[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: 40CFR725.105]

[Page 485]
 
                   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. 725.105  Persons who must report.

    (a) Manufacturers of new microorganisms. (1) MCAN submission is 
required for any person who intends to manufacture for commercial 
purposes in the United States a new microorganism. Exclusions are 
described in Sec. 725.110.
    (2) If a person contracts with a manufacturer to produce or process 
a new microorganism and the manufacturer produces or processes the 
microorganism exclusively for that person, and that person specifies the 
identity of the microorganism, and controls the total amount produced 
and the basic technology for the plant process, then that person must 
submit the MCAN. If it is unclear who must report, EPA should be 
contacted to determine who must submit the MCAN.
    (3) Only manufacturers that are incorporated, licensed, or doing 
business in the United States may submit a MCAN.
    (b) Importers of new microorganisms. (1) MCAN submission is required 
for a person who intends to import into the United States for commercial 
purposes a new microorganism. Exclusions are described in Sec. 725.110.
    (2) When several persons are involved in an import transaction, the 
MCAN must be submitted by the principal importer. If no one person fits 
the principal importer definition in a particular transaction, the 
importer should contact EPA to determine who must submit the MCAN for 
that transaction.
    (3) Except as otherwise provided in paragraph (b)(4) of this 
section, the provisions of this subpart D apply to each person who 
submits a MCAN for a new microorganism which such person intends to 
import for a commercial purpose. In addition, each importer must comply 
with paragraph (b)(4) of this section.
    (4) EPA will hold the principal importer, or the importer that EPA 
determines must submit the MCAN when there is no principal importer 
under paragraph (b)(2) of this section, liable for complying with this 
part, for completing the MCAN, and for the completeness and truthfulness 
of all information which it submits.
    (c) Manufacturers, importers, or processors of microorganisms for a 
significant new use. MCAN submission is required for any person who 
intends to manufacture, import, or process for commercial purposes a 
microorganism identified as having one or more significant new uses in 
subpart M of this part, and who intends either to engage in a designated 
significant new use of the microorganism or intends to distribute it in 
commerce. Persons excluded from reporting on significant new uses of 
microorganisms and additional procedures for reporting are described in 
subpart L of this part.