ANIMALS AND BIOTECHNOLOGY

A REPORT BY THE AEBC

DRAFT OF 26 FEB 2002

AprilDate 2002

CONTENTS                                                                                     

PART 1          INTRODUCTION

PART 2          SUMMARY OF CONCLUSIONS AND RECOMMENDATIONS

PART 3:        THE METHOD AND SCOPE OF OUR WORK

PART 3.1                   Our purpose

PART 3.2                   Our method

PART 3.3                   Present and future biotechnology applications to animals

PART 3.4                   Society’s relationships with and attitudes to animals

PART 3.5                   The present regulatory framework

PART 3.6                   Emerging findingsImplications

PART 4          WHAT SHOULD A REGULATORY FRAMEWORK DO?

PART 5 OUR CONCLUSIONS AND RECOMMENDATIONS

PART 5.1                   On legislation

PART 5.2                   On advisory bodies

PART 5.3                   On monitoring and enforcement

PART 5.4                   On responsibilities within government

PART 6          SOME OBSERVATIONS ON PUBLIC AND PRIVATE RESEARCH

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

PART 6.1  The present legislative framework

PART 6.2   Advisory bodies

PART 6.3  Monitoring and enforcement

PART 6.4     Responsibilities within Government

ANNEX AB Digest of Macnaghten report on contemporary UK public attitudes and sensibilities towards animals  Executive summary of the MORI report on the AEBC reference group on animals and biotechnology

ANNEX BC Executive summary of Lancaster University report on contemporary UK public attitudes and sensibilities towards animals Executive summary of the final MORI report on the AEBC reference group on animals and biotechnology

ANNEX CD      Who we are

ANNEX DE      What people told us

ANNEX EF      Contact us

PART 1          INTRODUCTION

1.      In our first report, Crops on Trial,[1] published in September 2001, we looked at the issues surrounding the Farm -Scale Evaluations (FSEs) in the United Kingdom of certain genetically- modified (GM) crops.  We made recommendations about the future conduct of the FSEs and the process leading up to decision-making about commercialisation of these crops. 

2.      Some varieties of GM crops are already in commercial agricultural production in a number of countries, although not the United Kingdom.  Many other biotechnology applications forto crops, principally GM, are well advanced in laboratory or field tests.  In contrast to this, widespread commercial agricultural production of GM or cloned animals is in most cases – except, perhaps, for fish and pet cats – some time away because the technology is at an earlier stage of development than for plants and possibly because the claimed benefits to producers are less apparent.  Many GM animals, the vast majority of them mice, have been created but these are for use in medical research in contained facilities.  The application of biotechnology to pets other than cats is still at an early stage.  Society therefore We have therefore somewhat has a little more more breathing space to consider the implications for agriculture and the environment of the commercial application of modern biotechnology to animals than we have had with crops.  

3.      The When issues arise about the commercialisation of GM animals in the future, as they almost certainly will, the regulatory system must be ready and able to deal with them in an appropriate way.  We want to avoid the polarised discussion that has surrounded the question of GM crops.  The Agriculture and Environment Biotechnology Commission (AEBC) sub-group on animals and biotechnology set out to consider how well current and likely future questions about animals and biotechnology, including genetic modification, can be answered by the current regulatory and advisory machinery.  The sub-group was composed of seven members of the Commission.  It met [x] times and reported regularly its emerging findings to meetings of the full Commission.  The sub-group also posted onto the AEBC website notes of its principal meetings and summaries of its emerging conclusions.  It took evidence from a wide range of officials involved in regulation in this area, industry, farmers’ representatives, non-governmental organisations and advisory bodies. 

4.      The sub-group discussed its emerging thinking and conclusions at meetings with key stakeholders.  Many stakeholders were challenging.  Sometimes that was because they disagreed with the substance of our emerging thinking.  Sometimes it seemed to be because we were trying out a new approach for producing a report like this, which was to test out very openly early emerging conclusions and early drafts of the report before a full case had been made for each conclusion.  We sometimes floated a broad range of ideas to stimulate debate and with the expectation that some of the ideas would be rejected in discussion.  One reason for working in this way was to seek genuine feedback from stakeholders so that if people thought that we were on the wrong track they had the chance to argue the case.  Not all our stakeholders always found it easy to adapt to this way of working, which is very different from the way bodies such as ours usually work.  But we believe that it has led to a better report overall.  Our consultation with stakeholders was genuine.  We have listened carefully to all the views put before us. 

5.      The sub-group also commissioned a literature survey and subsequently an independent social research project from Dr Phil Macnaghten of Lancaster University to gather information about public attitudes to biotechnology developments involving animals.  We wanted our advice to be informed by public concerns and interests.

6.      In addition, the sub-group tested out its emerging conclusions with a public reference group, recruited by MORI.  This too was an innovative part of the process.  The reason for testing our specific conclusions about the regulatory and advisory system with a group of people recruited from the general public because it is vital that the system commands public trust. 

7.      Although this report is based on the work of the sub-group, it is a report of the whole Commission.  The AEBC has a diverse membership embracing a wide spectrum of opinion on biotechnology and with a range of experience and expertise.  It was set up to offer independent strategic advice to Government on biotechnology issues which impact on agriculture and the environment, including ethical and social issues, and to identify any gaps in the regulatory framework.

8.      We are conscious that we are not the first body to consider some of the ethical and other issues raised by biotechnology and animals.  The Committee chaired in 1995 by Professor Michael Banner, who is now a member of the one of our own AEBCCommission members, and, and the Farm Animal Welfare Council’s report on cloning in 1998 are two important examples.[2]  The Royal Society produced a comprehensive survey of the use of genetically modified animals in 2000, which invited the AEBC to consider some of the issues it raised further.[3]  The Animals Procedure Committee issued a report on biotechnology in July 2001 in which it encouraged the AEBC to consider the adequacy of the current regulatory regimes in monitoring the ethical and welfare implications of the emerging biotechnologies for all animals; and also the effects on animal welfare of biotechnology products, the effects on the environment as a cost, and the welfare of animals imported into the UK.[4]  We have paid careful attention to these reports. , sought to avoid unnecessary duplication, examined the issues raised by them and where appropriate have endorsed and developed their conclusions.  We have sought to take a broad view of society’s relationships with animals and the application of biotechnology to animalsin drawing up our advice about the regulatory system for the application of modern biotechnology.  We commissioned social research to help us to do this.  We commend the recommendations in our report to Government.

PART 2          SUMMARY OF CONCLUSIONS AND

RECOMMENDATIONS

9.      The law relating specifically to GM and non-GM cloned animals is adequate for present and likely future purposes.  We see no need to change the legislation governing the use of animals for research, the Animal (Scientific Procedures) Act 1986.  General animal welfare legislation applies to GM, non-GM cloned and conventional animals.  Some of that needs updated.

Recommendation 1.  We recommend that the 1911 Protection of Animals Act should be updated.  In updating the legislation, issues Government should consider include the post-commercialisation of cloned GM or non-GM cloned farm animals; any welfare implications of the use of GM-derived products; and the potential welfare problems arising from breeding programmes.   

10. We see no reason to rule out the application of cloning or genetic modification per se in commercial agriculture or in relation to companion animals, any more than conventional selective breeding techniques.  The purpose of the application, its outcomes and any welfare implications of conventional and modern biotechnological techniques used to generate the animals need to be considered. Some potential outcomes from using  modern biotechnology in relation to animals can be considered intrinsically objectionable.  This should be taken into account in decision-making.  But consideration of intrinsically objectionable outcomes should apply to the outcomes of conventional processes too.  There should not be a double standard.  Questions in relation to modern biotechnology are more urgent and sensitive because of the speed and nature of changes to animals made possible by modern biotechnology, which are not otherwise possible by conventional techniques.  But even when this is the case, the purpose for which an application is being carried out, whether it by conventional or modern biotechnology techniques should be assessed similarly.  

11. If modern biotechnology is introduced into commercial livestock production then the modified or cloned farm animals should be monitored until it is clear that there are no particular welfare, environmental or other unforeseen implications in commercial production.

Recommendation 2.  There should be adequate post-commercialisation monitoring of GM animals and non-GM cloned animals for any welfare, environmental or other unanticipated effects, in addition to assessment prior to commercialisation.

The same monitoring should take place if companion animals were cloned but we believe that genetic modification and cloning, particularly when the welfare costs of generating cloned animals remain relatively high, should not be used for trivial purposes.  Cloning to replace pets which have died would seem to fall into this category.

