Select Committee on European Communities Second Report - Written Evidence


Memorandum by Novartis UK Ltd

THE APPROPRIATENESS AND EFFICACY OF CURRENT LEGISLATION ON RESEARCH

  1. Working practices and environmental safety of work with GMOs in research is governed by three basic EU directives 89/769, 90/219 and 90/220 and many derivatives of these.

    89/769 deals with workers safety;

    90/219 deals with the environmental safety of work done with GMOs in contained environments: the laboratory, the glasshouse, animal houses, factories, hospitals, etc;

    90/220 deals with environmental and human health safety aspects of work done on GMOs outside the commercialisation of GMOs. This is not correct. Most of the regulatory work generated by 90/220 covers research done with GMOs in the field.

2. FIELDS OF RESEARCH COVERED BY THESE DIRECTIVES

    —  Medical research involving genetically modified organisms. A key case is the use of genetically modified mice as disease models for human diseases.

    —  Medical research on xenotransplantation.

    —  Pharmaceutical research on human, animal and plant pathogens.

    —  The basic study of human, plant and animal pathogens.

    —  Research on plants, animals and micro-organisms involved in agriculture and food production. The most visible targets of such research are agricultural crops, but micro-organisms such as yeast, bacteria and fungi are as important targets.

  3. All the above are fields of applied research. Most of the use of genetically modified organisms in a research setting happens in basic research projects, the only aim of which is to obtain insight into the development, behaviour, ecology of living organisms.

  4. A special case is the use of genetically modified organisms in education. When 90/219 was developed (1988-90) it was almost inconceivable that experiments with GMOs would soon become part of the basic curriculum in higher education in life sciences. Undergraduate training in biology without experiments using GMOs is almost unthinkable today. All training experiments of course are done with micro-organisms at the lowest risk category. But because European regulation is based on the premise that the process of rDNA techniques might induce unique risk factors not encountered with any other form of biological experimentation (against the scientific consensus) there is no risk-free category for GMOs. This meant that in practice work with micro-organisms that had been the standard work horses for biology training suddenly was declared potentially dangerous, against all evidence to the contrary, and governed by new rules.

  5. In most EU member states, awareness of this situation was so low that it took years for government and academic authorities to realise that much of their science training had suddenly become technically illegal. They had not foreseen budgetary measures to implement the safety standards set up by the new regulation. Most EU member states have not foreseen any training of their new students in life sciences on the regulatory framework under which they will work during their professional careers.

  6. Many of the safety measures prescribed in 90/219 and its successors have had relatively little impact on the work done in contained environment in a company setting. The containment measures and working procedures prescribed in this directive have to a large degree followed those already known to scientists such as the GLP (good laboratory practices) and GMP (good manufacturing practices) regulations in force in the pharmaceutical industry. For work with potential dangerous organisms such as lethal pathogens, the isolation requirements closely follow those already used successfully in earlier legislation. It has been asked why there had to be an additional layer of regulation for these activities, since they basically lay down an additional layer of paperwork covering the same measures.

  7. It is different for the application of 90/219 in academic research. The bulk of this research has traditionally been done with organisms that are generally considered safe to work with, such as laboratory strains of the bacteria Escherichia coli and the bakers yeast Saccharomyces cerevisiae. Suddenly much of this research became technically dangerous, not because there had been an incident or any other indication of possible risk, but because there had been a new regulation, which is based exclusively on a hypothetical risk evaluation not supported by any experimental evidence and an extreme interpretation of the precautionary principle.

EXPERIMENTAL RELEASE IN THE ENVIRONMENT

  8. Most experimental releases in the field in an industrial setting involve the development of genetically modified crops, with the ultimate goal of developing new commercial varieties. Traditionally, new genotypes are tested extensively against relatives of proven performance. The introduction of directive 90/220 introduced new rules on isolation of the material, on its disposal and on post experiment monitoring. This has made experimental evaluation of genetically modified crops much more expensive. It also required that agronomic research stations that accepted GMOs in their work had to develop new safety infrastructure.

  9. The problem is compounded by the fact that much of the field research on the agronomic behaviour of crops is not done by the companies themselves, but has traditionally been subcontracted to private or public experimental stations that were not technically ready to work under the new regulations.

  10. Field research with GMOs in public research institutions has been severely affected by the directive 90/220. When this directive was negotiated little attention was given to the fact that much of the early research in the field was done in public research institutions. Legislators worked from a silent assumption, never publicly challenged, that almost all this work would in the future be done by companies that are used to work under the severe constraints imposed by a restrictive regulatory framework. These companies often have specialists in place to handle the administrative load of compliance with regulations, including the monitoring of compliance with requirements.

