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

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

4 Total $1,039,542 $2,775,112 $2,230,825 $36,704,264 $42,746,744