12. We recommend no changes to the Animals Procedures Committee.  We believe that separate advisory bodies should advise Government on research, farm and companion animals respectively.  It is important for public confidence that these bodies are listened to by Government.  Government should signal the importance it attaches to independent advice on farm animal welfare by making the Farm Animal Welfare Council (FAWC) a statutory advisory body.

Recommendation 3: We recommend that Government consider making the Farm Animal Welfare Council (FAWC) a statutory body. 

There is no comparable official advisory body for companion animals.  We believe that there should be.

Recommendation 4: We recommend that Government considers making the Companion Animal Welfare Council (CAWC) an official body, reporting to Government and being funded by Government. 

13. We believe there is a particular job for FAWC to do in advising Government on any welfare implications of novel products, which have been passed on food safety grounds, which it is intended to be applied commercially to farm animals.  Such novel products include products derived from genetically modified organisms.

Recommendation 5: We recommend that the Government should also seek advice from FAWC on the welfare implications of any proposal to use in UK livestock production products derived from genetically modified organisms, where the use of such substances is outside the scope of A(SP)A.  Where the decision is made at EU level, Government should invite views from FAWC to inform the UK’s position, unless FAWC are satisfied that animal welfare considerations will be adequately taken into account by the arrangements made by the EU for that purpose.

14. The individual advisory bodies should continue to provide advice guidance to Government on matters within their respective remits.  But some issues, particularly relating to modern biotechnology, cut across their respective areas of responsibility.  Cloning is a good example.  The use of selective breeding or genetic modification to change animal physical or behavioural characteristics is another.  There should be a new permanent strategic forum to consider these and other issues relating to animals and to give advice as required to Government.

Recommendation 6: We recommend that a new strategic advisory body should be set up to look at issues raised by modern biotechnology or other developments relating to animals.

15. We recruited a public reference group on which to test out our emerging conclusions.  The public reference group did not share our view that a new body should be advisory but wanted a single body which would have powers independent from Government to regulate biotechnology applications to animals.  People wanted confidence that the new body would be listened to by those working in the field.  They did not believe that an advisory, rather than regulatory, body would be listened to by Government or resourced properly. We believe that a single regulatory body would be unwieldy, and that the evidence suggests that the existing enforcement organisations across the different sectors of animal use are better placed individually to discharge their various responsibilities, which vary considerably, than as part of a single organisation.  But the views of our reference group strongly suggest that it is vital that Government takes seriously and is seen to take seriously the recommendations from its advisory bodies. 

16. The advice in our report throughout was informed by social research into public attitudes to animals and biotechnology.  We found both this and having a public reference group very helpful in drawing up our advice.  We believe that it is vital that advice to Government in this area is adequately informed by public attitudes.

Recommendation 7: We recommend that Government considers making available funding for the existing advisory bodies (APC, FAWC, CAWC) and the new strategic body to undertake or commission sufficient research into public attitudes in relation to their areas of responsibility to inform the recommendations they make to Government. 

This section would be an  executive summary of the report’s conclusions and recommendations, linked to the feedback received from our public reference group.

PART 3                   THE METHOD AND SCOPE OF OUR WORK

PART 3.1      OURur purposePURPOSE

17. Our purpose was to consider how well current and likely future questions about animals and biotechnology, including genetic modification, can be answered by the current regulatory and advisory system. 

PART 3.2      Our methodUR METHOD

18. To fulfil this remit we have attempted to develop an effective and innovative approach to give appropriate weight to all relevant considerations.  We:

·        we undertook a broad survey of what was going on in the development of biotechnological techniques in relation to animals;

·        we commissioned two social research projects to gain insight into society’s relationships with and attitudes to animals,.  The first piece of research was an examination of existing social research, predominantly quantitative opinion surveys, which gave some general indications of public attitudes in this area.  The second project was intended, through qualitative social research, to explore in greater depth the different perspectives people have on animals and in particular about the differences in people's attitudes to the various possible applications of modern biotechnology to animals; and  and to establish what the public’s future expectations might be for athe regulatory and advisory framework; and

·        we reviewed the present legislation relating to animals and the accompanying regulatory and advisory framework in order to identifyspot any gaps in relation to the present regulatory framework for the application of biotechnology to animals;

·        consulted stakeholders openly about our emerging conclusions;

·        recruited a public reference group to test out our thinking as it developed.  The feedback we received from the reference group was crucial to the development of our report.  We wanted to gain an idea of how our specific recommendations in relation to the regulatory system might be viewed by the public. This proved to be a very valuable exercise and we commend it to others.

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PART 3.3      PRESENT AND FUTURE BIOTECHNOLOGY APPLICATIONS RELATING TO ANIMALS

Modern biotechnology

19. In this section we outline some of the main areas where modern biotechnology is either being applied to animals or looks likely to be applied in the future.  We would like to stress that the following list is descriptive and should not be taken to imply approval or disapproval of any of the biotechnology applications, or of the claims or counter-claims made in relation to the present applications or in relation to what might be possible in the future. We will consider in more detail the issues raised by some of the particular examples in part 4 of the report. 

20. Conventionally, petsdogs, cats 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 productiveproduce more milk or grow faster than their original ancestors.  Selective breeding continues, aided now by artificial insemination techniques, which can mean an individual male with desirable characteristics can have a vastly more than expected greater numbers of offspring than was possible hitherto. (it was reported to us that some twenty percent [DEFRA will revert with figures] of the UK dairy herd is the offspring of a single American bull and that bull’s progeny).  Improved statistical analysis techniques and marker assisted breeding hass 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.   

21. Modern biotechnology potentially allows similar effects to conventional breeding to be achieved much even more quickly.  Unlike conventional breeding, it can also be used to transfer genetic material from one species to another. ItModern biotechnology also has a wider range of potential applications in relation to animals, particularly medical applications.

22. The first genetically modified animals were transgenic mice, created in the early 1980s.  Transgenic animals possess active copies of one or more genes which have been inserted into them from another individual from the same or a different species.  The technology has moved on to make it possible to ‘knock out’ specific genes from an individual animal or ‘knock in’ specific genes.  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 other applications of modern biotechnology to animals, including cloning not involving genetic modification[5] We have also taken into account other applications of modern biotechnology to animals, including cloning not involving genetic modification (i.e. in addition to cloning which is used in conjunction with genetic engineering); and marker-assisted breeding, where a genetic modification is introduced that gives rise to an easily identifiable phenotype to make identifying successfully modified offspring easier.  Animals that are not genetically modified or cloned are termed ‘conventional animals’ in the report. 

Applications relating to animals

23. The main present and likely future applications of modern biotechnology techniques in relation to all non-human living vertebrates (which includes fish) and also insects are set out below.  The list starts with applications already in use or expected soon, before going on to areas of research where the results are expected to take longer to feed through.  The recent Royal Society report on GM animals[6] and the Animal Procedures Committee report on Biotechnology[7] set out in detail the various applications of genetic modification underway at present or expected in coming years.  We have therefore not attempted to duplicate this effort but have instead summarised the Below is a summary of the principal present and expected applications of the technology.

Medical research

24. The major application of biotechnology to animals at present and for the immediate future is for the purpose of medical research, largely based on information derived from the human and animal genome sequences.  The vast majority (98 percent) of the GM animals involved are mice, which have been used since the early 1980s.  There are three main aspects to this research: the use of animals as models for specific human diseases; better understanding of the human genome; and testing substances for toxicity.  Between 1990 and 1999, the number of experimental procedures involving transgenic/GM animals[8] rose from some 50,000 to over 500,000.[9] In 1999, about 70 percent of the procedures involving GM animals were primarily concerned with breeding (e.g. used to generate and 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 5 percent were used in applied work, such as toxicity testing.  Their numbers of animals involved areis expected to rise substantially over the next few years, as the functions of new genes identified in genome sequencing projects are analysed.  There are three main aspects to this research: the use of animals as models for human diseases; better understanding of the human genome; and testing substances for toxicity.

