Biosafety and biosecurity measures: management of biosafety level 3 facilities☆
Introduction
The principal characteristics of an agent that render it hazardous are its capability to infect and cause disease in a susceptible human or animal host, its virulence as measured by the severity of the disease it causes, and the availability of preventive measures and effective treatments for the disease. The World Health Organisation (WHO) has recommended an agent classification for laboratory use that describes four general risk groups based on these principal characteristics and the route of transmission of the natural disease. The four groups address the risk to both the laboratory worker and the community. The US National Institutes of Health (NIH) guidelines establish a comparable classification and assign human aetiological agents to one of four risk groups on the basis of hazard. The descriptions of the WHO and NIH risk group classifications are given in Table 1. They correlate with, but do not equate to, biosafety levels.
Determining the risk group (RG) of a biological agent is part of the biosafety risk assessment and helps in assigning the correct biosafety level (BSL) for containment (see Section 2.4). In general, RG2 agents are handled at BSL2 and RG3 agents at BSL3. However, the use of certain RG2 agents in large quantities might require BSL3 conditions, whereas some RG3 agents may be safely manipulated at BSL2 under certain conditions [1], [2].
The protection of laboratory workers, the environment, the product and the biological agents is achieved by addressing laboratory management, laboratory biosafety measures and laboratory biosecurity measures.
Section snippets
Laboratory management
Highly infectious biological material includes samples such as human or animal tissues, body fluids and vectors that are known to carry certain viruses or bacteria. These are usually collected from field sites in endemic areas or during outbreaks of known or unknown aetiology. Samples can also be collected from hospitals for routine laboratory testing. It is important to use appropriate precautions when handling these samples.
Laboratory biosafety
A laboratory biosafety plan is a set of preventive measures designed to reduce the risk of accidental exposure to or release of a biological hazard. A biosafety plan includes a set of interrelated elements covering work practice, the primary barrier (e.g. personal protective equipment and biosafety cabinets) and the secondary barrier, such as facility design features. Biosafety programmes should prevent employees and their families from acquiring laboratory-associated infectious diseases,
Laboratory biosecurity
Laboratory biosecurity encompasses a set of preventive measures designed to reduce the risk of intentional removal (theft) of biological material. Today, the world is facing a new challenge in safeguarding public health from potential domestic or international terrorism involving the use of dangerous biological agents or toxins. Existing standards and practices may require adaptation to ensure protection from such hostile actions. In addition, all nations mandate increased security within the
Conclusions
It is important to heighten awareness of the need of BSL3 laboratory management, laboratory biosafety and laboratory biosecurity measures. One way to address this would be to introduce the concept through education at universities, within both life sciences and engineering departments.
Assessment of facilities requires setting specific goals and selecting management approaches. Creating rules and regulations, including penalties, and implementing strategy is the role of government ministries.
Acknowledgments
Dr Kenneth Earhart, Commanding Officer, US Naval Medical Research Unit #3 (NAMRU-3), Dr Mark Turner, Executive Officer, NAMRU-3, Dr Moustafa Mansour, Director, Research Science Directorate, NAMRU-3, Dr Emad Mohareb, Head Serology/Field Studies Unit, VZDRP, NAMRU-3, Mrs Salwa A. Mohanna, Administrative Support, NAMRU-3, and the US Department of State Biosecurity Engagement Program (BEP).
Funding: AZ is an employee of the US Government. This article was prepared as part of the author's official
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The views expressed in this article are those of the author and do not necessarily reflect the official policy or position of the Department of the Navy, Department of Defense, or the US Government.