40 CFR 790.40: Promulgation of test rules.

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

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

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

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

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

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

(iv) Standards for the development of test data.

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

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

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

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

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

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

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

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

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

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

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

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

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