Select Committee on European Communities Minutes of Evidence

Supplementary Memorandum by the Ministry of Agriculture Fisheries and Food and the Department of the Environment, Transport and the Regions, and on behalf of The Scottish Office and The Welsh Office.


  11. Is segregation something which should be left to the market, or is there a role for government? What about traceability? Is it feasible, desirable or indeed essential? Earlier this year, MAFF published a list of non-gm soya suppliers. To what extent does MAFF go to ensure that this soya is indeed non-gm. Is this a justifiable role for government? Iceland is sourcing their non-gm soya from Brazil. Do you believe that Brazilian soya is indeed non-gm?

  All GM varieties for use in Europe have been approved following a full safety assessment. Imposing segregation as a condition of approval would breach the TBT Agreement because it would be more trade-restrictive than is necessary to meet its objective (since consumer choice can be assured by requiring labelling, which is less trade-restrictive than segregation). Equally mandatory segregation could not be defended using the SPS Agreement, because it would not be a measure to protect health (since a product that is approved for marketing has already been assessed to be safe). The Government recognises that there is a demand for supplies of non-GM ingredients and market forces are responding to this by means of identity preservation at a commercial level. Indeed there is already evidence that this is happening, for example Iceland Frozen Foods are offering non-GM products, other supermarkets are also moving in this direction. MAFF recently produced a list of non-GM suppliers to help smaller companies. This list now stands at 57 suppliers. However, the Government has made it clear from the outset that it is for companies to satisfy themselves that the product that will be supplied is likely to meet their requirements before placing orders. The role of the Government is to ensure that the necessary legislation exists to check that foods are correctly labelled where they contain GM material and that this is appropriately enforced.

  The Government is aware that Iceland Frozen Foods is sourcing some of its soya from Brazil. As yet Brazil is not growing GM soya commercially, however, soya crushing plants in Brazil are known to process US soya in order to operate at full capacity. The Government understands, however, that Iceland obtains its Brazilian soya from an inland area and that they also have procedures in place to ensure that the processing plant does not process GM soya.


  12. What is the latest state of the Council negotiations on labelling? Is this the final word on the subject? If not, what remains to be negotiated? Should labelling go further than stating that a product is GM, and state the purpose of the modification, as is the case in Canada? What should be labelled (DNA, protein)? Should labelling on foods be required to the extent that the labelling can be verified by testing? What thresholds should be set?

  The EC novel foods regulation 258/97 came into effect on 15 May 1997. In addition to requiring a pre-market safety assessment this regulation contains specific labelling rules for novel foods which apply in addition to existing Community labelling requirements for foodstuffs as set out in Directive 79/112/EEC. The Council regulation 1139/98 on GM soya and maize labelling comes into effect on 1 September. The regulation requires labelling based on the presence of novel protein or DNA and is consistent with the labelling rules in the novel foods regulation 258/97 where a food is labelled if it is no longer equivalent to a conventional counterpart. Member States agreed unanimously that the presence of novel protein or DNA should be the trigger for labelling. To improve transparency a "negative list" is being developed of food ingredients that do not contain novel protein or DNA. In addition discussions will continue on the practicality of setting a de minimis threshold to ensure that labelling is not triggered by very low level adventitious contamination. In agreeing the text Member States also invited the European Commission to encourage the development of validated methods for the detection of protein or DNA resulting from genetic modifications.

  The Government is aware of the Canadian proposal for labelling issued in April 1997 which includes a provision for voluntary positive labelling to indicate that a novel food has particular attributes resulting from genetic modification. This is consistent with the labelling of tomato puree in the UK which includes a voluntary description of why the tomatoes were modified. Under the Canadian proposal where there is compositional difference or a health or safety issue which triggers mandatory labelling, then that labelling will require identification of the attribute rather than the fact that the product has been genetically modified (e.g., high laurate canola).

  The Government recognises that in many cases a company will wish to indicate why a product has been modified and this is allowable under the legislation.


