Select Committee on European Communities Seventeenth Report


Memorandum from the Ministry of Agriculture, Fisheries and Food


  The Government welcomes this detailed report from the Select Committee while the revision of Directive 90/220/EEC is underway. The effective and timely revision of Directive 90/220 on the deliberate release into the environment of GMOs is a major priority for the Government. It offers the opportunity to reinforce the existing legislation to secure full protection for human health and the environment, while providing a stable and predictable regime which will maintain UK and EU competitiveness in the commercial exploitation of biotechnology and genome research. The report makes an important contribution to the intense debate on the regulation of genetically modified organisms (GMOs) in agriculture in presenting a balanced and considered perspective on the key issues surrounding the application of biotechnology in agriculture and food production.

  The Government particularly welcomes a number of the Committee's recommendations. Rigorous and wide-ranging assessment of risks to the environment and human health must continue to form the foundations of the regulatory process. The Government is committed to ensuring that risk assessment provisions are strengthened and extended to include indirect and delayed effects. The Government also supports the Committee's recommendations on monitoring. This will allow a clear picture to be built up of the environmental effects of GMOs, and enable the assumptions in the risk assessment to be verified.

  The Government welcomes the Committee's recommendations on labelling and the thresholds at which labelling should be required. The Government is pressing the European Commission to develop proposals on labelling and especially thresholds, and is pleased to see additional support for these issues.

  Significant progress was made on the revision of the Directive by the Austrian Presidency. The UK was supportive of many of the broad positions in the final text sent to the Environment Council in December 1998, while recognising that some detailed work remained to be done on the text. At the Council, Ministers agreed to introduce new provisions on risk assessment and monitoring with immediate effect, in response to public concern over genetic modification.

  The European Parliament adopted its first reading Opinion in February 1999. The Government welcomes the Opinion, and supports the Parliament's call for moves to reach a common position shortly.


  The recommendations in italics refer to Part 4 of the Select Committee's Second report in the 1998-99 session and are referred to by number.


172.   Biotechnology in general and genetic modification in particular offer great potential benefits to agriculture, industry, consumers and even to the environment. We consider that GM technology may offer much to organic systems, for example through reduced inputs (paragraphs 65-72, 78).

  The Government agrees that the technology holds potential net benefits and we believe it should be allowed to proceed, subject to Government securing sufficient evidence to be confident that the genetic modification will not be detrimental to human health and the environment. We have yet to see any genetically modified (GM) crops grown commercially in the UK and must wait to see whether they will result in a reduction in agricultural inputs, but we recognise that this is the aim of some genetic modifications, and could bring benefits for the environment, if achieved.

  The Government notes with interest the view that genetic modification technology offers benefits to organic systems in terms of the potential to reduce pesticide and fertiliser inputs. However, this perception is not shared by most organic farming organisations. Their position is that GM crops have no role to play in their farming systems, and statements based on this position have been incorporated in the UK Register of Organic Food Standards for both production and processing. Furthermore, the draft EC Regulation amending Council Regulation 2092/91 on the organic production of agricultural products and foodstuffs, including livestock production, proposes a complete prohibition on the use of GMOs, and their derivatives at any stage in the production of organic food, with the exception of their possible use in veterinary medicinal products. This prohibition has received the support of all Member States and the European Parliament.

  Nevertheless, the Government believes that genetic modification and organic farming will have to find a modus vivendi. The Government is offering substantial support towards organic farming and is concerned that the introduction of GM crops into agriculture should not compromise organic production. It has therefore urged the proponents of the growing of GM crops here in the United Kingdom to address the issue of the interface with other crops, including organic crops, through specifying separation distances and consultation with neighbouring farms where appropriate.

173.   There are potential risks relating to the environment, including the impact on ecosystems of out-crossing, pest resistance and stress and multiple tolerances (paragraphs 73-86).

  The Government fully recognises that there are potential risks. No GMO may be released into the environment unless an environmental risk assessment has been carried out and reviewed, and a consent issued by the Secretary of State which sets the conditions of release. The environmental risk assessment takes into account the effects on ecosystems of outcrossing, any stress or multiple tolerances, and the development of pest resistance.

