725.190—Notice of commencement of manufacture or import.
(a) Applicability.
Any person who commences the manufacture or import of a new microorganism for nonexempt, commercial purposes for which that person previously submitted a section 5(a) notice under this part must submit a notice of commencement (NOC) of manufacture or import.
(b) When to report.
(1)
If manufacture or import for nonexempt, commercial purposes begins on or after May 27, 1997, the submitter must submit the NOC to EPA no later than 30 calendar days after the first day of such manufacture or import.
(2)
If manufacture or import for nonexempt, commercial purposes began or will begin before May 27, 1997, the submitter must submit the NOC by May 27, 1997.
(3)
Submission of an NOC prior to the commencement of manufacture or import is a violation of section 15 of the Act.
(c) Information to be reported.
The NOC must contain the following information: Specific microorganism identity, MCAN number, and the date when manufacture or import commences. If the person claimed microorganism identity confidential in the MCAN, and wants the identity to be listed on the confidential Inventory, the claim must be reasserted and resubstantiated in accordance with § 725.85(b). Otherwise, EPA will list the specific microorganism identity on the public Inventory.
(d) Where to submit.
All notices of commencement must be submitted to EPA in a manner set forth in this paragraph.
(1) Older notices.
Notices of commencement for a MCAN submitted before April 6, 2010 must be submitted on paper either via U.S. mail to the Document Control Office (DCO) (7407M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001 or submitted via courier to the Environmental Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004.
(2) Newer notices.
For MCANs submitted on or after April 6, 2010, EPA will accept notices of commencement only if submitted in accordance with this paragraph:
(i)
Notices of commencement may be submitted on paper on or before April 6, 2011. All paper-based notices of commencement must be generated using e-PMN reporting software and be completed through the finalization step of the software, and e-PMN software must be used to print the statement of withdrawal for submission to EPA. Paper notices of commencement must be submitted either via U.S. mail to the Document Control Office (DCO) (7407M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001 or submitted via courier to the Environmental Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004.
(ii)
Notices of commencement may be submitted as electronic files on optical disc on or before April 6, 2012. All notices of commencement submitted as electronic files on optical disc must be generated using e-PMN reporting software and be completed through the finalization step of the software. Optical discs containing electronic notices of commencement must be submitted by courier to the Environmental Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004.
(iii)
Notices of commencement may be submitted electronically to EPA via CDX on or after April 6, 2010. After April 6, 2012 all notices of commencement must be submitted electronically to EPA via CDX. Prior to submission to EPA via CDX, such notices of commencement must be generated and completed using e-PMN reporting software. See 40 CFR 720.40(a)(2)(iv) for information on how to obtain e-PMN software.