SUMMARY

  TB caused by the organism M bovis transmitted from cattle used to be a major cause of illness and death in humans. Since the war this risk to human health has been reduced to a very low level through the heat treatment of milk and action to reduce the levels of infection in cattle herds.

  Within herds, TB can spread between cattle. Herds are tested regularly. Animals which react positively are slaughtered, and herds isolated until further tests are clear. This approach has eliminated TB in other countries but not in GB. Although TB has been reduced to a low level here, it has risen again since the 1980s. The Government is examining whether to strengthen current arrangements, but it is clear that alone they will not eradicate the disease.

  We cannot be sure why TB is rising again, but the weight of scientific evidence suggests a reservoir of infection in wildlife, particularly in badgers. The Krebs report reviewed the evidence, confirmed that badgers were a significant source of infection, and made a number of recommendations designed to fill gaps in our knowledge, and develop a science-based approach to TB control.

  In the longer term vaccination offers good prospects for control. MAFF has set up a vaccine development programme building on recent scientific advances. It will probably take at least 10 to 15 years, and success is not guaranteed. We cannot rely on an effective practicable vaccine becoming available in the long term, and it will offer nothing for disease control meanwhile.

  MAFF has expanded its research programme. To improve understanding of the risk factors associated with TB incidents on cattle farms, new studies will cover wildlife, husbandry, animal nutrition, and local climatic and environmental influences. The results will be reflected in guidance for industry.

  These initiatives are unlikely to be effective unless we also reduce underlying infection levels and interrupt transmission between badgers and cattle. Having considered the alternatives, the Government has reluctantly concluded that we need to know when culling badgers can contribute effectively to TB control. It is therefore carrying out the culling trial proposed in the Krebs report, but—on welfare grounds—without using snares and with a closed season (the key points from consultation). The Bourne Group has designed this to integrate with the rest of the TB programme and provide the maximum amount of information.

I.  INTRODUCTION

  1.1  The Krebs report was published on 16 December 1997, together with the Government response which accepted its conclusions and recommendations in principle and subject to further consideration of the legal, financial and practical implications, and invited public comments on how to take them forward. This process of consultation was enhanced by the establishment in February 1998 of the Independent Scientific Group chaired by Professor John Bourne to advise on implementation and the subsequent release of its first report. A new research requirements document was published in April 1998 and followed by open meetings of scientists working on TB research.

  1.2  The Krebs report is a thorough assessment of the state of knowledge on TB in cattle, on TB in badgers, and of the links between them. It is perhaps invidious to suggest that any individual sentences from the report can encapsulate the whole, but three quotations focus on the major issues:

The current risk of human infection with M bovis in Great Britain is negligible. However, the disease has the potential to cause problems (paragraph 1.2.13)


The control of TB in cattle is a complex problem and there is no single solution. We recommend a combination of approaches on different timescales. (Executive summary, paragraph 1)


The sum of evidence strongly supports the view that, in Britain, badgers are a significant source of infection in cattle . . . in total the available evidence . . . is compelling. (Executive summary, paragraph 5)

  1.3  Following detailed consideration of the report, the advice presented by the Independent Scientific Group, and all other comments received, the Government announed on 17 August 1998, a five point strategy for controlling TB in cattle. This is intended to prevent widespread disease in dairy and beef cattle herds used for milk and meat to feed human beings and to tackle a disease which is a serious welfare issue for cattle, and a major source of disruption to livestock enterprises.

  1.4  The Government's strategy recognises that a vaccine for cattle may contribute substantially to control in the longer term, but that success is not guaranteed despite significant scientific advances in recent years. Even if vaccine research is successful, there is no prospect that a vaccine could be made available in time to address the immediate problem of increasing TB incidence. The strategy also recognises that while the overwhelming majority of comments received supported the generality of the Krebs recommendations, there was a clear division of views on the role of badgers and the action to be taken: many respondents considered the Krebs Group had been unnecessarily cautious in its conclusions and that the case had in fact been demonstrated for removing badgers in areas of high TB incidence; others took a contrary view suggesting that badger culling had not proved effective in the past and would not do so in future, and expressing serious concern about the badger welfare implications and practicality of the trial proposed in the Report.

  1.5  The Government's strategy therefore aims to put policy on a scientific footing through a holistic approach examining the gaps in our knowledge of TB, including potential risk factors and sources of infection, identified in the Krebs report and through the consultation process. It accepts that any policy which ignored Krebs' conclusions about the significance of badgers in the transmission cycle would be as flawed, and as ill-founded in science, as any policy which concentrated on badgers to the exclusion of other factors.