  The revision of Directive 90/220 aims to establish common principles for risk assessment to include both direct and indirect effects and to require post-market monitoring to ensure that the potential environmental risks are rigorously addressed. While the revision of the directive is underway, European Environment Ministers agreed last December to use the flexibility within the existing directive to introduce strict new principles for risk assessment and post-market monitoring, with immediate effect.

174.   We consider that environmental risks and benefits should be assessed at the same time (paragraphs 87-88).

  Safety to human health and the environment is the primary goal of the regulatory system. Under the current regime, releases of GMOs are judged solely on the basis of an assessment of the risks to human health and the environment. The regime does not permit the decision on whether to grant a consent to take into account the offset of any risks by benefits.

  There may be benefits to biodiversity from the planting of certain GM crops, where they may replace more damaging practices in conventional agriculture. We are currently considering the wider issues of GM crops with respect to how biotechnology fits into agriculture and our commitments to enhance biodiversity on farms. The Government's Advisory Committee on Releases to the Environment published a discussion paper on 18 February on the Commercial Use of Genetically Modified Crops in the UK: the Potential Wider Impact on Farmland Wildlife.


175.   The risks involved in genetic modification can, we believe, be controlled, if a strict risk management process is in place. A clear, coherent set of principles for environmental impact analysis is needed which allows for consistent interpretation by Member States (paragraphs 89, 92-93).

  The Government agrees that environmental risk assessment and strict risk management is the key to the safe use of GMOs. The current Directive requires a risk assessment to be carried out on a case-by-case basis before every release, but contains no specific provisions on how this should be done. The UK has encouraged the development of risk assessment guidelines in the Community for a number of years, and has issued risk assessment guidance to applicants for several years. Although no agreement has yet been reached on the amendment of the Directive, EU Environment Ministers agreed last December to introduce common principles for risk assessment, as noted above.

  The Government considers that a common approach to risk assessment would help to ensure a thorough and harmonised appraisal of the risks that each GMO may pose to human health and the environment. It would also help to increase the standard and quality of notifications submitted and ensure that competent authorities take a more harmonised approach to the appraisal of notifications, thereby helping decision-making at Community level and avoiding the long delays in issuing decisions experienced over the past years.

  For these reasons, we welcome in the proposed revision of the Directive the specific inclusion of an annex on risk assessment. General priciples of risk assessment are being developed in the course of the negotiations which will promote consistent implementation in the Member States.

176.   We recommend that risk assessment should include direct, indirect, immediate and delayed effects. The regulatory system should attempt to predict interactions. A system which attempted to identify an integrated approach would be preferable to what amounts to a first come, first served approach (paragraphs 94-95).

  The Commission's proposal for the amendment of Directive 90/220 requires risk assessments to take account of direct and indirect, and immediate and delayed, effects of GMOs. The Government fully supports the inclusion of the indirect and cumulative effects in risk assessment requirements in the new Directive, and is committed to taking account of the broader environmental impact of each release before issuing a consent.

  The indirect effects of GM crops on non-target species are already considered in the current regulatory regime where those effects may occur as a result of the crop itself. The current regime also addresses cumulative effects by considering the effect of a new GMO together with any interactions it might have with GMOs approved previously. This is particularly relevant in the case of herbicide-tolerant crops. The Government believes that cumulative effects should be made explicit in the context of risk assessment in the revised directive and is pressing for this. The combination of these changes would provide an integrated approach.

177.   In assessing risk, we recommend that modified plants and their management schedules should be compared with the use of a similar non-modified crop and best agricultural practice (paragraph 90).

  The risk assessment is always based on a comparison of the modified plant with the non-modified plant from which it is derived. The Government agrees that the overall assessment of risk needs also to take into account environmental effects of any change in agricultural practice that is likely to be necessary as a result of planting a GM crop.

178.   We recommend that there should be triggers other than genetic modification which bring the assessment and management system into action, as is the case for novel foods. We recommend that, from now on, any crop with novel traits which may have the potential to impact significantly on the environment should be subject to an oversight system (paragraph 91).

  The Government recognises that regulating on the basis of process rather than product could lead to anomalies. For example, crops can be bred by traditional means to express herbicide tolerance in a similar manner to that expressed as a result of genetic modification; indeed such crops are already grown commercially in Canada. The Government considers it right that the focus is on the genetic modification of organisms since this can result in the crossing of species barriers where risks have to be particularly carefully assessed and managed. The EC legislation on GMOs reflects this view.

