[Code of Federal Regulations]

[Title 42, Volume 1]

[Revised as of October 1, 2006]

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.