  1.6  The strategy is guided by two main principles: putting public health first, and giving full weight to a commitment to animal welfare. The five points are:

—  to minimise the risks to humans and set up new arrangements with the Department of Health to investigate potential links with human health and monitor human cases of M bovis;

—  for the long term, to carry out a 10-15 year research programme to devlop a cattle vaccine;

—  further research projects to understand better how infection is transmitted;

—  to continue routine cattle testing, slaughter of reactors and movement restrictions in order to prevent spread from cattle to cattle; and to consider whether these arrangements need to be strengthened to stop the spread of the disease in the short term;

—  to carry out the badger culling trial recommended by the Krebs and Bourne Committees in order to find out when culling is an effective approach and when it is not.

  1.7  The remainder of this memorandum examines progress made on the various elements in this strategy, and assesses the economic and financial implications. The latest figures for TB incidents in cattle are annexed.

II.  PROTECTION OF PUBLIC HEALTH

  2.1  At a meeting between the Chief Medical Officer and the Chief Veterinary Officer in March 1998, it was agreed that liaison on TB caused by M bovis should take place between their Departments at local, regional and national levels. Liaison between Departments has since been strengthened at all levels.

  2.2  At national level, quarterly meetings of officials have taken place in July and October 1998 and a further meeting is scheduled for January 1999. The established lines of communication to Environmental Health Departments to ensure that the milk from dairy herds that contain TB reactors is heat treated before it is drunk or processed into milk products, have been reviewed and reporting lines clarified. Guidance to Environment Health Officers is being prepared.

  2.3  Human health generally continues to be protected by the heat treatment of milk and by cooking meat. Procedures to prevent carcases with TB lesions entering the food chain have been reviewed. These comply with current EU regulations and it is considered they are adequate to protect public health.

  2.4  The possible occupational risks of M bovis have been considered in consultation with the Health and Safety Executive. Although they consider the occupational risks to be low, HSE advise that there may be an increase in exposure to M bovis for some occupational groups (such as veterinarians, abattoir workers, farmers, wildlife officers and researchers both in the field and laboratory) as a result of the increasing number of farms with TB incidents or because they come into contact with infected animals or carcases. Guidance is available on the appropriate precautions, including good occupational hygiene, protective clothing and equipment, vaccination and, in some cases, stringent laboratory containment measures.

  2.5  A study of human tuberculosis cases in 1995 confirmed that only 1 per cent are attributed to M bovis, but the small numbers did not allow conclusions to be drawn on the possibilities of increased risk in particular locations, or of association with possible occupational exposure to infected cattle. Ways of overcoming these difficulties are being investigated.

  2.6  It has been recognised that there could be considerable benefit from increased collaboration between the Public Health Laboratory Service and the Veterinary Laboratories Agency in particular in understanding the epidemiology of M bovis infections through new techniques for typing the organism at the molecular level. Two joint research proposals were put forward in response to the research requirements document published on 20 April 1998 (see paragraph 4.3 below). The first aims to develop molecular fingerprinting of bovine and human isolates of M bovis to standardise techniques in order to co-ordinate disease surveillance. The second will use recent isolates, including material derived from the culling trial to develop new diagnostic techniques for identifying M bovis in animals and man. Both proposals have been accepted and negotiations to finalise contracts are underway.

III.  DEVELOPMENT OF A VACCINE

  3.1  The Krebs report concluded that in the long run, the best prospect for control of TB is to develop a vaccine for cattle, but recommended that the prospect of a badger vaccine should also be retained as an option. Much of the preliminary research is relevant to vaccines for both species, and the Government is moving forward on both fronts.

  3.2  We do not, of course, start with virgin territory. In the early years of this century Drs Calmette and Guerin produced the BCG vaccine for humans from M bovis after 13 years' work. Used in conjunction with other measures, particularly improvements in hygiene and nutrition, BCG appears to have contributed usefully to reducing TB in humans. Its potential as a cattle vaccine has also been explored in several countries, notably New Zealand and South Africa. However, BCG is known to compromise the use of the tuberculin skin test.

  3.3  The BCG vaccine varies in efficacy around the world, but despite considerable effort over the intervening years which has been able to draw on the extensive resources available to develop human vaccines, it remains the only TB vaccine. Within the last decade, however, scientific advances, particularly in the sphere of molecular biology, have opened up new avenues for vaccine research and improved the prospects for success. We have to recognise, nevertheless, that work to develop a new TB vaccine for use in animals will be taking place at the frontiers of scientific knowledge, so there can be no guarantee of a successful outcome.

