Genetically Modified Organisms (Deliberate Release) Regulations 2003 (S.I. No. 500 of 2003).

These Regulations give effect to Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC. They replace the Genetically Modified Organisms Regulations 1994, other than Part II, and certain other provisions, of those Regulations in relation to the contained use of genetically modified organisms which were already replaced by the Genetically Modified Organisms (Contained Use) Regulations 2001. The fundamental objective of the Regulations is to protect people and the environment from any adverse effects arising from the deliberate release into the environment or marketing of genetically modified organisms (GMOs). In this regard, they provide for the application of various safety, public notice and procedural matters to deliberate releases and marketing. The Environmental Protection Agency (EPA) is the competent authority for the purposes of the new Regulations and it may consult the Genetically Modified Organisms Advisory Committee on any aspect of its functions. Subject to limited exclusions, all deliberate releases of GMOs to the environment must comply with the Regulations. Proposed releases must be subjected to an environmental risk assessment (e.r.a.) which must be submitted to the EPA. Part II regulates the deliberate release of GMOs to the environment for purposes other than marketing (for example, field trials). Part III regulates the first time placing on the market of products containing or consisting of GMOs. Part IV enables the EPA to impose fees and charges in respect of its duties under the Regulations, including in respect of applications and monitoring. Part V provides for enforcement by the EPA, including powers to prosecute offences, to obtain a High Court order to prohibit or restrict any activity involving a GMO, or to serve notice on a notifier to take specific measures for the protection of people or the environment.