January 25, 2005 Supporting Statement for a Request for OMB Review under the Paperwork Reduction Act 1 IDENTIFICATION OF THE INFORMATION COLLECTION 1( a) Title and Number of the Information Collection Title: TSCA Existing Chemical Test Rules, Consent Orders, Test Rule Exemptions, and Voluntary Test Data Submissions ICR Nos.: EPA ICR # 1139.07; OMB Control No. 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. Section 4 of the Toxic Substances Control Act ( TSCA) provides the authority for collecting these 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 that provide critical information on health effects, ecological effects and environmental fate that enables EPA and others to properly assess and manage health and environmental risks that may be posed by existing and new chemicals covered by TSCA. The " universe" of existing chemicals on the TSCA Chemical Substances Inventory that may present the greatest potential health and/ or environmental concerns have been and continue to be identified and refined through various existing chemical screening activities within OPPT. EPA also makes the testing data 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.) January 25, 2005  2 In addition to developing actions under TSCA section 4 that meet specific needs identified by OPPT, EPA may also develop such actions to meet the information needs of other 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).

EPA may obtain the needed test data ( 1) by issuing a test rule through notice and comment rulemaking, ( 2) through negotiation with industry and issuing an 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 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 Office of Pollution Prevention and Toxics ( OPPT) Docket, EPA Docket Center ( EPA/ DC), EPA West, Room B102, 1301 Constitution Ave., NW., Washington, D. C. The Public Reading Room is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. January 25, 2005  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, 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 January 25, 2005  4 type of health or environmental effects testing necessary to address unanswered questions about the effects of the chemical substance. EPA need not limit the scope of testing required to the factual basis for the TSCA section 4( a)( 1)( A)( i) or ( B)( i) findings, as long as EPA finds that there are insufficient data and experience upon which the effects of the manufacture, distribution 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 see: http:// www. epa. gov/ opptintr/ itc/.)

Although the Agency may not have yet made the TSCA section 4( a) finding for a particular chemical substance, EPA may still cooperate with industry or others to identify data gaps and develop testing plans to fill some or all of these gaps. These voluntary efforts help provide additional information about the many chemicals on the TSCA Inventory, and can be used to assess the potential risks associated with the manufacture, processing, distribution, use or disposal of the chemical, as well as allowing the Agency to establish a regulatory agenda that focuses on those chemicals of greater concern.

The information collected through the Chemical Testing Program, whether submitted pursuant to a rule or 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 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 toxicologic and health effects data, ecological effects data, and environmental fate data, will be used by scientists, professional industrial hygienists, other occupational health professionals and workers for hazard communication and right to know purposes, including Material Safety Data Sheets, and product labels. Additionally, data developed for chemicals used or produced in particular work sites will be useful in developing and/ or maintaining comprehensive safety and health programs at those facilities. Local, state and county governments rely on the Agency's ability to set health and environmental standards, as do other national governments. The paperwork related requirements imposed on the respondents as part January 25, 2005  5 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 TSCA 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 focused 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. January 25, 2005  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 Voluntary Challenge Programs EPA has searched the publicly available scientific data bases for chemicals embraced by the High Production Volume ( HPV) 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 August 30, 2004 ( 69 FR 39464, June 30, 2004). EPA received comments from the American Chemistry Council ( ACC) and the Synthetic Organic Chemical Manufacturers Association ( SOCMA). These comments are addressed in Attachment 4 to this ICR Supporting Statement.

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 ( formally Chemical Manufacturers Association ( CMA)) and Environmental Defense ( ED, formally 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.

Previous commenters on EPA's information gathering requirements under test rules, consent orders, and the exemption process have included numerous representatives of the chemical industry, environmental groups and the public at large. A number of issues were discussed including the schedule for the test rule and consent order process, what constitutes confidential information, how EPA should provide guidance for submission of equivalence data, how the Agency will provide standards for development of test data, enforceability of consent orders, and how to make consent orders equivalent to test rules.

In addition to the public notice and comment period required by the OMB regulations that implement the Paperwork Reduction Act ( see Section 3( b) of this Supporting Statement), the OMB regulations, 5 CFR 1320.8( d)( 1), also require agencies to consult with potential ICR January 25, 2005  7 respondents and data users about specific aspects of an ICR before the agency submits the ICR to OMB for review and approval. In accordance with this regulation and based on OPPTS Regulatory Coordination Staff guidance, EPA submitted questions to nine parties via email. A copy of the Agency's email with consultation questions to the above nine parties is provided as Attachment 5 to this Supporting Statement. The Agency received no responses to this solicitation for comments.

3( d) Effects of Less Frequent Collection Test rules and consent orders require the test sponsor to submit a letter notifying EPA who will be conducting the testing and study plans before beginning testing, and a 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 than CBI, which is discussed above. January 25, 2005  8 3( h) Electronic Reporting A description of data collection/ management activities specifically regarding the High Production Volume ( HPV) Chemical Challenge Program, including electronic reporting of data, is presented in Section 5( b).

4 THE RESPONDENTS AND THE INFORMATION REQUESTED 4( a) Respondents/ NAICS Codes Respondents affected by the collection activity may include, but are not limited to:

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.

4( b) Information Requested 4( b)( i) Data Items EPA may require any type of health effects, ecological effects and environmental fate testing necessary to address unanswered questions about the effects of a chemical substance. EPA need not limit the scope of testing required to the factual basis for the TSCA section 4( a)( 1)( A)( i) or ( B)( i) findings, as long as EPA also finds that there are insufficient data and experience upon which the effects of the manufacture, distribution in commerce, processing, use, or disposal of such substance or mixture or of any combination of such activities on health or the environment can reasonably be determined or predicted, and that testing is necessary to develop such data. This approach is explained in more detail in EPA's statement of policy for making findings under TSCA section 4( a)( 1)( B) ( frequently described as the " B" policy) in the Federal Register of May 14, 1993 ( 58 FR 28736, 28738 39; FRL 4059 9).

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. January 25, 2005  9 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 to which of these representative substances their chemical is equivalent. The type of data needed may vary with the chemical being tested, and will be described in detail in each individual test rule.

HPV Voluntary Challenge Program  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. 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 searches for relevant existing data. If data are found:  Determine whether the data are relevant;  Prepare and review summary of existing data; and  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: January 25, 2005  10 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.

HPV Voluntary Challenge Program. Exemption applications are not necessary for chemicals being tested under the HPV 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.

5 THE INFORMATION COLLECTION  AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT 5( a) Agency Activities Data collected under TSCA section 4 test rules and consent orders are received by the Office of Pollution Prevention and Toxics, Chemical Control Division, Chemical Information and Testing 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 Voluntary Challenge Program 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 January 25, 2005  11 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; and e) facilitate development of ECAs and VTAs.

In addition to the activities cited above the Agency maintains a facility inspection and test data audit program to ensure testing is done in compliance with GLPs, and may also participate in other activities related to this program, e. g., other voluntary efforts to identify data gaps and develop test data, efforts to establish test guidelines or standards that may be used in the Chemical Testing Program, and international efforts related to chemical testing and associated testing issues.

5( b) Collection Methodology and Management For each chemical identified for testing within EPA's TSCA Chemical Testing Program, the specific data requested, the testing necessary to generate those data  along with the test protocols, the time frame for completing the testing, and the date by which the requested data are to be submitted to the Agency, are established in the TSCA Section 4 Test Rule, TSCA Section 4 Enforceable Consent Agreement ( ECA), or Voluntary Testing Agreement ( VTA). Information about the data collection/ management activities specifically regarding the High Production Volume ( HPV) Chemical Challenge Program is presented at the end of this discussion It is also important to note that the TSCA Chemical Testing Program is an integral component of OPPT's TSCA Existing and New Chemicals Programs. These programs are responsible for assessing and managing health and environmental risks that may be posed by existing and new chemicals covered by TSCA. The " universe" of existing chemicals on the TSCA Chemical Substances Inventory that may present the greatest potential health and/ or environmental concerns have been and continue to be identified and refined through various existing chemical screening activities within OPPT.

Test data submitted to the Agency under the TSCA Chemical Testing Program are reviewed by scientists to determine whether or not the data developed are adequate for the purposes for which they were gathered and determining whether or not further regulatory action is necessary. In addition to being housed in an appropriate EPA TSCA docket, reference to the data are entered into the TSCA Test Submission Database ( TSCATS). TSCATS is a publicly available, online index to unpublished, nonconfidential studies covering chemical testing results and other submitted studies on the possible effects of chemicals on health and ecological systems. Submitted studies are indexed in TSCATS under three broad categories: health effects, ecological effects and environmental fate. TSCATS contains information that is pertinent to risk assessment and hazard evaluation processes. The information can be used in conjunction with published January 25, 2005  12 material and is a valuable source along with or in the absence of published data. The data are used by federal and state agencies, researchers, toxicologists, risk assessors, the regulated industry, attorneys, trade and professional associations as well as the public at large. TSCATS was developed by EPA in 1985 to make the results of ongoing and completed chemical testing available to the public and includes chemical exposure studies, epidemiology, environmental fate, monitoring, episodic incidents, such as spills and case reports. There are four primary types of documents referenced in the TSCATS database: TSCA section 4 chemical testing results, TSCA section 8( d) health and safety studies, TSCA section 8( e) substantial risk of injury to health or the environment notices, and voluntary documents submitted to EPA known as For Your Information ( FYI) submissions. TSCATS is available through a number of electronic sources; the studies referenced in TSCATS can be viewed in EPA's public TSCA docket located at EPA's Headquarters in Washington, DC or, alternatively, via microfiche copies that are available through the National Technical Information Service ( NTIS).

HPV Challenge Program Public access to hazard data is integral to the HPV Challenge Program. Test plan and data summary submissions, sponsor commitment information, chemical lists, guidance documents, and other materials can be found at the HPV Challenge Program web site ( http:// www. epa. gov/ chemrtk/ volchall. htm). EPA has recently provided enhanced search capability on its existing " Robust Summaries and Test Plans" web page ( http:// www. epa. gov/ chemrtk/ hpvrstp. htm) that allows the public to more efficiently search for test plan and data summary submissions.

Production of the HPV Information System ( HPVIS), a much more comprehensive, datasearchable application, is the ultimate goal. This system will allow users to thoroughly search across all test plan and data summary related materials   including the data presented within and among data summaries. Among other features, the system will ultimately allow the user to locate specific endpoint data, and it will recognize certain sponsor provided chemical synonym names in addition to the officially recognized chemical name. The first release of HPVIS is scheduled for late 2004 / early 2005.