  3.4  On the other hand, we are fortunate that these frontiers are being pushed forward across the globe, and that the UK vaccine development programme is taking place in an international context. It will both draw from and contribute to work in other countries. In 1994 the World Health Organisation, Food and Agriculture Organisation, and International Office for Epizootics held a joint consultation on animal tuberculosis vaccines. Their report concluded that basic research in three major areas—the pathobiology of M bovis, the nature of the host immune response and the development of vaccines and discriminatory diagnostic tests—would require effort over a fifteen year timescale. The Krebs report endorses this estimate.

  3.5  This amount of time is needed because, although the rate of progress to date suggests that many more potential vaccine candidates can be generated and tested in laboratory models within the next five years, the most promising candidates will then need to be evaluated in target species to establish appropriate vaccination protocols (dose, route of administration, etc) before field trials are carried out to determine efficacy and safety under operational conditions. Before any vaccine may be authorised for sale and use, it will also need to satisfy the standard criteria of safety, quality and efficacy which apply to all medicines. These include conformity with national and international guidelines regarding the use and release into the environment of biological materials, including genetically modified organisms.

  3.6  The Government has already spent £1.5 million since 1994 on preliminary work at the Veterinary Laboratories Agency to develop a badger vaccine. This work has produced techniques to generate vaccine candidates, and suitable laboratory models for testing them. It has also developed methods for studying badger immunology. This work has been refocused during 1998 to provide a sound launching pad for the larger programme on cattle recommended by Krebs, and to ensure that the results of work to date are published and available to the wider scientific community.

  3.7  An open competition to participate in the wider programme of vaccine research was included in the MAFF Animal Health and Welfare Research Requirements Document 1999-2000, published on 20 April 1998. On the day of publication, a seminar led by Professor Young of Imperial College was held in London to encourage co-operation between different research workers. Proceedings were published to ensure that all scientists and potential contractors were aware of latest developments in respect of both human and animal work. Scientists from Northern Ireland, the Republic of Ireland, New Zealand and the USA, and representatives from the vaccine and livestock industries participated in the workshop.

  3.8  The procedures for appraising research proposals similarly drew on a wide range of expertise, again involving experts from Great Britain, Northern Ireland, New Zealand, the Netherlands and the USA, scientists working on human tuberculosis vaccines, and the Bourne Group.

  3.9  The resultant new vaccine programme brings together successful bids from the Institute for Animal Health and the Veterinary Laboratories Agency, and involves collaboration with the Centre for Applied Microbiology and Research, Ag Research of New Zealand and other networks of scientists. Contracts are still being finalised for the work to start in April 1999. The cost is likely to be around £1.3 million annually.

  3.10  During its first three years this programme aims to generate vaccine candidates—which could be used in either cattle or badgers or both—and test them using an established low dose aerosol challenge guinea pig model (with a view to later challenge in cattle). The host immune response will be explored in cattle through work on antigen-presenting T cell responses to M bovis. An integral part of this programme will be a diagnostic test to differentiate between infected and vaccinated cattle, an essential element if vaccination is to be used to control the disease.

  3.11  A contract is being finalised with an independent programme consultant who will ensure integration of all aspects of this research, expand the liaison already developed with international scientists, and develop close links with the WHO task forces on human TB vaccines. The consultant will be involved in regular reviews of the work and report to MAFF on any redirection required to take account of new developments.

  3.12  Looking further ahead, before a vaccine can be brought into widespread use in cattle, two other developments must have occurred, neither directly related to research work. The most important concerns trade. Directive 64/432 as amended, which establishes animal health rules for intra community trade in cattle, requires the use of the intradermal tuberculin test. A positive reaction by any animal tested leads to the herd losing its Official Tuberculosis Free (OTF) status, which means that animals from that herd may not be exported and all milk from the herd must be heat treated. There would be serious problems with any vaccine which interfered with the skin test and risked herds losing their OTF status. If the programme is successful and we wish to adopt a TB control strategy which includes vaccination, it will be necessary to present the results of the vaccine programme to EU partners, and secure their co-operation.

  3.13  The second relates to marketing and distribution: links have been established with industry to ensure that vaccines identified are commercially viable and amenable to industrial production. At a later stage, the developer will need to identify a commercial partner to bring the product to market, and to negotiate with them an arrangement which will provide both the Ministry and the participating research institutes reasonable royalties on the financial and intellectual investments made.

