GM (Genetic Modification)

Answers to some frequently asked questions about GM crops and the Farm Scale Evaluations

Contents:

• Safety of GM crops
• ACRE
• The GM Public Dialogue
• Decision-Making on GM Crops
• Co-existence between GM and conventional/organic farming
• The Farm Scale Evaluations
• Other Issues

Q. What is the current situation with GM Crops?

No GM crop has all the required regulatory approvals to be grown commercially in the UK. GM crops are being grown for research and development purposes in a small number of sites around the UK. The main example of this is the Farm Scale Evaluation (FSE) GM crop trials.

The current EU legal framework assumes that the development and use of GM crops is a legitimate activity, subject to a detailed case-by-case risk assessment confirming that no adverse effects are likely to arise.  The Government supports this approach and, at the same time, has a voluntary agreement with the industry that GM crops will not be grown in the UK commercially before the results of the current programme of FSE trials have been assessed.

The Government’s overriding objective on this issue is to safeguard human health and the environment. The Government will not agree to the commercial release of GM crops if there is any significant doubt about their safety.

Safety of GM Crops

Q: How is the safety of GM crops assessed?

Both the European Union and the United Kingdom have strict regulations controlling the deliberate release and marketing of GM crops. The legislation adopts a step-by-step approach to the assessment of GM crops. This means that initial developments are carried out in containment and the GMOs are only released into the environment if they are assessed to be sufficiently safe. The scale of the releases is increased gradually and they are tested at each stage.

All of the crops involved in the Farm Scale Evaluations (FSEs) have undergone years of tests, both in the laboratory and on carefully controlled small-scale research sites.  In applying for consent to grow these GM crops the applicants have submitted a dossier of information from those tests.  This evidence has been considered by the Advisory Committee on Releases to the Environment (ACRE).ACRE has said that these crops pose no greater risk to human health or the environment than their non-GM counterparts. The information to support this and ACRE’s advice to Ministers is available through the National Public Register of releases at Defra’s office in Ashdown House, 123 Victoria Street, Westminster, London SW1E 6DE and on the Defra web-site at www.defra.gov.uk/environment/gm.

ACRE has experts covering various scientific disciplines and when undertaking a safety assessment they look at all the potential risk factors that may be associated with a GM crop plant, including possible allergenic or toxic effects to humans or animals, potential indirect or long-term effects, and the scope for gene transfer to other species.  If ACRE felt that a proposed GM release carried a significant uncertainty or that further information or testing was needed before they could make a proper assessment they would say so.  In that case release consent would not be granted until the relevant concern had been satisfactorily addressed.

As part of the risk assessment process ACRE will also assess whether the genes inserted into a GM plant will behave in a stable fashion.  There is always a risk of unintended effects, but after careful consideration ACRE has not identified any specific grounds for thinking that these might arise with the GM crops in the current FSE trials. All research releases of GM crops are monitored throughout the duration of the statutory consent, and in most cases post-trial monitoring is also required. Monitoring enables the assumptions made in the risk assessments to be verified, and any unanticipated effects of GMOs to be identified.

Q: What are separation distances and why are they used?

It is accepted that it is possible for a GM presence to arise in the equivalent non-GM crops or wild relatives (via cross-pollination or GM ‘volunteer’ crop weeds) and that cross-pollination between sexually compatible crops may take place over extended distances.  Separation distances aim to ensure that any cross-pollination with nearby compatible crops is minimised, but they do not rule out pollen transfer completely.  The separation distances applied to the GM crops in the FSEs are intended to ensure that cross-pollination with nearby compatible crops is below one per cent.  In the large majority of cases it will be much lower than 1%.

However, the fact that there will be GM gene flow does not mean that there will be an adverse effect on human health or the environment.  In their safety assessments ACRE consider the likelihood of gene flow occurring.  If there are doubts about whether it will actually occur ACRE take the precautionary approach of assuming that it will and then examine the potential consequences.  They have concluded in relation to the FSE crops that even if these transfer genes to other crops or wild relatives this poses a very low risk.

