Leaking From The Lab
THE USE OF GENETICALLY MODIFIED MICRO-ORGANISMS IN THE UK
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- 5.1 Small-Scale Use of GMMs
- 5.2 Large-Scale Use of GMMs
5. THE USE OF GENETICALLY MODIFIED MICRO-ORGANISMS IN THE UKThere are probably around 500 sites using GMMs in the UK including centres notified before 1992 and not included on the public register In an attempt to discover the scope of use of GMMs in the UK, GeneWatch consulted the HSE’s public register on Contained Use, made further inquiries through the HSE, sent a letter to all those installations registered as using GMMs on a large scale and made a search of relevant Parliamentary Answers. Because this research mainly elicited data on where GMMs were being used rather than what they were being used for, other research was conducted using trade associations and official documents. There are probably around 500 sites using GMMs in the UK including centres notified before 1992 and not included on the public register. This number includes both Group I and II organisms being used on a small and large scale. No absolute figure is available because prior to the introduction of the Contained Use regulations, such data was not in the public domain. Since 1992, there have been 275 centres registered for Group I work (34 of which have notified their intention of working on a large scale), and 196 for Group II work49. The HSE has estimated that about 5,500 new projects with GMMs are undertaken each year, 90-95% of which are classified as Group IA50. 5.1 Small-Scale Use of GMMsThe largest number of small-scale research centres are using Group I GMMs on a small scale. There are probably around 300 such sites in the UK. When GeneWatch examined the HSE’s public register, there were a total of 191 Group II centres which fall into three major categories as follows: Universities - 92 centres in 38 universities* Research Institutes - 57 centres in 45 research institutes Companies - 42 centres in 36 companies *This treats University of London colleges as separate universities. It is impossible to systematically analyse what research work is undertaken because:
The use of GMMs on a small scale is mainly for medical and other scientific research. In industrial laboratories, the production of chemicals/drugs is another important research dimension which includes:
Because it is not possible to undertake a comprehensive survey of the scientific research uses, the following gives an example of the sorts of work being undertaken and highlights some areas where there may be particular concern over work with human and domestic animal disease and pathogens, and plant viruses and other pathogens. There are serious risks from certain genetic modifications, both for the workers involved and the wider public or animal life should the GMM escape containment 5.1.1 Human and Domestic Animal Disease and Pathogens Inevitably, the vast majority of research with GMMs - both in commercial and public facilities - is being undertaken into diseases in humans. A smaller amount of work concerns disease in domestic animals. The work being undertaken is very varied but includes:
Understanding cancer and developing treatments is a particularly common area of research and there is undoubtedly a great deal of public sympathy for this kind of work. However, there are serious risks from certain genetic modifications, both for the workers involved and the wider public or animal life should the GMM escape containment. Many experiments are being planned which have the potential to alter the spectrum of species in which a micro-organism may be pathogenic. For example, the Institute of Animal Health at Pirbright, is transferring genes from canine distemper virus (CDV) into rinderpest virus (RPV) and investigating the effect on the ability of the resulting virus to infect laboratory species51. Neither of these morbilliviruses infect humans, but others (such as measles virus) do. Morbilliviruses have shown themselves able to cross species boundaries and a great deal of uncertainty exists about how they cause disease. Animal tests have limited predictive ability and may be misleading. For example, Sendai virus (another morbillivirus) was lethal in one strain of mice supplied in the UK, but not in the same strain of mice supplied from Japan52. Very small changes in a cell may also have a dramatic effect. A 1,000 fold increase in Senadi virus pathogenicity was seen when a single protein was modifiedError: Reference source not found. If the pathogenicity of such GM viruses was increased and they escaped, they could cause disease in workers and the public. These kinds of risks are only evaluated according to what level of containment is required - whether they need to be conducted in level 3 or 4 facilities, for example. Although there were questions from members of the technical sub-committee of the ACGM about the scientific justification for the CDV/RPV experiments, they have still been approved, in part because ‘it [is] not HSE policy to decide whether work should proceed, but whether it [is] sufficiently contained’ 53. This means that an assumption has to be made that the level of containment will be 100% effective in preventing any harm arising. However, if this does not prove to be the case, it will be very difficult, if not impossible, to justify the consequences. One risk assessment was said by an HSE reviewer to ‘..indicate a lack of understanding of the potential risk and an attitude which, in my opinion, greatly increases the risk’ Another area of concern is where genetic modification experiments are being undertaken to investigate and manipulate pathogenesis mechanisms. The National Institute for Medical Research (NIMR) at Mill Hill, asked the HSE for permission to genetically modify human influenza virus with a gene from the avian influenza virus. Although this work is not thought to be proceeding, the research could have resulted in the production of a flu virus very similar to that which caused the influenza epidemic of 1918, killing many tens of thousands of people. The risk assessment conducted by the NIMR in the event of the GM influenza virus escaping was said by an HSE reviewer to ‘..indicate a lack of understanding of the potential risk and an attitude which, in my opinion, greatly increases the risk’ 54. The investigation of how cancer arises may put workers at risk if cancer-causing genes (oncogenes), tumour viruses or mutagens are being used. In the case of cancer-causing genes, there is evidence that ‘naked’ (no longer contained in a cell) oncogenes can cause tumours in laboratory animals and there have been reports of an increased incidence of cancers in scientists working with such genes55. GMMs are also being used in defensive biological warfare research at the Defence Establishment Research Agency (DERA - previously the Chemical and Biological Weapons Defence Establishment) at Porton Down, using a range of human and animal pathogens such as Salmonella typhimurium, Clostridium perfringens and Yesinia pestis (the bubonic plague organism). 