  The Government recognises however that this matter would benefit from further examination and will ask ACRE to advise on what might be done to address the issue raised by the Committee.

179.   The knowledge of how a crop grown on farm and commercial scales will interact with the environment can only be acquired by growing it on such scales. Large scale trials are needed. We consider that an outright moratorium would be inappropriate (paragraphs 96-99).

  The Government is confident that the regulatory control of the risks from GM crops themselves, based as it is on risk assessment and the step-by-step approach, will ensure the environment is protected. However, there is an additional safeguard in the Directive which allows a Member State provisionally to stop the marketing of an authorised product where there is evidence of environmental harm. The Government agrees that a general moratorium is unnecessary and would be unhelpful, and believes that in any case imposing one unilaterally would be unlikely to stand up to legal challenge.

  The Government is taking seriously concerns raised by English Nature and others that the widespread introduction of some types of genetically modified crops could bring changes to the agricultural environment which may be damaging to farmland wildlife. Last October, the Government announced a managed development programme agreed with the plant breeding industry to address these concerns. We shall continue with research releases and farm-scale plantings in order to build up a fuller picture of the environmental effects—either positive or negative—of GM crops. This could not be achieved with a moratorium.


180.   We welcome the ability to set specific conditions for each commercial release. We are however concerned that the draft Directive does not envisage an end-point at which the GM crop is considered safe enough to be released into the environment without such constraints (though perhaps with certain management conditions) (paragraphs 100-101, 170).

  The Commission's proposal sets a seven year fixed period for consents. The UK has serious reservations about automatic time-limitation, although the Government is prepared to accept the principle, with the longest possible period, to ensure agreement is reached on the amendment. The Commission proposed a separate procedure for renewing marketing consents for further periods of seven years. We consider that the need for time limitations where consents are renewed should be considered on a case by case basis.

181.   Conditions and regulations should only be imposed where necessary, but must be adhered to when imposed. The general conditions may best be established through a (preferably pan-European) government-sponsored code of practice. It may be the case in this instance that a voluntary code of practice will not be sufficient; if so, the code of practice should be backed up by regulation (paragraphs 105-107).

  Conditions and regulations which form part of the consent are enforceable as part of the regulations. The proposed amendments to Directive 90/220 includes requirements such as post-market monitoring (which Member States have agreed to introduce now) and the provision of information to the public. We support these.

  The Government has agreed with the plant breeding and farming sectors in the industry group SCIMAC (Supply Chain Initiative on Modified Agricultural Crops) a programme of managed development of herbicide tolerant GM crops whereby the first farm-scale plantings are strictly limited and monitored for ecological effects along with comparable plantings of conventional crops.

  SCIMAC has also drawn up voluntary guidelines on the growing of herbicide tolerant crops. These seek to ensure best farming practice through, for example, separation of GM and non-GM crops, product identity and record keeping. Once the crops get to the point of commercial release, there will be industry sanctions to ensure the point of commercial release, there will be industry sanctions to ensure compliance, including withdrawal of access to GM crop varieties for serious breaches. The arrangements will complement the requirements of Directive 90/220 under which a consent can be modified or withdrawn if necessary. They will be backed up by a system of independent audit.

182.   Monitoring is not a substitute for risk assessment but can complement it. We consider that those involved should report on any predicted effects which do not occur and any unexpected events which do occur. We recommend that monitoring (to Community-wide standards) should be performed by an independent organisation, funded through levies on applicants. There must also be a Community-wide audit of enforcement as monitoring standards (in many fields) have in the past been subject to too great a variation (paragraphs 102-104).

  The Government strongly supports the proposals for amending Directive 90/220 to incorporate requirements for monitoring commercial releases. Monitoring requirements, based on risk assessment, would be set out on a case-by-case basis with each marketing consent and enforced by the relevant competent authority. As mentioned above, pending the revision of the Directive, the European Environment Ministers agreed last December to require stricter monitoring provisions under the existing Directive, based on monitoring requirements in the amending Directive. This requirement is currently being implemented in the UK.

