( a) Each test rule described in § 790.40 will specify whether manufacturers, processors, or both are subject to the requirement for testing of the subject chemical under section 4( b)( 3)( B) of the Act and will indicate who will be required to submit letters of intent to conduct testing.

( 1) If testing is being required to allow evaluation of risks:

( i) Primarily associated with manufacture of the chemical, or January 25, 2005 ( ii) Associated with both manufacturer and processing of the chemical, or ( iii) Associated with distribution in commerce, use, and/ or disposal activities concerning the chemical, each manufacturer of the chemical will be subject and must comply with the requirements of the test rule.

( 2) While legally subject to the test rule in circumstances described in paragraphs ( a)( 1) ( ii) and ( iii) of this section, processors of the chemical must comply with the requirements of the test rule only if processors are directed to do so in a subsequent notice as set forth in § 790.48( b).

( 3) If testing is being required to allow evaluation of risks associated solely with processing of the chemical, processors will be subject and must comply with the requirements of the test rule.

( 4) While legally subject to the test rule in circumstances described in paragraph ( a)( 1) of this section, persons who manufacture less than 500 kg ( 1,100 lb) of the chemical annually during the period from the effective date of the test rule to the end of the reimbursement period, must comply with the requirements of the test rule only if such manufacturers are directed to do so in a subsequent notice as set forth in § 790.48, or if directed to do so in a particular test rule.

( 5) While legally subject to the test rule in circumstances described in paragraph ( a)( 1) of this section, persons who manufacture small quantities of the chemical solely for research and development ( meaning quantities that are not greater than those necessary for purposes of scientific experimentation or analysis or chemical research on, or analysis of, such chemical or another chemical, including such research or analysis for development of a product) from the effective date of the test rule to the end of the reimbursement period, must comply with the requirements of the test rule only if such manufacturers are directed to do so in subsequent notice set forth in § 790.48, or if directed to do so in a particular test rule.

( 6) If testing is being required to allow evaluation of risks associated primarily with manufacture of a chemical for research and development ( R & D) purposes, manufacturers of the chemical for R & D will be subject and must comply with the requirements of the test rule.

( b) [ Reserved]

[ 50 FR 20657, May 17, 1985. Redesignated at 51 FR 23713, June 30, 1986, and amended at 55 FR 18884, May 7, 1990]

§ 790.45 Submission of letter of intent to conduct testing or exemption application.

( a) No later than 30 days after the effective date of a test rule described in § 790.40, each person subject to that rule and required to comply with the requirements of that rule as provided in § 790.42( a) must, for each test required, either notify EPA by letter of his or her intent to conduct testing or submit to EPA an application for an exemption from testing requirements for the test.

( b) EPA will consider letters of intent to test as commitments to sponsor the tests for which they are submitted unless EPA agrees to the substitution of an exemption application in instances where more than one person indicates an intent to sponsor equivalent tests.

( c) Each letter of intent to conduct testing must include: January 25, 2005 ( 1) Identification of test rule.

( 2) Name, address, and telephone number of the firm( s) which will be sponsoring the tests.

( 3) Name, address, and telephone number of the appropriate individual to contact for further information.

( 4) For sponsors participating in a testing consortium   a list of all members of the consortium, the signature of an authorized representative of each member, and a designation of who is to serve as principal sponsor.

( 5) A list of the testing requirements for which the sponsor( s) intends to conduct tests.

( 6) If EPA is requiring testing of more than one representative substance   which test substance the sponsor( s) intends to use in each of the tests.

( d)( 1) Any person not manufacturing or processing the subject chemical as of the effective date of the test rule describing in § 790.40 or by 30 days after the effective date of the rule who, before the end of the reimbursement period, manufacturers or processes the test chemical and who is subject to and required to comply with the requirements of the test rule must submit the letter of intent to test or an exemption application required by paragraph ( a) of this section by the date manufacture or processing begins, or ( 2) When both manufacturers and processors are subject to the rule, any person not processing the subject chemical as of the effective date of the test rule described in § 790.40 or by 30 days after publication of the Federal Register notice described in § 790.48( b)( 2) who, before the end of the reimbursement period, processes the test chemical and who is required to comply with the requirements of the rule must submit the letter of intent to test or an exemption application required by § 790.48( b)( 3) of the date processing begins.

( e) Manufacturers subject to a test rule described in § 790.40 who do not submit to EPA either a letter of their intent to conduct tests or a request for an exemption from testing for each test for which testing is required in the test rule will be considered in violation of that rule beginning on the 31st day after the effective date of the test rule described in § 790.40 or on the date manufacture begins as described in paragraph ( d) of this section.

( f) Processors subject to a test rule described in § 790.40 and required to comply with the requirements of test rule pursuant to § 790.42( a)( 2) or a Federal Register notice as described in § 790.48( b)( 2) who do not submit to EPA either a letter of their intent to conduct tests or a request for an exemption for each test for which testing is required in the test rule will be considered in violation of that rule beginning on the 31st day after the effective date of the test rule described in § 790.40 or 31 days after publication of the Federal Register notice described in § 790.48( b)( 2) or on the date processing begins as described in paragraph ( d) of this section, as appropriate.

§ 790.48 Procedure if no one submits a letter of intent to conduct testing. January 25, 2005 ( a) If only manufacturers are subject to the rule. ( 1) This paragraph applies if testing is being required solely to allow evaluation of risks associated with manufacturing and the test rule described in § 790.40 states that manufacturers only are responsible for testing.

( 2) If no manufacturer subject to the test rule has notified EPA of its intent to conduct one or more of the required tests within 30 days after the effective date of the test rule described in § 790.40, EPA will notify all manufacturers, including those described in § 790.42( a)( 4) and ( a)( 5), by certified mail or by publishing a notice of this fact in the Federal Register specifying the tests for which no letter of intent has been submitted and will give such manufacturers an opportunity to take corrective action.

( 3) If no manufacturer submits a letter of intent to conduct one or more of the required tests within 30 days after receipt of the certified letter or publication of the Federal Register notice described in paragraph ( a)( 2) of this section, all manufacturers subject to the rule will be in violation of the test rule from the 31st day after receipt of the certified letter or publication of the Federal Register notice described in this paragraph.

( b) If manufacturers and processors are subject to the rule. ( 1) This paragraph applies if testing is being required to allow evaluation of risks associated with manufacturing and processing or with distribution in commerce, use, or disposal of the chemical and the test rule described in § 790.40 states that manufacturers and processors are responsible for testing.

( 2) If no manufacturer subject to the rule has notified EPA of its intent to conduct testing for one or more of the required tests within 30 days after the effective date of the test rule described in § 790.40, EPA will publish a notice in the Federal Register of this fact specifying the tests for which no letter of intent has been submitted.

( 3) No later than 30 days after the date of publication of the Federal Register notice described in paragraph ( b)( 2) of this section, each person described in § 790.40( a)( 4) and ( 5) and each person processing the subject chemical as of the effective date of the test rule described in § 790.40 or by 30 days after the date of publication of the Federal Register notice described in paragraph ( b)( 2) of this section must, for each test specified in the Federal Register notice, either notify EPA by letter of his or her intent to conduct testing or submit to EPA an application for an exemption from testing requirements for the test.

( 4) If no manufacturer or processor of the test chemical has submitted a letter of intent to conduct one or more of the required tests within 30 days after the date of publication of the Federal Register notice described in paragraph ( b)( 2) of this section, EPA will notify all manufacturers and processors by certified letter or publish a Federal Register notice of this fact specifying the tests for which no letter of intent has been submitted. This letter or Federal Register notice will give the manufacturers and processors an opportunity to take corrective action.

( 5) If no manufacturer or processor submits a letter of intent to conduct one or more of the required tests within 30 days after receipt of the certified letter or publication of the Federal Register notice described in paragraph ( b)( 4) of this section, all manufacturers and processors subject to the rule will be in violation of the test rule from the 31st day after receipt of the certified letter or publication of the Federal Register notice described in paragraph ( b)( 4) of this section. January 25, 2005 ( c) Only processors are subject to the rule. ( 1) This paragraph applies if testing is being required solely to allow evaluation of risks associated with processing and the test rule described in § 790.40 states that only processors are responsible for testing.

( 2) If no processor subject to the rule has notified EPA of its intent to conduct one or more of the required tests within 30 days after the effective date of the test rule described in § 790.40, EPA will notify all the processors by certified mail or publish a notice in the Federal Register of this fact, specifying the tests for which no letter of intent has been submitted and give the processors an opportunity to take corrective action.

( 3) If no processor submits a letter of intent to conduct one or more of the required tests within 30 days after receipt of the certified letter or publication of the Federal Register notice described in paragraph ( c)( 2) of this section, all processors subject to the rule will be in violation of the test rule from the 31st day after receipt of the certified letter or publication of the Federal Register notice described in this paragraph.

[ 50 FR 20657, May 17, 1985. Redesignated at 51 FR 23713, June 30, 1986, and amended at 55 FR 18884, May 7, 1990]

§ 790.50 Submission of study plans.

( a) Who must submit study plans. ( 1) Persons who notify EPA of their intent to conduct tests in compliance with the requirements of a single phase test rule as described in § 790.40( b)( 1) must submit study plans for those tests prior to the initiation of each of these tests, unless directed by a particular test rule or consent agreement to submit study plans at a specific time.

( 2) Persons who notify EPA of their intent to conduct tests in compliance with the requirements of a Phase I test rule as described in § 790.40( b)( 2) must submit the proposed study plans for those tests on or before 90 days after the effective date of the Phase I rule; or, for processors complying with the notice described in § 790.48( b)( 2), 90 days after the publication date of that notice; or 60 days after the date manufacture or processing begins as described in § 790.45( d), as appropriate, to the address in § 790.5( b).

( 3) Study plans must be prepared according to the requirements of this subpart B and part 792 of this chapter. Only one set of study plans should be prepared and submitted by persons who are jointly sponsoring testing.

( 4) Any person subject to a test rule may submit a study plan for any test required by the rule at any time, regardless of whether the person previously submitted an application for exemption from testing for that test.

( 5) Unless EPA has granted an extension of time for submission of proposed study plans, manufacturers who notify EPA that they intend to conduct testing in compliance with the requirements of a Phase I test rule as described in § 790.40( b)( 2) and who do not submit proposed study plans for those tests on or before 90 days after the effective date of the Phase I test rule or 60 days after the date manufacture begins as described in § 790.45( d) will be considered in violation of the test rule as if no letter of intent to test had been submitted. January 25, 2005 ( 6) Unless EPA has granted an extension of time for submission of proposed study plans, processors who notify EPA that they intend to conduct testing in compliance with the requirements of a Phase I test rule as described in § 790.40( b)( 2) and who do not submit proposed study plans for those tests on or before 90 days after the effective date of the Phase I test rule or 90 days after the publication date of the notice described in § 790.48( b)( 2), or 60 days after the date processing begins as described in § 790.45( d), as appropriate, will be considered in violation of the test rule as if no letter of intent to test had been submitted.

