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Process Organism gory need to be operated aseptically but no containment steps are necessary, including prevention of escape of organisms. If the organism is placed in Hazard group 4 the stringent requirements of level 3 will have to be met before the process can be operated. Details of hazard categories for a range of organisms can be obtained from Frommer et al. (1989).

Genetically engineered organisms are classified as either harmless (Group I) or potentially harmful (Group II). The process is then classified as either small scale (A: less than 10 dm3) or large scale (B: more than 10 dm3) according to guidelines which can be found in the Health and Safety Executive document (1993). Therefore large scale processes fall into two categories, IB or IIB. IB processes require containment level B1 and are subject to GILSP, whereas IIB processes are further assessed to determine the most suitable containment level, ranging from B2 to B4 as outlined in Table 7.4. Levels B2 to B4 correspond to levels 1 to 3 for non-genetically engineered organisms.

In future it is possible, under new legislation, that no distinction will be made between non-genetically engineered and genetically engineered organisms. The key factor will be whether the organism is harmless or potentially harmful, regardless of its genetic constitution. Containment would then be decided using the scheme which is currently being used for genetically engineered organisms.

Other hazard-assessment systems for classifying organisms have been introduced in many other countries. Production and research workers must abide by appropriate local official hazard lists. Problems can occur when different official bodies place the same organism in different hazard categories. In 1989, the European

Process Organism

Non-genetically engineered

Hazard group allocation

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