---
kind: "section"
citation: "40 C.F.R. § 725.428"
title: "40"
number: "725.428"
heading: "Requirements for the Tier II exemption."
url: "https://uscodex.org/cfr/40/725.428"
---

# §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](/cfr/40/725.420.md).
- (b) The introduced genetic material meets the criteria under [§ 725.421](/cfr/40/725.421.md).
- (c) **Adequate physical containment and control technologies are used.** The criteria listed under [§ 725.422](/cfr/40/725.422.md) 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)](/cfr/40/725.455.md?p=d). EPA will review proposed process and containment procedures as part of the submission for a Tier II exemption under this section.

## Notes

### Authority

Authority: 15 U.S.C. 2604, 2607, 2613, and 2625.

### Source

Source: 62 FR 17932, Apr. 11, 1997, unless otherwise noted.