[Code of Federal Regulations]

[Title 40, Volume 31]

[Revised as of July 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 40CFR790.60]



[Page 18-19]

 

                   TITLE 40--PROTECTION OF ENVIRONMENT

 

         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)

 

PART 790_PROCEDURES GOVERNING TESTING CONSENT AGREEMENTS AND TEST RULES

--Table of Contents

 

   Subpart D_Implementation, Enforcement and Modification of Consent 

                               Agreements

 

Sec.  790.60  Contents of consent agreements.



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





    (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 Sec.  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.



[[Page 19]]



    (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]