  13. Do you have any proposals for improving public confidence in the regulatory system? MAFF would appear to have lost the confidence of the public, Brussels has a poor public image, the regulatory committees are invisible. Is greater transparency part of the answer? How can this be achieved without causing harm to the process itself?

  The Food Standards Agency Bill will be published shortly setting out proposals designed to restore consumer confidence in the regulatory system. Much has already been done. For example the advisory committees are now publishing minutes of their discussions, making their annual reports more widely available (the ACNFP 1997 annual report was placed on the internet last week) and holding meetings in public wherever possible. MAFF has also co-sponsored an exhibition developed by the Science Museum to explain the issues involved with GM foods.

  Improved transparency can help allay concerns, but consideration also needs to be given to what the underlying reasons for concern are and, as mentioned in the reply to question 9, steps are about to be taken to examine this in more detail.


  14. For trial releases, will anything be lost, or what might be lost, in the move from horizontal (GMO) to vertical (product) legislation? Expertise? Would this be appropriate for commercial release too?

  Does the application of the criteria for safety of novel foods to field trials where environmental risks are likely to be the major problem diminish trust in the risk assessment process?

  How is the environmental safety of novel foods that contain viable modified organisms assured?

  This was to a large extent addressed in the oral evidence in response to the question on the revision of 90/220/EEC.

  A key concern held by the Government is the proposal to remove from the scope of the directive those products under development which are covered by Community legislation which provides for a specific environmental risk assessment similar to that in this directive. The Government is concerned that this could have the result of environmental effects not being taken adequately into account because of the need to weigh them against other considerations addressed under product legislation. The Commission's proposal does not include any role for the 90/220 competent authorities in the assessment and decision-making for GMO products under development; the competent authorities' expertise on environmental risk assessments for the deliberate release of GMOs might therefore not be drawn upon. This would not encourage public confidence in the regulatory regime. Further, the proposal would not be helpful for those wishing to conduct research releases because it would add to the complexity of gaining a consent: one such release might require several approvals, and this could also result in a longer time than the current maximum 90 days before all proposals were granted.

  As regards commercial releases, the Commission has strongly advocated a "one door, one key" policy, whereby there would be only a single regulatory entry point for access to the Community market. Only three Community instruments have been adopted so far which remove GMO products from the scope of 90/220: the medicinal products regulation (2309/93), Commission Directive 94/40/EC amending Council Directive 87/153/EEC fixing guidelines in the assessment of additives in animal nutrition and the novel foods regulation (258/97); others, such as amendments to the seeds directives and a novel seeds regulation, are under negotiation or are planned. Each of these, in providing a derogation from 90/220, requires that necessary consultations be held with the bodies set up by the Community or the Member States in accordance with Directive 90/220. However, none of the instruments sets out procedures for the consultation or provides a mechanism to take into account the overall view of the 90/220 competent authorities. This has not presented difficulties up till now because only one notification to market a product under these instruments has been submitted. However, given the likely trend in the development of GMO products, the Commission and the competent authorities are seeking to introduce appropriate administrative mechanisms.

  While the "one door, one key" policy might be desirable in principle, the implications of the regulatory requirements and the administrative practicalities need to be considered. For example, if product based legislation is adopted at the expense of horizontal regulation for research and development trials crop plants may require approvals under more than one instrument, depending on the final uses of the crop. For example, a particular line of genetically modified wheat would be likely to require separate approvals under the seeds, novel foods and animal feeds legislation.

  Does the application of the criteria for safety of novel foods to field trials where environmental risks are likely to be the major problem diminish trust in the risk assessment process? How is the environmental safety of novel foods that contain viable modified organisms assured?

  We understand this question to be associated with the first of the two additional questions posed by the Lord Reay (see question 26).


  15. Regulatory transparency has to be balanced with commercial confidentiality. This is of especial concern over intellectual property and eco-terrorism. Is either the publication of dossiers or the exact location of field trials unwise? Are you considering any changes?

