AEBC

AEBC/02/09

COVERNOTE TO DRAFT ANIMALS AND BIOTECHNOLOGY REPORT

1. A final draft of a report on animals and biotechnology is attached for approval by the Commission.

2. The draft has been revised in the light of comments made by a number of Commission Members on a draft circulated at the end of May.

3. Anna Bradley will introduce at the Commission meeting the changes made to the draft report in the light of Members' comments and further work by the animals and biotechnology sub-group. The main headline changes are:

The report is more clearly focussed on biotechnology and animals in agriculture and the environment (not on research animals or pets);
An explicit acknowledgement that interpretation and enforcement of regulations has not been assessed by the sub-group, and a recommendation that the enforcement of farm animal regulations should be independently scrutinised;
New recommendations (drawing from existing discussion in the body of the report) about consumer choice; and about commercialisation of GM fish; and
The differences in society and on the Commission about the extent to which use of the technology on animals raises matters of principle are more extensively acknowledged and discussed.

The body of the report has also been revised in the light of these main changes and as far as possible to incorporate members more detailed points. The opening paragraphs of the executive summary are also now intended to convey more clearly the thrust of the report's message. Finally, a list of people and organisations consulted is now included as an Annex.

AEBC Secretariat
July 2002

ANIMALS AND BIOTECHNOLOGY

A REPORT BY THE AEBC

DRAFT OF 9 JULY 2002

CONTENTS

EXECUTIVE SUMMARY

PART 1: THE CONTEXT

PART 1.1 Our purpose
PART 1.2 Our method
PART 1.3 Applications of modern biotechnology to animals
PART 1.4 Public attitudes to animals and modern biotechnology
PART 1.5 What is different about modern biotechnology?

PART 2 THE REGULATORY FRAMEWORK

PART 2.1 Guiding principles for regulation
PART 2.2 Legislation
PART 2.3 Advisory bodies
PART 2.4 Interpretation and implementation
PART 2.5 Responsibilities within government

ANNEX A Description of the present regulatory framework

ANNEX B Conclusions of Breakwell literature review on research in the UK on public attitudes to biotechnology with animals

ANNEX C Digest of Macnaghten report on contemporary UK public attitudes and sensibilities towards animals

ANNEX D Executive summary of the final MORI report on the AEBC reference group on animals and biotechnology

ANNEX E What people told us

ANNEX F What the words mean

ANNEX G Who we are

ANNEX H Contact us

EXECUTIVE SUMMARY Developments in biotechnology have potentially large implications for society's relationships with animals. It is important that Government and the rest of society thinks about the issues now, not when the GM and cloned animals are almost at UK farm gates or ready for release into the environment. Government and the livestock industry need to get it right. Questions in relation to GM and cloning are more urgent and sensitive because of the speed and nature of changes to animals made possible by modern biotechnology, and the issues of concern and in some cases principle, that GM and cloning give rise to for some people. There is accordingly a need to strengthen the system for providing independent advice to Government on the implications of these new developments, and to engage the public on the issues. And the interpretation and enforcement of the law relating to farm animals should be reviewed. Commercial applications of GM or cloning to farm animals in the United Kingdom, except for some GM sheep which produce pharmaceuticals in their milk, are unlikely in the next several years. But the situation could change fast: overseas, prize cows and bulls have been cloned and sold at market and research on other farm animals is underway. We have taken a strategic look at the issues and at whether the regulatory system could cope with possible future developments in GM and cloned animals in agriculture and the environment. In doing so, we wanted to make sure that our recommendations were informed by public views. Our research suggested that mistrust of official institutions affects attitudes to GM and cloned animals. People value the integrity of animals' natures. There appears to be no outright rejection of applying GM and cloning to animals, but considerable concerns about the potential nature and speed of change and the possibility of unforeseen mistakes. People believe there should be clear justification of applications of the technology and want a transparent, and above all trustworthy, regulatory system.
The practical differences between modern biotechnology and conventional practices are not such as to suggest that GM or cloned farm (or other) animals should be governed separately in every aspect from conventional animals in the regulatory system. It makes sense also to consider GM and cloning in the context of society's wider relationships with animals and alongside conventional techniques of animal breeding. Practices in conventional livestock production need to be justifiable, as would the use of GM and cloning. In view of public concerns, however, we believe that it is right to bring the use of GM and cloning into sharp focus.	Recommendation: GM, cloned and conventional animals should be governed by the same regulations wherever possible.
We accordingly think that there is a strong case for a new standing advisory body to take a strategic look at the issues, particularly in relation to agriculture. It makes sense to consider issues around GM and cloned farm animals in the context of the application of GM and cloning to other animals: some biotechnology applications, such as cloning, already are or could be in principle applied to farm animals or pets or animals in research. And to effectively consider issues about GM and cloned animals in agriculture, the body would need to look at these in the context of conventional practice, taking account of the strategic direction of livestock farming. The new body should seek to chart possible ways through these difficult issues.	Recommendation: A new strategic advisory body should be set up by statute to look at issues raised by modern biotechnology and developments in conventional practices relating to farm and other animals.
Particular attention should be paid to engaging the public to determine under what conditions applications of modern biotechnology and conventional technology to animals are likely to be publicly acceptable. The new strategic body and existing advisory bodies should be given adequate resources to engage the public.	Recommendation: Particular attention should be paid to engaging the public to determine under what conditions applications of GM and cloning and conventional technology to animals are likely to be publicly acceptable.
We are satisfied that the law relating to farm animals is in principle adequate to meet concerns about any future GM farm animals which suffered reduced welfare or health problems or which gave rise to unacceptable human health or environmental risks. We believe, however, that there is a potential gap in the legislation in relation to the case of a GM or conventional farm animal which was judged intrinsically objectionable but which did not give rise to clear animal	Recommendation: Government should ensure that the new strategic body and existing advisory bodies are adequately funded to engage the public on the issues in their areas of responsibility.
welfare, animal or human health or environmental concerns. General animal welfare legislation applies to GM, cloned and conventional animals. It urgently needs to be updated and consolidated. The revised legislation	Recommendation: Identify and clarify if necessary regulatory provision to deal with any intrinsically objectionable farm animals.
should take account of the implications of novel procedures, including genetic modification, but should provide a framework for dealing with all the issues raised by society’s relationships with animals. We welcome the fact that DEFRA is now reviewing the legislation.	Recommendation: The 1911 Protection of Animals Act should be updated and the piecemeal general animal welfare legislation should be consolidated.
There is also a need for adequate monitoring of the long term stability and welfare of cloned and GM farm animals, if and when they enter conventional production, particularly because there is a question whether cloning itself causes animal health and welfare problems in adult cloned animals. Looking ahead, if and when GM or cloned livestock enter commercial production, it	Recommendation: If cloned or GM farm animals enter commercial agricultural production, there should be adequate post-commercialisation monitoring for any unanticipated welfare or other effects.
seems likely at present that some people would wish to choose to avoid GM or cloned animals. So thought should be given ahead of time to what arrangements would be needed in the livestock production industry to give consumers the choice. The general impact of GM and cloned farm animals on the environment would	Recommendation: Government should consider what arrangements would be necessary to maintain consumer choice were GM or cloned animals to enter commercial agricultural production.
seem unlikely to be very different in kind to conventional animals. The commercialisation of GM fish, on the other hand, would raise significant environmental concerns and we do not believe that GM fish should reared in offshore fish farms until such concerns are satisfied. The release of GM insects into the environment would also require	Recommendation: There should be a moratorium on the commercial production of GM fish in aquatic net pens unless and until concerns about fish escaping into the wild have been removed.
very careful consideration. For reasons of environmental protection and the need to ensure adequate post-commercialisation monitoring of cloned and GM animals, a system for tracing the international import and export of GM and cloned animals should be developed ahead of widespread commercialisation of cloned or GM animals. A system is needed because a GM animal would often look no different to its conventional	Recommendation: Adequate arrangements should be developed for monitoring the international movement of GM and cloned animals.
counterpart. We have not ourselves reviewed in depth the interpretation and implementation of existing regulations relating to animals in agriculture and the environment. In looking at the adequacy of the existing regulatory system to deal with any future commercialisation of GM and cloned animals, we heard evidence that suggested that the interpretation and enforcement of present regulation in relation to farm animals is insufficiently robust. We believe that there needs to be scrutiny of how well existing legislation is being implemented in relation to animals in agriculture and the environment. This will be all the more important as biotechnology develops.	Recommendation: To increase public trust in the regulatory system, the extent to which regulations relating to farm animals are being rigorously enforced should be reviewed.

PART 1 THE CONTEXT

PART 1.1 OUR PURPOSE

1. Our purpose was to take a strategic look at the current regulatory system in the light of present and future applications of biotechnology to animals in agriculture and the environment.

2. We have necessarily ranged more widely than our terms of reference, although our recommendations are focussed on agriculture and the environment. We have taken a broad view because first, the regulatory system is complex. Some of the legislation is specific to GM animals, some to farm animals, and some applies to GM, cloned and conventional animals. Second, the technology is being applied to different kinds of animals, and issues arising in one area can affect public attitudes to developments in other areas. Third, it is important to consider biotechnology in the context of conventional practices too animals, to avoid inconsistency.

PART 1.2 OUR METHOD

3. We have attempted an effective and innovative approach which gave appropriate weight to all relevant considerations. We first undertook a broad survey of what was going on in the development of biotechnological techniques in relation to animals.

4. We then sought information about public attitudes. The AEBC has a remit to advise on the public acceptability of developments in agricultural and environmental biotechnology. We have been clear from the outset public views must inform our recommendations about the regulatory system. Early in our work, therefore, we commissioned a literature survey, from Professor Glynnis Breakwell of Surrey University, of existing social research on attitudes to animals and biotechnology in the UK.

5. Professor Breakwell found that existing research consisted predominantly of quantitative opinion surveys, which gave some general indications of public attitudes in this area. Professor Breakwell noted that 'overall there would seem to be little research on this topic area in the UK - indeed it appears that the issue of animals and biotechnology has not formed the sole focus of any research. Rather the issue has been addressed within research that has a different, or broader, focus such as biotechnology in general or animal welfare.' [1]

6. Consequently we decided to commission qualitative research on contemporary UK public attitudes and sensibilities towards animals with a view to understanding their subtleties and complexities. We wanted, through qualitative social research, to explore in greater depth the subtleties of the different perspectives people have on animals and in particular about applying GM and cloning to animals; and the nature of public expectations of the regulatory system. We are very grateful to those members of the public who participated in this study. We attach at annexes B and C respectively summaries of Professor Breakwell’s literature review and Dr Macnaghten's report and have published both reports in full on our website.

7. We reviewed the present legislation relating to GM and cloned animals in agriculture and the environment; and surveyed the various regulatory and advisory bodies in order to identify any regulatory gaps in relation to the application of GM and cloning to animals. We did not make a detailed examination of the interpretation and implementation of regulation, but have made some observations on where we think further work might usefully be done on this. We bore in mind the Better Regulation Taskforce's principles of better regulation in making recommendations.

8. We consulted stakeholders openly about our emerging conclusions. We also recruited a public reference group with which to test out our thinking as it developed. We wanted to gain an idea of how our specific recommendations might be viewed by the public. The feedback we received from the reference group was important to the development of our report. We commend the use of a similar reference group to others.