ACRE

Q: What is ACRE?

The Advisory Committee on Releases to the Environment (ACRE) gives statutory advice on the risks to human health and the environment from the release and marketing of genetically modified organisms (GMOs). They also advise on the release of certain non-GM species of plants and animals that are not native to Great Britain.  ACRE advises the UK Government and devolved administrations of Scotland, Wales and Northern Ireland.

ACRE members are selected and appointed in open competition in accordance with guidance from the Office of the Commissioner for Public Appointments. Members are independent and selected purely for their scientific and technical expertise. The range of expertise on ACRE includes molecular biology, plant virology, farming practice, ecology, entomology, sustainable agriculture and biodiversity and conservation.

Q: What does ACRE look at and what evidence do they base their decisions on?

Any person wishing to release a Genetically Modified Organism (GMO) into the environment must have a consent covering that release.  There are two types of consent, Part B, which cover research releases and Part C, which cover commercial releases. To obtain either of these an applicant must submit a dossier of information to the authorities.  ACRE considers these dossiers and provides technical advice on them to Ministers. The dossier must provide 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 for evaluating foreseeable risks, whether they are immediate or delayed, from the release of the GMO.

Further information about ACRE and their advice is available on their website www.defra.gov.uk/environment/acre or by contacting the ACRE secretariatby e-mail at gm@defra.gsi.gov.uk or by post to: ACRE Secretariat, Zone 3/G9, Ashdown House, 123 Victoria Street, London, SW1E 6DE

The GM Public Dialogue

Q. Why is the Government sponsoring a GM Public Dialogue?

The Government recognises that people have questions and concerns about genetic modification, and that it will help to have an informed debate on this issue.  The idea of a debate was formally recommended to the Government by the independent Agriculture and Environment Biotechnology Commission.

The Government wants an open and balanced national discussion on all the issues surrounding genetic modification in order to broaden and deepen understanding of what genetic modification is, how it can be used and what the risks and benefits are.

There are three strands to the overall dialogue process:

(i) a public debate: this covers all the issues (scientific, economic, social and ethical) that need to be considered as part of the dialogue.  It is being organised by an independent Steering Board chaired by Professor Malcolm Grant of the Agriculture and Environment Biotechnology Commission (AEBC).  The Steering Board will submit a report on the public debate to the Government in September 2003.  For more details see www.gmpublicdebate.org (or write to GM Public Debate Steering Board, Bay 479, 1 Victoria Street, London SW1H 0ET; Tel. 0207 215 6508).

(ii) a study of the costs and benefits of genetic modification: thisis being undertaken by the Prime Minister’s Strategy Unit.  The study will consider a range of possible scenarios for the future development of GM crops in the UK, including a "no GM" scenario.  It will look at crops currently in trial and also at those in development that could be available within a ten-year timeframe.  The study is an open process, with submissions invited and all stages published on the website.  The study will be published in June.  Further background is available at www.strategy.gov.uk (or write to GM Crops Team, Prime Minister’s Strategy Unit, Cabinet Office, 4^th Floor Admiralty Arch, The Mall, London SW1A 2WH).

(iii) a scientific review: this is exploring the state of the science on GM, centred on reviews of particular topics of interest or concern to the public.  The aim of the review is to identify where there is consensus, disagreement or uncertainty on the science surrounding GM issues.  The review is also an opportunity for scientists to engage positively with the wider community, to demonstrate the benefits of science but also help people understand its limitations. There is a dedicated website (www.gmsciencedebate.org.uk) and open meetings have been held on the main issues identified for consideration.  The review is being led by the Government’s and Defra’s Chief Scientific Advisers working with the Food Standards Agency.  They are being assisted by a panel with independent members.  The outcome will be a published paper or papers summarising where there is relative scientific consensus, disagreement or uncertainty on each of the topics covered. The Science Review Panel is due to report in June.  The address for the GM Science Review Secretariat is: Bay 484, 1 Victoria Street, London SW1H 0ET (Tel. 0207 215 2237).

