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 Sec. 725.420.
(b) The introduced genetic material meets the criteria under Sec. 725.421.
(c) Adequate physical containment and control technologies are used. The criteria listed under Sec. 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 Sec. 725.455(d). EPA will review proposed process and containment procedures as part of the submission for a Tier II exemption under this section.