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EPA Regulations for GMM/GMOs
The Environmental Protection Agency (EPA) is the authority inIrelandthat implements Genetically Modified Micro-Organisms (GMM) and Genetically Modified Organisms (GMO) Regulations. The EPA is responsible for the licensing of GMO activity both for ‘contained use’ (usually in colleges/ industry /hospital laboratories) or deliberate release of a GMO for purposes other than placing on the market (field trials and/or clinical trials for purposes of R&D) and for the plaUpdate & Approvecing on the market of GMOs as or in products. It also has remit for transboundary movement of GMOs.
Any person/organisation are legally obliged to submit a notification to the Environmental Protection Agency in accordance with the requirements of the Contained Use legislation, seeking the Agency’s consent before commencing work with GMOs.
What is Contained Use?
Contained use relates to the use of GMMs/GMOs under containment i.e. the employment of physical barriers or a combination of physical barriers together with chemical (disinfectants) and/or biological barriers (specific nutritional requirements), to limit contact between the GMM/GMO and the environment and the general public.
In Ireland the contained use of GMMs/GMOs is largely carried out in research laboratories in universities, hospitals, state laboratories and in 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, animal, plant health or the environment as determined by a Risk Assessment.
|Class (GMM)||Risk to human/animal/plant/health or environment|
|Class 1||pose no or negligible risk|
|Class 2||pose a low risk|
|Class 3||pose a moderate risk|
|Class 4||pose a high risk|
As the risk posed by the GMM increases from Class 1 to Class 4, more stringent containment measures are required to be put in place.
GM plants and GM animals are not subject to the same classification system they are however required to be similarly contained.
GMO/GMM contained use application process: Flow chart & Time Frames << Click to download
Fees associated with applying for a GMM or GMO license:
|Class (GMM)||Fee: First time use* (Agency decision time frame)||Fee: Subsequent contained use** (Agency decision time frame)|
|Class 1 GMM||€250 (45 days)||Annual reporting|
|Class 2 GMM||€1,875 (45 days)||€625 (Art. 18(2)) (10 days)|
|Class 3 GMM||€4,500 (90 days)||€1,500 (Art. 19(2)) (45 days)|
|Class 4 GMM||€22,500 (90 days)||€7,500 (Art. 19(2)) (45 days)|
|GMO||€0 (45 days)||Annual reporting|
* First time use = Where a premises is being used for the first time for any GMM/GMO contained use activity. Each PI working with GMMs must register for first time use.
** Subsequent contained use = Where a user already submitted a notification to the EPA and received approval for the first time use of a premises and is embarking on a new Class 2/3/4 GMM contained use activity.