25. Mice and other animals can be genetically modified to provide models of human diseases.  Many of these animal models do not mimic all aspects of a given disease but the overall high similarity between mouse and human genomes coupled with common fundamental characteristics of cellular mechanisms makes this a valuable approach.  It allows the underlying pathology of the disease to be researched and provides a model to test potential treatments.  have a human genetic disease so that the disease pathways can be better understood and possible cures tried out on these living creatures, which are sufficiently similar to human beings in respect of their genome.  The GM

animal acts in this way as a model for the human disease in an attempt to mimic human genetic diseases.  Many such ‘models’ do not develop all the characteristics of the relevant human disease but even partial similarity can be enough to increase our understanding of the underlying pathology of an illness and to provide a test for possible treatments.

1.

26. In addition to researching specific diseases and possible cures, the The fact that mice and other animals share a great number of genes with humans is also being employed in basic research to better understand the human genome.  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[10] (Drosophila melanogaster), zebrafish, the South African claw-toed frog[11] (Xenopus laevis) and a nematode worm[12] (Caenorhabditis elegans) are among the main organisms involved in this fundamental research.  Experiments include ‘knocking out’ on a particular gene that is shared by an animal and humans, such as ’knocking out’ the gene in the animal, are being carried out to improve understanding of the functions of individual the human gene.s .  It is widely argued by researchers that this knowledge of gene function, which is widely expected to prove crucial for medical advances, could not be studied as effectively by other means. other than with GM animals (other than by experimenting on humans, which would be ethically acceptable to very few people).  The decoding of the entire human genome sequence has emphasised how little we understand about the function of most of our genes.  The manipulation and study of these genes in model organisms is proving to be a powerful method of learning their roles.  This knowledge will be crucial for medical advances over the next decades and in many cases cannot currently be acquired by any means other than producing GM animals.  ThThis is particularly considered to be the case the case when trying to understand the function of a gene within the whole physiological system of an animal: molecular and biochemical analysis is often done in isolated cell cultures or in test tubes, but thea holistic understanding can only be achieved with whole animal models.  It should be noted that some people disagree with researchers that animal models of this sort are in fact as useful as is claimed.

27. The third main area of research involving GM animals is a development of the use of conventionalnon-GM animals to test the toxicity of chemicals and drugs, for example in relation to 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,  e.g. by the modified utated genes,  turning blue wwhen removed from the animal and introduced into yeast cells, causing the yeast cells to change colour.  .  Other rodents hhave been modified to have much greater sensitivity to carcinogens than their non-GM 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 in such tests for toxicity is that the testing can be completed process is greatly speeded upmore quickly than  than when usingwith conventional animals.  This technique also means that fewer animals need to be tested to achieve the same result. 

1.All the above processes are already in use in research establishments in the UK and elsewhere. 

Faster growing fish

1. 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 suchgrowth hormone-expressing 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.[13]  Other GM fish, including trout, carp, catfish and tilapia have been the subject of research. are also in development.

1.

28. Salmon would appear to be the closest to reaching the market, subject to regulatory approval.  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 are discussed further in part 4.. The Advisory Committee on Releases to the Environment have published a case study[14] setting out the factors which they would expect to take into account in making decisions about commercialisation of GM fish in the UK. 

Companion animals

1.There are no major applications of modern biotechnology to companion animals (i.e. pets) at present.  The planned creation of cats by a small American company[15] that do not provoke a human allergic reaction has recently received publicity, however,[16] and it was stated that such cats could be produced by 2003, subject to commercial funding.  It is possible that there could be a demand for the cloning of favourite pets.  Genetic modification has been mooted as a means of changing animal behaviour although the genetic complexity underlying behaviour mean that this is at present technically impracticable.

1.It is claimed that biotechnology might also be used to seek to correct some severe welfare problems in pets e.g. hydrocephalus in bulldogs, dislocated hips in German shepherds, and so on, which have arisen as a result of conventional selective breeding.  Similar possibilities can be envisaged in relation to other animals which have been subject to conventional selective breeding. 

Pharming

29. ‘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.  Three companies in the world do this: in the United Kingdom, there is PPL Pharmaceuticals (Roslin), Pharming B.V. in the Netherlands and Genzyme Transgenics in the USA.  Some fifty products are in development, including treatments for Pompe's disease, hereditary angioedema, heart attacks, cystic fibrosis and haemophilia.  There are mMany genetic illnesses and syndromes that 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).  PPLPPL Pharmaceuticals (Roslin), for example, have a flock of some 600 GM sheep in Scotland producing a pharmed protein called I-1-antritrypsin (known generally as AAT) in clinical trials at present and state that they expect it to be on the market to treat people who do not produce their own AAT and so die of emphysema, in three or four years’ time, with a potential treatment for cystic fibrosis patients soon thereafter. 

GM insects

30. There is considerable A major iinterest ins using biotechnology to control in relation to insects which spread disease carriers.[17]  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.[18]  Sterilisation is currently achieveddone by irradiation, but this has the side effect of making the insects ten times less vigorous and so the control process less efficient. 

31. Much research has been undertaken in relation to mosquitoes, which carry the malaria parasite.  The aim is to create by genetic modification strains of mosquitoes that are resistant to the malaria virus and release them into the environment to replace the existing, susceptible, wild population.  Another possibility is would be mmodificationying 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.[19] The aim would be to reduce or eliminate Insects cause massive economic damage populations of insects which spread human disease or cause significant damage to agriculture.  and spread disease that kill many millions of people every year, so prima facie the potential benefits are considerable.

32. 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 may 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 carry a beneficial (beneficial to humans, that is) genetic modification through anthe insect population[20], using autonomous transposable elements or Wolbachia (bacteria living in insect cells), would be an irreversible strategy with implications for whole populations and even species.  Clearly tThe environmental and ethical and biosafety issues would beare significant and any such release would need could not be contemplated without very extensive justification and planning, which would need careful consideration.  The issue of the release of insects, like fish, highlights the raises the issue of international aspect of release gulation of such genetically modified organisms: release into the environment in one country could potentially have implications well beyond that country’s national land or sea boundaries., which we consider in Chapter 5.

Farm animals

33. 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 are some ten years from the market.  Small numbers of non-GM Ccloned farm animals have been produced, however, in Europe and the US.  Because the cloning process is expensive and remains inefficient, 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 with the intention of selling the cloned animals to China and elsewhere.  A few cloned calves of prize cattle are reported to have been sold at auction in the US. animals are closer, however, and tThere are reports that Kobe beef from cloned animals ishas been made available on a very limited basis for human consumption in Japan.  A number of biotechnology applications to farm animals may be possible.

1.

1. A number of other biotechnology applications to farm animals may be possible.  LikeAs 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 Work is also going on to manipulate the rumen micro-flora which break down poor quality or potentially toxic feed so that ruminants could derive greater nutritional value from poor quality feed.  The animal could be modified to enhance traits which consumers are perceived to value, for example. poultry  An example recently discussed is chickens wwith extra breast-meat, or .  Many other examples are being researched.  As well as faster growth, other nutritional modifications meat with a lowered cholesterol content or less saturated fat.

1.

34. Many other examples are being researched. 

1. There are major obstacles to producing GM farm animals at present, aside from issues of public acceptability of directly modified farm animals entering human food supplies.  These include the expense of the process: only 0.3% of all eggs into which the genetically modified nucleus is injected mature to become GM animals.  Knowledge of farm animal genomes is incomplete.  The longer breeding cycles of these animals 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 it is not an area of research that attracts the sort of venture capital funding available for medical biotechnology applications.

1.

1. 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 alone and which clearly causes welfare problems.  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, although the large number of breeds of cattle and large amount of subsequent breeding to spread the trait through the national herd or flock would make the latter two examples an ambitious undertaking.  Such diseases are the cause of much animal suffering as well as economic loss throughout the world.  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..

35.

36. It is further claimed that genetic modification could be used to improve farm animal welfare in other ways than improved disease resistancealleviate some of the many instances of poor animal welfare that have been caused by more intensive farming methods.  For example, This could be by sspecific modifications to correct a problem might be possible, such as strengthening the leg bones of broiler chickens to correct the apparent problem of leg weakness in some birds.  Some people would argue that other, conventional, means to achieve this would be preferable to genetic modification.  Genomics 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.  Work is also going on to manipulate the rumen micro-flora which break down poor quality or potentially toxic feed so that ruminants could derive greater nutritional value from poor quality feed. 

