GM (Genetic Modifications): Information

Genetically Modified Organisms: The Regulatory Process

Note: This document has also been made available in Adobe Acrobat format (140kb) for downloading. The Adobe Acrobat Reader can be freely downloaded. Viewers with visual difficulties may find it useful to investigate services provided to improve the accessibility of Acrobat documents -- http://access.adobe.com

Produced by the Joint Regulatory Authority on behalf of the Department for Environment Food & Rural Affairs, Defra and the Scottish Executive.

Introduction - what are GMOs?

All plants and animals contain genes, which carry the information necessary to produce the numerous proteins from which they are composed. Humans, for example, contain about 30,000 genes. Genes are lengths of deoxyribonucleic acid (DNA) that are contained in the nucleus of every cell. Plant breeders have in the past introduced desired characteristics into a plant by crossing different varieties to mix their genes and thereby alter the genetic make-up. Now that the function of individual genes is better understood and scientists have the ability to chop and splice DNA, it is possible to insert specific genes into a variety of organisms to create Genetically Modified Organisms (GMOs)

In Europe and the United Kingdom there are strict regulations controlling the deliberate release and marketing of GMOs. The principal aim of these regulations is to protect human health and the environment. The regulations apply to all GMOs, although plants have been the subject of most interest in recent years. The legislation adopts a step by step approach to the assessment of GMOs. This means that initial developments are carried out in containment and only released into the environment if they are assessed to be sufficiently safe. The initial releases outside of containment are small and carefully controlled and precautionary measures can be applied to prevent or minimise the spread of GM DNA. The scale of the releases are increased gradually and tested at each level. The tests at each stage indicate whether the next step can be taken.

Contained use

Initially, genetic modification activities are carried out under containment, for example in laboratories, industrial production plants or greenhouses. This allows specific controls to be put in place to limit any contact between the GMOs and the environment so as to provide a high level of protection. The contained use of GMOs is closely controlled by the Health and Safety Executive who also enforce and monitor the environmental protection aspects of the relevant regulations. Establishments undertaking the initial laboratory research into potential applications for GMOs must notify HSE.

The release of GMOs into the environment

European Directive 90/220/EEC governs the release and marketing of GMOs in the European Union. It recognises two broad categories of release of GMOs into the environment: part B releases for small scale research trials and part C releases for commercial purposes. In Great Britain, Directive 90/220 has been implemented by Part VI of the Environmental Protection Act 1990 and the Genetically Modified Organisms (Deliberate Release) Regulations 1992, as amended in 1995 and 1997 and in Northern Ireland there is separate but equivalent legislation. The release or marketing of GMOs cannot take place without the explicit consent of the regulatory authorities.

A new Directive (2001/18) to replace Directive 90/220 was published in April 2001. Member States have until October 2002 to introduce national rules to implement the new Directive. The main changes will include a ten year limit on the length of marketing consents, compulsory public consultations and defined time periods when considering consent applications. However, the basic distinction between the treatment of Part B research releases and Part C commercial releases will remain.

The entire regulatory process is underpinned by a detailed environmental risk assessment, prepared by the applicant, which examines and evaluates any possible harmful consequences of releasing a particular GMO. Government scientists in the Joint Regulatory Authority based at the Department for Environment, Food & Rural Affairs review this assessment and seek the advice of an expert committee. In assessing applications every possible precaution is taken to ensure that human health and the environment are protected. Only if the risks are considered to be very low will the release be allowed to proceed. In the context of GM plants, a very low risk generally means that the GM variety is not thought to pose any greater risk than the release of its non-GM equivalent.

How does a GMO get approval for a research trial?

Once a GM plant has been developed within the confines of the laboratory it may become necessary to continue the research by conducting field experiments. To obtain consent, from a Member State under part B of the Directive, to release a GMO, applicants must submit a detailed dossier of information to the Joint Regulatory Authority. The application has to include information on the nature of the GMO, how it has been modified, the precise nature of the research programme proposed, where it will be released and how the release will be monitored. The applicant must also supply information necessary for evaluating foreseeable risks, whether they are immediate or delayed, from the release of the GMO. For applications to release GMOs in England the Joint Regulatory Authority advises the Secretary of State at the Department for Environment, Food & Rural Affairs (Defra). For proposed releases in Northern Ireland, Scotland and Wales applicants submit the dossier to the Joint Regulatory Authority who act on behalf of the Devolved Administrations in Northern Ireland, Scotland and Wales.

The application dossier is reviewed by scientists in the Joint Regulatory Authority and is forwarded to experts in other Government departments, devolved administrations and statutory conservation bodies such as English Nature.

All applications are scrutinised by the Advisory Committee on Releases to the Environment (ACRE), an independent scientific committee whose members include leading academic scientists. ACRE's role is to advise the relevant Ministers and other bodies on environmental and human health aspects of activities involving GMOs. ACRE assesses the potential implications of proposed GMO releases very carefully, including possible toxic or allergenic effects, and the possible impact on soils and fauna such as bees. If ACRE, and the other official assessors are satisfied that the release poses a very low risk then Ministers are advised that the release be approved. However, if ACRE was not in any way satisfied that the risks to human health or the environment were very low then it would advise that consent should not be issued. ACRE is committed to openness and transparency in all its work, and publishes both agenda and minutes of its meetings.

