[Code of Federal Regulations]
[Title 40, Volume 28]
[Revised as of July 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR725.170]

[Page 489]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 725--REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS
--Table of Contents
 
  Subpart D--Microbial Commercial Activities Notification Requirements
 
Sec. 725.170  EPA review of the MCAN.

    General procedures for review of all submissions under this part are 
contained in Secs. 725.28 through 725.60. In addition, the following 
procedures apply to EPA review of MCANs submitted under this subpart:
    (a) Length of the review period. The MCAN review period specified in 
section 5(a) of the Act runs for 90 days from the date the Document 
Control Officer for the Office of Pollution Prevention and Toxics 
receives a complete MCAN, or the date EPA determines the MCAN is 
complete under Sec. 725.33, unless the Agency extends the period under 
section 5(c) of the Act and Sec. 725.56.
    (b) Notice of expiration of MCAN review period. (1) EPA will notify 
the submitter that the MCAN review period has expired or that EPA has 
completed its review of the MCAN. Expiration of the review period does 
not constitute EPA approval or certification of the new microorganism, 
and does not mean that EPA may not take regulatory action against the 
microorganism in the future.
    (2) After expiration of the MCAN review period, in the absence of 
regulatory action by EPA under section 5(e), 5(f), or 6(a) of the Act, 
the submitter may manufacture or import the microorganism even if the 
submitter has not received notice of expiration.
    (3) Early notification that EPA has completed its review does not 
permit commencement of manufacture or import prior to the expiration of 
the 90-day MCAN review period.
    (c) No person submitting a MCAN in response to the requirements of 
this subpart may manufacture, import, or process a microorganism subject 
to this subpart until the review period, including all extensions and 
suspensions, has expired.