37. Widespread production of GM livestock on a commercial scale looks unlikely at present.  Aside from issues of public acceptability of directly modified farm animals entering human food supplies, practical obstacles include the expense of the process, due partly to only a small proportion in many cases of the modified embryos developing into modified adult animals.  Knowledge of farm animal genomes is incomplete.  The longer breeding cycles of these animals 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 it is not likely to attract venture capital funding in the same way as medical biotechnology research. 

or by substituting a beneficial new procedure, based on GM, for a current procedure.

Companion animals

38. There are no major applications of genetic modification to companion animals (i.e. pets) at present.  The planned creation of cats by a small American company[21] that do not provoke a human allergic reaction has recently received publicity, however,[22] and it has been stated that such cats could be produced by 2003, subject to commercial funding.  There is clearly some demand, however, for the cloning of favourite pets.  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.[23] Genetic modification has 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 issue further in part 4.

39. It is claimed that genetic modification might also be used to seek to correct some welfare problems in companion animals, for example hydrocephalus in bulldogs, dislocated hips in German shepherds, and so on, which have arisen as a result of conventional selective breeding.  Again, as with farm animals, others would argue that it would be preferable to employ means other than genetic modification to achieve this.

Xenotransplantation

40. 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 are as a potential source of suitable organs or cells.  The aim of Ggenetic modification is may be able to make the organs or cells less susceptible to rejection by humans.  The recent successful production of cloned and then genetically modified and cloned pigs is a further step towards efficient genetic modification of pigs and as such is aimed at bringing xenotransplantation closer.  have been hailed as steps towards developing thisThere is debate about whether sufficient other necessary progress  technology further.  It may be that the technology will have been made advanced sufficiently to allow successful transplants from GM animals in the next five to ten years.  In addition to the matter of organ rejection, there remain , but there remain serious concerns about the possible transfer of animal viruses zoonoses to humans which will have to be satisfied addressed before the technology could be appliedfirst.  There are also concerns about physiological compatibility.

Sporting animals

41. There is no reason in principle why sporting animals could not be the subject of 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 modern biotechnology at present in racehorse breeding, including artificial insemination and cloning.

1.

Sporting animals

1.There is no reason in principle why sporting animals could not be the subject of genetic modification.  However, the breeding of racehorses is regulated by horseracing industry bodies, which stipulate an entirely natural process from fertilization to birth for the production of racehorses.  This effectively rules out modern biotechnology at present in racing, including artificial insemination and cloning.  If the technology was sufficiently advanced and racehorse performance could be improved by means of genetic engineering, there might be implications for the betting industry if this was perceived to give a ‘secret’ or ‘unfair’ advantage to racehorses.

42. Other parts of the equestrian sports industry do not have the same strict rules on breeding as exist for thoroughbred racehorses.  For these horses, Tthe industry rules are silent on the application of modern biotechnology.  This is the same for greyhound racing.  In short, tThe application of genetic modification to sporting animals does not appear to be a major area of activity at present, although there is some interest in the possibilities.[24]

PART 3.4       SOCIETY’S RELATIONSHIPS WITH, AND ATTITUDES TO, ANIMALS

43. In considering the implications for regulation of the present and potential developments in modern biotechnology, we believed it to be important to gain insight in to The social work attitudes to animals and biotechnology.  we

Method

commissioned on social attitudes has informed the conclusions we have come to in our report. 

1.

44. As a first step, Eearly on in this our work we commissioned a literature survey on the results of existing research relating to attitudes to animals and biotechnology in the UK. and, in particular, to see how far those findings explained public attitudes.  This was undertaken by Professor Glynnis Breakwell of Surrey University.  Her report The existing social research in this area was found to be predominantly quantitative opinion surveys, which gave some general indications of public attitudes in this area.  Her report examined the available data and drew a number of conclusions from it.  Professor Breakwell notedconcluded t that “Ooverall 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.”[25]

45. 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.[26] 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 the various possible applications of modern biotechnology to animals; and what public expectations might be for the regulatory framework.  We are very grateful to those members of the public who participated in  this study.  We attach at annexes A and B respectively summaries of Professor Breakwell’s literature review and Dr Macnaghten's report and have published both reports in full on our website.[27]

Findings

46. Care is needed in interpreting the results from both qualitative and quantitative social research.  In the former, the texture of participants' concerns and interests on a particular issue can be brought out in greater depth than in opinion poll surveys.  The findings from our focus groups suggest where wider public concerns may lie but they obviously are not a definitive account of the attitudes of the whole UK population.  Quantitative social research draws on a larger sample size but the nature of the questions asked and the options for answers tend to mean that it is harder to tease out the nature of people's interests and concerns. 

47. Professor Breakwell’s review summarised the findings of Both our studies confirmed that in the UK there is widespread strong feeling about animal use generally and animal welfare in particular.  The Macnaghten study suggested that people’s attitudes to animals and the uses they make of them are complex.  People often acknowledge that they hold internally contradictory attitudes to the use of animals, particularly when comparing the use of animals for food and as pets.  Professor Breakwell found that existing research showed evidence that people had a complex pattern of reasoning, knowledge and values - they are aware of inconsistencies and ambivalence and want to form opinions based on facts.  existing research as follows

Are people opposed to genetic modification per se?

48. 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'.[28]  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. In the qualitative social research we commissioned, the researchers sought to tease out whether it is genetic modification in itself that was the issue.   The researchers found that few participants ruled out the genetic modification of animals but most did see the technique as something 'new' and 'unnatural'.  People have a concern for the intrinsic nature of animals, animals 'in their nature', particularly when confronted by the question of fundamentally changing an animal's behaviour.  The pace of change to animal species potentially afforded by modern biotechnology techniques, the degree of intervention and precision involved and the anticipated likelihood of unanticipated mistakes are concerns.  The purpose of applying any biotechnology was critical to its acceptability.

49. A Eurobarometer poll[29] 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, so the poll did not rule out cloning as a technology per se. 

When is the application of biotechnology to animals acceptable?

50. The conclusions drawn by Professor Breakwell from the studies completed to date were that issues of risk and safety were generally not important in determining the extent of public support for a particular biotechnology application.  Rather, the main bases of people's judgement are whether the technology is useful and ethical.  Surveys indicate 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 biological development is right or wrong the possibility of animal harm is an important consideration.  Perceptions of moral unacceptability ‘act as a veto' in people's attitudes to what may be done with animals. 

51. The Macnaghten study suggested that most people’s approval of a particular application of biotechnology is conditional.  The purpose of the application is critical and, in common with other practices relating to animals, must be for an ethically justifiable end.  For example, medical applications were viewed more favourably than cosmetic ones.  This does not seem to be an issue about modern biotechnology per se:  people tend to interpret possible applications of biotechnology to animals in the context of their attitudes to existing practices and relationships with animals and made the same distinction in relation to conventional animal research. 

What are people's attitudes to the regulatory system?

52. 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.[30] The Macnaghten study indicated that the BSE crisis and the controversy about GM foods have damaged people’s trust in Government’s trustworthiness as a regulator of biotechnology applications.  We explored the implications of this mistrust in the course of our work in preparing our report Crops on Trial.[31] The Macnaghten study also suggested that there is a distrust of scientists if they are perceived as being in hock to industry; and a concern that corporate involvement with technology means that applying biotechnology to animals is for profit rather than any compelling moral motive.  Both the Breakwell and Macnaghten research suggested that people felt in the dark about developments in modern biotechnology and its application to animals and hence suspicious of developments, even though there was an evident willingness to strike 'reasonable' balances between animal welfare and technical advances.  People thought that public information and public debate were necessary.

Implications

53. The research suggested that public concerns in relation to GM animal technologies encompassed a number of distinct elements.  First, concerns about the intrinsic character of animals, including the need for animals to retain their 'integrity'.  Second, concerns about animal welfare.  And third, a range of additional issues pertaining to the surrounding conditions of regulation and institutional oversight and motive.  Macnaghten stated that the overall impression from the focus group discussions was that there is considerable scope for public controversy arising from the future uses of animals in the biotechnology domain.  The findings in the Macnaghten report 'underline that people are not saying that they are either in favour or not of GM animal technologies, but that their responses depend on the conditions under which it is done.  Key conditions for people appear to include, inter alia, the realism or fiction of 'benefits', the speed of innovation, the openness of public debate, the acceptance of ignorance and its consequences, and the commercial ethos of it all.'[32]

54. The social research suggests that applications of modern biotechnology which involve very rapid and profound changes to animals, particularly changes perceived as 'unnatural', do cause public concern.  These findings are consistent with what we discovered in the course of our work in preparing our report Crops on Trial.[33] The Macnaghten research suggested that most people accept trade-offs in relation to animal welfare and benefit to humans.  Few people in focus groups seemed to rule out genetic modification altogether after discussion of its purpose, although this is balanced by some opinion poll surveys which indicate a much more negative attitude.  The purposes for which modern biotechnology is used are key to determining public acceptability.  Trivial purposes are generally seen as unacceptable. Applications of modern biotechnology for what are considered to be ethically acceptable - especially medical - purposes enjoy the widest support.  But the Macnaghten study suggested that it is possible that this support could be eroded if negative public reaction to particular applications of genetic modification in a different context cast a shadow over medical and other applications for which there is general public support. 

