Title 40

SECTION 790.87

790.87 Approval of exemption applications.

§ 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;

(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)(1) EPA will give exemption applicants final notice that they have received a conditional exemption through one of the following ways:

(i) A final Phase II test rule that adopts the study plans in a two-phase rulemaking.

(ii) A separate Federal Register notice in a single-phase rulemaking.

(iii) A letter by certified mail will give exemption applicants final notice that they have received a conditional exemption.

(2) All conditional exemptions thus granted are contingent upon the test sponsors' successful completion of testing according to the specifications of the test rule.

[50 FR 20660, May 17, 1985, as amended at 78 FR 72830, Dec. 4, 2013]

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