  In submitting dossiers for application to release or market genetically modified organisms, applicants can indicate information which they consider to be commercial in confidence. The extent of such information is subject to review by and agreement of the Secretary of State before the application proceeds. The GMO deliberate release regulations prevent information agreed by the Secretary of State to be commercial in confidence from being released or published. Applicants are required to inform the Secretary of State once information is no longer commercial in confidence.

  Under the directive and the UK legislation, the location of field trials may not be kept confidential and this is part of the information required to be placed on the Public Register. One of the purposes of making this information public is to inform those in the neighbourhood of proposed release sites. It is regrettable that this information has also been misused recently by direct action protesters to locate and vandalise field trials of genetically modified crops. These trials are necessary in order to answer many of the questions that pressure groups and others have raised. Ministers have condemned these attacks but the scope for further action under the current legislation is limited. It is the responsibility of consent holders to safeguard their sites and they may involve the police to assist them where appropriate.

  The government is not, at present, considering any changes in the current arrangements.


  16. Have you identified any gaps in the current regulatory process which you are keen to see filled?

  The current legislation covering contained use, deliberate release and marketing of products provides a comprehensive package of controls to ensure protection of human health and the environment. There are no obvious gaps. However as described in the oral evidence in response to the question on animals, the Government proposes to strengthen the controls on the contained use of plants and animals by making additional provisions for notification.

  Concerns have been expressed that wider environmental issues associated with the commercial introduction of some GM crops may not be adequately covered. In practice, the environmental risk assessments carried out for the GMO legislation taken together with the pesticides legislation where appropriate should address such issues and no distinction is made between the agricultural and the natural environment. However the Government is reviewing whether there are any other environmental aspects which are not being addressed under the current regime.

  From the administrative point of view the Advisory committees have broad terms of reference and can also recommend that specific issues are taken forward by Ministers. On the food side the Food Advisory Committee had its terms of reference enlarged last year to enable it to consider any food related issues not considered by other committees.


  17. Within the US and EC, conventional crops are sometimes limited to particular geographic areas (or states) due to geographic concerns (wheat and absence of weedy relatives/potatoes and climate). Why might a GM crop be unsuited to growth in the EC or vice versa? Could this be done for GM crops on more political grounds?

  The Government is not aware of any instances where, for climatic reasons, a GM crop would not be suited to cultivation in the EC unless its non-GM counterpart was similarly constrained. There may be situations where farmers may not need to grow some disease resistant GM varieties if the disease is not prevalent in a given location. The Government is also aware of concerns associated with the cross pollination of GM herbicide tolerant crops with weedy relatives. Following publication of a discussion paper last year the Government will be making an announcement on proposals for the management of GMHT crops shortly.


  18. Refuges have been recommended as a way, for example, to maintain insect populations and to slow down the development of immunity to GMHT and GMPR crops. Should refuges be statutory or voluntary?

  One of the concerns expressed about widespread commercialisation of insect resistant GM crops is that it may encourage the development of resistance breaking insect populations. In areas of the United States where Bt cotton and Bt maize are grown widely, refuges of non-GM crops are employed to maintain a "bank" of non-resistant insects in the population. Population modelling and field work indicate that this works to delay the emergence of widespread resistance.

  Experience suggests that refuges are most effective in warm climates where target insects undergo several generations in one season. In temperate Northern Europe, including the UK, they may have little value. The Government has not yet formed a view as to whether such refuges are necessary nor whether they should be voluntary or statutory. More research is required in this area to evaluate the potential threat of resistant insects and to formulate effective measures to prevent or delay the selection of resistance. Although experience from managing resistance in existing agricultural practice suggests that effective measures can be found. This will help to identify the specific need for and extent of further research. Based on this, guidelines for best practice could be produced as they have been of other issues by the farming industry's Supply Chain Initiative for Modified Agricultural Crops (SCIMAC).