( b) Extensions of time for submission of study plans. ( 1) EPA may grant requests for additional time for the development of study plans on a case by case basis. Requests for additional time for study plan development must be made in writing to EPA at the address in § 790.5( b). Each extension request must state why EPA should grant the extension.

( 2) Under two phase rulemaking, extension requests must be submitted to EPA within 60 days after the effective date of the Phase I test rule as described in § 790.40( b)( 2); or for processors complying with the notice described in § 790.48( b)( 2), 60 days after the publication date of that notice; or 30 days after the date manufacture or processing begins as described in § 790.45( d), as appropriate.

( 3) EPA will notify the submitter by certified mail of EPA's decision to grant or deny an extension request.

( 4) Persons who have been granted an extension of time for submission of study plans as described in paragraph ( b)( 1) of this section and who do not submit proposed study plans in compliance with the requirements of a Phase I test rule in accordance with the new deadline granted by EPA will be considered in violation of the test rule as if no letter of intent to test had been submitted as described in § 790.45( e) and ( f).

( c) Content of study plans. ( 1) All study plans are required to contain the following information:

( i) Identity of the test rule.

( ii) The specific test requirements of that rule to be covered by the study plan.

( iii)( A) The names and addresses of the test sponsors.

( B) The names, addresses, and telephone numbers of the responsible administrative officials and project manager( s) in the principal sponsor's organization.

( C) The name, address, and telephone number of the appropriate individual to contact for oral and written communications with EPA.

( D)( 1) The names and addresses of the testing facilities and the names, addresses, and telephone numbers of the testing facilities' administrative officials and project manager( s) responsible for the testing.

( 2) Brief summaries of the training and experience of each professional involved in the study, including study director, veterinarian( s), toxicologist( s), pathologist( s), chemist( s), microbiologist( s), and laboratory assistants. January 25, 2005 ( iv) Identity and data on the chemical substance( s) being tested, including physical constants, spectral data, chemical analysis, and stability under test and storage conditions, as appropriate.

( v) Study protocol, including the rationale for any combination of test protocols; the rationale for species/ strain selection; dose selection ( and supporting data); route( s) or method( s) of exposure; description of diet to be used and its source; including nutrients and contaminants and their concentrations; for in vitro test systems, a description of culture medium and its source; and a summary of expected spontaneous chronic diseases ( including tumors), genealogy, and life span.

( vi) Schedule for initiation and completion of each short term test and of each major phase of long term tests; dates for submission of interim progress and final reports to EPA that are within the reporting deadlines specified by EPA In the final test rule.

( 2) Information required in paragraph ( c)( 1)( iii)( D) of this section is not required in proposed study plans submitted in compliance with the requirements of a Phase I test rule if the information is not available at the time of study plan submission; however, the information must be submitted before the initiation of testing.

( d) Incomplete study plans. ( 1) Upon receipt of a study plan, EPA will review the study plan to determine whether it complies with paragraph ( c) of this section. If EPA determines that the study plan does not comply with paragraph ( c) of this section, EPA will notify the submitter that the submission is incomplete and will identify the deficiencies and the steps necessary to complete the submission.

( 2) The submitter will have 15 days after the day it receives this notice to submit appropriate information to make the study plan complete.

( 3) If the submitter fails to provide appropriate information to complete a proposed study plan submitted in compliance with the requirements of a Phase I test rule on or before 15 days after receipt of the notice, the submitter will be considered in violation of the test rule as if no letter of intent to conduct the test had been submitted as described in § 790.45( e) and ( f).

( e) Amendments to study plans. Test sponsors shall submit all amendments to study plans to the Director, Office of Compliance Monitoring at the address in § 790.5( d).

[ 50 FR 20657, May 17, 1985. Redesignated and amended at 51 FR 23713, June 30, 1986; 52 FR 36569, Sept. 30, 1987; 54 FR 36313, Sept. 1, 1989; 55 FR 18884, May 7, 1990; 58 FR 34205, June 23, 1993; 60 FR 34466, July 3, 1995]

§ 790.52 Phase II test rule.

( a) If EPA determines that the proposed study plan described in § 790.50( a)( 2) complies with § 790.50( c), EPA will publish a proposed Phase II test rule in the Federal Register requesting comments on the ability of the proposed study plan to ensure that data from the test will be reliable and adequate.

( b) EPA will provide a 45 day comment period and will provide an opportunity for an oral presentation upon the request of any person. EPA may extend the comment period if it appears January 25, 2005 from the nature of the issues raised by EPA's review or from public comments that further comment is warranted.

( c) After receiving and considering public comments on the study plan, EPA will adopt, as proposed or as modified in response to EPA review and public comments, the study protocol section of the study plan, as defined by § 790.50( c)( 1)( v) of this chapter, as the test standard for the required testing, and the schedule section of the study plan, as defined by § 790.50( c)( 1)( vi) of this chapter, as the schedule for the required testing in a final Phase II test rule.

[ 50 FR 20657, May 17, 1985. Redesignated at 51 FR 23713, June 30, 1986, and amended at 52 FR 36569, Sept. 30, 1987]

§ 790.55 Modification of test standards or schedules during conduct of test.

( a) Application. Any test sponsor who wishes to modify the test schedule for the mandatory testing conditions or requirements ( i. e., " shall statements") in the test standard for any test required by a test rule must submit an application in accordance with this paragraph. Application for modification must be made in writing to EPA at the address in § 790.5( b), or by phone with written confirmation to follow within 10 working days. Applications must include an appropriate explanation and rationale for the modification. Where a test sponsor requests EPA to provide guidance or to clarify a non mandatory testing requirement ( i. e., " should statements") in a test standard, the test sponsor should submit these requests to EPA at the address in § 790.5( b).

( b) Adoption. ( 1) Where EPA concludes that the requested modification of a test standard or schedule for a test required under a test rule is appropriate, EPA will proceed in accordance with this paragraph ( b).

( 2) Where, in EPA's judgment, the requested modification of the test standard or schedule would not alter the scope of the test or significantly change the schedule for completing the test, EPA will not ask for public comment before approving the modification. EPA will notify the test sponsor by letter of EPA's approval. EPA will place copies of each application and EPA approval letter in the rulemaking record for the test rule in question. EPA will publish a notice annually in the Federal Register indicating the test standards or schedules for tests required in test rules which have been modified under this paragraph ( b)( 2) and describing the nature of the modifications. Until the Federal Register notice is published, any modification approved by EPA under this paragraph ( b)( 2) shall apply only to the test sponsor who applied for the modification under this paragraph ( a) of this section.

( 3) Where, in EPA's judgment, the requested modification of a test standard or schedule would significantly alter the scope of the test or significantly change the schedule for completing the test, EPA will publish a notice in the Federal Register requesting comment on the proposed modification. However, EPA will approve a requested modification of a test standard under paragraph ( b)( 3) of this section without first seeking public comment if EPA believes that an immediate modification to the test standard is necessary to preserve the accuracy or validity of an ongoing test. EPA may also modify a testing requirement or test condition in a test standard if EPA determines that the completion or achievement of this requirement or condition is not technically feasible. EPA may approve a test schedule extension under paragraph ( b)( 3) of this section without first seeking public comment if EPA determines, on a case by case basis, that a delay of over 12 months is not the fault of the test sponsor and is the result of unforeseen January 25, 2005 circumstances such as a lack of laboratory availability, lack of availability of suitable test substance ( e. g., 14   C labelled test substance), lack of availability of healthy test organisms, or the unexpected failure of a long term test. EPA will publish an annual notice in the Federal Register announcing the approval of any test standard modifications and test schedule extensions under paragraph ( b)( 3) of this section and provide a brief rationale of why the modification was granted.

( 4) For purposes of this paragraph ( b), a requested modification of a test standard or schedule for a test required under a test rule would alter the scope of the test or significantly change the schedule for completing the test if the modification would:

( i) Change the test species.

( ii) Change the route of administration of the test chemical.

( iii) Change the period of time during which the test species is exposed to the test chemical.

( iv) Except as provided in paragraph ( b)( 3) of this section, extend the final reporting deadline more than 12 months from the date specified in the final rule.

( c) Disapproval. Where EPA concludes that the requested modification of a test standard or schedule for a test required under a test rule is not appropriate, EPA will so notify the test sponsor in writing.

( d) Timing. ( 1) Test sponsors should submit all applications for test schedule modifications at least 60 days before the reporting deadline for the test in question.

( 2) EPA will not normally approve any test schedule extensions submitted less than 30 days before the reporting deadline for the test in question.

( 3) Except as provided in paragraph ( b)( 3) of this section, EPA may grant extensions for up to 1 year but will normally limit extensions to a period of time equal to the in life portion of the test plus 60 days.

( 4) EPA will normally approve only one deadline extension for each test.

( 5) Test sponsors should submit requests for test standard modifications as soon as they determine that the test cannot be successfully completed according to the test standard specified in the rule.

[ 50 FR 20657, May 17, 1985. Redesignated at 51 FR 23713, June 30, 1986, and amended at 52 FR 36571, Sept. 30, 1987; 54 FR 36314, Sept. 1, 1989; 60 FR 34466, July 3, 1995]

§ 790.59 Failure to comply with a test rule.

( a) Persons who notified EPA of their intent to conduct a test required in a test rule in part 799 of this chapter and who fail to conduct the test in accordance with the test standards and schedules adopted in the test rule, or as modified in accordance with § 790.55, will be in violation of the rule. January 25, 2005 ( b) Any person who fails or refuses to comply with any aspect of this part or a test rule under part 799 of this chapter is in violation of section 15 of the Act. EPA will treat violations of the Good Laboratory Practice standards as indicated in § 792.17 of this chapter.

Subpart D   Implementation, Enforcement and Modification of Consent Agreements Source: 51 FR 23715, June 30, 1986, unless otherwise noted.

§ 790.60 Contents of consent agreements.

( a) Standard provisions. All consent agreements will contain the following provisions:

( 1) Identification of the chemical( s) to be tested.

( 2) The health effects, environmental effects and/ or other characteristics for which testing will be required.

( 3) The names and addresses of each manufacturer and/ or processor who will sign the agreement.

( 4) The name and address of the manufacturer, processor or other entity who has agreed to act as the principal test sponsor.

( 5) The technical or commercial grade, level of purity or other characteristics of the test substances( s) or mixture( s).

( 6) Standards for the development of test data.

( 7) A requirement that testing will be conducted in accordance with the EPA Good Laboratory Practice ( GLP) regulations ( 40 CFR part 792).

( 8) Schedules with reasonable deadlines for submitting interim progress and/ or final reports to EPA.

( 9) A requirement that the principal sponsor will submit a study plan to EPA in accordance with § 790.62.

( 10) A statement that the results of testing conducted pursuant to the consent agreement will be announced to the public in accordance with the procedures specified in section 4( d) of the Act and that the disclosure of data generated by such testing will be governed by section 14( b) of the Act.