55. The focus group discussions in the Macnaghten study 'pointed to a collective 'blanking out' of those aspects of daily life that remain utterly dependent upon the instrumental use of animals, especially in the use of animals in meat production.  Yet, the very acknowledgment of 'hypocrisy' and 'selection' commonly expressed by participants represents what may be seen as a reflexive break from the past…In previous times people were more likely to regard the eating of meat as a given as part of the unspoken norms of traditional life.  Nowadays traditions have to explain themselves, to become open to interrogation or discourse.'[34] This general point would seem to support the view that the regulatory system and those involved in applying biotechnology to animals should adopt an open approach, so that information about particular biotechnological applications is available and the justification for their use made clear.  This will not be a sufficient condition for public acceptability of a particular application of the technology, but without such transparency public acceptance is unlikely to be achieved.  It cannot be taken for granted that people will accept developments without explanation and justification.

56. We consider further in part 4 what general features the regulatory system for animals and biotechnology should possess in the light of these indications of public attitudes.  In part 5 our recommendations about the present regulatory system are similarly informed by the social research we commissioned, by the responses we received from our public reference group, and wide consultation with stakeholders.  In the next part of the report, we set out the features of the present regulatory system relating to animals and biotechnology. 

·there is a particular negativity to animal biotechnology applications in the UK;

·overall the UK public are more polarised in their attitudes than the average European;

·issues of risk and safety are generally not important in determining the extent of public support;

·the main bases of judgement are whether the technology is useful and ethical;

·medical uses of GM animals are more acceptable than others (although a medical use certainly does not lead to automatic public acceptance);

·perceptions of moral unacceptability ‘act as a veto’;

·when considering whether a biological development is right or wrong the possibility of animal harm is an important consideration;

·the public perceive a lack of information about animal biotechnologies;

·there are often gender differences with women viewing animal applications more unfavourably and being more concerned about animal welfare;

·the specificity of questions and the context in which they are placed affect expressed attitudes;

·monitoring the acceptability of both products and processes is important;

·people evidence a complex pattern of reasoning knowledge and values - they are aware of inconsistencies and ambivalence and want to form opinions based on facts;

·credible evidence of serious social justification of particular technologies is taken into account when people are forming judgements;

·it is important to systematically track changes in attitudes over time.

1.Following consideration of Professor Breakwell’s conclusions 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 attach at Annex [X] the executive summaries of the report we commissioned, called ‘Public Attitudes and Sensibilities towards Animals and Biotechnology in Contemporary Britain’ and undertaken by Lancaster University.  We are very grateful to those members of the public who participated in  this study.

1.Some of the main general points about the texture and nature of social attitudes to biotechnology and animals suggested by the research are as follows:

·confirmation of the common impression that there is widespread strong feeling about animal use generally and animal welfare in particular; 

·people’s attitudes to animals and the uses they make of them are complex.  People often acknowledge that they hold internally contradictory attitudes to the use of animals, particularly when comparing the use of animals for food and as pets;

·people tend to interpret possible applications of biotechnology to animals in the context of their attitudes to existing practices  and relationships with animals; 

·most people’s approval of a particular application of biotechnology is conditional.  The purpose of the application is critical and, in common with other practices  relating to animals, must be for an ethically justifiable end;

·most people do not rule out the genetic modification of animals but do see the technique as something new.  The pace of change to animal species afforded by modern biotechnology techniques, the degree of intervention and precision involved and the anticipated likelihood of unanticipated mistakes are concerns; 

·members of regulatory or advisory committees should be chosen to reflect a range of concerns and interests, of which animal welfare should be a central concern, and be seen to act independently.

·the  BSE crisis and the controversy about GM foods have damaged people’s trust in Government’s trustworthiness as a regulator of biotechnology applications;

·there is a distrust of scientists if they are perceived as being in hock to industry (and a misconception that most are); and a concern that corporate involvement with technology means that the motive for applying biotechnology to animals is profit rather than any compelling moral one;

·there is a sliding scale of strength of feeling, with increasing concern (though not outright rejection) as the ‘naturalness’ of a GM animal becomes less: modifications involving swapping traits between very distant species, for example fish and strawberries, are viewed with greater concern than apparently less radical modifications, even if the process is scientifically identical.

[develop Breakwell report conclusions, quantitative work and Lancaster material further to indicate texture and contour of public concerns, related to developments in the technology in part 3]

PART 3.5      THE PRESENT REGULATORYREGULATORY FRAMEWORK

LegislationDescription

57. The regulation of activities involving modern biotechnology and animals is designed to achieve at least three different objectives: to minimise the risk to human health; to minimise the risk of harm toing the environment; and to ensure that animalsafeguard t he welfare considerationsof animals are taken into account in those activities.  Some of the legislation also requires the regulatory bodies to have regard to the needs of science and industry.  This is achieved in part through a combination of legislation and regulations that are specific to biotechnological processes, and partly through laws, regulations and codes of practice which apply both to GM and non-GM cloned animals and to conventional animals.  Legislation relating to animals is based on the general principle that the use of animals is acceptable provided it is humane.[35]

1. At present, GM animals are regulated in the first instance in the United Kingdom by the Animals (Scientific Procedures) Act 1986 (A(SP)A)[36].  This requires that any experimental or otherll scientific experiments or procedures which may cause pain, suffering, distress or lasting harm to a protected animal mustcarried out on living animals to be licensed by the Home Office if they may cause pain, suffering, distress or lasting harm to the animal.  The Act applies until the death of the animal unless the animal is specifically discharged. 

1.

58. At present all activities involving the creation or subsequent breeding of GM animals, and all cloning and breeding of animals for xenotransplantation, are governed by the provisions of the Act, because they are being undertaken for scientific or other experimental purposes.   results of such activities are considered uncertain.

59. Offspring from GM animals are treated as genetically modified (even if one parent is unmodified and even if they are subsequently bred by conventional means) and come under the control of A(SP)A unless or until they are discharged.  Before considering discharge, the Home Office will require, as a minimum, welfare records for two generations of animals living a full lifespan.Discharge requires health and welfare records for the preceding two generations.  None GM animal has been discharged to date.[37]

60. The diagram below illustrates how the main regulations pertaining to GM and cloned farm, companion and research animals apply.

Regulations specific to GM animals

1. Establishments where genetic modification is undertaken, or where GM animals are kept or reared, are also regulated by the Genetically Modified Organisms (Contained Use) Regulations 2000, which implement EU Directive 98/81/EC.  The Contained Use Regulations apply to all GM organismsplants, invertebrates and  vertebrates. 

1.

1. These regulations  Contained Use Regulations are concerned with protection of human health and safety and protection of the environment from the contained use of GMOs genetically modified animals and plants. .  The degree of containment of the GM plant or animal ismust be determined by the assessment of the risk to human health or to the environment.  The regulations are enforced by the

1.

61. The Health and Safety Executive must also be notified of any incidents involving a ‘significant and unintended release from containment of GMOs that present any sort of danger to human health and safety’.

62. These regulations cover the original creation of a GM animal and any breeding from it which is carried out in containment including all GM animals supplied by others excepting animals that have a marketing (Part C) consent granted under the EU Deliberate Release Directive (there isare none at present). 

63. Part VI of the Environmental Protection Act (EPA) 1990 and the Genetically Modified Organisms (Risk Assessment) (Records and Exemptions) Regulations 1996 make a similar requirement for an assessment of risk to the environment for each activity involving GM animals (although there is no requirement to notify anyone of that risk).    This is then used in part to determine what type and level of containment is most appropriate.[38] .

