The Scottish Government opposes the cultivation of Genetically Modified (GM) crops which could damage Scotland's rich environment and threaten our reputation for producing high quality and natural foods. The Scottish Government believes GM cultivation would diminish Scotland's image as a land of food and drink.
Taking account of this policy, SASA provides advice on the release of GM crop plants and other organisms (GMOs) into the environment and on the contained use of GMOs. In addition the GM team provides GM diagnostic testing services.
The GM Inspectorate is also based at SASA. Key services provided are:
SASA also provides a diagnostic testing service for the GM Inspectorate.
Advances in molecular biology made in the mid 1970s enable the genetic material of an organism (either DNA or RNA) to be altered using methods that do not occur in nature. These alterations are known as genetic modification (GM) and plants, animals or microbes resulting from such modifications are known as genetically modified organisms (GMOs). GM covers a variety of techniques which have been applied worldwide in human and veterinary medicine, horticulture, agriculture, biotechnology and for research purposes.
GM raises important safety issues for human health and protection of the environment. European, Scottish and UK GM legislation requires that these are addressed at every stage of a GMO’s (or GMO product’s) development, starting in the laboratory through to commercial production (see the GM Regulatory Framework page).
GMOs are primarily regulated through EU legislation with supporting UK and Scottish legislation.
For detailed information, see the Genetic Modification (GM) Legislation page on the gov.scot website.
All work involving GMOs is regulated. Work carried out in laboratories, glass houses or which is otherwise contained, where there is no release into the environment, is considered ‘contained use’ work. The HSE is responsible for assessing risk to human health of all work involving the contained use of GMOs in the UK. The GM team at SASA and scientific experts from other Scottish-based organisations provide advice about the environmental risk of contained use GMO work to be carried out in Scotland. For more information on working with GMOs in a contained way and how to notify your work, or apply for consent see the HSE webpage.
Consents for releasing GMOs into the environment for research purposes are granted on a case by case basis by Scottish Ministers. A detailed risk assessment must be submitted to the CAP Reform and Crop Policy Team at Saughton House, and is considered by ACRE (Advisory Committee on Releases to the Environment). ACRE comprises independent scientific experts who advise on the risks to human health and the environment from the release of GMOs. Scottish Ministers also take advice from SASA, the Health and Safety Executive, the Food Standards Agency and Scottish Natural Heritage as appropriate. Consents set out the conditions and limitations governing releases.
Consents for releasing GMOs for commercial reasons are granted at the EU level and are effective throughout the EU. The EU legislation has recently been amended to allow member states to opt-out or ban GM cultivation on their territory. This legislation allows member states and regions to ban biotech crops for reasons other than the risks to health and the environment assessed by the European Food Safety Authority (EFSA).
Compliance with the above regulations is established by official inspection. Non-compliance with consent conditions can lead to enforcement action including forwarding cases to the Procurator Fiscal Service where necessary. SASA has taken responsibility for the inspection and enforcement of the deliberate release and marketing of GMOs (principally crops plants) in Scotland since May 2000. For England and Wales, GM inspection and enforcement services for the deliberate release of GMOs are provided for Defra by the Animal and Plant Health Agency (APHA).
Allied to the GMO regulations are traceability and labeling rules, 1830/2003/EC, which include a threshold of 0.9%, above which the adventitious (accidental) 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.
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.
The GM Team provide advice and technical support to Scottish Government colleagues and participates in UK committees on experimental deliberate release and contained use of GMOs (SACGM and ACRE). They also administer and provide assessors for applications for the Contained Use of GMOs in Scotland. They are full members of ENGL (the European Network of GMO Laboratories) providing input into EU level GM technical documentation, and also through ENGL, other international technical documentation such as ISO standards. They provide analytical testing to support enforcement activities, and also strategic development and improvement of molecular methods for use in GMO testing.
Scottish Government GM inspectors are appointed under Part VI of the Environmental Protection Act 1990. The work is in support of the CAP Reform and Crop Policy Branch of the Rural and Environment Directorate who are Scotland’s Competent Authority for the regulation of the deliberate release of GMO’s under EC Directive 2001/18.
For details of the GM legislation that inspectors work to see the GM Regulatory Framework page.
The Animal and Plant Health Agency (APHA) is authorised by Defra to carry out equivalent inspection and enforcement services in England. SASA liaises closely with the GM Inspectorate in APHA, particularly in sharing information about seed material that crosses borders for production or marketing, and incidents that are common to both England and Scotland. Northern Ireland and Wales have separate arrangements.
Genetically modified crops are steadily being grown more widely throughout the world since they were first commercialised in 1996. Where GMO crops are grown in seed producing areas, there is a risk of cross-pollination or GM seed inadvertently becoming mixed amongst conventional (non-GM) seedlots. This is known as adventitious GM presence (AGMP).
To assist Scottish merchants, processors and packers (MPP) minimise the risk of marketing seed that may contain AGMP, the GM Inspectorate runs a voluntary scheme to determine whether seed of high risk species has been imported directly into Scotland. Questionnaires are sent out to all MPPs biannually.
To assist seed producers or importers who wish to market agricultural seed for the purposes of tests and trials see Guidance to market seed for tests and trials.
It is important to note that participation in the monitoring programme should not be seen as an assurance that the GM Inspectorate will not exercise its powers in appropriate cases under Part VI of the Environmental Protection Act 1990.
