790.60 Contents of consent agreements.§ 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.
(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.
(18) Payment identity number, as required in § 700.45(g)(4) of this chapter.
(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.
(d) Fees. Manufacturers and/or processors signing the consent agreement are subject to the applicable fee specified in § 700.45(c) of this chapter.[51 FR 23715, June 30, 1986, as amended at 54 FR 36314, Sept. 1, 1989; 83 FR 52724, Oct. 17, 2018]