---
kind: "section"
citation: "40 C.F.R. § 725.910"
title: "40"
number: "725.910"
heading: "Persons excluded from reporting significant new uses."
url: "https://uscodex.org/cfr/40/725.910"
---

# §725.910. Persons excluded from reporting significant new uses.

- (a) A person who intends to manufacture, import, or process a microorganism identified in subpart M of this part and who intends to distribute it in commerce is not required to submit a MCAN under subpart D of this part, if that person can document one or more of the following as to each recipient of the microorganism from that person:
  - (1) That the person has notified the recipient, in writing, of the specific section in subpart M of this part which identifies the microorganism and its designated significant new uses, or
  - (2) That the recipient has knowledge of the specific section in subpart M of this part which identifies the microorganism and its designated significant new uses, or
  - (3) That the recipient cannot undertake any significant new use described in the specific section in subpart M of this part.
- (b) The manufacturer, importer, or processor described in [paragraph (a)](#a) of this section must submit a MCAN under [subpart D](/cfr/40/subpartD.md) of this part, if such person has knowledge at the time of commercial distribution of the microorganism identified in the specific section in [subpart M](/cfr/40/subpartM.md) of this part that a recipient intends to engage in a designated significant new use of that microorganism without submitting a MCAN under this part.
- (c) A person who processes a microorganism identified in a specific section in subpart M of this part for a significant new use of that microorganism is not required to submit a MCAN if that person can document each of the following:
  - (1) That the person does not know the specific microorganism identity of the microorganism being processed, and
  - (2) That the person is processing the microorganism without knowledge that the microorganism is identified in subpart M of this part.
- (d)
  - (1) If at any time after commencing distribution in commerce of a microorganism identified in a specific section in subpart M of this part, a person who manufactures, imports, or processes a microorganism described in subpart M of this part and distributes it in commerce has knowledge that a recipient of the microorganism is engaging in a significant new use of that microorganism designated in that section without submitting a MCAN under this part, the person is required to cease supplying the microorganism to that recipient and to submit a MCAN for that microorganism and significant new use, unless the person is able to document each of the following:
    - (i) That the person has notified the recipient and EPA enforcement authorities (at the address in [paragraph (d)(1)(iii)](#d-1-iii) of this section), in writing within 15 working days of the time the person develops knowledge that the recipient is engaging in a significant new use, that the recipient is engaging in a significant new use without submitting a MCAN.
    - (ii) That, within 15 working days of notifying the recipient as described in [paragraph (d)(1)(i)](#d-1-i) of this section, the person received from the recipient, in writing, a statement of assurance that the recipient is aware of the terms of the applicable section in [subpart M](/cfr/40/subpartM.md) of this part and will not engage in the significant new use.
    - (iii) That the person has promptly provided EPA enforcement authorities with a copy of the recipient's statement of assurance described in [paragraph (d)(1)(ii)](#d-1-ii) of this section. The copy must be sent to the Director, Office of Compliance (2221A), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
  - (2) If EPA notifies the manufacturer, importer, or processor that the recipient is engaging in a significant new use after providing the statement of assurance described in [paragraph (d)(1)(ii)](#d-1-ii) of this section and without submitting a MCAN under this part, the manufacturer, importer, or processor shall immediately cease distribution to that recipient until the manufacturer, importer, or processor or the recipient has submitted a MCAN under this part and the MCAN review period has ended.
  - (3) If, after receiving a statement of assurance from a recipient under [paragraph (d)(1)(ii)](#d-1-ii) of this section, a manufacturer, importer, or processor has knowledge that the recipient is engaging in a significant new use without submitting a MCAN under this part, the manufacturer, importer, or processor must immediately cease distributing the microorganism to that recipient and notify EPA enforcement authorities at the address identified in [paragraph (d)(1)(iii)](#d-1-iii) of this section. The manufacturer, importer, or processor may not resume distribution to that recipient until any one of the following has occurred:
    - (i) The manufacturer, importer, or processor has submitted a MCAN under this part and the MCAN review period has ended.
    - (ii) **The recipient has submitted a MCAN under this part and the MCAN review period has ended.**
    - (iii) The manufacturer, importer, or processor has received notice from EPA enforcement authorities that it may resume distribution to that recipient.

## Notes

### Authority

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

### Source

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