[Code of Federal Regulations]
[Title 9, Volume 1]
[Revised as of January 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR121.1]

[Page 740-741]
 
                  TITLE 9--ANIMALS AND ANIMAL PRODUCTS
 
  CHAPTER I--ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF 
                               AGRICULTURE
 
PART 121_POSSESSION, USE, AND TRANSFER OF BIOLOGICAL AGENTS AND 
TOXINS--Table of Contents
 
Sec.  121.1  Definitions.

    Administrator. The Administrator, Animal and Plant Health Inspection 
Service, or any person authorized to act for the Administrator.
    Animal and Plant Health Inspection Service (APHIS). The Animal and 
Plant Health Inspection Service of the United States Department of 
Agriculture.
    Attorney General. The Attorney General of the United States or any 
person authorized to act for the Attorney General.
    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 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.
    Centers for Disease Control and Prevention (CDC). The Centers for 
Disease Control and Prevention of the United States Department of Health 
and Human Services.
    Clinical laboratory. A laboratory facility that receives patients 
and collects specimens for processing or shipping to another laboratory.
    Diagnostic laboratory. A laboratory facility that receives specimens 
for the purpose of determining the identities of pests, pathogens, 
contaminants, or causes of disease.
    Entity. Any government agency (Federal, State, or local), academic 
institution, corporation, company, partnership, society, association, 
firm, sole proprietorship, or other legal entity.
    Import. To move into, or the act of movement into, the territorial 
limits of the United States.
    Interstate. From one State into or through any other State, or 
within the District of Columbia, Guam, the Virgin Islands of the United 
States, or any other territory or possession of the United States.
    Overlap agent or toxin. Any microorganism (including, but not 
limited to, bacteria, viruses, fungi, rickettsiae, or protozoa) or toxin 
that poses a risk to both human and animal health and that is listed in 
Sec.  121.3(b).
    Permit. A written authorization by the Administrator to import or 
move interstate biological agents or toxins, under conditions prescribed 
by the Administrator.
    Proficiency testing. A sponsored, time-limited analytical trial 
whereby one or more analytes, previously confirmed by

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the sponsor, are submitted to the testing laboratory for analysis and 
where final results are graded, scores are recorded and provided to 
participants, and scores for participants are evaluated for acceptance.
    Responsible official. The individual designated by an entity to act 
on its behalf. This individual must have the authority and control to 
ensure compliance with the regulations in this part.
    Specimen. A sample of material collected for use in testing, such as 
tissues, gastrointestinal contents, feces, bodily fluids (blood, serum, 
etc.), soil, water, feed or feed ingredients, swabs, cultures, and 
suspensions.
    State. Any of the several States of the United States, the 
Commonwealth of the Northern Mariana Islands, the Commonwealth of Puerto 
Rico, the District of Columbia, Guam, the Virgin Islands of the United 
States, or any other territory or possession of the United States.
    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.
    United States. All of the States.
    USDA. The United States Department of Agriculture.