  19. It has been put to us that the growing of GM crops might be limited (voluntary or statutory) to particular areas within Member States, either to protect particular biodiversity or to assist segregation as value-added modifications are introduced. What is your view on such zoning?

  The Government has no legal powers to apply additional conditions to marketing consents for GM crops. However, as has been mentioned in reply to question 17 the Government will be making an announcement on the management of GMHT crops shortly.


  20. The best way to prevent a super weed is by making plants male sterile. This would end the practice of farmers saving up to 30 per cent of their seed. The same effect could be enforced contactually. Is this a change the Government would be concerned by?

  We were told by the American Soya Bean Association representatives that until the advent of the Bt Soya bean they had kept upto of of the seed sown in each year, and only purchased approximately . Their contracts do not now allow them to keep any seed at all. The introduction of hybrid varieties, which cannot be kept as the yield drops substantially after the first year, or of male sterile seed would mean that farmers could not keep seed effectively. Should this be a concern?

  United Kingdom and European Union plant breeders' rights legislation* specifically provides for farmers to save seed of the main agricultural species which have historically been farm saved in the EU (e.g., cereals, potatoes, oilseeds). In addition, the recently adopted Directive on the Legal Protection of Biotechnological Inventions contains a provision which states that farmers can use farm saved seed containing a patented invention, without this use constituting infringement of the patent. This applies to the same extent and subject to the same conditions as Community plant breeders' rights. These provisions aim to strike a balance, which we would wish to encourage, between the use of farm saved and certified seed.

  We have no experience of the contracts which American companies are said to use to control the use of farm saved seed. The nature of the seeds market in the UK is such that plant breeders do not normally enter into direct contracts with individual farmers. Seeds merchants are licensed by plant breeders to deal in protected varieties and it is the merchant who sells seed to the farmer to produce a commercial crop.

  The farm saved seed provisions do not extend to seed saved from a crop grown from a hybrid variety, but a crop resulting from such seed would have limited value. There are also a range of varieties available to farmers. Hybrids are common in the oilseeds sector, for example, but there are still plenty of non-hybrid oilseed varieties for a farmer to select, which can be farm saved.

    * See the Plant Varieties Act 1997, s.9 and Council Regulation 2100/94, Article 14.


  21. How concerned is the Government by the use of antibiotic resistant marker genes? Have you recommended a phase-out?

  The presence of antibiotic resistance marker genes in Genetically Modified Organisms released to the environment has been considered by the Advisory Committee on Releases into the Environment (ACRE). In particular, the committee has reviewed the presence of antibiotic resistance genes in genetically modified plants and examined the potential environmental safety issues, including the possibility of gene transfer to soil microbes. ACRE hav concluded that the risk to human health and the environment from the current markers (mostly for kanamycin and ampicillin resistance) is low. This is primarily because of the prevalence of antibiotic resistance that already exists in the environment. Any addition made to this resistance background that might result from the release of GMOs will be negligible.

  That said, ACRE is concerned that resistance markers for antibiotics which have an important role in medicine are not used in GMOs to be released. Further, the committee has recommended that in principle, products which come to the market should not contain material (including marker genes) which does not contribute to the modification for which the product is being marketed. This is not for safety reasons but for the sake of good practice as the marker genes have no function in the final plants.

  The Advisory Committee on Novel Foods and Processes (ACNFP) has examined the concerns raised in connection with the use of antibiotic resistant market genes in considerable detail and has produced two reports. Copies of the ACNFP reports are enclosed. [not printed]. The Committee's overall conclusion was that the use of antibiotic resistance marker genes should be considered on a case by case basis taking into account:

    —  the clinical use of the antibiotic;

    —  the likelihood of transfer into and expression in gut micro organism; and

    —  the toxicity of allergenicity of the gene product.

  The ACNFP also recommended that those developing food GMOs should develop alternative markers or find ways of removing those used. There is evidence that companies are starting to act on this recommendation.