Q. How will the three dialogue strands interact?

Each strand of the dialogue can draw on the outputs of the other strands as appropriate.  For example, issues raised in the public debate can be considered in the science review, and vice versa.  The groups leading the different strands are keeping each other informed of activities.  All three strands are committed to operating with transparent and open processes, including publishing key outputs as they go along.

Q. How much is the Government contributing to the public debate?

The UK Government, together with the Devolved Administrations, have recently confirmed a contribution of £500,000 to fund the public debate, double the original budget.  In addition, we are covering certain additional costs and providing considerable administrative support.

Q. How will the Government take account of the views expressed when taking decisions on GM crops?

The Government will listen to, and learn from, the views that emerge from the debate.  It will inform the Government’s decision-making on GM issues, including its policy on the commercial cultivation of GM crops.  We have also given a commitment that we will make a written response to the report from the independent Public Debate Steering Board and explain what we have learned from the debate when making future policy announcements on GM.

Q. How will people be able to contribute?

The initial stages of the debate have already been completed and included foundation discussion workshops composed of members of the public.  The Steering Board recently announced its plans for the main, high profile phase of the debate.  This is designed to reach a wide cross-section of society and will be conducted in June and July.  The programme includes six national and regional meetings; smaller county level meetings organised in collaboration with participating county councils, and facilitated discussions at village and local group level.  These should provide the opportunity for all regions to be appropriately represented and everybody to be involved who wants to be.  In addition to these elements, the meetings of the Steering Board are open for members of the public to attend and contributions can be posted on the GM Public Debate website.

Decision-Making on GM Crops

Q. How will Government come to decisions on GM Crops

There are established criteria in EU and UK legislation which will provide a basis for the future decision making process. The starting point is that decisions are based on the scientific evidence as to whether there is a risk to human health or the environment.

Q. What regulatory approvals are needed before GM crops can be grown commercially?

Separate approvals are needed under the EU Directive on the release of GMOs and seeds legislation (the National List process for new plant varieties). Approvals may also be needed under pesticides legislation (for the associated herbicide use) and under the EU Novel Foods regulations (for the associated food uses).  No GM crop currently has all the required approvals for commercial cultivation in the UK.

Q. When will decisions be taken on whether GM crops can be grown commercially in the UK?

No decisions have yet been taken in the UK on the commercial cultivation of GM crops, including those being grown in the Farm Scale Evaluation (FSE) crop trials.  Nor are final decisions, whether about the cultivation or import of GM crops, likely to be taken at EU level until the end of the year, by which time we will have the report of the GM Public Debate and the first set of results from the FSEs.

A number of applications, for both import and cultivation of GM crops, are currently being processed under the EU Directive on the release of GMOs. The Government must meet its legal obligations and cannot avoid taking part in EU decisions when these come forward. It is important that we contribute to the thorough scrutiny of these applications, especially as non-participation would not delay the timetable for taking decisions.  We will reach a view on these new applications on a case-by-case basis.

Some of the applications for commercial cultivation are for herbicide-tolerant crops.  Since the FSEs are assessing the environmental impact of the herbicide use associated with these crops, we intend to comment to the effect that we will not be able to give our final view until we have assessed the FSE results.  In any event, we have a voluntary agreement with the UK agri-biotech industry that no GM crops will be grown commercially in the UK until the FSE results have been assessed.

By the time final decisions are expected to be taken at EU level we will have the first set of results from the FSEs, the report of the Public Debate, and the information provided by the other parts of the work programme on GM that the Government has put in place.  We will decide our policy on the commercial cultivation of GM crops in the UK, in consultation with the Devolved Administrations, based on an objective assessment of all the available information.

