...
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.
[62 FR 17954, Apr. 11, 1997]