[Code of Federal Regulations]
[Title 42, Volume 1]
[Revised as of October 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR73.1]

[Page 438-439]
 
                         TITLE 42--PUBLIC HEALTH
 
    CHAPTER I--PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 73_SELECT AGENTS AND TOXINS--Table of Contents
 
Sec. 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 Sec. 73.3.
    Overlap select agent and/or toxin means a biological agent or toxin 
listed in Sec. 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 Sec. Sec. 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

[[Page 439]]

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.