Q. Is it possible to use EU Directive 2001/18, covering the release of GM crops, to make a particular area GM free?

It has been suggested that conditions could be attached to any consent authorising commercial GM crops to ensure that they cannot be marketed either in the UK as a whole or in localised “GM free areas”.  This is not how Directive 2001/18/EC operates.  It works on the basis that GMOs can be marketed without restriction across the EU if all appropriate measures are taken, including an assessment of the risks, to avoid adverse effects on human health and the environment.  In principle, therefore, the only grounds for narrowing the geographical scope of a GMO marketing consent would be if this were justified by some clear evidence identified in the risk assessment that the GMO in question would pose a risk to a particular area.  Under the Directive, if a GMO was considered unsafe for commercial use in a large geographical area within the EU, it is highly likely that authorisation would be refused outright.

Co-existence between GM and conventional/organic farming

Q. How will conventional and organic farming be protected from GM contamination?

We are considering how best to protect the interests of all farmers, including organic farmers.  Our approach to GM must be compatible with our support for the Organic Farming Action Plan, which aims to increase the share of the UK organic food market which is supplied by UK producers from 30% to 70% by 2010.  We therefore need to consider the terms upon which GM and non-GM production might co-exist.  This might include, for example, establishing separation distances which severely limit cross-pollination between GM and non-GM crops to a minimum level as well as resolving questions of liability where contamination of conventional or organic products does occur.

Q: Who will be held liable if any damage is incurred as a result of GM crops?

The European Commission has tabled proposals for an environmental liability regime covering a range of activities, including the release of GMOs, which, if adopted, would provide liability rules for GM crops covering damage to biodiversity. We are considering these proposals. The Government’s strategic advisory body in this area, the Agriculture and Environment Biotechnology Commission (AEBC), is also currently exploring issues of liability relating to GMOs.

Q. How is the Government ensuring seed stocks are free from GM contamination?

Proposed EU thresholds for adventitious GM presence in conventional seed remain under discussion in Brussels. We still await sight of the European Commission’s final proposals on seeds but our aim in negotiations will be to preserve choice by seeking adequate protection for the integrity of non-GM seeds.

Q. Will GM products have to be labelled?

Under current EU legislation, Genetically Modified Organisms (GMOs) must be labelled, as must GM food ingredients and non-GM ingredients that have a more than 1% incidental GM presence. Proposals are currently being negotiated within the EU to extend rules on the authorisation, traceability and labelling of GMOs. The Government supports clear GM labelling rules, but they must be practical, enforceable and proportionate.

Q. What is the Government doing to provide for those who want to be able to buy GM free products?

The Government appreciates that there are people who want their food to be GM-free.  This raises important questions about producer and consumer choice.  The Government wants to preserve informed choice as far as possible. Clearly, labelling thresholds will not guarantee that unlabelled foods are completely ‘GM-free’, though in practice most foods will not have any GM presence.  Currently there are no wholly GM foods on sale in the European Union and the range of foods that might have a GM content is strictly limited.  For example, there are currently no fresh fruit and vegetables that are GM, and meat does not have a GM presence.  The GMOs that are being used or are likely to be used in food production for the foreseeable future are crops like soya, maize and oilseed rape.  These are used to produce processed food ingredients or animal feed.  It is largely processed foods, therefore, that may have a small GM presence which is not indicated on the label.

The Farm Scale Evaluations

Q: What are the Farm Scale Evaluations?

Some companies have developed genetically modified (GM) crop plants that are resistant to specific weed-killers that are already widely used in agriculture.  The Farm-Scale Evaluations (FSEs) are a three-year research programme to study what effect, if any, the use of these weed-killers with the GM Herbicide Tolerant crops might have on farmland wildlife.  Researchers are studying differences in the number and types of weeds and insects (including bees and butterflies) in GM and non-GM halves of the trial sites.

Q: Why do we need the Farm Scale Evaluations?