IV.  OTHER RESEARCH PROJECTS AND RELATED WORK

(a)   Krebs' recommendations for research

  4.1  In addition to the recommendations concerning vaccines, the Kerbs report recommended that a number of projects, all essentially directed at better understanding the transmission of TB and using that knowledge to control it more effectively, should be commissioned from those with the best expertise from throughout the research community. A complete review of MAFF's TB research programme was therefore carried out early in 1998.

  4.2  There have been three principal outcomes: the refocussing of existing projects to ensure that results are published and are available to provide a basis for long-term work, the establishment of a number of short-term projects during 1998-99, and the development of a major new research programme to start in April 1999.

(b)   Research programme, 1999 onwards

  4.3  The requirements document built on the results of epidemiological, modelling and molecular typing studies previously financed by MAFF. It contained research questions based on the whole range of Krebs recommendations and other policy needs for TB research. Some projects have been commissioned with MAFF Agencies to maintain essential epidemiological and molecular fingerprinting expertise, but the majority of projects are being placed on the basis of open competition. The areas covered in the document were:

—  integrated modelling approaches to improve understanding of disease transmission and assess the costs and benefits of different control strategies;

—  assessment of the correlates of local variations in TB risk to individual herds;

—  investigating the role of other wildlife species in transmitting TB to cattle;

—  developing molecular typing techniques for use in studying TB transmission between wildlife, cattle and other species (including man), the variation of different genotypes of M bovis, and variations in risk;

—  developing improved tests based on DNA amplification techniques to detect M bovis in badger carcases, excreta and environmental samples;

—  developing a test to establish M bovis prevalence in living badgers;

—  developing ways of estimating badger populations using field signs;

—  developing improved ways determining the effects of disturbance on badger populations.

  4.4  23 proposals relating to these questions were received and appraised with the help of external experts and the Bourne Group. In some cases overlap between bids meant that best value for money could be obtained if projects could be combined on a collaborative basis. On this basis negotiations are currently under way to finalise contracts for 13 research projects to start during the 1999-2000 year. 10 of these will interface with the work of the randomised badger culling trial, and this factor too is being reflected in the contract negotiations.

  4.5  In order to accommodate this work, the MAFF TB research budget has been increased from £1.7 million, to an estimated £3.1 million in 1999-2000. Of this around £1.3 million a year will be spent on vaccine development, the majority of the remainder being allocated to the projects described in this section.

(c)   Short term projects, 1998-99

  4.6  In July 1998 an invitation to bid for finance to undertake a multivariate analysis of MAFF's existing data on TB incidents in cattle, and to use the results to refine the questions pursued during the forthcoming epidemiological investigation (see below) was published. Six applications were received, and contracts are currently being negotiated with two of these.

  4.7  Additional funds are being made available to the Veterinary Laboratories Agency to integrate their information on TB molecular types (known as spoligotypes) in cattle and badgers into a geographical information system. This will allow better presentation of maps and permit a more focused analysis of similiarities and differences between the nature of M bovis strains infecting animals in an area.

  4.8  Resources have been committed to two projects which will allow the badger culling trial to be undertaken more efficiently. First, the protocol used for badger post mortems is being validated to make it as sensitive as possible in detecting TB. Second, an assessment is being made of the impact on TB detection levels of long term storage (freezing) of carcases.

  4.9  In its first report the Independent Scientific Group recommended that, because cage traps rarely resulted in the capture of more than 80 per cent of badgers in an area, MAFF should urgently investigate other humane capture methods in particular leg cuffs, and assess the actual welfare implications of snaring. Ministers decided not to undertake further research on snares, but accepted that there should be further work on the efficacy and acceptability of leg cuffs. A trial has been commissioned under a Home Office licence, using a cuff design based on one recommended by the Animal Welfare Institute of North America for its humaneness in other species (although it has not been tried on badgers). It is a padded cuff 0.75 of an inch wide made from a band of synthetic fibre, which is both strong and supple. Initially the leg cuffs will be tested on two to four badgers in specially designed observation pens under constant video surveillance. If no problems occur, the cuffs would be trialled on a slightly larger number of badgers under field conditions to test their efficacy as a method of capture. If badgers are injured at any stage, the trial will be abandoned.

(d)   Farm Management Risk Factors

  4.10  The Milk Development Council has provided finance for the Veterinary Laboritories Agency to use existing MAFF data and the results of a prospective postal survey for a multivariate analysis of the risk factors associated with farm management practices. It is intended that this will complement the analysis described at paragraph 4.6 above, and help to explain why some farms suffer TB breakdowns while others, apparently at the same risk of exposure to infection from wildlife or other sources, do not.

