GMOs are regulated through EU, UK and Scottish legislation each of which requires risk assessments to be carried out at every phase of their development.
CONTAINED USE LEGISLATION
The GMO (CU) Regulations cover all aspects of contained use involving genetically modified micro-organims (GMMs) and the human health aspects of contained use involving genetically modified (GM) animals and plants.. The principal legislation is the Genetically Modified Organisms (Contained Use) Regulations 2000 (GMO(CU) and its amendment the Genetically Modified Organisms (Contained Use) (Amendment) Regulations 2002 and the Genetically Modified Organisms (Contained Use) (Amendment) Regulations 2005.
The Scottish Government and the Health and Safety Executive (HSE) are joint Competent Authorities for Contained Use legislation in Scotland. The Scottish Government has lead responsibility in Scotland for the effects from contained use of GMOs (GMMs, GM plants and GM animals) have on the environment. The HSE has lead responsibility for human health and safety throughout Great Britain. The HSE administers the permissions process and enforces the legislation on behalf of the Scottish Government. Further Guidance can be obtained from the HSE website.
DELIBERATE RELEASE LEGISLATION
In Scotland the EU Directive 2001/18/EC is implemented via the Environmental Protection Act (1990) and the Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002. These provide a statutory safety procedure, involving risk assessment, and the need for prior approval before any GMO can be released or marketed.
Scottish Ministers consent to the release of GM crops for research and development purposes. NIEWS acts as a clearing house for applications for deliberate release; provides the secretariat for the Advisory Committee on Releases to the Environment (ACRE) (see below); and co-ordinates the 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 placing on the market. In the UK, Part B consents are granted, on a case-by-case basis, after a detailed risk assessment has been submitted to the Northern Ireland, England, Wales and Scotland GM Unit (NIEWS) in Defra and considered by, a statutory Advisory Committee, consisting of independent scientific experts who advise on the risks to human health and the environment from the release of GMOs. The committee advises Scottish Ministers on whether an application for a release in Scotland should be allowed. Scottish Ministers also take advice from the Health and Safety Executive, the Food Standards Agency and Scottish Natural Heritage as appropriate. Consents set out the conditions and limitations governing releases. Part C releases are granted at the EU level and are effective throughout the EU.
Compliance with the above legislation regulations is established by official inspection. Non-compliance with consent conditions can lead to enforcement action including, where necessary, forwarding cases to the Procurator Fiscal Service. SASA took responsibility for the inspection and enforcement of the deliberate release and marketing of GMOs (principally crops plants) in Scotland in May 2000. At that time, the Central Science Laboratory (CSL) was contracted by Defra to carry out the equivalent inspection and enforcement service for England and Wales. CSL was merged along with a number of Defra’s delivery divisions and Inspectorates to form the Food and Environment Research Agency (Fera).
GENETICALLY MODIFIED FOOD AND FEED INCLUDING TRACEABILITY AND LABELLING
In April 2004, EU Regulation EC/1829/2003 on GM food and feed came into force throughout the European Union. The regulation provides a single community procedure for the authorisation of any GMO whose produce, or derived products, that are intended for food or feed, including the cultivation of crop plants that are intended for these uses. The majority of marketing applications are now processed through this regulation. This single unified approval for food and feed uses will not then require approval under Part C of Directive 2001/18/EC. The European Food Safety Authority (EFSA) manages the application and authorisation procedure centrally. For applications including cultivation an environmental risk assessment in keeping with the requirements of 2001/18/EC is required, and EFSA is obliged to consult the 2001/18 competent authorities concerning environmental risk assessments. The Foods Standards Agency leads on these applications in the UK, while the role of ACRE is to advise on the environmental risk assessments provided with applications for cultivation. Allied to this regulation are new traceability and labelling rules, EC/1830/2003, which include a threshold of 0.9%, above which the adventitious presence of material from an EU authorised GMO in a non-GM product triggers traceability and labelling of the product. Enforcement of these regulations (1829/2003 and 1830/2003) in Scotland is the responsibility of Local Authority Environmental Health (food) or Trading Standards (feed) Departments.
GENETICALLY MODIFIED VARIETIES AND SEEDS
EU legislation on seeds (notably Directive 2002/53/EC on the Common Catalogue of varieties of agricultural plant species and 2002/55/EC on the marketing of vegetable seed) requires national authorities that have agreed to the marketing of seed of a certain variety on their territory to notify the acceptance of the variety to the European Commission. Seed legislation also requires that genetically modified varieties must be authorised in accordance with EU Directive 2001/18/EC before they are included in the Common Catalogue and marketed in the EU.