PART 1.3 APPLICATIONS OF MODERN BIOTECHNOLOGY TO ANIMALS

Modern biotechnology

9. In this section we outline some of the main areas where GM and cloning is either being applied to animals or looks likely to be applied in the future. We should stress that the following list is descriptive. It implies no approval or disapproval of any of the biotechnology applications, or of the claims or counter-claims made in relation to them or to what might be possible in the future. We consider in more detail the issues raised by some of the particular examples, and some of the general features of the technology, in part 1.5 of this report.

10. Conventionally, pets and farm animals have all been selectively bred for particular characteristics perceived as desirable. The natural genetic variation in animal populations makes this possible. Selective breeding has produced all the many breeds of domestic dog. It has produced the modern dairy cow, pig and chicken which have been bred over many generations to be more productive than their ancestors. Selective breeding continues, aided now by artificial insemination techniques, which can mean an individual male with desirable characteristics can have a vastly greater number of offspring than was possible in the past. Improved statistical analysis has greatly increased the efficiency of conventional selective breeding. Marker-assisted breeding, which uses knowledge of farm animals’ genetic maps to test animals for desired traits, is having a similar effect.

11. Modern biotechnology potentially allows similar effects to conventional breeding to be achieved faster and with greater precision. Unlike conventional breeding, it can also be used to transfer genetic material from one species to another. It has also made possible the cloning of some individual adult animals which is impossible to achieve by conventional means. Compared with conventional technologies, modern biotechnology also has a wider range of potential applications to animals, particularly for medical purposes.

12. The first genetically modified animals were transgenic mice, created in the early 1980s. Transgenic animals possess active copies of one or more genes that have been inserted into them from another individual from the same or a different species. It is also possible to stop production of a protein by a particular gene - ‘knocking out’ the gene function; or to insert - 'knock in' - genetic material to a specific gene to modify the type of protein produced by the gene or the way the protein is regulated. Chromosome engineering allows large-scale rearrangements of DNA in an animal. All of these techniques are commonly referred to as ‘genetic modification’ or ‘GM’ and the animals produced are termed ‘GM animals’ and this is how the term should be understood in our report. We have also taken into account cloning not involving genetic modification (referred to in this report simply as 'cloning'). Animals that are not genetically modified or cloned are termed ‘conventional animals’ in the report.

Applications of GM and cloning to animals

13. The recent Royal Society report on GM animals and the Animal Procedures Committee report on Biotechnology set out in detail the various applications of genetic modification underway at present or expected in coming years. We have not attempted to duplicate this effort but have instead summarised the principal present and expected applications of the technology.

Medical research

14. The principal application of modern biotechnology to animals at present is for medical and biological research, largely drawing on information derived from human and animal genome sequences. The vast majority (98 per cent) of the GM animals involved are mice. There are three main aspects to this research: the use of animals as models for specific human diseases; better understanding of basic human biology; and testing substances for toxicity. Between 1990 and 2000, the number of experimental procedures involving transgenic/GM animals rose from some 50,000 to over 580,000. In 2000, about 65 percent of the procedures involving GM animals constituted breeding to maintain populations with a specific genetic modification. About a quarter of the procedures involved using animals as human disease models or research into gene function. The remaining five percent were used in applied work, such as toxicity testing. The number of GM animals involved is expected to rise substantially over the next few years, as the functions of new genes identified in genome sequencing projects are analysed.

15. Mice and other animals can be genetically modified to provide models of human diseases. Animal models are used because of the overall high similarity between mouse and human genomes coupled with common fundamental characteristics of cellular mechanisms. The object is to research the underlying pathology of the disease and to test potential treatments.

16. In addition to researching specific diseases and possible cures, the fact that mice and other animals share a great number of genes with humans is also being employed in research to understand the fundamental biology of humans. The decoding of the entire human genome sequence has emphasised how little we understand about the function of most of our genes. Mice, fruit flies, zebrafish, the South African claw-toed frog and a nematode worm are among the main organisms involved in this fundamental research. Experiments include knocking out a particular gene that is shared by an animal and humans to improve understanding of the function of the gene.

17. The third main area of research involving GM animals is a development of the use of conventional animals to test the toxicity of chemicals and drugs, for example whether they cause cancer. Some rodents have been genetically modified so that if a mutation in a gene occurs, the change can be easily detected. This can be achieved, for example, by the modified genes, when removed from the animal and introduced into yeast cells, causing the yeast cells to change colour. Other rodents have been modified to be much more sensitive to carcinogens than their conventional relatives, so that they will develop cancer much faster if a carcinogen is present in a test substance. The advantage of using the sensitised GM animals is that safety testing of new products can be completed more quickly and with fewer animals than in conventional tests.

Faster growing fish

18. Many species of fish have been genetically modified in the laboratory to produce a wide variety of traits. One US company has developed a GM salmon known as AquaAdvantage®. This fish has been genetically modified to grow at two to three times the rate of unmodified salmon. An application for a licence for commercial use of such salmon has been made for marketing approval to the US Food and Drug Administration and the company is reported to expect that if the application is successful the fish will reach US supermarkets within four to six years. Other fish, including trout, carp, catfish and tilapia have been the subject of research. Subject to regulatory approval, salmon would appear to be the closest to reaching the US market. There are significant environmental concerns relating to the intended or unintended release into the marine environment of faster-growing fish or fish modified in other ways, which we discuss in part 2. Pharming

19. ‘Pharming’ is the production of pharmaceutical products in animals, usually farm animals, which have been modified for the purpose. The pharmaceutical product is synthesised by the animals and commonly expressed in their milk, urine or eggs. Some fifty products are in development, including treatments for Pompe's disease, hereditary angioedema, heart attacks, cystic fibrosis and haemophilia. Many genetic illnesses and syndromes are caused by absence of a single protein (usually an enzyme). In some cases this can be effectively or completely treated by providing the missing enzyme, normally by injection. In other cases a factor can be provided to treat non-genetic conditions (e.g. bleeding and clotting complications, heart attack). PPL Pharmaceuticals (Roslin), for example, have a flock of some 600 GM sheep in Scotland producing a pharmed protein called alpha-1-antitrypsin (known generally as AAT) in clinical trials at present. PPL and Bayer hopes to achieve regulatory approval for the product in 2007. The product is intended to cure hereditary emphysema. PPL are also working on a potential treatment for cystic fibrosis patients.

20. Animals are also being modified to express non-pharmaceutical products. For example, GM goats have been engineered to express spiders' silk in their milk. The aim would be to harvest the silk, which has exceptional strength and other properties, for military body armour and for medical and other commercial purposes.

GM insects

21. There is considerable interest in using biotechnology to control insects which spread disease. Techniques under development include using genetic manipulation to improve an existing method of reducing the numbers of insects in a particular area, which involves releasing many sterile male insects into a local population. Sterilisation is currently achieved by irradiation, but this has the side effect of making the insects ten times less vigorous and so the control process less efficient.

22. Much research has been undertaken in relation to mosquitoes, which carry the malaria parasite. The aim is to genetically modify mosquitoes to be resistant to the malaria virus and to release them into the environment to replace the existing, susceptible, wild population. Another possibility is modification of the malaria parasite itself. It may be possible to apply these technologies to a wide range of insect disease-carriers and to other invertebrates such as nematodes. The aim would be to reduce or eliminate populations of insects which spread human disease or cause significant damage to agriculture.

23. The risks which have been noted in connection with GM insects include the unpredictability of widespread release of GM insects in to a wild population and the possibility that the beneficial genetic modification might mutate or undergo partial deletion. There might be undesirable unintended behavioural changes in modified insects (e.g. increased aggressiveness in biting insects). The use of ‘gene drivers’ to spread a particular genetic modification through an insect population would be an irreversible strategy with implications for whole populations and even species. The environmental and biosafety issues would be significant and any release would need extensive justification and planning.

Farm animals

24. There are no GM farm animals (except for those in biopharming) in commercial production at present in the UK. We understand that at least in the United Kingdom, GM animals produced for human consumption would, if given regulatory approval, be some ten years from the market. Aside from the question of the public acceptability of GM livestock entering human food supplies, there are practical obstacles. These include the expense of the process, due in part to only a small proportion in many cases of modified embryos surviving into adulthood. Knowledge of farm animal genomes is incomplete. The longer breeding cycles of these animals can limit the pace at which research can move forward. Moreover, production of farm animals in the UK is not generally financially rewarding at present, so is unlikely to attract venture capital funding in the same way as medical biotechnology research.

25. Small numbers of cloned farm animals, however, have been produced overseas. The cloning process is expensive and inefficient, so commercial agricultural applications to date have been limited to high-value individual farm animals. High-performing bulls have been cloned under commercial licence in Australia for sale to China and elsewhere. A few cloned calves of prize cattle are reported to have been sold at auction in the US. There are reports that Kobe beef from cloned animals has been made available on a very limited basis for human consumption in Japan.

26. A number of biotechnology applications to farm animals may be possible. As with fish, it is likely to be possible to use genetic modification to create faster growing animals which reach market earlier. A line of animals could be genetically engineered to enhance traits which are perceived to confer market advantage, for example poultry with extra breast-meat, or meat with a lowered cholesterol content or less saturated fat. Many other examples are being researched.

27. Other applications would include engineering resistance to specific infectious diseases within the animal population. An example is Marek’s disease in poultry, a virus-induced lymphatic cancer, which costs the UK poultry industry alone some £100m a year and is clearly detrimental to the birds' welfare. It might be possible to make animals resistant to infectious diseases that are also human health risks such as Salmonella in poultry or to produce BSE-resistant cows or scrapie-resistant sheep. The large number of breeds of cattle and extent of subsequent breeding to spread the trait through the national herd or flock, however, would make the latter two examples an ambitious undertaking. A further example relates to high agricultural value strains of cows which cannot be maintained successfully in sub-Saharan Africa. This problem could be overcome, it is claimed, by introducing disease resistance genes from local cattle.

28. It is further claimed that genetic modification could be used to improve farm animal welfare by correcting physiological problems which have arisen as a result of conventional selective breeding. Increased knowledge of animal genome sequences has the potential to allow some of the same effects to be achieved by identifying effective genetic maps that will improve marker-assisted breeding techniques.

Pets

29. There are no widespread applications of genetic modification to pets ('companion animals') at present. The planned genetic modification by a small American company of cats so that the animals do not provoke a human allergic reaction has recently received publicity, however, and the company has claimed that such cats could be produced by 2003, subject to commercial funding.

30. The first cloned pet cat was produced in the United States in December 2001 by researchers at Texas A&M university. The 'Missyplicity' research project funded by a US company, Genetic Savings and Clone (GSC), to clone a specific pet dog, called Missy, has been underway for some time. Dogs have not yet been successfully cloned. GSC also funded the cloned cat project. GSC and other companies have stored the DNA of other pets at the request and expense of their owners against the day when it may be possible to clone those animals. Genetic modification has also been mooted as a way of changing animal behaviour although the genetic complexity underlying behaviour mean that this is at present technically impracticable. We discuss this last possibility further in part 1.5.

