The Genetically Modified Organisms (Contained Use) (GMOs) 2014 contains practical guidance, advice on risk assessments, classification and accident reporting for duty holders to comply with the law. These regulations specifically involve working with GMOs in contained facilities.“Contained Use” means where humans and the environment are protected as much as possible; barriers can be physical, chemical or biological. The regulations include interactions with the closely related Control of Substances Hazardous to Health 2002 (COSHH).
Genetic modification involves the mutation, insertion, or deletion of genes. Inserted genes usually come from a different species which have the desired entity, for example, inserting a plant with the gene of another to offer it protection from pests, i.e herbicide resistant plants, known as Genetically Modified Crops. Gene(s) are moved from one organism to another (the latter becomes “transgenic”) in a laboratory or other establishment. GMOs are used in medical research, production of drugs, experimental medicine (e.g. gene therapy), and agriculture.
The Scientific Advisory Committee on Genetic Modification (Contained Use) (SACGM(CU)) is an advisory committee which provides scientific advice to authorities on the contained use of GMOs, particularly in respect of hazard identification and risk assessment. The first point in the risk assessment is to consider the hazardous properties of the microorganism. There is an approved list of biological agents available from HSE. Consideration must also be given to how the micro-organism is being modified, for example, enhancement of function, and, and as a result the impact on its hazardous properties, i.e will it now become more hazardous or stay the same. Consideration should also be given to the work processes and where the work will be undertaken. The risks must be adequately controlled by containment and control measures. These risks are classed one to four, i.e CL1 – 4, with a containment necessary to control the risk which could be Level 1 – 4. See table 1. The GMO guidelines contain detailed information on how this table works (Schedule 8 of the regulations). The risk assessment should be proportionate to the work being done. For example, routine work involving cloning of mammalian genes will use a series of well-defined processes. Whereas, work on a pathogenic virus will require a different approach.
When the risk assessment has been carried out, it needs to be reviewed and reconsidered in terms of levels and classification of works. The recorded risk assessment should be considered a ‘living’ document and be kept relevant and up to date with regard to any changes in the work environment. If a new establishment is planned to be used for contained use, a notification must be submitted to the authority. One should refer to schedule 5 for more information on this. The authority must be notified of any significant changes to the risks associated with the contained use. In all aspects involving micro-organisms, it is the duty of the employer and employees to minimise risks to humankind and the environment.
Table 1 http://www.hse.gov.uk/pubns/priced/l29.pdf