40 CFR § 725.370 - EPA review of the TME application.
General procedures for review of all submissions under this part are contained in §§ 725.28 through 725.60. In addition, the following procedures apply to EPA review of TME applications submitted under this subpart:
(a) No later than 45 days after EPA receives a TME, the Agency will either approve or deny the application.
(b) A submitter may only proceed with test marketing activities after receipt of EPA approval.
(c) In approving a TME application, EPA may impose any restrictions necessary to ensure that the microorganism will not present an unreasonable risk of injury to health and the environment as a result of test marketing.