Deliberate release of genetically modified organisms: the UK regulatory framework

This paper reviews the development and operation of the regulations coverin g the release of genetically modified organisms (GMOs) in the UK. The regul atory framework aims to prevent or minimise damage to the environment by es tablishing a statutory system of risk assessment and prior consent, before any GMO can be released or marketed. Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms does much t o harmonise the release of GMOs across the European Community. The Directiv e recognises two classes of release depending of the purpose; Part B releas es for research and Part C releases for marketing. Individual Member States differ in how the Directive has been implemented and in the UK. No GMO may be released without the express consent of the Secretary of State. All UK applications for Part B (research) releases are submitted to the Department of the Environment Transport and the Regions, and the Advisory Committee o n the Releases to the Environment (ACRE) advise whether the release should be allowed. In issuing consent the Secretary of State will also take accoun t of views expressed by other Government Departments, the Statutory Nature Conservation Bodies and the general public. Applications for Part C (market ing) consent follow a different procedure and are submitted initially to an y one of the 15 Member States, which then review the application and form a n opinion. The other 14 States then evaluate the application. If there are no objections the lead Member State issues the marketing consent which appl ies throughout the European Community. If one or more State objects to the application then it falls to the Commission and Council to resolve. The cur rent system, based on Directive 90/220/EEC, has been criticised mainly beca use of lengthy delays in obtaining marketing consent. Discussions are in pr ogress to revise it in a number of key areas. An overview of the main propo sed changes is given in the paper.