( 11) A requirement that the manufacturers and/ or processors signing the consent agreement will comply with the notification requirements of section 12( b)( 1) of the Act and part 707 of this chapter if they export or intend to export the substance or mixture for which the submission of data is required under the agreement and a statement that any other person who exports or intends to export such substance or mixture is subject to the above cited export notification requirements. January 25, 2005 ( 12) A requirement that, in the event EPA promulgates a significant new use rule applicable to the test chemical under section 5( a)( 2), the consent agreement will have the status of a test rule for purposes of section 5( b)( 1)( A) and manufacturers and/ or processors signing the agreement will comply with the data submission requirements imposed by that provision.

( 13) A statement that each manufacturer and/ or processor signing the agreement agrees that violation of its requirements will constitute a " prohibited act" under section 15( 1) of the Act and will trigger all provisions of TSCA applicable to a violation of section 15.

( 14) A statement that, in the event one or more provisions of the agreement are determined to be unenforceable by a court, the remainder of the agreement would not be presumed to be valid and EPA will then either initiate a rulemaking proceeding or publish in the Federal Register the Administrator's reason for not initiating such a proceeding.

( 15) A statement that the Agency may conduct laboratory inspections and/ or study audits of the testing being conducted pursuant to the consent agreement in accordance with the authority and procedures contained in section 11 of the Act.

( 16) A statement that EPA acceptance of a consent agreement constitutes " final agency action" for purposes of 5 U. S. C. 704.

( 17) Any other requirements that the parties agree are necessary to achieve the purposes of the Act.

( b) Contents of standards for the development of data. The standards for the development of the data included in consent agreements will be based on the TSCA test guidelines in 40 CFR parts 796, 797, and 798, the Organization for Economic Cooperation and Development ( OECD) test guidelines, the EPA pesticide assessment guidelines published by The National Technical Information Service ( NTIS), or other suitable test methodologies. During the negotiation of consent agreements, EPA will initially propose suitable test guidelines as the required test standards; manufacturers and processors or other interested parties may then suggest alternative methodologies or modifications to the Agency's proposed guidelines. These alternative methodologies or modifications will be adopted only where, in the judgment of EPA, they will develop at least equally reliable and adequate data on the chemical substance or mixture subject to the agreement.

( c) Statement of rationale for consent agreement. EPA will prepare a written explanation of the basis for each consent agreement. This document will summarize the agreement, describe any ITC testing recommendations for the chemical involved, outline the chemical's use and exposure characteristics, and explain the objectives of the testing to be conducted and the rationale for the specific studies selected. This document will be published in the Federal Register and, for ITC designated chemicals, will constitute the statement of EPA's reasons for not initiating rulemaking required by section 4( e)( 1)( B) of the Act.

[ 51 FR 23715, June 30, 1986, as amended at 54 FR 36314, Sept. 1, 1989]

§ 790.62 Submission of study plans and conduct of testing. January 25, 2005 ( a) Timing of submission. The principal sponsor of testing conducted pursuant to a consent agreement shall submit a study plan no later than 45 days prior to the initiation of testing.

( b) Content of study plans. All study plans are required to contain the following information:

( 1) Identity of the consent agreement under which testing will be performed.

( 2) The specific test requirements to be covered by the study plan.

( 3) The name and address of the principal test sponsor.

( 4) The names, addresses, and telephone numbers of the responsible administrative official[ s] and project manager[ s] in the principal sponsor's organization.

( 5) The names, addresses, and telephone numbers of the technical contacts at each manufacturer and/ or processor subject to the agreement.

( 6) The names and addresses of the testing facilities responsible for the testing and the names, addresses, and telephone numbers of the administrative officials[ s] and project manager[ s] assigned to oversee the testing program at these facilities.

( 7) Brief summaries of the training and experience of each professional involved in the study, including study director, veterinarian[ s], toxicologist[ s], pathologist[ s], chemist[ s], microbiologist[ s], and laboratory assistants.

( 8) Identity and supporting data on the chemical substance[ s] being tested, including physical constants, spectral data, chemical analysis, and stability under test and storage conditions, as appropriate.

( 9) Study protocol, including the rationale for any combination of test protocols; the rationale for species/ strain selection; dose selection ( and supporting data); route( s) or method( s) of exposure; description of diet to be used and its source, including nutrients and contaminants and their concentrations; for in vitro test systems, a description of culture medium and its source; and a summary of expected spontaneous chronic diseases ( including tumors), genealogy, and life span.

( 10) A schedule, with reasonable timeables and deadlines, for initiation and completion of each short term test and of each major phases of long term tests, and submission of interim progress and/ or final reports to EPA.

( c) Review and modification. ( 1) Upon receipt of a study plan, EPA will review it to determine whether it complies with paragraph ( b) of this section. If EPA determines that the study plan does not comply with paragraph ( b) of this section, EPA will notify the submitter that the plan is incomplete and will identify the deficiencies and the steps necessary to complete the plan. It is the responsibility of the test sponsor to review the study protocols to determine if they comply with all the mandatory testing conditions and requirements in the test standards ( i. e., " shall statements").

( 2) The submitter will have 15 days after the day it receives a notice under paragraph ( c)( 1) of this section to submit appropriate information to make the study plan complete. January 25, 2005 ( 3) If the submitter fails to provide appropriate information to complete a study plan within 15 days after having received a notice under paragraph ( c)( 1) of this section, the submitter will be considered to be in violation of the consent agreement and subject to enforcement proceedings pursuant to § 790.65 ( c) and ( d).

( 4) The test sponsor shall submit any amendments to study plans to EPA at the address specified in § 790.5( b).

( d) Functions of the principal test sponsor. When testing is being conducted pursuant to a consent agreement, the principal test sponsor will be responsible for submitting interim progress and final reports to EPA, informing the Agency of any proposed changes in standards for the development of data, study plans or testing schedules, and communicating with the Agency about laboratory inspections and other matters affecting the progress of testing.

[ 51 FR 23715, June 30, 1986, as amended at 54 FR 36314, Sept. 1, 1989; 60 FR 34466, July 3, 1995] § 790.65 Failure to comply with a consent agreement.

( a) Manufacturers and/ or processors who have signed a consent agreement and who fail to comply with the test requirements, test standards, GLP regulations, schedules, or other provisions contained in the consent agreement, or in modifications to the agreement adopted pursuant to § 790.68, will be in violation of the consent agreement.

( b) The Agency considers failure to comply with any aspect of a consent agreement to be a " prohibited act" under section 15 of TSCA, subject to all of the provisions of the Act applicable to violations of section 15. Section 15( 1) of TSCA makes it unlawful for any person to fail or refuse to comply with any rule or order issued under section 4. Consent agreements adopted pursuant to this part are " orders issued under section 4" for purposes of section 15( 1) of TSCA.

( c) Manufacturers and/ or processors who violate consent agreements are subject to criminal and/ or civil liability. Under the penalty provisions of section 16 of TSCA, such firms could be subject to a civil penalty of up to $ 25,000 per violation with each day in violation constituting a separate violation of section 15. Intentional violations could lead to the imposition of criminal penalties of up to $ 25,000 for each day of violation and imprisonment for up to one year. In addition, EPA could invoke the remedies available under section 17 of TSCA, including seeking an injunction to compel adherence to the requirements of the consent agreement.

( d) Noncompliance with a consent agreement will constitute conduct " in violation of this Act" under section 20( a)( 1) of TSCA. Thus, failure to comply with the requirements of a consent agreement could result in a citizens' civil action under section 20( a)( 1) of TSCA.

§ 790.68 Modification of consent agreements.

( a) Changes in the scope of testing. ( 1) Manufacturers or processors subject to a consent agreement, other persons or EPA may seek modifications in the scope of testing performed under the consent agreement. If, upon receiving a request for modification, EPA determines that new issues have been raised that warrant reconsideration of the scope of testing, or if EPA determines on its own that such reconsideration is appropriate, EPA will publish a Federal Register notice describing the proposed modification and soliciting public comment. If, based on the comments January 25, 2005 received, EPA concludes that differences of opinion may exist about the proposed modification, EPA will establish a schedule for conducting negotiations and invite parties who wish to participate in or monitor these negotiations to contact the Agency in writing. Any negotiations that EPA conducts will conform to the procedures specified in § 790.22( b).

( 2) The scope of testing required by a consent agreement will be modified only where there is a consensus concerning the modified testing requirements among EPA, affected manufacturers and/ or processors, and other persons who have asked to participate in or monitor negotiations under paragraph ( a)( 1) of this section. In determining whether a consensus exists, EPA will employ the criteria specified in § 790.24. In the absence of consensus, EPA may initiate rulemaking under section 4( a) of the Act if it concludes that any testing beyond that required by the consent agreement is necessary and that the other statutory findings required by section 4( a) can be made. While such rulemaking proceedings are underway, the consent agreement will remain in effect unless EPA finds that the testing required by the agreement is or may be unnecessary in view of the testing requirements included in EPA's proposed rule.

( b) Changes in test standards or schedules. ( 1) Any test sponsor who wishes to modify the test schedule for any test required under a consent order must submit an application in accordance with this paragraph. Application for modification must be made in writing to EPA at the address in § 790.5( b), or by phone with written confirmation to follow within 10 working days. Applications must include an appropriate explanation and rationale for the modification. EPA will consider only those applications that request modifications to mandatory testing conditions or requirements (" shall statements" in the consent order). Where a test sponsor requests EPA to provide guidance or to clarify a non mandatory testing requirement ( i. e., " should statements"), the test sponsor should submit these requests to EPA at the address in section 790.5( b).

( 2)( i) Where EPA concludes that the requested modification of a test standard or schedule for a test required under a consent agreement is appropriate, EPA will proceed in accordance with this paragraph ( b)( 2).

( ii) Where, in EPA's judgment, the requested modification of a test standard or schedule would not alter the scope of the test or significantly change the schedule for completing the test, EPA will not ask for public comment before approving the modification. EPA will notify the test sponsor, and any other persons who have signed the consent agreement, by letter of EPA's approval. EPA will place copies of each application and EPA approval letter in the administrative record maintained for the consent agreement in question. EPA will publish a notice annually in the Federal Register indicating the test standards or schedules for test required in consent agreements which have been modified under this paragraph ( b)( 2)( ii) and describing the nature of the modifications.

( iii) Where, in EPA's judgment, the requested modification of a test standard or schedule would significantly alter the scope of the test or significantly change the schedule for completing the test, EPA will publish a notice in the Federal Register requesting comment on the proposed modification. However, EPA will approve a requested modification of a test standard under paragraph ( b)( 2)( iii) of this section without first seeking public comment if EPA believes that an immediate modification to the test standard is necessary to preserve the accuracy or validity of an ongoing test. EPA also may modify a testing requirement or test condition in a test standard if EPA determines that the completion or achievement of this requirement or condition is not technically feasible. EPA may approve a requested modification of a test schedule under January 25, 2005 paragraph ( b)( 2)( iii) of this section without first seeking public comment if EPA determines, on a case by case basis, that a delay of over 12 months is not the fault of the test sponsor and is due to unforeseen circumstances such as a lack of laboratory availability, lack of availability of suitable test substance ( e. g., 14   C labelled test substance), lack of availability of healthy test organisms, or the unexpected failure of a long term test. EPA will publish an annual notice in the Federal Register announcing the approval of any test standard modifications and test scheduled extensions under paragraph ( b)( 2)( iii) of this section, and provide a brief rationale of why the modification was granted.