Deliberate Release into the Environment

64. It is an offence under Part VI of the EPA to release a GMO into the environment without the prior consent of the Secretary of State or the National Assembly for Wales or the Scottish Executive in Wales and Scotland respectively.  Such releases are regulated by the GMO (Deliberate Release) Regulations 1992 (as amended in 1995 and 1997).  New regulations will be brought into force in 2002 to implement the revised EU Directive[39] on deliberate release.

International trade in GM animals

65. If a GM animal received Part C consent for marketing purposes in any EU Member State, it could be imported for marketing or release into the UK.  (GM animals imported only into contained use facilities do not require Part C consent.s.)  Conditions can be attached to that consent, and it is not yet clear what sort of conditions might be applied (none has yet been granted for a GM animal).  Enforcement of conditions relating to imported GM animals will be the responsibility of DEFRA.

66. Under the Biosafety Protocol 2000, any country exporting a GM animal for release into the environment will be required to give advance notice to the importing country.  AAlthough it has yet to be ratified, existing EU legislation already requires this in respect of imports into the EU.  Proposals from the European Commission for are expected later this year to applying the protocol to exports from the EU were published in February 2002[update].  There are funds under the protocol to assist with capacity building in developing countries.  The clearing house for information provides information about knowledge of which GMOs have approval for release in other countries (at present, only plants).  This allows the UK to take appropriate steps to ensure GMOs are not are not imported deliberately or inadvertently without consent. 

67. Applications can also be made to tThe Home Office authorises the acquisition and use to import of a GM or non-GM cloned animal imported in to the UK for experimental or scientific purposes (but not the importation itself).  for research purposes or to be kept in contained premises.  It will then become subject to the requirements of A(SP)A and/or the Contained Use Regulations.  Similarly, GM and non-GM cloned animals can be exported to an overseas laboratory, with Home Office approval, at which point A(SP)A ceases to apply to those animals.  The Home Office and the HSE are responsible for ensuring imported GM animals comply with their respective legislation.

Xenotransplantation

1. The UK Xenotransplantation Interim Regulatory Authority (UKXIRA) is responsible for has advising Ministers on the action necessary to regulate xenotransplantation; and any specific applications to carry out a xenotransplantation procedure on humans (unless it was gene therapy) would be made to UKXIRAoverarching responsibility for xenotransplantation.  Any TGMransgenic animals created for the purposes of xenotransplantation research areare covered by A(SP)A and would also be covered by the Contained Use Regulations unless they receive Part C consent for release.[40] There is no commercial, work or research using pigs going on at present in the UK although related research with mice continues(although there are no lon here.ger any in the UK following Imutran’s relocation to Canada), and will also be covered by the Contained Use Regulations unless they receive a marketing consent under the Deliberate Release Directive.

1.

68. Animals bred and reared by conventional breeding methods for medical purposes (e.g. heart valves) are outside the scope of A(SP)A and fall under the provisions for agricultural animals. 

General animal welfare legislation

1. At present the main source of welfare protection for GM animals is A(SP)A.  If a GM animal were to be discharged from the Act (with the Home Secretary’s permission) and released into the environment (with an appropriate consent), or if genetic modification ceased to come within the remit of the Act, GM animals’ welfare would be protected by existing animal welfare legislation. 

69. All farm, companion, zoo and sporting animals are protected in England and Wales by the provisions of the Protection of Animals Act 1911.  In Scotland the Protection of Animals Act (Scotland) 1912 gives effect to the same provisions and hereafter ‘the 1911 Act’ should be understood as including both Acts.  The 1911 Act makes it an offence to cause unnecessary suffering to any animal.  Northern Ireland has similar (but expanded) provisions in the Welfare of Animals Act (Northern Ireland) 1972, which replaced the majority of the 1911 Act in Northern Ireland. No one department has sole responsibility for enforcing this act, The 1911 Act which is used in England, Scotland and Wales by, among others, the State Veterinary Service, RSPCA, SSPCA, the police and local authorities when bringing prosecutions for cruelty to animals.

70. GM and non-GM cloned animals are protected by general animal welfare legislation as well as coming under the provisions of A(SP)A.  If a GM or non-GM cloned animal were to be discharged from the Act and released into the environment (with an appropriate consent), or if genetic modification ceased to come within the remit of the Act, the GM or non-GM cloned animal would remain under the protection of general animal welfare legislation. 

Until June 2001 the Home Office was the lead department on animal issues, but responsibility has now transferred to DEFRA.

Farm animal welfare legislation

71. GM animals which fall within the definition of ‘livestock’[41] arewill be covered by the Agriculture (Miscellaneous Provisions) Act 1968, under which it is an offence to cause unnecessary pain or distress to any livestock kept on agricultural land.  The Welfare of Farmed Animals (England) Regulations 2000 enacts various an EU directives about conditions for farm animal welfare, including EU Directive 98/58/EC, which sets out general rules for the protection of animals (including fish) kept for farming purposes with separate directives governing laying hens, calves and pigs.  [expand] It states 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’.  Similar legislation has been enacted in Scotland, Wales and Northern Ireland.  This legislation would not be expected to apply to GM animals in pharming if and when they were discharged from A(SP)A because the animals would not be classed as livestock kept for an agricultural purpose.  But it would apply to other GM or non-GM cloned livestock.

1. It should be remembered that Under the Agriculture (Miscellaneous Provisions) Act 1968, codes of recommendation, or ‘welfare codes’ can be introduced with the approval of both Houses of Parliament [check position in the devolved administrations].  Although these do not lay down statutory requirements, livestock farmers are required by law to be familiar with them, and they can be used to back up legislative requirements.

72. At EU level, EU Directive 98/58/EC sets out general rules for the protection of animals (including fish) kept for farming purposes, and there are separate directives governing laying hens, calves and pigs.  In general, lEuropean Community law relating to animals is most commonly made at EU level. issued as Directives which Member States are obliged to transpose the EC directives into national law.  [expand]  In addition the Council of Europe has five Conventions covering animal welfare, including one on the Protection of Animals kept for Farming Purposes and also one on the Protection of Pet Animals.  The EU (and individual Member States) are obliged to abide by World Trade Organisation rules in drawing up legislation. 

1.Other aspects of animal welfare (GM or otherwise) are regulated by the Welfare of Animals (Transport) Order 1997, the Welfare of Animals at Markets Order 1990, the Welfare of Animals (Slaughter and Killing) Regulations 1995/6 etc.  DEFRA is responsible for this legislation and for its enforcement.  Permission must be obtained from the Home Office before transporting a GM animal, and the animal has to be certified fit for travel by a member of the State Veterinary Service (SVS).

Advisory bodies

PART 3.5  ADVISORY BODIES

[Include diagrams to show how structures relate to one another]

RResearch animals

73. The Animal Procedures Committee (APC) advises the Home Secretary on matters concerned with A(SP)A and his functions under it.  The APC has an obligation to have regard both to the legitimate requirements of science and industry and to the protection of animals against avoidable suffering and unnecessary use in scientific procedures.

Farm animals

74. The Farm Animal Welfare Council (FAWC) was set up in 1979.  It is a non-statutory advisory body whose operation is funded by DEFRA.  Its terms of reference are to "to keep under review the welfare of farm animals on agricultural land, at market, in transit and at the place of slaughter, and to advise the Minister of Agriculture, Fisheries and Food, the First Minister of the Office of the Scottish Executive and the First Secretary of the National Assembly for Wales of any legislative or other changes that may be necessary".  The Council can investigate any topic falling within its remit, communicate freely with outside bodies, the European Commission and the public and publish its advice independently.

75. FAWC operates by making reports, which can form the basis for Codes of Practice for England which are prepared by DEFRA and laid before both Houses of Parliament for affirmative resolution.   [A similar mechanism is employed check in the Scottish Parliament and the National Assembly for Wales.position in Scotland and Wales].  Like the Highway Code, these Codes can be taken into account in Court although failure to comply with them is not an offence in itself. . 

Companion animals

76. The Companion Animals Welfare Council (CAWC) is different from the APC and FAWC in that it was not set up by statute or Government.  It is a voluntary body set up in 1999 and neither it nor its reports have any formal status.  Its members were chosen by a panel set up, though not by gGovernment, for the purpose.  CAWC receives no Government funding.  It hoped when it was set up to receive Government funding in the same way as FAWC but when this was not forthcoming its founders launched it anyway, in the hope that if it proved its worth by the reports it producedset up, then it might attract Government sponsorship similar to FAWC.

