BMRiskAssessments

RISK ASSESSMENTS

It is the responsibility of the principal investigator or laboratory supervisor to conduct a risk assessment to determine the proper work practices and containment requirements for work with biohazardous material.

The selection of an appropriate biosafety level or work with a particular agent or animal study is dependent upon a number of factors and must be based on the risk assessment. Two of the most helpful tools available for performing a microbiological risk assessment is the listing of risk groups for microbiological agents found in the Classification of Human Etiologic Agents on the Basis of Hazard and the Agent Summary Statements found in Section 8 of the Biosafety in Microbiological and Biomedical Laboratories (BMBL).

Generally, work with known agents should be conducted at the biosafety level recommended in the Agent Summary Statements of the BMBL and generally, the risk group level of the agent will correlate to the corresponding biosafety level. However, simple reference to the risk grouping for a particular agent is insufficient in the conduct of a risk assessment. A proper assessment will take the risk group as well as other factors into consideration in establishing the appropriate biosafety level. Other factors that should be considered, as appropriate, include:

	a.	Pathogenicity of the agent and infectious dose
	b.	Potential outcome of exposure
	c.	Natural route of infection
	d.	Other routes of infection, resulting from laboratory manipulations (parenteral, airborne, ingestion)
	e.	Stability of the agent in the environment
	f.	Concentration of the agent and volume of concentrated material to be manipulated
	g.	Presence of a suitable host (human or animal)
	h.	Information available from animal studies and reports of laboratory-acquired infections or clinical reports
	i.	Laboratory activity planned (sonication, aerosolization, centrifugation, etc.)
	j.	Any genetic manipulation of the organism that may extend the host range of the agent or alter the agent's sensitivity to known, effective treatment regimens
	k.	Local availability of effective prophylaxis or therapeutic interventions

3.	Therefore, occasions will arise when it will be necessary to assign a biosafety level higher than that recommended in these guidelines. For example, an agent that is assigned to Risk Group 2 may generally require Biosafety Level 2 facilities, equipment, practices and procedures for safe conduct of work. However, if particular experiments require the generation of high-concentration aerosols, then Biosafety Level 3 may be more appropriate to provide the necessary degree of safety, since it ensures superior containment of aerosols in the laboratory workplace.
4.	In general, the biosafety level used for activities involving infectious agents or infected animals must be commensurate with that required for the agent of highest virulence known, or likely to be encountered in the course of the contemplated work.

5.	If, in the course of research or other laboratory examination, there is evidence that the materials being studied contain an agent of higher or lower risk than expected, the biosafety level can be raised or lowered accordingly.
6.	Research involved with materials derived from humans (e.g., blood, tissue, cell lines) must maintain compliance with OSHA's Bloodborne Pathogens Standard and handled under Universal Precautions (treating all material as if infectious). Additionally, all material of human origin must be performed in compliance with Biosafety Level 2 guidelines.
7.	Refer to the following resources to assist in your risk assessment:
	a. NIH Recombinant DNA Guidelines
	b. Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition (CDC/NIH)
	c. WHO (World Health Organization) Biosafety Manual

University of the Sciences in Philadelphia • 600 South Forty-third Street • Philadelphia, PA 19104-4495 • phone: 215-596-8800 • email: safety@usp.edu