  The competent authority reviews the notifier's proposed monitoring as part of the assessment of the notification. Consent holders may carry out monitoring themselves or contract independent organisations to do it for them. The methodology for the proposed monitoring and the results of the monitoring are subject to review by the competent authority (and in the UK by ACRE); adjustment, or under the revised Directive, renewal, of the consent takes the results of that review fully into account. The Government believes that such control, together with the regular meetings of the competent authorities, will help to secure sound monitoring across the Community. The Government considers that the financial responsibility for monitoring commercial releases lies with the consent holder.


183.   We consider the regulatory process for assessing the safety of novel foods to be thorough and proper and we see no reason to doubt the safety of foods which have been approved by the regulatory process. The emphasis should not be on "genetically modified" but on the new characteristics of any individual product (paragraphs 109-116).

  The Government welcomes this conclusion. Although the regulatory process considers the method of production, the main focus is on the safety of the product as sold to the consumer. The experience gained through assessing individual applications is used to inform subsequent assessments and is built into periodic reviews of the regulatory procedures. The Advisory Committee on Novel Foods and Processes keeps a very close watch on emerging science and takes account of this in its safety assessments. The Government is therefore satisfied that all GM foods currently approved for sale in the UK have been rigorously assessed and judged, on the basis of extensive scientific knowledge, to be as safe as their non-GM counterparts for all sections of the population. The Government is still committed to exploring options for the post-market monitoring of GM foods.

184.   Antibiotic-resistant marker genes should be phased out as swiftly as possible. Research needs to be conducted into how best to consider applications involving genes without proven track records of food use. We support the call for the accumulation and sharing of national data to assist regulators (paragraphs 75, 109-116).

  The Government encourages companies to develop alternatives to antibiotic resistance marker genes (ARMs) and to develop methods to jettison those used where they are not an essential part of the final food. The safety of ARMs is considered on a case by case basis taking into account an assessment of the clinical use of the antibiotic; the likelihood of transfer of the antibiotic resistance gene into, and expression in, gut micro-organisms; and the toxicity of the gene product. The potential cumulative effect of ARMs in different products is also taken into account. The ACNFP has published two reports on the use of antibiotic resistance marker genes in genetically modified food organisms and keeps a very close watch on developments.

185.   Internal work at MAFF to prepare for the Food Standards Agency is poor substitute for its launch. We would be encouraged if legislation were to be brought forward in this Session (paragraphs 118-122).

  The Government intends to establish the Food Standards Agency at the earliest opportunity, and the necessary legislation will be given priority if extra time becomes available in the present Parliamentary session. In the meantime, the Government has published a draft Bill for full public consultation. The draft Bill has also been subject to pre-legislative scrutiny by an ad hoc Select Committee of the House of Commons to help ensure that it is of a high quality when it is introduced in Parliament.

186.   Genetic modification does not concern a single product or variety but will soon affect the whole spectrum of agriculture. To require traceability for all agricultural commodities would be an exceedingly costly exercise for little benefit, especially when there is no anticipated risk to human health (paragraph 117).

  Requiring full traceability for imported commodities, where these have already met EU food safety requirements, could also be challenged as a contravention of our obligations under the World Trade Organisation.


187.   Once the regulatory process has ensured safety, the success or failure of the technology must be left to consumer choice in the marketplace. The two issues involved in providing choice are the supply of GM and non-GM products and labelling (paragraph 128).

  The Government is determined that all foods that contain GM material should be clearly labelled to facilitate consumer choice. The UK has campaigned hard in Europe to secure better labelling of GM foods. A Regulation on the labelling of GM soya and maize, came into force on 1 September. Regulations enforcing this EC regulation recently came into effect in Great Britain. These GB regulations also extend the labelling requirements to establishments selling non-prepacked foods such as catering premises. These requirements will enable consumers to choose whether or not to eat foods containing genetically modified material. But choice also depends on having alternatives. To assist in this, in March 1998, the Government published a list of companies offering non-GM soya. This list currently contains details of some 59 suppliers. The intention was to facilitate the ability of the market to respond to any perceived demand for non-GM supplies.

