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EHS Biosafety follows the NIH Guidelines categorization of Risk Groups as follows: RG1 – Are not associated with disease in healthy adult humans or animals. RG3 – Are associated with serious or lethal human disease for which preventative or therapeutics may be available.
The NIH Guidelines defines the risk groups as: Risk Group 1 (RG1) - Agents that are not associated with disease in healthy adult humans. This group includes a list of animal viral etiologic agents in common use. These agents represent no or little risk to an individual and no or little risk to the community. Risk Group 2 (RG2)
The investigator must make an initial risk assessment based on the risk group of the agent(s) being utilized in the activity. There are 4 risk groups as identified by The NIH Guidelines, according to their relative pathogenicity for healthy adult humans. DePaul University currently can only support research with Risk Group 1 or
Risk Assessment Overview: The risk assessment framework of the NIH Guidelines uses the risk group of the parent organism as a starting point for determining the necessary containment level. For example, genetic modifications of a Risk Group 3 organism would generally be carried out at Biosafety Level 3 (BSL-3)
NIH Guidelines on Recombinant DNA (April 2002) (1) Risk Group 1 (RG1) agents are not associated with disease in healthy adult humans. (4) Risk Group 4 (RG4) agents are likely to cause serious or lethal human disease for which preventive or therapeutic interventions are not usually available.
Experiments Using Risk Group 2, Risk Group 3, Risk Group 4, or Restricted Agents as Host-Vector Systems (See Section II-A, Risk Assessment) 17. Section III-D-2 Experiments in Which DNA From Risk Group 2, Risk Group 3, Risk Group 4, or Restricted Agents is Cloned into Nonpathogenic Prokaryotic or Lower
There is no world-wide standard list of microorganisms and their Risk Groups. Some countries and some cell culture vendors have provided lists, but no single list includes all species, so you might need to check several sources. iGEM recommends three sources for Risk Group information: Canadian PSDS, NIH Guidelines,
DNA from Risk Group 2 or Risk Group 3 agents transferred into nonpathogenic prokaryotes or lower eukaryotes or exempt from the NIH Guidelines (see Section III-F). May be performed at BSL-1or BSL-2 depending on the risk assessment by the IBC. Examples: Yersinia pseudotuberculosis genes encoding outer membrane
The NIH Guidelines established a comparable classification and assigned human etiological agents into four risk groups on the basis of hazard.2 The descriptions of the WHO and NIH risk group classifications are presented in Table 1. They correlate with but do not equate to biosafety levels.
B.2 NIH Guidelines Human Etiologic Agents. This section provides a list of human pathogens and their Risk Group (RG) 2, RG3, and RG4 designations as excerpted from Appendix B, Classification of Human Etiologic Agents on the Basis of Hazard, of the NIH Guidelines, amendment effective November 6, 2013.

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March 2018