53. The policy announced on 17 August 1998 is "guided by two main principles: putting public health first, and giving full weight to a commitment to animal welfare". MAFF claimed that it "aims to put policy on 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".[135] The strategy has five components:

• to minimise the risk to humans
• to carry out a 10-15 year research programme to develop a cattle vaccine
• further research projects to understand better how infection is transmitted
• to continue routine cattle testing, slaughter and movement restrictions to prevent spread of infection between cattle
• to carry out the badger culling trial in order to find out when culling is an effective method of control.[136]

The first and fourth parts of this policy have not changed greatly with the implementation of Krebs. As we have seen, public health is not immediately at risk by the increased incidence of bovine TB. Nevertheless, we welcome the Government initiative to increase liaison between the Chief Medical Officer and the Chief Veterinary Officer at local, regional and national levels to ensure that the situation does not deteriorate.[137] We also welcome the announcement that two of the new research projects accepted by MAFF involve studies aimed at bovine TB in both animals and humans. As regards action to detect and contain bovine TB in cattle, the programme is largely dictated by EU rules. However, we note in this context that the Government is financing research into improved or complementary diagnostic tests, including a blood test.[138] The other elements of the strategy arise more directly from the Krebs report and require much closer scrutiny.

Vaccine research

54. The Krebs report identified "the best prospect for control of TB in the British herd" as the development of a cattle vaccine.[139] Whilst recognising that "this is a long-term project and success cannot be guaranteed", Krebs recommended that "the development of a cattle vaccine and an associated diagnostic test to distinguish infected from vaccinated cattle should be a high priority for MAFF's long-term research strategy".[140] He estimated that "a vaccine for field trials could be available within ten years", although he noted that "achieving this timetable will require considerably more resources than the £0.4 million a year currently spent by MAFF", and he recommended that "targets and milestones ... be identified to monitor and evaluate progress at five yearly intervals".[141] This approach represented a major shift from MAFF's previous research strategy which since 1994 had concentrated on the development of a vaccine to prevent TB in badgers. A total of £1.96m will have been spent on that project by the end of the 1998-99 financial year.[142] Krebs recommended that a vaccine for badgers should be kept as an option "as much of the basic research required will be relevant to both badgers and cattle".[143] He also proposed that MAFF should draw on the work being carried out worldwide on new vaccines for humans.[144]

55. MAFF responded to Krebs' recommendations in this area by refocusing the work on the badger vaccine "to provide a sound launching pad for the larger programme on cattle... and to ensure that the results of work to date are published and available to the wider scientific community".[145] On 10 March 1999, the Minister announced the award of £1.4 million in 1999/2000 for vaccine development at the Institute of Animal Health and the Veterinary Laboratories Agency (VLA), with a number of sub-contractors including experts in New Zealand.[146] In its initial three years, the programme aims to generate and test vaccine candidates for either cattle or badgers and to develop a diagnostic test to differentiate between infected and vaccinated cattle. At the same time, the Minister announced that MAFF and the Wellcome Trust had agreed joint funding for a project to sequence the complete genome of M. bovis, the report of which is expected by March 2000. MAFF believed that this work by the VLA, the Sanger Centre and the Institut Pasteur in Paris could have a major impact on the development of a cattle vaccine.[147]

