[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: 40CFR725.1]

[Page 466]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 725--REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS
--Table of Contents
 
             Subpart A--General Provisions and Applicability
 
Sec. 725.1  Scope and purpose.


    (a) This part establishes all reporting requirements under section 5 
of TSCA for manufacturers, importers, and processors of microorganisms 
subject to TSCA jurisdiction for commercial purposes, including research 
and development for commercial purposes. New microorganisms for which 
manufacturers and importers are required to report under section 
5(a)(1)(A) of TSCA are those that are intergeneric. In addition, under 
section 5(a)(1)(B) of TSCA, manufacturers, importers, and processors may 
be required to report for any microorganism that EPA determines by rule 
is being manufactured, imported, or processed for a significant new use.
    (b) Any manufacturer, importer, or processor required to report 
under section 5 of TSCA (see Sec. 725.100 for new microorganisms and 
Sec. 725.900 for significant new uses) must file a Microbial Commercial 
Activity Notice (MCAN) with EPA, unless the activity is eligible for a 
specific exemption as described in this part. The general procedures for 
filing MCANs are described in subpart D of this part. The exemptions 
from the requirement to file a MCAN are for certain kinds of contained 
activities (see Secs. 725.424 and 725.428), test marketing activities 
(see Sec. 725.300), and research and development activities described in 
paragraph (c) of this section.
    (c) Any manufacturer, importer, or processor required to file a MCAN 
for research and development (R&D) activities may instead file a TSCA 
Experimental Release Application (TERA) for a specific test (see 
Sec. 725.250). A TERA is not required for certain R&D activities; 
however a TERA exemption does not extend beyond the research and 
development stage, to general commercial use of the microorganism, for 
which compliance with MCAN requirements is required. The TERA exemptions 
are for R&D activities subject to other Federal agencies or programs 
(see Sec. 725.232), certain kinds of contained R&D activities (see 
Sec. 725.234), and R&D activities using certain listed microorganisms 
(see Sec. 725.238).
    (d) New microorganisms will be added to the Inventory established 
under section 8 of TSCA once a MCAN has been received, the MCAN review 
period has expired, and EPA receives a Notice of Commencement (NOC) 
indicating that manufacture or importation has actually begun. New 
microorganisms approved for use under a TERA will not be added to the 
Inventory until a MCAN has been received, the MCAN review period has 
expired, and EPA has received an NOC.