(e)   Epidemiological investigation

  4.11  For several years MAFF has collected information about farms where there have been TB breakdowns. Following the Krebs review, an expanded epidemiological investigation will collect information on a wider range of possible risk factors agreed in liaison with ISG, and incorporated in a new form, numbered TB99. This will be used on farms with TB and matched farms (controls) which have not experienced recent TB incidents. The new forms, which MAFF staff will complete with the help of farmers, will collect information about cattle movements, husbandry practices, wildlife on farms, and the local environment. This will be analysed alongside data on local weather conditions and patterns of badger activity collected during the badger culling trial to determine which factors seem to be associated with TB in cattle. The results will be used to develop control strategies, possibly including changes to animal husbandry practices.

  4.12  During November and December 1998 a pilot exercise was carried out using TB99 forms on approximately 30 farms in England and Wales, half of which have suffered TB incidents, the remainder acting as controls. The forms are currently being reviewed to reflect findings from the pilot study and other comments from consultation, and will be subject to further review in the light of experience and to reflect the findings of the multivariate analyses mentioned at 4.6 and 4.10 above.

  4.13  TB99 forms will be used for new TB incident farms from early 1999. Because detailed information on badger activity will be available only for areas surveyed for the badger culling trial, all control farms will initially be selected in the trial areas. Interim analyses will be made a soon as sufficient data have been collected, but because of the complexity of factors associated with TB infections it may require a considerable amount of data and time before clear conclusions emerge.

(f)   Road traffic accident survey

  4.14  The culling trial will provide detailed information on the prevalence of TB in badgers for the first time. In areas selected for proactive culling (see para 6.4) this will be relatively accurate, less so for areas with reactive culling. Elsewhere such information will be lacking as it has been in the past. The Independent Scientific Group has therefore recommended that badgers killed in road traffic accidents in seven counties should be collected and subject to post mortem. This will both provide a picture of badgers' TB infection status over a wider area, and permit comparisons with the more detailed information emerging from the trial areas to assess the reliability of road traffic accident surveys as a source of additional information of TB. It is planned to start the survey in spring 1999. Staff involved in the collection of carcases will be given instructions and protective personal equipment to protect their health and safety.

(g)   Trace elements

  4.15  It has been suggested by some that animals with mineral deficient diets might have increased susceptibility to TB, particularly in areas where soils are deficient in trace elements such as copper or selenium. There is no persuasive scientific evidence which either confirms or refutes this theory. MAFF is working to gain further evidence on the nutritional status of badgers and cattle.

  4.16  For badgers, staff in MAFF laboratories have analysed the livers of 343 badgers to determine the levels of trace elements. The relatively small number of badger livers analysed in this limited study do not yield results sufficiently robust to be of interest to a scientific journal. The results will, therefore, not be published. They are being written up and will be made available on request. For cattle, questions relating to nutritional status generally and to mineral supplements in particular have been included in the TB99 forms and will be analysed along with information relating to other possible risk factors.

V.  ACTION TO DETECT AND CONTAIN THE DISEASE IN CATTLE

  5.1  Since 1964 it has been Government policy to detect and contain tuberculosis in cattle by routine tuberculin testing of cattle herds and by examination of carcases at slaughter. The frequency of testing varies between one and four years depending on local TB incidence. Cattle which react to the test are slaughtered, and the herds from which they come are placed under movement restrictions until a programme of further tests gives negative results. Since our accession to the European Community these tests have been required by Community law. The Government's strategy relies on these arrangements continuing, and if necessary being strengthened.

  5.2  The Community rules were modifed during 1998, with minor changes due to come into effect in 1999. The opportunity is being taken to review the current arrangements and ensure that the geographical distribution of testing frequencies is optimal for detection of TB in cattle and reflects current patterns of disease. Ministers have considered whether further action is needed in the short term, but have concluded that, except for the regular adjustment of testing frequencies to reflect changing patterns of disease, it would not be sensible to make additional changes which pre-judge the results of the review.

  5.3  However, in order to improve the effectiveness of tracing cattle moved on or off holdings with TB breakdowns, so that herds at potential risk may also be tested, enhancements to the MAFF Animal Health and Cattle Tracing System databases are planned.

  5.4  The tuberculin test is well proven, is highly specific (ie it gives few false positive results) and is the standard test used around the world. However, like other screening tests it is not 100 per cent effective in all infected animals. An improved or complementary diagnostic test could improve the detection of disease and reduce the risk that disease could go unnoticed and so spread between animals. The Government is therefore continuing to finance research into alternative tests including the development and evaluation of a gamma interferon assay using blood samples. The blood test has undergone field trials in Northern Ireland and some field evaluation is planned in Great Britain. It is not sufficiently specific to replace the tuberculin test, but the trials may show that it can supplement the tuberculin test, especially by helping to clarify the disease status of cattle which have given an inconclusive reaction to the tuberculin test.

