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15 U.S.C. 2604, 2607, 2613, and 2625.
62 FR 17932, Apr. 11, 1997, unless otherwise noted.
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The manufacturer or importer of a new microorganism for commercial purposes may submit to EPA a Tier II exemption request in lieu of a MCAN under subpart D of this part if all of the following conditions are met:
(a) The recipient microorganism is listed in and meets any requirements specified in § 725.420.
(b) The introduced genetic material meets the criteria under § 725.421.
(c) Adequate physical containment and control technologies are used. The criteria listed under § 725.422 for physical containment and control technologies of facilities should be used as guidance to satisfy the Tier II exemption request data requirements listed at § 725.455(d). EPA will review proposed process and containment procedures as part of the submission for a Tier II exemption under this section.