5.1.2 Plant Viruses and Other Pathogens A smaller amount of research is being undertaken into plant viruses and other pathogens. The dangers of using GM plant viruses are similar to those associated with human and animal pathogens. If there are unexpected changes in the spectrum of plants a virus can infect or its pathogenicity, both crops and wild plants may suffer if they escape confinement. Despite the Contained Use regulations having been introduced in 1992, the HSE still does not have guidelines covering the use of GM plants in containment (which will be used in experiments with plant pathogens). Furthermore, the Ministry of Agriculture, Fisheries and Food (MAFF), which is responsible for non-GM plant pathogen work, has not been aware, in at least one case, of the requirement for centres using GM plant pathogens to inform the HSE and undertake the appropriate risk assessment56. There is very little information about the exact nature of the plant pathogen work which is taking place and there appears to be less discussion of it at the ACGM or its Technical Sub-Committee whose preoccupation seems to be with risks to human health. Centres registered to use GM plant pathogens include the John Innes Centre at Norwich, the Institute of Virology at Oxford and the Scottish Crop Research Institute. Other pathogen work at Zeneca’s Jealott’s Hill Research Station includes the large scale use of a GM yeast including gene sequences from an insect virus. This is being developed to make the yeast infectious to certain insects for use in biological control techniques. 5.2 Large-Scale Use of GMMsAccording to data supplied by the HSE and given in reply to a Parliamentary Question, there are 34 centres registered as using Group I GMMs on a large scale (Group IA - see Appendix 2). Because other centres were registered before 1992 and are not included on the public register, this is likely to be a significant underestimate of the real number of sites where GMMs are used on a large scale. According to the HSE, no Group II organisms are being used on a large scale. However, a GeneWatch survey of the companies and institutes has shown that the HSE’s list of large scale users of GMMs is out of date. For example, one institution (Plymouth Marine Laboratory) was wrongly listed as undertaking Group IB work in information supplied to GeneWatch. Because there is no requirement to inform the HSE when projects start or finish, several others replied that although they may have once been registered as undertaking Group IB work, they were no longer involved in such activities. There are 34 centres registered as using Group I GMMs on a large scale. This is likely to be a significant underestimate of the true figure “For discharges to water …there is no requirement to inform [the Enivronment Agency] if GM material (whether de-activated or not) is present.” Companies are generally unwilling to reveal any information about their activities (see Appendix 2). Furthermore, there are no public data held on what substances are being produced by companies using GMMs on a large scale in the UK because ‘where the substance produced is not a live GMO this falls outside the scope of the Contained Use Regulations’ 57. Not even the Environment Agency has such data even though it is responsible for effluents from industrial facilities58. The kinds of products which may be produced by GMMs include enzymes, food additives, and human and veterinary medical products. Currently, only GM bacteria and yeasts are used in commercial production systems. 5.2.1 Enzymes Enzymes produced by GMMs are used in food processing (see Table 3), in detergents or other industrial processes. The GMMs are grown and multiplied in a fermenter in a factory and the product is extracted from the resulting mix. As far as GeneWatch can determine, only one enzyme from a GMM - pullulanase - is produced in the UK at Rhodia Enzymes, a subsidiary of Rhône Poulenc. The others are imported, mainly from other parts of Europe. Table 3: Commercially Available Enzymes Made By Genetically Modified Micro-organisms For Use In Food Processing (source: Association of Manufacturers of Fermentation Enzyme Products)
These enzymes are used to treat ingredients for use in a processed food product Key: Bake = Bakery; Bevr = Beverages (soft drinks, beer, wine); Cheese = cheese; Diet = Dietary food; Egg = egg; Fats = fats & oils; Fish = fish; Meat = meat; Sald = salads; Stch = cereal and starch; Sugr = sugar and honey. 5.2.2 Food Additives An increasing number of drugs and vaccines are being produced using GMMs There are also several food additives which can be produced by GMMs in the same way as enzymes. No comprehensive list is available but they include riboflavin and aspartamate59. 5.2.3 Human and Veterinary Drugs and Vaccines An increasing number of drugs and vaccines are being produced using GMMs. A non-exhaustive list is given in Table 4.Antibiotics are not included, although it is likely that these are being produced using GMMs in some cases. Many of these will not be produced in the UK, but it is equally likely that some are. Pharmaceutical companies notified as centres using GMMs on a large scale were approached for this information but refused to provide it on grounds of commercial confidentiality. Table 4: Medical products made using GMMs
The medicines and vaccines included on this list are produced and/or developed by companies involved in recombinant DNA research or other biotechnology applications. Source: The Biotechnology Industry Organization, http://www.bio.org/bioproducts/guide99.html
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