VI.  THE RANDOMISED BADGER CULLING TRIAL

(a)   Introduction

  6.1  The most controversial element of the strategy is the implementation of the culling trial recommended in the Krebs Report as necessary to measure the quantitative contribution of badgers to the development of TB in cattle and to answer questions relating to the epidemiology of TB in both cattle and badgers that will assist in the ultimate control of the disease. A key task of the Bourne Group was to design a trial, taking account of the practical difficulties and the need to minimise adverse effects on badger welfare, which was capable of yielding robust results, and providing a scientific basis on which a future sustainable TB control policy could be based. The way the Group tackled its remit, the factors considered, and the reasons underlying the trial design recommended to Ministers are set out in its first report, Towards a Sustainable Policy to Control TB in Cattle, presented to Ministers in July 1998.

  6.2  The Bourne group endorsed the scientific approach recommended by the Krebs report and also concluded that this could be best provided by a randomised trial based on the trial areas grouped in triplets in which different culling strategies were tested. Only by carrying out the trial in this way was the Bourne Group satisfied that fundamentally important questions on the epidemiology of TB in cattle and badgers would be answered. The trial permits the structured collection of data on a range of factors for analysis, both directly and through the research programme described at section IV above. The trial is therefore integrated closely with the other research work. It will provide much needed information on the role of badgers and other wildlife species. The post mortem examination of badgers from the trial and from the proposed road traffic accident survey, together with the culture of tissues and spoligotyping of any M bovis isolates found, will provide information on the disease status of badgers correlated geographically and to other factors associated with TB infection in cattle.

(b)   How the Trial will be carried out

  6.3  The Group recognised that the trial would need to have sufficient statistical power to accommodate a wide range of variables and draw reliable correlations between them. It would need to accommodate the fact that the trial was to be conducted on a voluntary basis and there would be variations in the extent to which landholders allowed access to their land. It would also have to take into account that the capture methods adopted would ensure the survival of a small proportion of the original badger population, that there might be interference with the trial in particular from disruption and the unlawful removal of badgers in trial areas, and that it could be difficult to quantify this. It reviewed the conclusions of the Krebs group and confirmed that a trial conducted over 30 areas each of around 100 km2 should provide sufficient power, although it has cautioned that in the event of excessive influence from factors such as the above, the trial may need to run for longer than five years before reliable conclusions could be drawn.

  6.4  The 30 areas will be grouped into ten "triplets" of three areas. Triplets will be brought into the trial as resources permit. As triplets will be selected in those areas of the country with the highest incidence of TB in cattle, this phased approach allows the latest data on TB incidence to determine where the trial will take place. Each triplet will be surveyed for badger activity, after which each area in the triplet will be allocated randomly to one of three treatments:

—  "proactive" culling (where as many badgers as possible are removed from the whole area and the area is kept as free from badgers as possible for the rest of the trial);

—  "reactive" culling (where badgers are only removed from social groups associated with farms where TB is found in cattle);

—  "survey only" control areas (where no badgers are culled).

  6.5  In the proactive cull area, traps will then be sited, baited for up to 14 days, then set to catch badgers. Once the cull in the proactive treatment area is complete, culling will start in response to confirmed TB incidents in cattle in the reactive cull area of the triplet. The proactively culled area will be revisited regularly for the duration of the trial to remove immigrant badgers. In reactively culled areas, repeat removals will take place only if there are repeat breakdowns. All three areas will be resurveyed on a sample basis three and five years after the initial survey.

(c)   Recruitment of Additional Wildlife Staff

  6.6  A trial on this scale requires considerably more staff resource than is currently available through the Ministry's Wildlife Unit. Accordingly, a recruitment exercise for 30 additional temporary staff at the Unit's office in Gloucestershire, and a similar number in Cornwall, was launched last December. The aim is to have the new recruits trained and in post before the end of the 1999 closed season.

  6.7  Staff are graded in the Ministry's Support Grade Band 1 and as such no formal qualifications are required. However, a number of specific abilities are needed, and were set out in job advertisements placed in Job Centres across Cornwall and Gloucestershire, and in Farmers' Weekly, West Briton, and Stroud Journal. Because the use of firearms is an integral part of the job advertisements were also placed in Shooting Times. More than 1,000 applications are currently being sifted, with interviews due to begin later this month. Recruitment will be in accordance with MAFF equal opportunities policy. All successful applicants will be required to undergo a medical examination, and will be subject to security clearance procedures.

