HC Deb 01 July 2002 vol 388 cc63-4W
Dr. Gibson

To ask the Secretary of State for Environment, Food and Rural Affairs if she will set out the sequence for regulation of the approval process for GM crops in the UK. [635921

Mr. Meacher

Before a GMO, including a GM crop, can be released in the UK or the EU it must be assessed for safety to human health and the environment and be approved under either Part B or Part C of Directive 90/220/EEC on the Deliberate Release into the Environment of Genetically Modified Organisms.

Directive 90–220 has been updated and is being replaced by the new Directive 2001/18/EC, which must be implemented by member states by October 2002. My Department is currently consulting the public on draft implementing regulations for England. Copies of the consultation paper have been placed in the Parliamentary libraries and are available on the DEFRA website www.defra.gov.uk/environment/gm/index). The Scottish Executive, the National Assembly for Wales and the Department of Environment for Northern Ireland will make separate implementing regulations on issues for which they have devolved powers.

Decision making on proposed non-commercial releases of GMOs under Part B of the directive (e.g. research trials) occurs at the member state level. In England, a person wishing to undertake such a release must apply to DEFRA for a Part B consent, whereupon DEFRA seeks independent expert advice from the Advisory Committee on Releases into the Environment (ACRE) before a decision is taken on whether to grant or refuse a consent. Where appropriate the advice of other experts, for instance the Advisory Committee on Novel Foods and Processes, will also be sought. Directive 2001–18 clarifies and extends risk assessments to ensure that "direct, indirect, immediate and delayed" effects on human health and the environment are covered. It also introduces a new requirement for mandatory public consultation before decisions on Part B applications are taken. We propose that such consultation should last for a minimum of 48 days.

Decision-making on proposed commercial releases of GMOs under Part C of the directive occurs at the EU level. A person wishing to market a GMO in the EU must apply for a Part C consent to a competent authority of one of the member states, and the competent authority must prepare a report recommending a course of action. If the report recommends that a consent is refused, the application is rejected. If the report recommends that a consent is granted it must be forwarded to the European Commission and other member states, which discuss the application and can ask for further information, make comments on, or present reasoned objections to, the proposed release. Under the new directive, the Commission must also consult the public (for two separate periods of 30 days) while the application is being considered, and responses are copied to all member states. The Commission and member states then make a collective decision on the application, and a Part C consent is either granted or refused.

Directive 2001–18 also introduces "post-market monitoring", under which any GMO which is granted a Part C consent must be monitored for unanticipated effects on the environment. The new directive (like its predecessor) ensures that if new information comes to light regarding the risks posed by the GMO to human health or the environment, the consent can be altered or revoked as appropriate.

GM crops are also subject to other legislation. Varieties of the main agricultural and vegetable species, whether GM or non-GM, cannot be marketed commercially until they have been added to the UK national list of plant varieties or to the EU Common Catalogue (a compendium of member states' national lists). Addition to the national list is dependent on satisfactory completion of a minimum of two years of listing trials, to establish that the variety is distinct, uniform and stable and, for agricultural species, has a value for cultivation and use in the UK. A GM crop cannot be formally proposed for addition to the national list until it has Part C marketing approval under the deliberate release directive (and Novel Foods authorisation where appropriate).

In addition to clearance of the crop itself, any foods obtained from a GM crop would have to be approved under the EU Novel Foods Regulation EC/258/97. The Food Standards Agency is the UK competent authority for this legislation. Furthermore, if the GM crop is a herbicide tolerant variety, the associated herbicide use would have to be approved under pesticides legislation.