Select Committee on Animals In Scientific Procedures Report


8.1  A genetically modified (GM) animal is one whose genetic make-up (its DNA) has been changed using the technologies of genetic engineering. In some cases genes are moved from one species (for example, a human) to another (normally a mouse). In other cases one or more genes that would normally be found in a species are removed. The most commonly used method of genetic engineering is microinjection — the injection of foreign DNA into a fertilised egg under a microscope.[183] The creation and use of genetically modified animals is regulated by the 1986 Act.[184]

8.2  At present, the principal uses of GM animals are in basic scientific research, typically to understand more about the functioning of human genes. It is hoped by those who advocate such research that this will lead to advances in human and animal medicine.[185]

8.3  The overwhelming majority of GM animals used in the UK are mice. Of the 581,740 procedures on GM animals counted in the 2000 Statistics, 575,160, or nearly 99%, involved mice.[186] Other GM animals counted were rats, rabbits, ungulates, birds, reptiles, amphibians and fish. There were no procedures on GM cats, dogs or primates.

8.4  While the total number of animals used in scientific procedures has remained fairly static over the last few years, the proportion of GM animals used has dramatically increased. In 1995, 215,300 procedures on GM animals were included in the Home Office Statistics (8% of the total); in 2000, 581,740 procedures on GM animals were included (21% of the total).[187] Most of our witnesses considered that this trend of an increase in GM animal use would continue. We note, however, that the number of GM animals actually used in research programmes is far below the number recorded by the Statistics. We return to this below.

8.5  Some witnesses raised concerns about the technology of genetic modification as applied to animals. Mice, for example, are often genetically engineered with the express intention of breeding animals which develop cancers and other diseases. Witnesses argued that the process of genetic modification is imprecise and cannot be exactly targeted. This not infrequently leads to the creation of malformed foetuses and offspring. They also argue that genetic modification is inherently different from "traditional" methods of selective breeding.[188]

8.6  Other witnesses have argued that GM animals have great potential to advance scientific understanding and human well-being.[189] GM animals can be used to research links between genetics and disease. Witnesses also argue that GM animals can be better models than non-GM animals for human diseases and their treatment. The production of genetically engineered mice should aid research against a wide range of diseases such as muscular dystrophy, sickle-cell anaemia, Alzheimer's disease, atherosclerosis and various cancers. The production of the human protein alpha-1-antitrypsin by sheep may help people with cystic fibrosis or emphysema. We also note that the development of certain strains of GM animals may help to introduce refinements: for example, GM mice are being developed to replace primates in testing polio vaccine (Q. 870).

8.7  There is already a burgeoning literature on genetic engineering, which has been a highly controversial subject across Europe. There are also a number of reports about the use of GM animals. ECVAM produced a report of a workshop The Use of Transgenic Animals in the EU in 1998.[190] In May 2001, the Royal Society produced a report on the use of GM animals which concluded that:

"the development of GM animals has been hugely beneficial in many areas…but serious concerns remain about welfare and health and safety issues".[191]

8.8  Just one month later, in June 2001, the Animal Procedures Committee produced a report on Biotechnology.[192] The APC considered that GM animals did not need new legislation, but did require special consideration under the Act, particularly with regard to welfare.[193] We note that, after a year, the Government have still not responded to the recommendations of that report. Also in 2001, the Department of Health looked at infection risks in xenotransplantation.[194] The Agriculture and Environment Biotechnology Commission is due to report on animals and biotechnology in September 2002.[195] There have also been a number of reports by Non-Governmental Organisations which have been critical of the development and use of GM animals.[196] In the light of the rapid pace of development across the whole field of GM animals, the Committee has not felt it appropriate to produce yet another detailed review of an area which will soon move on. Instead, we confine ourselves to two general points.

8.9  The first is that, from the point of view of the 1986 Act, an important question is whether a new strain (or variety) of GM animal is "normal" from a welfare point of view — that is, it suffers no more than do ordinary animals of the species. If the GM strain is in this sense normal, then no special regulations under the 1986 Act should apply. Our witnesses disagreed over the extent to which GM animals suffered. Moreover, we note that some animals created by traditional methods of selective breeding also suffer: Dr MacArthur Clark from FAWC said that "selective breeding of poultry…has now resulted in a bird that is likely to be clinically lame by the time it is eight weeks old" (Q. 1092). In the reports by the Royal Society, the APC and others, there is at least a consensus that there is not enough information about the actual levels of suffering, if any, experienced by GM animals.

8.10  We endorse the emphasis of the APC report, that much better information on the welfare of GM animals needs to be obtained. Such a preliminary assessment would be made by the first users of the strain (the project licence holder, the Named Veterinary Surgeon and the Named Animal Care and Welfare Officer) and monitored by the Inspectorate.

