---
kind: "section"
citation: "40 C.F.R. § 725.400"
title: "40"
number: "725.400"
heading: "Scope and purpose."
url: "https://uscodex.org/cfr/40/725.400"
---

# §725.400. Scope and purpose.

- (a) This subpart describes exemptions from reporting under subpart D of this part, and from review under this part altogether, for manufacturing and importing of certain new microorganisms for commercial purposes.
- (b) Recipient microorganisms eligible for the tiered exemption from review under this part are listed in [§ 725.420](/cfr/40/725.420.md).
- (c) Criteria for the introduced genetic material contained in the new microorganisms are described in [§ 725.421](/cfr/40/725.421.md).
- (d) Physical containment and control technologies are described in [§ 725.422](/cfr/40/725.422.md).
- (e) The conditions for the Tier I exemption are listed in [§ 725.424](/cfr/40/725.424.md).
- (f) In lieu of complying with [subpart D](/cfr/40/subpartD.md) of this part, persons using recipient microorganisms eligible for the tiered exemption may submit a Tier II exemption request. The limited reporting requirements for the Tier II exemption, including data requirements, are described in §§ [725.450](/cfr/40/725.450.md) and [725.455](/cfr/40/725.455.md).
- (g) EPA review procedures for the Tier II exemption are set forth in [§ 725.470](/cfr/40/725.470.md).
- (h) **Subparts A through C of this part apply to any submission under this subpart.**

## Notes

### Authority

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

### Source

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