CHAPTER 8: GENETICALLY MODIFIED ANIMALS|
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.
The creation and use of genetically modified animals is regulated
by the 1986 Act.
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.
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
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).
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
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.
8.6 Other witnesses have argued that GM animals
have great potential to advance scientific understanding and human
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.
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".
8.8 Just one month later, in June 2001, the Animal
Procedures Committee produced a report on Biotechnology.
The APC considered that GM animals did not need new legislation,
but did require special consideration under the Act, particularly
with regard to welfare.
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.
The Agriculture and Environment Biotechnology Commission is due
to report on animals and biotechnology in September 2002.
There have also been a number of reports by Non-Governmental Organisations
which have been critical of the development and use of GM animals.
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
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.
Of the 581,740 procedures included in the 2000 Statistics,
only in 118,551 procedures were animals actually used in scientific
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.
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
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
www.apc.gov.uk/reference/biorec.pdf (at July 2002). Back
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
See APC Biotechnology report, pp. 32-35. Back
Statistics, Table 3.3. Back
Home Office Statistics, p. 91. Back
See memoranda by FRAME (p. 152), the NAVS (pp. 242-44), and the
RSPCA (para. 305). Back
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
Available at http://altweb.jhsph.edu/publications/ECVAM/ecvam28.htm
(as at July 2002). Back
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
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
Of the 24 recommendations made by the APC, 16 make reference to
the assessment or consideration of animal welfare. Back
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
The latest version of the draft prepared by the Sub-Group is
available at www.aebc.gov.uk Back
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
See further discussion of the Statistics in Chapter 9. Back
See Table 3.3 of the Statistics, and para. 9 of this report. Back
This opinion is endorsed by, among others, the Physiological Society
(p. 260), and Professor J. M. W. Slack, University of Bath (p.