Notification requirements for GM plant field trials

Notification requirements for GM plant field trials or any experimental release into the environment
                                                                                                                                                                                                         A person proposing to carry out a GM plant field trial or any experimental release into the environment is required to submit a notification to the EPA under Article 14 of the GMO (Deliberate Release) Regulations, S.I. No. 500 of 2003, comprising the following:

• A technical dossier on the proposed deliberate release containing information specified in the Third Schedule of S.I. No 500 of 2003 in so far as it is appropriate to the proposed deliberate release.
o Part I of the Third Schedule relates to the release of GMOs other than higher plants, i.e. the performance of clinical trials
o Part II of the Third Schedule relates to the release of Genetically Modified Higher Plants i.e. field trials

                                              
• A summary of the notification (i.e. Summary Notification Information Format or SNIF) in accordance with Council Decision 2002/813/EC
o Part 1 of Council Decision 2002/813/EC relates to a SNIF for the release of GMOs other than higher plants
o Part 2 of Council Decision 2002/813/EC relates to a SNIF for the release of Genetically Modified Higher Plants


• A environmental risk assessment (ERA) in accordance with the Second Schedule of S.I. No 500 of 2003 (amended by the GMO (Deliberate Release) (Amendment) Regulations S.I. No 506 of 2019)


• The conclusions arrived at by the notifier, in accordance with Part D of the Second Schedule of S.I. No 500 of 2003 (amended by the GMO (Deliberate Release) (Amendment) Regulations S.I. No 506 of 2019) together with any bibliographic references and details of methods used
o Part D.1. of the Second Schedule refers to GMOs other than higher plants
o Part D.2. of the Second Schedule (amended by Part 3, Schedule 2 of the GMO (Deliberate Release) (Amendment) Regulations S.I. No 506 of 2019) refers to Genetically Modified Higher Plants


• A fee of €3,000, as set out in Article 46 of S.I. No 500 of 2003.

The deliberate release of a combination of GMOs on the same site, or a GMO or a combination of GMOs on different sites, may be notified to the Agency in the same notification, provided that:
• the purpose of the proposed deliberate release is the same; and,
• the release will be carried out within a defined period of time.
Article 14(5)