31. Welfare problems in some pet animals, for example tendencies to develop hydrocephalus in bulldogs, hip dysplasia in German shepherds, and so on, have arisen as a result of conventional selective breeding. It is possible that genetic modification could be used to try to correct these problems.

32. In the context of the above various possible applications, some people argue that it would always be preferable to employ means other than genetic modification, particularly conventional or marker-assisted breeding, to achieve the various desired changes to farm animals and pets.

Xenotransplantation

33. This is the transplantation of cells or whole organs from animals to humans. There is a serious shortage of human organ donors and some animals, particularly pigs, are being examined as a potential source of suitable organs or cells, genetically modified to reduce the chance of rejection by humans. The recent successful production of cloned pigs is a further step towards efficient genetic modification of pigs and as such is aimed at bringing xenotransplantation closer. There is debate about whether sufficient other necessary progress will have been made to allow successful transplants from GM animals in the next five to ten years. Besides organ rejection, there remain serious concerns about the possible transfer of animal viruses to humans that will have to be addressed before the technology could be applied; and concerns about physiological compatibility.

Sporting animals

34. There is no reason in principle why sporting animals could not be subject to genetic modification. The breeding of racehorses is regulated by the horseracing industry, however, which stipulates an entirely natural process from fertilization to birth of the horse. This effectively rules out GM and cloning at present in racehorse breeding (and artificial insemination).

35. Other parts of the equestrian sports industry do not have the same strict rules on breeding as exist for thoroughbred racehorses. For these horses, the industry rules are silent on the application of GM and cloning. This is the same for greyhound racing. The application of GM to sporting animals does not appear to be a major area of activity at present, although there is some interest in the possibilities.

36. Genetic modification of sporting animals conceivably could become an issue for industries using sporting animals. Just as there is a lot of effort put in to detect and so prevent doping of animals (and, indeed, in human sports) so trying to stop genetic modification of sporting animals could come to the fore. If so, this might drive research to find practicable ways to detect particular modifications in animals.

PART 1.4 PUBLIC ATTITUDES TO ANIMALS AND MODERN BIOTECHNOLOGY

37. Having surveyed possible applications of GM and cloning to animals, we now look at what we have learnt about public attitudes to what is going on and what appears to be coming over the horizon. From the social research we commissioned, a number of important points emerged which we have grouped as follows: attitudes to animals; attitudes to GM and cloning; and attitudes to applying the technology to animals.

Attitudes to animals

38. Both the Macnaghten and Breakwell studies confirmed that in the UK there is widespread strong feeling about animal use generally and animal welfare in particular. The Macnaghten study involved people who collectively had a wide range of everyday experiences of animals, as pets, as wildlife, as prey, as working and gaming partners and as livestock. The findings suggest that people’s attitudes to animals and the uses they make of them are complex. The Macnaghten report found that people tended to adopt divergent ways of talking about animals depending on the nature of their relationship with animals, although the differences should not be over-emphasised. Farmers, for example, were more likely to view genetic modification of farm animals as the next stage of selective breeding, although sceptical that it would deliver tangible benefits to them.

39. The Macnaghten report found that 'many people have close, affective relationships with animals in domestic and other contexts.' It also noted that people recognised 'frequent personal contradictions in their behaviours towards animals, moving between close, even intimate and inter-dependent family connections' and using animals for food, clothing and in laboratories. Moreover, the researchers found that 'a degree of ‘denial’, and even hypocrisy, in this regard is frequently acknowledged. Such reactions appear to signal shifting social awareness of the tensions between ‘moral’ and ‘instrumental’ approaches to animals in modern society.'

40. Professor Breakwell found that existing research showed evidence that people had a complex pattern of reasoning, knowledge and values. People were aware of inconsistencies and ambivalence and wanted to form opinions based on facts when making judgments about what is justifiable in society's relationships with animals.

Attitudes to modern biotechnology

41. In 1996, sixty percent of UK citizens interviewed in the European Commission's Eurobarometer poll tended to agree with the statement that 'only traditional breeding methods should be used, rather than changing the hereditary characteristics of plants and animals through modern technology'. In the same poll, on the other hand, a majority tended to agree that developing GM animals for laboratory research, such as a mouse that has genes that cause it to develop cancer, was useful; but a majority also tended to think that this was morally unacceptable.

42. A Eurobarometer poll in 1999 suggested some public misgivings in the UK and elsewhere in Europe about the cloning of animals. A majority of respondents rejected the cloning of animals for medical purposes, although there was moderate support for the cloning of human cells for the same purpose.

43. These two examples, cited in the Breakwell study, seem to illustrate that people's attitudes to biotechnology in relation to animals bears comparison with attitudes to applying modern biotechnology to crops. There is a spectrum of views about GM and cloning, as we noted in our first report, Crops on Trial. Some of the changes are perceived to be 'unnatural' in some sense. At one end of the spectrum, 'GM technology is not simply an advance in molecular biology, but a major and irreversible watershed in human intervention in nature. Seen from this perspective, the specific concerns expressed about the uncertainties and limitations of present GM knowledge often demonstrate a wider ontological unease at the hubris of such fundamental human manipulation of nature.' At the other end of the spectrum is the view that genetic modification or cloning represents a progressive evolution from selective breeding in animal production and is not qualitatively different from them.

44. In the Macnaghten study, the researchers sought to tease out whether genetic modification in itself is at issue in the public mind; and the nature of public views about applying modern biotechnology, including genetic modification, to animals. They found that people viewed modern biotechnology developments in the light of their attitudes to existing practices and relationships involving animals. The research also found that most people regarded the direct genetic modification of animals as both ‘new’ and ‘unnatural’. Although few people rejected the use of the technology out of hand, people expressed considerable concern about the pace of developments, the nature of the techniques used, and they anticipated unforeseen mistakes arising from use of the technology. The researchers found that people commonly were 'wary of 'going against nature', a term that the researchers considered was key to the distinctiveness of people’s concerns about animals and biotechnology.

45. The researchers found that people’s concerns about biotechnology included a concern for the ‘intrinsic character of animals, including the need for animals to retain their integrity'. Concerns about going against nature, then, seem to relate both to a concern for the integrity of the nature of the animal itself and also to perceived potential wider undesirable effects resulting from changes made to the animal.

When is it acceptable to apply GM and cloning to animals?

46. The Macnaghten report found that in relation to animal experimentation in general (not only involving GM and cloning) people’s attitude depended critically on the purpose of the research. Medical applications made people less uncomfortable than cosmetic applications, although there appeared to be 'an emerging acknowledgement of the difficulty of maintaining such clear-cut distinctions.' Key conditions for applying GM to animals included the requirement to demonstrate a genuine and authentic need for undertaking such procedures, commensurate with people's considerable concerns about the technology.

47. As noted earlier, the vast majority of GM animals at present are produced for research purposes. The Macnaghten study suggested that most people have only a limited understanding of the nature and extent of experimentation on animals in the UK. People agreed, in response to the suggestion that modern biotechnology may require a substantial increase in animal testing, that such additional testing of animals may well be justified, especially on health grounds, but they would want to judge the evidence for themselves. In the light of such an increase, 'the question of justification became a more urgent matter, demonstrable not just to expert committees but also to the public at large.' This finding points, among other things, to the importance of transparency in decision-making in this area and to the importance of fostering greater public understanding in relation to the use of GM animals for research.

48. The conclusions drawn by Professor Breakwell from existing research were that the main bases of people's judgement are whether the technology is 'useful' and 'ethical'. Perceptions of moral unacceptability ‘act as a veto' in people's attitudes to what may be done with animals. These criteria are applied even if the perceived risk of particular application to human health and the environment is low. Surveys supported the finding in the Macnaghten report that medical uses of GM animals were generally more acceptable than others (although a medical use certainly does not lead to automatic public acceptance). When considering whether a biotechnological development is right or wrong the possibility of harm to animals is an important consideration.

49. Other data also suggest that public views about developments in the field are tied up with their attitudes to the regulatory system and in particular the parties responsible for regulating activities in these areas. A MORI survey undertaken in the UK for Government in 1998/99 found that only 35 percent of those surveyed trusted Governments to make decisions on their behalf in the regulation of the biological sciences. A recently published study, funded by the European Commission, of public perceptions of agricultural biotechnologies in a number of EU countries found widespread public mistrust of regulators in this area. Public concerns expressed in the focus groups used in the research were mostly based 'on empirical lay knowledge about the past behaviour of institutions responsible for the development and regulation of technical innovations and risks, supported by numerous commonly shared experiences…In this context BSE was not regarded as an exception. Rather…an exemplary case demonstrating the normal behaviour of such institutions.' We explored the implications of public mistrust of Government as a regulator in Crops on Trial.

50. The Macnaghten research brings out this point. In the course of the discussions, the researchers found that:

'Repeatedly, the crises over BSE and GM foods were invoked in support of suggestions that institutions of science, government and agri-business were not to be trusted as key institutions responsible for overseeing such innovations - dependent as they were on taking animals further away from their nature - in a responsible and ethically sensitive fashion. Perceiving such institutions as being 'in denial' of such realities exacerbated people's sense of the likelihood of subsequent retribution, of 'throw backs', of 'nature striking back', and of 'us getting carried away without thinking about the repercussions.'

The researchers found that the main message for the Government about GM and cloning and animals from participants in the research was not to reject the technology out of hand, but 'to proceed cautiously, slowly, openly, and with recognition of the scale and scope of what was being undertaken.'

51. In summary, mistrust of institutions is an important characteristic of public views about GM and cloning and animals. So is concern for the ‘integrity' of animals. It may be that some of the public expressions of concern in relation to GM crops are exacerbated in relation to animals, at least the 'higher' animals, due to people's existing relationships with animals and the consequent respect many people have for the integrity of animals' natures. There appears to be no outright rejection of modern biotechnology in relation to animals, but considerable concerns about the potential nature and speed of modifications made to animals and the possibility of unforeseen mistakes. People believe there should be clear justification of applications of the technology and want a transparent, and above all trustworthy, regulatory system.

PART 1.5 WHAT IS DIFFERENT ABOUT MODERN BIOTECHNOLOGY?

52. The information about public views above suggests that the application of GM and cloning to animals should be examined in the context of society's wider relationships to animals and to existing practices, because people's attitudes are mediated by their existing relationships with animals. It also seems likely that few members of the public are aware of all the constituent parts of the regulatory system already in place.

53. New regulations should be created only where there is a genuine need for them; and any new regulation should be consistent with regulation already in place. Accordingly, we started by looking at the scope of present regulation to deal with present and likely future developments in GM and cloning and people's likely views about the developments. Our presumption has been that is would be better not to create separate regulation to deal with GM and cloning where the existing system is adequate. To test out the applicability of this approach, it is necessary first to examine the differences and similarities between the uses of GM and cloning and conventional practices involving animals.

Environmental impact

54. As noted earlier, there are no farm animals other than those used for biopharming, in commercial production in the UK. The environmental impact of research animals, whether GM or not, is not a major issue because the animals are kept in contained premises. It is difficult to see any new issue for biodiversity or environmental impact from any commercialisation of GM or cloned farm animals. Livestock farming of course has significant environmental impact, but these impacts would not be specific to GM and cloning applications. Present regulations would nonetheless require assessment of the environmental impact of a GM animal, including a GM farm animal, prior to commercialisation. The possible environmental impact of commercialisation of GM fish, on the other hand, does raise more serious environmental issues (see part 2). The release of GM insects would also require particular care and attention.