( iv) For purposes of this paragraph ( b)( 2), a requested modification of a test standard of schedule for a test required under a consent agreement would alter the scope of the test or significantly change the schedule for completing the test if the modification would:

( A) Change the test species.

( B) Change the route of administration of the test chemical.

( C) Change the period of time during which the test species is exposed to the test chemical.

( D) Except as provided in paragraph ( b)( 2)( iii) of this section, extend the final reporting deadline more than 12 months from the date specified in the consent order.

( 3) Where EPA concludes that the requested modification of a test standard or schedule for a test requirement under a consent agreement is not appropriate, EPA will so notify the test sponsor in writing.

( c) Timing. ( 1) Test sponsors should submit all applications for test schedule modifications at least 60 days before the reporting deadline for the test in question.

( 2) EPA will not normally approve any test schedule extensions submitted less than 30 days before the reporting deadline for the test in question.

( 3) Except as provided in paragraph ( b)( 2)( iii) of this section, EPA may grant extensions as shown necessary for up to 1 year but will normally limit extensions to a period of time equal to the in life portion of the test plus 60 days.

( 4) EPA will normally approve only one deadline extension for each test.

( 5) Test sponsors should submit requests for test standard modifications as soon as they determine that the test cannot be successfully completed according to the test standard specified in the consent order.

[ 51 FR 23715, June 30, 1986, as amended at 52 FR 36571, Sept. 30, 1987; 54 FR 36314, Sept. 1, 1989; 60 FR 34466, July 3, 1995]

Subpart E   Exemptions From Test Rules Source: 50 FR 20660, May 17, 1985, unless otherwise noted. January 25, 2005 § 790.80 Submission of exemption applications.

( a) Who should file applications. ( 1) Any manufacturer or processor subject to a test rule in part 799 of this chapter may submit an application to EPA for an exemption from performing any or all of the tests required under the test rule.

( 2) Processors will not be required to apply for an exemption or conduct testing unless EPA so specifies in a test rule or in a special Federal Register notice as described in § 790.48( b)( 2) under the following circumstances:

( i) If testing is being required to allow evaluation of risks associated with manufacturing and processing or with distribution in commerce, use, or disposal of the chemical and manufacturers do not submit notice( s) of intent to conduct the required testing; or ( ii) If testing is being required solely to allow evaluation of risks associated with processing of the chemical.

( b) When applications must be filed. ( 1) Exemption applications must be filed within 30 days after the effective date of the test rule described in § 790.40 or, if being submitted in compliance with the Federal Register notice described in § 790.48( b)( 2), within 30 days after the publication of that notice.

( 2) Exemption applications must be filed by the date manufacture or processing begins by any person not manufacturing or processing the subject chemical as of the effective date of the test rule described in § 790.40 or by 30 days after the effective date of the test rule described in § 790.40, who, before the end of the reimbursement period, manufactures or processes the test substance and who is subject to the requirement to submit either a letter of intent to test or an exemption application.

( 3) When both manufacturers and processors are subject to the rule, exemption applications must be filed by the date processing begins by any person not processing as of the effective date of the test rule described in § 790.40 or by 30 days after publication of the Federal Register notice described in § 790.48( b)( 2) who, before the end of the reimbursement period, processes the test substance and who is subject to the requirement to submit either a letter of intent to test or an exemption application.

( c) Scope of application. A person may apply for an exemption from all, or one or more, specific testing requirements in a test rule in part 799 of this chapter.

[ 50 FR 20660, May 17, 1985, as amended at 58 FR 34205, June 23, 1993]

§ 790.82 Content of exemption application.

The exemption application must contain:

( a) The identity of the test rule, the chemical identity, and the CAS No. of the test substance on which the application is based. January 25, 2005 ( b) The specific testing requirement( s) from which an exemption is sought and the basis for the exemption request.

( c) Name, address, and telephone number of applicant.

( d) Name, address, and telephone number of appropriate individual to contact for further information.

( e)( 1) If required in the test rule to establish equivalence:

( i) The chemical identity of the test substance on which the application is based.

( ii) Equivalence data specified in § 790.85.

( 2) If a test rule requires testing of a single representative substance, EPA will consider all forms of the chemical subject to that rule to be equivalent and will not require the submission of equivalence data as described in § 790.85.

[ 50 FR 20660, May 17, 1985, as amended at 54 FR 36315, Sept. 1, 1989]

§ 790.85 Submission of equivalence data.

If EPA requires in a test rule promulgated under section 4 of the Act the testing of two or more test substances which are forms of the same chemical, each exemption applicant must submit the following data:

( a) The chemical identity of each technical grade chemical substance or mixture manufactured and/ or processed by the applicant for which the exemption is sought. The exact type of identifying data required will be specified in the test rule, but may include all characteristics and properties of the applicant's substance or mixture, such as boiling point, melting point, chemical analysis ( including identification and amount of impurities), additives, spectral data, and other physical or chemical information that may be relevant in determining whether the applicant's substance or mixture is equivalent to the specific test substance.

( b) The basis for the applicant's belief that the substance or mixture is equivalent to the test substance or mixture.

( c) Any other data which exemption applicants are directed to submit in the test rule which may bear on a determination of equivalence. This may include a description of the process by which each technical grade chemical substance or mixture for which an exemption is sought is manufactured or processed prior to use or distribution in commerce by the applicant.

§ 790.87 Approval of exemption applications.

( a) EPA will conditionally approve exemption applications if:

( 1)( i) For single phase test rules, EPA has received a letter of intent to conduct the testing from which exemption is sought; January 25, 2005 ( ii) For two phase test rules, EPA has received a complete proposed study plan for the testing from which exemption is sought and has adopted the study plan, as proposed or modified, as test standards and schedules in a final Phase II test rule; and ( 2) The chemical substance or mixture with respect to which the application was submitted is equivalent to a test substance or mixture for which the required data have been or are being submitted in accordance with a test rule; and ( 3) Submission of the required test data concerning that chemical substance or mixture would be duplicative of data which have been or are being submitted to EPA in accordance with a test rule.

( b)( 1) If a single representative substance is to be tested under a test rule, EPA will consider all forms of the chemical subject to that rule to be equivalent and will contact the exemption applicant only if information is missing or unclear.

( 2) If two or more representative substances are to be tested under a test rule, EPA will evaluate equivalence claims made in each exemption application according to the criteria discussed in the test rule.

( i) If EPA finds an equivalence claim to be in error or inadequately supported, the applicant will be notified by certified mail. The applicant will be given 15 days to provide clarifying information.

( ii) Exemption applicants will be notified that equivalence has been accepted or rejected.

( c) The final Phase II test rule which adopts the study plans in two phase rulemaking, a separate Federal Register notice in single phase rulemaking, or a letter by certified mail will give exemption applicants final notice that they have received a conditional exemption. All conditional exemptions thus granted are contingent upon the test sponsors' successful completion of testing according to the specifications in the test rule.

§ 790.88 Denial of exemption application.

( a) EPA may deny any exemption application if:

( 1) EPA determines that the applicant has failed to demonstrate that the applicant's chemical is equivalent to the test substance; or ( 2) The exemption applicant fails to submit any of the information specified in § 790.82; or ( 3) The exemption applicant fails to submit any of the information specified in § 790.85 if required in the test rule; or ( 4)( i) For single phase test rules, EPA has not received a letter of intent to conduct the test for which exemption is sought; or ( ii) For two phase test rules, EPA has not received an adequate study plan for the test for which exemption is sought; or January 25, 2005 ( 5) The study sponsor( s) fails to initiate the required testing by the deadlines adopted in the test rule; or ( 6) The study sponsor( s) fails to submit data as required in the test standard and deadlines for submission of test data as adopted in the test rule or as modified in accordance with § 790.55.

( b) EPA will notify the exemption applicant by certified mail or Federal Register notice of EPA's determination that the exemption application is denied.

§ 790.90 Appeal of denial of exemption application.

( a) Within 30 days after receipt of notification that EPA has denied an application for exemption, the applicant may file an appeal with EPA.

( b) The appeal shall indicate the basis for the applicant's request for reconsideration.

( c)( 1) The applicant may also include a request for a hearing. Hearings will be held according to the procedures described in § 790.97.

( 2) Hearing requests must be in writing and must be received by EPA within 30 days of receipt of the letter or publication of the Federal Register notice described in § 790.88( b). Hearing requests must provide reasons why a hearing is necessary.

( d) If EPA determines that there are material issues of fact, then the request for a hearing will be granted. If EPA denies a hearing request, EPA will base its decision on the written submission.

( e) EPA will notify the applicant of its decision within 60 days after EPA receives the appeal described in paragraph ( a) of this section or within 60 days after completion of a hearing described in paragraph ( c) of this section.

( f) The filing of an appeal from the denial of an exemption shall not act to stay the applicant's legal obligations under a test rule promulgated under section 4 of the Act.

§ 790.93 Termination of conditional exemption.

( a) EPA shall terminate a conditional exemption if it determines that:

( 1) The test which provided the basis for approval of the exemption application has not been started by the deadlines for initiation of testing adopted in the test rule or modified in accordance with § 790.55; or ( 2) Data required by the test rule have not been generated in accordance with the test standards or submitted in accordance with the deadlines for submission of test data that were adopted in the test rule or modified in accordance with § 790.55; or ( 3) The testing has not been conducted or the data have not been generated in accordance with the Good Laboratory Practice requirements in part 792 of this chapter. January 25, 2005 ( b) If EPA determines that one or more of the criteria listed in paragraph ( a) of this section has been met, EPA will notify each holder of an affected conditional exemption by certified mail or Federal Register notice of EPA's intent to terminate that conditional exemption.

( c) Within 30 days after receipt of a letter of notification or publication of a notice in the Federal Register that EPA intends to terminate a conditional exemption, the exemption holder may submit information to rebut EPA's preliminary decision or notify EPA by letter of its intent to conduct the required test pursuant to the test standard established in the final test rule. Such a letter of intent shall contain all of the information required by § 790.45( c).

( d)( 1) The exemption holder may also include a request for a hearing. Hearings will be held in accordance with the procedures set forth in § 790.97.

( 2) Hearing requests must be in writing and must be received by EPA within 30 days after receipt of the letter or publication in the Federal Register notice described in paragraph ( b) of this section.

( e) EPA will notify the exemption holder by certified letter or by Federal Register notice of EPA's final decision concerning termination of conditional exemptions and will give instructions as to what actions the former exemption holder must take to avoid being found in violation of the test rule.

