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BioSafety Risks Defined
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BIOSAFETY RISKS DEFINED

European Economic Community (DIRECTIVE 93/88/EEC, Oct. 1993)

(1) Group 1 biological agent means one that is unlikely to cause human disease;

(2) Group 2 biological agent means one that can cause human disease and might be a hazard to workers; it is unlikely to spread to the community; there is usually effective prophylaxis or treatment available;

(3) Group 3 biological agent means one that can cause severe human disease and present a serious hazard to workers; it may present a risk of spreading to the community, but there is usually effective prophylaxis or treatment available;

(4) Group 4 biological agent means one that causes severe human disease and is a serious hazard to workers; it may present a high risk of spreading to the community; there is usually no effective prophylaxis or treatment available.

NIH Guidelines on Recombinant DNA (April 2002)

(1) Risk Group 1 (RG1) agents are not associated with disease in healthy adult humans.

(2) Risk Group 2 (RG2) agents are associated with human disease which is rarely serious and for which preventive or therapeutic interventions are often available.

(3) Risk Group 3 (RG3) agents are associated with serious or lethal human disease for which preventive or therapeutic interventions may be available.

(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.

Canadian Laboratory Biosafety Guidelines (2nd ed. 1996)

(1) Risk Group 1 (low individual and community risk) This group includes those microorganisms, bacteria, fungi, viruses and parasites, which are unlikely to cause disease in healthy workers or animals.

(2) Risk Group 2 (moderate individual risk, limited community risk) A pathogen that can cause human or animal disease but under normal circumstances, is unlikely to be a serious hazard to healthy laboratory workers, the community, livestock, or the environment. Laboratory exposures rarely cause infection leading to serious disease; effective treatment and preventive measures are available and the risk of spread is limited.

(3) Risk Group 3 (high individual risk, low community risk) A pathogen that usually causes serious human or animal disease, or which can result in serious economic consequences but does not ordinarily spread by casual contact from one individual to another, or that can be treated by antimicrobial or antiparasitic agents.

(4) Risk Group 4 (high individual risk, high community risk) A pathogen that usually produces very serious human animal disease, often untreatable, and may be readily transmitted from one individual to another, or from animal to human or vice-versa directly or indirectly, or casual contact.

CDC/NIH Biosafety in Microbiological and Biomedical Laboratories (4th Edition 1999)

(1) BIOSAFETY 1 is suitable for work involving well-characterized agents not known to cause disease in healthy adult humans, and of minimal potential hazard to laboratory personnel and the environment.

(2) BIOSAFETY LEVEL 2 is similar to Level 1 and is suitable for work involving agents of moderate potential hazard to personnel and the environment.

(3) BIOSAFETY LEVEL 3 is applicable to clinical, diagnostic, teaching, research, or production facilities in which work is done with indigenous or exotic agents which may cause serious or potentially lethal disease as a result of exposure by the inhalation route.

(4) BIOSAFETY LEVEL 4 is required for work with dangerous and exotic agents which pose a high individual risk of aerosol-transmitted laboratory infections and life-threatening disease.

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