55. In principle, it is possible that farm animals might be genetically modified to have a more beneficial environmental impact; for example ruminants might be modified to produce less greenhouse gas. Environmental problems from livestock production equally might be addressed by conventional means.

Consumer choice

56. If and when GM or cloned farm animals entered commercial production, however, there might need to be separate management arrangements, if not regulation, to preserve consumer choice if, as seems likely at present, there is consumer demand for non-GM meat or animal products. The system would need to prevent accidental cross-breeding on the farm or mixing of products in the supply chain. This is likely to be a practical difference between GM and conventional farm animals.

Animals' natures

57. Are the nature of the changes which could potentially be made to animals by GM and cloning grounds for considering that GM and cloned animals are something quite different from conventional animals? Our social research suggested a strong regard for the 'integrity' of an animal's nature. Violating the nature of an animal is often seen as fundamentally objectionable.

58. Is this possibility in fact peculiar to modern biotechnology? It would seem not. The Banner report cites the case of the production of turkeys of such a size as to be incapable of natural breeding without risk of body damage to the hen. The current Farm Animal Welfare Council (FAWC) Welfare Code recommends saddles for hens and toe cutting of male turkeys to prevent injury during natural mating. The FAWC report on turkeys, did not find any particular welfare problems arising from the widespread practice of using artificial insemination. But the Banner report found that regardless of the welfare issue, 'the breeding of birds who are physically incapable of engaging in behaviour which is natural to them is fundamentally objectionable'.

59. Genetic modification does, however, give rise to greater public concern about the possibilities of changes to an animal’s nature, principally because of the perceived possible speed and types of change allowed by genetic modification. Some at present hypothetical examples about the possible modification of animal behaviour may help to illustrate this concern and its implications.

60. The possibility of using GM to modify the hunting instinct in domestic cats has been mooted. It is claimed that one possible effect of this could be to increase the numbers of songbirds in the United Kingdom, where cats are thought to kill millions of such birds every year. If such a development ever became technically feasible and a commercially viable proposition, therefore, there would be an environmental aspect; and the welfare of the modified cats also would need to be considered.

61. But the question is whether it would be appropriate to change the fundamental nature of an animal in this way, regardless of the putative purpose. Some would argue that although cats, like dogs, have been selectively bred over many generations so that modern cats look and behave quite differently from their wild ancestors, the hunting instinct should remain as a necessary part of a cat’s nature. Others might argue that further change is acceptable since cats have already lost many 'natural' characteristics in the course of domestication.

62. The same point emerges in relation to a sometimes discussed theoretical application of biotechnology to the livestock industry, namely the use of genetic modification to reduce the sentience of farm animals in order to increase those animals’ ability to withstand a stressful management regime. The production of a line of animals with reduced sentience is purely hypothetical, principally because there is insufficient knowledge about how genes control behaviour to be able to design such animals (similarly for changing the hunting instinct in cats). We should stress that we understand that this is not at present the subject of scientific research.

63. The Banner report considered that development of an animal with reduced sentience was objectionable in principle because it would stop the farm animal living in accordance with its natural end in life and being a proper example of its species, regardless of whether the modified animal experienced suffering. It is important to note that this point would not be confined solely to biotechnology and animals. Selective breeding could in theory produce similar results. Some would argue that the long process of domestication of animals has already at least partially done so.

64. Moreover, animal behaviour can be modified - for good or ill - by means other than GM. Witness the recently created 'Roborat' which is a normal rat with electrodes implanted in its brain which allow a human to remotely control the direction of movement of the animal. It seems to us that changing the nature of animal by conventional means, such as selective breeding, should be judged on the same grounds as making the same change using GM.

65. Thinking about modification of animal behaviour raises difficult and complex issues. It is right in principle that decision-making about what may be done to animals should take account of the view that there can be intrinsic objections to certain fundamental changes to an animal’s nature. Otherwise, it might be thought that absolutely anything is permissible, in any circumstances, in relation to the creation of new strains of animal, whether by genetic modification or by other means.

Cloning

66. Cloning of adult animals is something that has only become possible through modern biotechnology. Unlike other examples cited above, the same result could not be achieved through conventional techniques. There are welfare considerations at present associated with the procedures for production of cloned animals (see below).

67. There is a question of whether cloning causes surviving animals to have inherent defects which impinge on their welfare. Professor Ian Wilmut, the leader of the team that cloned Dolly, the cloned sheep which developed arthritis at a relatively young age, has stated that 'it is not possible to know if her condition is in any way a result of her being a clone. However, this occurrence emphasises the need to monitor the health of a considerable number of clones throughout their expected life span to discover if any conditions normally associated with age develop in unusually young animals.' In its assessment of the implications of cloning farm animals, the Farm Animal Welfare Council did not rule out the use of cloning as a matter of principle but recommended that there should be adequate post-commercialisation monitoring of cloned animals for any unforeseen welfare or other effects. We support this recommendation (see part 2 below).

68. The technology is capable in principle of being applied to a variety of animals for quite different purposes. A pet cat has been cloned. Sheep and goats have been cloned for pharmaceutical production, where a possible justification in terms of human benefit from the production of new medicines, and economic activity, ought to be fairly obvious.

69. The purpose matters. This is illustrated by the recommendation of the Animal Procedures Committee (APC) that ‘no licences should be issued for trivial objectives, such as the creation or duplication of favourite pets, or of animals intended as toys, fashion accessories or the like, and the Home Office should consider the motives and character of would-be licensees’. The conclusion reached by the APC is that replacing your favourite pet is not sufficient justification for embarking on a cloning programme, even though cloning may not be considered to violate an animal's nature in the same way as some other changes, for example, reduced sentience.

70. In the future, if no or minimal welfare considerations applied because cloning of a particular species had become more efficient, some may argue that cloning of pets should be allowed, on the grounds that it is not morally so different from other practices with pets. It seems likely that the cloning of pets at that point would be considered in the context of other permitted practices, including selective breeding.

Speed and nature of change made possible by genetic modification

71. Does the potential speed of change make a difference? It seems to be an important feature of public concerns. It is certainly the case that genetic modification – and, in a different way, cloning – seem likely to have the potential to produce very rapid changes to animals. Genetically modifying salmon to grow three times as fast is a dramatic change. Less dramatic, but still remarkable, are the increases in growth rate of chickens achieved through selective breeding in recent decades.

72. Our research suggested that the potential speed itself with which GM could make significant changes to animals causes unease. When combined with the potentially dramatic nature of some changes, particularly the insertion of genetic material from one species of animal or a plant to another, concerns for the integrity of animals and for their welfare, and worries about nature ‘biting back’ in some way - particularly in relation to animals consumed by people - this concern would seem to be reinforced.

73. The potential speed of a particular technological development is not usually thought to be necessarily a reason for not pressing quickly ahead. Mobile phones are an example where there are probably fewer concerns about the pace of change. But this technology differs from applying GM or cloning to animals because they do not involve living beings, with the attendant welfare considerations and respect for other living creatures' integrity. There are also not the same potential impacts on ecosystems as could occur with animals. These things make concern about the pace of change more appropriate in relation to modern biotechnology.

Welfare implications of procedures for generating GM and cloned animals

74. Development of GM animals by random incorporation of the transgene following microinjection and in vitro culture or both is relatively inefficient. Production of cloned mammals by nuclear transfer leads in some species of animal to a high degree of embryo mortality and foetal abnormality. Several associated procedures with both techniques, such as the use of vasectomised males, Caesarean section and other surgery have animal welfare implications. Although some conventional selective breeding also relies on the latter techniques, they are used to a comparatively greater extent in the production of GM and cloned animals. GM and cloning procedures, therefore, can have animal welfare implications. The practical difficulties arising from the unpredictability at present of GM and cloning is also a limiting factor on the usefulness of the techniques.

75. Other kinds of breeding can also have welfare implications. For example, another relatively novel technique, the use of implanted embryos in cattle breeding, has led to some cows giving birth to a different breed of calf which is larger than the maternal breed’s normal offspring. This has had the effect of increasing the number of caesarean births in cattle. Veterinary surgeons noticed this trend and there are now embryo transfer regulations in place. Also, conventional breeding of livestock in modern agriculture can involve considerable strains on animals.

76. Generation of farm animals by GM or cloning has animal welfare implications. If and when the techniques become more efficient for mammals, the welfare implications of GM and cloning may become less of a concern. For now, the welfare implications of GM and cloning techniques certainly should be taken into account in decision-making, but conventional animal generation can have welfare implications too, which equally should be taken into account.

Welfare implications of the outcomes of breeding programmes

77. In terms of the outcome for the animals themselves, the issues raised by conventional selective breeding and GM and cloning programmes bear comaprison. Some selective breeding processes have led to major changes in the characteristics of some species of farm animals (and pets). Some of these changes have led to negative consequences for the animals themselves, for example congenital weaknesses in some specialised pet dog breeds.

78. It may also be the case that undesired effects for producers could arise from selective breeding. For example, DEFRA have in place a programme of research to investigate the causes of the steady decline in the fertility of the dairy and pig herds. The causes of infertility appear to be related to increased growth and performance of livestock but are not understood at present.

79. The generation of more productive farm animals illustrates the comparability of conventional and modern biotechnological techniques. Conventional selective breeding has already produced some animals that grow much faster or are otherwise more productive than their ancestors in previous decades. Marker-assisted breeding could allow the process of selective breeding to take place more quickly. It may also prove possible to use genetic modification to produce higher-yielding animals.

80. If marginal welfare problems arise from generating a faster-growing or otherwise more productive farm animal, then these would need to be considered alongside other factors, including economic interests and other factors, such as environmental effects. If the welfare problems were great, then that might override other considerations. The welfare implications for faster-growing farm animals resulting from the application of each of conventional techniques and of GM and cloning are not different in kind. In each case, the benefits and problems would have to be weighed up.

81. We would not want to lose sight of the benefits which selective breeding can and has brought to livestock production. Other selective breeding programmes can be beneficial to animals as well as producers: such as breeding in greater disease resistance for example: work is underway to try to select for resistance to mastitis in dairy cows, for example (GM research is also underway with the same goal). The result of many breeding programmes has been in part to produce cheaper and more plentiful meat. In principle selective breeding could be used to help correct welfare problems in future generations.

82. In order to realise such benefits, however, breeding companies need to make sufficient information available to farmers about benefits not directly related to productivity. Where such benefits - such as health or improved welfare - are economically beneficial, this should be highlighted, so that farmers will be encouraged to take these into consideration. The wider issue of how to reconcile such benefits with the tendency for productivity improvements to drive developments needs to be looked at if greater account is to be taken of benefits to health or welfare which do not offer direct productivity gains.

83. In summary, GM, cloning and conventional techniques could lead to either desirable, or undesirable, outcomes in relation to farm animal welfare. As noted earlier, cloning in particular needs to be monitored in this regard.

Justifications

84. We do not believe that the use of GM and cloning is in itself the key factor for determining public acceptability of particular applications. The justification for a particular application is of paramount importance, although where people have concerns about GM and cloning, then these would need to be dealt with in a way which conventional techniques might not.

