---
kind: "section"
citation: "40 C.F.R. § 725.424"
title: "40"
number: "725.424"
heading: "Requirements for the Tier I exemption."
url: "https://uscodex.org/cfr/40/725.424"
---

# §725.424. Requirements for the Tier I exemption.

- (a) **Conditions of exemption.** The manufacture or import of a new microorganism for commercial purposes is not subject to review under this part if all of the following conditions are met for all activities involving the new microorganism:
  - (1) The recipient microorganism is listed in and meets any requirements specified in [§ 725.420](/cfr/40/725.420.md).
  - (2) The introduced genetic material meets the criteria under [§ 725.421](/cfr/40/725.421.md).
  - (3) The physical containment and control technologies of any facility in which the microorganism will be manufactured, processed, or used meet the criteria under [§ 725.422](/cfr/40/725.422.md).
  - (4) The manufacturer or importer submits a certification described in [paragraph (b)](#b) of this section to EPA at least 10 days before commencing initial manufacture or import of a new microorganism derived from a recipient microorganism listed in [§ 725.420](/cfr/40/725.420.md).
  - (5) The manufacturer or importer complies with the recordkeeping requirements of [§ 725.65](/cfr/40/725.65.md) and maintains records for the initial and subsequent uses of the new microorganism that verify compliance with the following:
    - (i) **The certifications made in paragraph (b) of this section.**
    - (ii) All the eligibility criteria for the Tier I exemption including the criteria for the recipient microorganism, the introduced genetic material, the physical containment and control technologies.
- (b) **Certification.** To be eligible for the Tier I exemption under this subpart, the manufacturer or importer must submit to EPA a document signed by a responsible company official containing the information listed in this paragraph.
  - (1) **Name and address of manufacturer or importer.**
  - (2) **Date when manufacture or import is expected to begin.**
  - (3) The identification (genus, species) of the recipient microorganism listed in [§ 725.420](/cfr/40/725.420.md) which is being used to create the new microorganism which will be used under the conditions of the Tier I exemption.
  - (4) **Certification of the following—**
    - (i) Compliance with the introduced genetic material criteria described in [§ 725.421](/cfr/40/725.421.md).
    - (ii) Compliance with the containment requirements described in [§ 725.422](/cfr/40/725.422.md), including the provision in [paragraph (a)(3)](#a-3) of this section.
  - (5) The site of waste disposal and the type of permits for disposal, the permit numbers and the institutions issuing the permits.
  - (6) 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 I exemption.

## Notes

### Authority

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

### Source

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