  11. It was not much noticed that there was great excitement among public scientists about the opportunities offered by the use of genetically modified plants and microorganisms for basic field studies in ecology, physiology and population genetics, among others. Academic research is ill equipped to work under heavy regulatory constraints. Its decentralised nature makes it difficult to develop the expertise in handling the regulatory requirements, and the constant funding problems force hard choices between investing in research or in regulatory compliance. The result has been that fieldwork with GMOs in academic institutions still represents only a tiny fraction of total research done on them. What is done is mostly concentrated in a few research institutions that have invested in setting up a regulatory compliance infrastructure.

  12. This has direct consequences on our knowledge of potential risks associated with GMOs. The bulk of this research is done in contained environment, or in the form of computer models. Very little research is actually done in the field, at least in part because of the restrictions imposed by the regulations. This leads to the situation where the regulations make it very difficult to test their own validity in real life situations.

COMMERCIAL SCALE RELEASE IN THE ENVIRONMENT

  13. This is governed by 90/220, part C. No GMO can be released on a commercial scale without a comprehensive risk assessment. This automatically includes series of field trials done under the requirements of 90/220 part B. Over the years several new directives have refined the procedures associated with 90/220. It sets up an administrative process to assess risk, based on the scientific method.

  14. However, it has procedural flaws that have become clear over the past three years, as the first generation of genetically modified crops have moved through the process. After the end of the risk assessment process, there is no provision for evaluation of its conclusion in the broader context of a cost benefit analysis or of a comparative risk analysis.

    —  90/220 is a risk assessment, not an environmental impact analysis. The technical analysis of an application for field release does not take into account the potential environmental benefits of a new GMO.

    —  It is scientifically impossible to prove the absence of risk (although several environmentalist groups are asking just that). Any application for introducing to the market will therefore come through the scientific risk evaluation process with a report stating that the risk is small, even negligible, but never zero.

    —  In the European system, any file that has not received unanimous approval in the administrative process (and the positions of Austria and Luxembourg make unanimity impossible for most files) moves on to the political level for decision making. Nowhere in this transfer is there a place where the risk assessment can be set in the context of the total impact of the new crops. There is in other words no provision for companies to present their products in such a way, as the only dossiers they can introduce in the system officially are the risk assessment files linked to directive 90/220 and the novel food regulation 97/258 (see below).

    —  As political decision-makers never get to see an environmental cost-benefit analysis as a basis for their deliberations, the only basis they have for decisions is the concept of acceptable risk. There is also no provision for a comparative risk assessment of the hypothetical risks of the new product against the risks associated with existing products and techniques.

  15. This leads to counter productive decision-making. For example, the present controversy over insect resistant crops totally disregards the fact that these crops were developed to widen the options for insect pest control, and that this in most cases results in reductions of pesticide use. There is no place in the European decision making process to evaluate these different options. In fact, GMOs are treated from the premise that they have no potential for environmental benefits at all, which is absurd. The large-scale introduction of insect resistant cotton in the USA has reduced the use of chemical pesticides on this crop by one-half to two-thirds, depending on the region. Nowhere in the European evaluation process is there room to find out if some of the GMO crops could do similar things to European agriculture.

  16. Another major flaw of directive 90/220 is that is does not formally lay down rules for monitoring after commercialisation of a genetically modified crop. There is a broad consensus in the field that good monitoring makes good business sense as well as being environmentally sound. Companies have invested heavily in these products, and want them to be effective for a very long time.

  17. Post marketing product stewardship is not new to the seed sector. Much of the so called traditional breeding over the past half century focused on developing varieties with new resistances against pests and diseases. It is well known among plant breeders that sooner or later a disease will overcome the resistance of the crop. This is a logical consequence of the theory of evolution by natural selection. Therefore, breeders and seed certification bodies have for a long time had networks for gathering information on the behaviour of varieties, to provide them with early warning if a resistance shows signs of weakening. This often gives them time to introduce new resistance genes in new varieties before the problem starts having an economic impact. There is every indication that the same system can be used with success for genes that were introduced through modern gene technology.

  18. The absence of monitoring schemes based on existing knowledge rather than on theoretical scenarios based on an extreme interpretation of the precautionary principle leads to the development of entirely new bodies for oversight of monitoring by some member states, and to demands for "monitoring" that have in fact no relation to the activity as such. For example, in France a body was set up to evaluate monitoring schemes for insect resistant maize after approval was given for commercial production. The bulk of the "monitoring" work proposed was in fact basic research into soil bacterial ecology, not monitoring of insect resistance management.