§ 790.97 Hearing procedures.

( a) Hearing requests must be in writing to EPA and must include the applicant's basis for appealing EPA's decision.

( b) If more than one applicant has requested a hearing on similar grounds, all of those appeals will be considered at the same hearing unless confidentiality claims preclude a joint hearing.

( c) EPA will notify each applicant of EPA's decision within 60 days after the hearing.

§ 790.99 Statement of financial responsibility.

Each applicant for an exemption shall submit the following sworn statement with his or her application:

I understand that if this application is granted before the reimbursement period described in section 4( c)( 3)( B) of TSCA expires, I must pay fair and equitable reimbursement to the person or persons who incurred or shared in the costs of complying with the requirement to submit data and upon whose data the granting of my application was based.

Appendix A to Subpart E of Part 790   Schedule for Developing Consent Agreements and Test Rules EPA intends to follow the schedule set forth in this Appendix to evaluate testing candidates, conduct negotiations, develop consent agreements where appropriate, and propose and promulate test rules in those instances where testing can be required under section 4( a) of TSCA but agreement cannot be reached in timely manner on a consent agreement. Where deadlines are January 25, 2005 imposed by the statute, they are binding on EPA and will be observed by the Agency. The remaining dates represent targets that EPA intends to meet.

This schedule is based on what EPA currently believes are reasonable target dates. As EPA gains experience with the process and determines the feasibility of these schedules, it may adjust the schedule accordingly. EPA will solicit public comment before implementing any changes in the schedule.

 Week \ 1\ Event  0............................. Receive ITC report, recommendation. 2............................. Publish ITC report, 8( a) and 8( d) notices, and invitation for public participation in negotiations. 3 6........................... Comment period on ITC report. 6............................. Public focus meeting. 7 14.......................... 8( a) and 8( d) reporting period. 22............................ Public meeting on course setting decision and deadline for requests to participate in negotiations. 22 30........................ Negotiations. 32............................ EPA decision point: consent agreement or test rule.  \ 1\ The dates contained in the left hand column are calculated from the date EPA receives the ITC report recommending a chemical for testing.

 Week Consent Agreement Week Test Rule  36 40.......... Comment period on 32 60 Rule preparation, consent agreement. agency review and sign off. 42............. Comment resolution 62 Publish proposed rule meeting if necessary. in Federal Register.\ 1\ 48............. Sign off consent 70 106 Agency reviews agreement and Federal comments; Register notice. preparation of final rule or no test decision, agency review and sign off.\ 1\ 50............. Publish Federal 108 Publish final rule or Register notice. no test decision in Federal Register.\ 1\  \ 1\ As stated in § 790.26, EPA may publish an Advance Notice of Proposed Rulemaking ( ANPR) where the testing recommendations of the ITC raise unusually novel and complex issues that require additional Agency review and opportunity for public comment. EPA intends to publish such ANPRs by Week 62 following receipt of the initial ITC report; to publish a proposed rule or decision not to test by Week 108; and to publish a final rule or notice terminating the rulemaking January 25, 2005 process by Week 154.

[ 51 FR 23717, June 30, 1986]

Attachment 3 Wage Rates Estimation January 25, 2005 8 Internal EPA phone call between Carol Rawie ( OPPT/ EETD/ RIB) and Carl Koch ( OPPE/ RMD/ IMB), May 3, 1994. ATTACHMENT 3 Wage Rates Estimation A. Overview Wage rates including fringe benefits and overhead for government labor and three broad industry categories of labor ( managerial, technical, and clerical) were used in this cost analysis. The labor categories and loaded wage rates were developed during previous studies. The methodology used in developing wage rates is summarized below.

LABOR CATEGORY LOADED HOURLY RATE Government GS 13, Step 1 $ 55.47 Industry Managerial Technical Clerical $ 53.82 $ 46.08 $ 24.47 B. Government The Federal government collection activity procedures described in this report are expected to be accomplished by a GS 13, Step 1, Federal full time equivalent ( FTE) employee. One FTE is equivalent to 2,080 hours per year. The 2004 cost of an FTE employee was based on the Office of Personnel Management's 2004 General Schedule Locality Rates of Pay for Washington Baltimore, DC MD VA WV ( OPM 2004).

The annual costs per FTE are derived by multiplying the annual pay rate by 1.6, the benefits multiplication factor. The multiplication factor used is recommended in EPA's Office of Policy, Planning, and Evaluation's Instructions for Preparing Information Collection Requests ( ICRs) ( June 1, 1992). The benefits multiplication factor of 1.6 includes not only benefits but also overhead. 8 See Table A 1 for the full calculation.

C. Technical, Managerial, and Clerical Labor The basic method used to derive loaded wage rates for technical, managerial, and clerical personnel is described more fully in Wage Rates for Economic Analysis of the Toxics Release Inventory Program ( Rice, 2002). January 25, 2005 9 Employer Costs for Employee Compensation, Private industry workers, Goods producing industries, white collar occupations, as published by the U. S. Department of Labor, Bureau of Labor Statistics. The December 2003 values for these series are listed in Table 11 of the Employer Costs for Employee Compensation Summary, released February 2004.

10An overhead rate of 17 percent applied to wages is used for consistency with recent EPAB economic analyses for two major rulemakings: Wage Rates for Economic Analyses of the Toxics Release Inventory Program, June 10, 2002, and the Revised Economic Analysis for the Amended Inventory Update Rule: Final Report, August 2002. In reports for an earlier SNUR ( EPAB 1999), the 17 percent was applied to wages plus fringe benefits. Applying it only to wages reduces calculated overhead. December 2003 average wages for technical, managerial, and clerical labor were taken from the Employer Costs for Employee Compensation ( ECEC) report from the Bureau of Labor Statistics ( BLS) for all goods producing, private industries. 9 The additional cost of benefits, such as paid leave and insurance (" fringe benefits"), specific to each labor category, are also taken from the same BLS series. Fringe benefit as a percentage of wage is then calculated separately for each labor category. For example, the average wage rate in December 2003 for technical labor was $ 28.36; the average fringe benefit was $ 12.90. So fringe benefit as a percentage of wage rate for technical labor was 12.90/ 28.36, or approximately 45.5 percent.

An additional loading factor of 17 percent is applied to wages for overhead. 10 This overhead loading factor is added to the benefits loading factor, and the total is then applied to the base wage to derive the fully loaded wage. The fully loaded wage for technical labor, for example, is $ 28.36*( 1+ 0.455 + 0.17) = $ 28.36*( 1.625) = $ 46.08.

Fully loaded costs for managerial and clerical labor were calculated in a similar manner. See Table A 1 for the full calculations.

D. References BLS 2004. Bureau of Labor Statistics. Employer Costs for Employee Compensation  December 2003: Private industry, goods producing workers by occupational group ( Table 11), February 24, 2004.

EPAB 1999. Economic Analysis of Expedited Significant New Use Rules for 41 Chemical Substances and Background Support Document for Economic Analysis of Significant New Use Rules. Washington, DC: U. S. EPA/ OPPT/ EETD/ EPAB, July 20, 1999. EPA Docket OPPTS OPM 2004. U. S. Office of Personnel Management. Salary Table 2004 DCB ( Washington Baltimore).

Rice 2002. Cody Rice. Wage Rates for Economic Analyses of the Toxics Release Inventory Program, Washington, DC: U. S. EPA, Office of Environmental Information, Environmental Analysis Division, June 10, 2002. January 25, 2005 Table A 1 Derivation of Loaded Wage Rates Labor Category Data Sources Uninflated wages and fringes / hour Fringe benefits as % of wage Overhead as % of wage* Fringe + Overhead factor Loaded Wage Rate before inflation Inflation factor Loaded Wage Rate ( 2003 dollars)

Date Wages $ Fringe benefits $

Technical BLS Employer Costs for Employee Compensation, Table 11. Private industry, goods producing industries, professional, specialty and technical. Dec 03. [ BLS 2004] Dec 2003 $ 28.36 $ 12.90 45.5% 17% 1.625 $ 46.09 1 $ 46.09 Managerial BLS Employer Costs for Employee Compensation, Table 11. Private industry, goods producing industries, executive,

administrative, and managerial.

Dec 03. [ BLS 2004] Dec 2003 $ 32.90 $ 15.33 46.6% 17% 1.636 $ 53.82 1 $ 53.82 Clerical BLS Employer Costs for Employee Compensation, Table 11. Private industry, goods producing industries, administrative support,

including clerical. Dec 03. [ BLS 2004] Dec 2003 $ 15.09 $ 6.81 45.1% 17% 1.621 $ 24.46 1 $ 24.46 EPA staff FTE Office of Personnel Management ( OPM) pay rates for GS 13 Step 1 for 2004. [ OPM 2004] 2004 $ 72,108 per year    1.6 $ 115,37 3 per year 1 $ 115,373 per year $ 55.47 per hour**

* An overhead rate of 17 percent applied to wages is used for consistency with recent EPAB economic analyses for two major rulemakings: Wage Rates for Economic Analyses of the Toxics Release Inventory Program, June 10, 2002, and the Revised Economic Analysis for the Amended Inventory Update Rule:

Final Report, August 2002.

** Hourly rate = Annual salary/ 2,080 hours January 25, 2005 ATTACHMENT 4 EPA Response to Comments Received on ICR # 1139.07: TSCA Existing Chemical Test Rules, Consent Orders, Test Rule Exemptions, and Voluntary Test Data Submissions January 25, 2005 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON D. C., 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES MEMORANDUM SUBJECT: Response to Comments Received on ICR # 1139.07: TSCA Existing Chemical Test Rules, Consent Orders, Test Rule Exemptions, and Voluntary Test Data Submissions FROM: James Willis, Director // s// Chemical Control Division ( 7405)

TO: Angela Hofmann, Director Regulatory Coordination Staff ( 7101)

DATE: January 26, 2005 ____________________________________________________________

BACKGROUND The data collection program covered by this ICR renewal 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.

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). This memorandum summarizes the comments submitted by ACC and SOCMA and provides EPA's responses to those comments.

COMMENTS FROM ACC/ EPA RESPONSES Comment 1. ACC claims that EPA has overstated its authority to require testing under TSCA Section 4. Specifically, ACC contends that the following statement made by EPA in Section 2( a) January 25, 2005 of the ICR Supporting Statement ( Need/ Authority for the Collection) enlarges the actual scope of EPA's authority under Section 4.

" Once the Agency has made a finding under TSCA section 4( a)( 1), EPA may require any type of health or environmental effects testing necessary to address unanswered questions about the effects of the chemical substance. EPA need not limit the scope of testing required to the factual basis for the 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.

ACC contends that, although EPA is not strictly required to limit testing requirements to the factual basis for its findings, it must nevertheless ensure that any such requirements are " relevant" to filling the perceived data gap.

