StacksVerified U.S. regulatory reference

40 CFR §725.428

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
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:
  1. (a)The recipient microorganism is listed in and meets any requirements specified in § 725.420.
  2. (b)The introduced genetic material meets the criteria under § 725.421.
  3. (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.