Genetically Modified Organism (GMO) in the United Kingdom

Concordat on the implementation of Directive 2001/18/EC and Regulation 1946/2003/EC

Agreement between the Department of the Environment in Northern Ireland, the National Assembly for Wales, the Scottish Executive and the UK Government

This Concordat (“the Concordat”) sets out the agreed framework for co-operation between the Department of the Environment in Northern Ireland (DoENI), the Department for Environment, Food and Rural Affairs (Defra), the Welsh Assembly Government (WAG), as the executive of the National Assembly for Wales, and the Scottish Executive (SE), on the administration and coordination of the regulatory frameworks established under:

• Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms; and
• Regulation (EC) No.1946/2003 on transboundary movements of genetically modified organisms.

In the UK, responsibility for the regulation of Genetically Modified Organism deliberate releases and transboundary movements of Genetically Modified Organisms in Northern Ireland, Wales and Scotland has been devolved to the administrations responsible for those territories. Defra has responsibility for the regulation of these matters in England. Defra and the devolved administrations are each responsible for implementing the Directive and the Regulations in their respective territories.

The UK has four territorial competent authorities (TCAs) with responsibility for implementing the regulatory frameworks in Northern Ireland, England, Wales and Scotland respectively. These are the Secretary of State for Environment, Food and Rural Affairs in England, the Deputy Minister for Environment and Rural Development in Scotland, the Minister of State with responsibility for the Department of the Environment in Northern Ireland, and the National Assembly for Wales in Wales. In terms of the practical working arrangements in this document the term “territorial competent authority” or “TCA” also applies to officials acting on behalf of the TCA.

UK lines on the development of EU policy matters or on applications presented by other Member States should be agreed between the four Territorial Competent Authorities before EU level negotiations take place. Defra will represent the UK on the basis of this agreed line. In agreeing UK lines, every effort should be made by the four Territorial Competent Authorities to reach agreement, including (if necessary) embarking on the procedure set out in the Concordat on co-ordination of European Union policy issues, providing that a common line can be agreed within the necessary timescale. If this is not possible, the UK negotiating position should be set by the UK Government on the basis of expert scientific advice, and taking into account the views of the devolved administrations, in order that the UK can take part in EU level discussion and decision making.

Administration

The parties to the Concordat have jointly established the Northern Ireland, England, Wales and Scotland GM Unit (NIEWS). NIEWS is a body consisting of scientists and administrators that serves the four Territorial Competent Authorities in administering the GMO deliberate release regime in Northern Ireland, England, Wales, and Scotland.

It provides for:

administration and technical support – e.g. by processing Part B and Part C applications on behalf of the Territorial Competent Authorities to which the application has been made (i.e. subject to the instructions of that Territorial Competent Authorities acting in accordance with the Concordat). It will also undertake other work to assist the four Territorial Competent Authorities to run the two regimes (e.g. providing scientific and procedural advice to Territorial Competent Authorities);
communication – by ensuring that a high level of communication exists between the four Territorial Competent Authorities on the function of the two regimes at the Territorial Competent Authorities, UK and EU levels. This includes being the “post-box” for correspondence flowing between the territorial/UK and UK/European levels;
co-ordination – by being the conduit through which the 4 Territorial Competent Authorities discuss and agree UK positions (e.g. UK lines to be communicated by Defra at the EU level).

When the Northern Ireland, England, Wales and Scotland GM Unit (NIEWS) functions at the territorial/UK level it will do so on behalf of one of the Territorial Competent Authorities – e.g. if NIEWS processes an application received by the Scottish Territorial Competent Authorities it will be working directly for the Scottish Territorial Competent Authority. When NIEWS functions at the UK/European or UK/international level it will do so on behalf of the UK Government.

Expert scientific advice

The Advisory Committee on Releases into the Environment (ACRE) is the statutory committee of independent scientific experts appointed by each of the UK’s four Territorial Competent Authorities to provide them with expert advice on administering the deliberate release regime in Northern Ireland, England, Wales and Scotland respectively.

The four Territorial Competent Authorities have also jointly established the ACRE secretariat, a body of officials that provides administrative and technical support to ACRE. In practice, NIEWS will undertake all functions of the ACRE secretariat jointly on behalf of the four Territorial Competent Authorities.