[Code of Federal Regulations]
[Title 9, Volume 1]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR121.1]

[Page 739-740]
 
                  TITLE 9--ANIMALS AND ANIMAL PRODUCTS
 
  CHAPTER I--ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF 
                               AGRICULTURE
 
PART 121--POSSESSION OF BIOLOGICAL AGENTS AND TOXINS--Table of Contents
 
Sec. 121.1  Definitions.

    Biological agent. Any microorganism (including, but not limited to, 
bacteria, viruses, fungi, rickettsiae, or protozoa), or infectious 
substance, or any naturally occurring, bioengineered, or synthesized 
component of any such

[[Page 740]]

microorganism or infectious substance, capable of causing:
    (1) Death, disease, or other biological malfunction in a human, an 
animal, a plant, or another living organism;
    (2) Deterioration of food, water, equipment, supplies, or material 
of any kind; or
    (3) Deleterious alteration of the environment.
    Facility. Any individual or government agency, university, 
corporation, company, partnership, society, association, firm, or other 
legal entity located at a single geographic site that may transfer or 
receive through any means a biological agent or toxin subject to this 
part.
    Overlap agent or toxin. A microorganism (including a virus, 
bacterium, fungus, rickettsia) or toxin that poses a risk to both human 
and animal health and that is listed in Sec. 121.2(a). The term also 
includes:
    (1) Genetically modified microorganisms or genetic elements from 
organisms listed in Sec. 121.2(a), shown to produce or encode for a 
factor associated with a disease; and
    (2) Genetically modified microorganisms or genetic elements that 
contain nucleic acid sequences coding for any of the toxins listed in 
Sec. 121.2(a), or their toxic subunits.
    Person. Any individual, firm, corporation, company, society, or 
association; any Federal, State, or local governmental entity; or any 
organized group of any of the foregoing.
    Responsible facility official. An official authorized to transfer 
and receive biological agents or toxins, including overlap agents and 
toxins, covered by this part on behalf of a facility. This person should 
be either a safety officer, a senior management official of the 
facility, or both. The responsible facility official should not be an 
individual who actually transfers or receives a biological agent or 
toxin at the facility.
    Toxin. The toxic material or product of plants, animals, 
microorganisms (including, but not limited to, bacteria, viruses, fungi, 
rickettsiae, or protozoa), or infectious substances, or a recombinant or 
synthesized molecule, whatever their origin and method of production, 
and includes:
    (1) Any poisonous substance or biological product that may be 
engineered as a result of biotechnology produced by a living organism; 
or
    (2) Any poisonous isomer or biological product, homolog, or 
derivative of such a substance.

[67 FR 52388, Aug. 12, 2002, as amended at 67 FR 60520, Sept. 26, 2002]