73.1—Definitions.
For purposes of this part:
Administrator means the Administrator, Animal and Plant Health Inspection Service, or any person authorized to act for the Administrator.
Animal and Plant Health Inspection Service (APHIS) means the Animal and Plant Health Inspection Service of the U.S. Department of Agriculture.
Attorney General means the Attorney General of the United States or any person authorized to act for the Attorney General.
Biological agent means 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 death, disease, or other biological malfunction in a human, an animal, a plant, or another living organism; deterioration of food, water, equipment, supplies, or material of any kind; or deleterious alteration of the environment.
CDC means Centers for Disease Control and Prevention of the Department of Health and Human Services.
Diagnosis means 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 means any government agency (Federal, State, or local), academic institution, corporation, company, partnership, society, association, firm, sole proprietorship, or other legal entity.
HHS means the Department of Health and Human Services.
HHS Secretary means the Secretary of the Department of Health and Human Services or his or her designee, unless otherwise specified.
HHS select agent and/or toxin means a biological agent or toxin included in § 73.3.
Overlap select agent and/or toxin means a biological agent or toxin listed in § 73.4 and 9 CFR part 121.4.
Principal investigator means the one individual who is designated by the entity to direct a project or program and who is responsible to the entity for the scientific and technical direction of that project or program.
Proficiency testing means the process of determining the competency of an individual or laboratory to perform a specified test or procedure.
Responsible Official means 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 means unless otherwise specified, all of the biological agents or toxins listed in §§ 73.3 and 73.4.
Specimen means samples of material from humans, animals, plants or the environment or isolates or cultures from such samples for the diagnosis, verification, or proficiency testing.
State means 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 means 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 any poisonous substance or biological product that may be engineered as a result of biotechnology, produced by a living organism; or any poisonous isomer or biological product, homolog, or derivative of such a substance.
United States means all of the States.
USDA means the United States Department of Agriculture.
Verification means the demonstration of obtaining established performance (e.g., accuracy, precision, and the analytical sensitivity and specificity) specifications for any procedure used for diagnosis.