85. To return to the theoretical examples considered earlier, interference with an animal’s normal behaviour may be considered at first sight intrinsically objectionable and impermissible regardless of the putative benefits. But the precise circumstances and intention behind the production of a fundamentally altered animal need to be carefully considered. It may widely be considered inherently objectionable to create a new line of GM pigs or GM cows with reduced sentience for agricultural production. But the production in the laboratory of a small number of animals which suffer reduced sentience or some other deleterious consequence as an effect of knocking out a gene as part of a research programme intended to improve understanding of gene function, may be considered differently.

86. Understanding the links between gene function and behaviour is at an early stage so it may be that any such effects are unexpected. But whether expected or not, the intent here would not be to produce a line of ‘debilitated’ animals as such. Rather, the debilitation would be a consequence of the knock-out procedure, which was itself being carried out for medical research. The modified animals would not be produced or perpetuated outside the confines of the experimental procedure. Other factors, such as having procedures in place to humanely alleviate any welfare problems that arise for the animals within the procedure, would also be relevant. A procedure that produces effects considered intrinsically objectionable in one context - production of a line of farm animals or a cat with a reduced hunting instinct - therefore, may not be considered absolutely impermissible in another context.

87. The justification for undertaking the procedure is the critical consideration. Our social research suggests that people are likely to look carefully at the justification for the use of the technology (and who is making the justification) in arriving at judgments about the acceptability of particular procedures. The example above of reduced sentience also suggests that it is important in thinking about GM and cloning, a broad view should be taken of what is going on in the fields of research, farm animals and pets to ensure a consistent approach.

88. GM and cloning and an enhanced understanding of the human genome seem likely to offer a succession of new opportunities for creation of products, such as functional foods or 'lifestyle' pharmaceutical products produced using biopharming (or by other means). Some new possibilities of this sort, which may be developed using GM animals in production or testing, would straddle the boundary between medical and other kinds of perceived benefit. Given this, the justification for the use of GM animals in producing them seems likely to be quite complex. The genetic modification of livestock to have lower fat content or some other perceived health benefit also would seem likely to raise potentially new issues of the grounds on which the activity with animal might be justified. Future developments in GM and cloning may therefore add new complexity to questions of justification in some aspects of society's relationships with animals. It would be better to consider the questions posed by such possible future developments ahead of time. In Part 2 we recommend that a new strategic advisory body could usefully consider these and similar issues.

Conclusions

89. As our social research indicated, some people do believe that applying GM and cloning to animals represents a fundamental change in our relationship with animals. On this understanding, GM and cloning require a special sort of justification on ethical and other grounds. Others disagree, seeing GM and cloning as essentially an extension of existing practices relating to animals. Both views, broadly, are represented in the AEBC. We have a range of views, too, about the desirability of applying the technology in agriculture and elsewhere. There are also different views about the significance of emerging trends in the numbers of GM and cloned animals which may be generated for use for various purposes in society, and the value of the purposes for which these animals are being used, in research and elsewhere, or may be used in the future. The different positions are sincerely and strongly held.

90. We can agree, however, on a number of points for the purposes of this examination of the regulatory system for GM and cloned animals, and in particularly the implications for agriculture and the environment. Commercial production of GM fish and release of GM insects would raise particular environmental concerns which would need to be addressed. Commercialisation of GM or cloned livestock would seem likely at present to give rise to consumer choice issues. The procedures for applying GM and cloning, which are relatively inefficient, can adversely affect animal welfare, as can conventional practices. In terms of the animals produced, in each case there can be negative or positive results for animal welfare. Some potential changes to animals, by whatever means, are fundamentally objectionable. These issues need to be considered and dealt with in the regulatory system. The practical differences between modern biotechnology and conventional practices are not such as to suggest that GM or cloned animals should be governed separately in every aspect from conventional animals in the regulatory system.

91. It makes sense also to consider GM and cloning in the context of society's wider relationships with animals. But questions in relation to GM and cloning are more urgent and sensitive because of the speed and nature of changes to animals made possible by modern biotechnology, and the issues of concern and in some cases principle, that GM and cloning give rise to for some people. Conventional practices relating to animals should be justifiable and so should GM and cloning. In view of public concerns, we believe that it is right to focus on the use of GM and cloning. Justification for their use needs to be as transparent as possible and the reasons for its use assessable by the public. This is of paramount importance for the regulatory system. The important corollary is that the application of conventional technologies to animals also should be closely scrutinised.

PART 2 THE REGULATORY FRAMEWORK

PART 2.1 GUIDING PRINCIPLES FOR REGULATION

92. We now look at the regulatory system in the light of our conclusions in part 1. A detailed description of the system is at Annex A. Is it capable of dealing with all the relevant factors for decision-making? Is it enforceable and coherent? Is the public likely to have faith in the system as developments continue in the field of animals and biotechnology? Focussing on agriculture and the environment, we now look at the different components of the system: legislation, advisory bodies, and the interpretation and implementation of regulations.

Principles of good regulation

93. The Better Regulation Task Force (BRTF) have set out five principles of better regulation, which enjoy wide acceptance. We have sought to look at the present system of legislation, regulatory and advisory bodies in the light of these principles. The BRTF principles are that good regulation should be:

transparent: legislation must be easy to understand with aims written in clear and simple language;

accountable: people who develop new legislation should answer to Ministers and Parliament, and the public;

targeted: legislation should focus on the problems and reduce side effects to a minimum;

consistent: new regulation should be consistent with regulation that is already in place and should be predictable; and

proportionate: the effect the rules will have on people should be identified and the right balance between risk and cost must be found.

General

94. In 1999, MORI found that 'The vast majority of the public (97%) believes that it is important that there are rules and regulations in place to control biological developments and scientific research, and as many as 88% believe this is very important.' This, MORI stated, is a high figure for responses in the ‘very important’ category. People want a robust system.

95. The basic historical driver for regulation of activities involving animals in the United Kingdom was to prevent unnecessary suffering to animals used for business or pleasure, a principle which was enshrined in the early part of this century in the Protection of Animals Act (1911). As noted in the Banner report, the present regulatory framework is founded on the premise that the uses of animals as livestock or in research or as pets is legitimate, subject to that use being humane.

96. The principal relevant factors in relation to society’s existing relationships with animals include: benefit to society at large (for example, through medical research); particular economic interests (of producers and consumers); animal welfare; environmental considerations; human health (especially in relation to farm animals produced for human consumption); and the public acceptability of particular developments in society's relationships with animals. The relevance and weight of these different factors will vary according to the nature of the relationship with the animal. The regulatory system should reflect this, but in a targeted way, focusing on preventing problems, including unjustified reductions in animal welfare.

GM and cloning in the regulatory system

97. At present, all GM and cloned animals in Britain are covered by the Animals (Scientific Procedures) Act 1986 (A(SP)A), because they are considered to be subject to experimental procedures. A(SP)A requires tight regulation of experimentation on these animals, and careful justification of procedures to be carried out on them. There is already, therefore, a requirement to justify the initial generation of individual GM and cloned farm (and other) animals, as part of the general requirement to justify an experimental procedure.

98. If and when GM or cloned animals enter production on the farm, however, then they would have been released by the Home Office from the provisions of A(SP)A. They would, like conventional animals, be governed by the same regulatory framework as non-research animals. We believe that it is desirable that GM and cloned animals should be governed post-commercial release by the same legislation as conventional animals. It makes no sense to consider the issues raised by any commercialisation of farm animals (or indeed pets) created using GM and cloning in isolation from the breeding and management of animals by conventional means. To do so would run the risk of incoherence. 99. Nonetheless there is a need for adequate monitoring of the long term stability and welfare of cloned and GM farm animals, if and when they enter conventional production. And consumer choice issues will need to be addressed. There will be a need to look very carefully at the environmental impact of any deliberate release of GM fish, and GM insects. We do not believe that GM or cloned farm (or other) animals require a separate regulatory system as a matter of principle on grounds of animal welfare or for other reasons.

Recommendation: GM, cloned and conventional animals should be governed by the same regulations wherever possible.

PART 2.2 LEGISLATION

General animal welfare legislation

100. The existing foundation piece of legislation for general animal welfare, the Protection of Animals Act 1911 (in Scotland the Protection of Animals (Scotland) Act 1912), applies to GM, cloned and conventional animals, on the farm or elsewhere. We concluded early on that the 1911 Act should be updated, both to take account of modern biotechnology and more generally. The 1911 Act focuses on a relatively narrow range of practices, some of which, such as the use of dogs for carriage are no longer contemporary; and the notion of unnecessary suffering requires explication. Practice and attitudes in society have changed since the Act. For example, the provisions in the Breeding Dogs (Welfare) Act 1999 of provisions for a minimum age and limit on the number of litters that a bitch can be expected to bear. It also seemed to us desirable to consolidate and simplify the plethora of different pieces of animal welfare legislation, not least to make the legislative framework more intelligible. We accordingly welcomed the launch by DEFRA earlier this year of a review of the 1911 Act and related general animal welfare legislation. For the same reasons, we would welcome a review in Scotland of the 1912 Act.

101. Recent animal welfare legislation in Sweden and Germany takes account of the possibility that selection and breeding procedures can result in poor animal welfare. This is not something covered in the 1911 Act, which does not address incremental man-made changes to an animal species which have welfare implications. The provision in the Welfare of Farmed Animals (England) Regulations 2000 that 'no animals shall be kept for farming purposes unless it can be reasonably expected, on the basis of their genotype or phenotype, that they can be kept without detrimental effect on their health or welfare' potentially goes some way towards recognising this problem, although how in practice this provision will be given effect remains to be seen. Animals could be produced with a genotype phenotype which causes unacceptable welfare problems by GM and cloning or through conventional or marker-assisted breeding. We believe this provision should be borne in mind in the revision of the 1911 Act and of general animal welfare legislation.

102. There will be other factors that Government will no doubt wish to consider as part of the review. For example, whether there ought to be a positive duty on people to ensure the welfare of animals for which they are responsible, something that is a feature of the Welfare of Farmed Animals (England) Regulations 2000 and the equivalent legislation in Scotland, Wales and Northern Ireland. The extent to which wild animals should be brought within the ambit of the legislation is another issue. The provisions for enforcement of the legislation must also be borne in mind alongside any changes to the Act. Modernising the Act and consolidating associated regulation will not of itself improve animal welfare. The pressures on farmers to increase productivity mean that developments in relation to farm animals tend to be driven by this factor rather than other considerations, such as animal welfare. This needs to be taken into consideration.

Recommendation: The 1911 Protection of Animals Act should be updated and the piecemeal general animal welfare legislation should be consolidated.

GM farm animals

103. We are satisfied that the law relating to farm animals is in principle adequate to meet concerns about GM farm animals which suffer reduced welfare or health problems (through the Welfare of Farmed Animals regulations ) or which give rise to unacceptable human health or environmental risks (through the Deliberate Release Directive). Collectively, the legislation covers those factors that could give rise to concern. We believe, however, that there may be a potential gap in the legislation in relation to the case - at present hypothetical - of a GM or conventional farm animals, the generation of which might be judged intrinsically objectionable but which do not give rise to clear animal welfare, animal or human health or environmental concerns.