NOVEL FOOD REGULATION

  19. The novel food regulation (97/258) and its dependant directives are the logical complement of the environmental directives on GMOs. Nationally, 97/258 applies to all novel foods, regardless of how they are produced, but most of the text, and almost all the public debate surrounding it indicates that it was written essentially for GMO derived food.

  20. The EU novel food regulation is based on work of the OECD Group of National Experts on biosafety in biotechnology. This group produced a consensus document based on the notion of substantial equivalence. This notion, well documented in US regulations, was used as the basis for deciding whether a GMO or a derived product should be treated as a novel food or not, and should be subject to additional regulation. When the notion of substantial equivalence was introduced in the EU novel food regulation though, it was given an interpretation that is much narrower than that in the USA. Moreover, different standards have emerged for the determination of equivalence in the debate of safety evaluation (which is the basis for the novel food regulation), and in the debate over labelling.

  21. For labelling purposes, substantial equivalence has essentially come to mean chemical identity. Moreover, chemical identity is defined as absence of difference in gene content as determined with state of the art technology. Analytical methodology is an evolving field, and setting a zero tolerance limit in such a situation is always a dangerous regulatory approach. It means that a food producer can be selling food that is non-GMO today, and may with exactly the same ingredients be found working with GMOs tomorrow. The status of food products, especially processed food with relatively long shelf life, may well change between the day they were produced and the day they are tested, not because the food has changed, but because the detection techniques have. This puts food companies in a situation where they face random public outcries about their products that have nothing to do with safety nor with their compliance with the law.

  22. The novel food legislation is unenforceable as long as there is no agreement on threshold values. The present situation sets a zero threshold value, and this is technically impossible to police. Modern DNA detection techniques (especially PCR) allow detection of the presence of a foreign gene in a product made with say soybean, even if beans containing that gene are only present in a concentration of one in 10,000.

  23. Food is never "pure" by these standards. In practice, the PCR technique gives many "false positives". For example, transporting non-GMO soybeans in a ship that contained GMO soybeans on its previous shipment will almost certainly give a positive signal in PCR. The dust in the ship (which is mainly composed of fragments of seed hulls) contains enough DNA to show up in such tests as positive.

  24. A further complication is that PCR, although extremely sensitive, is not easily quantifiable. If a threshold value—say one per cent—was introduced, PCR is not likely to be able to distinguish between food that contain 0.5 to 1.5 per cent GMO derived material.

  25. As long as no threshold values are introduced, and reliable measuring methods agreed upon, the only way for food producers to avoid random scandals about their products is to label almost all their products with the label "may contain GMO products" or some equivalent term. This effectively destroys the basis for the labelling regulation: preservation of the consumer's right to choose. It has become clear over the past two years that the only practical way to provide consumers with real choice is by the introduction of threshold values, in a way similar to what is done with agrochemicals in organic food.

  26. It has recently become clear to many associations of organic farmers that they are themselves not able to comply with present standards to guarantee the GMO free status of their products. This provides an additional push towards the negotiation of a practical threshold value, and an agreed technique for policing the norms.

  27. An alternative, which is used in practice now, is to essentially do away with controls, and provide segregated food on the basis of certificates of origin of the raw materials. This is a dangerous situation. A regulation with high exposure to public concern, in which large amounts of material will be categorised purely on the basis of a paper trail, which is not certified by strong policing activities, is an open door to the development of fraud.

  28. Finally, threshold values are indispensable for seed certification. Modern seed varieties are sold with an unprecedented level of purity, even before the advent of biotechnology. Depending on the crop certified seed has to be from 95-99 per cent pure (i.e., of the variety mentioned on the package). Seed lots that fail this requirement are rejected. In real life no seed lot is ever 100 per cent pure though, nor need it be. There are technical limits to the seed producer's capability to keep elite seed separate from other seed lots, while maintaining a reasonable price. But as it is impossible to deliver seed that is guaranteed 100 per cent free from any GMOs, it is by definition impossible to deliver food up to that standard.

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

  29. The United Kingdom and France were the member states that had systems in place for regulatory oversight of research with GMOs before 1980. This is a logical consequence of the longstanding tradition of world class research in the life sciences in these two countries. The introduction of a common regulatory framework for environmental and worker safety by the EU did not present a major problem in these countries, as expert bodies were already in place and functioning.

  30. The UK, Denmark and the Netherlands were the only EU member states with a novel food regulation in place before the introduction of the EU directive 97/258. Partly this was the result of British and Dutch frustration with the slow progress made in the development of a common European regulatory framework for novel foods. These three countries have maintained the lead in the evaluation and introduction of novel foods containing GMO derived raw materials.

THE MOST APPROPRIATE JURISDICTIONS FOR DECISIONS ON GENETICALLY MODIFIED ORGANISMS

  31. Safety issues related to GMOs fall in two distinct categories: those related to human health, and those related to the environment.

