1 Supporting Statement for a Request for OMB Review under

The Paperwork Reduction Act

1 IDENTIFICATION OF THE INFORMATION COLLECTION 1(a) Title of the Information Collection Title: TSCA Section 4 Test Rules, Consent Orders, and Test Rule Ex emptions EPA ICR No.: 1139.08 OMB Control No.: 2070
- 0033
1(b) Short Characterization/Abstract This data collection program is designed to provide the Environmental Protection Agency (EPA) with necessary

test data on health effects, ecological effects and environmental fate to predict the probable impacts on human health or the environment of chemicals that may present an unreasonable risk. Section 4 of the Toxic Substances Control Act (TSCA) provides the authority for collecting these test data, and is intended to ensure that chemicals that may pose serious risks to human health or the environment undergo testing b y m anufacturers or processors, and that the results of such testing are made available to EPA. EPA uses the information collected to assess risks associated with the manufacture, processing, distribution, use or disposal of a chemical, and to support any necessary

regulatory

action with respect to that chemical. (TSCA is avai lable on the Internet at http://epw.senate.gov/tsca.pdf.) The Chemical Testing Program in EPA’s Office of Pollution Prevention and Toxics (OPPT) also works with members of the U.S. chemical industry and other interested parties to develop needed data vi a TSCA Section 4 Enforceable Consent Agreements (ECAs) and consent orders and Voluntary

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

- upon pollution prevention and other ty

pes of product stewardship initiatives by the chemical industry

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

- making. (For more information about the Chemical Testing Program, go to: http://www.epa.gov/oppt/chemtest/index.html .) In addition to developing actio ns under TSCA s ection 4 that meet specific needs identified by

OPPT, EPA may

also develop such actions to meet the information needs of other2

offices within EPA and other agencies. For example, te st 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 b y activities conducted during this IC R renewal period will be used, in addition to those above, b y other agencies, including the Occupational Safety and Health Administration (OSHA) and the Organization for Economic Cooperation and Development (OECD). EPA may obtain the needed test data (1) b y issuing a test rule through notice and comment rulemaking, (2) through negotiation with industry and issuing an ECA, or (3) through commitments from industry as VTAs. The testing specified in a rule or consent order issued under TSCA section 4 only needs to be conducted once for each specified chemical. As such, only one of the entities that manufacture, import or process the specified chemical, or a consortia formed by these entities, will conduct the specified testing and report the results of that testing to EPA. An entity subject to a test rule may

also apply

for an exemption from the testing requirement if that testing will be or has been performed b y another party. Responses to the collection of information specified in a rule issued under TSC A section 4 are mandatory

(see 40 CFR part 790 , Attachment 3 ), while response to a consent order issued under TSCA section 4 is only mandatory

for participants in the ECA. Participating in a VTA is voluntary . The export notification provisions of TSCA section 12 apply to any exporter of a chemical subject to a rule or consent order issued under TSCA section 4, regardless of their participation in the ECA or any related testing consortia. Respondents may

claim all or part of a document confidential. EPA wil l disclose information that is covered by a claim of confidentiality onl y to the extent permitted by, and in accordance with, the procedures in TSCA section 14 and 40 CFR part 2. EPA maintains an official record for all activities conducted under TSCA section 4 (rulemakings, 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 phys ically locat ed 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 el ectronic comments submitted during an applicable comment period, is available for inspection in the Office of Pollution Prevention and Toxics (OPPT) Docket, EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution Ave., NW, Washington, D.C. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday , excluding legal holiday s.3

2 NEED FOR AND USE OF THE COLLECTION 2(a) Need/Authority for the Collection TSCA section 2(b)(1) states that it is the policy of the United States that “adequate data should be developed with respect to the effect of chemical substances and mixtures on health and the environment and that the development of such data should be the responsibility of those who manufacture [which is defined by statute to include import] and those who process such chemical substances and mixtures.” To implement this policy , TSCA section 4(a) mandates that EPA require manufacturers and processors of chemical substances and mixtures to conduct testing if it finds that: “(1)(A)(i) the manufacture, distribution in commerce, processing, use, or disposal of a chemical substance or mixture, or that any combination of such activities, may present an unreasonable risk of injury to health or the environment, (ii) there are insufficient data and experience upon which the effects of such manufacture, distributi on 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 e ffects 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 f or 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 i s 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 unreas onable 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 ty pe of health or environmental effects testing necessary to address unanswered questions about the effects of the chemi cal substance. EPA need not limit the scope of testing required to the factual basis for the TSCA section 4(a)(1)(A)(i) or (B)(i) findings, as long as EPA finds that there are insufficient data and experience upon which the effects of the manufacture, distribution4

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

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

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

- 39; FRL

- 4059

- 9). The statute also specifies that EPA should give priority consideration to chemicals that the Interagency

Testing Comm ittee (ITC) places on the TSCA section 4(e) “Priority Testing List.” The ITC is an independent advisory committee to the EPA Administrator that includes 16 U.S. Government organizations. The ITC was created under TSCA section 4(e) to: 1) review chemicals regulated by