104. How might this situation arise? The Animal Procedures Committee has already recommended that if someone were to seek to genetically modify an animal with the intention of stripping it of its biological integrity or rendering it incurably insentient, no licence should be given. So development of such intrinsically objectionable animals in the UK with the ultimate object of commercial agricultural production is unlikely to be given approval. It is conceivable, however, that such an animal could be created abroad and imported for commercial use into the UK. If such an animal had been produced using genetic modification, it is unclear whether the Deliberate Release Directive, which is concerned with human health and environmental concerns, could be used to prevent release on broader ethical grounds. If the animal did not suffer health or welfare problems, it is not clear whether there is provision in existing UK farm animal or general animal welfare legislation to prevent such animals being used in agriculture in the UK, were it be decided that such use should be prevented. This also would seem to hold true for a conventional similarly intrinsically objectionable animal.

105. This apparent gap should be examined by Government in case any such examples arise. It seems unlikely that many examples of such animals will be produced, given the effort and expense needed to successfully complete a GM or conventional breeding programme, or that there would be much appetite among producers to commercially keep such animals. But it is worth addressing the issue, not least because if no such provision was available, the introduction of an intrinsically objectionable case could have a severe knock-on effect on public attitudes to other biotechnology developments.

106. The regulatory system is perhaps more likely to face far less black and white cases than clearly intrinsically objectionable developments. Greyer cases, which push at but do not necessarily breach the boundaries of what most people think is acceptable, are difficult to deal with, especially incremental developments. People might be inclined to object to a particular outcome of the breeding of one kind of animal which over time, combined with other changes to the animal, may lead to positive benefits for the animal or society which people would welcome. Alternatively, each step in changing an animal's characteristics for commercial agricultural production (or in some other context) may not itself be clearly objectionable. But the cumulative effect over time may be negative for that sort of animal (for example a shortened natural life span or an increased rate of embryo loss) or for the environment and lead to public concern at the end result. Incremental shifting of ethical boundaries is normal in society, and should be reflected in how the regulatory system works. What is required in relation to animals and biotechnology is the capacity in the regulatory system for independent scrutiny of the complex and difficult cases, especially incremental changes to farm animals, taking a strategic and long-term look at developments, informed by information about public attitudes. We go on to recommend a new strategic body to provide that capacity. There also needs to be provision in law for intervention where that is judged necessary.

Recommendation: Identify and clarify if necessary regulatory provision to deal with any intrinsically objectionable farm animals.

Cloned farm animals

107. There is a potential regulatory gap in relation to cloned farm animals to which FAWC drew attention in their 1998 Report on Cloning. At present, because the cloning is being carried out for scientific and experimental purposes, cloned animals fall within the scope of A(SP)A. But that could change because A(SP)A specifically excludes procedures which are ‘recognised veterinary, agricultural or animal husbandry practice’. Thus the cloning of animals, if it became routinely used in agriculture, would fall outside A(SP)A, although aspects of it might be regulated by the professional veterinary societies.

108. Before considering discharge of a GM or cloned animal from A(SP)A, the Home Office would require as a minimum welfare records for two generations of animals living a full lifespan. As we noted above it would also be important to continue to assess if and when cloned animals are commercialised whether there are longer-term welfare problems caused by cloning, particularly in a commercial agricultural environment.

109. We therefore endorse FAWC’s recommendation that particular consideration is given to ensuring that cloned agricultural animals continue to enjoy similar protection to research animals, at least until, as FAWC recommended, the point at which the effects of the cloning and any associated genetic manipulation have been scientifically evaluated in the environment of commercial agricultural practice.

110. Were cloning of pets or other animals for commercial production ever to be approved, we believe similar considerations should apply.

Recommendation: If cloned or GM farm animals enter commercial agricultural production, there should be adequate post-commercialisation monitoring for any unanticipated welfare or other effects.

Environment, human health and consumer choice

111. The Contained Use and Deliberate Release regulations are concerned variously with protection of human health and safety and protection of the environment in relation to GM organisms. Revised regulations about deliberate release into the environment of GM organisms, giving effect to the European Directive EC/2001/18, have been the subject of a public consultation exercise by DEFRA and the devolved administrations, and are due to come into force in October 2002. We have not come across any specific new issues for these regulations in looking at prospective applications of GM to farm (or other) animals. But we have noted that the present regulations and associated risk assessments are focussed on plants rather than animals. Were greater numbers of GM animals to enter experimental use outside the laboratory, the terms of the regulations and the nature of the risk assessments should be reviewed to check that they adequately cover all the necessary areas.

112. In the case of GM fish and GM insects, protection of the environment will be a serious and potentially difficult issue for Government. Environmental concerns about the unintended or intended release of such faster-growing fish into the natural marine environment which might lead to these fish competing with or having unintended negative consequences for native wild species are likely to be very important in considering what sort of regulation may be necessary. There is currently widespread scientific opposition to the commercialisation in sea pens of GM fish. The Royal Society of Canada has called for a moratorium on rearing GM fish in aquatic net pens and for approval for commercial production to be conditional on production taking place in land-locked facilities. The Royal Society has endorsed this. It is difficult to see how the spread of the released GM fish through suitable marine habitats could be controlled. Any predicted effects on native fish stocks could have economic consequences also.

113. The Advisory Committee on Releases to the Environment have published a case study setting out the factors which they would expect to take into account in making decisions about commercialisation of GM fish in the UK. Our social research suggests that there could well be significant public concern about the consequences of producing faster-growing GM fish. In addition to environmental impact, any health or welfare implications for fish that have been genetically modified to grow faster for the purpose of improved productivity should be assessed.

Recommendation: There should be a moratorium on the commercial production of GM fish in aquatic net pens unless and until concerns about fish escaping into the wild have been removed.

114. Any environmental issues, including implications for genetic diversity in livestock, of the large-scale commercial (Part 'C') release of GM or cloned animals should also need to be addressed prior to deliberate release. The new directive on deliberate release (EC/2001/18) makes provision for assessment of long-term effects.

115. Wider issues of public acceptability and consumer choice would also need to be taken into account if and when commercialisation went ahead if, as seems likely at present, there would be a desire on the part of many consumers to able to choose between GM and non-GM livestock.

Recommendation: Government should consider what arrangements would be necessary to maintain consumer choice were GM and cloned animals to enter commercial agricultural production.

Import of GM and cloned animals

116. The APC report on biotechnology drew attention to a potential gap in relation to the monitoring of the welfare of GM animals imported into the UK. At present, the acquisition and use of GM and cloned animals after import is licensed by the Home Office. If such animals were not to be used for a scientific or experimental procedure, however, then they would not be subject to A(SP)A and the welfare monitoring provided for in the Act.

117. If a GM farm (or other) animal had received 'Part C' marketing consent in the EU because it was being imported for commercial use there would not be a problem provided that the granting of Part C consent had taken into full account any welfare issues relating to particular strains of animals. It is not clear that there is provision in the Deliberate Release Directive to do so, because the Directive is concerned with human health and the environment. We believe that welfare and other relevant considerations must be dealt with before Part C consent were given, in addition to any environmental and human health considerations. For cloned animals, which are not considered to be covered by the deliberate release regulations, it would be necessary for the cloned farm animal to be identified as such so that a suitable post-commercialisation monitoring regime could be put in place.

118. In advance of any GM animal receiving Part C approval, the animal would be required to be suitably contained under the deliberate release regulations. It ought in principle, therefore, to be possible to monitor any such animals, even if they were not being brought in for experimental or other scientific purposes. It would be worth thinking through now how best that might be done in advance of the time when an animal of this kind might be imported for non-experimental purposes but before the animal had been released for commercialisation.

119. There is a further question: might such animals be smuggled into the UK? This could cause a problem with regard to consumer choice in relation to animals for human consumption; monitoring of the welfare of cloned animals; and in relation to environmental impact. In practice, it seems unlikely that smuggling is likely to become a major issue in the immediate future, because the vast majority of such animals are being used for experimental purposes, and it is unlikely that the establishments using GM animals for experimental purposes would risk failing to obtain a Home Office licence for the acquisition and use of the imported animals, just as is required for animals generated in the UK. It also seems unlikely at the present time that the relatively small number of high-value GM or cloned animals used in biopharming or agriculture are likely to be the subject of smuggling: the animals are too valuable to the producers. This is just as well, because it is hard to imagine how the regulatory system would deal with trying to identify a smuggled or GM animal, at a port of entry. One could not assess by inspection whether a pig, let alone an embryo, had been genetically modified.

120. When importing an animal from outside the EU, it is not possible to know that it has been genetically modified unless the exporting country informs the relevant EU Border Inspection Post responsible for examining imported animals (which could be in any Member State). Should the UK be the importing country, the enforcing agency would be the State Veterinary Service, whose principal concern in relation to imports at present is examination of animal health. There is at present no requirement for the export certificate to state whether animals or embryos have been genetically modified or cloned.

121. If cloned or GM animals became more widespread, therefore, then an international system for tracking them would seem to be the only practicable regime. The Cartagena Protocol on Biodiversity provides an international framework for GM organisms to require exporters to seek prior consent from importing countries. Thought should be given to tracking cloned animals also. In the case of farm animals for human consumption EU labelling and traceability requirements would be expected to provide the necessary safeguards.

122. No international system will, however, be able to guard completely against the adventitious or deliberate spreading of some GM animals, particularly fish or insects, released into the environment in one part of the world and brought into the UK. This has occurred many times through history with conventional foreign species which have been introduced into a different eco-system.

123. Smuggling of fish or insects would seem likely to pose a greater threat than mammals. The fact that some fish move around the world’s oceans means that regulation in this area is a trans-national issue. International monitoring of the movement of GM and cloned animals (and other GM organisms) seems the most likely solution to address the monitoring of welfare and to help guard against adverse environmental impacts of release of particular GM animals in particular ecosystems. The arrangements envisaged in the Cartagena Protocol should be developed sufficiently ahead of time before any production and trade in GM or cloned animals becomes widespread. There will need to continue to be support from developed countries to build capacity in developing countries relating to questions of deliberate release into the environment of GM organisms and to monitor their production and export if and when that occurs.

Recommendation: Adequate arrangements should be developed for monitoring the international movement of GM and cloned animals.

Research animals

124. The vast majority of animals under the aegis of A(SP)A are used for non-agricultural research and do not raise particular environmental concerns because they are kept in laboratories. We have noted that the generation of all new GM and cloned animals would require a licence under the Act, so there is in principle scope for effective regulatory oversight of the production in research of new GM and cloned farm animals. But we have not looked in detail at the quality of the decision-making process under A(SP)A and within the Animal Procedures Committee (APC), the statutory advisory body set up under the Act, as this falls outside our remit. We note that the House of Lords Select Committee on Animals in Scientific Procedures, on the other hand, has been examining the operation of A(SP)A.

125. The overall number of GM animals used in research has been raised as a concern in some quarters. In recent years the total number of animals used in research has tended to decline. But the number of GM animals is rising steeply and is set to reverse the overall decline in numbers. The legislation requires that the numbers of animals used in individual procedures should be minimised. It has no concern, however, with the overall effect of new technologies on the numbers of animals used in research. The House of Lords inquiry may look at tends in numbers of GM animals. The new strategic advisory body we propose below could be another candidate to consider this issue.

