[Code of Federal Regulations]
[Title 9, Volume 1]
[Revised as of January 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR121.1]

[Page 765-766]
 
                  TITLE 9--ANIMALS AND ANIMAL PRODUCTS
 
  CHAPTER I--ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF 
                               AGRICULTURE
 
PART 121_POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS--Table 
of Contents
 
Sec. 121.1  Definitions.




Sec.
121.1 Definitions.
121.2 Purpose and scope.
121.3 VS select agents and toxins.
121.4 Overlap select agents and toxins.
121.5 Exemptions for VS select agents and toxins.
121.6 Exemptions for overlap select agents and toxins.
121.7 Registration and related security risk assessments.
121.8 Denial, revocation, or suspension of registration.
121.9 Responsible official.
121.10 Restricting access to select agents and toxins; security risk 
          assessments.
121.11 Security.
121.12 Biosafety.
121.13 Restricted experiments.
121.14 Incident response.
121.15 Training.
121.16 Transfers.
121.17 Records.
121.18 Inspections.
121.19 Notification of theft, loss, or release.
121.20 Administrative review.

    Authority: 7 U.S.C. 8401; 7 CFR 2.22, 2.80, and 371.4.

    Source: 70 FR 13284, Mar. 18, 2005, unless otherwise noted.


    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.
    Overlap select agent and/or toxin. A biological agent or toxin that 
is listed in Sec. 121.4 and 42 CFR 73.4.
    Permit. A written authorization by the Administrator to import or 
move interstate select agents or toxins, under conditions prescribed by 
the Administrator.
    Proficiency testing. The process of determining the competency of an 
individual or laboratory to perform a specified test or procedure.
    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. Unless otherwise specified, all of the 
biological agents or toxins listed in Sec. Sec. 121.3 and 121.4.

[[Page 766]]

    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
    (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.
    VS. The Veterinary Services Programs of the Animal and Plant Health 
Inspection Service.
    VS select agent and/or toxin. A biological agent or toxin listed in 
Sec. 121.3.