[Code of Federal Regulations]
[Title 40, Volume 21]
[Revised as of July 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR172.43]

[Page 262-263]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 172--EXPERIMENTAL USE PERMITS--Table of Contents
 
   Subpart C--Notification for Certain Genetically Modified Microbial 
                               Pesticides
 
Sec. 172.43  Definitions.

    Source: 59 FR 45612, Sept. 1, 1994, unless otherwise noted.


    Terms used in this subpart shall, with the exception of those 
defined below, have the meaning set forth in the Act and in Sec. 172.1.
    Containment and inactivation controls means any combination of 
mechanical, procedural, or biological controls designed and operated to 
restrict environmental release of viable microorganisms from a facility.
    Deliberately modified means the directed addition, rearrangement, or 
removal of nucleotide sequences to or from genetic material.
    Introduction of genetic material means the movement of nucleotide 
sequences into a microorganism, regardless of the technique used.
    Inversions of genetic material means the replacement of an internal 
section of a chromosome in the reverse orientation.
    Microbial pesticide means any pesticide whose active ingredient is a 
microorganism intended for preventing, destroying, repelling, or 
mitigating any pest, or intended for use as a plant regulator, 
defoliant, or desiccant.

[[Page 263]]

    Microbial pesticides resulting from rearrangements means a microbial 
pesticide resulting from translocations or inversions of genetic 
material.
    Microorganism means a bacterium, fungus, alga, virus, or protozoan.
    Nonindigenous microbial pesticide means a microbial pesticide 
brought into one of the following geographic areas from outside that 
area:
    (1) The continental United States, including Alaska, and the 
immediately adjoining countries (i.e., Canada and Mexico).
    (2) The Hawaiian Islands.
    (3) The Caribbean Islands including Puerto Rico and the U.S. Virgin 
Islands.
    Pesticidal property means a characteristic exhibited by a 
microorganism that contributes to the intentional use of the 
microorganism to prevent, destroy, repel, or mitigate a pest or to act 
as a plant regulator, defoliant, or desiccant.
    Single genome means the sum total of chromosomal and 
extrachromosomal genetic material of an isolate and any descendants 
derived under axenic culture conditions from that isolate.
    Small-scale test means the experimental use of a microbial pesticide 
in a facility such as a laboratory or greenhouse, or use in limited 
replicated field trials or other tests as described in Sec. 172.3(c).
    Test or testing means any use of a microbial pesticide consistent 
with section 5 of the Act, including limited replicated field trials and 
associated activities.
    Translocations of genetic material means a chromosomal configuration 
in which part of a chromosome becomes attached to a different 
chromosome, or inserts in a different location on the same chromosome.