  32. Issues related to human health are essentially universal. It would therefore be logical to ensure adoption of common food safety evaluation methods worldwide. In practice the ongoing controversy between the USA and EU about novel food containing GMOs makes it unlikely that such common standards will be reached soon. This has further consequences for international trade. It means that the USA and the EU are at odds with each other over food safety in the international arena. There is an urgent need for the EU and the USA to come to common grounds on food safety issues in general, because in this area it is all too obvious that cultural differences and/or trade considerations are sometimes translated into safety terms to justify different standards. Ideally, food safety standards, with GMOs as well as with other foods, should be the subject of world-wide legislation.

  33. Issues related to the environment are more diverse, as the behaviour of organisms is always the result of the interaction between their genetic make-up and the environment in which they develop. However, environmental safety issues related to the introduction of crops do transcend individual countries. The current dominant level of regulation—the EU—seems to be the appropriate one from the scientific point of view. It is also the only one that would not impede the principles of the common market.

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

  34. The seed industry is hit with high and unpredictable costs. When seed companies introduce their files for approval, they are already upscaling seed production, which is a slow process. If the application files are delayed, a full year's seed may be produced for nothing and has to be destroyed. It is sometimes assumed that such seed can then simply be used elsewhere. This is usually not the case. The varieties developed with a particular gene (eg., insect resistance) are different for different regions, as they should be: their growing environment is different, and they have to be locally adapted. On the other hand, companies can not afford to delay the production of seed until they are absolutely certain of having the permission to sell. This would also delay sales by one or two years, and could destroy any development lead they have spent a large amount of money to build.

  35. In the long run this cost is bearable for the seed companies. If the current uncertainties continue to exist for many more years, companies may become more and more reluctant to invest in GMO seed. They will still sell seed to the farmer: the "traditional" varieties sold today.

  36. The hardest hit though is the farming sector. EU farmers are squeezed between the high cost structure of European farming and the demands to reduce agricultural subsidies. In the long run, the solution has to come from a combination of two factors: reduction of the cost structure, and creation of higher value output.GMO crops are delivering important openings for the achievement of both these objectives.

    —  The introduction of crops designed to have better pest and disease resistance, and more rational herbicide use, have an immediate impact on production costs for the farmer. The cost reduction is much higher than replacement cost of the agrochemicals saved. Most of the cost of crop protection is not in the products used, but in the investment in equipment and time to apply them to the field. Major cost saving are possible there.

    —  The introduction of crops with altered output traits is changing several commodity agricultural crops into groups of speciality crops. The best-known European example has been the creation of a potato variety with a specialised starch composition that makes it uniquely suitable as a raw material for the chemical industry (high amylopectin potato). Scientists of the Agricultural University of Wageningen in the Netherlands developed the variety. Such crops automatically command higher prices as they open new market niches. Similar projects are under development (or already commercialised in the USA) with the vegetable oil composition of major oil crops: oilseed rape and soybean. The attractiveness of these crops lies in the fact that they can prevent several expensive post harvest processing steps, and thereby bring part of the added value that was previously created in the factory back to the farm.

  37. An "industry sector" that is often overlooked when considering the impact of legislation on high technology is the "research industry". As our society moves from material to knowledge production as the engine of growth, the research sector becomes an ever more important component of our overall economy. Intellectual inputs can only reach their expected levels of economic impact in terms of national growth if they can be properly protected and valued, and if they can be translated in economic realities in the form of improved goods or services.

  38. The first of these requirements has required much more time in the EU than in its major competitors. The EU directive on intellectual property rights for biotechnology has only recently been adopted by the European Parliament, more than 10 years after its initiation.

  39. For the second requirement, a stable regulatory environment for R&D is essential. The continuous controversy over GMOs has created great uncertainty among the scientific community about the long-term commitment of the EU to its declared objective of making biotechnology into one of its key development areas over the coming decades. This leads to a brain drain as well as an investment drain. Even today, investment in biotechnology in the EU lags behind our main trading partners. Investment in a knowledge intensive sector like this translates directly into high added value employment. The employment generates the proprietary knowledge that generates new income.

  40. Especially the public research institutions are hard hit by the complexity and instability of the regulatory framework, since they often do not have the means to respond timely. The effects of this are creeping, and therefore easily overlooked. They translate into a steady reduction of field agronomic work with GMOs. They can, if continued, also translate in a steady loss of the best brains. Switzerland today offers a severe example of how this can happen. The uncertainty generated by the Swiss referendum on products of biotechnology has made it very difficult for the highly reputed Swiss public research institutes to recruit world class young scientists lately, a situation unheard of until a year ago.



 
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