56. The emphasis on a vaccine for cattle as a long-term solution to the problem of cattle TB has received widespread support. It would seem an ideal solution as it would be easy to administer and monitor and would focus directly on the animal we wished to protect against disease. For this reason, it is not surprising that wildlife groups in particular have called for more money to be invested in fast-track research towards an effective cattle vaccine.[148] The Wildlife Trusts, for example, whilst accepting that "the development and implementation of a TB vaccine for cattle [is not] a universal panacea", argued that the resources currently going into the culling trial should be spent on vaccine research instead.[149] However, there is reason to be cautious on this front. There is no evidence that investing much greater sums of public money in vaccine development would reap faster rewards. A candidate needs to be found before any field test may begin. The BCG vaccine which has been successful in controlling TB in humans is the only vaccine available at the current time.[150] Unfortunately, as Dr Hewinson of MAFF told us, although "BCG might be quite an interesting candidate for badgers", it is not suitable for cattle for three reasons: "it compromises skin testing, its efficacy is very variable [and] it does not protect against pulmonary tuberculosis".[151] The problem of skin testing is of particular concern to farmers as an inability to distinguish between infected and vaccinated cattle could lead to a herd losing its tuberculosis-free status under EU regulations and thus prevent a farmer exporting his animals or selling unpasteurized milk. It is essential therefore that a test is developed in line with the vaccine which allows the distinction to be made and which is accepted throughout the EU and by the European Commission. Only then would a vaccination programme be acceptable to the Farmers' Union of Wales or other representative organisations.[152] The Forest of Dean Badger Patrol argued that MAFF should have already begun negotiations with the Commission on this issue.[153] It may be too early to do this in the absence of a candidate for approval but the Government should keep the EC informed of developments in this field.

57. Once a candidate has been developed, it has to be tested for safety and efficiency, including "conformity with national and international guidelines regarding the use and release into the environment of biological material, including genetically modified organisms".[154] Dr Hewinson told us that "even if we were to have a vaccine tomorrow, it would still probably take about ten years to get into the field"[155] and that in any case "there is an international consensus that 15 years is a reasonable time frame".[156] This accords with other estimates we have been given but is disappointing in light of the fact that in 1996 our predecessor Committee was also told that a vaccine was 10 to 15 years away.[157] Both Professor Krebs and Professor Bourne argued that it was not a question of money. Professor Krebs believed that MAFF had "increased the budget significantly" but "it is an extremely complicated problem and that is why I am loath to say that if MAFF threw tens of millions of pounds at it they would crack it in a short period of time".[158] Professor Bourne stressed that "it is not a question of throwing money at the area, it is a question of identifying the appropriate questions and getting groups who are able to do the work to do it. I am persuaded that is now happening".[159] We also learned that the Bourne Group had "been asked by Ministers to advise on other complementary research, including vaccines and vaccinations".[160] We assume that this includes the monitoring of progress on vaccine development recommended by Krebs but would welcome clarification of this point.

58. One reason to accept the difficulties of cattle vaccine research comes from comparing it with work on vaccines for humans. As Professor Krebs told us, "if you look at the case of human TB where vastly more amounts of money are being spent than on cattle TB, the development of better vaccines than the ones that were developed many years ago has moved very slowly".[161] To illustrate the potential costs, Dr Hewinson gave the example of the United States where "they estimate $800 million will be required for a human vaccine".[162] However, in written evidence MAFF pointed out that there had been more hopeful developments in this field recently with "scientific advances, particularly in the sphere of molecular biology".[163] This has immediate implications for a vaccine for cattle. Professor Bourne, the RCVS and Dr Hewinson all agreed that the best way forward was "to piggy-back on the advances that are going to happen in the human TB field".[164] Dr Hewinson also argued that this should involve focussing on "what is different between bovis and TB".[165] We agree that this is the correct approach and we recommend that the Government review its entire TB vaccination strategy to ensure that sufficient funding is given as a priority to human vaccine development, that research is conducted into the difference between TB in cattle and humans, and that UK scientists have access to the latest developments in this field.

59. The change in emphasis from a badger to a cattle vaccine has not received universal support. The CLA argued that "by reducing the level of infection in badgers, a vaccine would further reduce the rate of transmission to cattle",[166] while a former chairman of the Badger Panel considered that vaccinating cattle alone "would still leave the badger population with a potentially devastating level of TB likely to spill over into other wildlife (e.g. wild deer) and remain a constant source of disease if things were to go wrong with the cattle vaccination process".[167] The difficulties with a vaccine for badgers were spelt out by the NFBG, who nevertheless support the development of such a vaccine alongside that for cattle. They argued that "as only a very small proportion of badgers are likely to suffer from infection with TB, it is our view that a vaccine for badgers would not represent a pragmatic way of controlling suffering in badgers", and so a badger vaccine is not required as a welfare issue. Furthermore, it would not protect cattle from other sources of infection and would be difficult to administer and monitor, even if the other problems associated with vaccines could be overcome.[168] MAFF told us of a programme in progress in the Republic of Ireland to test the BCG vaccine on badgers, where the use of chocolate peanuts resulted in 80% uptake, although there were no means of guaranteeing the dose.[169] These difficulties persuade us that a cattle vaccine offers more potential in the control of bovine TB, although we advocate the continuation of research into a vaccine for badgers.

