§ Dr. Ian Gibson (Norwich, North)European directive 90/220 will certainly not set the world alight, nor will it knock Delia Smith off the top of the bestsellers list at Christmas, but I would like to put it in context because it raises some important issues.
The Secretary of State for Trade and Industry said recently:
Knowledge is the key to competitive advantage in the global economy.He went on to say that the Government have a vital role in building and maintaining a powerful knowledge base in our universities, which is why we are putting an extra £1.4 billion, with the Wellcome Trust, into upgrading Britain's science, reversing years of neglect—as was admitted recently in an astonishing burst of honesty from the right hon. Member for Wokingham (Mr. Redwood), the shadow Science Minister.Other Government initiatives include a £50 million university challenge fund to exploit university research and develop it in industry. The Department of Trade and Industry has emphasised the startling advances in science and technology, and especially in biotechnology. The Science and Technology Select Committee is currently holding an inquiry into the process of innovation—how scientific discoveries are moved into the workplace—here and in the United States of America. It is clear that moving ideas into industry and the marketplace will require a proactive Government and individual creativity.
The European directive fits into that pattern. It governs a new technology, stating that it regulates
the deliberate release into the environment of genetically modified organisms".These days, that generally means plants. The directive is designed for experimental and marketing purposes. It follows laboratory stages and tests and is used to assess growth, yields and survivability of plants. The tests start in pots and progress to a few square metres, and finally a large number of hectares.The regulations require applicants to submit detailed information covering all aspects of the proposed release, the genes and organisms and the transformation methods used, as well as a comprehensive risk assessment, evaluating the risks posed to human health and the environment. Applicants must include full details of how the risk will be managed. There is a fast-track procedure to get information in 30 days, but the standard procedure takes 90 days before approval is given. The final stage after that is the commercialisation of the product.
Companies wanting to market seed in Europe must seek clearance under directive 90/220. Seed directives require national testing before any seed can be grown commercially. The next stage involves approval by every EU competent authority in all member states. Anomalies have certainly arisen in the process. The procedure, and especially the approval process, means that member states can object to anything approved in Britain, for example, while anything approved in Europe can be marketed in this country.
The public are disturbed by the use of genetically modified plants as foodstuffs. A debate is going on about the benefits versus the risks of the technology, not only 928 to human health but to biodiversity and the environment. An assessment can be made only by monitoring, experiments and field trials.
I invite the Minister to comment on weekend newspaper reports stating that a key Government report on the effects of growing genetically modified crops has been suppressed because of a controversial warning of serious environmental risks to our hedgerows, birds and indigenous plants posed by growing genetically modified crops on a commercial scale. It is rumoured that the document also reveals a series of gaps in the UK regulatory framework.
In general, procedures for small experimental releases, which include control measures for reducing pollen transfer, for example, work well, because member states have a fair degree of autonomy. The main problems arise when approval is sought for marketing across the European Union. Within the UK, marketing proposals have been dealt with efficiently and within the deadlines agreed in the directive. Decisions at EU level take an excessive and unpredictable time.
Short licence periods—it is now suggested that they be up to seven years—have been proposed, with no further guarantee of renewal. That is extremely frustrating in an area of plant production in which continuous development is needed. The monitoring processes are too detailed, complex and cumbersome.
The directive applies only to the products of genetic modification and ignores similar modifications made by conventional breeding. If, for example, we consider the potential long-term environmental and agricultural impact of genetically modified plants with herbicide tolerance, we should take account of similar varieties produced by conventional breeding. It is illogical for the full weight of regulatory oversight to fall on GM varieties, while the potential input of similar, conventionally bred, varieties is largely ignored.
The risk assessment carried out before releasing a GM organism must be based on a careful scientific analysis. We in the UK have worked hard to maintain a strong scientific base in that process. An important part of the underlying research has been carried out by or in association with people in my constituency, at the John Innes centre in Norwich, but there is strong evidence that political considerations have influenced the decisions in the EU regulatory process. Public concerns must be listened to and taken into account, but in the long term political concerns should not be used to influence scientific assessment in the application of GM organisms. The scientific and political processes should be kept separate.
It is important for decisions made in one EU country to be acceptable in another. We need to continue the hard work to attempt to achieve harmonisation of the regulations in the risk assessment process among member states and between the EU and other continents, especially north America—although I doubt that the Americans will agree at this stage, because their regulations are very much more lax than ours.
Monitoring the impact of GM crops on the environment, and on food and feed, should be an integral part of the commercialisation process. Certain risk assessment issues are scale dependent and can realistically be assessed only as part of the scale-up procedure, with the hectare field trials that I mentioned. Public and scientific confidence will 929 be improved by instigating a careful, scientifically rigorous monitoring programme. Many scientists in this country, including those in Norwich, will play a major part in that monitoring process and in using their scientific expertise to develop it.