As the HPV Challenge Program enters its final year and as EPA prepares to provide the industry submitted data to the public in a searchable database format, the Agency has made great strides to press forward with developing and planning for the delivery of a Global HPV Portal. The Portal is a system that will provide a central location for domestic and international users to access consolidated international HPV chemical data repositories. EPA is collaboratively working with the European Union, in consultation with the Organization for Economic Cooperation and Development ( OECD), and with the additional participation of Canada and Japan to develop this system. The aim of the Global HPV Portal is to provide seamless information sharing between the European Union's ( E. U.) International Uniform Chemical Information Database ( IUCLID) and EPA's HPVIS. The two leads   the European Commission ( EC) and EPA   have worked diligently on the Portal requirements in an effort to share information and make data more readily available to stakeholders from around the world.

5( c) Small Entity Flexibility January 25, 2005  13 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.

5( d) Collection Schedule This information collection activity does not involve more than one submission per activity. Required testing is conducted only once, and each related submission is a one time onoccasion submission. The testing period is based on the individual rule, consent order, or VTA, the standard time required to conduct the required test according to the testing guidelines, according to the timing established in the approved test plan, or timing otherwise established by the Agency.

The time period for screening level testing, like that conducted under the HPV Initiative, is usually less than a year. The typical time period for other types of testing is around three years, although it can be longer and varies according to the chemical and the test required.

6 ESTIMATING THE BURDEN AND COST OF THE COLLECTION Overview The methodology used in estimating the annual burden and costs to industry resulting from TSCA section 4 test rules, consent orders and agreements, and voluntary submissions over the next three years is based on EPA's most recent cost and burden estimates. These have been combined with current information concerning the number and type of TSCA section 4 test rules under development, estimates of the potential number of consent orders and agreements, and the current and anticipated level of industry participation in the voluntary HPV Challenge Program, all of which may result in industry submitting existing data or conducting new testing to provide EPA with information necessary to evaluate chemicals under its TSCA section 4 mandate.

Individual actions covered by this ICR may impact industry over most or all of the three year ICR period. In these cases, the impacts of the action have been converted to an annual basis January 25, 2005 1 69 FR 80 ( April 26, 2004), page 22402.

2 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.

 14 by assuming, for example, that one third of the chemicals covered by the action would be addressed in each of the three years.

Additional data collection efforts beyond those identified in this ICR may arise during the approval period for this ICR, but are not currently specifically addressed in this ICR. In most cases this is because the scope of such activities can not be estimated or the activity is otherwise still under development. The Agency has identified other potential testing activities ( rules, ECAs or VTAs) in the Semi Annual Regulatory Agenda ( see http:// www. epa. gov/ fedrgstr/ unified. htm, and look up the listing for actions under TSCA). If any of these activities are finalized during the three year approval period for this ICR, the Agency will need to ensure that those activities are approved under this ICR. For rulemakings, the ICR will be amended when the final rule is issued ( see further discussion of the rulemaking process below). For ECAs and VTAs, the ICR covers the burden predicted, but, if the Agency subsequently determines that the total annual burden covered by this ICR needs to be increased ( e. g., should the ECAs completed during the approval cycle exceed the predictions in this ICR), the Agency 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.

6( a) Respondent Cost and Burden TSCA Section 4 Test Rules This ICR covers one TSCA section 4 test rule, the " OSHA dermal absorption" test rule promulgated by EPA on April 26, 2004. The rule requires in vitro testing to determine dermal absorbency characteristics for 34 chemicals. 1 This ICR includes the costs and burdens associated with the completion of the two short term tests specified for each chemical. As noted above, EPA assumes one third of the chemicals are addressed in each of the three years covered by this ICR, thus 11 chemicals are assumed to be tested per year.

In its economic analysis of the OSHA dermal test rule, EPA identified 84 corporate entities responsible for producing the specified chemicals ( USEPA 2004). In EPA's experience, groups of chemicals covered by TSCA section 4 test rules may be represented by one sponsor or a panel representing multiple sponsors. 2 For burden estimation purposes EPA applied the ratio of one sponsor per five chemicals used in previous ICR submissions. Thus, EPA estimates that an average of two sponsors per year will respond to the OSHA dermal test rule. 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. For each sponsor of the OSHA dermal test rule, EPA January 25, 2005  15 assumes that five companies will apply for an exemption, or an average of one exemption per chemical. This is also consistent with past ICR submissions.

The OSHA dermal test rule requires sponsors to conduct testing to determine a short term absorption rate and a permeability constant for each chemical. In addition to laboratory costs, sponsors will incur expenses associated with the administration of the testing. For example, each sponsor must submit one letter of intent and one set of study plans for each study, and one final report for each study. These administrative costs are estimated to be 25 percent of the laboratory costs, based on a prior survey examining actual laboratory and administrative costs incurred in response to TSCA section 4 test rules ( USEPA 1989).

EPA has estimated the laboratory costs of testing to meet these requirements to be $ 27,190 per chemical with an additional administrative cost of $ 6,797 per chemical, for a total of $ 33,987 per chemical in 2003 dollars ( USEPA 2004). Applicants for exemption requests are assumed to incur two hours of technical labor at a 2003 rate of $ 43.24, for a total cost of $ 86.48 per exemption.

Although several other TSCA section 4 rules are under development, they are not currently covered by this ICR. Until a final TSCA section 4 rule is issued, the proposed data collection activities in the proposed rule  or under consideration prior to proposal  are not authorized. The estimated paperwork burden and costs for a proposed TSCA section 4 rule are provided for public comment at the time of the proposal, and in the context of the proposal. At that time, the Agency connects the proposal to this ICR and indicates that the final rule will present the adjusted estimates  adjusted to reflect public comment received and the content of the final rule. In the context of finalizing a TSCA section 4 rule, the Agency submits an addendum or amendment for this ICR to OMB for review and approval under the PRA. Once approved by OMB, the total authorized burden and costs under this ICR is then adjusted by OMB to include the collection activities in the final rule, thereby authorizing or approving them as required by the PRA. When the Agency prepared the next renewal package for ICR, the approved burden for any such final rules will be incorporated into the Supporting Statement for the Renewal ICR.

As indicated in the terms of clearance for this ICR, OMB has told the Agency that no estimated burden or costs for proposed rules will be approved under this ICR until the final rule is issued and OMB specifically approves an amendment to the ICR to capture the approval of the activities in the final rule. This is consistent with the OMB regulations for the PRA.

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 consent agreement will be issued per year for a total of three consent orders/ agreements issued during the ICR period. Past consent orders and agreements have covered an average of one to five chemicals. For this ICR, EPA assumes five chemicals will be covered by each order/ agreement.

The testing required under future consent orders or agreements cannot be predicted and will be determined on a case by case basis. For purposes of the ICR, EPA assumes as in past ICRs that each chemical will be evaluated by performing the tests specified in a " Standard" testing January 25, 2005 3 " Short term studies" are tests that can be concluded in the year they begin; " long term studies" are concluded within three years.

4 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.

 16 battery ( see Table 1). The test battery includes 11 studies per chemical ( 7 short term, 4 long term). 3 Each test sponsor must submit one letter of intent and one set of study plans for each study; five semi annual progress reports for each long term study; and one final report for each study. These assumptions are used to estimate the cost and burden factors ( or multipliers) in Table 3.

EPA generates and maintains a listing of the laboratory cost and burden data for numerous TSCA and OECD test protocols. Test cost estimates were adjusted to end of year 2003 dollars using the Bureau of Labor Statistics' Employment Cost Index ( ECI) and are shown in Table 1. The mean cost of the " Standard" battery is $ 1,264,454 and the average laboratory burden associated with this testing is 11,555 hours. 4 Table 1. TSCA Section 4 " Standard" Testing Battery Costs and Laboratory Burdens Test Protocol Name Protocol Number Date of Estimate Mean Cost Estimate ($ 2003) a Lab Burden ( hours)

1. Algal Acute Toxicity 797.1050 08/ 03/ 90 $ 9,446 57 2. Daphnid Acute Toxicity 797.1300 04/ 25/ 96 $ 9,283 54 3. Fish Acute Toxicity 797.1400 04/ 25/ 96 $ 13,627 65 4. Gene Mutations in Somatic Cells 798.5300 08/ 16/ 94 $ 20,794 144 5. Subchronic Oral Toxicity 870.3100 09/ 03/ 96 $ 153,837 882 6. Prenatal Developmental Tox. ( 2 species) 870.3700 08/ 27/ 96 $ 236,208 2,314 7. Reproduction/ Fertility Effects 870.3800 08/ 27/ 96 $ 609,411 6,086 8. Salmonella Reverse Mutation Assay 870.5265 09/ 16/ 96 $ 7,650 48 9. In vivo Bone Marrow Cytogenetics 870.5395 02/ 27/ 97 $ 16,012 125 10. Developmental Neurotoxicity 870.6300 08/ 27/ 96 $ 188,186 1,780 TOTAL $ 1,264,454 11,555 a Where multiple versions of a test have been costed by EPA ( e. g., covering different species or routes of exposure), the mean cost estimate is used. All test costs updated to 2003 dollars. Source: U. S. EPA, Office of Pollution Prevention and Toxics, Economics, Exposure and Technology Branch. January 25, 2005 5 HPV chemicals are those manufactured in or imported to the United States in annual quantities of one million pounds or more. The HPV program covered 2,089 chemicals at its launch.

 17 Voluntary Programs This ICR also incorporates estimates of the burdens and costs associated with the voluntary component of the high production volume ( HPV) chemicals testing program, launched in 1998.5 Under the HPV Challenge program manufacturers of chemicals targeted for testing agree to voluntarily submit data on hazard endpoints. EPA would exclude any chemicals enrolled in the Challenge program from its planned section 4 test rules and would provide recognition to Challenge participants for their voluntary actions.

Table 2 shows the full set of endpoints to be submitted under the HPV Challenge program. The testing suite is based on the Tier I tests from the OECD Screening Information Data Set ( SIDS). The Tier I battery includes 16 endpoints, each of which will be fulfilled by completing one short term study. The estimated cost of completing the full suite of testing in 2003 dollars is $ 288,568.

