§725.428. Requirements for the Tier II exemption.
40 C.F.R. § 725.428
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:
The recipient microorganism is listed in and meets any requirements specified in § 725.420.
The introduced genetic material meets the criteria under § 725.421.
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.
Notes, amendments, and revision history
Authority
Authority: 15 U.S.C. 2604, 2607, 2613, and 2625.
Source
Source: 62 FR 17932, Apr. 11, 1997, unless otherwise noted.