PART 2.3 ADVISORY BODIES

Farm animals

126. The Farm Animal Welfare Council (FAWC) is the independent advisory body concerned with farm animal welfare in England, Scotland and Wales. It is charged with keeping under review the welfare of farm animals on agricultural land, at market, in transit and at the place of slaughter; and to advise the Government of any legislative or other changes that may be necessary. The evidence we have heard from industry and Government suggests that FAWC’s good links to the agricultural industry are useful. They ensure that the economic requirements of UK producers are taken into account in drawing up their advice, which is necessary if recommendations are to be realistic.

127. We have been concerned to learn that Government has not always responded quickly (or sometimes at all) to the reports of the Farm Animal Welfare Council (FAWC). At present FAWC is awaiting responses to two reports it made in 1998, on Broiler Breeders and Cloning respectively. They have received only partial responses to the Reports on Laying Hens (1997), Dairy Cattle (1997) and Enforcement of Animal Welfare Legislation (1999). To add to the list, FAWC has produced a further two reports in 2001 and one in 2002. The high number of reports not yet responded to would appear to be partly due to resource constraints in the relevant division of MAFF (now DEFRA) and partly the complexity of some of the issues FAWC raises. DEFRA officials have told us that they are committed to improving the response rate. This is important. The failure of Government even to respond to the recommendations, of one of its advisory bodies will not inspire public confidence in the regulatory system. This was a point that was made to us strongly by members of our public reference group.

128. In addition to improving the response rate to FAWC reports, and ensuring Government might usefully send a public signal about the importance it attaches to receiving, and giving proper consideration to, independent advice about farm animal welfare. It could do so by making FAWC a statutory body. Making FAWC statutory in itself would not improve farm animal welfare, nor should it change the functioning of the Council. FAWC's terms of reference should stay the same, as should its present freedom to set its own priorities for its workplan. Rather, it would be a symbolic act, as part of a bolstering of the priority given to farm animal welfare.

129. Some of the respondents we consulted from non-governmental animal welfare organisations expressed concern that FAWC did not have sufficient teeth. FAWC is an advisory, not a regulatory body. It is simply not in a position to undertake the huge operational job of enforcing farm animal welfare standards, nor could it be. That is the responsibility of others. We believe that there is a case for reviewing the enforcement of existing farm animal legislation, and we recommend this in part 2.4 below.

130. Livestock farming has environmental implications. The Environment Agency, the Scottish Environmental Protection Agency, the Sustainable Development Commission the Royal Commission on Environmental Pollution, English Nature, the Countryside Council for Wales, Scottish Natural Heritage and the Joint Nature Conservation Committee variously regulate, advise and work with rural communities in relation to the natural environment, including the impact of agricultural practices. Consideration of any environmental impacts of applications of GM and cloning to farm animals is outside FAWC’s remit. We see the benefit in environmental advisory bodies concentrating on the environment and FAWC retaining its focus on farm animal welfare in the context of a viable livestock industry. But we also see benefit in having a forum where the environmental, industry and welfare interests can be considered together as and when necessary: one reason for our recommendation below for a new strategic advisory body.

131. The recommendation of the Policy Commission on the Future of Food and Farming for England that the present Red Tractor assurance scheme should be extended to cover environmental standards and that welfare standards should be reviewed is relevant here. The Food Standards Agency is undertaking a review of food and farm assurance schemes. These schemes are designed to assure consumers that food has been produced in accordance with certain standards. FAWC have made an interim report on such schemes. As the Policy Commission said, a revamped scheme of this sort could offer farmers recognition of good practice in relation to food safety, animal welfare, hygiene, agriculture and the environment. The system, which has been adopted in Sweden, which ties incentive payments to the livestock industries for, improved welfare bears examination in this context, and we welcome FAWC's intention to look at this further.

132. The devolved administrations have undertaken different studies into the future of agriculture in their respective areas. We hope that they will take into account similar considerations. If the UK Government accept the Policy Commission's recommendation we would expect FAWC, working closely with industry, environmental regulatory bodies, the Food Standards Agency to give independent advice on a revised baseline farm assurance scheme. It would also be possible for FAWC to work on these issues with comparable bodies in Scotland and Wales.

Release into the environment of GM animals

133. The Advisory Committee on Releases to the Environment (ACRE) has already considered the environmental implications of questions of release of GM fish. In a statement about GM animals made to the AEBC in July 2001, ACRE reported that it strives to be proactive in thinking about future release applications. One of its working groups will consider GM animals and produce guidance on where the boundaries lie between contained use and deliberate release. ACRE has not had to deal to date with applications for the deliberate release of GM animals. If and when it had to do so, it would seek an expert opinion where it did not have sufficient expertise among the present Committee membership and look to have its membership adjusted as required if there were an increasing number of applications for GM animal release. We welcome all this. The issue of the potential cost of environmental effects caused by the use of GM animals was flagged up by the APC in their report on biotechnology. We believe that this is important as part of the decision-making process and that ACRE is best placed to assess the potential environmental effects of GM animal release. We would expect Government to take into account ACRE's advice on the environmental impact of the deliberate release of a GM farm (or other) animal.

Other advisory bodies

134. In line with our terms of reference, we have concentrated on issues for agriculture and the environment. But because developments in research may have implications for agriculture; and because possible developments in GM and cloning with farm animals need to be viewed in the context of developments with pets, sporting and other animals, we also cover briefly below some issues in relation to other animal advisory bodies.

Pets

135. The application of GM and cloning to pets (‘companion animals’) is outside the terms of reference of the AEBC, not least because it does not raise any environmental issues. But selective breeding has been applied to both pets and agricultural animals and so is GM and cloning. Moreover, the lucrative pet market could drive research priorities in modern biotechnology, with wider implications (see part 1.3). By way of illustration, some aspects of human in vitro fertilisation research, such as applying the technology to much older women, has been driven by private funding.

136. Given our remit, our conclusions in this area are accordingly tentative. We believe first that it is important that the implications of prospective applications of GM and cloning to pets are assessed strategically alongside developments in research and agriculture. We also believe that serious consideration should be given to affording the welfare of pets - with which society has a different relationship from farm animals - the same sort of independent consideration as FAWC is set up to do in relation to farm animals. We believe there is a good case for Government making the Companion Animal Welfare Council (CAWC) an official body, reporting to Government and being funded by Government. We suggest that CAWC should remain separate from FAWC because the interests, including commercial and other issues connected with pets, are sufficiently different from farm animals, particularly in relation to the economics of food production, which obviously are irrelevant in relation to pets. As CAWC is at a much earlier stage of operation than FAWC, we suggest that CAWC need not be made a statutory body at this stage. As CAWC develops, it could become appropriate to change this.

Animals in research

137. For the reasons set out earlier, we have not explored the way in which the law is interpreted and applied, only the extent to which it could in principle cover issues relating to biotechnology in agriculture and the environment. It is clear, however, that the way in which the law in relation to research is interpreted and applied will be key to the public acceptability, or otherwise, of the use of biotechnology in non-research environments. The Animal Procedures Committee (APC) will therefore need to command public confidence in the approach it adopts. This means it must be in touch with public sensibilities to animal uses and sensitive to them in its deliberations. It will also need to as transparent and open as possible in its workings.

138. The APC has considered recently the question of greater openness about animal experimental procedures, concluding that 'total openness, as supported by a number of individuals and animal protection organisation' responses [to an APC consultation] is not practical, chiefly because of concerns in relation to personal security, but also because of issues about commercial confidentiality.' The APC's 'aim, however, has been to recommend measures which will lead to the greatest degree of openness compatible with those concerns.' This is a difficult area, but we would add our encouragement to the Home Office and APC to pursue this goal, because the data we have on public attitudes to GM and cloning and the regulatory system more generally suggests the importance of making transparent the justifications for applications of the technology to animals. Our social research suggests that people feel somewhat in the dark in relation to what is going on in research using biotechnology and animals and this will affect their attitudes to biotechnology and animals more generally..

139. The APC reported in 2001 on modern biotechnology.

Other animals

140. The breeding of racehorses and greyhounds are subject to rules set by industry bodies. Retired sporting animals might be classed as companion animals but careful thought would be needed, however, about the extent to which sporting animals should be included in the advisory framework for animals. Sporting animals do not fall obviously within our remit and we have accordingly not considered this area in further detail.

Use of novel products on animals

141. The Animal Procedures Committee’s report on biotechnology drew attention to a concern about the implications for animal welfare of the application of products derived from genetically modified organisms (GMOs) to animals. If these substances were administered to animals for scientific or other experimental purposes A(SP)A would apply, but not if they were administered as part of recognised veterinary practice or husbandry procedures. An example of this is recombinant bovine somatotrophin (BST), which is designed to promote increased milk yield in cows. BST has been banned in the EU on human health and animal welfare grounds, although its use is widespread in the US. A similar technology is being developed aimed at increasing piglets’ weight at two months by 40 percent as a result of injecting them at three weeks of age with ‘a package of DNA that boost the production of the pig’s natural growth hormone’.

142. Approval of novel veterinary products, including all GM-derived products, on farm animals is undertaken at EU level. The example of BST suggests that the EU is likely to take into account welfare considerations as well as food safety in coming to conclusions about the use of these products. The Veterinary Products Committee (VPC) is the advisory body in the UK that deals with welfare issues in this context. It is important that animal welfare, as well as human and animal health and environmental considerations continue to be taken into account in assessing novel products for approval and that the VPC continues to monitor that this happens. Government will also wish to consider whether novel products are likely to raise issues of consumer choice or other concerns with regard to animal products which would need to be addressed.

A new strategic advisory body

143. We have heard several calls for a new body to deal with aspects of society’s relationships with animals. The Banner report called for a new advisory standing committee to be created to take responsibility for broad ethical questions relating to current and future developments in the use of animals. FAWC recommended the establishment of a National Standing Committee to oversee the development of cloning technology.

144. We have concluded that a new strategic advisory body is needed. It has an important role to play in developing thinking on GM and cloned animals ahead of possible commercialisation. We have focussed on agriculture and the environment in this report. We see a real need in the area of agriculture for a strategic consideration of the possible applications of biotechnology to farm animals. But we believe it makes sense to consider issues around GM and cloned farm animals in the context of the application of modern biotechnology to other animals: some biotechnology applications, such as cloning, already are or could be in principle applied to farm or pets or animals in research. In order to effectively consider GM and cloned animals in agriculture, the body would need to look at developments in other aspects of society's relationships with animals. It also should view these developments in the context of conventional practices relating to farm animals, taking account of the strategic direction of livestock farming.

145. The new advisory body would be a forum for taking a holistic view of the implications of developments common to the different sectors of animals, both in relation to GM and cloning and other developments, particularly where the issues are complex and likely to be of interest to the public and stakeholders. The new body should ensure that GM and cloning applications, particularly those in agriculture and the environment, are spotlighted, to deal with the public concerns which already exist and to anticipate future ones. We believe it is vital to anticipate the likely trajectory of public concerns about the application of GM and cloning and to take a strategic look at the key conditions necessary for the public to have confidence in the system. The new body should seek to chart possible ways through these potentially difficult issues.