Containment/deliberate release of GM animals

77. In respect of the contained use of GM animals, including micro-organisms, the Health and Safety Commission is advised by the Advisory Committee on Genetic Modification (ACGM).  Its remit includes all aspects of human and environmental safety of the contained use of GMOs (even though the Contained Use Regulations are not concerned with risk to the environment).  At the local level Genetic Modification Safety Committees advise on the risk assessments prepared under the regulations.  They often advise on environmental assessments as well, even though they have no statutory duty to do so. 

78. The Advisory Committee on Releases into the Environment (ACRE) advises Government on applications for the deliberate release of GMOs into the environment.  To date no applications to release a GM or non-GM cloned animal have been made. 

Enforcement

79. It is worth noting here that effective enforcement of regulations is critical to the effective working of any regulatory system.  In our report we have concentrated on reviewing the legislation and advisory bodies relating to animals and biotechnology, although we have heard and considered some evidence about enforcement in the course of that examination.

80. There are different enforcement bodies whose work is relevant to animals and biotechnology.  The Animals Scientific Procedures Inspectorate in the Home Office is responsible for enforcing regulation on research animals.  Specialist inspectors from the Health and Safety Executive enforce both the Contained Use Regulations and Part VI of the EPA 1990 on behalf of the Department for the Environment, Food and Rural Affairs (DEFRA).  Outside the field of research, for farm, companion and zoo animals, enforcement of legislation falls variously to local authorities, the police and the State Veterinary Service, with animal welfare societies, principally the Royal, Scottish and Ulster Societies for the Prevention of Cruelty to Animals (RSPCA, SSPCA and USPCA respectively) also playing an independent role.  In part 5 we note some points which have made to us about different aspects of enforcement.

PART 3.6      EMERGING FINDINGSO UR FINDINGS

81. It is clear that the potential scope of modern biotechnology applications involving animals is wide, including .  Biotechnology willf have implications for all categories of domesticated animals: farm animals and farmed fish and, companion animals. , It has alreadyand made a great difference to the way medical research is undertakenanimals in research establishments.  In the future there may be a wish to apply modern biotechnology to zoo[42] or wild animals. Moreover, tThe potential applications go beyond the laboratory, farm and home;.  There they are likely to have implications for the wider environment, particularly in the case of insects and fish.  It is also clear that some people object to the application of genetic modification or other techniques of modern biotechnology to animals as a matter of principle.  As our social research showed, it seems likely that the nature and speed of changes which can be undertaken by means of modern biotechnology are matters of public concern that will continue to have a bearing on the regulatory decision-making process alongside judgements about the potential claims for the benefits of applying modern biotechnology to animals.

Procedures for generating animals using modern biotechnology

82. It is necessary to look first at the implications of the particular processes of generating animals for human use.  The current procedures for generating GM and non-GM cloned mammals have animal welfare implications which need to be taken into account.  Creation of GM animals by random incorporation of the transgene following microinjection and/or in vitro culture remains 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.  It is important that these factors are not ignored in the decision-making process about the desired outcome of the creation of the animal and the use that will be made of the animal.  If and when the techniques become more efficient for mammals, the welfare problems around GM generation may become less of a concern. 

83. The welfare implications of transgenic generation are different from conventional breeding but we do not believe that they are sufficient to merit treating transgenic generation of animals separately from other kinds of generation.  For example, another relatively novel technique, the use of implanted embryos involving smaller breeds of cattle giving birth to a different breed of calf which is larger than the maternal breed’s normal offspring, has had the effect of increasing the number of elective caesareans in cattle.  Vets noticed this and there are now embryo transfer regulations in place.  To take another example, there may be as yet unrecognised welfare and other implications of selectively breeding sheep for scrapie resistance.  The particular welfare implications of the processes for generating animals using modern biotechnology should be taken into account in decision-making, alongside other considerations. 

84. As noted earlier the potential speed of changes to the genotype of animals which modern biotechnology may allow is a feature of the technology that our social research has indicated is potentially a matter of public concern.  It will be important that any such changes to farm or companion animals produced for commercialisation are carefully justified, while not imposing a double standard on biotechnology applications in this regard compared with conventional or marker-assisted breeding techniques. 

1.We concluded, quite early on in our work that it made no sense to make recommendations about the kinds of animals created using modern biotechnology and what was done with them in isolation from the breeding of animals by conventional means or the use of animals outside agriculture.  To do so would run the risk of incoherence.  Our report therefore examines biotechnology and animals firmly in the context of society’s relationships with animals more generally. 

1.

1.Why do we think this?  First, because the practical issues relating to the application of modern biotechnology to animals are similar to those relating to conventional animals.  The outcomes of breeding programmes and animal management whether using conventional selective breeding processes or modern biotechnology raise similar issues.  Second, if animals subject to modern biotechnology, including genetic modification, are commercialised they would fall under the existing regulatory system relating to  conventional animals. 

1.

Outcomes of breeding programmes

1. Issues about the arising from the outcomes of artificial breeding programmes, are similar for whether conventional selective breeding orand modern biotechnology,. are similar. Some selective breeding processes have led to major changes in the characteristicsphenotype of some species of companion and farm animals.  It was put to us that the present regulatory system has no means of addressing incremental man-made changes to an animal species which may have welfare implications for the animals produced [discuss further in context of farm animal welfare regulations 2000.]

1.

85. Broiler chickens have been raised are a commonly cited with us in evidence as an exampleexample.  We have heard conflicting reports on the issue of whether these birds suffer significantly painful skeletal defects because they grow so fast.  We understand that the information which was gathered by the broiler industry following publication of thea Farm Animal Welfare Council report in 1992[43] and which has been the subject of some dispute is being reviewed by an independent statistician, with a view to publication thereafter.  We welcome this.  We also welcome the fact that DEFRA are tendering for an independent research study into the factors affecting chicken leg health and look forward to seeing the outcomes of both..  We recognise that determining this is a complex problem. 

86. What does seem clear is that there is a real possibility of adverse effects on animals welfare as a result of selective breeding.  It has been argued could reasonably be argued thatthat the inability of male turkeys to mount female birds for the purposes of reproduction due to the enlarged size of the male birds’ breast, or the difficulty in mating experienced by other farm animals [research further if used] is an further exampleindicator of this.  The congenital weaknesses in some specialised breeds of pet dogs points in the same direction.  It may also be the case that undesired effects for producers as well as or in addition to the animals themselves may arise from selective breeding. For example, DEFRA have in place a programme of research to investigate the causes of theMore striking, perhaps, is the steady long-term decline in the fertility of the diairy and pig herd and pig herds.  The causes of infertility appear to be related to increased growth and performance of livestock but are not understood at present.[44] population which may be related to

1. a less modern biotechnology,  [research further]The congenital weaknesses in some specialised breeds of dogs also points in the same directionWe would not want to lose sight of the benefits which selective breeding can and has brought to livestock production.  The result of many breeding programmes has been in part to produce cheaper and more plentiful meat.  Traits of benefit to farm animals as well as to producers and consumers can be produced by both modern biotechnology and conventional or marker-assisted selective breeding.  The key point in relation to looking at the application of biotechnology to animals, however, is that the potential benefits and problems which result from the application of each of conventional techniques and of modern biotechnology are not different in kind.  In each case, the benefits and problems have to be weighed up.  There should be no double standards in regulation between applying modern biotechnology and other processes which can lead to similar - positive or negative - outcomes.

87. In noting the potential problems, however, we would not want to lose sight of the benefits which selective breeding can and has brought to  livestock production.  The aim of many breeding programmes has been in part to produce cheaper and more plentiful meat to satisfy strong consumer demand. 

Applying modern biotechnology to animals

1.It should be noted here, however, that in addition to the outcomes of applying the technology it is also important to consider the implications of the particular methods of generating animals for human use.  The current procedures for generating GM and/or cloned animals, involving random incorporation of the transgene following microinjection and/or in vitro culture, have animal welfare implications.  The procedures generate a high degree of embryo mortality and foetal abnormality.  Moreover animal welfare is adversely affected by several other associated procedures, such as the use of vasectomised males, Caesarean section and other surgery.  These procedures are qualitatively different from conventional reproductive techniques, and are responsible for significantly reduced animal welfare.  It is important that these factors are not ignored in the decision-making process about the desired outcome of the creation of the animal and the use that will be made of the animal.  If and when the techniques improve, this would obviously become less of a concern.  this  must be taken in the round.