(d)   Progress to end-December 1998

  6.8  The first two triplets, selected on the basis of TB incidence data up to the end of 1997, lay across the Devon/Cornwall and the Gloucestershire/Worcestershire/Herefordshire county boundaries. Work in these areas started as soon as Ministers had announced that the trial would go ahead. On 19 August officials wrote to all landowners known to MAFF in the trial areas to arrange visits to seek agreement to survey land and, if appropriate, to cull badgers according to the treatment allocated to that area. Surveying began in both triplets on 28 August 1998.

  6.9  On 4 November, the random allocation of treatments within the first (Devon/Cornwall) triplet was made in the presence of an independent witness. The result was not divulged until 11 November, when Professor Bourne agreed that surveying in this triplet was almost complete, and arrangements had to be put in hand to start the proactive cull by siting traps. This started in the Putford area of Devon on 16 November. Pre-baiting with peanuts, during which traps are securely tied open to allow badgers to become familiar with their presence without risk of capture, began on 23 November. Trapping began on 1 December and ended on 13 December (12 nights).

  6.10  Altogether 238 badgers were captured and shot. The carcases have been taken for post mortem examinations and for the culture of tissues. Because of the time taken to culture mycobacteria this information will not be available before late February, and will then need to be analysed with other information gained from the Putford area.

  6.11  Surveying in the Gloucestershire/Worcestershire/Herefordshire triplet is still continuing and is expected to be completed in February 1999. By then, the ISG will have identified the next group of triplets to be taken into the trial.

(e)   Number of badgers to be killed

  6.12  Until the trial has been completed it is impossible to say how many badgers will be killed. Using the assumption that average badger density is 5/km² the Krebs report suggested that some 12,500 might be killed during a five-year trial. At Putford only 238 were taken: there is no reason to believe this area is typical of those parts of the country where the rest of the trial is to be carried out, but it suggests the Krebs figure may be an over estimate. The figure of 20,000 which has gained some public credence following its proposal by the National Federation of Badger Groups looks almost certain to be considerably exaggerated. In any case, the trial is being conducted over less than 1 per cent of the area of Great Britain and will not have a significant effect on the overall badger population.

(f)   Badger Welfare

  6.13  Many comments received during the consultation on the Krebs report, and at meetings with wildlife organisations, expressed concern about the welfare implications of the trial. These focused on the use of snares, and the possibility that culling lactating female badgers, as recommended in the Krebs report, would leave dependent cubs to starve underground.

  6.14  The Bourne Group recommended against using snares in the badger culling trial, but recommended also that MAFF should investigate other capture methods in particular leg cuffs (see paragraph 4.9 above), and assess the actual welfare implications of snaring. Ministers strongly argued that snares should not be used in the culling experiment and decided not to conduct research on snares. In both proactive and reactive trial areas badgers will be cage trapped and despatched humanely by shooting by trained Ministry staff.

  6.15  The Krebs report recommended that there should not be a closed season for badger culling. However, the Group examined evidence relating to badger breeding seasons and concluded that badger welfare would be enhanced by a closed season. The three months from February to April were selected because over a period of years they would offer protection to a greater proportion of dependent cubs than any other three month period, while the logistical challenge in managing field operations would not be insuperable.

(g)   Release of data

  6.16  Following analysis MAFF will release whatever information can be made public without compromising future stages of the trial. In its first report, the Group expressed a particular concern that premature release of data, and of analyses based on those data, could jeopardise the viability of the whole investigation by undermining compliance with the regimes proposed (para 18.2). Because the Government's primary motivation in conducting the investigation is to arrive at a sound scientific basis for future policy decisions, the Group's recommendations in this area have been accepted by Ministers. Ultimately, however, it is intended that the results are published in peer-reviewed scientific literature, and the data (once private information such as the names and addresses of individuals has been removed) should be made available for other researchers.

(h)   External audit

  6.17  The reliability of the conclusions to be drawn from the evaluation of the trial results will depend critically on the trial design being properly implemented and carefully analysed. MAFF have drawn up standard operating procedures which have been approved by the Bourne Group and are used by officials carrying out the trial. MAFF will review these in the light of experience and revise them on the basis of further advice from the Group. The Group also recommended that arrangements for an external audit of operations and of the adequacy of the standard operating procedures should be put in place. Following open competition on the basis of an invitation to tender, a contract for one year is being finalised. A further tender notice will be published to invite bids for later contracts.