146. In addition, the need to provide more information and seek to build public confidence in the regulatory system was a point made to us by a range of stakeholders, including both non-governmental organisations and representatives of industry; as well as in our reference group workshops and in the Macnaghten report, and the new body should have an important role in public engagement to help achieve this; and in taking a strategic look at decision-making in relation to applying GM and cloning to farm and other animals.

Remit

147. The remit of the new strategic advisory body could include the following:

to provide strategic advice to Government about issues raised by modern biotechnology and developments in conventional practices relating to farm and other animals, taking account of the different relationships society has with animals, all relevant factors, ethical considerations, and the key conditions of public acceptability around how animals are treated;
reviewing the extent to which Government is responding to independent advice on the issues;
to seek to lead the debate in the United Kingdom, within the EU and internationally;
to greatly improve public understanding of the uses made and treatment of animals and in particular all the factors relevant to science and agriculture, spotlighting developments in modern biotechnology;
to facilitate as appropriate proper co-ordination and exchange of best practice between the advisory and enforcement organisations relating to farm and research animals and pets ;
to look ahead at scientific and commercial developments, and their implications, maintaining an international perspective; and
to enhance engagement with the public, drawing on existing best practice and developing innovative approaches.

Work topics

148. Areas the body could look at include advising on the review of the 1911 Act and related legislation; the underlying social issues relating to our relationships with animals; the implications for agriculture and for industries employing animal research and agriculture of developments in the EU and overseas and internationally; and spotting any gaps in social and scientific research in relation to society’s relationships with animals. The new body could take a periodic look at the processes of decision-making in relation to animals, particularly with regard to GM and cloned animals, to assist consistency of approach as appropriate.

149. The new body could also examine how effectively existing regulation was being interpreted and enforced in relation to animals. We see a requirement for such a review in agriculture (see our recommendation in part 2.4 below). It could also review how Government and industry respond to the existing advisory bodies' recommendations. The implications of trends in the overall numbers of GM and cloned animals could also be a subject it might look at. So could a strategic look at the likely environmental impacts of GM animals.

150. In addition, as noted earlier, consumer choice seems likely at present to be an issue if and when GM and cloned livestock entered commercial production. The use of novel products in livestock production, including GM products, may raise issues of consumer choice. Consequently, thought needs to be given now to what arrangements might need to be put in place to deal with this. This could be an area for the new strategic body to consider.

Options for a new body

151. We considered a number of possible options for a new strategic body to meet these requirements.

152. Mistrust of Government as a regulator in this area came out strongly in our public reference group workshops, and also in the social research we commissioned. To deal with this, we believe that the new strategic body should be, and be seen to be, independent from Government. Accordingly, a committee of Government officials from different departments would not fit the bill. A purely coordinating body of the three existing advisory chairs would not be sufficient for the larger job that there is to do in building public confidence in decision-making on GM and cloned animals. That said, it is important that those working in each regulatory and advisory area are sufficiently well informed of relevant developments in the other areas. The new body would be likely to facilitate the exchange of best practice, building on the present regular exchanges between the chairs of the existing advisory bodies in the Animal Welfare Advisory Bodies forum.

153. We believe that the new strategic advisory body should be set up by statute as a standing body. Statutory, because this will be symbolic of Government's intention to take issues around GM and cloned animals seriously and that it plans pay careful attention to the new body's advice. Standing, because we are at the relatively early stages of the application of modern biotechnology to farm and other animals and ongoing thinking and monitoring will be required.

154. We rejected the option of creating an overarching regulatory body with oversight of other regulators because that would be relatively disproportionate, untargeted and probably impracticable. It would not clearly add value. We do not believe that a new advisory body would lead to an unwarranted regulatory burden.

155. The existing advisory bodies would continue to report on the areas within their terms of reference. But they could turn to the new strategic body in considering some of these broader and more strategic issues. If the chairs of the existing bodies were members of the new strategic body we believe that that would also help ensure that duplication was avoided. Our public reference group at its second workshop highlighted the main dangers facing the new body as excessive bureaucracy at one end and having too wide a remit at the other. We agree that the new body must avoid both, and this arrangement should help achieve that.

Views of our public reference group

156. We tested out our conclusion that a new strategic body should be advisory rather then regulatory with our public reference group. None of the public reference group members at their third workshop, at which AEBC sub-group members presented this conclusion, initially shared our view that the body should be advisory but wanted instead a single body that would have powers independent from Government to regulate biotechnology applications to animals. The report of the workshop notes that:

'the most common, and most vehemently expressed concern was that the strategic body as proposed by the AEBC would not have regulatory powers, but would be ‘yet another’ advisory body…A purely advisory body, as they saw it, would have a ‘lack of teeth’. This perception seems to come from an ingrained assumption that advisory public bodies are simply layers of bureaucracy and government pawns, rather than independent organisations having important effects. Power is equated, in this assumption, with ‘teeth’. Participants wanted to know the exact status of existing bodies, and some idea of how much they are actually listened to. Some participants in one group compared the strategic body to OFSTED. Their ideal body would be feared, as OFSTED is, by those who came under its umbrella.'

157. Reference group members at the third workshop were also concerned that a new body should be resourced adequately, and wondered whether funding would be made available to implement its recommendations. They were further concerned that EU and WTO rules might prevent its recommendations being implemented.

158. This feedback supports the idea that we should look to the new strategic body to help the UK to take the lead in international fora in relation to developments relating to animals. It should take an international perspective and might usefully seek to build links with European counterparts and seek to lead the debate in the UK and in the EU about appropriate ways forward, recognising that it is of course always a matter for Ministers to decide ultimately whether and how to implement recommendations from advisory bodies.

159. In the course of the dialogue AEBC members had with the reference group, we explained why we did not believe that a strategic regulatory body could be justified at this stage as proportionate. To add a regulatory body on top of or to replace the existing structures would be duplicatory and certainly unwieldy. We also said that we were nonetheless convinced of the need to have a new strategic body to consider issues relating to animals, particularly relating to GM and cloning - and that there was a much better chance of gaining agreement in Government and also among some influential stakeholders in this debate if our recommendation was for an advisory and not a regulatory body. The report from the workshop notes that 'these arguments were encouraging for many participants, and caused their scepticism about creating an advisory body to subside.' However, 'the general view among participants was that the proof will be in the pudding and nothing will convince them to give whole-hearted approval until then.'

160. Despite the strongly expressed views of our reference group in favour of a new regulatory body, we remain of the view that a new regulatory body would be unwieldy. We take the concerns expressed by our reference group seriously. Their reaction strongly suggests that it is vital that Government takes seriously and is seen to take seriously the recommendations from any new and existing advisory bodies. Again, from the report of the workshop:

'The role of government was the second most common cause for questioning and concern. In particular, this focussed on a belief that governments keep information behind closed doors or disclose snippets (but only snippets) selectively as and when it suits their purposes. In addition, participants feared the body would become a government mouthpiece. Their approach to this was a ‘we’ll believe it when we see it’ approach. Around half took on board the argument that placing the new body between existing bodies and the government would simply add another new layer of bureaucracy, and acknowledged that specialist bodies must be able to communicate directly with government. However, the distrust in governments’ reliability to be free and open, that was expressed so vociferously in both July and October, was clearly borne out here in participants’ quick condemnation of the prominence of government in the proposed picture.'

161. If any new advisory body's recommendations - and those of existing advisory bodies - are not taken seriously by Government, there seems to us likely that pressure may grow for new regulatory structures in relation to GM and cloning.

Membership

162. The precise membership of the new advisory body would be a matter for Ministers in the usual way, but we believe that it should not be too large; should have a respected independent chair; have as members the three chairs of the APC, FAWC and CAWC; and have among its members or within its easy reach people with a set of skills and experience drawn from science, the biotechnology industry, veterinary and human medicine, food and farming industries, sporting and other non-agricultural animals, moral philosophy, law, economics, environment, social science, consumer interests and non-governmental organisations. The membership must give the public confidence that the body will take an independent approach and that it can look across the whole area of society’s relationships with animals.

163. Our reference group gave considerable thought at their second workshop to membership of a new body. The kinds of people they thought should be involved are included in this list. The reference group thought it equally important that both technical experts and non-scientists were included on a new body. The reference group, at both its second and third workshops, were less certain about direct lay membership on the new body. But they were very clear that the body needed to ensure it was aware of and dealing with public views, and in particular minority views. They also wanted it to be accountable, and in their second workshop said that its remit should fall within ethical parameters set by Parliament. One of the key priorities for reference group members at their second workshop was to be able to trust the members of the relevant advisory bodies to act in a responsible and unbiased way.

164. The new strategic body itself should operate in an open and transparent way. It might be called the Animals Council. We would expect Government to fund its operation. We do not think that the AEBC could fulfil the function of this body, because the animals strategic body needs a different membership to the AEBC, would address issues outside our remit, and would need to be a standing body.

Recommendation: A new strategic advisory body should be set up by statute to look at issues raised by modern biotechnology and developments in conventional practices relating to farm and other animals.

Public engagement

165. We would again emphasise the requirement for a stronger connection between the public and the advisory and regulatory process. In the light of indications about public attitudes, dialogue will be necessary if the same problems encountered over GM crops are to be avoided and in order to determine what are the key necessary conditions for public acceptance of prospective developments. Our reference group, at its second workshop, set out some way that the public might be enthused to take part in dialogue in this area. Throughout, reference group members said they would welcome a body that sought to make available more and better, jargon free information about developments relating to animals.

Recommendation: Particular attention should be paid to engaging the public to determine under what conditions applications of GM and cloning and conventional technology to animals are likely to be publicly acceptable.

166. Some group members did not necessarily want much more information: knowing that there was this transparency, combined with having trustworthy people involved in the advisory regime, would be sufficient. This chimes with experience in public engagement elsewhere: people differ in what they need and want by way of information and dialogue. Most people are not seeking active involvement all the time. The evidence from our reference group suggest that what they want is a system that they can trust and that is open to dialogue, with information available for those who want it. We believe that it is important that the advisory bodies have sufficient resources to undertake public engagement activities.

Recommendation: Government should ensure that existing advisory bodies and the new strategic body are adequately funded to engage the public on the issues in their areas of responsibility.

167. A new strategic body would wish to draw on existing expertise in providing advice on different areas of society’s relationships with animals. It will no doubt consider the different ways in which past and present bodies which have provided advice in these areas have approached their task, particularly regarding emerging biotechnologies. These include in particular the Committee to Consider the Ethical Implications of Emerging Technologies in the Breeding of Farm Animals , which sets out three principles explicating the humane use of animals; the Farm Animal Welfare Council, the use of an Ethical Matrix to evaluate the issues involved, employed, for example, in a recent Food Ethics Council report, and the work of the Animal Procedures Committee.

PART 2.4 INTERPRETATION AND IMPLEMENTATION

168. Agreed standards relating to animals can be enshrined in regulation but the regulatory provisions must be interpreted and implemented effectively. In areas of public concern, this must be seen to be effective. On the question of interpretation, we have flagged up earlier our concern about how and to what extent the provision in the Welfare of Farmed Animals Regulations, that only animals with a suitable phenotype and genotype sho