  22. English Nature have based their call for a moratorium on the fact that research is needed into the effects of GM crops. What research has been commissioned and when are results expected?

  What is the impact on wildlife of GM crops? Are you funding research in this area? If not, why not? If yes, when are the results likely to be published?

  The reduction in the volume of herbicide that needs to be used is well known, and is arguably good for the good for the soil and consumer, but what impact on biodiversity has there been?

  What is the impact on wildlife of GM crops?

  The DETR has funded a programme of research since 1987 into the issues and implications raised by the release of GM crops into the environment. Results of research programmes are published as Research Reports and are widely available from the DETR publications sales centre. The scope of the published projects relating to the possible impact of GM crops are summarised below.

    Report no. 1.—Genetically modified crops and their wild relatives—a UK perspective—assessed the likelihood of transgenes being transferred from genetically modified crops to wild species growing in the UK. This included, where relevant, establishment of the crops themselves as feral applications.

    Report no. 8. Gene flow in natural populations of Brassica and Beta—addressed the issue of transfer of modified genes between crops and wild relatives. Such information is important in evaluating both the potential for the escape of transgenes, and the environmental risk assessments of each release.

    Report no.9. Selectable marker genes in genetically modified organisms—evaluated the potential hazards of the use of selectable markers in plants, microorganisms and animals intended for release into the environment.

  Currently there are three ongoing research projects that should provide additional information on the environmental impact of growing GM crops. These projects are:

    Environmental impact of insect resistance in GM plants. Completion date December 1999.

    Impact of multiple tolerance in GM plants. Completion date December 1999.

    Environmental impact of disease resistance in GM plants. Completion date September 2000.

  In addition to these three projects, another project is planned to investigate the Environmental risks of stress tolerance in GM plants. The aim of this is to provide more information to help evaluate the risks of the release of such plants. This project is planned to be completed in September 2001.

  In 1990 MAFF started a programme of research to look at the possible risks to the agricultural environment from the release of genetically modified organisms. Over £3.5 million has been committed to the programme and, to date results have not indicated any risks to the agricultural environment from the release of GMOs. In 1997, new research on the risks to the agricultural environment from the release of herbicide tolerant crops was commissioned with a total budget of over £500,000. A list of some of the work covered in the herbicide tolerance projects is given in paragraph 13 of the original briefing submitted to the Committee.

  The impact on wildlife of the release of GM plants has, thus far, been negligible. The releases conducted to date have been for experimental purposes and are only approved after a rigorous risk assessment has indicated they will be safe. Over 300 field trials of GM crops have been carried out in the UK and the post trial monitoring has demonstrated that none of these has resulted in harm to the environment.

  The wider implications of the commercialisation of GM crops for wildlife is the subject of current debate, particularly the possible reduction in farmland biodiversity that changes in agricultural practice may cause. The results from DETR funded research projects provide valuable information on a number of possible environmental issues that may arise from growing GM crops. None of the results obtained so far, either from completed projects or those ongoing, give cause to believe that the GM crops studied will necessarily be any more damaging to the environment than conventional agricultural practice.

  The Government is working with the Advisory Committee on Releases into the Environment and Conservation Bodies, including English Nature and RSPB, to address their concerns about impact on wildlife and find a way forward. This consultation is focusing on the wider implications of GM crops and their possible effect on wildlife. This will highlight areas in which further research is needed and help to formulate the most appropriate questions to be addressed.


  23. In the event of something going wrong with a GM crop, who would be responsible? Is this an issue that concerns you? Would this be different if it were a food or feed product?

  Civil liability for damage caused by a genetically modified organism is governed by the Common Law as developed by the courts. On the basis of Common Law principles, the firm holding the marketing consent for the genetically modified crop may be liable in law for any damages arising from ill effects attributed to the crop. Depending on the facts of the case the statutory regime for product liability may also be relevant.

  The issue of environmental liability is an important one and the principal that those who damage the environment should pay for remedying the damage caused is one that the Government supports.