188.   Segregation must be driven by the market and not required by Government. Producers and manufacturers should however be under no illusion as to the climate of consumer opinion in Europe and it would be advisable for the immediate future for segregation to occur to facilitate consumer choice. The identity preservation system is to be commended. The crop and product must still be subject to the standard testing and labelling regimes as GM material has often been found in supposedly unmodified shipments (paragraphs 129-134).

  The SCIMAC managed development programme described above will guarantee segregation and clear labelling throughout the supply chain of all GM crops grown in the UK.

  The Government appreciates the difficulties associated with obtaining the segregation of GM and non GM crops on a large scale. This does not alter the Government's view that segregation would have been a better way to introduce GM crops into the UK market.

  This said, the labelling regime which is now being introduced will in effect ensure the identity of products and many suppliers will choose to keep GM and non-GM products separate to satisfy consumer demand. With effective labelling, the ability of enforcement authorities to test label claims, and the availability of non-GM alternatives, consumers will be in a position to purchase products which best suit their needs. Indeed as indicated below there is evidence that the market is already responding to consumer demand for non-GM alternatives.

  The Government is satisfied that all GM foods currently on sale have been subject to a rigorous safety assessment and consequently considers that there are no safety concerns to warrant imposing segregation as a condition of approval. On this basis we believe that any attempt to impose segregation as a condition of import would not be defensible under WTO rules.

  The Government recognised that to facilitate consumer choice there was a need to encourage the development of an alternative market in non-GM ingredients. As indicated in the response to conclusion 187 the Government has facilitated the development of such a market. There is already evidence that several large supermarket chains are now obtaining their ingredients from suppliers offering identity preservation systems. They will nevertheless need to ensure that food containing these ingredients can comply with the labelling rules as currently drafted.

189.   We welcome the requirement for the explicit labelling of GM products in order to help provide consumer choice. We agree with the Commission and Government that only products where the transgene or its product are detectable should be labelled. To demand labelling where such detection is impossible would be meaningless. A Community list of products which do not require labelling is urgently required (paragraphs 135-139, 145).

  The Government welcomes this conclusion, indeed it is determined to ensure the clear labelling of foods containing GM ingredients to enable consumers to make informed choices. In respect of the creation of a list of products which do not contain GM material from GM soya or maize and therefore do not require labelling, the Government is pressing the European Commission to bring forward a proposal as envisaged in EC Regulation 1139/98 as a matter of urgency. The Government understands that the Commission is currently awaiting advice on this from the EC Scientific Committee for Food.

190.   Any ingredient or additive to a product should be identified as GM when the presence of GM material can be detected above an established threshold. No labelling should be required below the threshold. Additionally, if a finished product contains GM material above a threshold the product itself should be labelled.

  The Government is pressing the European Commission to develop detailed labelling rules for additives as a matter of urgency. A first draft of a proposal is expected later this month. It is anticipated that this will take the form of a Commission regulation made under the food labelling directive 79/112/EEC and will follow the approach contained in regulation 1139/98 by requiring labelling based on the presence of GM material (protein or DNA). The Commission is also developing a proposal for a de-minimis threshold such that adventitious contamination of a non-GM supply below a given threshold will not require labelling. However, where GM material is present above such a threshold it will still need to be labelled.

191.   The absence of a testing and thresholds policy is a serious gap in current European and domestic legislation. Until a Community policy is agreed we recommend that MAFF should issue interim guidelines. A workable but cautious threshold for GM presence would perhaps be 2 per cent (paragraphs 136-139, 141-144).

  The Commission is actively developing a proposal for a de minimis threshold for labelling. The Commisson has indicated that it intends to come forward with a proposal by the end of March. The proposal is based on the concept that non-GM, supply in which low levels of adventitious GM material are present will not require labelling if this is below an agreed level. The Government agrees that a threshold is a necessary measure to avoid a proliferation of GM labelling where all reasonable attempts have been made to ensure that the material being used is non-GM. Representatives from a majority of member states agree that a figure of 2 per cent is a reasonable limit given the specificity of current detection methods and the Government is considering this and whether such a threshold would be acceptable to consumers. We are however, of the view that any agreed figure should be seen as a maximum limit and that producers should continue to endeavour to keep well below this figure by following best practice in the cultivation, transport and processing of crops.