(i)   Bern Convention

  6.18  Wildlife organisations have claimed that the trial contravenes the Bern Convention on the Conservation of European Wildlife and Natural Habitats, and presented their case for these claims to the Convention Standing Committee meeting in Strasbourg on 2 December 1998. The Committee adopted a recommendation calling for the trail to be suspended to allow time for consideration of the case and a UK response to it. The Government is reflecting on the recommendation. Meanwhile it does not accept that it has acted in breach of the Convention and has started to prepare its response.

VII.  ECONOMIC EFFECTS OF BOVINE TB

  7.1  TB in cattle imposes a significant financial burden on the taxpayer (public expenditure figures at section VIII below) and the farming industry. Routine cattle testing disrupts farming operations and imposes costs. The additional costs of breakdowns are borne disproportionately by the minority of farmers who keep cattle in particular regions of the country. Even though farmers receive compensation for slaughtered animals, there are costs associated with lost production and the additional costs arising from the movement restrictions placed on the premises. These can include extra costs for buildings, equipment and bedding, disruption of breeding programmes, loss of revenue from selling cattle at less than optimum times, purchasing or leasing additional milk quota to allow extra production to be marketed, loss of subsidy, and costs for additional feed. Restrictions on the movement of cattle can cause significant disruption to a farm business, and can have prolonged effects on the viability of a farm. Farms with a history of TB incidents can experience difficulty in obtaining insurance cover at realistic premiums for these costs.

  7.2  Farmers have a responsibility to take preventive action where possible, so compensation for slaughtered reactor cattle is not intended to cover the full economic costs of a breakdown. On 17 August Ministers announced that compensation would be increased to the full market value of slaughtered reactor cattle to reflect the fact that the ending of general badger culling could increase cattle exposure to infection from wildlife sources. This change was made on 26 August in England and Wales and 4 September in Scotland. The National Famers Union have estimated the average cost to farmers arising from a TB incident is £5,300 per animal slaughtered, although the cost to individual farm business varies widely.

  7.3  There are also social costs from a variety of factors although these are largely unquantifiable.

VIII.  PUBLIC EXPENDITURE POSITION

  8.1  Total expenditure on controlling TB in cattle in Great Britain in 1997 was £16.1 million, distributed in the following manner:

  8.2  Had there been no change in Government policy, these costs would have risen significantly as TB incidence increased. The Government has recognised that tackling the bovine TB problem will require additional resources, which can only be made available within Department allocations following the Comprehensive Spending Review. For the financial year 1999-2000, compared with 1997, the additional costs are expected to be as follows:

  ⁱ  Increases due to increasing prevalence of TB.

  ⁱⁱ  Increases due to increasing prevalence of TB, increased rates of payment, and changes arising from EC legislation.

  ⁱⁱⁱ  £6 million additional finance, taken with the £1.7 million saved by ending general badger removal operations, provides an envelope from which the road traffic accident survey, the culling trial and all data collection work for epidemiological analysis will be financed.

IX.  FUTURE TB CONTROL POLICY

  9.1  There has been much speculation as to what future policy will be if the trial shows that proactive—or reactive—culling reduces the incidence of TB. It is not possible to answer such questions at this stage. The trial will yield a lot of information in addition to the comparison of approaches to culling, and is itself only a part of a wider programme. In the longer term vaccination offers good prospects for controlling TB, but even if the vaccine development project is successful it is unlikely that a vaccine will prove fully effective without complementary action to reduce infection levels. Action of this sort will remain the only option for controlling the disease in the shorter term. The detailed nature of such action will only become clear in the light of the results of the Government's whole programme of work and of relevant developments overseas. Further decisions on TB policy will need to be similarly broadly based.

  9.2  The Government policy described in this memorandum is directed to the control of TB in cattle. It fully recognises that, although not an endangered species, the badger enjoys considerable protection in law. The Government hopes, in particular, to show whether badger culling is necessary or effective. The present multifaceted approach is designed to develop a scientifically sustainable approach which will control TB for the benefit of cattle, badgers and the population as a whole.

18 January 1999

NOTES:

1.  West Region consists of Cornwall, Devon, Somerset, Dorset, Gloucestershire, Avon, Wiltshire, Hereford and Worcester and Shropshire.
2.  Figures for 1995, 1996 and 1997 are taken from the Chief Veterinary Officer's Annual Reports.
3.  For 1998 confirmed figures are available only until June because of the time taken for the laboratory work needed to confirm breakdowns. However, it is expected that end-year figures will show an increase of 50-60 per cent on 1997 figures. The January to June figures are: