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Volume 1: Findings and Conclusions 59 This is a summary of the more significant events in the BSE story. In responding to the emergence of BSE, the Ministry of Agriculture, Fisheries and Food (MAFF) and the Department of Health (DH) took the lead. For the most part, Wales, Scotland and Northern Ireland followed that lead. This summary will focus on the action taken by MAFF and DH. 60 A TSE known as scrapie has been endemic in the sheep population of the UK for nearly 200 years. In the later stages of the disease the fabric of the brain is attacked. The pathologist can diagnose the disease by the spongiform appearance of the diseased brain. At the end of 1986 pathologists at the Central Veterinary Laboratory (CVL) identified similar degenerative changes in the brain samples of diseased cattle from two different herds. These were early cases of BSE. 61 By May 1987 this novel disease had been confirmed in four herds. No publicity, even within the State Veterinary Service (SVS), had been given to these early cases and it is likely that others had gone unrecognised and unreported. From May, however, the fact of the existence of a novel disease was gradually disseminated and Mr John Wilesmith, head of the CVL's Epidemiology Department, was asked to investigate its cause. 62 Over the next six months, as he carried out his task, reported incidents of the disease proliferated. By 15 December 1987 there were 95 confirmed cases on 80 farms. Mr Wilesmith had formed the provisional view that the cause of the outbreak was contaminated meat and bone meal (MBM) that had been incorporated in cattle feed. His confidence in this theory grew stronger early in 1988, and he concluded that the likely contaminant was offal of scrapie-infected sheep, rendered down to make MBM. Enquiries of feed compounders tended to confirm this view. 63 On 18 May 1988 Mr John MacGregor, the Minister of Agriculture, on the advice of Mr William Rees, the Chief Veterinary Officer (CVO), decided on what proved to be the principal step taken to eradicate BSE. A prohibition on feeding ruminant protein to ruminants ('the ruminant feed ban') was introduced on 14 June 1988 to take effect on 18 July. This was, at the time, regarded as a measure to protect animal health. The risk that BSE posed to human health had not, however, been ignored. 64 Officials at MAFF had been concerned from the outset at the possibility that BSE might pose a risk to human health. Diseased cattle were going into the human food chain. Scrapie was not transmissible to humans, but there was no certainty that the same would be true of BSE. By 19 February 1988, 264 cases of BSE from 223 farms had been confirmed. On 24 February Mr Derek Andrews, the Permanent Secretary, forwarded a submission to Mr MacGregor. This recommended that BSE should be made a notifiable disease and that a policy of compulsory slaughter with compensation should be introduced. Mr MacGregor had reservations about such a policy and accepted the suggestion that the advice of Sir Donald Acheson, the Chief Medical Officer (CMO), should be sought on the implications that BSE had for human health. 65 Sir Donald, in turn, recommended that an expert working party should be set up to advise on the implications of BSE. This was done. The Working Party was chaired by Sir Richard Southwood. 66 Before the first meeting of the Southwood Working Party, and at the same time that the ruminant feed ban was introduced, Mr MacGregor, on the advice of his officials, introduced a requirement for compulsory notification of all cases of BSE. 67 On 21 June 1988 the Southwood Working Party made interim recommendations that included the compulsory slaughter of animals showing symptoms of BSE and the setting up of a committee to advise on research. The Government accepted these recommendations and, on 8 August 1988, an Order came into force making slaughter of BSE suspects compulsory. Compensation of 50 per cent of the sound value of the animal was paid if, on post-mortem, it was shown to have had BSE and 100 per cent if it did not. Although made under the Animal Health Act 1981, the primary object of this measure was to take sick animals out of the human food chain. 68 By 13 January 1989, 2,296 cases of BSE had been confirmed on 1,742 farms. 69 The Southwood Report was submitted to Ministers on 9 February 1989. This endorsed Mr Wilesmith's conclusion that the source of infection was probably scrapie-infected meat and bone meal. It concluded that it was 'most unlikely that BSE would have any implications for human health'. It recommended that the Health and Safety Executive (HSE) and the authorities responsible for human and veterinary medicines, which had already been alerted by the Working Party, should take appropriate measures to address possible risks posed by BSE, and advised manufacturers of baby foods not to include in their products ruminant offal including thymus, which, from what was known about scrapie, would be most likely to be infective. Sir Richard Southwood clarified later in February that this offal did not include liver or kidney. 