Table 2. TSCA Section 4 ICR SIDS TIER I ( HPV) TESTING Protocol Name Protocol Number Date of Estimate Mean Cost Estimate ($ 2003) a Lab Burden ( hours)

BATTERY 1. Melting Point OECD 102 04/ 20/ 98 $ 1,453 13 2. Boiling Point OECD 103 04/ 20/ 98 $ 1,514 14 3. Vapor Pressure OECD 104 06/ 11/ 98 $ 15,224 118 4. Water Solubility OECD 105 04/ 20/ 98 $ 5,971 53 5. Partition Coefficient ( shake flask) OECD 107 04/ 20/ 98 $ 6,819 50 SUBTOTAL $ 30,981 248 6. Photodegradation OECD 113 $ 5,886 62 7. Inherent Biodegradation OECD 302 04/ 20/ 98 $ 17,768 175 8. Stability in Water OECD 111 $ 53,957 194 9. Transportation/ Distribution EQC Model $ 125 2 SUBTOTAL $ 77,736 433 10. Acute Toxicity to Aquatic Plants OECD 201 05/ 12/ 98 $ 8,914 62 11. Acute Toxicity to Fish OECD 203 04/ 16/ 98 $ 10,053 56 12. Acute Toxicity to Daphnia OR OECD 202( I) 04/ 20/ 98 $ 7,793 40 Chronic Toxicity to Daphnia 850.1300 01/ 18/ 97 $ 33,064 173 SUBTOTAL ( AVERAGE) $ 39,369 225 13. Acute Oral Toxicity OR OECD 401 03/ 21/ 98 $ 3,440 41 Acute Dermal Toxicity OR OECD 402 03/ 22/ 98 $ 4,942 43 Acute Inhalation Toxicity OECD 403 04/ 20/ 98 $ 16,532 184 SUBTOTAL ( AVERAGE) $ 8,305 89 14. Genetic Toxicity ( Salmonella) OECD 471 03/ 23/ 98 $ 7,182 44 15. Chromosomal Aberration, in vitro OR OECD 473 04/ 20/ 98 $ 20,263 159 Chromosomal Aberration, in vivo OECD 474 04/ 23/ 98 $ 16,109 130 January 25, 2005 Table 2. TSCA Section 4 ICR SIDS TIER I ( HPV) TESTING Protocol Name Protocol Number Date of Estimate Mean Cost Estimate ($ 2003) a Lab Burden ( hours)

6 For aquatic toxicity tests, EPA assumed that labs running both OECD 201 ( acute toxicity to aquatic plants) and OECD 203 ( acute toxicity to fish) would use the same matrix and thus would only need to run the validation once. For these two tests, therefore, EPA assigned half the short term validation cost, or $ 1,750.

 18 SUBTOTAL ( AVERAGE) $ 25,368 189 16. Combined Repeated Dose with Repro./ Devel. Toxicity Screen OR OECD 422 12/ 08/ 94 $ 113,977 1,146 Repeated Dose Oral Toxicity AND OECD 407 02/ 15/ 97 $ 45,588 328 Repro./ Devel. Toxicity Screening Test OECD 421 04/ 01/ 97 $ 54,054 445 SUBTOTAL ( AVERAGE) $ 106,809 960 " SIDS TIER I"  GRAND TOTAL $ 288,568 2,144 a Cost adjusted to end of year 2003 using the Bureau of Labor Statistics' Employment Cost Index. See Attachment 3.

EPA has also included costs for analytical chemistry method development and validation where it was judged that such method development would be necessary to conform to good laboratory practices. Method development and validation is typically performed to determine the effectiveness of an analytical method to determine the levels of the chemical in the dosing matrix in toxicity studies. For each of SIDS Tier 1 toxicity tests shown in Table 2, EPA assigned a method development and validation cost of $ 3,500 for short term studies and $ 8,500 for longterm studies, based on typical costs cited by industry experts ( Piccirillo 2004). 6 For chemicals undergoing the complete suite of SIDS tests, analytical chemistry method development and validation adds $ 40,250 to the $ 288,568 in testing costs, for a total laboratory cost of $ 328,818.

During the previous ICR period many of the HPV Challenge program participants undertook a search for any existing chemical testing studies, and submitted " robust summaries" of such studies to EPA. For those endpoints not adequately covered by existing studies, sponsors also prepared test plans and submitted these to EPA. Based on the studies and test plans received by February 2004, EPA estimates that the current sponsorship program encompasses 1,494 chemicals. This includes 1,267 chemicals for which sponsors had submitted test plans ( of which 1,235 represented chemicals that had been previously sponsored and 32 represented chemicals that had not.) Test plans were still pending for 259 chemicals ( 1,494  1,235 = 259). On an annual basis, this implies 422 sponsored chemicals per year ( 1,267 ÷ 3) will be addressed by filling testing gaps, and 86 chemicals per year ( 259 ÷ 3) will be addressed through test plans and necessary testing.

Following review of a subset of test plans, EPA assumes that industry participation in the voluntary HPV Challenge program will result in new testing to satisfy an average of one additional endpoint per sponsored chemical during the first year of this ICR for those chemicals for which a test plan has been submitted. The cost per endpoint ranges from $ 125 for the transportation/ distribution endpoint ( which is modeled) to $ 122,477 for the repeated dose test with reproductive and developmental toxicity. The weighted average cost of outstanding testing, including validation, is $ 32,906, obtained by weighting the cost of each test by the percent of chemicals that need to complete the test. January 25, 2005  19 Submitters are assumed to incur an administrative cost equal to 25 percent of the test cost, the burden factor EPA normally uses for test rules and consent orders/ agreements. Using the weighted average test cost of $ 32,906, the average administrative cost is $ 8,227. This is divided by the weighted average hourly labor rate of $ 43.31, for an average burden of 190 hours per chemical.

For the 259 chemicals for which EPA has not received test plans, EPA assumes sponsors will submit test plans during the ICR period and conduct all necessary testing. For purposes of estimating testing needs for these chemicals, EPA analyzed the number of tests proposed for chemicals with test plans submitted and found that approximately 70 percent of chemicals had no testing proposed and more than 90 percent proposed fewer than five tests. EPA assumed that each test plan still to be submitted will cover five endpoints at the weighted average test cost of $ 32,906 for a total of $ 164,530. ( This is probably a conservative estimate since the median number of tests proposed is 1.25). The cost of submitting the test plan is estimated at two hours of technical time using a loaded labor rate of $ 46.09, or a total cost of $ 92.17.

The number of sponsors was determined based on a review of HPV chemical sponsorship patterns. Currently, there are 113 consortia participating in the program and these consortia account for approximately one third of the HPV Challenge chemicals, or 493 chemicals ( 1,494 x 0.33). The remaining 1,001 chemicals are sponsored individually. The total number of sponsors participating is thus 1,114 ( 1,001 + 113), and the ratio of chemicals to sponsors is approximately 1.33: 1. Applying the same ratio of one sponsor per 1.33 chemicals to the 1,267 chemicals for which test plans have been submitted, EPA estimates there are a total of 953 sponsors covering these chemicals. For the 259 chemicals with test plans outstanding, EPA estimates there will be 195 sponsors ( 259 ÷ 1.33). On an annual basis, this translates to 317 sponsors who have already submitted test plans and 65 sponsors with test plans still outstanding.

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 in Table 3.

Table 3. Assumptions Used in Estimating Costs and Burdens TSCA Section 4 ICR Assumptions OSHA Dermal Test Rule Consent Orders and Agreements HPV Challenge w/ Test Plans HPV Challenge No Test Plans Totals a No. of orders/ agreements issued 1 1 1 1 4 b Chemicals per order/ agreement 11 5 422 86

c Total no. of chemicals ( a × b) 11 5 422 86 524 d No. of chemicals per sponsor 5 5 1.33 1.33

e No. of sponsors per rule or order ( b ÷ d) 2 1 317 65

f Total no. of sponsors ( a × e) 2 1 317 65 385 g Letters of intent/ study plans per sponsor 1 1 1 1

h Total letters of intent/ study plans ( f × g) 2 1 317 65 385 i No. of short term studies per chemical 2 7 1 5

j Total no. of short term studies © × i) 22 35 422 430 909 k No. of long term studies per chemical 0 4 0 0

l Total no. of long term studies © × k) 0 20 0 0 20 m Total no. of studies per chemical ( i + k) 2 11 1 5

n Total no. of studies ( j + l) 22 55 422 430 929 January 25, 2005 Table 3. Assumptions Used in Estimating Costs and Burdens TSCA Section 4 ICR Assumptions OSHA Dermal Test Rule Consent Orders and Agreements HPV Challenge w/ Test Plans HPV Challenge No Test Plans Totals  20 o No. of semi annual progress reports per Short term study 0 0 0 0

Long term study 0 5 0 0

p Total no. of semi annual progress reports Short term studies ( o x j) 0 0 0 0 0 Long term study ( o x l) 0 100 0 0 100 q No. of final reports per study 1 1 1 1

r Total no. of final reports ( n × q) 22 55 422 430 929 s Total no. of reports ( h + p + r) 24 156 739 495 1,414 t Total reports per sponsor ( s ÷ f) 12 156 2 8

u Total reports per rule/ order ( s ÷ a) 24 156 739 495

v Total reports per chemical ( s ÷ c) 2 31 2 6

w No of exemptions per sponsor 5 0 0 0

x No. of exemptions per rule/ order 11 0 0 0

y Total no. of exemptions 11 0 0 0 11 z Total no. of responses ( s + y) 35 156 739 495 1,425 aa No. of responses per rule/ order ( e + x) 13 1 317 65

bb Total no. of respondents ( f + y) 13 1 317 65 396 Total Number of Respondents The Agency's estimates assume that on an annual basis there will be two respondents to the OSHA dermal test rule, one respondent to an enforceable consent orders or agreement, 317 sponsors of HPV Challenge chemicals covered by test plans already submitted to the Agency, and 65 sponsors of HPV Challenge chemicals for which test plans have yet to be submitted to the Agency ( line f), for a total of 385 respondents. A total of 11 respondents per year are estimated to apply for exemptions from the OSHA dermal test rule ( line y). The estimated annual total number of respondents for this ICR is 396 ( i. e., 385 sponsors and 11 exemption applicants) ( Table 3, line bb).

