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Biohazardous Agent Defined

The purpose of the definition is to identify individuals who must register their activities with the IBC.  Additionally, faculty, staff, &/or students who work in labs where biohazardous materials are used must be appropriately trained.  Biohazardous materials are defined as materials of biological origin that have the capacity to produce deleterious effects on humans or animals. They include:

  1. Recombinant or synthetic nucleic acid molecules and/or genetically modified/engineered organisms that are transferred into human research participants (human gene transfer).
  2. Recombinant or synthetic nucleic acid molecules, and/or genetically modified/engineered organisms, that are introduced into vertebrate or invertebrate animals.
  3. Synthetic nucleic acid segments which are likely to yield a potentially harmful polynucleotide or polypeptide; e.g., a toxin or pharmacologically active agent.
  4. Microorganisms where there is a deliberate transfer of a drug-resistant trait or of nucleic acids containing genes for the biosynthesis of products potentially toxic for vertebrates.
  5. Microorganisms classified as risk group 2 (RG-2) or RG-3 agents (Note: RG-4 agents are not allowed in any Virginia Tech spaces) whether infectious or defective.
  6. Microorganisms where more than two-thirds of the nucleic acids from RG-2 or RG-3 agents is cloned into other nonpathogenic agents.
  7. Biological products derived from RG-2 or RG-3 microorganisms.
  8. Clinical/medical waste; e.g., diagnostic specimens that are used in research and are known or are reasonably expected to contain pathogens classified as RG-2, RG-3, or RG-4 agents.
  9. Culture of more than 10 liters of a biological agent.
  10. Materials requiring the use of BSL-2 containment, or higher (e.g. human and/or non-human primate materials, including vendor-purchased cell lines).

Basis for the Classification of Biohazardous Agents by Risk Group

Risk Group Risk to the Individual and the Community
Risk Group 1
Agents that are not associated with disease in healthy adult humans.
Risk Group 2
Agents that are associated with human disease which are rarely serious and for which preventive or therapeutic interventions are often available.
Risk Group 3
Agents that are associated with serious or lethal human disease for which preventive or therapeutic interventions may be available (high individual risk but low community risk).
Risk Group 4
Agents that are likely to cause serious or lethal human disease for which preventive or therapeutic interventions are not usually available (high individual risk and high community risk)