GM Inspectorate

The Scottish Government opposes the cultivation of GM crops which could damage Scotland's rich environment and would threaten our reputation for producing high quality and natural foods.  It would diminish Scotland's image as a land of food and drink.

Taking account of this policy, SASA provides advice on plant health issues related to the contained use of GMOs and, through the GM Inspectorate, advice and inspection services on the release of GM crop plants into the environment.

Key services provided by the GM Inspectorate are:

SASA also provides a diagnostic testing service for the GM Inspectorate.

What is Genetic Modification?

Advances in molecular biology 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 and these alterations can be replicated and/or transferred to other cells or organisms. 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 gene insertion techniques which have been applied worldwide in human and veterinary medicine, horticulture, agriculture and as whole products, or ingredients, in food and feed production.

GM raises important safety issues for human health and protection of the environment. Scottish and UK GM legislation requires that these are addressed at every stage of a GMOs or its product’s development, starting in the laboratory through to commercial production (see UK GM Regulatory Framework).

UK GM Regulatory Framework

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.
 

Aims and Key Services

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.

The full range of services we provide is set out in an agreed work plan. The latest plan is published in the 2010-12 Review of SASA GM Inspectorate.  View a list of all Annual Reports and Reviews.

For details of the GM legislation that inspectors work to see UK GM Regulatory Framework.

The Food and Environment Research Agency (Fera), is authorised by Defra to carry out equivalent inspection and enforcement services in England. SASA liaises closely with the Scottish Government GM Inspectorate at Fera, 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 make their own arrangements.

Seed Notification Scheme

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.

  • Declarations of importation: where a notification is made on the questionnaire, this will be followed up with further enquiries so that compliance with the GM Deliberate Release Regulations can be demonstrated. This may lead, on a case-by-case basis, to an audit and if necessary inspection of the imported seed. See Guidance for seed importers
  • Nil returns: where high risk seed has been bought from seed suppliers within the UK, we recommend that you read Guidance to market seed supplied from within the UK.

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 Annual Report or Reviews.

AGMP

Adventitious GM presence in Conventional Seed

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:

  • Turnip fodder rape and related crops (Brassica rapa)
  • Winter and spring oilseed rape and related crops (Brassica napus)
  • Fodder maize & sweet corn (Zea mays)

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).

 

Guidance: UK Supplied Seed

Guidance for marketing seed that has been supplied from other companies from within the UK

Anyone considering marketing, species of certified, conventionally-bred crop varieties in Scotland that are of a high risk category of containing adventitious GM presence are advised to:

  • Obtain from your UK seed suppliers, letters of assurance or details of analytical tests on individual batches or seedlots, that follow the Fera GM Inspectorate Guidance for importers and producers on the prevention of adventitious GM presence in conventional varieties.

In Scotland, high risk category species are winter and spring oilseed rape & related species fodder maize & sweet corn.

This information will assist your company 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.

Guidance: Imported Seed

Guidance for marketing seed of a high risk category of containing adventitious GM material that has been imported directly into the Scotland from out with the UK

Seed importers that have made a seed declaration on the Scottish Government GM Inspectorate’s Seed Monitoring form are advised to:

  • Obtain a letter of assurance from the breeder giving assurances that the seed is free from adventitious GM presence; or
  • Obtain details of analytical tests on individual seed batches or seedlots.

These measures should follow the Fera 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:

  • The species of the seed
  • The variety of seed
  • The field or lot reference number of the seed
  • The certification category of the seed
  • The country where the seed was produced
  • The weight of seed being imported
  • A letter of assurance or results of analytical tests as described above.

Should you have any queries over these measures contact the GM Inspectorate.

Guidance: Test and Trial Seed

Guidance for marketing seed for tests and trials (scientific purposes and selection work)

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 by 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 Cereals Branch or by telephone (0131 244 8856).

For those species that have a high risk category of containing adventitious GM presence, the SG 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 Fera 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.

Case by Case Investigations

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.

Recent 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 Annual Reports or Reviews.

 

Site Monitoring

The Scottish Government GM Inspectorate has agreed to directly monitor or oversee monitoring of sites where inadvertent sowings of GM crop seed took place on three sites in September 2008. Monitoring will continue until the autumn of 2011.

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’.

GM Diagnostics

SASA’s Diagnostic and Molecular Biology Branch provides analytical testing support for the GM Inspectorate by detecting genetically modified material using multi-element profiling and event-specific tests.

SASA is a full member of the European Network of GMO laboratories (ENGL) and is one of three UK National Reference Laboratories who assist the EU Community Reference Laboratory in testing and validating methods for detecting and identifying GMOs. Competence in GMO testing is also maintained by regular participation in ISTA GMO Proficiency Ring Tests.

For enquiries concerning GM testing telephone either 0131 244 8878 or 8845.

GM - Useful Links

This page provides links to websites relating to the regulation of GM crop plants


Competent Authority for Deliberate Release to the Scottish Environment

CAP Reform Crops Policy Branch
Scottish Government, Agriculture and Food Division
D Spur
Saughton House
Broomhouse Drive
Edinburgh EH11 3XD
Telephone: 0131 244 9499 or 9503

UK Lead Territorial Competant Authority for Deliberate Release
Department for Environment, Food and Rural Affairs,
GM Team
Area 8A, Millbank
17 Smith Square
London SW1P 3JR
Tel: 020 7238 2051 or 2054

Government GM web sites
Scottish Government – Genetic Modification 
Defra GM (Genetic Modification) (Department for Environment, Food and Rural Affairs)

Government Advisory committees
Advisory Committee on Releases to the Environment (ACRE)
Advisory Committee on Genetic Modification (ACGM)
ACGM Compendium of Guidance
Advisory Committee on Novel Foods and Processes (ACNFP)
Human Genetics Commission (HGC)

Other public bodies/Agencies
Food Standards Agency, Scotland (FSA)
Health and Safety Executive (HSE)
Fera GM Inspectorate (the English GM Inspectorate at Fera HQ, York)

Legislation
Directive 2001/18/EC the European directive covering GM releases to the environment
The Environmental Protection Act (1990)
The Genetically Modified organisms (Contained Use) Regulations 2000
The Genetically Modified Organisms (Contained Use) (Amendment) Regulations 2002
The Genetically Modified Organisms (Contained Use) (Amendment) Regulations 2005
The Genetically Modified (Deliberate Release) (Scotland) Regulations 2002

International bodies
ENGL European Network of GM Laboratories
ISTA GMO Proficiency Tests (International Seed Testing Association)