192.   Information supplementary to that provided on the label of GM foods must be available to the consumer. We recommend that Member State governments co-ordinate (but not necessarily be responsible for) the establishment within each State of a source of information regarding GM foods, to which the consumer may resort for information not provided on the product label. In the United Kingdom, this should as soon as possible fall under the remit of the proposed Food Standards Agency (paragraph 140).

  The Government encourages the provision of additional information to enable consumers to make informed choices.The Government is also committed to an open and transparent approval system, where decisions are no longer made behind closed doors. The Minutes of the ACNFP are already published on the internet together with detailed agendas and committee papers. Applicants are also encouraged to deposit the data which supports an application in the British Library. The Government is currently considering what additional steps can be taken to open up the system still further whilst recognising that rules on data confidentiality need to be developed at community level.

  The Government is currently updating the Food Sense leaflet on genetically modified food to take account of recent developments in legislation.The ACNFP has recently produced a corporate brochure containing details of how the Committee assesses products and when foods were approved.


193.   It is highly desirable that there should be competition between a sufficient number of agro-chemical/seed companies on a world-wide basis. We consider that consolidation should not progress any further (paragraph 85).

  The Government notes the Committee's comments on consolidation in the agrochemical sector. Where mergers or acquisitions involving agrochemical companies quality for investigation under either UK or EC competition jurisdiction, they will be given careful consideration on their individual merits. In assessing the effects of a merger under either domestic or EC procedures, the effect on competition and the degree of consolidation within the sector are factors which are generally taken into account.

194.   Provided that the farmer can afford any extra costs, we do not consider either the licensing of the right to plant or the sale of seeds which will produce sterile crops to be a problematic development (paragraph 86).

  The Government agrees broadly with the Committee's conclusion as to the growing of these crops in the developed world. No farmer should be forced to grow these crops, though if the market finds that they fulfil the claims made for them, there is likely to be a commercial incentive to do so. Licensing of the right to plant will add to the environmental safeguards on their production, while use of seeds which will produce sterile plants will help to prevent gene transfer.

195.   The regulatory process should only judge products on safety: ethical questions should be addressed before regulation, not during or after. In the same way as agreeing the principles for risk assessment, the Council of Ministers will need to agree on how to deal with potentially ethically sensitive modifications such as the inclusion of animal or fish genes in crops. The market might be a suitable arbiter. For some people the use of GM products to any extent is an ethical issue (paragraphs 126-127).

  The Commission's proposal for the revision of Directive 90/220 contains a reference in the preamble to the possibility that the Commission may consult its ethics committee on general matters. The Government fully endorses the view that ethical questions must be addressed with regard to GMOs, and fully supports the Commission's proposal. We believe that in the context of the Directive, ethical questions should be treated generically rather than as a part of the review of each notification.

  In addition, there are a number of committees, including the ACNFP, in the UK which have ethical experts amongst their members and are therefore equipped to take account of ethical issues when advising Ministers. The Government is acutely aware that some people do not wish to use GM products and so is committed to providing information to allow consumer choice. Under the EU novel foods regulation there is a requirement to label food containing GM material not present in conventional counterparts that gives rise to ethical concerns. This requirement is based on a recommendation by the Polkinghorne Committee that food from GM crops should be labelled to indicate whether ethically sensitive genes have been introduced.

  The question of whether ethical issues are fully addressed by the current regulatory frameworks being considered as part of the review referred to in response to conclusion 198.

196.   The destruction of trials of GM crops by certain groups fundamentally opposed to the technology must be condemned, but increasing confidentiality is not the answer. The advisory committees should continue to place as much information as possible in the public domain. We welcome the Commission's proposal to do the same at Community level. We agree that public comment should be taken into account formally before ACRE makes its recommendation, rather than informally as at present. Transparency, however, must not affect the efficient working of the regulatory committees (paragraphs 123-125).

  The Government is fully committed to providing public information and to a transparent and open regime. For this reason, the applications for releases of GMOs, and the full dossiers of supporting information including trial locations are open to public inspection. It is regrettable that this important element of transparency in the regulatory process has been abused. The agendas, reports and minutes of ACRE are all available for public inspection on the DETR-ACRE website, along with a range of supplementary information. In addition, the establishment of a stakeholder forum to discuss the environmental aspects of GM crops is under consideration by the Government.