Total 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, 3.7 reports per year ( i. e., 1,414 reports ÷ 385 sponsors = 3.7). 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 covered in this ICR. Table 5 presents estimates of the laboratory and administrative costs, and administrative burdens. These are discussed in detail below.

Laboratory Costs January 25, 2005 7Some 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.

 21 The costs incurred by sponsors performing laboratory testing are presented in Table 4. Total laboratory costs associated with activities covered by this ICR are estimated to be $ 34.66 million per year ( line f). These costs include $ 0.30 million for the OSHA dermal test rule; $ 6.32 million for consent orders and agreements; $ 13.89 million for testing related to HPV Challenge chemicals covered by test plans; and $ 14.15 million for HPV Challenge chemicals not yet covered by test plans. With a projected total of 929 studies to be conducted ( line d), the average laboratory cost is $ 37,306 per study ( line i). 7 Table 4. Laboratory Cost and Burden Estimates ( Annual)

TSCA Section 4 ICR Factors OSHA Dermal Test Rule Consent Orders/ Agreeme nts HPV Challenge w/ Test Plans HPV Challenge No Test Plans TOTALS a Total no. of rules/ orders 1 1 1 1 4 b Total no. of chemicals 11 5 422 86 524 c Total no. of sponsors 2 1 317 65 385 d Total no. of studies 22 55 422 430 929 e Lab. cost per chemical $ 27,190 $ 1,264,454 $ 32,906 $ 164,530 $ 66,140 f Total lab. costs ( b × e) $ 299,090 $ 6,322,270 $ 13,886,332 $ 14,149,580 $ 34,657,272 g Admin. reporting costs $ 69,899 $ 254,781 $ 1,985,191 $ 1,394,674 $ 3,704,545 Admin. non reporting costs $ 4,874 $ 1,325,787 $ 1,486,392 $ 2,142,721 $ 4,959,774 Total admin. costs a $ 74,773 $ 1,580,568 $ 3,471,583 $ 3,537,395 $ 8,664,319 h Total lab. and admin. costs ( f + g) $ 373,863 $ 7,902,838 $ 17,357,915 $ 17,686,975 $ 43,321,591 i Lab. costs per study ( f ÷ d) $ 13,595 $ 114,950 $ 32,906 $ 32,906 $ 37,306 j Admin. costs per study ( g ÷ d) $ 3,399 $ 28,738 $ 8,227 $ 8,227 $ 9,327 k Total testing costs per study ( i + j) $ 16,994 $ 143,688 $ 41,133 $ 41,133 $ 46,632 l Total testing costs per sponsor ( h ÷ c) $ 186,932 $ 7,902,838 $ 54,757 $ 272,107 $ 112,524 m Admin. reporting burden b 1,708 6,175 46,623 33,990 88,496 Admin. non reporting burden c 113 30,612 34,320 49,474 114,519 Total admin. burden 1,821 36,787 80,943 83,464 203,015 n Admin. burden per study ( m ÷ d) 83 669 192 194 219 o Total admin. burden per sponsor ( m ÷ c) 911 36,787 255 1,284 527 a Administrative costs and burdens are assumed to equal 25 percent of laboratory costs and burdens. b The reporting burdens are derived in Table 6. c The non reporting administrative burden is estimated by dividing the administrative cost by $ 43.31, which represents the weighted average wage rate. The weighted average wage reflects an assumed 20/ 60/ 20 mix of managerial/ technical/ clerical labor.

Administrative Costs EPA's experience in test rule development has shown the administrative costs associated with testing programs to be approximately 25 percent of the laboratory costs EPA has applied this 25 percent factor to estimate the administrative costs associated with the OSHA dermal test rules, consent orders and agreements, and actions covered in the current ICR period related to the HPV Challenge Program. Following these assumptions, the total administrative cost is estimated to be $ 8.66 million annually ( line g). These administrative costs are assumed to comprise both reporting and non reporting activities. January 25, 2005  22 Reporting Costs and Burdens. Part of the administrative costs 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 HPV Challenge program.

In addition, EPA is currently developing a new HPV Information System ( HPVIS) for all HPV Challenge submissions. A key focus of that effort is to put HPV data into a database to facilitate more robust search capabilities. In August 2004, EPA sent a letter to HPV sponsors asking if they would be willing to resubmit information they had already submitted in a format consistent with HPVIS. The 317 sponsors assumed to have already submitted test plans have three options for resubmission:

Option 1: Sponsor may enter previously submitted data directly into HPVIS, which EPA estimates will take 8 to 16 hours to complete.

Option 2: Sponsor may submit an International Uniform Chemical Information Database ( IUCLID) 4.02 export file to EPA and will validate the submission once EPA completes the upload to the HPVIS. EPA estimates this option to take one hour to complete.

Option 3: Sponsor may validate previously submitted data that are entered by EPA into the HPVIS. In this case there is no incremental burden for sponsors but the Agency burden would increase.

Estimates of the respondents' annual reporting costs and the burden associated with each reporting activity are detailed in Table 5. The unit wage rate information is explained in Attachment 3. The unit labor hours are derived from previous information collection requests and are believed to be reflective of the annual amount of time required for each activity over the next three year period.

As noted above, 317 sponsors have submitted test plans and will have to resubmit test plan data in electronic format. To estimate this burden, EPA assumed that data in IUCLID format exists for 60 percent, or 750 of the 1,267 HPV chemicals ( Moore 2004) and has estimated the burden for the remaining chemicals at 16 hours per chemical, based on the high end of the estimates for the three submission option s ( i. e., via the HPVIS system). For the 65 sponsors who have not yet submitted test plans, EPA assumes that 40 hour administrative burden assigned for each chemical includes electronic submission of the test plans. The total annual respondent cost and burden for reporting activities is $ 3.70 million and 88,496 hours ( for reporting costs see Table 5, line g; for reporting burdens see Table 5, line m).

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 January 25, 2005  23 difference between the total administrative costs and burdens and the reporting costs and burdens derived above and in Table 4. Based on this calculation, non reporting activities associated with laboratory testing are estimated to cost $ 4.96 million annually. These costs are translated into burden estimates using an average labor cost of $ 43.31 per hour, which is based on a labor mix that is 20 percent managerial, 60 percent technical, and 20 percent clerical. The estimated burden based on this approach is 114,519 hours annually ( for non reporting costs see Table 4, line g; for non reporting burdens see Table 5, line m). January 25, 2005  24

Table 5. Total Annual Respondent Cost and Burden for Reporting Activities COLLECTION ACTIVITY UNIT LABOR UNIT SUPPLY COSTS ANNUAL ITEMS GRAND TOTAL TYPE a HOURS RATE COST HOURS COSTS INTERIM REPORTS Letter of Intent and Study Plans T 40 $ 46.09 $ 1,843.60 $ 20.00 385 15,400 $ 717,486 Electronic Submission of Past Study Plans via HPVIS T 16 $ 46.09 $ 737.44 $ 0.00 188 3,008 $ 138,639 Electronic Submission of Past Study Plans via IUCLID T 1 $ 46.09 $ 46.09 $ 0.00 129 129 $ 5,946 Prepare Progress Report T 8 $ 46.09 $ 368.72 $ 5.00 100 800 $ 37,372 INTERIM REPORTS SUBTOTAL $ 2,995.85 19,337 $ 899,442 FINAL REPORTS Short term Studies Record and Prepare Test for Submission T 40 $ 46.09 $ 1,843.60 $ 0.00 909 36,360 $ 1,675,832 Laboratory Review T 6 $ 46.09 $ 276.54 $ 0.00 909 5,454 $ 251,375 Corporate Review M 6 $ 53.82 $ 322.92 $ 0.00 909 5,454 $ 293,534 Type and Print Results S 20 $ 24.46 $ 489.20 $ 0.00 909 18,180 $ 444,683 Record Keeping S 1 $ 24.46 $ 24.46 $ 5.00 909 909 $ 26,779 Short term Subtotal $ 2,956.72 66,357 $ 2,692,203 Long term Studies Record and Prepare Test for Submission T 80 $ 46.09 $ 3,687.20 $ 0.00 20 1,600 $ 73,744 Laboratory Review T 9 $ 46.09 $ 414.81 $ 0.00 20 180 $ 8,296 Corporate Review M 9 $ 53.82 $ 484.38 $ 0.00 20 180 $ 9,688 Type and Print Results S 40 $ 24.46 $ 978.40 $ 0.00 20 800 $ 19,568 Record Keeping S 1 $ 24.46 $ 24.46 $ 5.00 20 20 $ 589 Long term Subtotal $ 5,589.25 929 2,780 $ 111,885 FINAL REPORTS SUBTOTAL 69,137 $ 2,804,088 EXEMPTION REQUESTS T 2 $ 46.09 $ 92.18 $ 0.00 11 22 $ 1,014 TOTALS 88,496 $ 3,704,545 a Labor Type   T = Technical; M = Managerial; S = Secretarial January 25, 2005  25 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, consent orders and agreements, and voluntary testing programs are discussed below and detailed in Table 6.

The Agency collection procedures are estimated to be accomplished, on average, by a GS 13, Step 1, employee. The annual 2004 loaded cost of a full time equivalent ( FTE) for this level employee is $ 115,373. This includes a base wage of $ 72,108 plus 60 percent for overhead and benefits ( i. e., $ 43,265). Dividing this value by 2,080 ( i. e., the number of hours in a work year) equals an hourly wage rate of $ 55.47 ( see Attachment 3 for the derivation of these factors).

AGENCY LABOR CATEGORY LOADED HOURLY RATE ($ 2004)

GS 13, Step 1 $ 55.47 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 ICRs 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 $ 0.33 million and 5,900 hours ( or 2.8 FTEs). The Agency's annual exemption processing costs and burden is $ 610 and 11 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 $ 55.47 $ 166.41 $ 0.00 385 1,155 $ 64,068 Progress Reports 1 $ 55.47 $ 55.47 $ 0.00 100 100 $ 5,547 Final Reports 5 $ 55.47 $ 277.35 $ 0.00 929 4,645 $ 257,658 SUBTOTAL 1,414 5,900 $ 327,273 Exemptions 1 55.47 $ 55.47 $ 0.00 11 11 $ 610 GRAND TOTAL 1,425 5,911 $ 327,883 January 25, 2005  26 6( c) Annual Burden Hours and Costs 6( c)( i) Respondent Tally Table 7 summarizes the average burden per response. EPA estimates that this ICR will impose 203,014 burden hours on respondents annually. This total burden covers 1,425 responses annually for an average of 142 hours per response.

