[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: 40CFR725.12]

[Page 469-470]
 
                   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. 725.12  Identification of microorganisms for Inventory and other listing 
purposes.

    To identify and list microorganisms on the Inventory, both taxonomic 
designations and supplemental information will be used. The supplemental 
information required in paragraph (b) of this section will be used to 
specifically describe an individual microorganism on the Inventory. 
Submitters must provide the supplemental information required by 
paragraph (b) of this section to the extent necessary to enable a 
microorganism to be accurately and unambiguously identified on the 
Inventory.
    (a) Taxonomic designation. The taxonomic designation of a 
microorganism must be provided for the donor organism and the recipient 
microorganism to the level of strain, as appropriate. These designations 
must be substantiated by a letter from a culture collection, literature 
references, or the results of tests conducted for the purpose of 
taxonomic classification. Upon EPA's request to the submitter, data 
supporting the taxonomic designation must be provided to EPA. The 
genetic history of the recipient microorganism should be documented back 
to the isolate from which it was derived.
    (b) Supplemental information. The supplemental information described 
in paragraphs (b)(1) and (b)(2) of this section is required to the 
extent that it enables a microorganism to be accurately and 
unambiguously identified.
    (1) Phenotypic information. Phenotypic information means pertinent 
traits that result from the interaction of a microorganism's genotype 
and the environment in which it is intended to be used and may include 
intentionally added biochemical and physiological traits.
    (2) Genotypic information. Genotypic information means the pertinent 
and distinguishing genotypic characteristics of a microorganism, such as 
the

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identity of the introduced genetic material and the methods used to 
construct the reported microorganism. This also may include information 
on the vector construct, the cellular location, and the number of copies 
of the introduced genetic material.