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Title 40 Part 790 → Subpart D

Title 40 → Chapter I → Subchapter R → Part 790 → Subpart D

Electronic Code of Federal Regulations e-CFR

Title 40 Part 790 → Subpart D

e-CFR data is current as of December 10, 2019

Title 40Chapter ISubchapter RPart 790 → Subpart D


Title 40: Protection of Environment
PART 790—PROCEDURES GOVERNING TESTING CONSENT AGREEMENTS AND TEST RULES


Subpart D—Implementation, Enforcement and Modification of Consent Agreements


Contents
§790.60   Contents of consent agreements.
§790.62   Submission of study plans and conduct of testing.
§790.65   Failure to comply with a consent agreement.
§790.68   Modification of consent agreements.

Source: 51 FR 23715, June 30, 1986, unless otherwise noted.

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§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]

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§790.62   Submission of study plans and conduct of testing.

(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.

(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 using the method 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; 78 FR 72830, Dec. 4, 2013]

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§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, including the failure to pay requisite fees as specified in §700.45 of this chapter, to be a “prohibited act” under section 15 of TSCA, subject to all 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.

[51 FR 23715, June 30, 1986, as amended at 83 FR 52724, Oct. 17, 2018]

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§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 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 §790.22(b)(8). 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 agreement must submit an application in accordance with this paragraph. Application for modification must be made using the method specified in §790.5(b). 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 agreement). Where a test sponsor requests EPA to provide guidance or to clarify a non-mandatory testing requirement (i.e., “should statements”), the test sponsor shall submit these requests to EPA using the method specified in §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 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; 75 FR 56476, Sept. 16, 2010; 78 FR 72830, Dec. 4, 2013]

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