The FSE programme is designed to examine whether there are any differences in the diversity and abundance of farmland wildlife associated with the farmers’ management of GM herbicide tolerant crops as compared with equivalent non-GM crops.  Small-scale evaluations in experimental plots or laboratory conditions cannot provide information on the complex ecology of the agricultural ecosystem; so no existing research is available to help answer the important questions that must be answered about the wider impact, if any, of these new herbicide regimes.  This can only be found out by testing under farm conditions.

Q. What happens to the crops when the trial is over?

Plant material from the trials is either incorporated into soil or goes to landfill.  The crops are being grown purely for research and do not have all the necessary approvals for commercial use.

Q: Why are the Farm Scale Evaluations not comparing GM crops with organic farming methods?

Organic farming methods do not allow the use of GM crops or the herbicides to which the plants in the FSEs are tolerant.  It would therefore not be possible to conduct the FSEs, which require one half the field to be GM, on organic farms.  However, interpretation of the data from the FSEs will allow a comparison to be made with organic farming methods.

Q: When will the results of the Farm Scale Evaluations be known?

For the spring-sown crops the fieldwork of the FSEs ended in 2002, but for the autumn sown oilseed rape crops the fieldwork will continue into 2003.  The results and statistical analysis will then be submitted to The Philosophical Transactions of the Royal Society. The journal will independently subject the papers to peer review. If accepted, the journal will publish the work in a theme issue devoted to the Farm-Scale Evaluations. The results are unlikely to be published before September.

Q: What will happen after the Farm Scale Evaluations are finished?

The results and statistical analysis will be presented for scrutiny by the Scientific Steering Committee (SSC). Ministers are likely to wish to refer the results to ACRE and the Advisory Committee on Pesticides (which has to approve the herbicide for use with the crops involved) for advice.  Both advisory committees will then advise Ministers, the National Assembly of Wales and the Scottish Executive.  This will inform the decisions the Government has to make on whether the GM crops concerned should be grown commercially in the UK.

Other Issues

Q. Why are GM crops being considered when the benefits are not clear?

At the moment we do not have a clear view of what GM technology may achieve because it is still at a relatively early stage of development.  Clearly, there are both potential risks and benefits.  The Government believes we should keep an open mind and allow the technology to develop within a strict regulatory system that is designed to protect human health and the environment. 

Q. What consideration is being given to the experiences of countries where GM crops are already being grown?

The Government is aware of reports that GM crops in North America have not performed as expected or led to problems. One frequently cited report is the ‘Seeds of Doubt’ report produced by the Soil Association. We welcome this report as a contribution to the public dialogue on GM issues that the Government is now sponsoring.  As part of the dialogue the Strategy Unit is undertaking a study of the costs and benefits of GM crops, including their impact on organic producers.  The Soil Association report is relevant to this and will be taken into account.  A representative of the Soil Association is on the expert panel which is helping the team compiling the study of costs and benefits with their analysis. At present there is conflicting information about theagronomic and economic impact of GM crops and we hope that the Strategy Unit study will provide a clearer basis for evaluating this.

Q. There are concerns that a generation of herbicide tolerant weeds (“superweeds”) has appeared in Canada as a result of cross-pollination?  Could such a possibility arise in Britain?

Crop weeds in Canada have acquired multiple herbicide-tolerance because different types of GM herbicide-tolerant oilseed rape are being grown.  This is known as ‘gene stacking’ and it gives rise to the concern that volunteer crop weeds may become difficult to eradicate, possibly resulting in agronomic or environmental problems.  Gene stacking cannot occur with the GM crops which are the subject of our Farm Scale Evaluation trials because they do not cross-pollinate with each other.  If it is proposed that other crops that could result in gene-stacked weeds should be grown here, the risks will be fully evaluated beforehand, taking into account the evidence from North America.  The conservation body English Nature has published a report on gene-stacking in Canada, and the author of that report is a member of ACRE, the independent expert group that advises the Government on GM safety issues. We have a clear policy that we will not allow GM crops to be grown in the UK if there is any significant doubt about their effect on human health or the environment.

Department for Environment, Food & Rural Affairs
May 2003