Genetically Modified Organisms

On 1 October 2014, the Genetically Modified Organisms (Contained Use) Regulations 2014 (GMO (CU) Regulations) came into force consolidating and revoking earlier legislation.

The GMO (CU) Regulations provide for human health and safety and environmental protection from genetically modified micro-organisms in contained use, and human health and safety from genetically modified plants and animals. The key requirement of the 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 consolidation was recommended by Professor Löfstedt’s 2011 report, Reclaiming Health and Safety for All: An independent review of health and safety legislation.

The HSE says the new regulations are more risk-based and proportionate and take account of advances in technology. They include changes to provisions related to containment measures, notification and administrative arrangements.

Transitional arrangements enable (with limited exceptions) existing contained uses notified in accordance with the previous 2000 Regulations to be transferred across to the 2014 Regulations without the need to re-notify. These do not apply to new contained uses notified after the 1 October 2014.

A summary of the changes can be found in a table on the HSE website at: www.hse.gov.uk/biosafety/GMO/whats-new.htm

The revised (fifth) edition of HSE guidance on the regulations (L29) provides practical advice on compliance with legal duties in relation to working with GMOs in contained facilities and explains how the regulations interact with the Control of Substances Hazardous to Health 2002 (COSHH).

The guidance also describes the law that applies, sets out the containment measures and other controls that need to be considered and explains the role of the competent authority. It covers the key requirements of:

• carrying out the risk assessment;

• classifying the contained use work;

• notifying to the competent authority;

• applying the relevant control measures; and

• accident reporting