[Code of Federal Regulations]
[Title 42, Volume 1]
[Revised as of October 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR73.1]

[Page 445]
 
                         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:
    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 of a listed select agent or toxin 
provided that such analysis is directly related to protecting the public 
health or safety.
    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 Department of Health and Human Services or 
his or her designee, unless otherwise specified.
    HHS select agent or toxin means a biological agent or toxin included 
in Sec. 73.4.
    Overlap select agent or toxin means a biological agent or toxin 
included in Sec. 73.5.
    Proficiency testing means a sponsored, time-limited analytical trial 
whereby one or more analytes, previously confirmed by 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.
    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.
    Select agent or toxin or select agent and toxin without 
identification as HHS or overlap means all of those biological agents or 
toxins included in Secs. 73.4 and 73.5 of this part.
    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 the United States of America, the District of 
Columbia, Puerto Rico, and the territories and possessions of the United 
States.
    USDA means the United States Department of Agriculture.
    USDA Secretary means the Department of Agriculture or his or her 
designee, unless otherwise specified.
    Verification means the processes required to assure the accuracy, 
precision, and the analytical sensitivity and specificity of any 
procedure used for diagnosis.

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