60. In sum then, we agree that the development of a cattle vaccine should be a high priority. Nevertheless, it is not certain that this goal can be delivered even within the fifteen year time frame. It offers nothing for short term control and additional unlimited financing would do little to overcome the formidable scientific and legal obstacles or speed up the process. As a result, it would be wrong to pin too many hopes on a cattle vaccine at the expense of other measures which have the potential to limit the incidence of bovine TB in the short and medium term. As English Nature advised us, "a strategy which relied completely on the development of a cattle vaccine would ... carry significant risk of failure".[170] Mr Rooker was adamant that "there is not a vaccine, I have no guarantee of a vaccine, I have no guarantee of a timescale of a vaccine, or the effectiveness, whether it is for cattle or for badgers".[171] He concluded that it was therefore necessary to proceed with the Krebs programme on all fronts. We agree with this analysis.

The 1999/2000 research programme

61. The Government announced its full programme of research projects for 1999/2000 on 10 March 1999. Vaccine development apart, the 19 separate projects were divided into those to improve our understanding of herd breakdowns and those to examine the role of the badger more closely, at a cost in the first year of £1.5 million and £475,000 respectively. The latter projects relate particularly closely to the culling trial and are meant to address the acknowledged difficulties in estimating badger numbers and population density and to increase knowledge of the role of the badger in transmitting disease. Many of the other projects are also integrated into the trial, including work on transmission, risk analysis, other wildlife sources of bovine TB, and molecular fingerprinting techniques. These are all clearly important to the success of the Bourne Group in establishing the scientific basis upon which a sustainable policy of controlling bovine TB can be based.

Research into transmission

62. One element of the research programme which has attracted particular attention is that of how infection is transmitted between animals. Professor Krebs admitted the ignorance of the scientific world on this question and also the problems: "I think that more effort should be put into understanding transmission and not enough has been put into it ... It is relatively easy to understand where the badgers might be depositing the bacterium but it is not that easy to show what the major routes of transmission are."[172] Professor Bourne agreed, adding that it was "no surprise to me that we only had one proposal for transmission experiment".[173] This was a project for integrated modelling of M. bovis transmission in badgers and cattle run by six different institutions. It does not, however, examine the possible transmission route from other wildlife species. MAFF and the RCVS suggested that it was perhaps unnecessary to prove how a disease was spread in order to deal with it successfully.[174] We disagree, as it would answer much of the debate if the transmission routes were to be identified. Like Professor Bourne, we look forward to the development of molecular epidemiology which will give us "another tool which we can bring to bear on this",[175] and we note that the research programme includes a large-scale project to develop and evaluate strain typing methods for M. bovis. Much insight into transmission patterns and routes could also be obtained through modelling their spatial distribution using data from Woodchester Park. We recommend that MAFF provide more funding for such research commissioned from the best scientists in the field.

Other research

63. MAFF drew our attention to other areas of research it is conducting in addition to the 1999/2000 programme announced on 10 March. These are short term projects, an epidemiological investigation, the road traffic accident survey and research into trace elements. Five short term projects were established during 1998/99 - funding for the integration of existing information on spoligotypes (TB molecular types) into a geographical information system; two projects concerning post mortem procedures; a multivariate analysis of existing data on TB incidents in cattle, and research into the use of leg cuffs as a capture method as recommended by the Bourne Group. The multivariate analysis is designed to identify "evidence of risk factors and improved understanding of the dynamics of the disease in cattle".[176] Dr Woodroffe from the Bourne Group explained that "if there are farms where they have badgers heaving with TB and yet they have never gone down with tuberculosis ... analysing that sort of situation is something which could potentially be very powerful in getting at that question about susceptibility versus exposure", that is which factors determine whether a cow will become infected when it comes into contact with the bacterium.[177] This examination of data is to be used to refine the questions asked during the new epidemiological investigation launched on 31 March, and it will be complemented by research financed by the Milk Development Council into the risk factors associated with farm management practices.[178] We return to the epidemiological questionnaire, the TB99 form, in our discussion of husbandry (see paragraphs 109 and 110).