In addition, ACC noted that EPA's Final Statement on the " B" policy states that the Agency would consider frequency, level and duration of exposure when making the " sufficiency of data" and " necessity of testing" findings under TSCA Section 4( a)( 1)( A) and ( B). ACC commented that, to their knowledge, EPA has never made such a consideration, yet these very issues have a significant impact on the burden of testing programs required under Section 4.

EPA Response 1. EPA disagrees with ACC's comment that it has misinterpreted its authority under TSCA section 4. Since the 1993 publication of its final policy for exposure based findings under TSCA section 4 (" B policy"), EPA has consistently taken the position that TSCA authorizes EPA to require any type of health or environmental effects testing necessary to address unanswered questions about the effects of a chemical substance ( 58 FR 28736, May 14, 1993, see also, e. g., 69 FR 22402, 22404, April 26, 2004). The Agency need not limit the scope of testing required to the factual basis for its 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 a 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. Id.

TSCA section 4( a) states: ( 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 January 25, 2005 ( 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 * * * 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. 15 U. S. C. 2603( a).

Clearly, if EPA were simply to make a 4( a)( 1)( A)( i) or 4( a)( 1)( B)( i) finding, it could not on that basis alone proceed to require any type of health or environmental effects testing it pleased. As stated in the B policy ( 58 FR 28736, 28738, May 14, 1993), the final paragraph of section 4( a) sets out EPA's authority to require testing once the Agency has made a finding under section 4( a)( 1)( A) or ( B). The directive of this final paragraph clearly relates to the " data insufficiency" and " testing is necessary" findings of sections 4( a)( 1)( A)( ii) and ( iii) and ( B)( ii) and ( iii); it bears no dependence on or other relationship to the findings under either subsection 4( a)( 1)( A)( i) or ( B)( i).

In addition, if Congress had intended that the testing required under TSCA section 4 be related to the basis for an 4( a)( 1)( A)( i) or 4( a)( 1)( B)( i) finding, it is reasonable to conclude that Congress would have used the word " or" instead of " and" when directing the Administrator to require testing " to develop data with respect to the health and environmental effects***" in the final paragraph of section 4( a). However, the explicit choice of the word " and" in this final paragraph indicates that Congress authorized EPA to require health and environmental effects testing independent of the basis for a 4( a)( 1)( A)( i) or 4( a)( 1)( B)( i) finding. Indeed, EPA has consistently interpreted the " testing is necessary" finding under TSCA sections 4( a)( 1)( A)( iii) and ( B)( iii) to mean that EPA may require any health or environmental effects testing for which data are insufficient and which EPA believes are " capable of developing the necessary information." See 45 FR 48524, 48530, July 18, 1980. Further support for EPA's position on this issue is provided in EPA's B policy ( 58 FR 28736, 28738 39, May 14, 1993).

ACC suggests that EPA must " ensure that any such [ testing] requirements are ` relevant' to filling the perceived [ endpoint specific] data gap." The statute indicates, however, that testing requirements must be relevant to the more general determination that activities associated with the substance do or do not present an unreasonable risk to health or the environment.

The Agency disagrees with ACC's suggestion that information regarding frequency, level, and duration of exposure is relevant to the ICR. However, EPA does in fact use such information in January 25, 2005 11 Polymers, which typically exhibit low toxicity due to poor absorption because of their physical size ( e. g., high molecular weight) and other characteristics, are unlikely to present significant risk concerns. making decisions regarding testing under TSCA section 4. For example, information of this nature, when available, may result in the Agency's deciding not to propose testing upfront. Where EPA does not have information of this sort pre proposal, but receives it post proposal, it generally would not result in the Agency's dropping a chemical from the rulemaking because such information is often incomplete, for example it represents an industry segment rather than the entire industry. However, EPA does invite the submission of all relevant information, including information regarding frequency, level, and duration of exposure, at any time during the course of a TSCA section 4 rulemaking. As stated in its B policy ( 58 FR 28736, 28743, May 14, 1993), "[ i] t is the responsibility of interested parties to provide any information they believe may be relevant to the Agency's determination to require testing of a particular chemical substance under TSCA section 4. Consequently, EPA always welcomes the submission of such information during the notice and comment period provided prior to the promulgation of any final test rule."

Comment 2. ACC notes that, in Section 2( b) ( Use/ Users of the Data), EPA states that "  approximately 540 of the 15,000 chemical sub set of the TSCA Inventory have been subject of testing actions within the OPPT Existing Chemicals Testing Program." In their comments, ACC states that EPA should provide a reference, description or clarification of how the 15,000 sub set value was reached and also that EPA should describe or list which chemicals have been subject to testing actions.

EPA Response 2. The current TSCA Inventory contains almost 82,000 chemicals. For priority setting purposes, OPPT has focused its existing chemical data development and data collection efforts on a subset of about 15,000 non polymeric chemicals reported in the two most recent Inventory Update Rule reporting cycles as being produced in quantities greater than 10,000 pounds per year. 11 On average, there are about 9,000 non polymeric organic chemicals reported as produced in quantities greater than 10,000 pounds per year. However, the IUR is a relatively dynamic database. OPPT experience is that up to 4,000 non polymeric organic chemicals reported as produced in quantities greater than 10,000 pounds in one IUR cycle might not be reported in the following cycle. Many chemicals periodically fall above or below the reporting threshold and the lack of information concerning production status during the years between reporting years makes it difficult to determine production trends with certainty. Therefore, for priority setting purposes, OPPT considers data from two cycles ( 9,000 average plus 4,000 chemicals reported in the previous cycle) to represent the number of organic chemicals in commerce at or above this level of production. OPPT also adds an estimated 2,000 inorganic chemicals, resulting in approximately 15,000 non polymeric chemicals that are of interest for priority setting purposes.

The table titled " Sunset Date/ Status of TSCA Section 4 Testing, Reimbursement, and Reporting Requirements and TSCA Section 4 Triggered TSCA Section 12( b) Export Notification Requirements" ( located at http:// www. epa. gov/ oppt/ chemtest/ sunset. htm) lists all chemical substances and mixtures that are and/ or have been the subject of final TSCA Section 4 test rules and/ or TSCA Section 4 enforceable consent agreements/ orders ( ECAs) issued by EPA since the January 25, 2005 12 The sunset date is the end of the TSCA Section 4 reimbursement period that begins when the data from the last test required under a TSCA Section 4 test rule or ECA are submitted to EPA and terminates after an amount of time equal to that required to develop those data or after 5 years, whichever is later. inception of the TSCA Existing Chemicals Testing Program and for which:

( 1) the TSCA Section 4 testing, reimbursement, and reporting requirements and/ or TSCA Section 4 triggered TSCA Section 12( b) export notification requirements have terminated (" sunset") or have been calculated to sunset12; or ( 2) some other TSCA Section 4 or TSCA Section 4 triggered TSCA Section 12( b) status is indicated.

Comment 3. ACC commented that Section 5( b) of the Supporting Statement should include a discussion of the critical role of the new HPV Information System and the EU's International Uniform Chemical Information Database ( IUCLID) and the Envisioned HPV Portal. ACC states that during the period covered by this ICR there will be cost/ burden impacts both on EPA and industry during the transition to this globally recognized system for data management. ACC states that these impacts will include purchase and use of the IUCLID software, education and training in use of the HPVIS, and possibly development of guidance. ACC acknowledges that a burden estimate might be speculative at this time, but ACC urges the Agency to at least address these major changes in key data management activities.

EPA Response 3. EPA agrees that Section 5( b) would benefit from addition of a discussion of current and anticipated future data management activities for the HPV Challenge Program. Therefore, a discussion of current and anticipated future data management activities has been added to Section 5( b) of the Supporting Statement.

Comment 4. ACC noted that EPA included one TSCA section 4 test rule in Section 6( a) ( Respondent Cost and Burden), the OSHA dermal absorption test rule, promulgated on April 26, 2004. ACC noted that EPA states that additional data collection efforts beyond this test rule may be conducted during the ICR approval process, but the extent of such activities cannot be projected at this time. However, ACC notes that EPA is working on other test rules that will be implemented during this ICR period including one already proposed HPV rule, and a follow up HPV rule. ACC suggests that EPA should include estimates for the additional test rules in this version of the ICR.

EPA Response 4. Under the PRA, the ICR must address paperwork burden and costs for authorized or approved collection activities. 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 January 25, 2005 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. At the time of renewal, the approved burden for the final rules will be incorporated into the Supporting Statement for the Renewal ICR.

As indicated in the terms of clearance imposed by OMB in approving this ICR three years ago, 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.

Since the potential development of a TSCA section 4 rulemaking, whether at the pre proposal or early stages of development or after proposal, is specifically captured by the Semi Annual Regulatory Agenda, the Agency has addressed the commenter's suggestion by amending the ICR to include a specific reference to the Semi Annual Regulatory Agenda, and the above explanation with regard to the process that applies to rules under development.

Comment 5. ACC noted that, in Section 6( a) ( Respondent Cost and Burden), EPA assumes that one consent order or consent agreement will be issued per year for a total of three consent orders/ agreements during the ICR period. ACC notes that, in a recent symposium, EPA identified eight consent agreement proposals submitted under the Hazardous Air Pollutants proposed rulemaking as priorities to complete in 2004 and 2005 and that these eight consent agreements were not included in EPA's burden estimation. In addition, ACC noted that it is not clear whether EPA considered the ongoing negotiations for a PFOA enforceable consent agreement in its calculations. ACC stated that if EPA is aware that these activities are coming up within the three year period of this ICR, then EPA should include them in the calculations to provide as accurate a burden estimate as possible.

EPA Response 5. Although the ICR does assume that one ECA will be issued each year, each ECA is assumed by EPA to cover five ( 5) chemicals. In addition, testing for each of the five chemicals in each ECA is assumed by EPA to include 11 tests ( 7 short term and 4 long term tests) for a total of 55 tests per ECA at a total estimated cost of $ 7.9 million per ECA. Thus, EPA estimated that ECAs may be issued for 15 chemicals ( which includes 165 tests) over the three year life of this ICR at a total estimated cost of about $ 24 million.

In a recent symposium, EPA did identify eight ECA proposals submitted under the HAPs proposed rulemaking as EPA priorities for consideration/ development in 2004 and 2005. However, each of these eight ECAs will likely be for single chemicals and will likely involve far fewer that 11 tests per chemical. Since all of the eight HAPs related ECAs under consideration are single chemical ECAs with far fewer than 11 tests per chemical, the costs of these ECAs, if issued, should easily fall within the current ICR estimates. The PFOA ECAs, if issued, will likely include multiple chemicals, at least for some tests; however, far fewer than 11 tests per chemical are envisioned. In any case, as indicated in the Supporting Statement and the terms of clearance January 25, 2005 applied by OMB on the previous approval of this ICR, before an ECA can be finalized the Agency is responsible for ensuring that the burden and cost estimated for an ECA fits within the total approved burden for ECA's under this ICR. If it does not, the Agency must ask OMB to amend the ICR approval to include the additional burden. Since finalizing an ECA is not usually set in stone ( e. g., the HAPs related ECAs have been under development for several years), this is a reasonable approach for estimating potential burden and costs related to uncertain ECA activities during the 3 year period of the ICR, and is supported by the history of ECAs issued under this ICR during past ICR approval periods.

