---
kind: "section"
citation: "40 C.F.R. § 725.455"
title: "40"
number: "725.455"
heading: "Information to be included in the Tier II exemption request."
url: "https://uscodex.org/cfr/40/725.455"
---

# §725.455. Information to be included in the Tier II exemption request.


The submitter must indicate clearly that the submission is a Tier II exemption request for a microorganism instead of the MCAN under subpart D of this part and must submit the following information:

- (a) **Submitter identification.**
  - (1) **The name and headquarters address of the submitter.**
  - (2) The name, address, and office telephone number (including area code) of the principal technical contact representing the submitter.
- (b) **Microorganism identity information.**
  - (1) **Identification (genus, species, and strain) of the recipient microorganism.** Genus, species designation should be substantiated by a letter from a culture collection or a brief summary of the results of tests conducted for taxonomic identification.
  - (2) **Type of genetic modification and the function of the introduced genetic material.**
  - (3) **Site of insertion.**
  - (4) Certification of compliance with the introduced genetic material criteria described in [§ 725.421](/cfr/40/725.421.md).
- (c) **Production volume.** Production volume, including total liters per year, and the maximum cell concentration achieved during the production process.
- (d) **Process and containment information.**
  - (1) **A description of the process including the following—**
    - (i) **Identity and location of the manufacturing site(s).**
    - (ii) Process flow diagram illustrating the production process, including downstream separations, and indicating the containment envelope around the appropriate equipment.
    - (iii) **Identities and quantities of feedstocks.**
    - (iv) Sources and quantities of potential releases to both the workplace and environment, and a description of engineering controls, inactivation procedures, and other measures which will reduce worker exposure and environmental releases.
    - (v) A description of procedures which will be undertaken to prevent fugitive emissions, i.e. leak detection and repair program.
    - (vi) A description of procedures/safeguards to prevent and mitigate accidental releases to the workplace and the environment.
  - (2) Certification of those elements of the containment criteria described in [§ 725.422](/cfr/40/725.422.md) with which the manufacturer is in compliance, including stating by number the elements with which the manufacturer is in full compliance.
- (e) The site of waste disposal and the type of permits for disposal, the permit numbers and the institutions issuing the permits.
- (f) The certification statement required in [§ 725.25(b)](/cfr/40/725.25.md?p=b). Certification of submission of test data is not required for the Tier II exemption.

## Notes

### Authority

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

### Source

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