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The law

The primary piece of legislation that applies to the use of genetically modified organisms in the workplace is the Genetically Modified Organisms (Contained Use) Regulations 2000 (GMO(CU)) as amended by Genetically Modified Organisms (Contained Use) (Amendment) Regulations in 2002, 2005 and 2010. A note clarifying the minor changes made in 2010 was sent to biosafety officers.

The GMO (CU) Regulations provide for human health and safety and environmental protection from genetically modified micro-organisms in contained use, and additionally the human health and safety from genetically modified plants and animals (GMOs). The key requirement of the GMO (CU) Regulations is to assess the risks of all activities and to make sure that any necessary controls are put in place. The GMO (CU) Regulations provide a framework for making these judgments, and place clear legal obligations on people who work with GMOs.

The Genetically Modified Organisms (Contained Use) Regulations 2000:

• require risk assessment of activities involving genetically modified micro-organisms and activities involving organisms other than micro-organisms. All activities must be assessed for risk to humans and those involving GMMs assessed for risk to the environment;
• introduce a classification system based on the risk of the activity independent of the purpose of the activity. The classification is based on the four levels of containment for microbial laboratories;
• require notification of all premises to HSE before they are used for genetic modification activities for the first time;
• require notification of individual activities of Class 2 (low risk) to Class 4 (high risk) to be notified to the Competent Authority (which HSE administers). Consents are issued for all Class 3 (medium risk) and Class 4 (high risk) activities. Class 1 (no or negligible risk) activities are non notifiable, although they are open to scrutiny by HSE's specialist inspectors who enforce the Regulations. Activities involving GM animals and plants which are more hazardous to humans than the parental non modified organism also require notification;
• require fees payable for the notification of premises for first time use, class 2, 3 and 4 activities notifications, and notified activities involving GM animals and plants.
• require the maintenance of a public register of GM premises and certain activities.

There are also other pieces of health and safety legislation that are relevant to work with GMOs. These include the general requirements of the Health and Safety at Work Act 1974, the Management of Health and Safety at Work Regulations 1999, and the Carriage of Dangerous Goods legislation. There are also some biological agents aspects of the Control of Substances Hazardous to Health Regulations 2002 which may be applicable in some circumstances.

Further pieces of legislation covering the environmental risks posed by work in contained facilities with GM plants and animals are

• Section 108 (1) of the Environment Protection Act 1990
• The Genetically Modified Organisms (Risk assessment)(Records and Exemptions) Regulations 1996
• The Genetically Modified Organisms (Deliberate Release and Risk Assessment-Amendment) Regulations 1997

The Department for Environment Food and Rural Affairs (DEFRA) is responsible for deliberate releases of genetically modified organisms (GMOs). Further guidance can be obtained from the DEFRA website.

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