10.1 Definitions

  • ARO (Alternate Responsible Official) – Individual assigned the same responsibilities as the Responsible Official (RO), and will act in place of the RO when the RO is absent for an extended period of time.
  • 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 death, disease or other biological malfunction in a human, animal, plant or another living organism; deterioration of food, water, equipment, supplies or material of any kind; or deleterious alteration of the environment.
  • 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.
  • Entity – Any government agency (Federal, State or local), academic institution, corporation, company, partnership, society, association, firm, sole proprietorship or other legal entity. 
  • Facility Director – Staff member to whom the laboratory space is assigned.
  • Laboratory Manager – Properly trained individual responsible for the day-to-day oversight of the laboratory space, supervised by the Facility Director.
  • Proficiency Testing - The process of determining the competency of an individual or laboratory to perform a specified test or procedure.
  • RO (Responsible Official) - Individual designated by the University with the authority and control to ensure compliance that all activities of the Select Agent Program are in compliance with 42 CFR 73, 7 CFR 331 and 9 CFR 121 (Haley Sinn, Biological Safety Officer, EHS, 335-8501).
  • Select agent and/or toxins - Those biological agents and/or toxins listed in 7 CFR 331, 9 CFR 121, 42 CFR 73. 
  • Specimen – Sample of material from humans, animals, plants or the environment or isolate or culture from such sample for the diagnosis, verification or proficiency testing.
  • Toxins - The toxic material or product of plants, animals, microorganisms or infectious substances, or a recombinant or synthesized molecule, and include 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.  
  • Verification - The demonstration of obtaining established performance (e.g., accuracy, precision, and the analytical sensitivity and specificity) specifications for any procedure used for diagnosis.