Comment 6. ACC states that EPA should revise correct cost estimates provided in the ICR for the Dermal Absorption Test Program. EPA estimated the laboratory costs for the dermal absorption test rule requirements to be $ 27,190 per chemical, with an additional administrative cost of $ 6,797. ACC stated that information collected by ACC from a number of contract laboratories shows the average costs to be $ 40,250 for the static cell design and $ 46,250 for the flow through design. ACC estimates management costs at $ 5,000 to $ 10,000 per chemical.

EPA Response 6. EPA's development of test cost estimates for the ICR follows the same approach used in the economic assessment of the final dermal testing rule. This approach used a range of costs for testing for the static cell method and for the flow through method and chose an average for each test ( static cell method = $ 25,787; flow through method = $ 28,592 ). These two costs were then averaged together to derive an estimate for the cost of the dermal testing requirement of $ 27,190. An administrative cost of $ 6,797 was added to the cost of testing ( within the range proposed by the commenter). These cost estimates are meant to represent what the respondent would experience should they conduct the testing on their own and necessarily would not include any mark up or profit that a contract research organization might include in its laboratory pricing.

EPA recognizes that there exists a range of costs for testing and that some who are subject to reporting requirements may experience higher or lower levels of burden and cost than EPA estimates. However, EPA's believes that its estimates are well within the range of costs that a respondent may incur and has not adjusted its costs in the ICR Comment 7. ACC stated that EPA should clarify respondent activities for the HPV Challenge Program by revising item ( b) in Section 4( b)( ii) ( Respondent Activities) as follows: ( b) Conduct extensive searches for relevant existing data. If data are found: ° Determine whether the data are relevant and valid. ° Prepare and review summary of existing data ° Submit summary and existing data to EPA EPA Response 7. EPA has modified Section 4( b)( ii)( b) in the Supporting Statement to read as follows. We have not included the adjective " extensive" as suggested by ACC because the Agency has not requested that sponsors conduct " extensive" searches. Rather, EPA has requested that sponsors assemble and review available test data. ( b) Conduct searches for relevant existing data. If data are found: January 25, 2005 ° Determine whether the data are relevant; ° Prepare and review summary of existing data; and ° Submit summary and existing data to EPA.

Comment 8. ACC stated that EPA's Supporting Statement should not include a discussion of the Master Testing List ( MTL) as part of Section 5( b) ( Collection Methodology and Management) because the MTL is irrelevant in light of the HPV and dermal absorption programs.

EPA Response 8. Section 5( b) of the Supporting Statement has been revised to more clearly describe the collection methodology and management activities related to the Section 4 Chemical Testing Program and the High Production Volume ( HPV) Chemical Challenge Program. In addition, the Agency has updated Section 3( h) ( Electronic Reporting).

Comment 9. ACC comments that EPA's calculations to determine a burden estimate only consider actions taken AFTER a company has determined it is required to conduct testing and do not include any cost factors associated with a company's internal efforts prior to initiating testing under TSCA Section 4 or other TSCA programs. Thus, ACC states that the current burden estimate fails to consider that companies need to expend many hours evaluating a Section 4 test rule to understand the rule, conduct searches of their chemicals to determine if they manufacture or import the listed substances, and determine if they are obligated to respond to the test rule. ACC states that these activities are as much a part of TSCA requirements as is submitting a report, and must be included in the overall burden estimation.

EPA Response 9. The respondent activities considered in this ICR specifically include the anticipated activities for potential respondents to review the rulemaking and/ or participate in the discussions related to an ECA or VTA, as well as the burden for searching files and planning activities. These activities would occur before the potential respondent has determined that they must respond.

It is important to note that the ICR is intended to present the estimated burden and costs of paperwork activities imposed on the respondents, it is not intended to reflect any and all burden and costs related to the rulemaking or any activity that a company might engage in to comply with a rulemaking. The cost of the rulemaking is presented in the Economic Analysis prepared for the rulemaking, which will include estimated paperwork burden as a component of the overall estimated costs. Activities not imposed or required to comply with the paperwork activities are not captured by the ICR.

The Agency's consideration of potential respondents is appropriate and reasonable because rulemakings, ECAs and VTAs apply to specific chemicals, and therefore only impose requirements on the manufacturers and importers of those chemicals. Were the rules to apply more generally to manufacturers or importers of all chemicals, the Agency would consider the universe of manufacturers and importers in estimating the burden and costs for initial activities like rule familiarization. January 25, 2005 In estimating the burden for the preliminary activities in this ICR, the Agency uses the universe of potential respondents ( or identifiable manufacturers and importers), even though the other respondent activities related to data generation and submission is only required to occur once for each chemical. Since the Agency is able to use public information to identify the potential manufacturers or importers, it is difficult to imagine that the companies themselves would have to conduct extensive research to determine whether or not they manufacture or import the chemical. The Agency believes that any burden associated with such a determination is likely to be minimal, similar to that associated with determining identification information.

COMMENTS FROM SOCMA/ EPA RESPONSES Comment 10. SOCMA believes that production volume alone is not a reasonable surrogate for exposure and should not be used as such in the chemical testing program nor in the HPV Challenge Program.

EPA Response 10. SOCMA's comment that EPA uses production volume as a surrogate for exposure in the HPV Challenge Program oversimplifies the Agency's approach to HPV substances. Although the Agency views high production volume as a factor pointing to increased potential for exposure, the HPV program itself provides for limited test data for closed system intermediates. In the context of voluntary programs, the determination of the parameters of those programs is negotiated by EPA and program participants; thus, for example, the use of production volume in determining which chemicals are included in a voluntary program is appropriate for that purpose.

Indeed, EPA has stated that production volume information alone is not typically adequate as a proxy for exposure information for purposes of risk assessment and risk screening ( see, e. g., 64 FR 46772, 46779, Aug. 26, 1999). However, in the context of TSCA section 4 actions, production volume cannot be the sole basis for exposure based findings under TSCA section 4( a)( 1)( B). In addition to the production volume based " substantial quantity" finding under section 4( a)( 1)( B)( i), findings must be made as to either substantial release ( 4( a)( 1)( B)( i)( I)) or significant or substantial human exposure ( 4( a)( 1)( B)( i)( II)).

Comment 11. SOCMA notes that, in the Supporting Statement to the ICR, EPA attempts to generally outline the steps taken by sponsors during participation in a testing program. SOCMA believes that better precision could be achieved by detailing the actual steps that consortia typically go through when sponsoring a chemical for testing, which are not captured in the Supporting Statement. SOCMA provided an Annex to their comments that contains an outline of the steps that consortia generally take when sponsoring a chemical under an EPA or other testing program. SOCMA urges EPA to consider these line items when estimating the actual burden to industry.

EPA Response 11. EPA believes that it has considered the items that SOCMA has identified in its list of steps that consortia generally take when sponsoring a chemical. EPA has developed an estimate for the administrative costs of reporting and organizing a testing program that includes January 25, 2005 many of the steps identified by SOCMA and the relevant costs are already contained in the estimate. As stated in the economic analysis, EPA's estimates include preparing letters of intent, study plans, and progress reports; preparing test results for submission; recording test results; conducting laboratory reviews; record keeping; conducting administrative activities for organizing, preparing for, and overseeing the testing program; obtain and review bids from labs; and preparing and submitting samples to the laboratory for testing; among others, which are part of SOCMA's list. EPA believes SOCMA's list of activities to be too inclusive as it includes many costs that EPA is not required to account for as part of the information collection, such as travel, lodging, and food.

SOCMA states that its list is generally applicable to information collection activities from testing programs. Therefore, not all of the activities would necessarily be undertaken by all respondents to EPA requirements. In fact, several of the activities identified by SOCMA, such as those associated with the OECD SIDs program and REACH program, are associated with international requirements and not EPA and thus, are irrelevant to this collection request and would be inappropriate to consider.

Given the overly inclusive nature of SOCMA's list of activities and EPA's inclusion of the relevant items in its estimate of administrative costs and burdens, EPA finds no reason to further adjust its estimates.

Comment 12. SOCMA notes that Table 6 of the Supporting Statement lists hourly rates for technical, managerial and secretarial labor types. SOCMA states that these figures do not reflect actual employment costs to companies in the chemical sector.

EPA Response 12. EPA has reviewed the development of its wage estimates for this ICR. The wage estimates developed for technical, managerial, and secretarial labor types are derived from the Department of Labor's Bureau of Labor Statistics ( BLS) figures on the Employer Costs for Employee Compensation. Specifically, EPA chose wage rates for private industry, goodsproducing industries, white collar occupations. Additional loading factors for fringe benefits and overhead, also based on BLS statistics, were applied to develop loaded wage rate estimates. EPA recognizes that these figures may not represent actual wage rates of all employers in the chemical industry sector but believes that they are a reasonable representation based upon current data.

Comment 13. SOCMA states that most consortia, even those with toxicologists as members, are in a position where they must hire consultants to perform much of the technical writing, including review of study reports. SOCMA states that the hourly rate for consultants is much higher than the rates used in the Supporting Statement. Therefore, SOCMA states that the Supporting Statement should include an estimate of the average number of consultant hours needed per sponsored chemical and associated costs.

EPA Response 13. Under the PRA, agencies estimate the potential burden and costs to the identified respondents based on the activities imposed as part of the collection activities, or required to complete the collection activity. Although individual respondents may choose a January 25, 2005 number of different methods for responding to the collection activity, like hiring consultants or otherwise contracting with another entity to facilitate their compliance, the collection activity imposed or required for responding, is still the same regardless of who performs the tasks. The individual choices of a respondent are unknown to the Agency, and the Agency does not believe that collecting such information would improve the collection activity. EPA believes that the ICR provides a reasonable estimate of average burden and costs for the anticipated activities like preparing and reviewing the study reports, as well as anticipated paperwork activities related to a respondent's participation in a consortia.

Although the preparation and review burden might vary from one study to another based on the complexities of the study, by providing an average estimated burden and costs for the paperwork activities, the ICR presents a reasonable overall estimate. In addition, including a respondent's contractor costs for these activities may increase the overall estimated costs, but it actually results in a reduction of the overall burden estimate. The costs for a respondent to hire a consultant or contractor will capture non paperwork burden and costs ( i. e., marketing and profit costs that the consultant or contractor include in their costs). In general, agencies are not allowed to transfer the estimated burden for the respondent's paperwork activities, to be estimated costs. Nevertheless, the Agency is interested in learning more about the typical respondent activities that SOCMA referenced and will consult with SOCMA during the approval period to identify whether the Agency's description of anticipated activities and related burden estimates can be improved before the next renewal.