The directive has features that could turn scientists and companies away from Europe and towards the United States of America or elsewhere, thus weakening the competitiveness of European agriculture and destroying the scientific base in our biotechnology industry, which is one of the best in the world and one of the great hopes for industry in this country, producing new vaccines, medicines and the plants about which I have spoken.
The directive needs amendment, adaptation and revision, so that permission to release GM organisms is based on sound scientific and objective information. Each release should be approved by a committee that is truly independent and not based on European political in-fighting. I suggest that the European Medical Agency is just such a body, in which scientific differences could be discussed, and indeed reconciled, to prevent such conflicts as have arisen and will arise again in the coming year or even months.
§ The Parliamentary Under-Secretary of State for the Environment, Transport and the Regions (Mr. Alan Meale)I join my hon. Friend the Parliamentary Secretary, Privy Council Office in conveying seasonal greetings to you, Mr. Deputy Speaker, and to others in the House.
I congratulate my hon. Friend the Member for Norwich, North (Dr. Gibson), who has always been deeply concerned with science. He has always been at the forefront in the House in promoting debate on science. I note that he mentioned the John Innes centre, which is famous among the many gardeners who follow developments in fertiliser and was connected with the late Percy Thrower, who did such a marvellous job for horticulture in the United Kingdom.
The principle of sound science is fundamental to the Government's approach to the regulation of genetically modified organisms. That is the case at the national, European and wider international levels. The Government recognise that the technology has enormous potential to improve the quality of life and the competitiveness of the economy, and that the regulatory system needs to support technical developments without imposing unjustified burdens on industry. However, the protection of human health is paramount and the impact on the environment and biodiversity, along with ethical issues, must be thoroughly assessed. The Government are determined that the regulatory system will not allow any product to move to commercialisation before practical evidence on safety is available.
My hon. Friend the Member for Norwich, North asked about recent press reports. The draft report in question was written by a senior scientist in the Department of the Environment, Transport and the Regions and explores the wider implications for farmland wildlife and the environment of the commercial cultivation of genetically modified crops. The risks arising from genetic modification itself are fully covered by scientific legislation, and the 930 report addressed other possible indirect effects. We have no evidence of any harmful effects, but the issues must be explored and have been under debate in the Department for some time. I assure my hon. Friend that no report has been suppressed. The risks of the introduction of genetically modified crops into commercial agriculture are being openly discussed and closely regulated.
In order to address concerns about the possible effects on farmland wildlife, my right hon. Friend the Minister for the Environment announced on 21 October that ecological studies will be undertaken on farm-scale planting of genetically modified, herbicide-tolerant crops, starting in 1999. The Government's Advisory Committee on Releases to the Environment—ACRE—will now take wider biodiversity issues into account when considering proposals to market genetically modified crops. Those issues will be discussed in detail through an ACRE expert working group and the conclusions will be made public and published.
The United Kingdom has an active and successful biotechnology industry. It spans a wide range of sectors including the pharmaceutical, diagnostic and agri-food sectors. There are more than 250 biotechnology small and medium-sized enterprises in the United Kingdom, with total biotechology-dependent sales by UK companies reaching £4 billion. That figure is expected to rise to £9 billion by 2000. United Kingdom biotechnology start-up companies alone currently employ more than 11,000 people. If the anticipated growth occurs, that figure will increase substantially. However, the continued success of the industry depends on public confidence in the technology and a strong, transparent regulatory regime is a vital factor.
At the national level, advice on the release of GMOs into the environment is given to the Secretary of State for the Environment frequently by ACRE, which is one of four statutory scientific and technical committees that give advice to the Government on GMOs. Members of ACRE are appointed on the basis of their technical and scientific expertise in subjects necessary for the assessment and understanding of the highly technical information provided in applications to release genetically modified organisms. Currently, they are a mix of specialists in sciences related to biotechnology, entomology and plant ecology, food safety and human health, and environmental affairs. ACRE is increasingly being asked to address wider issues, and my Department proposes to strengthen the committee's expertise in ecology and biodiversity, agronomy and farming practice.
In the European arena, the United Kingdom has welcomed the Commission's proposals to amend directive 90/220. Experience has shown the importance of the existing sound regulatory framework that secures the protection of the environment and human health while at the same time encouraging the development of biotechnology products and providing a route to their marketing in the community. However, the technology is developing quickly and we recognise that the existing directive needs to be updated.
The main problems that have been encountered with the directive have been the bureaucracy entailed in the approvals procedure in the European Commission and the difficulty of resolving differences of opinion between member states about the products. Concern has also been expressed, by ourselves and others, that the directive does not provide the framework necessary to address the 931 increasing concerns of the public and industry. In our view, the Commission's proposal went some way towards dealing with those problems, although it could do more.
The Government's aim in negotiating the amendment with our European partners has been to ensure that the right balance is struck between protecting the environment and human health and at the same time providing enough certainty for business to allow it to have the confidence to develop new products. The Government believe that our approach is right for the environment and right for business. The revised directive will include agreed time scales—which are vital to the industry—for the approvals procedures. Negotiations have centred on the balance between periods for consideration of dossiers by competent authorities and periods for mediation.