Questionnaires can be returned by email or post. The address for email returns is: GMInspectorate@sasa.gsi.gov.uk. Postal returns should be sent to Scottish Government GM Inspectorate, SASA, Roddinglaw Road, Edinburgh, EH12 9FJ.
A summary of the biannual surveys and any resulting follow-up action is published in the Scottish Government GM Inspectorate’s Report or Reviews.
In seed producing areas where GM crops co-exist with seed crops of conventionally bred varieties, there is a risk that seed from conventionally bred seed may inadvertently contain GM seed (AGMP) through cross-pollination or physical mixing of seed during processing. The legislative EU framework requires the labelling of conventional seed lots that contain any detectable traces of authorised GM seeds. If unauthorised GM seed is found in conventional crop seed, there is zero tolerance and the affected seedlot cannot be marketed.
Risk analyses undertaken on conventionally breed crops suggest that some species are at a higher risk, relative to other crops, from incorporation of adventitious GM material during seed production. Crops that are important to Scottish Agriculture that fall into this high risk category are:
The risk status of all crop species listed above is regularly reviewed.
Importers, producers, processors and merchants of non-GM (conventionally bred) agricultural and vegetable seed are recommended to take all reasonable steps to ensure, before obtaining or marketing high risk category seed it is free of AGMP (see relevant Guidance pages).
Anyone considering marketing seed of certified, conventionally-bred crop varieties in Scotland that are of a high risk category of containing adventitious GM presence are advised to:
In Scotland, high risk category species are winter and spring oilseed rape, turnip fodder rape & related species, fodder maize & sweet corn.
This information will assist your company to meet your legal duties to ensure that you have taken steps to minimise the risk of adventitious GM presence in conventional seed. It will also help you in answering customers questions relating to adventitious GM presence.
Should you have any queries over these measures contact the Scottish Government GM Inspectorate.
Seed importers that have made a seed declaration on the Scottish Government GM Inspectorate’s Seed Monitoring form are advised to:
These measures should follow the GM Inspectorate Guidance for importers and producers on the prevention of adventitious GM presence in conventional varieties of the relevant crops.
It is the role of the Scottish Government GM Inspectorate to audit seed importers to ensure appropriate steps (due diligence) have been taken and that appropriate documentation is available. We will contact import companies and will request access to the following information:
Should you have any queries over these measures contact the GM Inspectorate.
It is a requirement under the Seed (Scotland) (Amendments for Tests and Trials etc.) Regulations 2007 (2007 No. 224) and Regulation 9 of the Beet Seed No.2. (Scotland) 2010 (2010 No. 148) that authorisation is given by either the Scottish Government or another European Authority for seed to be marketed for the purposes of conducting tests or trials, including tests for scientific purposes and selection work.
Breeders or Merchants, Processors or Packers based in Scotland should apply for the authorisation to use seed for these purposes by contacting SASA either in writing to Seed Certification Branch, using GM Inspectorate email address or by telephoning Mike Parker (0131 244 8853).
For those species that have a high risk category of containing adventitious GM presence, the Scottish Government GM Inspectorate also recommends that you obtain a letter of assurance from the breeder of the variety giving assurances that the seed is free from adventitious GM presence or obtain details of analytical tests on individual seed batches or seedlots, that follow the GM Inspectorate Guidance for importers and producers on the prevention of adventitious GM presence in conventional varieties of the relevant crops.
Should you have any queries over these measures contact the GM Inspectorate.
The GM Inspectorate investigates incidents that arise by through their routine duties or through enquiries that have been brought to the attention the Scottish Government’s CAP Reform and Crop Policy Branch.
Previous incidents have involved the trialling of conventional varieties which contained adventitious GM seed that were not authorised for cultivation.
Investigations are reported to the Scottish Government and are summarised in the GM Inspectorate’s Reports or Reviews.
The Scottish Government GM Inspectorate directly monitored, or oversaw monitoring of, three sites where inadvertent sowings of GM crop seed took place in September 2008. Monitoring was continued until the autumn of 2011 with no further presence detected.
Although all Scottish consents for GM crop research trials have expired, landowners of former GM research trial sites, particularly those for oilseed rape, still have an obligation to ensure the produce of following conventional crops complies with the traceability and labelling requirements for food and feed products of GMOs (EU Regulation 1830/2003). This is because GM oilseed rape volunteers can persist at levels that may require a following non-GM oilseed rape crop to be labelled as ‘GM’
Competent Authority for Deliberate Release to the Scottish Environment
CAP Reform Crops Policy Branch
Scottish Government, Agriculture and Food Division
Edinburgh EH11 3XD
Telephone: 0131 244 9503
UK Lead Territorial Competant Authority for Deliberate Release
Department for Environment, Food and Rural Affairs,
GM Policy, Science and Regulation Unit
Area 3B, Nobel House
17 Smith Square
London SW1P 3JR
Government Advisory committees
Advisory Committee on Releases to the Environment (ACRE)
Scientific Advisory Committee on Genetic Modification (Contained Use (SACGM)
SACGM Compendium of Guidance
Advisory Committee on Novel Foods and Processes (ACNFP)
Directive 2001/18/EC the European directive covering GM releases to the environment
Directive (EU) 2015/412 amending Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of GMOs in their territory
The Environmental Protection Act (1990)
The Genetically Modified (Deliberate Release) (Scotland) Regulations 2002
The Genetically Modified Organisms (Contained Use) Regulations 2014
GMOs authorised for Deliberate release in the EU for marketing and import
Application and consent process for research purposes in the UK
Genetically Modified Organisms: Applications and Consents