TSCA, 2) determine which chemicals need ecological effects, environmental fate or health effects test data and 3) add those chemicals with test data needs to the Priority

Testing List and recommend them for testing or information reporting in May and November Reports to the EPA Administrator. (For more information about the ITC, see: http://www.epa.gov/opptintr/itc/.) Although the Agency

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

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

a genda that focuses on those chemicals of greater concern. The information collected through the Chemical Testing Program, whether submitted pursuant to a rule or consent order or voluntarily , provides critical information on health effects, ecological eff

ects and environmental fate that enables EPA and others to properl y assess and manage health and environmental risks that may be posed by

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

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

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

- to

- know purposes, including Material Safety Data Shee ts (MSDSs), and product labels. Additionally , data developed for chemicals used or produced in particular work sites will be useful in developing and/or maintaining comprehensive safety and health programs at those facilities. L ocal, 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

t esting data will be developed, that the results meet basic scientific standards of5

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 su pport 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 regul ation or concern, or should otherwise be treated as a low priority for further consideration. In addition, since EPA is required under section 4(d) of TSCA to publish a Federal Register notice announcing the receipt of test data developed under a TSCA section 4 rule, the data collected may

be used by

other agencies, and interested parties. Since 1979, approximately 230 of the 15,000 chemicals on the TSCA Inventory that are, or have been, produced in quantities greater than 10,000 pounds per year have been the subject of testing actions within the OPPT Existing Chemicals Testing Program. Virtually all of the 230 chemicals are “ High Production Volume ( HPV) chemicals.” The testing actions taken to date include a mix of formal TSCA s ection 4 Test Rules and s ec tion 4 Enforceable Consent Agreements, and Negotiated Testing Agreements. In addition, almost 250 formal TSCA s ection 4 “Decisions Not t o Test” (DNTs) have been issued by EPA to date. Screening efforts to identify priorities and determine testing needs for other chemicals are currently underway

in OPPT.

3 NON
- DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA 3(a) Non
- Duplication Test Rules and Consent Orders Prior to proposing a test rule or issuing a consent order, EPA searches the scientific literature, holds public information gathering meetings if deemed appropriate, and has discussions with industry representatives in order to determine what types of data have already been obtained about the chemical under consideration. The Agency proposes a test rule or issues a consent order onl y after it has determined that necessary tests have not yetbeen conducted. Exemptions Exemption applicants are not required to supply information that the Agency can obtain by other existing processes. The equivalence information required provides verification that a chemical is the same. Often this information is CBI and onl y the manufacturer or processor of the chemical has this information.6

3(b) Public Notice Required Prior to ICR Submission to OMB
Prior to submission to OMB, this I CR will be made available to the public for comment through a Federal Register notice. The public will have 60 day s to provide comments. Any comments received will be given consideration when completing the supporting statem ent that is submitted to OMB. 3(c) Consultations The Agency

has issued two procedural rules on the test rule development and exemption process (October 1984 and May 1985) and one procedural rule on the consent order process (June 1986) that describe the information collection requirements for test rules and consent orders. Of particular note, the Agency held a series of public meetings at the request of the American Chemistry

Council (formerl y the Chemical Manufacturers Association (CMA)) and Environmental Defense (ED) (formerl y the Environmental Defense Fund) during the spring and summer of 1985 to develop the consent order process. In addition to the procedural rules, each individual test rule solicits comment on the information collection requirements. Previous commenters on EPA’s information gathering requirements under test rules, consent orders, and the exemption process have included numerous representatives of the chemical industry , environmental groups and the public at large. A number of issues w ere 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 d ata, enforceability of consent orders, and how to make consent orders equivalent to test rules. In addition to the public notice and comment period required b y the OMB regulations that implement the Paperwork Reduction Act (see Section 0 ) of this Supporting Statement), the OMB regulations, 5 CFR 1320.8(d)(1), also require agencies to consult with potential I CR respondents and data users about speci fic aspects of an ICR before the agency submits the ICR to OMB for review and approval. In accordance with this regulation and based on OPPTS Regulatory

Coordination Staff guidance, EPA will solicit comments from no more than nine potential I CR respondents and data users with respect to the renewal of this I CR. 3(d) Effects of Less Frequent Collection Test rules and consent orders require the test sponsor to submit a letter notifying EPA who will be conducting the testing, study plans before beginning testing, and a final report of the study results. Each exemption applicant is required to submit an exemption application. Less frequent information collection would jeopardize EPA’s ability to ensure that testing is being conducted in accordance with the rules and consent orders, and to grant exemptions from test rules. 3(e) General Guidelines The data retention requirements for test rules and consent orders exceed one of the Paperwork Reduction Act guidelines contained in 5 CFR 1320.6. Documentation reco rds, raw data, and specimens pertaining to a test rule or consent order study are required to be retained for7

ten years from the effective date of the applicable test rule or publication date of the consent order. This requirement is necessary to permit su fficient 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 perfo rm 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 reso lution 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
In formation submitted to EPA in response to test rules and consent orders and in exemption applications is, in most cases, non - confidential. EPA has also discouraged the submission of CBImaterial. 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 proced

ures described in 40 CFR p art 2 and the TSCA Confidential Business In formation Security Manual, which call for careful protection of confidential business information. 3(g) Sensitive Questions The information requested does not include information of a sensitive nature other than CBI, which is discussed above. 3(i) Electronic Reporting A description of data collection/management activities , including electronic reporting of data is presented in s ection 5(b)

.