It is generally agreed that the existing 30-day period is not long enough for a competent authority fully to consider a new marketing dossier. A longer period of, perhaps, 45 days appears to be preferred, with a similar period for mediation. Fifteen days is also considered by many to be inadequate for assessing whether a notification complies with the criteria for simplified procedures. We are still some distance from reaching agreement on those points and further discussions on the details surrounding time scales and procedures will be necessary.
The Commission has proposed an enabling provision for simplified procedures for marketing notifications of certain GMO products, but did not specify the procedures or the criteria. Considerable misgivings have been expressed about such an open provision and they have led to calls for criteria, or guidelines for criteria, to be developed before the amending directive is adopted.
The United Kingdom has supported the introduction of differentiated procedures for marketing applications in principle, but of course the criteria will be critical. If there is any ambiguity, notifiers applying under the simplified procedure could find that the competent authority does not agree and rejects their notification. Even if the competent authority which receives the notification agrees that it fulfils the simplified procedure criteria, other competent authorities might disagree and object to notification. Should it not prove possible at this stage to develop clear guidelines or criteria, it may be appropriate to abandon the provision.
To ensure full protection for human health and the environment, the Government support the view that thorough risk assessments are essential and should address direct and indirect effects, and immediate and delayed effects. The United Kingdom has long emphasised the need to develop a harmonised approach to risk assessment for the release of GMOs, and that will be helped by the proposed introduction of the principles of risk assessment. That will foster the harmonisation that will improve the approvals procedures.
The Government believe it right to take a cautious approach during the early stages of relatively large-scale use of the technology. Hon. Members will be interested to know that the current directive does not require any monitoring after a marketing consent has been issued, although it would be possible to attach a specific monitoring condition to such a consent. Rigorous post-commercialisation monitoring forms a fundamental part of the revised procedures.
The Commission proposes to require notifiers to supply a detailed monitoring plan. The United Kingdom believes that no matter how detailed the scientific evidence 932 indicating that a product will not have adverse effects, we still require field observations to confirm that. There should be a means by which unexpected adverse effects can be fed back to the consent holder and the competent authority.
Clear and unambiguous labelling of genetically modified products will be vital to ensure consumer acceptance. The Commission proposal requires that products be labelled either "contains GMOs" or "may contain GMOs". Most member states want to remove the latter option as it offers little useful information to the end user. However, requiring that products be labelled positively raises the question of how to deal with cases in which a GMO is present in trace amounts or in which there are impurities in a non-GMO product.
Further difficulties arise where similar GMO and non-GMO products are mixed together, as sometimes occurs with commodities. One possibility is the establishment of a mechanism to determine thresholds for specific classes of GMO products or individual GMOs, rather than fixing a single cut-off point for labelling. That would ensure that information was freely available to the consumer on GMO products, and that is another important step towards securing consumer confidence in the technology.
As far as action by the UK is concerned, my right hon. Friend the Minister for the Environment recently announced that agreement had been reached with the plant breeding industry for a programme of managed development of herbicide-tolerant GM crops under which the first farm-scale plantings of herbicide-tolerant GM crops would be strictly limited and monitored for ecological effects alongside comparable plantings of conventional crops.
That process will be underpinned by the code of practice of the Supply Chain Initiative on Modified Agricultural Crops, a consortium of bodies representing plant breeders, agri-chemical companies and farmers. The code is voluntary for farmers who wish to grow GM crops developed by SCIMAC. Independent scientists would be able to see whether there were any harmful effects by studying crops on the field scale before widespread commercialisation. If ecological monitoring did reveal harm to the environment, the Government would take appropriate action, including a ban if necessary.
There have been a number of reports that we have imposed a three-year moratorium on insect-resistant crops, but that is not true. We have established with industry that no insect-resistant GM crops are in the final stages of development to be suitable for cultivation in the UK. For that reason, we do not expect insect-resistant GM crops to be grown commercially in the UK for at least three years. The concept of managed development provides a precautionary way forward to investigating, in a proper scientific framework, concerns that some GM crops might be harmful to the environment.
The principle of sound science runs through our policies, in domestic measures such as those that I have outlined and in our negotiations in Europe on directive 90/220. That principle also runs through our measures in the wider international field. The UK has supported a twin-track approach to the development of an international framework on biosafety, based on the promotion of the United Nations Environment Programme's comprehensive international technical 933 guidelines on safety in biotechnology and the development of a biosafety protocol on the transboundary movement of living modified organisms under the convention on biological diversity. In current negotiations on the biosafety protocol, the UK is working with European Union colleagues and through other international groupings to produce an effective international instrument that will contribute to the safe use of biotechnology on the basis of scientific risk assessment and the precautionary principle.
That is an outline of the Government's position on these matters, which has been badly misrepresented in the media. I pay tribute to my hon. Friend the Member for Norwich, North for the magnificent way in which he continues to develop the debate on science and technology. I wish him well in his endeavours.
§ Sitting suspended.