Table 7. Average Burden Hours Per Response COLLECTION ACTIVITY RESPONDENT BURDEN PER RESPONSE TOTAL HOURS TOTAL ITEMS HOURS PER RESPONSE Reporting Activities Letters of Intent/ Study Plans 18,537 385 48 Progress reports 800 100 8 Final Reports 69,137 929 74 Exemption Requests 22 11 2 Subtotal ( all responses) 88,496 1,425 62 Non reporting activities 114,518 1,425 80 Total 203,014 1,425 142 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 Hours Cost Reporting activities Letters of Intent and study plans 18,537 $ 862,071 Progress reports 800 $ 37,372 Final Reports 69,137 $ 2,804,088 Exemption Requests 22 $ 1,014 Subtotal 88,496 $ 3,704,545 Nonreporting activities 114,518 $ 4,959,774 TOTAL ( all responses) 203,014 $ 8,664,319 6( c)( ii) Agency Tally January 25, 2005  27 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 AGENCY BURDEN AND COSTS BURDEN ( Hours) COSTS Letter of Intent and Study Plans 1,155 $ 64,068 Progress Reports 100 $ 5,547 Final Reports 4,645 $ 257,658 Exemptions 11 $ 610 TOTAL 5,911 $ 327,883 6( d) Reasons for Changes in Burden Compared with the previous ICR the present ICR represents an decrease in the respondent burden from 1,182,574 hours to 203,014 hours, or a decrease of 979,560 hours. The respondent cost decreases from $ 51.04 million to $ 8.66 million, or a decrease of $ 42.38 million.

In the previous ICR, the Agency's estimated burden was based on the assumption that it would issue three average test rules and eight ECAs, and included estimates of testing needs to be completed under the voluntary HPV Challenge and the voluntary Children's Chemical Evaluation Program. For this ICR, the burden is based on the Agency's expectation that it will issue one test rule and three ECAs, and also the Agency's estimate of the expected level of testing remaining to be done under the HPV Challenge Program. Therefore, total annual burden has decreased. However, burden per respondent has increased because this analysis includes additional nonreporting administrative burden that was not included in the previous analysis.

In addition to these changes, the Agency has adjusted all costs to reflect an update in the labor rates, and more recent laboratory testing costs.

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 142 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 numbers for EPA's regulations in title January 25, 2005  28 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.

To comment on 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, EPA has established a public docket for this ICR under Docket ID No. OPPT 2004 0098, which is available for public viewing at the Pollution Prevention and Toxics Docket in the EPA Docket Center ( EPA/ DC), EPA West, Room B102, 1301 Constitution Ave., NW, Washington, DC. The EPA Docket Center Public Reading Room is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is ( 202) 566 1544 and the telephone number for the Pollution Prevention and Toxics Docket is ( 202) 566 0280. An electronic version of the public docket is available through EPA Dockets ( EDOCKET) at http:// www. epa. gov/ edocket. Use EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. Once in the system, select " search," then key in the docket ID number identified above. Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Office for EPA. Please include the EPA Docket ID No. OPPT 2004 0098 and OMB control number 2070 0033 in any correspondence.

References Moore 2004. Jack Moore, Memo to National Pollution Prevention and Toxics Advisory Committee, part of minutes from May 13, 2004 meeting, available at www. epa. gov/ oppt/ npptac/ summarymay2004. pdf.

Piccirillo 2004. Vincent Piccirillo, personal communication. September 20, 2004.

USEPA 2004. Economic Impact Analysis and Small Entity Impact Analysis of the TSCA Section 4( a) Test Rule for 34 Chemicals Targeted for in Vitro Dermal Absorption Rate Testing. Economic and Policy Analysis Branch, Economics, Exposure and Technology Division, Office of Pollution Prevention and Toxics. February 3, 2004.

USEPA 2002. " Wage Rates for Economic Analysis of the Toxics Release Inventory Program." Memorandum from Cody Rice, Analytical Support Branch, Environmental Analysis Division, Office of Environmental Information, U. S. EPA. April 11, 2002.

USEPA 1989. " Administrative costs and burden hours for test rule." Note from Dan Axelrad to Bob Lee and Libby Parker, Regulatory Impacts Branch, Office of Pollution Prevention and Toxics, U. S. EPA. October 26, 1989. January 25, 2005  29 ATTACHMENTS 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  Wage Rates Estimation Attachment 4  EPA Response to Public Comments Attachment 5  Section 3( c) Consultations Note: Attachments not included in the electronic file for the supporting statement are available electronically in a separatefile as indicated above or by accessing the docket for this ICR at http:// www. epa. gov/ edocket. Use the " Quick Search" for a docket function and Docket ID No. OPPT 2004 0098. January 25, 2005 ATTACHMENT 1 Toxic Substances Control Act Section 4 15 USC 2603 January 25, 2005 TITLE 15  COMMERCE AND TRADE CHAPTER 53  TOXIC SUBSTANCES CONTROL SUBCHAPTER I  CONTROL OF TOXIC SUBSTANCES Sec. 2603.  Testing of chemical substances and mixtures ( a) Testing requirements If the Administrator 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 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; and ( 2) in the case of a mixture, the effects which the mixture's manufacture, distribution in commerce, processing, use, or disposal or any combination of such activities may have on health or the environment may not be reasonably and more efficiently determined or predicted by testing the chemical substances which comprise the mixture; the Administrator shall by rule require that testing be conducted on such substance or mixture to develop data with respect to the health and environmental effects for which there is an insufficiency of data and experience and which are relevant to a determination that the manufacture, distribution in commerce, processing, use, or disposal of such substance or mixture, or that any combination of such activities, does or does not present an unreasonable risk of injury to health or the environment.

( b) Testing requirement rule ( 1) A rule under subsection ( a) of this section shall include  ( A) identification of the chemical substance or mixture for which testing is required under the rule, ( B) standards for the development of test data for such substance or mixture, and ( C) with respect to chemical substances which are not new chemical substances and to mixtures, a specification of the period ( which period may not be of unreasonable duration) within which the persons required to conduct the testing shall submit to the Administrator data developed in accordance with the standards referred to in subparagraph ( B). In determining the standards and period to be included, pursuant to subparagraphs ( B) and ( C), in a rule under subsection ( a) of this section, the Administrator's considerations shall include the relative costs of the various test protocols and methodologies which may be required under the rule and the reasonably foreseeable availability of the facilities and personnel needed to perform the testing required under the rule. Any such rule may require the submission to the Administrator of preliminary data during the period prescribed under subparagraph ( C). January 25, 2005 ( 2)( A) The health and environmental effects for which standards for the development of test data may be prescribed include carcinogenesis, mutagenesis, teratogenesis, behavioral disorders, cumulative or synergistic effects, and any other effect which may present an unreasonable risk of injury to health or the environment. The characteristics of chemical substances and mixtures for which such standards may be prescribed include persistence, acute toxicity, subacute toxicity, chronic toxicity, and any other characteristic which may present such a risk. The methodologies that may be prescribed in such standards include epidemiologic studies, serial or hierarchical tests, in vitro tests, and whole animal tests, except that before prescribing epidemiologic studies of employees, the Administrator shall consult with the Director of the National Institute for Occupational Safety and Health. ( B) From time to time, but not less than once each 12 months, the Administrator shall review the adequacy of the standards for development of data prescribed in rules under subsection ( a) of this section and shall, if necessary, institute proceedings to make appropriate revisions of such standards.

( 3)( A) A rule under subsection ( a) of this section respecting a chemical substance or mixture shall require the persons described in subparagraph ( B) to conduct tests and submit data to the Administrator on such substance or mixture, except that the Administrator may permit two or more of such persons to designate one such person or a qualified third party to conduct such tests and submit such data on behalf of the persons making the designation. ( B) The following persons shall be required to conduct tests and submit data on a chemical substance or mixture subject to a rule under subsection ( a) of this section: ( i) Each person who manufactures or intends to manufacture such substance or mixture if the Administrator makes a finding described in subsection ( a)( 1)( A)( ii) or ( a)( 1)( B)( ii) of this section with respect to the manufacture of such substance or mixture. ( ii) Each person who processes or intends to process such substance or mixture if the Administrator makes a finding described in subsection ( a)( 1)( A)( ii) or ( a)( 1)( B)( ii) of this section with respect to the processing of such substance or mixture. ( iii) Each person who manufactures or processes or intends to manufacture or process such substance or mixture if the Administrator makes a finding described in subsection ( a)( 1)( A)( ii) or ( a)( 1)( B)( ii) of this section with respect to the distribution in commerce, use, or disposal of such substance or mixture.

( 4) Any rule under subsection ( a) of this section requiring the testing of and submission of data for a particular chemical substance or mixture shall expire at the end of the reimbursement period ( as defined in subsection ( c)( 3)( B) of this section) which is applicable to test data for such substance or mixture unless the Administrator repeals the rule before such date; and a rule under subsection ( a) of this section requiring the testing of and submission of data for a category of chemical substances or mixtures shall expire with respect to a chemical substance or mixture included in the category at the end of the reimbursement period ( as so defined) which is applicable to test data for such substance or mixture unless the Administrator before such date repeals the application of the rule to such substance or mixture or repeals the rule.

( 5) Rules issued under subsection ( a) of this section ( and any substantive amendment thereto or repeal thereof) shall be promulgated pursuant to section 553 of title 5 except that ( A) the Administrator shall give interested persons an opportunity for the oral presentation of data, views, or arguments, in addition to an opportunity to make written submissions; ( B) a transcript shall be made of any oral presentation; and ( C) the Administrator shall make and publish with the rule the findings described in paragraph ( 1)( A) or ( 1)( B) of subsection ( a) of this section and, in the case of a rule respecting a mixture, the finding described in paragraph ( 2) of such subsection. January 25, 2005 ( c) Exemption ( 1) Any person required by a rule under subsection ( a) of this section to conduct tests and submit data on a chemical substance or mixture may apply to the Administrator ( in such form and manner as the Administrator shall prescribe) for an exemption from such requirement.

