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Deliberate Release
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Friday, September 10, 2010
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Deliberate Release
If the genotypic expression and performance of a GMO is to be evaluated outdoors, the next phase, after development of the GMO under containment, will be to apply to conduct experimental field trials. This may lead, once sufficient information is known about the organism, to a further application to market a product.
The release of Genetically Modified Organisms into the environment in the EU, for both experimental and commercial releases, is controlled under Directive 2001/18/EC. In the UK, this is effected via The Environmental Protection Act (1990) and The Genetically Modified (Deliberate Release) (Scotland) Regulations 2002. The procedures required under these legislation are also based on risk assessment before approval by the Competent Authority: The Scottish Parliament. The Scottish Executive issues consents to release GM crops for research and development purposes in Scotland.
Defra, the National Assembly of Wales, and the Department of the Environment in Northern Ireland, undertake similar responsibilities. Defra also provides UK representation at the EU. Within Defra, the Northern Ireland, England, Wales and Scotland GM Unit ((NIEWS), formally the Joint Regulatory Authority), acts as a clearing house for all applications for deliberate release in the UK. The unit also provides the secretariat for the Advisory Committee on Release to the Environment (ACRE) (see
Advice
); and is the lead authority for international presentation of UK policy.
The EU Directive recognises two classes of release depending upon their purpose: Part B releases for research and development and Part C releases for marketing. In the UK, Part B consents are granted on a case-by-case basis after a detailed risk assessment has been submitted to the NIEWS GM Unit and considered by ACRE.
ACRE advises Scottish Ministers on whether an application for a release for non- commercial purposes or marketing should be issued and whether any limitations and conditions should be attached to those consents, including post-release monitoring measures. Ministers also take advice from the Health and Safety Executive, the Food Standards Agency and Scottish Natural Heritage as appropriate.
Part C consents, granted at the EU level by qualified majority vote of the Member States, are effective throughout the EU.
For further information on deliberate release visit SEERAD's genetic modification web site.
SASA GM INSPECTORATE
Scottish Ministers have appointed Inspectors at SASA under Section 114 (1) of Environment Protection Act (Part VI) to undertake inspection and enforcement activities relating to the consent conditions set for deliberate release and marketing of GMOs in Scotland. The scope of the work conducted by Inspectors is defined by the Act. It is the role of the SASA GM Inspectors to establish that releases of GMOs in Scotland are being conducted in accordance with the conditions of consents granted by Scottish Ministers and, in the case of non-compliance, to take enforcement action.
See section on
GM Inspectorate
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