Regulation of the United Kingdom biotechnology industry and global competitiveness.

  • Great Britain. Parliament. House of Lords. Science and Technology Committee.
Date:
[1993]
Catalogue details

Licence: Open Government Licence

Credit: Regulation of the United Kingdom biotechnology industry and global competitiveness. Source: Wellcome Collection.

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    unfortunate case was drawn to our attention where “... an American group supported by the USDA (United States Department of Agriculture) have produced heavily-muscled “Arnold Schwarznegger” pigs by introducing a ski proto-oncogene” (Goldspink p 95). Indeed Goldspink thought that “The production of transgenic animals in Europe will probably not be focused on improving food and fibre value of agricultural animals for some years because of the animals rights and environmental pressure groups. The exception to this is possibly the introduction of gene to improve disease resistance” (p 95). 5.23 Wewere told that the use of live vaccines in gene therapy, using viruses and bacteria as vectors to carry normal copies of genes into cells and tissues, could carry indirect risks. The concerns expressed were that viruses which had been rendered harmless and non-replicating for use as vectors might recombine with other wild type co-infecting viruses and replicate with devastating effect (Harris p 100; Poste Q 391). Dr Poste speculated that “If you have a pan-tropic’ vector which can affect all kinds of cell including spermatozoa and ova, then you have inadvertently created a vertical genetic modification” (Q 391). The Clothier Committee on the Ethics of Gene Therapy reported in January 1992 (Cm 1788). It concluded that “... there is insufficient knowledge to evaluate the risks [of gene modification of sperm or ova or cells that produce them] to future generations. We recommend, therefore, that gene modification of the germ line should not yet be attempted”. 5.24 Novel foods: So far as novel foods were concerned, some witnesses took the view that food substances produced by methods which employed GMOs at some stage in their production present no particular risk to the consumer. “Genetic modification per se presents no special food safety risk; modified genes, like the rest of DNA present in food, are digested and cannot be incorporated into our own genetic make up. So, provided the characteristics for which the inserted genes code, if they are present in the food, are themselves safe, the modified organism will be as safe as the unmodified” (Food and Drink Federation p 88). The Department of Health told us that “The use of biotechnology to modify materials consumed as food may lead to the over-production of chemicals that may be toxic, particularly in plants but possibly in animals” (Department of Health p 78). Dupont told us that the United States FDA had also recognised this possibility (Dupont de Nemours (France) S.A. p 87). However, as we have already noted (paragraph 5.16) hazardous levels of toxins, new substances or allergenicity can also occur as a result of traditional plant breeding programmes. It is important to note that many of the safety issues raised are not unique to genetic engineering (Dupont p 81). OECD stated “... the evaluation (of safety) of food and food components obtained from organisms developed by the application of the newer techniques does not necessitate a fundamental change in established principles, nor does it require a different standard of safety” (Concepts and Principles Underpinning Safety Evaluation of Food Derived by Modern Biotechnology, 1992) It should be noted that under the present regulatory system all food products, genetically modified or otherwise, must pass the tests of safety and quality. Contained use: classification of activities 5.25 Weturn now to the views of witnesses on the mechanics of the contained use regulations. As we showed in Chapter 4, the procedures governing contained use of GMOs depend on whether they are pathogenic (Group II organisms) or not (Group I organisms) or whether the operations are small scale eg under “about” 10 litres (Type A operations) or bigger (Type B operations). It was pointed out that these classifications “may have changed the atmosphere for the use of modified organisms markedly” (Kinderlerer p 117). They departed from the United Kingdom 1989 regulations and followed EC definitions originally devised by OECD for large scale work. They were unsuitable for laboratory work. Their chief effect is that advance notification rather than retrospective notification is required for low risk activities on a scale of more than 10 litres. On the whole, witnesses found certain aspects of these classifications of scale and pathogenicity risible. Pan-tropic - able to affect many or all tissues. 125703 A*S5