4 THE RESPONDENTS AND THE INFORMATION REQUESTED 4(a) Respondents/NAICS Codes Respondents affected b y the collection activity may include, but are not limited to facilities within the following industry categories : Type of Entity NAICS Example of Potentially Affected Entities Chemical Manufacturers and Importers 325, 32411 Persons who manufacture (defined b y 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.8

4(b) Information Requested (i) Data Items EPA may require any

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

to address unanswered questions about the effects of a chemical substance. EPA need not limit the scope of testing required to the factual basis for the TSCA section 4(a)(1)(A)(i) or (B)(i) findings, as long as EPA also finds that there are insufficient data and experience upon which the effects of the manufacture, distribution in commerce, processing, use, or disposal of such substance or mi xture 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 fin dings 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 te st rules are found in 40 CFR part 790. The requirements regarding Good Laboratory

Practice standards (GLPs) are found in 40 CFR part 792, the various test guidelines that are incorporated into the individual test rules are in 40 CFR parts 795 through 799, and the chemical specific testing requirements are in 40 CFR part 799. The following is an overview of the specific requirements for each typ e of activity : Test Rules And Consent Orders

- EPA promulgates a rule or consent order describing what ty pe of te sting must be performed on the chemical and specifying specific test guidelines that have been published by the EPA or alternative methods proposed by industry and approved by EPA as methods. In combination with the GLPs requirements, these guidelines or m ethods 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

- In formation collection authorized by section 4(c) of TSCA is designed to reduce the burden of duplicative testing under test rules. Test rules generally require testing of only a single representative chemical substance and all chemicals subject to the test rule are assumed equivalent to it. Exemption applicants are required to submit only that information necessary to establish the identity

of the applicant and the test requirements from which the exemption is being requested. In those few cases in which more than one representative substance is to be tested under a test rule, exemption applicants will also be required to submit data showing to which of these representative substances their chemical is equivalent. The ty pe of data needed may

vary with the chemical being tested, and will be described in detail in each individual test rule.9 (ii) Respondent Activities Respondents may

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

of existing data to EPA. (c) Submit “Letter of Intent” to EPA or an application for an exemption. (d) P lan necessary

activities, e.g., consortia, arran ge for conduct of studies, etc. (e) Prepare and submit periodic progress reports. (f) Record and prepare test data for submission (includes QA/QC reviews). (g) Prepare and review final report. (h) Review submission for CBI. (i) Submit final report with 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 onl y the manufacturer or processor of the chemical has this information. Ingeneral, 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 onl y 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 mi nimum chemical specific requirements in the individual test rules. This approach was devised in response to comments by industry that appl yi ng the broad equivalence data requirements to all exemptions candidates would, in some cases, result in submission o f unnecessary data. Consent Orders . Exemption applications are not necessary for chemicals being tested under consent orders because the consent order process inherentl y eliminates duplicative testing.10

5 THE INFORMATION COLLECTION
- AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT 5(a) A gency Activities Data collected under TSCA section 4 test rules and consent orders are received by the Office of Pollution Prevention and Toxics (OPPT), Chemical Control Division (CCD), Chemical In f ormation and Testing Branch (CITB), where they are reviewed for completeness and then routed to biologists, chemists, toxicologists, and wildlife scientists within OPPT to determine whether the subject chemicals are likel y to present an unreasonable risk t o human health or the environment. If the data indicate that potential hazards may exist, then these data

– coupled with exposure and use information received under the Inventory Rule Update Amendments (IURA) and other information sources

– will be reviewe d by EPA staff. Once reviewed, these data may support possible risk management action. To date, EPA has collected data that have been used to support such activities as the development of water quality criteria, hazardous waste listings, chemical advisories, and reduction of workplace exposures. In order to sustain this p rogram, the EPA must undertake the following applicable activities: a) Review letters of intent and study plans for completeness; b) Review progress reports; c) Review final reports for c ompleteness, accuracy , adherence to test rule guidelines and GLPs; d) P rocess and review exemption applications; and e) F acilitate development of ECAs and VTAs. In addition to the activities cited above the Agency maintains a facility

inspection and test data a udit program to ensure testing is done in compliance with GLPs, and may also participate in other activities related to this program, e.g., other voluntary efforts to identify

data gaps and develop test data, efforts to establish test guidelines or standards that may be used in the Chemical Testing Program, and international efforts related to chemical testing and associated testing issues. 5(b) Collection Methodology and Management For each chemical identified for testing within EPA’s TSCA Chemical Testing Program, the specific data requested, the testing necessary to generate those data, along with the test protocols, the time frame for completing the testing, and the date b y which the requested data are to be submitted to the Agency , are establishe d in the TSCA Section 4 Test Rule, TSCA Section 4 ECA or VTA. It is also important to note that the TSCA Chemical Testing Program is an integral component of OPPT’s TSCA existing and new chemicals programs. These programs are responsible for assessing an d managing health and environmental risks that may be posed by existing and new chemicals covered b y TSCA. The “universe” of existing chemicals on the TSCA Chemical Substances Inventory that may present the greatest potential health and/or11

environmental concerns have been and continue to be identified and refined through various existing chemical screening activities within OPPT. Test data submitted to the Agency under the TSCA Chemical Testing Program are reviewed b y s cientists to determine whether or n ot the data developed are adequate for the purposes for which they