  The Government understands that the European Commission intends to issue a White Paper on liability for environmental damage. This may include the question of damage caused by genetically modified organisms. The Government will study the detail of the Commission's proposals before reaching any conclusions on this matter.

  The Government is of the view that in the event of something going wrong with a GM crop the company that holds the marketing consent for the crop would be liable. Indeed an applicant is already required to report any information which might affect the original risk assessment.

  The Government supports in principle the proposal in the European Commission Green Paper on Food Law to extend product liability to primary agricultural produce and agrees that the extension of product liability to primary agricultural produce should be considered afresh, but the full implications must be explored before any final decisions are taken. It is important that the liability for producers is matched by the reasonable defence of due diligence.


  24. Is risk assessment for novel foods an EC process or for Member States?

  The risk assessment for novel foods is initially undertaken at Member State level. An application is submitted to the Member State where a product is intended to be marketed first. That Member State has 90 days to provide an initial safety assessment. This initial assessment is then considered by all Member States within 60 days. If Member States raise objections or identify the need for a more detailed assessment the application is considered further under a centralised authorisation procedure. Final approval is therefore a matter for the Community as a whole. The European Commission produced guidelines on the safety assessment of novel foods to accompany the Novel Foods Regulation 258/97. A copy of the Commission guidelines and the electronic version developed in the UK are enclosed. [not printed].


  25. The regulations at present are causing a stockpile of food, predominantly from the US. What approvals do imports require? Do they require an environmental assessment? Is this necessary where they are only to be imported for food use? How may the system be speeded up without any extra risk to the consumer or the environment?

  Where a GMO is intended to import solely for processing into food products approval is only required under the EC Novel Foods Regulation (258/97). If the crop is to be grown in Europe approval is also required under Directive 90/220/EEC. Under both sets of legislation an environmental risk assessment is required for viable material, e.g., grain, which could be grown in Europe. If the crop is only imported for food use an environmental risk assessment is still required to assess the impact of accidental spillage during transport. The Government is seeking to speed up the approval process without compromising safety. The Commission's proposed revisions to Directive 90/220 should help in this respect. In addition the Government is encouraging companies to submit applications in the US and EU in parallel rather than in the sequential way that has so far predominated and lead to many of the stockpiling problems referred to.

Additional questions posed by Lord Reay

  26. For commercial release, the directive exempts GMOs for which product legislation exists. There is a novel foods regulation. Would an application to grow and to use for food, for example a frost-resistant wheat, be subject to both 90/220 and the novel food regulation?

  Directive 90/220 and the Novel Foods Regulation operate in tandem: Consent would be required under 90/220 to sow, cultivate and harvest a genetically modified crop, and, at present, to use it as an animal feedingstuff. Under the Novel Food Regulation, consent would be required in order to market novel foods consisting of the genetically modified crop plant or derived from it. Both instruments require an assessment of the risks to the environment and to human health. However, while the scope of the environmental risk assessment under 90/220 must address all the risks associated with all the release activities, that is, sowing and cultivation, etc., the assessment under the Novel Foods Regulation needs only to cover any aspects that would involve release to the environment of the novel food itself. Usually there will be no such release, or a very limited release. Therefore the scope of the risk assessment is tailored in each case to the activities governed by the respective instrument. There can therefore be trust that together, the instruments provide for a comprehensive assessment of the risk.

  27. The Commission has proposed ending the use of PVC. If a plastic duck is made from a plastic produced in a GM plant and contains the gene product, would it need to be labelled as GM? Would it be subject to monitoring and potential seven year recall?

  Under current EC legislation the seeds from such GM plants would have to be labelled, however the plastic duck made from them would not, as the only non-viable products that have to be labelled as genetically modified are those food products which contain genetically modified material. The plastic derived from the GM plant would not be covered by this legislation, or by Directive 90/220/EEC. The plants growing the plastic would be subject to the proposed monitoring and potential seven year recall but not the ducks themselves.

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