40 CFR 172.43 - Definitions.
Terms used in this subpart shall, with the exception of those defined below, have the meaning set forth in the Act and in § 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 a microbial agent intended for preventing, destroying, repelling, or mitigating any pest, or intended for use as a plant regulator, defoliant, or desiccant, that:
(1) Is a eucaryotic microorganism including, but not limited to, protozoa, algae and fungi;
(2) Is a procaryotic microorganism, including, but not limited to, Eubacteria and Archaebacteria; or
(3) Is a parasitically replicating microscopic element, including, but not limited to, viruses.
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 § 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.