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

- confidential studies covering chemical testing results and other submitted studies on the possible effects of chemicals on health and ecological sy stems. Submitted studies are indexed in TSCATS under three broad categories: health effects, ecological effects and environmental fate. TSCATS contains information that is pertinent to risk assessment and hazard evaluation processes. The information can be used in conjunction with published material and is a valuable source along with or in the absence of published data. The data are used b y federal and state agencies, researchers, toxicologists, risk assessors, the regulated industry , attorney s, trade and professional associations as well as the public at large. TSCATS was developed by EPA in 1985 to make the results of ongoing and completed chemical testing available to the public and includes chemical exposure studies, epidemiology , environmental fate, mo nitoring, episodic incidents, such as spills and case reports. There are four primary ty pes of documents referenced in the TSCATS database: TSCA section 4 chemical testing results, TSCA section 8(d) health and safety studies, TSCA section 8(e) substantial risk of injury to health or the environment notices, and voluntary documents submitted to EPA known as For Your Information (FYI) submissions. TSCATS is available through a number of electronic sources; the studies referenced in TSCATS can be viewed in EPA ’s public TSCA docket located at EPA’s Headquarters in Washington, D.C., or, alternatively , via microfiche copies that are available through the National Technical Information Service (NTI S). 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 appl yi ng 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 r ule 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 o f EPA to assist in resolving the conflict and the Agency will certainl y 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.12

5(d) Collection S chedule
This information collection activity does not involve more than one submission per activity . Required testing is conducted only once, and each related submission is a one

- time on occasion submission. The testing period is based on the individual r ule, 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 b y the Agency

. The time period for screening level testing, like that conducted under the HPV Initiative, is usually less than a ye ar. The ty

pical time period for other types of testing is around three ye ars, although it can be longer and varies according to the chemical and the test required.

6 ESTIMATING THE BURDEN AND COST OF THE COLLECTION
Overview The methodology

used in estimating the annual burden and costs to industry resulting from TSCA section 4 test rules, consent orders and agreements, and voluntary submissions over the ne xt three years is based on EPA’s most recent cost and burden estimates. These have been combined with current information concerning the number and type of TSCA section 4 test rules under development, estimates of the potential number of consent orders and agreements, all of which may

result in industry

submitting existing data or conducting new testing to provide EPA with information necessary to evaluate chemicals under its TSCA section 4 mandate. Individual actions covered by this ICR may

impact industry over most or all of the three ye ar ICR period. In these cases, the impacts of the action have been converted to an annual basis by assuming, for example, that one

- third of the chemicals covered by the action would be addressed in each of the three ye ars. Additional data collection efforts beyond those identified in this I CR may be conducted during the three ye ar IC R period, but the extent of such activities cannot be projected at this time. The following sections explain the assumptions and methods that were used to estimate the burden and costs for this I CR, along with a summary of the cost and burden calculations.
6(a)
- (b) Estimating Total Respondent Burden and Cost Consent Orders and Enforceable Consent Agreements Based on historical experience with the TSCA testing program and expected consent order activity

over the three year ICR period, EPA assumes that one consent order or enforceable consent agreement (ECA) will be issued per ye ar for a total of three consent orders/agreements13

issued during the IC R period. Past consent orders and agreements have covered an average of one to five chemicals. For this I CR, EPA assumes five chemicals will be covered by each order/agreement. The testing required under future consent orders or agreements cannot be predicted and will be determined on a case b y case basis. For purposes of the ICR, EPA assumes as in past ICRs that each chemical will be evaluated b y performing the tests specified in a “Standard” testing battery

(see14

Table 1 ). The test battery includes 10 studies per chemical (7 short term, 3 long term). 1 Each test sponsor must submit one letter of intent and one set of study plans for each chemical; five semi

- annual progress reports for each long

- term study ; and one final report for each study. EPA estimates that 10 percent of the studies completed will be accompanied by a robust summary . These assumptions are used to estimate the costs and are recorded in

1 “Short

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

- term studies” are concluded within three years.15

Table 2

. EPA generates and maintains a listing of the laboratory cost and burden data for numerous TSCA and OECD test protocols. Test cost estimates were adjusted to end

- of

- ye ar 20 10 dollars using the Bureau of Labor Statistics’ Employ ment Cost Index (ECI) and are shown in Table 1. The mean cost of the “Standard” battery is $1, 465,985

. 2
EPA has also included costs for anal ytical chemistry method development and validation where it was judged that such method development would be necessary to conform to good laboratory

practices. Method development and validation is ty pically performed to determine the effectiveness of an anal yt ical method to determine the levels of the chemical in the dosing matrix in toxicity

studies. Short term and long

- term studies are assigned a cost of $3 , 835 and $ 9,314 respectivel y, based on typical costs cited b y industry experts (Picciri llo, 2004). Total validation costs for the testing battery are $54,787, resulting in a total laboratory cost of $1, 465,985

. Exemption applications are not necessary for chemicals being tested under consent orders because the consent order process inherentl y eliminates duplic ative testing.

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

Table 1 : TSCA Section 4 “Standard” Testing Battery Costs Test Protocol Name Protocol Number Date of

Estimate Mean Cost

Estimate (2010$) 1 Validation

Costs (2010$) Algal Acute Toxicity 797.1050 8/3/1990 $28,986.83 $3,835.11 Daphnid Acute Toxicity 797.1300 4/25/1996 $11,232.48 $3,835.11 Fish Acute Toxicity 797.1400 4/25/1996 $22,806.83 $3,835.11 Gene Mutations in Somatic Cells 798.5300 8/16/1994 $25,160.49 $3,835.11 Subchronic Oral Toxicity 870.3100 9/3/1996 $186,149.49 $3,835.11 Prenatal Developmental Tox. (2 species) 870.3700 8/27/1996 $142,943.18 $9,313.83 Reproduction/Fertility Effects 870.3800 8/27/1996 $737,572.04 $9,313.83 Salmonella Reverse Mutation Assay 870.5265 9/16/1996 $9,256.85 $3,835.11 In vivo Bone Marrow Cy togenetics 870.5395 2/27/1997 $19,376.05 $3,835.11 Developmental Neurotoxicity 870.6300 8/27/1996 $227,713.28 $9,313.83 Subtotal $1,411,198 $54,787 Total $1,465,985 1 Where multiple versions of a test have been assessed by EPA (e.g., covering different species or routes of exposure), the mean cost estimate is used. All test costs updated to 2010 dollars. Source: U.S. EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branch. Based upon the assumption s and testing batteries discussed above, various factors can be derived that are emplo ye d to estimate total costs and burdens for the respondents. These factors are summarized in17

Table 2

.18

Table 2 : Assumptions Used in Estimating Annual Costs and Burdens TSCA Section 4 ICR Assumptions Total 1
a Number of Orders/Agreements I ssued 1 b Chemicals Per Order/Agreement 5 c Total no. of chemicals (a × b) 5 d No. of Chemicals per sponsor 5 e No. of sponsors per rule or order (b ÷ d) 1 f Total no. of sponsors (a × e) 1 g Letters of intent/study plans per sponsor 1 h Total letters of intent/study plans (f × g) 1 i No. of short

- term studies per chemical 9 j Total no. of short

- term studies (c × i) 47 k No. of long term studies per chemical 4 l Total no. of long

- term studies (c × k) 20 m Total no. of studies per chemical (i + k) 13 n Total no. of studies (j + l) 67 o No. of semi

- annual progress reports per

short term study 0 long term study 5 p Total no. of semi

- annual progress reports

short term studies ( o x j) 0 long term studies ( o x l) 100 q No. of final reports per study 1 r Total no. of final reports (n × q) 67 s No. of robust summaries 2 6.7 t Total no. of reports (h + p + r + s) 174.7 u Total reports per sponsor (t ÷ f) 174.7 v Total reports per rule/order (t ÷ a) 174.7 w Total reports per chemical (t ÷ c) 35 x No. of exemptions per sponsor 0 y No. of exemptions per rule/order 0 z Total no. of exemptions 0 aa Total no. of responses (t + z) 173 bb No. of responses per rule/order (e + y) 1 cc Total no. of respondents (f + z) 1 1 Numbers are rounded

- calculations may not appear exact. 2 For consent orders, only 10 percent of studies are expected to be accompanied by robust summaries. Total Number of Respondents The Agency

assume s that on an annual basis there will be one respondent to an enforceable consent order or agreement annually (19

Table 2 , line f)

. Th is respondent is expected to provide reporting with no third party disclosures associated with these activities. Exemption applications are not necessary for chemicals under the t est rule so there are no e xemption applicants counted among the respondents (20

Table 2 , line y).21

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

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

- annual progress reports for long

- term studies, and the final reports for each study

. Types of Costs and Burdens The following discussion presents estimates of the costs and burdens of each of the main categories of collection activities covered in this ICR. Table 3 presents estimates of the laboratory

and administrative costs, and administrative burdens, and is discussed in detail below. Laboratory Costs The costs incurred b y sponsors performing laboratory testing are presented in Table 3

. Total laboratory

costs associated with activities covered b y this ICR are estimated to be $ 7 .3 million per year ( Table 3 , line f). With a projected total of 67 studies to be conducted ( Table 3 , line d), the average laboratory cost is $ 109,409 per study 3 ( Table 3 , line i).

3 Some long

- term tests assumed to be conducted under consent order may take more than a year to complete. For purposes of the ICR EPA assumes the full cost and burden of completing the testing is incurred during each year.23

Table 3 : Annual Laboratory Cost and Burden Estimates

TSCA Section 4 Factors Consent Orders & Agreements (2010$) a Total no. of rules/order 1 b Total no. of chemicals 5 c Total no. of sponsors 1 d Total no. of studies 67 e Lab oratory cost per chemical $1,466,084 f Total lab oratory costs $7,330,422 g A dministrative Reporting costs $373,531 Administrative non - reporting costs $1,832,606 Total A dministrative costs a $2,206,136 h Total lab oratory

and administrative costs (f + g) $9,536,559 i Lab oratory

costs per study

(f÷ d) $109,409 j A dministrative costs per study (g÷ d) $32,927.41 k Total testing costs per study (i + j) $142,337 l Total testing costs per sponsor (h÷ c) $9,536,558.56 m A dministrative Reporting burden b 6,951 Administrative non - reporting burden c 32,282 Total admin. Burden 39,233 n A dministrative burden per study (m÷ d) 586 o Total admin istrative burden per sponsor (m÷ c) 39,233 Numbers throughout table have been rounded
a Admi nistrative non

- reporting costs and burdens are assumed to equal 25% of laboratory costs and burdens. b The reporting burdens are derived in Table 5.
c The non

- reporting administrative burden is estimated by dividing the administrative cost by $56.77 , which represents the we ighted average wage rate. The weighted average wage reflects an assumed 20 /60/20 mix of managerial/technical/clerical labor. Administrative Costs Administrative costs are assumed to comprise both reporting and non - reporting activities and are explained in detail below. The average administrative cost is calculated based on the average lab cost per study of $ 109,409 ( Table 3 , line i), and is equal to $ 32,927 ( Table 3 , line j). The average administrative cost is divided by the weighted average hourl y labor rate of $ 56.77 per hour to result in an average burden of 586 hours per chemical ( Table 3 , line n). The weighted average hourl y labor rate is based on a labor mix that is 20 percent managerial, 60 percent technical, and 20 percent clerical. The total administrative cost is estimated to be $ 2.2 million annually

( Table 3 , line g).24

Reporting Costs and Burdens Part of the administrative costs associated with this IC R is derived from reporting activities undertaken b y respondents. These activities include: preparing letters of intent and study plans; preparing progress reports; preparing test results for submission to EPA; recording test results; conducting laboratory or corporate reviews; performing associated clerical work for final report preparation; record keeping; conducting administrative activities to preparing for and oversee the testing program; and appl yi ng for exemptions. The burden estimates and unit su pply costs associated with these activities are reported in Table 4 and are based on estimates provided in the prior I CR. Estimates of the respondents ’ annual reporting costs and the burden associated with each reporting activity are detailed in Table 4 . The unit wage rate information is explained in the Appendix . The unit labor hours are derived from previous information collection requests and are believed to be reflective of the annual amount of time required for each activity over the next three ye ar period. For the seven sponsors who have not ye t submitted test plans and the one sponsor for the consent order, EPA assumes that there is a 40

- hour administrative burden assigned for submission of the test plans, and letter of intent in the case of the consent order. The total annual respondent cost and burden for reporting activities is $ 2.2 million and 39,233 hours (for reporting costs see Table 3 , line g; for reporting burdens see Table 3 , line m; for total reporting costs and burd ens see Table 4 ). Non
-reporting Administrative Costs and Burdens EPA’s experience in test rule development has shown the non

- reporting administrative costs associated with testing programs to total approximately 25 percent of the laboratory costs, and is divided as follows. Non

- reporting administrative activities include the effort of respondents to organize a testing program, obtain and review bids from laboratories that would conduct the testing, and prepare and submit samples to the laboratory for testing. EPA has included a burden equal to 15 percent of the test cost to account for management of the consortium. This includes activities such as identifying manufacturers, meetings, organizing pay ment for testing, developing contracts for testing, and employing toxicologists who may be hired to provide technical expertise for the testing. An additional 10 percent of the testing cost will be added to cov er the costs of technical experts that may work for the consortium and covers study review and site visits to the laboratory . This amounts to a total of 25 percent for burden associated with administering the testing consortium and testing. In some cases, the actual burden of these activities may be undertaken by

an organization or individual contracted by the respondent and would be included as a cost. However, because respondents may undertake some or all of these activities themselves, the burden is included in this analy sis. Based on these assumptions, non

- reporting activities associated with laboratory testing are estimated to cost $ 1.8 million annually ( Table 3 , line g). These costs are translated into burden estimates using a weighted average labor cost of $56.77 per hour, which is based on a labor mix that is 20 percent managerial, 60 percent technical, and 20 percent clerical. The estimated non

- reporting administrative burden based on this approach is 32,282 hours annuall y ( Table 3 , line m).25

Table 4 : Tota l Annual Respondent Cost and Burden for Reporting Activities Collection Activity Unit Labor Unit Supply Costs Total

Annual Items Grand Total Type a Hours Rate Cost Hours Costs INTERIM REPORTS Letter of Intent and Study Plans T 40 $61.71 $2,468.32 $21.91 1 40 $2,490.24 Prepare Progress Report T 8 $61.71 $493.66 $5.48 100 800 $49,371.96
Subtotal 48 $2,961.99 101 840 $51,862.20
FINAL REPORTS Short
- termStudies Record and Prepare Test for Submission T 40 $61.71 $2,468.32

- 47 1,880 $116,011.23 Laboratory Revie w T 6 $61.71 $370.25

- 47 282 $17,401.68 Corporate Review M 6 $69.74 $418.44

- 47 282 $19,666.51 Ty pe and Print Results S 20 $28.98 $579.62

- 47 940 $27,242.33 Recordkeeping S 1 $28.98 $28.98 $5.48 47 47 $1,367.60
Subtotal 73 $3,865.61 - -- 3,431 $181,689.35 Long
- termStudies Record and Prepare Test for Submission T 80 $61.71 $4,936.65

- 20 1,600 $98,732.96 Corporate Review M 9 $69.74 $627.65

- 20 180 $12,553.09 Ty pe and Print Results S 40 $28.98 $1,159.25

- 20 800 $23,184.96 Recordkeeping S 1 $28.98 $28.98 $5.48 20 20 $585.10
Subtotal T 130 $61.71 $6,752.53

- -- 2,600 $135,056.11
Robust Summaries T 12 $61.71 $740.50 - 7 80 $4,961.33 FINAL REPORTS SUBTOTAL 215 $11,358.64 74 6,111 $321,706.79 EXEMPTION REQUESTIONS T 2 $61.71 $123.42

- 0 0

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

a Labor Type Codes are as follow s: T = Technical; M = Managerial; S =Secretarial26

6(c) Estimating Agency Burden and Cost The cost and burden to the Agency to process, review, and anal yz e the information collected under section 4 test rules, consent orders and agreements, and voluntary testing programs are discussed below and detailed in Table 5

. The Agency

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

- 13, Step 1 employee. The annual 20 10 loaded cost of a full

- time equivalent (FTE) for this level employee is $ 142,453 . This includes a base wage of $ 89,033 plus 60 percent for overhead and benefits (i.e., $ 53,420 ). Dividing this value by 2,080 (i.e., the number of hours in a work ye ar) results in an hourl y wage rate of $ 68.48 (see the Appendix for the derivation of these figures). AGENCY LABOR CATEGORY LOADED HOURLY RATE ($2010)

GS

- 13, Step 1 $68.48 The estimated unit Agency burden of processing le tters of intent and study plans (three hours), progress reports (one hour), and final reports ( five hours) is derived from the previous ICRs and is believed to be reflective of the time required for each activity . This information is presented in Table 6. It takes approximately one hour for the Agency to process and review each exemption application and 16 hours for the Agency to enter study

plans and results into the HPV In formation Sy stem (HPVI S). The total annual Agency costs and burden for processing letters and reports is $ 175,298.48 and 2,560 hours, or approximately 1 .2 FTEs per year, where one FTE is equivalent to 2,080 hours per ye ar. There are no exemptions associated with these actions and therefore no associated cost or burden. Table 5 : Annual Agency Cost and Burden Estimates Collection Activity Unit Labor Unit Supply Costs Total

Annual Items Grand Total Hours Rate Cost Hours Costs Letter of Intent and Study Plans 3 $68.48 $205.44 0 1 3 $205.44 Progress Reports 1 $68.48 $68.48 0 100 100 $6,848.00 Final Reports 5 $68.48 $342.4 0 67 103 $22,940.80 HPVI S Data Entry 16 $68.48 $1095.68 0 7 112 $7,669.76 Robust Summary 1 $68.48 $68.48 0 7 7 $458.82 SUBTOTAL 182 557 $38,122.82 Exemptions 1 $68.48 $68.48 0 0 0 $0 TOTAL 182 557 $38,122.8227

6(d) Bottom Line Burden Hours and Costs Respondent Annual Hours and Costs

Table 6 summarizes the average annual burden per response. EPA estimates that this I CR will impose 39,233 burden hours on respondents annually with an average of 2 24 hours per response. Table 6 : Average Annual Respondent Burden Hours per Response Collection Activity Respondent Burden Per Response Total Hours Total Items Hours Per Response Reporting Activities Letters of Intent/Study Plans 40 1 40 Progress Reports 800 100 8 Final Reports 6,111 74 83 Exemption Requests 0 0 0 Subtotal (all responses) 6,951 175 40 Non

- reporting activities 32,282 175 18 4 TOTAL 39,233 175 22 4 The total annual burden hours and costs for respondents were derived in Table 4 , above, and are summarized below in Table 7

. Table 7 : Summary of Annual Respondent Burden and Costs Estimates Collection Activity Total Hours Cost Reporting Activities Letters of Intent/Study

Plans 40 $2,490 Progress Reports 800 $49,372 Final Reports 6,111 $321,707 Exemption Requests 0 $0 Subtotal (all responses) 6,951 $373,569 Non

- reporting activities 32,282 $1,832,606 TOTAL 39,233 $2,206,175 Agency Annual Hours and Costs The total annual burden hours and costs for the government were derived in Table 5 and are summarized below in28

Table 8

.29

Table 8 : Summary of Annual Agency Burden and Costs Estimates Collection Activity Total Agency Burden and Costs Hours Cost Reporting Activities Letters of Intent/Study

Plans 3 $205 Progress Reports 100 $6,848 Final Reports 335 $22,941 HPVI S Data Entry 112 $7,670 Exemptions 0 $0 TOTAL 550 $37,664 6(e) Reasons for Change in Burden This request represents a decrease of 112 , 729 hours ( from 151,962 hours to 39,233 hours ) from that currently

in the OMB inventory

. Th is decrease reflects a decrease in the estimat ed number of items to be received from respondents. Inthe previous ICR, EPA estimated 602 total items to be received from respondents. For this I CR, EPA estimates a total of 175 items. Due to a smaller reporting univers e and the end of the HPV Challenge Program, EPA expects the overall burden for respondents to decrease

. This change is an adjustment. Inaddition to these changes, the Agency

has adjusted all unit costs to reflect the latest available labor wage rat es. 6(f) Burden Statement The annual public burden for this collection of information, which is approved under OMB Control No. 2070

- 0033, is estimated to average about 224 hours per response ( see Table 6 ). Burden is defined in 5 CFR 1320.3(b). An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a current and valid OM B control number. The OMB control numbers for EPA’s regulations in title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR part 9 and included on the related collection instrument or form, if applicable. The Agency

has establish ed a public docket for this I CR under Docket ID No. EPA

- HQ

OPPT

- 2010

- 10 10 , which is available for online viewing at www.regulations.gov, or in person viewing at the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution Ave., NW, Washington, DC . The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday

through Friday , excluding legal holiday s. The telephone number for the Reading Room is (202) 566

- 1744, and the telephone number for the Pollution Prevention and Toxic s Docket is (202) 566

- 0280. You may submit comments regarding the Agency's need for this information, the accuracy of the provided burden estimates and any suggested methods for minimizing respondent burden, including the use of automated collection techniques. Submit your comments, referencing Docket ID No. EPA

- HQ

- OPPT

- 2010

- 10 10 and OMB Control No. 2070

- 00 33 , to (1) EPA online using www.regulations.gov (our preferred method), or b y mail to: Document Control Office (DCO), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency , Mail Code: 7407T, 1200 Pennsylvania Ave., NW, Washington, D.C. 20460, and (2) OMB b y mail to: Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street, NW, Washington, DC 20503.30

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

Table 9 : Industry Wage Rates (December 2010)

Labor Category Wage

($/hour) 1 Fringe

Benefits ($/hour) 1 Fringes

as % Wage Overhead

% Wage 2 Fringe +

Overhead Factor Loaded

Wages ($/hour)
(a) (b) (c) =

(b)/(a) (d) (e)=(1)+(c)+(d) (f) = (a) x (e) Managerial $42.82 $19.64 45.87% 17% 1.63 $69.74 Technical $36.93 $18.50 50.09% 17% 1.67 $61.71 Clerical $17.36 $8.67 49.94% 17% 1.67 $28. 98 Weighted Average 3 -- -- -- -- -- $56.77 Notes : 1 Em ployer Costs for Employee Compensation Supplementary Tables: December 2010, US Bureau of Labor Statistics, March 9, 2011 (BLS, 2011a) 2 An overhead rate of 17 percent was estimated based on industry data gathered for the Revised Economic Analysis for the Amended Inventory Update Rule: Final Report (EPA, 2002a) 3 The weighted average wage reflects an assumed 20/60/20 mix of managerial/technical/clerical labor.31

Table 10 presents the derivation of the Agency wage rates for 2010 used in this I CR.
Table 10 : Agency Wage Rate for GS
- 13 Step 1 (January 2010)

Labor Categor y Data Source for Wage Informatio n Dat

e Wage ($) Fringe Benefi t Fringes as % wage Overhea

d as % wage Fringe +

overhea d factor Loaded

Wage ($) (a) (b) (c) = (b)

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

+ (d) + 1 (f) = (a)

* (e) EPA staff FTE Annual

federal staff cost: OPM Washington

- Baltimore

Northern Virginia, DC

- MD

PA

- VA

WV area, GS

- 14 Step 5 pay rates a Jan

10 $89,03 3 (annual ) -- [Include

d in 60% overhead ] 60% b 1.6 $142,45 3 (annual) $42.80 (hourly ) $68.48 (hourly)

Notes:
aThe Agency salary is the unloaded federal GS

- 13 Step 1 salary ($89,033 for 2010), from the OPM salary table for the Washington

- Baltimore

-Northern Virginia Locality Pay Area (OPM, 2010). Hourly rates are based on annual salary divided by 2,080 hours. b The 60 percent fringes

- and

- overhead rate is from an EPA guide, Instructions for Preparing ICRs (EPA, 1992).32

(40 CFR part 790 is available on the Internet at http://ecfr.gpoaccess.gov/cgi/t/text/text

idx?c=ecfr&tpl=/ecfrbrowse/Title40/40cfr790_main_02.tpl .)