  The revision of Directive 90/220 provide an opportunity to make the regulatory procedures more transparent at European level, and the Government has pushed strongly for this. The European Parliament has, in its first reading, called for public consultation to take place within the timetable for assessing notifications.

  Public comment on individual applications for consent to release GMOs is already taken formally into account by the competent authority. When relevant scientific information is submitted to the authorities, it is referred to ACRE.

197.   We do not question ACRE's integrity, but it and its members must be seen to be acting independently. The remit of ACRE should be adjusted so that it considers, for example, indirect and cumulative environmental effects when judging individual applications (paragraphs 148-150).

  The Government recognises the high quality of the advice received from ACRE. Under the chairmanship of Professor John Beringer, ACRE has provided expert advice on over 160 applications to release genetically modified organisms since February 1993 when the current regulations came into force. ACRE's advice is independent of any interference from Government or influence from industry or pressure groups.

  The Government has already acted upon criticism that ACRE's remit is too narrow. Until recently, within the terms of the current regulatory framework ACRE only offered advice on the direct and indirect impact of genetically modified organisms on the environment and human health. The remit of ACRE has now been extended so that the committee also considers the wider indirect effects, such as changes in agricultural practice, subsequent and consequent effects on biodiversity, and cumulative effects.

198.   We believe that a new committee, similar to that proposed by the Royal Society, is needed to examine more general issues which arise from the use of genetic modification in agriculture and to co-ordinate and plan policy as a seamless whole (paragraphs 151-153).

  The Government recognises that the Committee structure set up some years ago may not provide the full range of advice needed in today's climate. The Government is therefore undertaking a thorough review of the framework for overseeing developments in biotechnology, focusing particularly on the range of committees that have been established to provide the Government with expert advice and to regulate in this area. The Government is also engaged in a public consultation on developments in the biosciences which is due to report in Spring 1999. The review of the framework for overseeing developments in biotechnology will report at the same time.

  The Government seeks to have in place a system that provides sound advice and proportionate regulation and is at the same time as simple and transparent as possible; that has the flexibility to respond to the fast moving developments in the technology and to public concerns; and that commands the respect of users and the public. The review is assessing the current system in the light of these criteria. It seeks to address the following questions.

    —  what gaps exist in coverage of biotechnology by the existing committees and how might these be remedied?

    —  what overlaps exist and are they justified? If not, how might they be remedied?

    —  could the current system be structured in a more simple way?

    —  how could the system for providing advice to Government be made more transparent?

    —  are ethical and other wider issues addressed fully and properly within the current system?

    —  are stakeholders given the appropriate opportunities to make their views known? For example, would an environmental stakeholder forum be a valuable addition to the current framework?

    —  is the framework flexible enough to cope with the rapid development of this technology which is likely in the future?

    —  does the public have confidence in the system currently in place?

199.   Domestic pressures, ecological and agricultural conditions vary across the Community. We consider that Member States should have the right to opt-out of growing certain GM crops for domestic or environmental reasons. The products of such crops, food or other, should however be available throughout the Community and the market will determine their acceptability and so success or failure (paragraph 160).

  The Government's overriding concern is that human health and the environment should be properly protected. The statutory procedures under Directive 90/220 and the managed development arrangements with ecological monitoring, should ensure that this is the case for GM crops grown in the UK. Provided that no problems arise, the Government sees not reason for Member States to impose additional restrictions, and agrees that the market will decide which crops are grown. The legality of allowing a Member State to restrict growing of a product which could be imported from another Member State would need careful consideration.

200.   We consider that consultation of the Commission's scientific committees will be useful for resolving inter-Member State disputes. The appointment membership and operation of the committees must be open to scrutiny. The current method of appointment is inadequate. The structure of the committees could also be streamlined to increase their relevance to the regulation of GM releases. The committees require improved resources in Brussels (paragraphs 163-164).

  A new article in the Commission's proposal for the revision of Directive 90/220 requires the Commission to consult one or more EC scientific committees on any matter which is likely to have effect on human health and/or the environment before the decision procedure is initiated. A similar provision already exists in the EC novel foods regulation. Scientific committees have been used under the current directive to seek additional expertise on marketing applications where there has been no clear consensus among Member States. However, ACRE will continue to review in depth the environmental risk assessments submitted as a part of each notification and there is no question of this responsibility being transferred to the EC scientific committees.

