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 U.S. 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;
Centers for Disease Control and Prevention (CDC). The Centers for Disease Control and Prevention of the U.S. Department of Health and Human Services.
Diagnosis. The analysis of specimens for the purpose of identifying or confirming the presence or characteristics of a select agent or toxin, provided that such analysis is directly related to protecting the public health or safety, animal health or animal products, or plant health or plant products.
Entity. Any government agency (Federal, State, or local), academic institution, corporation, company, partnership, society, association, firm, sole proprietorship, or other legal entity.
HHS Secretary. The Secretary of the Department of Health and Human Services or his or her designee, unless otherwise specified.
HHS select agent and/or toxin. A biological agent or toxin listed in 42 CFR 73.3.
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 select agent and/or toxin. A biological agent or toxin that is listed in § 121.4 and 42 CFR 73.4.
Permit. A written authorization by the Administrator to import or move interstate select agents or toxins, under conditions prescribed by the Administrator.
Proficiency testing. The process of determining the competency of an individual or laboratory to perform a specified test or procedure.
Responsible official. The individual designated by an entity with the authority and control to ensure compliance with the regulations in this part.
Select agent and/or toxin. Unless otherwise specified, all of the biological agents or toxins listed in §§ 121.3 and 121.4.
Specimen. Samples of material from humans, animals, plants, or the environment, or isolates or cultures from such samples, for diagnosis, verification, or proficiency testing.
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
United States. All of the States.
USDA. The U.S. Department of Agriculture.
Verification. The demonstration of obtaining established performance (e.g., accuracy, precision, and the analytical sensitivity and specificity) specifications for any procedure used for diagnosis.
VS. The Veterinary Services Programs of the Animal and Plant Health Inspection Service.
VS select agent and/or toxin. A biological agent or toxin listed in § 121.3.