70 The Working Party concluded that the risk posed by BSE-infected animals which had not yet developed clinical signs did not justify any further measures to protect human food. The Government accepted this, and on publication of the Southwood Report announced that secondary legislation would make it illegal to sell baby food containing the types of offal identified by the Report. MAFF Ministers, however, had concerns which, after discussion with officials and with DH and after wide consultation, led, on 13 November 1989, to the introduction of a ban on the use for human consumption of Specified Bovine Offals (SBO), namely those tissues in cattle considered most likely to be infective. This became known as 'the human SBO ban'. Tissues from cattle aged under six months were exempt from the ban on the basis that scrapie infectivity had not been found in lambs of this age. 71 Meanwhile, on 27 February 1989, the establishment of a committee chaired by Dr David Tyrrell was announced. The Tyrrell Committee was to advise on research in relation to BSE, thus implementing one of the first recommendations of the Southwood Working Party. This Committee met three times and delivered to the Minister of Agriculture and the Secretary of State for Health what they described as an 'Interim Report' on 13 June 1989. This identified the key research questions that needed to be answered and set in an order of priority the research studies needed to answer those questions. 72 The Report was not published until 9 January 1990. By this time funding had been put in place which enabled the Food Minister, Mr David Maclean, to announce that all projects identified by the Tyrrell Committee as 'urgent' or of 'high priority' had either been put in train or would start as soon as possible. Experiments to check the belief that BSE was transmissible had been put in hand at an early stage. In September 1988 transmission to mice by intracerebral inoculation of brain tissue had been confirmed. By February 1990 transmission to cattle had been established by the same route and transmission to mice by oral ingestion had been achieved. 73 Meanwhile, on 28 July 1989, the EU banned the export of UK cattle born before 18 July 1988 and of offspring of affected or suspect females. This was the first of a number of restrictions placed by the EU on the export from the UK of live cattle and (from June 1990) of beef. 74 By the end of 1989, 10,091 cases of BSE had been confirmed in the UK. 75 Anxiety had been expressed in many quarters that 50 per cent compensation might be inadequate to procure full compliance with the requirement to notify BSE suspects and, on 14 February 1990, Mr John Gummer, who had succeeded Mr MacGregor as Minister of Agriculture, introduced entitlement to 100 per cent compensation. 76 On 1 March 1990 the EU restricted exports of live cattle to those aged less than six months. Importing Member States were required to ensure that these were slaughtered before they reached that age. Offspring of whatever age of affected or suspected females continued to be banned from export. 77 On 3 April it was announced that Dr Tyrrell was to chair a new expert committee - the Spongiform Encephalopathy Advisory Committee (SEAC). The Committee had a wider membership than the Tyrrell Committee and wider terms of reference: To advise the Ministry of Agriculture, Fisheries and Food and the Department of Health on matters relating to spongiform encephalopathies. 78 It was government policy in relation to BSE to act on 'the best scientific advice'. Thereafter the Government was to look to SEAC to provide that advice. 79 One of the recommendations of the Southwood Working Party had been the need for surveillance of CJD cases in order to detect whether there were any changes in their incidence that might be attributable to BSE. In May 1990 the CJD Surveillance Unit was set up under Dr Robert Will, a consultant neurologist at the Western General Hospital in Edinburgh. 80 On 10 May 1990 it was announced that a Siamese cat had died of a spongiform encephalopathy - the first known case of feline spongiform encephalopathy (FSE). This resulted in a rash of media comment, speculating that the cat had caught BSE and that humans might be next. Humberside Education Authority had already banned beef from school meals and a number of other Authorities threatened to follow this example. Public statements by the CMO and by Mr Gummer that beef was safe to eat failed wholly to reassure. The House of Commons Agriculture Committee announced an Inquiry into BSE. After receiving evidence from most of the key players in the BSE story, the Committee reported on 12 July 1990 that, while there were too many unknowns to say anything with absolute certainty, 'we heard no evidence of any sort to constrain those taking a more balanced view of the risks from eating beef'. The measures taken by the Government 'should reassure people that eating beef is safe'. 81 On 8 June 1990 the EU Council of Ministers agreed that bone-in beef exported from the UK must come from holdings where BSE had not been confirmed in the previous two years, while boneless beef was required to have obvious nervous and lymphatic tissue removed. 