  The Government supports consultation of the European Commission's committees in principle. However, clarification is needed about exactly when and how a Committee should advise. Many Member States, including the UK, consider that the scientific committees should only be consulted if there has been an objection to the marketing, or if the safeguard clause has been invoked. This would avoid unnecessary duplication of effort. In the context of novel foods the UK is encouraging the competent authorities to formulate specific questions for the Scientific Committee for Food when addressing objections raised by Member States. Many, again including the UK, also support fixing the length of time allowed for consultation of the scientific committees to ensure that there is a clear, effective and predictable consultation process.

  The entire system of scientific advice used by the Commission in the field of consumer health and food safety was reformed in 1997, and the Government understands that the appointment and selection procedures are now open to scrutiny. The committees are composed of scientific experts appointed by the Commission following the publication of a call for expressions of interest and a selection procedure to identify the most suitable applicants. The resourcing of the committees is a matter for the Commission. The Government agrees that the scientific committee system needs to be as transparent as possible and welcomes recent moves by the committees to publish their advice on the internet. The Government understands that the Commission is considering the need for increased support for the scientific committees. The Government will monitor the performance of the scientific committees and call for review where appropriate.

201.   We welcome the introduction of strict time limits and the definition of risk assessment which should help end discrepancies between Member States and provide the predictable system desired by industry. There are however two flaws. The first is too ready a willingness to stop the clock. We consider that the efficiency of the scientific committees' working should be improved before resorting to stopping the clock. If this proves impossible, consideration will need to be given as to whether it would be preferable to make the committees permanent or to stop the clock. Additionally, the Commission has failed to set itself a time limit for approving or rejecting a release following the (in)decision of the Council (paragraphs 165-168).

  A number of difficulties with the regulatory system have led to delays in approvals over recent years. This has generated an uncertain and inconsistent environment for industry and agriculture. Sufficient time must, of course, be allowed for a thorough scrutiny of applications, but the current regime has permitted unacceptable delays at many stages of the process. The UK is therefore pressing strongly for fixed time periods for each stage in the decision-making process.

  The Commission's proposal for the revision of Directive 90/220 tackles this problem on two fronts. Firstly, time limits are to be introduced for nearly every stage of the process, including those dealt with by the Commission which has been responsible for many of the delays in the past. Secondly, clarification of the scope of the directive and risk assessments should lead to fewer delays as implementation will be less uneven across the Community, so necessitating fewer objections from Member States to marketing applications on weak grounds. The introduction of a timetable, if strictly applied, should solve these problems while continuing to provide for rigorous assessment of risks.

  We are confident that these measures will make the regulatory process less prone to delay, and equally importantly, they should make the system more consistent and predictable. The Government believes that the Committees should work within defined periods; stopping the clock is not appropriate.

202.   We find no merit in the proposal to limit marketing consents to seven year periods (paragraph 170).

  The Government has serious reservations about automatic time-limitation of consents since it cannot be justified generally on scientific grounds and may introduce a degree of uncertainty for applicants and consent holders. We are prepared to accept the principle in order to ensure agreement on the revised Directive as quickly as possible, but wish to see the longest period which should be on a case-by-case basis up to a maximum of 15 years. It is important to remember that where there are strong reasons for a shorter period, this can be accommodated in individual consents.

203.   GMOs need to be regulated, at least until our knowledge develops further, but it would be extremely damaging if Europe's access to this technology was subjected to inappropriate impediments (paragraph 171).

  The Government's position, as laid down in our domestic regulations, and as argued in European and international negotiations, is to recognise that the environment and human health must be protected while ensuring that a stable and predictable climate exists for the biotechnology industry. The Government agrees that there can be no question of a free for all. However, it is important to recognise that this technology has the potential to bring considerable benefits to farmers, consumers and the environment, and that Europe should not be denied access to them.


204.   The Committee considers that the proposed revisions to the EC regulation of genetic modification in agriculture raise important questions to which the attention of the House should be drawn, and makes this report to the House for debate.

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