GMO/GMM (Deliberate release)
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