---
kind: "section"
citation: "40 C.F.R. § 725.100"
title: "40"
number: "725.100"
heading: "Scope and purpose."
url: "https://uscodex.org/cfr/40/725.100"
---

# §725.100. Scope and purpose.

- (a) This subpart establishes procedures for submission of a notice to EPA under section 5(a) of the Act for persons who manufacture, import, or process microorganisms for commercial purposes. This notice is called a Microbial Commercial Activity Notice (MCAN). It is expected that MCANs will in general only be submitted for microorganisms intended for general commercial use. Persons who manufacture, import, or process a microorganism in small quantities solely for research and development as defined in [§ 725.3](/cfr/40/725.3.md) are not required to submit a notice to EPA. Persons who manufacture, import, or process a microorganism for research and development activities that do not fit the definition of small quantities solely for research and development may nonetheless qualify for more limited reporting requirements in [subpart E](/cfr/40/subpartE.md), including the TERA which can be used for review of research and development involving environmental release.
- (b) Persons subject to MCAN submission are described in [§ 725.105](/cfr/40/725.105.md).
- (c) Exclusions and exemptions specific to MCAN submissions are described in [§ 725.110](/cfr/40/725.110.md).
- (d) Submission requirements applicable specifically to MCANs are described at [§ 725.150](/cfr/40/725.150.md).
- (e) Data requirements for MCANs are set forth in §§ [725.155](/cfr/40/725.155.md) and [725.160](/cfr/40/725.160.md).
- (f) EPA review procedures specific to MCANs are set forth in [§ 725.170](/cfr/40/725.170.md).
- (g) **Subparts A through C of this part apply to any MCAN submitted 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.