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Risk Groups Defined


Biosafety Level for a given project is assigned based upon the highest Risk Group material utilized.
  • Risk Group 1 (RG1) agents are not associated with disease in healthy adult humans.
  • Risk Group 2 (RG2) agents are associated with human disease which is rarely serious and for which preventive or therapeutic interventions are often available.
  • Risk Group 3 (RG3) agents are associated with serious or lethal human disease for which preventive or therapeutic interventions may be available.
  • Risk Group 4 (RG4) agents are likely to cause serious or lethal human disease for which preventive or therapeutic interventions are not usually available.

RISK GROUP DETERMINATION
The applicant should consult the following resources to make a conservative determination of Risk Group (and Biosafety Level).

   Resources for Risk Group Determination

CULTURED CELLS, BACTERIA, FUNGI, VIRUSES 
RECOMBINANT DNA (rDNA)
  • Appendix B of the NIH Guidelines
  • If the  rDNA is toxic or virulent, the Risk Group may need to be classified according to the pathogens expressed by the rDNA.
HUMAN OR NON-HUMAN PRIMATE DERIVED MATERIALS
  •  These materials are not formally classified as Risk Group agents by NIH; however, their capacity to host infectious agents requires employment of  BSL-2 or greater procedures and containment.


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