The backbone of the practice of biosafety is risk assessment. While there are many tools available to assist in the assessment of risk for a given procedure or experiment,the most important component is professional judgement. Risk assessments shouldbe performed by the individuals most familiar with the specific characteristics of theorganisms being considered for use, the equipment and procedures to be employed,animal models that may be used, and the containment equipment and facilitiesavailable. The laboratory director or principal investigator is responsible for ensuringthat adequate and timely risk assessments are performed, and for working closely withthe institution’s safety committee and biosafety personnel to ensure that appropriateequipment and facilities are available to support the work being considered. Onceperformed, risk assessments should be reviewed routinely and revised when necessary,taking into consideration the acquisition of new data having a bearing on the degreeof risk and other relevant new information from the scientific literature.One of the most helpful tools available for performing a microbiological risk assess-ment is the listing of risk groups for microbiological agents (see Chapter1). However,simple reference to the risk grouping for a particular agent is insufficient in the conductof a risk assessment. Other factors that should be considered, as appropriate, include:1.Pathogenicity of the agent and infectious dose2.Potential outcome of exposure3.Natural route of infection4.Other routes of infection, resulting from laboratory manipulations (parenteral,airborne, ingestion)5.Stability of the agent in the environment6.Concentration of the agent and volume of concentrated material to be manipulated7.Presence of a suitable host (human or animal)8.Information available from animal studies and reports of laboratory-acquiredinfections or clinical reports9.Laboratory activity planned (sonication, aerosolization, centrifugation, etc.)10.Any genetic manipulation of the organism that may extend the host range of theagent or alter the agent’s sensitivity to known, effective treatment regimens (seeChapter16)11.Local availability of effective prophylaxis or therapeutic interventions.