Deliberate release of GMOs
Deliberate release means the intentional release of Genetically Modified Organisms (GMOs) into the environment.
Two types of deliberate release are covered by Directive 2001/18/EC and were transposed into Irish Law as GMO (Deliberate Release) Regulations, S.I. No. 500 in 2003.
- Part B release: deliberate release of GMOs for any purpose other than placing on the market, for example: Field trials in the case of GMO crops; Hospital clinical trials in the case of Genetically Modified Micro-organisms (GMMs) used for gene delivery systems for medicinal purposes, such as administering a GM vaccine or a GM virus which delivers a gene therapy product to animals or humans.
Examples of a Part B release include the growing of GM crops, the administration of a GM vaccine or a GM virus which delivers a gene therapy product to animals or humans. To carry out a Part B release, users are legally obliged to notify the Environmental Protection Agency (EPA) in accordance with the requirements of the deliberate release.
- Part C release: refers to placing GMOs on the market - as GMOs or in products. You can obtain consent to carry out a Part C release by notifying the EPA
Please see the EPA website for additional information on Deliberate release
Biological Safety
Bithshábháilteacht
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