Select Committee on European Communities Second Report - Written Evidence


Memorandum by GeneWatch

THE APPROPRIATENESS AND EFFICACY OF CURRENT REGULATION OF:

(a) Research

  1. GeneWatch believes that the shortcomings in the way in which research into genetically engineered organisms (GEOs) is regulated include a lack of due attention to the final commercial intentions of the research and the lack of adequate research on long term hazards.

  2. The commercial reason for undertaking research involving the release of GEOs should be taken into account in assessing risks. Whilst small scale experiments may appear to pose a minor or negligible risk, the impacts on a commercial scale will be on a much greater. An assessment of the risks in the context of intended use would aid in identification of the information required to evaluate hazards at an early stage and ensure that the appropriate data was available to assess risk when a commercial application was made. This should improve the quality of the research by ensuring experiments are properly designed and likely to achieve their objectives. If it was clear that a commercial use would not be acceptable or that the overall research programme did not address the risks in a rigorous way, experiments should not be allowed. Such an approach would improve the efficiency as well as the safety of the system.

  3. For example, when the first application is made to test, say, an insect resistant plant the data requirements for evaluation of a commercial scale should be identified. The benefits of having this approach to research can be seen from problems which have already arisen but could have been avoided. In the case of the Novartis insect and herbicide resistant maize which also contains an ampicillin resistance gene, a research plan should have been produced following negotiation between the authorities and the company to ensure the appropriate data would be provided to allow a robust and agreed decision on marketing. The continuing controversy and dispute between member states of the European Union might have been avoided if it had been made clear at an early stage that detailed justification for the inclusion of an antibiotic resistance gene was needed,[15] that the potential of secondary impacts on non-target species would have to be fully investigated,[16] and research to develop a resistance management scheme was required.[17]

  4. Having such an evaluation of research requirements at an early stage would help address the lack of research on long-term hazards to health, the environment and agriculture. Most experimental field trials of GE crops focus on agronomic traits such as yield leaving other effects such as invasiveness less rigorously addressed[18]. Although small scale experimental field trials will always have limited ability to answer questions about large scale commercial use[19], they could be made more scientifically rigorous. For example, studies have shown that experiments to investigate the potential for GEOs to be invasive need to be undertaken for at least three years however many sites are used[20].

  5. GeneWatch believes that the proposed revisions to the Deliberate Release Directive (90/220/EEC) should include provision for the identification of basic research requirement for commercialisation at the initial research stage.

(b) Release into the environment

  6. The fundamental problem with the Deliberate Release Directive is that its scope has been defined far too narrowly. This is particularly evident at the stage when companies are applying for consents to market GEO. Not only have there been disputes between member states about all applications to market GEOs, but the regulations do not satisfy either the industry or Non-Government Organisations. The report of a series of workshops held in 1995 identified the serious mismatch which exists between the construction of the risks under the present regulations and the way in which industry and NGOs consider the risks. This is appended at Appendix I. The same mismatch between the regulations and the public's concerns about GEOs was found in research into public attitudes towards GE foods. This is appended at Appendix II (not printed). Unless this mismatch is corrected, public confidence in the regulations will never be achieved.

  7. The present regulatory approach is to assess releases on a case-by-case basis, using data from small scale experiments to determine safety. The focus is on the GEO and the immediate changes to the organism. Whilst recognising the importance of this aspect, GeneWatch believes that the wider impacts on the environment and agriculture should also be borne in mind when evaluating the risks of GEO. For example, it is questionable whether the use of herbicide resistant crops is beneficial, because the use of certain chemicals will increase and complex weed problems may be created resulting in other chemical herbicides being used. The cumulative impacts on the environment and agriculture of more and more GEOs are also neglected in the Deliberate Release Directive. For example, as more and more insect resistant crops are used there may be harmful effects on non-target insects and the birds that rely upon them for food. Looking at each application in isolation from the others tends to make these sorts of risks seem unimportant as the "big picture" is ignored. Although the industry feels that the potential benefits of GEOs are not addressed, GeneWatch believes that there is a "taken-for-granted" assumption behind the risk assessments that GEOs represent positive progress for agriculture[21].

  8. To address the mismatch between public concerns and the present regulatory system, GeneWatch believes that the revision of the Deliberate Release Directive must allow for:

    —  an evaluation of the public benefit of releases of GEOs through an evaluation of their effect on sustainable agriculture;

    —  an assessment of the cumulative impacts of commercial scale releases through an evaluation of the hazards of each class of crop (e.g., herbicide, insect and disease resistance) which should take place before individual applications are considered

    —  a mandatory segregation and monitoring scheme throughout the food chain to allow for tracking, the early identification of problems and consumer choice;

    —  a system of compulsory liability for any damage to the environment or human health arising from the use of a GEO.

(c) Novel foods and their labelling

  9. The Novel Foods Regulation has failed to ensure a labelling system for GEOs which takes into account the means of production. Attached as Appendix III is a briefing GeneWatch has prepared on this subject. (not printed).