More details about ACRE can be found on its website (www.defra.gov.uk/environment/acre/index.htm)

In cases where the application refers to a GMO that will be used in food or animal feed then the Advisory Committee on Novel Foods and Processes (ACNFP) and the Advisory Committee on Animal Feedingstuffs (ACAF) are also asked for their expert advice.

After a GMO has been through this part of the regulatory process and has been assessed, by Government and independent scientists, as posing a low risk then it will receive a consent in England from the Secretary of State for Environment, Food and Rural Affairs. For releases in the devolved administrations then the relevant Minister will grant the consent. Once a GMO has received a part B consent it may still only be released at specified sites and under certain conditions. For example, there may be consents where the crop is prevented from flowering or where particular separation distances and pollen barriers are specified. Inspections and monitoring are routinely carried out by scientists at the Central Science Laboratory (CSL) and by the Scottish Agriculture and Science Agency (SASA) to ensure that any conditions placed on the release are being followed.

As mentioned above the regulatory process is based on a step by step approach. This means that the first releases of any GMO tend to be carried out on a small scale, have a large number of risk management conditions in the consent and are monitored for a number of years after the release has taken place. This allows information to be gathered on the GMO. The size of release will only be allowed to be increased if the JRA, ACRE and Ministers are satisfied that there have been no problems with the smaller scale releases. As the size of release is increased and more is known about the GMO then the risk management protocols may also be reduced. The information from the small-scale releases and larger releases can then be used in applications for approval for the GMO to be placed on the European market.

Information from all applications is also placed on a GMO Public Register. This register can be viewed at the Defra offices in London and copies of public register entries for specific applications can be obtained by ringing 020 7944 3409. The location of each release must be advertised in the local newspapers, prior to planting, in the area where the release is to take place. An index of the GMO Public Register and the locations of Part B trials are also published on the Defra website at: www.defra.gov.uk

How does a GMO get approval to be placed on the European market?

Consents for crops to be grown, processed or imported for commercial purposes are categorised under the Directive as Part C (marketing) releases. These consents are agreed at a European Union level and are valid across the EU. Under the step by step approach applications for Part C consent for GMOs must have considerable evidence about the GMO's properties, usually gained following years of smaller scale testing under Part B consent arrangements.

To obtain a Part C consent an applicant must submit a comprehensive dossier, containing all of the relevant information about the GM crop, including a detailed risk assessment, to one Member State of the EU. In addition to the information submitted in a Part B application, a part C dossier must also include: information about the diversity of sites that may use the product; information concerning the ecosystems that could be affected and an assessment of any risks posed to human health and the environment; any conditions for use and handling and a proposal for labelling and packaging. The relevant Member State takes the lead and conducts a thorough review of the application. After the review, and only if the lead Member State is entirely satisfied that the GMO poses a very low risk, it will forward the dossier to the European Commission in Brussels. The Commission circulates the dossier to the other Member Sates for further evaluation and comments by their competent authorities.

As part of the review of any Part C application, the Joint Regulatory Authority will seek the advice of the Advisory Committee on Releases into the Environment. ACRE critically reviews the application and only if ACRE is satisfied can the application proceed.

The Joint Regulatory Authority also forward the application to experts in other Government departments, administrations in Northern Ireland, Scotland and Wales and conservation bodies such as English Nature.

When all Member States have commented and if there are no objections then the application will proceed. The European Commission will then instruct the lead Member State to issue a marketing consent, which is valid throughout the European Union. If, however, any of the Member States object to the GMO being placed on the market the regulatory process allows for a resolution of differences with the possibility that the application could be rejected. If the application is approved, a Part C consent is valid for the whole of the European Union subject to any conditions or restrictions agreed by Member States, and to the completion of any other regulatory procedures that may be relevant to the product concerned.

Other regulations

GMO products may have to satisfy other regulatory procedures that apply to the commercial use of similar products, whether or not their production involves genetic modification. For example, any new variety of a GM crop, e.g. oilseed rape or maize, must satisfy the same requirements as conventional varieties for addition to the National List of Seeds or the European Common Catalogue. This requires a series of tests to demonstrate distinctiveness, uniformity and stability. Any use of pesticides on these crops also has to be approved by the relevant authority.

In addition any GM product to be used as or in food must also be approved under European Union Novel Foods Regulations. Two independent scientific committees, the Advisory Committee on Novel Foods and Processes (ACNFP) and the Advisory Committee on Animal Feedingstuffs (ACAF) review every product and advise on any concerns they may have.

There are also separate regulatory procedures that any human or animal vaccines containing GMOs have to pass through before being allowed to be administered to humans or animals.

Further information

For information on the contained use of GMOs: www.hse.gov.uk

Further information on the work of ACRE: www.defra.gov.uk/environment/acre/index.htm

For information on GM foods: www.foodstandards.gov.uk

GM Science and Regulation Unit
Department for Environment, Food and Rural Affairs
Zone 3/G9, Ashdown House
123 Victoria Street
London SW1E 6DE
Telephone: 020 7082 8122
E-mail: gm@defra.gsi.gov.uk

GM Co-ordination Team
Environment Group - Rural Affairs
The Scottish Executive
Area 1-H76
1 Victoria Quay
Edinburgh EH6 6QQ
Telephone 0131 244 7575