Genetically Modified Organisms (Contained Use) Regulations, 2001 (S.I. No. 73 of 2001).

These Regulations give effect to Council Directive 90/219/EEC, as amended by Directive 98/81/EC, on the contained use of genetically modified micro-organisms. They replace Part II of the Genetically Modified Organisms Regulations, 1994, and all other provisions and Schedules of those Regulations which relate to contained use activities. The Environmental Protection Agency (EPA) is the competent authority for the purposes of these Regulations. The principal objective of the Regulations is to protect people and the environment from any adverse effects arising from the contained use of genetically modified organisms (GMOs). In this regard, they provide for the application of various procedural matters to contained use activities. Part II provides specifically for regulation of the contained use of genetically modified micro-organisms (GMMs) and gives full effect to the EU Directives. Part III provides an updated framework for the regulation of all contained uses involving GMOs other than GMMs covered under Part II. Subject to limited exclusions in Parts II and III, all contained uses must comply with the Regulations. Proposed uses must be subjected to an environmental risk assessment which must be submitted, or otherwise made available, to the EPA for evaluation. Proposed contained uses of GMMs which fall into the moderate and high classes of risk may not proceed without explicit consent from the Agency. As well as applying specific containment measures in each case, users of GMMs are required to apply principles of good microbiological practice, and good occupational safety and hygiene, and users of GMOs are required, as appropriate, to apply good greenhouse, growthroom or animal-house practice. All users are required to keep appropriate records and to submit them, or otherwise make them available, to the EPA. A register of all contained uses must be maintained by the EPA and made available to the general public. The Regulations include provision for their enforcement by the EPA.