8.11  The Inspectorate already advise on cost/benefit decisions involving GM animals. In order to perform this function, Inspectors need to have a sense of whether a particular GM animal is in pain or suffering: this is required for the full "cost" element in the cost/benefit analysis to be taken into account. Inspectors must therefore already be carrying out some form of assessment of any pain or suffering inherent in a strain of GM animal.

8.12  We recommend that a welfare assessment of all new strains of animals used in experiments (whether produced by new technologies or by more traditional methods) should be made as a matter of course.

8.13  The second general point we wish to make concerns the recording of GM animals in the annual Statistics.[197] Of the 581,740 procedures included in the 2000 Statistics, only in 118,551 procedures were animals actually used in scientific research programmes.[198] The breeding of any GM animal is currently classified as a scientific procedure, even though many animals suffer no adverse welfare implications as a consequence of the genetic modification. We agree with the MRC (Q. 722) that animals which are not subject to "pain, suffering, distress or lasting harm" should not be included in the published Statistics.[199]

8.14  We consider that the current practice of including in the Statistics all GM animals which are bred, whether they have adverse welfare implications or not, is misleading. If only the animals actually used in research programmes were counted, the total number of animals, including GM and normal, reported as having been used in the Statistics would have fallen over the last few years. We consider that the headline figures of the number of animals used or procedures undertaken which are given in the annual Statistics, are therefore misleading.

8.15  The Inspectorate told us that certain strains of GM animals can be excluded from the Statistics if they can be proved to be normal (Q. 1950). We consider that the welfare of all GM animals needs greater attention, but that, as a corollary, those animals which are assessed as having no immediate welfare implications should be removed from the aegis of the Act.

8.16  We recommend that animals from genetically modified strains which are bred but not otherwise used in regulated procedures should be excluded from the Home Office Statistics, provided they have no characteristics with adverse welfare implications.

183   See the Animal Procedures Committee Report on Biotechnology (June 2001) pp. 8-9; available at (at July 2002). 

184   In addition, in the UK any laboratory involved in genetic modification must be registered under the Genetically Modified Organisms (Contained Use) Regulations 2000. These require all work with GM animals to be subject to a risk assessment for effect on human health and safety. The Environmental Protection Act 1990 requires that anyone keeping GM animals must carry out an assessment of the risks to the environment, which must include hazards arising from the escape of the animals and the risk of such hazards occurring. Back

185   See APC Biotechnology report, pp. 32-35. Back

186   Statistics, Table 3.3. Back

187   Home Office Statistics, p. 91. Back

188   See memoranda by FRAME (p. 152), the NAVS (pp. 242-44), and the RSPCA (para. 305). Back

189   See the Wellcome Trust (p. 356) and the report by the Royal Society, The Use of Genetically Modified Animals, Policy Document 5/01 (London, 2001). Back

190   Available at (as at July 2002). Back

191   The Use of Genetically Modified Animals, p. viii. This report was not universally welcomed: for one critique see Dr. Mae-Wan Ho, Director, Institute of Science in Society (p. 215). Back

192   See footnote 183 above. See also the review, 'A Critique of the Animal Procedures Committee Report on Biotechnology', Alternatives to Laboratory Animals (ATLA), 30 (2002), pp. 131-34, which is largely favourable, though makes the criticism that ethical frameworks for considering GM animals are not considered. Back

193   Of the 24 recommendations made by the APC, 16 make reference to the assessment or consideration of animal welfare. Back

194   Muir, D. A. & Griffin, G. E. (2001) Infection Risks in Xenotransplantation: Prepared for the Department of Health, London. "Xenotransplantation" is the replacement of an organ in an individual by the equivalent organ taken from another species. Experiments on xenotransplantation are regulated by the 1986 Act. Clinical and regulatory issues relevant to xenotransplantation are kept under review by UKXIRA (United Kingdom Xenotransplantation Interim Regulatory Authority). Back

195   The latest version of the draft prepared by the Sub-Group is available at Back

196   For example, by GeneWatch UK (Rutovitz, J. & Mayer, S. (2002) Genetically Modified and Cloned Animals. All in a Good Cause?) and Compassion in World Farming (Turner, J. (2002) The Gene and the Stable Door: Biotechnology and Farm Animals). Back

197   See further discussion of the Statistics in Chapter 9. Back

198   See Table 3.3 of the Statistics, and para. 9 of this report. Back

199   This opinion is endorsed by, among others, the Physiological Society (p. 260), and Professor J. M. W. Slack, University of Bath (p. 338). Back

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