About Genetically Modified Organisms (Contained Use)
Advances in molecular biology since the early 1970s have resulted in the growth of a wide variety of techniques, which result in genetic modification. These techniques have been applied to a wide range of micro-organisms, plants and animals, resulting in increased scientific understanding of organisms, their interactions, genetics, and functions, as well as enabling production of enyzmes, therapeutic agents and gene therapy vectors.
Genetic modification (GM) occurs where the genetic material of an organism (either DNA or RNA) is altered by use of a method that does not occur in nature and the modification can be replicated and/or transferred to other cells or organisms. Typically, GM involves the removal of DNA, its manipulation outside the cell and reinsertion into the same or another organism. The aim of GM is often to introduce a new or altered characteristic to the target organism.
The organism which has been modified is referred to as a genetically modified organism (GMO). GMOs may be plants, animals or (most commonly) micro-organisms (including bacteria, viruses parasites and fungi). Where the GMO is a micro-organism it is typically referred to as a genetically modified micro-organism (GMM). An important point to note about GMOs is that in the case of humans, even if they have undergone genetic modification as a result of, for example, gene therapy, they are not regarded as GMOs in HSE's legislation.
It is similarly important to clarify what is meant by 'contained use'. Contained use is where control measures are used to limit contact between GMOs and humans and the environment so as to provide a high level of safety. In practice, this involves work in laboratories, animal houses, plant growth facilities (including growth rooms in buildings and suitable glasshouses) and large-scale production facilities on industrial sites.
The vast majority of work with GMOs in contained use is inherently safe. This is because most work involves the insertion of genes into micro-organisms that have been deliberately "crippled" with disabling mutations so that they will not grow outside of the controlled environment of a laboratory test tube. Safety is thus built into the experimental design. Only a small number of activities involve GMMs that are not disabled and still capable of growth outside of the laboratory. Risk assessments for all such work must be submitted to the regulatory authorities for approval before work can commence. The regulatory authorities are thus in a position to ensure that the work is carried out in facilities and equipment that contain the infectious materials during the work activities. The assignment of these containment measures tends to be done on a precautionary basis to allow some margin of safety, where there is any uncertainty over the risks. Gradually as knowledge increases some precautionary safeguards are being removed, where there is clear evidence that they are not necessary, and efforts are being focused on ensuring the safety of those projects where there are tangible hazards. The safety record in this industry is extremely good
About this website
This site describes the health and safety regime covering work with genetically modified organisms (GMOs) in contained facilities, such as research laboratories or biotechnology production facilities.
The types of work covered range from routine laboratory work, involving the cloning of human genes in bacterial strains that are inherently safe, to projects that are at the very frontiers of our understanding of the way in which the most serious pathogens cause disease.
This site does not cover the deliberate release of modified plants in field trials of GM crops.
This site is primarily designed to provide information to assist biological safety officers, employers and others working in the field, in their task of complying with health and safety legislation. There is also some information that will also be of interest to others with a more general interest in biosafety.