CFR > Title 40 - Protection of Environment > CHAPTER I—ENVIRONMENTAL PROTECTION AGENCY > SUBCHAPTER R—TOXIC SUBSTANCES CONTROL ACT (Parts 700–799) > PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS > SUBPART G—General Exemptions for New Microorganisms (§725.400 to §725.470) > 725.428—Requirements for the Tier II exemption.

725.428—Requirements for the Tier II exemption.

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.