Large Scale Processing of Genetically Manipulated Organisms -- Assessing the Risks by Q.R.A. Methodology. Nigel J. Brace, COSH Services, Townhead, Beckermet, Cumbria
In biochemical engineering processes, the utilisation of genetically modified micro-organisms provides considerable commercial potential in the manufacture of pharmaceutical, vaccine, therapeutic and food products. Since the introduction of this technology, concerns have been expressed about the potential health hazards to the workers involved as well as the public and environment at large. As a result, common national and international safety standards have been developed. These standards are based on general engineering principles of design and containment which are categorised and applied according to the nature of the process and the micro-organisms involved. Such categorisations have been based on qualitative assessments of the likely risk.
Views have been expressed on whether such safety measures are justifiable, particularly in comparison to those risks created from conventional chemical or pharmaceutical processes. Except for specific Hazop type studies, quantitative methods have not been commonly adopted to evaluate the risks and safety measures.
Quantitative analytical methods now form part of the evaluations in assessing risks for major hazardous operations, such as toxic and flammable chemical processes, nuclear industries, offshore installations and transportation. These evaluations enable decisions to be made on the tolerability of the risks for workers and the general public and accordingly, whether the safety measures are justifiable in societal terms. It follows that such assessment methods should be considered in examining the health hazards from processes using genetically modified microorganisms.
In this paper, the risks for a particular process involving genetically
manipulated microorganisms are examined and compared to a conventional
chemical process with similar inherent health hazard levels.
As this is a comparative study, Preliminary Hazard Analysis and
short-cut quantitative risk assessment methodologies are adopted.
This modelling approach suggests that the risks from the modified
organisms are lower than comparable chemical processes, but attention
still needs to be given to allergenic hazards created by airborne
biological matter released from the plant during normal operations
and failure events. However, the study also emphasises those
aspects of plant operation worthy of more elaborate quantitative
risk analysis and suggests how these methods could be applied
to assessing risks across the range of genetical manipulation
processes.