1.In short, we believe that issues about the outcomes of animal breeding, whether by conventional means or by means of modern biotechnology, must be addressed in the regulatory framework.  We have therefore taken a broad strategic view of the regulatory system as it applies to the production of animals for agricultural, research and other purposes.  The system must be sufficiently robust to address the outcomes of both modern biotechnological or conventional breeding processes.

Commercialisation of GM and non-GM cloned animals

88. We have noted that these three categories of animal (farm, research and companion) exist in quite different environments and give rise to different sets of issues.  At present, all GM and non-GM cloned animals in Britain are covered by A(SP)Athe legislation relating to research animals and/or contained use regulations.  This tightly regulates experimentation on these animals.  They do not fall under the legislation applying to conventional farm, companion or other animals.  But iIf and when GM and non-GM cloned animals enter production on the farm, were on sale in pet shops or looked after by pet owners, however, then they would have been at presentreleased by the Home Office from the provisions of A(SP)A.  Tthey would, like conventional animals, be governed by the fall same under the regulatory framework as non-research animalswhich covers conventional animals in relation to animal welfare.  Consequently, we have examined the present regulatory system for farm, research and companion animals to see if they are adequate to deal with present biotechnology applications to animals and possible future applications.

We have concluded that the practical issues around  GM and cloned animals, once those animals have been created, either for research, conventional agricultural production or biopharming, or indeed as companion animals, particularly in relation to animal welfare, are not different in kind from those relating to conventional animals in each category. 

1.We would expect, therefore, GM and cloned animals in these areas  to be covered by the legislation which applies to other kinds of animals.  (The possible comparatively greater impact on the environment of GM fish and insects, however, may require special measures.)  In the course of our examination of the present system for regulating GM and cloned animals, we came across features which we believe should be improved. 

Findings

89. From these emerging findings, we concluded that it made no sense to make recommendations about the kinds of animals created using modern biotechnology and what was done with them in isolation from the breeding of animals by conventional means or the use of animals outside agriculture.  Our report therefore has examined biotechnology and animals firmly in the context of society’s relationships with animals more generally.

90. Why do we think this?  First, because the practical issues relating to the application of modern biotechnology to animals are similar to those relating to conventional animals.  The outcomes of breeding programmes and animal management whether using conventional selective breeding processes or modern biotechnology raise similar issues.  Second, if animals subject to modern biotechnology, including genetic modification and cloning, are commercialised they would fall under the existing regulatory system relating to conventional farm or companion animals.  We therefore have examined what the regulatory system ought to try to do; whether the existing regulations are adequate to cope with commercialisation; and whether, outside the laboratory, there are any specific issues about GM and non-GM cloned animals which would require a different regime from conventional animals.  We consider the implications for the regulatory and advisory system in part 5, as well as what we believe will be the public's expectation of the issues that need to be considered and the standards applied.

91. One of the findings from our public reference group is relevant in this context.  Most people’s principal concern was about the reasons behind the particular uses made of animals, rather than whether the animals were genetically modified or cloned.  This would seem to support the approach of considering applications of biotechnology to animals in a wider context.

Clearly our recommendations in this area would apply equally to conventional animals as to GM and cloned animals.  Here too we considered it essential to take a strategic and broad view of the issues surrounding animalsAccordingly, our recommendations about the legislative framework, advisory structures and enforcement machinery in relation to animals in Part 6 have implications for both animals which have been the subject of modern biotechnology techniques and non-GM animals.

1.

92. In short, we believe that issues about the outcomes of animal breeding, whether by conventional means or by means of modern biotechnology, must be addressed in the regulatory framework.  The particular animal welfare implications of the different techniques used need to be considered, along with other factors, as part of decision-making.  It makes no sense to consider the issues raised by any commercialisation of farm or companion animals created using modern biotechnology in isolation from the breeding and management of animals by conventional means.  To do so would run the risk of incoherence and setting double standards. 

Summary

1.The scope of our report includes all the techniques of modern biotechnology relevant to animals, including genetic modification, cloning and marker-assisted breeding.. 

1.But we also concluded, quite early on in our work that it made no sense to make recommendations about the kinds of animals created using modern biotechnology and the purposes for which they are made in isolation from the breeding of animals by conventional means or animals outside agriculture.  To do so would run the risk of incoherence.  Our report therefore examines biotechnology and animals firmly in the context of society’s existing  relationships with animals more generally.

1.

1.In short, therefore, we believe that issues about the outcomes of animal breeding, whether by conventional means or by means of modern biotechnology, must be addressed in the regulatory framework.  We have therefore taken a broad strategic view of the regulatory system as it applies to the production of animals for agricultural, research and other purposes.  The system must be sufficiently robust to address the outcomes of both modern biotechnological or conventional breeding processes.  Accordingly, our recommendations about the legislative framework, advisory structures and enforcement machinery in relation to animals in Part 6 have implications for both  modern biotechnological animals and conventional animals. 

PART 4      WHAT SHOULD AA LEGISLATIVE AND REGULATORY FRAMEWORK

DO?

Introduction

93. To be effective, a regulatory system should allow consideration of all relevant factors in relation to the activity which is the subject of regulation.  The reason in general for regulation in the first place is to seek to prevent what society considers to be undesirable consequences in relation to an activity.  As regards animals, the basic historical driver for regulation in the United Kingdom was in relation to prevention of 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 evention of Cruelty to Animals Act (1911)[45].  As discussed in part 3, Tthere is now an extensive set of regulations (see part 6) in the United Kingdom relating to society’s different relationships with animals. 

94. The principal factors which are taken into account in regulation 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; and human health (especially in relation to farm animals produced for human consumption).  The relevance and weight of these different factors will vary according to the nature of the relationship with and use made of the animal.  In relation to the treatment of animals generally, including the application of biotechnology, it seems clear that there is widespread public support for a regulatory and advisory system which takes appropriate account of all relevant factors. 

1. All of the relevant factors have an ethical dimension (not only animal welfare)The relative importance society gives to different factors changes over time: for example, what has been thought to be acceptable treatment of animals has changed, as the debates in Parliament and in society before the 1911 Act illustrates[46].  What these factors mean in particular instances to people and animals outside the United Kingdom may also be considered relevant to the decision-making process. 

1.

95. In relation to the treatment of animals generally, including the application of biotechnology, it seems clear that there is widespread public support for a regulatory and advisory system which takes appropriate account of all relevant factors: an ethical decision-making process.  For the purposes of decision-making, ethical considerations need not be considered as something different from the principal factors in the decision-making process set out above.. Ethical considerations in relation to animals are sometimes portrayed as solely matters relating to animal welfare.  But for the purposes of making and implementing public policy, it is more helpful to think of an ethical process as one which encompasses appropriate consideration of the various relevant factors.  For example, Ddecisions which fall under the category of protection of the environment for future generations invariably involve ethical considerations.  are not different from ethical considerations.  Similarly for economic considerations: supporting legitimate economic activity that promotes economic well-being and job opportunities, or at least not effectively preventing individuals and businesses from undertaking legitimate economic activity, can be considered an ethical duty of Government. 

96. In practice, appropriate consideration of these factors for decision-making in the regulatory system involves an assessment of the different relevant factors relating to relationships with those animals.  In general, this is not an entirely open-ended balancing of the various factors.  The factors have certain boundaries.  In relation to economic interests, it is generally accepted that there is a legitimate interest in individuals making a living from animals, whether by rearing them for food, selling them as pets,  providing veterinary services, or for the commercial pursuit of improvements in human and animal medicine by using animals in research.  Regulation, therefore, takes place within a boundary that it is proper to pursue legitimate economic interests.  As noted in the Report of the Committee to cConsider the eEthical iImplications of eEmerging tTechnologies in the bBreeding of fFarm aAnimals[47], the present regulatory framework is founded on the premise that the uses of animals as livestock or in research or as companion animals is legitimate, subject to that use being humane.

97. For the use of animals to be humane, the The main constraint governing society’s various relationships with animals is considerations of animal welfare of animals must be taken into account..  Certain practices, for example cock-fighting or badger-baiting, have come to be considered inhumane in the UK and are consequently illegal.  Any economic interest in those activities would not be considered to outweigh the welfare considerations.  Detailed provisions in legislation and codes of practice have sought to give practical expression to the concept of the humane use of animals.[48].  At a fundamental level, therefore, the fact that