82 Meanwhile, there had been controversy as to whether the SBO that had been banned from human food should be permitted to be fed to animals. Pet food manufacturers had voluntarily ceased to incorporate it in their products. UKASTA, the feed producers' trade association, had pressed strongly for a ban on including SBO in the material rendered to make MBM for inclusion in pig and poultry feed, and advised their members to exclude it. MAFF officials and Ministers opposed a ban on the ground that it was without any scientific justification. SEAC was about to advise on this question when, early in September, a pig, which had been inoculated with BSE-infected brain tissue, succumbed to the disease. In an emergency meeting SEAC advised that, as a precautionary measure, SBO should not be fed to any animals. MAFF, which had anticipated this possibility, immediately banned the incorporation of SBO or its products in animal feed ('the animal SBO ban'). Export of feed containing SBO to the EU was also banned. This was followed in July 1991 by a ban on the export of material derived from SBO to third countries. 83 Among the many matters on which SEAC was asked to advise were slaughterhouse practices. There was concern that the removal of brain and spinal cord (both SBO) in slaughterhouses might contaminate meat going for human consumption. There was also concern about the practice of the mechanical recovery of remnants of meat and other tissues adhering to the vertebral column, in that these might include scraps of spinal cord not cleanly removed by slaughterhouse operators. SEAC advised that head meat should be removed before brain, but that no further measures were necessary provided that the rules were properly followed and supervised. This advice was implemented first by guidance and then, in March 1992, by statutory regulation. 84 By the end of 1990, 24,396 cases of BSE had been confirmed in the United Kingdom. 85 One of a number of recommendations of the House of Commons Agriculture Committee was that the Government should 'establish an expert committee to examine the whole range of animal feeds and advise on how industries which produce them should be regulated'. Some debate ensued as to how to implement this recommendation, but on 6 February 1991 MAFF announced the establishment of an Expert Group on Animal Feedingstuffs chaired by Professor Eric Lamming. It met on 14 occasions over the next year and reported on 15 June 1992. The Group considered the steps taken to prevent the BSE agent being transmitted to animals in feed and concluded that they were satisfactory and adequate. In particular the Group considered whether the practice of feeding animal protein to animals should be discontinued. It decided that there was no scientific justification for such a step. It did, however, recommend that: . . . an independent Animal Feedingstuffs Advisory Committee be established to take an overview of all feedingstuffs issues. 86 Although the Government initially accepted this recommendation, it subsequently decided not to proceed with it. 87 With compulsory slaughter of sick animals and the human SBO ban to deal with potentially infective tissues in apparently healthy animals incubating BSE, the Government considered that there were in place appropriate measures to deal with the risk that BSE might be transmissible to humans in food. Action was taken to see that medicinal products both for humans and for animals were not sourced from potentially infective bovine tissues. Ruminants were protected by the ruminant feed ban and other animals by the animal SBO ban. No further major measures were considered necessary to protect human or animal health in the period with which we are concerned. In March 1992 SEAC concluded 'that the measures at present in place provide adequate safeguards for human and animal health'. Several relatively uneventful years were to pass before it became apparent that the measures in place were not achieving all that had been expected of them. 88 Because of BSE's lengthy incubation period, it was appreciated when introducing the ruminant feed ban that years would pass before it would have a visible effect. What was not known was the rate at which cattle had been infected in the period up to 18 July 1988, when the ruminant feed ban came into force. At the time of the Southwood Report suspected cases of BSE were being reported at the rate of about 400 a month. It was considered that these had been infected with scrapie and that this source would have continued to infect cattle until the ban at about the same rate. Whether, or to what extent, recycling of BSE might have increased the rate of infection was not known. 89 It soon became apparent from the numbers of BSE cases reported 1 that the rate of infection had not reached a plateau, but had been increasing rapidly in the years leading up to the ruminant feed ban, and that the reason for this was the effect of recycling the BSE agent in MBM. 90 Thus the Government found it had to deal with many more cases infected before the ban than it had expected. But of even more concern were cases in cattle that had been born after the ban (BABs). The first of these was announced on 27 March 1991. 