GMO - Strengthened GMO Safety Legislation For England

The Government today announced the entry into force of new English Genetically Modified Organisms (Deliberate Release) Regulations 2002.

The new regulations transpose EU Directive 2001/18 on the deliberate release into the environment of genetically modified organisms. Similar regulations for Scotland, Wales and Northern Ireland will follow shortly.

Directive 2001/18 and the new regulations strengthen the existing legislation for assessing the safety of GMOs, and improve transparency and public consultation. The new regime applies to applications for commercial releases of GMOs, and research trial releases. It will provide a more robust framework for taking safety-based decisions on whether to allow, or to prevent, the release of GMOs in England and the EU.

Among other things, the new regime introduces:

• an explicit requirement for environmental risk assessments to cover indirect and long-term effects of GMOs (e.g. wider impacts on biodiversity);
• the introduction of mandatory post-market monitoring, to look for unanticipated effects of any GMO that is released commercially;
• mandatory public consultation before decisions are taken on applications for consents to release GMOs;
• mandatory labelling for all GMOs released commercially in the EU. GMOs must also be traceable throughout the production and supply chain;
• phasing out of antibiotic resistance marker genes that may have adverse effects on human health and the environment;
  
• time limits on all commercial approvals (max. 10 years) after which consents must be reassessed.

Environment Minister Michael Meacher said:
"We welcome the entry into force of Directive 2001/18, and the new regulations that implement it in England. The new Directive clarifies and improves the existing EU regulatory framework under which decisions are taken on whether to allow, or to prevent, proposed releases of GMOs.

The new regime provides an increased level of protection to consumers and the environment from any potential risks posed by GMOs. It also takes large steps towards improving transparency and public involvement in decision making.

In the absence of any significant commercial growing of GM crops in Europe, it is particularly welcome that the new Directive will apply to proposed imports of GMOs that may enter the UK from outside the EU. An increasing area of the world's farmland is being used to grow GM crops, and a large proportion of some key agricultural commodities are now GMOs. We need to ensure that such imports are subject to the stringent standards of Directive 2001/18."

The following additional notes are provided:

• EU legislation controlling the deliberate release of GMOs has existed since 1990. Directive 2001/18 updates and replaces the old Directive 90/220. The new Directive enters into force on 17 October (as do the new English regulations that implement it).
• Under the new regime, Defra must hold minimum 48-day (7 weeks) mandatory public consultations on all GMO research trial applications in England - and there is a mandatory requirement for public views to be taken into account in decision making. On proposed commercial releases of GMOs, the European Commission must hold two separate periods of 30 days EU-wide public consultation.
• Defra Ministers are advised on risks posed by GMOs by the Advisory Committee on Releases to the Environment (ACRE), a statutory body of 13 independent scientific experts. In each case, ACRE scrutinises the environmental risk assessment that must be supplied with each application, and more information is demanded from the applicant if necessary. Once ACRE are satisfied they have all the necessary information, they advise Ministers. In the case of proposed GMO research trials, Ministers then decide whether to grant or refuse authorisation. In the case of proposed commercial releases, ACRE's advice informs the UK's position in EU-level collective decision making.
  
• The new regime maintains the approach by which, if new information on risk comes to light after a consent has been issued, any consent can be varied or revoked as appropriate. Such new information may come to light, say, as a result of new scientific evidence (e.g. from the new mandatory post market monitoring), or reassessment of existing information.
  
• Defra held two public consultations on implementation of the Directive - the first on general issues raised, the second on the regulations in draft. These revealed a general view that the new regulatory framework was a significant improvement. Environmentalists thought the new regime was a big step in the right direction, but felt the Directive should have gone even further. Industry accepted the new regime, but were concerned that it could impede development of the technology, particularly the commercialisation of GMOs in the EU. Summaries of responses to the two consultations will be placed on the Defra website (address below).
  
• Defra will publish draft guidance to accompany the new regulations on the Defra website at www.defra.gov.uk/environment/gm/index.htm