[Code of Federal Regulations]

[Title 7, Volume 5]

[Revised as of January 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 7CFR331.1]



[Page 477-478]

 

                          TITLE 7--AGRICULTURE

 

 CHAPTER III--ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF 

                               AGRICULTURE

 

PART 331_POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS--Table 

of Contents

 

Sec. 331.1  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;

    (2) Deterioration of food, water, equipment, supplies, or material 

of any kind; or

    (3) Deleterious alteration of the environment.

    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.

    Permit. A written authorization by the Administrator to import or 

move interstate select agents or toxins, under conditions prescribed by 

the Administrator.

    PPQ. The Plant Protection and Quarantine Programs of the Animal and 

Plant Health Inspection Service.

    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. A biological agent or toxin listed in 

Sec. 331.3.

    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



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    (2) Any poisonous isomer or biological product, homolog, or 

derivative of such a substance.

    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.