  10. Only foods which contain foreign DNA of protein as a result of the genetic modification come within the scope of the Regulation. Therefore products of GEOs which do not contain these will be exempt from mandatory labelling. This will exclude, for example, oil from crops such as oilseed rape and soybean and which are found in a very large number of GE foods. This restriction on labelling is based on the assumption that it is only when foreign DNA or protein is present in food that a label can be justified on "scientific" grounds as these alterations are the only source of any health risk. This narrowing of the scope fails to allow people to make a choice based on an evaluation of the whole technology and its dangers not only to health but the environment and the course of agriculture. Using the logic behind the Novel Foods Regulation, free range eggs would not be labelled as their chemical composition is the same as factory farmed eggs.

  11. Such a limitation on consumer choice is clearly unacceptable, especially given the depth of public concerns about GE.

  12. GeneWatch believes that only comprehensive labelling can fulfil consumers' rights to make choices about what they eat. This is dependent upon the introduction of a statutory segregation scheme for GEOs at all stages to allow food producers and retailers to produce reliable information about the contents of foods.

THE APPROPRIATENESS AND EFFICACY OF CURRENT REGULATION AT THE LEVEL OF THE UNITED KINGDOM AND OTHER MEMBER STATES

  13. In Europe, Member States have experienced considerable difficulties in reaching agreement on decisions whether to allow the marketing of genetically modified organisms (GMOs) under Part C of 90/220. Every application has been disputed and the French Government has now introduced a moratorium on the commercial use of GMOs while a public consultation takes place. This has further highlighted the problems and confusion.

  14. The disputes and therefore the low efficacy of the regulation stem, in part, from differences over the interpretation of the scope of the Deliberate Release Directive. Some Member States such as Austria and Denmark include indirect effects on agriculture as part of the risk assessment. In addition there are differences in how "harm" is defined between Member States. Much of this comes down to different value judgments about whether, for example, genetic pollution matters and whether current agricultural practices form the base line against which to judge something as harmful or not.

  15. GeneWatch believes progressive standards should be set to help remove some of the points of disagreement to reflect the intended precautionary nature of the regulations relating to GEOs. Current agricultural practices have proved seriously damaging to the environment and accepting a level of harm based on this will not protect the environment. Genetic pollution should be considered undesirable because of its irreversible nature and the unpredictability of its effects. Setting a standard to protect European biodiversity by not allowing the release of GEOs which have related wild European species would be one way of doing this.

  16. In the UK, one problem with the way in which the regulations are implemented is that it has proved difficult in practice for members of the public to obtain data about applications for both field trials and commercial releases. This is not simply frustrating but means important local knowledge may be lost to the evaluation process. For example, when the license was given to allow the testing of genetically modified maize in Cornwall, the advisory committee may not have realised that a neighbouring farmer's livelihood could be threatened if there was cross fertilization of his crop and the loss of his organic status. We believe that information should be available more easily and quickly to the public.

  17. To do this Member State should ensure knowledge of a proposed deliberate release is made widely available. Any requests for information about a proposed deliberate release must be supplied within 10 days.

THE MOST APPROPRIATE JURISDICTION FOR DECISIONS ON GENETICALLY MODIFIED ORGANISMS

  18. It is crucial that both national and international regulations are in place. National scrutiny is required to ensure local knowledge is brought to bear on a decision. International regulation is required because GEOs are living organisms which will not respect national borders.

THE EFFECT OF REGULATION ON DIFFERENT SECTORS OF THE INDUSTRY AND COMPETITION

  19. There has to be effective regulation on the release of GEOs if confidence is to be maintained in the UK's food production systems. BSE and the collapse of the British beef industry has underlined how important this is. If regulations are relaxed and shortcomings not addressed, if and when risks were to materialise farmers could be seriously damaged through a sudden loss of consumer confidence.

  20. Effective regulation which accounts for the interests of farmers who do not wish to grow genetically engineered crops is also important. If cross fertilisation between genetically engineered varieties and conventional crops, a farmer may be unable to provide the demand for non GE crops and, if they are an organic farmer could undermine their whole farming system.

  21. GeneWatch believes that all sectors of industry will be best served by strict regulation under the precautionary principle. Without this confidence in British food will be undermined.

4 June 1998



15   Williamson, M (1996) Can the risks from transgenic crop plants be estimated? Trends in Biotechnology 14: 449-450. Back

16   Kareiva, P, Parker, I M and Pascual, M P (1996) Can we use experiments and models in predicting the invasiveness of genetically engineered organisms? Ecology 77: 1651-1675. Back

17   This is supported by research into the regulatory system, e.g., Levidow, L (1994) Biotechnology regulation as symbolic normalisation. Technology Analysis and Strategic management 6: 273-288. Back

18   (1990 C.43). Back

19   (OJ No. L 117, 8 May 1990, p. 1). Back

20   (OJ No. L 117, 8 May 1990, p. 15). Back

21   (SI 1992/3217). Back


 
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