GMOs and the law
The primary piece of legislation that applies to the use of genetically modified organisms (GMOs) in the workplace is the Genetically Modified Organisms (Contained Use) Regulations 2014 ('the GMO(CU) Regulations').
The GMO(CU) Regulations provide for human health and safety and environmental protection from genetically modified micro-organisms (GMMs) in contained use, and human health and safety from genetically modified plants and animals. The key requirement of the GMO(CU) Regulations is to assess the risks of all contained uses and to ensure the 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 GMO(CU) Regulations:
- require risk assessment of contained use involving GMMs and larger GMOs. All contained uses must be assessed for risk to humans and those involving GMMs assessed for risk to the environment
- require competence advice to be obtained on the risk assessment before the contained use can start
- introduce a classification system based on the risk of the contained use independent of the purpose of the contained use. The classification is based on the four levels of containment for microbial laboratories
- require notification of all premises[42] to HSE before they are used for contained use for the first time
- require notification of individual contained uses[43] 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) contained uses. Class 1 (no or negligible risk) contained uses are non notifiable, although they are open to scrutiny by HSE's specialist inspectors who enforce the Regulations. Contained use involving larger GMOs 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 contained use notifications, and notified contained use involving larger GMOs
- require the maintenance of a public register[44] of premises undertaking genetic modification and certain contained uses
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[45]. 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 Environmental Protection Act 1990[46]
- The Genetically Modified Organisms (Risk assessment) (Records and Exemptions) Regulations 1996[47]
- The Genetically Modified Organisms (Deliberate Release and Risk Assessment-Amendment) Regulations 1997[48]
The Department for Environment Food and Rural Affairs (DEFRA) is responsible for deliberate releases of genetically modified organisms GMOs in England. Scottish and Welsh Governments are responsible for deliberate releases of GMOs in Scotland and Wales respectively. Further guidance can be obtained from the DEFRA[49].
Legislation intended to enhance the security of certain pathogens and toxins held within the UK is also relevant to work with GMOs. This legislation can be found in the text of Part 7 and Schedule 5 of the Anti Terrorism Crime and Security Act 2001 and the Security of Pathogens and Toxins (Exceptions to Dangerous Substances) Regulations 2002. The current full list of pathogens and toxins contained within Schedule 5, and guidance notes are available from the National Counter Terrorism and Security Office[50].