42 C.F.R. § 73.1

Current through September 30, 2024

Section 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.

Conotoxins means short, paralytic alpha conotoxins containing the following amino acid sequence X₁CCX₂PACGX₃X₄X₅X ₆CX₇, whereas:

(1) C = Cysteine residues are all present as disulfides, with the 1st and 3rd Cysteine, and the 2nd and 4th Cysteine forming specific disulfide bridges;

(2) The consensus sequence includes known toxins [ALPHA]-MI and [ALPHA]-GI (shown above) as well as [ALPHA]-GIA, Ac1.1a, [ALPHA]-CnIA, [ALPHA]-CnIB;

(3) X₁ = any amino acid(s) or Des-X;

(4) X₂ = Asparagine or Histidine;

(5) P = Proline;

(6) A = Alanine;

(7) G = Glycine;

(8) X₃ = Arginine or Lysine;

(9) X₄ = Asparagine, Histidine, Lysine, Arginine, Tyrosine, Phenylalanine or Tryptophan;

(10) X₅ = Tyrosine, Phenylalanine, or Tryptophan;

(11) X₆ = Serine, Threonine, Glutamate, Aspartate, Glutamine, or Asparagine;

(12) X₇ = Any amino acid(s) or Des X; and

(13) "Des X" = "an amino acid does not have to be present at this position." For example if a peptide sequence were XCCHPA then the related peptide CCHPA would be designated as Des-X.

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 § 73.3 .

Information security means protecting information and information systems from unauthorized access, use, disclosure, disruption, modification, or destruction in order to provide-

(1) Integrity, which means guarding against improper information modification or destruction, and includes ensuring information authenticity;

(2) Confidentiality, which means preserving authorized restrictions on access and disclosure, including means for protecting personal privacy and proprietary information; and

(3) Availability, which means ensuring timely and reliable access to and use of information.

Occupational exposure means any reasonably anticipated skin, eye, mucous membrane, parenteral contact, or respiratory aerosol exposure to select agents or toxins that may result from the performance of an employee's duties.

Overlap select agent and/or toxin means a biological agent or toxin listed in § 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.

Recombinant nucleic acids means:

(1) Molecules that are constructed by joining nucleic acid molecules and that can replicate in a living cell or

(2) Molecules that result from the replication of those described in paragraph (1) of this definition.

Responsible Official means the individual designated by an entity with the authority and control to ensure compliance with the regulations in this part.

Security barrier means a physical structure that is designed to prevent entry by unauthorized persons.

Select agent and/or toxin means unless otherwise specified, all of the biological agents or toxins listed in §§ 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.

Synthetic nucleic acids means:

(1) Molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules (i.e., synthetic nucleic acids) or

(2) Molecules that result from the replication of those described in paragraph (1) of this definition.

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 all of the States.

USDA means the United States Department of Agriculture.

Validated inactivation procedure means a procedure, whose efficacy is confirmed by data generated from a viability testing protocol, to render a select agent non-viable but allows the select agent to retain characteristics of interest for future use; or to render any nucleic acids that can produce infectious forms of any select agent virus non-infectious for future use.

Viability testing protocol means a protocol to confirm the validated inactivation procedure by demonstrating the material is free of all viable select agent.

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.

42 C.F.R. §73.1

70 FR 13316, Mar. 18, 2005, as amended at 77 FR 61110, Oct. 5, 2012; 82 FR 6290, Jan. 19, 2017