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Institutional Biosafety Committee (IBC)

NIH Risk Group Classifications

Factors That Determine the Specific Risk Group Classification for Infectious Agents

  • pathogenicity of the organism
  • mode of transmission and host range
  • availability of effective preventive measures (for example, vaccines)
  • availability of effective treatments (for example, antibiotics)

NIH Basis for the Classification of Biohazardous Agents by Risk Group (RG)

Risk Group 1
(RG1)

Agents that are not associated with disease in healthy adult humans.

Risk Group 2
(RG2)

Agents that are associated with human disease which is rarely serious and for which preventive or therapeutic interventions are often available.

Risk Group 3
(RG3)

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
(RG4)

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).

Refer to Appendix B of the NIH Guidelines for Research Involving Recombinant DNA Molecules for a current list of microorganisms in each risk group.

Containment categories for some commonly used academic    cells and biological agents.

Cells and cell lines

(Guidelines adapted from ATCC recommendations; ATCC catalog)

BL1

  • Cell lines which are of sub-primate or normal primate origin, which do not harbor a primate virus, and which are not contaminated by fungi, bacteria, mycoplasma, etc.

BL2

  • Primate cell lines derived from lymphoid or tumor tissues
  • All cell lines exposed to or transformed by a primate oncogenic virus
  • All human clinical materials
  • All mycoplasma-contaminated cell lines

Miscellaneous: cell lines known to contain/produce an infectious etiologic agent or virus should be classified at the same level as that recommended for the etiologic agent or virus.

Infectious agents and vector systems

BL1

  • Recombinant DNA (generic K12 E. coli)
  • Murine retrovirus vectors
  • Baculovirus
  • Adeno-associated virus (AAV) and AAV vectors
  • Herpesvirus saimiri
  • Avian and murine retroviruses and vectors derived from any of these viruses.

BL2

  • Adenovirus and adenovirus vectors
  • Human herpesviruses 1 thru 7
  • Human papillomaviruses
  • Respiratory syncytial virus
  • Poliovirus
  • Influenza virus
  • Enterotoxic E. coli
  • Neisseria
  • Staph and Strep
  • Mycoplasma
  • Vaccinia virus and recombinant vaccinia virus vectors

BL2+ (serum banking)

  • Lab scale HIV
  • Lab scale HTLV
  • Lab scale SIV
  • SFV vectors (from Life Technologies: SFV is listed as NIH RG3, but this system was specifically approved for BL2+ use)

BL3 (serum banking)

  • Mycobacterium tuberculosis
  • Rickettsia spp
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