64. The research into leg cuffs is a matter of great concern to the animal welfare lobby. MAFF has commissioned a trial into whether a particular design of cuff would be efficient and acceptable as a capture method for badgers. A very small number of animals is involved in the trial and MAFF has undertaken that "if badgers are injured at any stage, the trial will be abandoned".[179] Both the NFBG and the RSPCA compared the leg cuffs to snares, which have already been ruled out on the grounds of public acceptability.[180] It seems unlikely that the current trials will meet with greater public approval. Although we have not been persuaded that this method of capture would injure badgers, for the sake of public perception, we urge MAFF not to pursue this route.

The road traffic accident survey

65. The Bourne Group also recommended that badgers killed in road traffic accidents in Cornwall, Devon, Gloucestershire, Herefordshire, Worcestershire, Shropshire and Dorset should be collected and examined for TB. This followed Krebs proposal for a limited reintroduction of the survey which had been carried out nationwide from 1972 to 1990 and abandoned on cost grounds.[181] Krebs believed that "Data gathered in this way on the prevalence and severity of the disease will allow a more rigorous analysis of the link between herd breakdowns and the prevalence of TB in badgers over time and space".[182] This recommendation won almost universal support in evidence to us as a means of discovering information about badgers, some 50,000 of which are killed on the roads each year,[183] without adding to the slaughter. Indeed, many advocated the extension of the survey to the whole country, including the Wildlife Trusts, the former head of the Badger Panel and the RCVS who wished also to include other wildlife species.[184] Members of the Bourne Group told us that they were "keen to get the road traffic accident survey going as soon as possible".[185] However, as yet, no date has been set even for its limited implementation and MAFF officials prevaricated when asked, saying only it would be "probably weeks or months" before it began.[186]

66. The reason for this delay appears to be disagreement between MAFF officials and the Bourne Group over the cost-effectiveness of the exercise. MAFF told us that "looking at road traffic accident badgers would not give you an indication of the prevalence or level of disease in badgers in that county" and to extend the survey across the nation would be "very resource intensive".[187] The Chief Veterinary Officer explained: "we are limited by the availability of laboratory facilities, because of Health and Safety constraints and the number of badgers that can be put through; but I am also saying, what is the benefit of looking at all these road traffic accident surveys from other parts of the country".[188] Advice had yet to be given to Ministers on this issue but Mr Rooker instinctively took a different line, arguing that "to me, it does not make sense just to do it in the hot spots".[189] He saw badgers killed by motorists as "a resource that is ... going to waste",[190] and he also affirmed that his general principle was to implement the Krebs report in full and "that includes a road traffic accident survey".[191] It is clear from Mr Rooker's frank admission that the whole question of which areas are to be included, and therefore the policy behind this research project, is still undetermined.[192] We accept that there are limitations on the number of badger carcases that can be handled by the laboratory facilities available to MAFF and that priority should be given to examining badgers taken from the culling trial. In addition, badger post mortems cost at least £37 each[193] so the value of the data obtained through this exercise must be weighed against the cost of acquiring it. On balance, we believe that the approach proposed by the Bourne Group is correct and we recommend that the road traffic accident survey be implemented in the counties identified by the Bourne Group as soon as possible in order that information may be gathered to substantiate that from the culling trial. For counties outside the culling trial, we recommend that the Bourne Group determine how many badgers are necessary to identify prevalence within acceptable limits and the cost-effectiveness of such an exercise.

