Directive 2009/41/EC covers the Contained Use of Genetically Modified Micro-organisms (GMMs).
This Directive has been transposed into Irish law under the GMO (Contained Use) Regulations 2001-2010 comprising:
Directive 2009/41/EC only applies to GMMs (bacteria, fungi, parasites, viruses, animal and plant cells in culture). However, the scope of the national regulations has been broadened to include Genetically Modified Organisms (GMOs, GM plants and GM animals).
Contained use refers to the use of physical barriers, or the combined use of physical barriers, to limit contact between the GMO and the environment and to provide protection for the general public. As well as being physical, barriers can be chemical (use of disinfectants) and/or biological (nutritional requirements).
In Ireland, the contained use of GMOs is predominantly carried out in laboratories in colleges, universities and hospitals and by industry (e.g. biopharmaceutical companies).
GMMs may be classified as Class 1, Class 2, Class 3 or Class 4, based on the risk the GMM poses to human health and the environment as determined by a risk assessment.
Performing a risk assessment will identify:
This in turn will determine the Class.
|Level of risk the GMM presents
|Containment level required to control the risk
|No or negligible risk
|Containment level 1
|Containment level 2
|Containment level 3
|Containment level 4
A risk assessment must also be performed in respect of GMO activities.
It is the responsibility of the user to carry out an assessment of the potential risks to human health and the environment. It is also the user’s responsibility to ensure that all appropriate measures are taken to avoid adverse effects on human health or the environment.
After the assessment, the user is required to submit a notification to the EPA.