Comment 14. SOCMA states that the Supporting Statement does not include the costs of developing and validating analytical chemistry methods for each substance. Analytical chemistry is essential for measuring the amount of chemical.

EPA Response 14. EPA agrees that developing analytical chemistry methods are important for certain types of toxicological testing. These costs had not been included as part of the burden and cost estimate for this ICR; however, EPA has since developed some cost estimates that have been included in its revision of the economic analysis. Generally, EPA has included costs only for toxicological testing as it does not believe that analytical chemistry method development is necessary for physical chemical property testing.

Comment 15. SOCMA states that testing requirements for chemicals should be in accordance with each chemical's general use ( e. g., industrial, commercial or consumer) and not rely solely upon volume. To enhance the quality of information collected under the ICR, SOCMA recommends that EPA take a tiered, risk based approach to testing. The tiered approach could further categorize chemicals according to general use. Once the chemicals are categorized according to use, then an appropriate test battery could be assigned, which would maximize the utility of the collected information by keeping it focused on risk management.

EPA Response 15. EPA's response to the similar previous comment made by SOCMA ( see Comment # 10) is an appropriate response to this comment as well. SOCMA's comment that EPA uses production volume as a surrogate for exposure in the HPV Challenge Program January 25, 2005 oversimplifies the Agency's approach to HPV substances. Although the Agency views high production volume as a factor pointing to increased potential for exposure, the HPV program itself provides for limited test data for closed system intermediates. In the context of voluntary programs, the determination of the parameters of those programs is negotiated by EPA and program participants; thus, for example, the use of production volume in determining which chemicals are included in a voluntary program is appropriate for that purpose.

Indeed, EPA has stated that production volume information alone is not typically adequate as a proxy for exposure information for purposes of risk assessment and risk screening ( see, e. g., 64 FR 46772, 46779, Aug. 26, 1999). However, in the context of TSCA section 4 actions, production volume cannot be the sole basis for exposure based findings under TSCA section 4( a)( 1)( B). In addition to the production volume based " substantial quantity" finding under section 4( a)( 1)( B)( i), findings must be made as to either substantial release ( 4( a)( 1)( B)( i)( I)) or significant or substantial human exposure ( 4( a)( 1)( B)( i)( II)).

Comment 16. With regards to potential minimization of burden that may be afforded by way of electronic reporting, SOCMA states that the burdens of interest to SOCMA are associated with the cost of preparation of the information, not the medium on which the information resides. From SOCMA's point of view, keying the information directly into a database generally takes the same amount of time no matter which database is being used. SOCMA states that industry already uses word processing software and other modern conveniences, so there will be no reduction in paperwork burden using a different data entry system.

EPA Response 16. EPA appreciates SOCMA's answer to one of the questions for which EPA solicited comments in the Federal Register notice ( 69 FR 39464, June 30, 2004). No revisions to the ICR Supporting Statement are recommended in this comment.

Comment 17. SOCMA understands that the ICR only covers collections under TSCA Section 4, but SOCMA recommends that an acknowledgment in the Supporting Statement with regards to the importance and use of exposure information would be in line with the Agency's mission and would better demonstrate the practical utility of the information to be collected.

EPA Response 17. Although the use of exposure information is implicitly acknowledged in several locations in the Supporting Statement when statements are made that Section 4 information enables EPA and others to properly assess and manage health and environmental risks, no explicit statement to that effect is made. Therefore, the first sentence of Section 2( b) has been modified as follows: " Data collected under the Chemical Testing Program, in conjunction with exposure information, are used by EPA scientists to determine whether the subject chemicals are likely to present an unreasonable risk to human health or the environment."

Comment 18. In Section 2( b) of the Supporting Statement, SOCMA notes that EPA asserts that data generated for " chemicals used or produced in particular work sites will be useful in developing comprehensive safety and health programs" for workers. SOCMA states that in the January 25, 2005 chemical manufacturing sector, sites already have comprehensive health and safety programs, which are required under OSHA and other labor laws and, thus, the EPA statement does not demonstrate the necessity or practical utility of certain information information that will be collected under this ICR.

EPA Response 18. EPA acknowledges that, in the chemical manufacturing sector, sites already have comprehensive health and safety programs, which are required by OSHA and other labor laws. However, not all business sectors or all sites within a given sector that may use products or formulations containing chemicals have comprehensive health and safety programs. Thus, data developed under the TSCA Chemical Testing Program may indeed be useful to those sectors. In addition, data developed under the TSCA Chemical Testing Program will be useful in maintaining up to date health and safety programs at those sectors/ sites with comprehensive health and safety programs in place. Therefore, to clarify EPA's interpretation of the usefulness of chemical testing data, EPA has added the phrase " and/ or maintaining" following the word " developing" in the sentence quoted by SOCMA from Section 2( b).

Comment 19. In Section 2( b), EPA states that submitted test data could be used to " determine the appropriate action necessary to avoid or mitigate" a risk that may be posed by a particular chemical. SOCMA believes that if actions are already taken to reduce risk, by reducing potential exposures, then certain data collected under this ICR no longer have the intended utility.

EPA Response 19. In Section 2( b), EPA states that " 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." SOCMA's comment does not include the first phrase of this sentence ( i. e., " If the test data submitted indicate that potentially unreasonable risks may exist, the data will be used by EPA and the manufacturer"). This first phrase provides the context in which to evaluate the second phrase of the sentence as quoted by SOCMA. EPA believes that if new test data indicate that a chemical may be more hazardous than had been previously known, then that new hazard information should be evaluated by EPA and those manufacturers practicing responsible product stewardship to ensure that situations posing potentially unreasonable risks are avoided or mitigated. One cannot necessarily assume that exposure controls in place to avoid/ mitigate risks based on previously known hazards are adequate to avoid/ mitigate risks for a more serious hazard.

Comment 20. SOCMA notes that the Agency addresses the potential for disproportionate burdens on small businesses by using consortia as the primary means for flexibility. SOCMA states that while it is true that the majority of consortia share direct testing and reporting costs according to market share, that arrangement is not always possible for specialty chemical manufacturers. Specialty chemicals frequently have only one or two producers, which in many cases are small batch manufacturers. In the case of a single producer, the costs are borne solely by the company. In the case of two or three producers, antitrust and competitiveness implications may prevent companies from sharing production data, which results in equal cost sharing. Equal cost sharing places the smaller market player at a disadvantage. In addition, the costs of joining a consortium and the management fees associated with running the group are shared equally, not in January 25, 2005 accordance with a company's market share. These costs can easily outweigh the actual testing costs for small companies, since testing costs are shared according to a company's position in the marketplace.

EPA Response 20. In developing estimates of costs and burdens of information collections, EPA looks at the overall cost of the collection and averages it across respondents. This estimate is not expected to be an exact estimate for each individual respondent, as it is understandable that costs and burdens will vary based upon individual circumstances. EPA believes that its estimate reasonably represents the burden that will result from this information collection, understanding that it may be an underestimate in some cases and an overestimate in others.

Comment 21. SOCMA notes that when estimating the burden and cost of collection in Section 6( a), EPA covers only the OSHA dermal absorption test rule. EPA has publicly stated that it intends to issue the first final test rule for HPV chemicals late in 2004, but it is not listed as " anticipated" in the ICR. SOCMA states that if the Agency intends to finalize the proposed HPV test rule, then it should be added to the ICR.

EPA Response 21. EPA has already responded to the suggestion. See " EPA Response 4" above. January 25, 2005 ATTACHMENT 5 Section 3( c) Consultations January 25, 2005 Section 3( c) Consultations Under 5 CFR 1320.8( d)( 1) OMB requires agencies to consult with potential ICR respondents and data users about specific aspects of an ICR before the agency submits the ICR to OMB for review and approval. In accordance with this regulation and based on OPPTS Regulatory Coordination Staff guidance, EPA submitted questions to nine parties via email. The individuals contacted were:

ACC Mr. Steven Russell steven_ russell@ americanchemistry. com 703 741 5178 SOCMA Mr. James Cooper cooperj@ socma. com 202 721 4158 Dow Chemical Co. Dr. Susan Hearn shearn@ dow. com 989 636 9192 GE Plastics Ms. Jessine Monaghan jessine. monaghan@ ge. com 202 637 4003 American Petroleum Institute Dr. Lorraine Twerdok twerdokl@ api. org 202 682 8344 Environmental Defense Dr. Richard Denison rdenison@ environmentaldefense. org 202 387 3500 Interagency Testing Committee Dr. John Walker walker. johnd@ epa. gov Improving Kids Environment Thomas Neltner neltner@ ikecoalition. org 317 442 3973 January 25, 2005 Texas Southern University Martina Cartwright mcartwri@ hotmail. com 713 313 1019 A copy of the Agency's e mail with consultation questions to the above nine parties is attached.

Email sent by Keith Cronin on 07/ 14/ 2004 requesting comment on TSCA Existing Chemical Test Rules, Consent Orders, Test Rule Exemptions, and Voluntary Test Data Submissions Information Collection Request On June 30, 2004, EPA published a Notice in the Federal Register ( 69 FR 39464) for TSCA Section 4 Test Rules, Consent Orders, Test Rule Exemptions, and Voluntary Data Submission; Request for Comment on Renewal of Information Collection Activities. The Notice provides a 60 day public comment period. In addition to to the Notice and comment requirement, agencis also are required under Office of Management and Budget Regulations ( 5 CFR 1320.8( d)( 1)) to consult with potential respondents and data users specific aspects of an Information Collection Request ( ICR) before submitting it to OMB for review and approval, regardless, in the case of ICR renewals, of whether changes have or have not been made to the collection activity.

As part of this required consultation, I am contacting you to solicit your input. I also must note that, if you take this opportunity to provide input, your name, affiliation, and phone number and any information you provide ( e. g., copies of emails) will be incorporated and attached to the ICR supporting statement which will be a public document. In addition, you may be contacted by the OMB Desk Examiner for the ICR to verify the accuracy of any comments as reported in the ICR by EPA.

EPA solicits your input on the following questions:

Are the data EPA seeks under this ICR available from any public source, or already collected by another EPA office or by another agency? If so, where can the data be found?

Is it clear, based on the form and instructions, what is required for data submission? If not, are there any suggestions for clarifying instructions? Is the form clear, logical, and easy to complete?

Would you be interested in an electronic/ data submission option? What type of alternative would you be most likely to utilize  web form, diskette, CD  ROM?

For electronic submission, how should signature requirements be handled  Private Key Infrastructure, PINS and Passwords, signed paper cover sheet? How does CBI affect your choice or use of an electronic medium? Would you be more inclined to submit CBI on diskette than on paper and what benefits would you realize ( burden reduction? Greater efficiency in compiling information? Etc).

Do you agree with EPA's estimated burden and costs ( ICR addresses only costs associated with paperwork)? Are the labor rates accurate? January 25, 2005 Your timely response will be greatly appreciated! Our plans call for submission of this ICR renewal to OMB to be August 30th. Thank you for your assistance.