Trace elements

67. A late addition to MAFF's projects was research into the nutritional status of badgers and cattle, following speculation that animals with trace element deficiencies, particularly copper and selenium, may be more susceptible to TB. MAFF stated categorically that "there is no persuasive scientific evidence which either confirms or refutes this theory".[194] The evidence submitted to us on this question was equivocal.[195] Professor Krebs and Professor Bourne were doubtful of the link, with the former pointing out that the key questions would be "why has mineral deficiency gone up in the last five years as the disease has gone up, what has been changing, how does mineral deficiency explain the spatial variation".[196] MAFF has conducted experiments on the livers of 343 badgers to determine the levels of trace elements. At first it declined to publish the results of this study because of the small number of samples, but earlier this year details were released on the departmental website.[197] The withholding of information in this case created an unnecessary degree of suspicion that MAFF was unwilling to pursue this line of investigation. We accept the arguments of the Soil Association and the NFBG[198] that the Government should investigate the potential role of trace elements in the incidence of TB in cattle. Questions on this subject as regards cattle are to be included in the epidemiological questionnaire but we recommend that in determining future research projects the role of trace elements in susceptibility to bovine TB in cattle and badgers should be specifically included. Indeed, part of the failure of MAFF to control TB is probably because it has concentrated its efforts on aspects of exposure to infection and failed to address more specific questions on the factors influencing susceptibility. This is surprising since tuberculosis in humans is generally considered a disease to which weakened individuals are more susceptible.

General criticisms of research strategy

68. The Krebs report made two general criticisms of MAFF's past policy on research into bovine TB. First, that only 5% of the Ministry's TB research budget was contracted out and that more effort needed to be made to commission research from those with the best expertise from throughout the UK research community.[199] The process by which the research proposals for 1999/2000 were commissioned indicates that MAFF has changed its practices in response to the report as we note the range of contractors engaged in this round and the award of research contracts to institutions not just in UK universities but as far afield as New Zealand. This approach of drawing on the expertise of other countries and researchers seems to us to offer the best hope of reaching a solution to the bovine TB issue.

69. Krebs' second criticism was addressed to the imbalance between the amount of money spent on TB control and on research, with over nine times as much spent on the former at the time of the report. In New Zealand, the ratio was much smaller, with the amount spent on control just under twice that spent on research. The difference was in the research budget, standing as it did at £1.7 million in Great Britain and nearly £5 million in New Zealand.[200] Krebs recommended that the research budget should be reviewed and that farmers should perhaps be expected to contribute to the control costs. In its response, the Government was non-committal on the latter issue, but agreed to review the amount spent on research both in absolute terms and as a proportion of the total MAFF TB budget.[201] The outcome is that in 1999/2000 an extra £7.4 million has been allocated to research, consisting of £1.4m for the programme outlined above and £6.0 million for the culling trial, the road traffic accident survey and all data collection work for epidemiological analysis.[202] The NFBG objected to the combining of the trial with research such as the TB99 form and the survey of badger casualties[203] and argued that "there is still a huge imbalance in the allocation of funding towards research".[204] However, we believe that the increased funding for TB research represents a victory for MAFF and that it is more important now to direct this money wisely. This, we believe, MAFF is doing. There has to remain a question over the future funding of the research programmes as the CSR settlement covers only three years, and will be reviewed after two years.[205] We recommend that MAFF ensure that funding for research into bovine TB remain a priority and that the level of funding is sufficient to ensure that the programme of research recommended by Krebs be completed.

70. The NFBG and others who remain supportive of the research strategy proposed in the Krebs report expressed some criticism of the speed with which it has been implemented.[206] While we acknowledge the time needed to complete the process of putting proposals out to tender, we believe that the lack of information on the research programme at a time when the culling trial was underway contributed to the impression of MAFF bias against the badger in the eyes of many witnesses. This was at best unfortunate. Coupled with the continued indecision over the road traffic accident survey and the withholding of information on the trace elements experiment, it has done much to undermine the goodwill of the animal welfare lobby and to break the perception of the Krebs report as a package of measures, rather than as the culling trial alone.