( 2) If, upon receipt of an application under paragraph ( 1), the Administrator determines that  ( A) the chemical substance or mixture with respect to which such application was submitted is equivalent to a chemical substance or mixture for which data has been submitted to the Administrator in accordance with a rule under subsection ( a) of this section or for which data is being developed pursuant to such a rule, and ( B) submission of data by the applicant on such substance or mixture would be duplicative of data which has been submitted to the Administrator in accordance with such rule or which is being developed pursuant to such rule, the Administrator shall exempt, in accordance with paragraph ( 3) or ( 4), the applicant from conducting tests and submitting data on such substance or mixture under the rule with respect to which such application was submitted.

( 3)( A) If the exemption under paragraph ( 2) of any person from the requirement to conduct tests and submit test data on a chemical substance or mixture is granted on the basis of the existence of previously submitted test data and if such exemption is granted during the reimbursement period for such test data ( as prescribed by subparagraph ( B)), then ( unless such person and the persons referred to in clauses ( i) and ( ii) agree on the amount and method of reimbursement) the Administrator shall order the person granted the exemption to provide fair and equitable reimbursement ( in an amount determined under rules of the Administrator)  ( i) to the person who previously submitted such test data, for a portion of the costs incurred by such person in complying with the requirement to submit such data, and ( ii) to any other person who has been required under this subparagraph to contribute with respect to such costs, for a portion of the amount such person was required to contribute. In promulgating rules for the determination of fair and equitable reimbursement to the persons described in clauses ( i) and ( ii) for costs incurred with respect to a chemical substance or mixture, the Administrator shall, after consultation with the Attorney General and the Federal Trade Commission, consider all relevant factors, including the effect on the competitive position of the person required to provide reimbursement in relation to the person to be reimbursed and the share of the market for such substance or mixture of the person required to provide reimbursement in relation to the share of such market of the persons to be reimbursed. An order under this subparagraph shall, for purposes of judicial review, be considered final agency action. ( B) For purposes of subparagraph ( A), the reimbursement period for any test data for a chemical substance or mixture is a period  ( i) beginning on the date such data is submitted in accordance with a rule promulgated under subsection ( a) of this section, and ( ii) ending  ( I) five years after the date referred to in clause ( i), or ( II) at the expiration of a period which begins on the date referred to in clause ( i) and which is equal to the period which the Administrator determines was necessary to develop such data, whichever is later.

( 4)( A) If the exemption under paragraph ( 2) of any person from the requirement to conduct tests and submit test data on a chemical substance or mixture is granted on the basis of the fact that test data is being developed by one or more persons pursuant to a rule promulgated under subsection ( a) of this section, then ( unless such person and the persons referred to in clauses ( i) and ( ii) agree on the January 25, 2005 amount and method of reimbursement) the Administrator shall order the person granted the exemption to provide fair and equitable reimbursement ( in an amount determined under rules of the Administrator)  ( i) to each such person who is developing such test data, for a portion of the costs incurred by each such person in complying with such rule, and ( ii) to any other person who has been required under this subparagraph to contribute with respect to the costs of complying with such rule, for a portion of the amount such person was required to contribute. In promulgating rules for the determination of fair and equitable reimbursement to the persons described in clauses ( i) and ( ii) for costs incurred with respect to a chemical substance or mixture, the Administrator shall, after consultation with the Attorney General and the Federal Trade Commission, consider the factors described in the second sentence of paragraph ( 3)( A). An order under this subparagraph shall, for purposes of judicial review, be considered final agency action.

( B) If any exemption is granted under paragraph ( 2) on the basis of the fact that one or more persons are developing test data pursuant to a rule promulgated under subsection ( a) of this section and if after such exemption is granted the Administrator determines that no such person has complied with such rule, the Administrator shall ( i) after providing written notice to the person who holds such exemption and an opportunity for a hearing, by order terminate such exemption, and ( ii) notify in writing such person of the requirements of the rule with respect to which such exemption was granted.

( d) Notice Upon the receipt of any test data pursuant to a rule under subsection ( a) of this section, the Administrator shall publish a notice of the receipt of such data in the Federal Register within 15 days of its receipt. Subject to section 2613 of this title, each such notice shall ( 1) identify the chemical substance or mixture for which data have been received; ( 2) list the uses or intended uses of such substance or mixture and the information required by the applicable standards for the development of test data; and ( 3) describe the nature of the test data developed. Except as otherwise provided in section 2613 of this title, such data shall be made available by the Administrator for examination by any person.

( e) Priority list ( 1)( A) There is established a committee to make recommendations to the Administrator respecting the chemical substances and mixtures to which the Administrator should give priority consideration for the promulgation of a rule under subsection ( a) of this section. In making such a recommendation with respect to any chemical substance or mixture, the committee shall consider all relevant factors, including  ( i) the quantities in which the substance or mixture is or will be manufactured, ( ii) the quantities in which the substance or mixture enters or will enter the environment, ( iii) the number of individuals who are or will be exposed to the substance or mixture in their places of employment and the duration of such exposure, ( iv) the extent to which human beings are or will be exposed to the substance or mixture, ( v) the extent to which the substance or mixture is closely related to a chemical substance or mixture which is known to present an unreasonable risk of injury to health or the environment, ( vi) the existence of data concerning the effects of the substance or mixture on health or the environment, January 25, 2005 ( vii) the extent to which testing of the substance or mixture may result in the development of data upon which the effects of the substance or mixture on health or the environment can reasonably be determined or predicted, and ( viii) the reasonably foreseeable availability of facilities and personnel for performing testing on the substance or mixture. The recommendations of the committee shall be in the form of a list of chemical substances and mixtures which shall be set forth, either by individual substance or mixture or by groups of substances or mixtures, in the order in which the committee determines the Administrator should take action under subsection ( a) of this section with respect to the substances and mixtures. In establishing such list, the committee shall give priority attention to those chemical substances and mixtures which are known to cause or contribute to or which are suspected of causing or contributing to cancer, gene mutations, or birth defects. The committee shall designate chemical substances and mixtures on the list with respect to which the committee determines the Administrator should, within 12 months of the date on which such substances and mixtures are first designated, initiate a proceeding under subsection ( a) of this section. The total number of chemical substances and mixtures on the list which are designated under the preceding sentence may not, at any time, exceed 50.

( B) As soon as practicable but not later than nine months after January 1, 1977, the committee shall publish in the Federal Register and transmit to the Administrator the list and designations required by subparagraph ( A) together with the reasons for the committee's inclusion of each chemical substance or mixture on the list. At least every six months after the date of the transmission to the Administrator of the list pursuant to the preceeding [ 1] sentence, the committee shall make such provisions in the list as it determines to be necessary and shall transmit them to the Administrator together with the committee's reasons for the revisions. Upon receipt of any such revision, the Administrator shall publish in the Federal Register the list with such revision, the reasons for such revision, and the designations made under subparagraph ( A). The Administrator shall provide reasonable opportunity to any interested person to file with the Administrator written comments on the committee's list, any revision of such list by the committee, and designations made by the committee, and shall make such comments available to the public. Within the 12 month period beginning on the date of the first inclusion on the list of a chemical substance or mixture designated by the committee under subparagraph ( A) the Administrator shall with respect to such chemical substance or mixture either initiate a rulemaking proceeding under subsection ( a) of this section or if such a proceeding is not initiated within such period, publish in the Federal Register the Administrator's reason for not initiating such a proceeding.

( 2)( A) The committee established by paragraph ( 1)( A) shall consist of eight members as follows: ( i) One member appointed by the Administrator from the Environmental Protection Agency. ( ii) One member appointed by the Secretary of Labor from officers or employees of the Department of Labor engaged in the Secretary's activities under the Occupational Safety and Health Act of 1970 ( 29 U. S. C. 651 et seq.). ( iii) One member appointed by the Chairman of the Council on Environmental Quality from the Council or its officers or employees. ( iv) One member appointed by the Director of the National Institute for Occupational Safety and Health from officers or employees of the Institute. ( v) One member appointed by the Director of the National Institute of Environmental Health Sciences from officers or employees of the Institute. ( vi) One member appointed by the Director of the National Cancer Institute from officers or employees of the Institute. January 25, 2005 ( vii) One member appointed by the Director of the National Science Foundation from officers or employees of the Foundation. ( viii) One member appointed by the Secretary of Commerce from officers or employees of the Department of Commerce.

( B)( i) An appointed member may designate an individual to serve on the committee on the member's behalf. Such a designation may be made only with the approval of the applicable appointing authority and only if the individual is from the entity from which the member was appointed. ( ii) No individual may serve as a member of the committee for more than four years in the aggregate. If any member of the committee leaves the entity from which the member was appointed, such member may not continue as a member of the committee, and the member's position shall be considered to be vacant. A vacancy in the committee shall be filled in the same manner in which the original appointment was made. ( iii) Initial appointments to the committee shall be made not later than the 60th day after January 1, 1977. Not later than the 90th day after such date the members of the committee shall hold a meeting for the selection of a chairperson from among their number.

( C)( i) No member of the committee, or designee of such member, shall accept employment or compensation from any person subject to any requirement of this chapter or of any rule promulgated or order issued thereunder, for a period of at least 12 months after termination of service on the committee. ( ii) No person, while serving as a member of the committee, or designee of such member, may own any stocks or bonds, or have any pecuniary interest, of substantial value in any person engaged in the manufacture, processing, or distribution in commerce of any chemical substance or mixture subject to any requirement of this chapter or of any rule promulgated or order issued thereunder. ( iii) The Administrator, acting through attorneys of the Environmental Protection Agency, or the Attorney General may bring an action in the appropriate district court of the United States to restrain any violation of this subparagraph.

( D) The Administrator shall provide the committee such administrative support services as may be necessary to enable the committee to carry out its function under this subsection.

( f) Required actions Upon the receipt of  ( 1) any test data required to be submitted under this chapter, or ( 2) any other information available to the Administrator, which indicates to the Administrator that there may be a reasonable basis to conclude that a chemical substance or mixture presents or will present a significant risk of serious or widespread harm to human beings from cancer, gene mutations, or birth defects, the Administrator shall, within the 180 day period beginning on the date of the receipt of such data or information, initiate appropriate action under section 2604, 2605, or 2606 of this title to prevent or reduce to a sufficient extent such risk or publish in the Federal Register a finding that such risk is not unreasonable. For good cause shown the Administrator may extend such period for an additional period of not more than 90 days. The Administrator shall publish in the Federal Register notice of any such extension and the reasons therefor. A finding by the Administrator that a risk is not unreasonable shall be considered agency action for purposes of judicial review under chapter 7 of title 5. This subsection shall not take effect until two years after January 1, 1977.

( g) Petition for standards for the development of test data January 25, 2005 A person intending to manufacture or process a chemical substance for which notice is required under section 2604( a) of this title and who is not required under a rule under subsection ( a) of this section to conduct tests and submit data on such substance may petition the Administrator to prescribe standards for the development of test data for such substance. The Administrator shall by order either grant or deny any such petition within 60 days of its receipt. If the petition is granted, the Administrator shall prescribe such standards for such substance within 75 days of the date the petition is granted. If the petition is denied, the Administrator shall publish, subject to section 2613 of this title, in the Federal Register the reasons for such denial [ 1] So in original. Probably should be '' preceding''. January 25, 2005 ATTACHMENT 2 40 CFR 790 Procedures Governing Testing Consent Agreements and Test Rules January 25, 2005 Title 40: Protection of Environment PART 790   PROCEDURES GOVERNING TESTING CONSENT AGREEMENTS AND TEST RULES Subpart A   General Provisions § 790.1 Scope, purpose, and authority.

( a) This part establishes procedures for gathering information, conducting negotiations, and developing and implementing test rules or consent agreements on chemical substances and mixtures under section 4 of TSCA.

( b) Section 4 of the Act authorizes EPA to require manufacturers and processors of chemical substances and mixtures to test these chemicals to determine whether they have adverse health or environmental effects. Section 4 ( a) empowers the Agency to promulgate rules which require such testing. In addition, EPA has implied authority to enter into enforceable consent agreements requiring testing where they provide procedural safeguards equivalent to those that apply where testing is conducted by rule.

( c) EPA intends to use enforceable consent agreements to accomplish testing where a consensus exists among EPA, affected manufacturers and/ or processors, and interested members of the public concerning the need for and scope of testing. If such a consensus does not exist and the Agency believes that it can make the findings specified in section 4( a), EPA will initiate proceedings to promulgate test rules which will be codified in part 799 of this chapter.

( d) Appendix A to this part presents timetables for various steps in the evaluation of chemicals under consideration for testing, the initiation and completion of negotiations to develop consent agreements, and the proposal and promulgation of test rules. All deadlines which are imposed by the Act are binding on EPA and will be observed by the Agency. The remaining deadlines represent target dates that EPA intends to meet.

[ 51 FR 23712, June 30, 1986]

§ 790.2 Applicability.

This part is applicable to manufacturers and processors of chemical substances or mixtures who are subject to the testing requirements of a consent agreement or a rule under section 4( a) of the Act. The procedures for test rules are applicable to each test rule in part 799 or this chapter unless otherwise stated in specific test rules in part 799 of this chapter.

[ 51 FR 23712, June 30, 1986]

§ 790.3 Definitions.

Terms defined in the Act and not explicitly defined herein are used with the meaning given in the Act. For the purpose of this part:

Act means the Toxic Substances Control Act, 15 U. S. C. 2601 et seq. January 25, 2005 Additive means a chemical substance that is intentionally added to another chemical substance to improve its stability or impart some other desirable quality.

Chemical means a chemical substance or mixture.

Consortium means an association of manufacturers and/ or processors who have made an agreement to jointly sponsor testing.

EPA means the U. S. Environmental Protection Agency.

Equivalence data means chemical data or biological test data intended to show that two substances or mixtures are equivalent.

Equivalent means that a chemical substance or mixture is able to represent or substitute for another in a test or series of tests, and that the data from one substance can be used to make scientific and regulatory decisions concerning the other substance.

Exemption means an exemption from a testing requirement of a test rule promulgated under section 4 of the Act and part 799 of this chapter.

Impurity means a chemical substance which is uninitentionally present with another chemical substance.

Joint sponsor means a person who sponsors testing pursuant to section 4( b)( 3)( A) of the Act.

Joint sponsorship means the sponsorship of testing by two or more persons in accordance with section 4( b)( 3)( A) of the Act.

Person means an individual, partnership, corporation, association, scientific or academic establishment, or organizational unit thereof, and any other legal entity.

Principal sponsor means an individual sponsor or the joint sponsor who assumes primary responsibility for the direction of a study and for oral and written communication with EPA.

Protocol means the plan and procedures which are to be followed in conducting a test.

Reimbursement period refers to a period that begins when the data from the last non duplicative test to be completed under a test rule are submitted to EPA and ends after an amount of time equal to that which had been required to develop data or after five years, whichever is later.

Sponsor means the person or persons who design, direct and finance the testing of a substance or mixture.

Test substance means the form of chemical substance or mixture that is specified for use in testing.

[ 49 FR 39782, Oct. 10, 1984, as amended at 51 FR 23712, June 30, 1986]

§ 790.5 Submission of information. January 25, 2005 ( a) All submissions to EPA under this part must bear the Code of Federal Regulations ( CFR) section number of the subject chemical test rule, or indicate the identity of the consent agreement. For all submissions under this part, six copies must be provided to EPA.

( b) Submissions containing both confidential business information or non confidential business information must be addressed to the Document Control Office ( 7407), Office of Pollution Prevention and Toxics, U. S. Environmental Protection Agency, Room G   099, 1200 Pennsylvania Ave., NW., Washington, DC 20460, ATTN: TSCA Section 4.

[ 50 FR 20656, May 17, 1985, as amended at 51 FR 23712, June 30, 1986; 58 FR 34205, June 23, 1993; 60 FR 31922, June 19, 1995; 60 FR 34466, July 3, 1995]

§ 790.7 Confidentiality.

( a) Any person subject to the requirements of a consent agreement or a test rule under section 4 of the Act may assert a claim of confidentiality for certain information submitted to EPA in response to the consent agreement or the test rule. Any information claimed as confidential will be treated in accordance with the procedures in part 2 of this title and section 14 of the Act. Failure to assert a claim of confidentiality at the time the information is submitted will result in the information being made available to the public without further notice to the submitter.

( b) A claim of confidentiality must be asserted by circling or otherwise marking the specific information claimed as confidential and designating it with the words " confidential business information," " trade secret," or another appropriate phrase indicating its confidential character.

( c) If a person asserts a claim of confidentiality for study plan information described in § § 790.50( c)( 1)( iii)( D), ( iv), ( v), and ( vi) and 790.62( b)( 6), ( 7), ( 8), ( 9), and ( 10), the person must provide a detailed written substantiation of the claim by answering the questions in this paragraph. Failure to provide written substantiation at the time the study plan information is submitted will be considered a waiver of the claim of confidentiality, and the study plan information will be disclosed to the public without further notice.

( 1) Would disclosure of the study plan information disclose processes used in the manufacture or processing of a chemical substance or mixture? Describe how this would occur.

( 2) Would disclosure of the study plan information disclose the portion of a mixture comprised by any of the substances in the mixture? Describe how this would occur.

( 3) What harmful effects to your competitive position, if any, do you think would result from disclosure of this information? How would a competitor use such information? How substantial would the harmful effects be? What is the causal relationship between disclosure and the harmful effects?

( 4) For what period of time should confidential treatment be given? Until a specific date, the occurrence of a specific event, or permanently? Why?

( 5) What measures have you taken to guard against disclosure of this information to others? January 25, 2005 ( 6) To what extent has this information been disclosed to others? What precautions have been taken in connection with such disclosures?

( 7) Has this information been disclosed to the public in any forms? Describe the circumstances.

( 8) Has the information been disclosed in a patent?

( 9) Has EPA, another Federal agency, or any Federal court made any pertinent confidentiality determination regarding this information? If so, copies of such determinations must be included in the substantiation.

( d) If the substantiation provided under paragraph ( c) of this section contains information which the submitter considers confidential, the submitter must assert a separate claim of confidentiality for that information at the time of submission in accordance with paragraph ( b) of this section. [ 49 FR 39782, Oct. 10, 1984, as amended at 51 FR 23713, June 30, 1986]

Subpart B   Procedures for Developing Consent Agreements and Test Rules Source: 51 FR 23713, June 30, 1986, unless otherwise noted.

§ 790.20 Recommendation and designation of testing candidates by the ITC.

( a) Recommendations with intent to designate. The ITC has advised EPA that it will discharge its responsibilities under section 4( e) of the Act in the following manner:

( 1) When the ITC identifies a chemical substance or mixture that it believes should receive expedited consideration by EPA for testing, the ITC may add the substance or mixture to its list of chemicals recommended for testing and include a statement that the ITC intends to designate the substance or mixture for action by EPA in accordance with section 4( e)( 1)( B) of the Act.

( 2) Chemical substances or mixtures selected for expedited review under paragraph ( a)( 1) of this section may, at a later time, be designated for EPA action within 12 months of such designation. The ITC's subsequent decision would be based on the ITC's review of TSCA sections 8( a) and 8( d) data and other relevant information.

( 3) Where the ITC concludes that a substance or mixture warrants testing consideration but that expedited EPA review of testing needs is not justified, the ITC will add the substance or mixture to its list of testing recommendations without expressing an intent to designate the substance or mixture for EPA action in accordance with section 4( e)( 1)( B) of the Act.

( 4) The ITC reserves its right to designate any chemical that it determines the Agency should, within 12 months of the date first designated, initiate a proceeding under section 4( a) of the Act.

( b) EPA consideration of ITC recommendations. ( 1) Where a substance or mixture is designated for EPA action under section 4( e)( 1)( B) of the Act, the Agency will take either one of the following actions within 12 months after receiving the ITC designation:

( i) Initiate rulemaking proceedings under section 4( a) of the Act. January 25, 2005 ( ii) Publish a Federal Register notice explaining the Agency's reasons for not initiating such rulemaking proceedings. EPA may conclude that rulemaking proceedings under section 4( a) of the Act are unnecessary if it determines that the findings specified in section 4( a) of the Act cannot be made or if the Agency has entered into a consent agreement requiring testing in accordance with the provisions of this subpart.

( 2) Where a substance or mixture has been recommended for testing by the ITC without an intent to designate, EPA will use its best efforts to act on the ITC's recommendations as rapidly as possible consistent with its other priorities and responsiblities. EPA may respond to the ITC's recommendations either by:

( i) Initiating rulemaking proceedings under section 4( a) of the Act.

( ii) Publishing a Federal Register notice explaining the Agency's reasons for concluding that testing is unnecessary.

( iii) Entering into a consent agreement in accordance with this subpart. § 790.22 Procedures for gathering information and negotiating consent agreements on chemicals which the ITC has recommended for testing with an intent to designate.

( a) Preliminary EPA evaluation. Following receipt of an ITC report containing a recommendation with an intent to designate, EPA will use the following procedure for completing a preliminary evaluation of testing needs. Appendix A 1 to this part presents the schedule that EPA intends to follow for this purpose.

( 1) EPA will publish the ITC report in the Federal Register and announce that interested persons have 30 days to submit comments on the ITC's testing recommendations.

( 2) EPA will publish a Federal Register notice adding all ITC recommended chemicals to the automatic reporting provisions of its rules under sections 8( a) and 8( d) of the Act ( 40 CFR parts 712 and 716).

( 3) EPA will hold a public " focus meeting" to discuss the ITC's testing recommendations and obtain comments and information from interested parties.

( 4) EPA will evaluate submissions received under the sections 8( a) and 8( d) reporting requirements, comments filed on the ITC's recommendations, and other information and data compiled by the Agency.

( 5) EPA will make a preliminary staff determination of the need for testing and, where testing appears warranted, will tentatively select the studies to be performed.

( 6) EPA will hold a public meeting to announce its preliminary testing determinations.

( b) Negotiation procedures for consent agreements. Where EPA believes that testing is necessary, the Agency will explore whether a consent agreement can be negotiated that satisfies the testing needs identified by the Agency. EPA will use the following procedures for negotiating, formulating and accepting consent agreements. Appendix A 1 to this part presents the schedule that EPA intends to follow for this purpose. January 25, 2005 ( 1) In the Federal Register notice described in paragraph ( a)( 1) of this section, EPA will explain its procedures and timetable for negotiating consent agreements and invite persons interested in participating in or monitoring negotiations to contact the Agency in writing.

( 2) Persons who respond to EPA's notice by the announced date of the Agency's course setting meeting will be deemed " interested parties" for purposes of any negotiations that EPA conducts.

( 3) Following the course setting meeting announcing EPA's preliminary testing determinations, the Agency will meet with manufacturers, processors and other interested parties for the purpose of attempting to negotiate a consent agreement. To facilitate attendance at these meetings, EPA will contact all interested parties who have expressed a desire to participate in or monitor negotiations under paragraph ( b)( 2) of this section and advise them of meeting dates.

( 4) All negotiating meetings will be open to members of the public. The minutes of each meeting will be prepared by EPA. Meeting minutes, testing proposals, background documents and other materials exchanged at or prepared for negotiating meetings will be included in the public file established by EPA on each ITC recommended chemical. Materials in this file will be made available for inspection in the OPPTS Reading Room during EPA working hours.

( 5) While negotiations are underway, EPA will promptly circulate meeting minutes, testing proposals, correspondence and other relevant materials to interested parties who expressed a desire to participate in or monitor negotiations pursuant to paragraph ( b)( 2) of this section.

( 6) As negotiations progress, EPA will make a tentative decision either to proceed with formulation of a consent agreement or to initiate rulemaking. EPA will terminate negotiations after 10 weeks and proceed with rulemaking unless negotiations are likely to result in a draft consent agreement within 4 additional weeks. By the end of this 4 week period, EPA either will have prepared a draft consent agreement reflecting the apparent consensus of the parties or will terminate negotiations and proceed with rulemaking. If EPA decides to proceed with rulemaking, no further opportunity for negotiations will be provided. EPA will promptly send written notice to all interested parties of the termination of negotiations.

( 7) Where EPA prepares a draft consent agreement, it will be circulated for comment to all interested parties who expressed a desire to participate in or monitor negotiations under paragraph ( b)( 2) of this section. A period of 4 weeks will be provided for submitting comments or written objections under § 790.24( a).

( 8) If necessary, EPA will hold a public meeting to discuss comments on the draft consent agreement and to determine whether revisions in the agreement are appropriate.

( 9) Where a consensus exists concerning the contents of a draft consent agreement, it will be circulated to EPA management and interested parties for final approval and signature.

( 10) Upon final approval of a consent agreement, EPA will publish a Federal Register notice that summarizes the agreement, describes the ITC recommendations for the test substance, outlines the chemical's use and exposure characteristics, and explains the background, objectives and rationale of the testing to be conducted, and codifies in subpart C of part 799 the name of the substance( s) to be tested and the citation to the Federal Register notice of the agreement. January 25, 2005 § 790.24 Criteria for determining whether a consensus exists concerning the provisions of a draft consent agreement.

( a) EPA will enter into consent agreements only where there is a consensus among the Agency, one or more manufacturers and/ or processors who agree to conduct or sponsor the testing, and all other interested parties who identify themselves in accordance with § 790.22( b)( 2). EPA will not enter into a consent agreement in either of the following circumstances:

( 1) EPA and affected manufacturers and/ or processors cannot reach a consensus on the testing requirements or other provisions to be included in the consent agreement.

( 2) A draft consent agreement is considered inadequate by other interested parties who, pursuant to § 790.22( b)( 2), have asked to participate in or monitor negotiations; and these parties have submitted timely written objections to the draft consent agreement which provide a specific explanation of the grounds on which the draft agreement is objectionable.

( b) EPA may reject objections described in paragraph ( a)( 2) of this section only where the Agency concludes the objections are either:

( 1) Not made in good faith.

( 2) Untimely.

( 3) Do not involve the adequacy of the proposed testing program or other features of the agreement that may affect EPA's ability to fulfill the goals and purposes of the Act.

( 4) Not accompanied by a specific explanation of the grounds on which the draft agreement is considered objectionable.

( c) The unwillingness of some manufacturers and/ or processors of a prospective test chemical to sign the draft consent agreement does not, in itself, establish a lack of consensus if EPA concludes that those manufacturers and/ or processors who are prepared to sign the agreement are capable of accomplishing the testing to be required and that the draft agreement will achieve the purposes of the Act in all other respects.

§ 790.26 Initiation and completion of rulemaking proceedings on ITC designated chemicals.

( a) Where EPA concludes that a consensus does not exist concerning the provisions of a draft consent agreement and that the findings specified by section 4( a) can be made, the Agency will proceed with rulemaking under section 4( a) of TSCA.

( b) When EPA decides to proceed with rulemaking under paragraph ( a) of this section, the Agency intends to publish a rulemaking proposal and a final rule or a notice terminating the rulemaking proceeding in accordance with the schedule specified in Appendix A 1 to this part.

1Editorial Note: Appendix A appears at the end of subpart E.

( c) Where the testing recommendations of the ITC raise unusually complex and novel issues that require additional Agency review and opportunity for public comment, the Agency may publish an January 25, 2005 Advance Notice of Proposed Rulemaking ( ANPR). The schedule that EPA intends to follow for rulemaking proceedings initiated by publication of an ANPR is presented in appendix A 1 to this part.

§ 790.28 Procedures for developing consent agreements and/ or test rules for chemicals that have not been designated or recommended with intent to designate by the ITC.

( a) Where EPA believes that testing is needed, it may also develop consent agreements and/ or test rules on chemical substances or mixtures that either:

( 1) Have been recommended but not " recommended with intent to designate" by the ITC.

( 2) Have been selected for testing consideration by EPA on its own initiative.

( b) When EPA wishes to initiate negotiations concerning chemicals described in paragraph ( a) of this section, it will publish a Federal Register notice describing its tentative evaluation of testing needs, announcing a date for a public course setting meeting, and inviting persons interested in participating in or monitoring negotiations to contact the Agency in writing. Any negotiations that EPA conducts will conform to the procedures specified in § 790.22( b) and, to the extent feasible, will follow the schedules presented in appendix A 1 to this part.

( c) EPA will enter into consent agreements on chemicals described in paragraph ( a) of this section only if there is a consensus among EPA, affected manufacturers and/ or processors, and any other persons who have asked to participate in or monitor negotiations. In determining whether such a consensus exists, EPA will employ the criteria specified in § 790.24. In the absence of consensus, EPA will initiate rulemaking if it concludes that the findings specified in section 4( a) of the Act can be made. The schedule for initiating and completing such rulemaking proceedings will, to the extent feasible, follow the schedule specified in appendix A 1 to this part.

Subpart C   Implementation, Enforcement, and Modification of Test Rules Source: 50 FR 20657, May 17, 1985, unless otherwise noted. Redesignated at 51 FR 23713, June 30, 1986.

§ 790.40 Promulgation of test rules.

( a) If EPA determines that it is necessary to test a chemical substance or mixture by rule under section 4 of the Act, it will promulgate a test rule in part 799 of this chapter.

( b) EPA will promulgate specific test rules in part 799 of this chapter either by a single phase rulemaking procedure or by a two phase rulemaking procedure.

( 1) Under single phase test rule development, EPA will promulgate a test rule in part 799 of this chapter through a notice and comment rulemaking which specifies the following:

( i) Identification of the chemical for which testing is required under the rule.

( ii) The health or environmental effect or effects or other characteristics for which testing is being required. January 25, 2005 ( iii) Which test substance( s) must be tested.

( iv) Standards for the development of test data.

( v) The EPA Good Laboratory Practice requirements for the required testing.

( vi) Schedule for submission of interim reports and/ or final reports to EPA.

( vii) Who must submit either letters of intent to conduct testing or exemption applications.

( viii) What types of data EPA will examine in determining equivalence if more than one test substance is to be tested.

( 2) Under two phase test rule development, EPA will promulgate a Phase I test rule in part 799 of this chapter through a notice and comment rulemaking which specifies the following:

( i) Identification of the chemical for which testing is required under the rule.

( ii) The health or environmental effect or effects or other characteristics for which testing is being required.

( iii) Which test substance( s) must be tested.

( iv) A reference to appropriate guidelines for the development of test data.

( v) The EPA Good Laboratory Practice requirements for the required testing.

( vi) Who must submit either letters of intent to conduct testing and study plans, or exemption applications.

( vii) What types of data EPA will examine in determining equivalence if more than one test substance is to be tested.

( 3) Under two phase test rule development, test standards and schedules will be developed in a second phase of rulemaking as described in § § 790.50 and 790.52.

[ 50 FR 20657, May 17, 1985. Redesignated and amended at 51 FR 23713, June 30, 1986; 54 FR 36313, Sept. 1, 1989]

§ 790.42 Persons subject to a test rule.