91 When exploring the possible sources of infection of the BABs, the CVL epidemiologists were able to rule out maternal transmission in most cases. The likely source of infection of the earlier BABs was thought to be ruminant feed in which ruminant protein had been incorporated before the ban and which was in the distribution pipeline, or still unused on farms when the ban came into force. This remained the view of MAFF officials at the beginning of 1994, by which time Mrs Gillian Shephard had succeeded Mr Gummer as Minister of Agriculture. Cross-contamination of ruminant feed by non-ruminant feed in the feedmills was considered, but discounted after September 1990, when the animal SBO ban should have prevented SBO from being incorporated in any animal feed. 92 In the course of 1994 opinions changed as to the source of infection of BABs. By August the CVL had reached the conclusion that the more recent BABs had been infected by feed which had been contaminated in the feedmill by feed containing ruminant protein. Two factors had led to this conclusion. First, there had been an increasing volume of evidence, some of it cogent, of widespread infringement of the animal SBO ban, so that SBO was contaminating non-ruminant feed. Second, interim results of an experiment, which started in 1992, indicated that a single quantity of as little as 1 gram of infective material - the size of two peppercorns - had sufficed to infect cattle to which this had been fed. 93 MAFF officials approached the problem of the cross-contamination of cattle feed on two fronts. Their primary emphasis was on tightening up the implementation of the animal SBO ban. This was facilitated by the transfer of enforcement functions in slaughterhouses to central government. What had been the responsibility of some hundreds of individual local authorities became the task of a new national Meat Hygiene Service (MHS) from 1 April 1995. A revised statutory scheme was introduced that required SBO to be identified by a distinctive blue dye and kept separate at all times from other material. At the same time plants rendering SBO were required to do so in separate facilities. The consultation process was thorough and lengthy, with the result that the introduction of the new Regulations was not completed until August 1995. Their introduction was combined with a campaign of more rigorous enforcement and monitoring of the Regulations by the MHS and the Veterinary Field Service (VFS). 94 At the same time as tightening up on the implementation of the animal SBO ban, MAFF officials took steps to address cross-contamination in feedmills. So far as these were concerned, effective monitoring of compliance with the ruminant feed ban had been initially impossible for want of any method of testing for the presence of ruminant protein in animal feed. It had been hoped that an 'ELISA test' would be perfected within about 12 months, capable of detecting this. In the event, it was not until 1994 that the test was ready for use, and even then its results were not sufficiently reliable to provide evidence that would support a prosecution for breach of the Regulations. The test was, however, employed on a voluntary basis, with cooperation from UKASTA, and resulted in at least some feedmills taking steps to reduce the possibility of cross-contamination. 95 Hindsight confirms that, between 1989 and 1994, the ruminant feed ban had resulted in a steady but substantial year-on-year reduction in the numbers of infections, and that the measures taken in 1994 and 1995 radically accelerated this decline (see Volume 16, Figures 3.2 and 3.34). 96 The years 1994 and 1995 also saw developments in relation to the risks posed by BSE to human health. An interim result of a pathogenesis experiment conducted by the CVL demonstrated infectivity in the distal ileum (small intestine) of a calf within six months of oral infection with BSE. This led MAFF, with the agreement of DH, to extend the human SBO ban to include the intestines and thymus of calves which had died aged over two months. 97 On 27 July 1994 the European Commission decided that existing restrictions on the export of UK beef should be replaced with two measures. One was a ban on export of bone-in beef except from cattle which had not been on holdings where BSE had been confirmed in the previous six years. The other measure affected beef from cattle which had been on such a holding within that time. This could not be exported unless it was deboned with adherent tissues removed. In December 1994 the Commission amended this decision to exempt from these measures beef from cattle born after 1 January 1992. Subsequently in July 1995 this exemption was replaced with one that exempted beef from cattle less than 30 months of age at slaughter. 98 In July 1994 Mrs Shephard was succeeded by Mr William Waldegrave, who oversaw the introduction of the MHS. He in turn was succeeded by Mr Douglas Hogg in July 1995. At the direction of Mr Hogg, the MHS set about raising standards of meat inspection, a task that was to prove to require the employment of several hundred additional staff. 99 More rigorous monitoring of slaughterhouses in 1995 disclosed a number of occasions on which Meat Inspectors had applied the health stamp to a carcass to which fragments of spinal cord remained attached. This led SEAC to recommend a ban on the practice of extracting mechanically recovered meat (MRM) from the spinal column of cattle. MAFF accepted that advice and introduced the ban in December 1995. 100 In the course of 1995 a number of events served to increase public anxiety that it might be possible to contract CJD as a consequence of eating beef. Cases of CJD were reported in farmers whose herds had had BSE and in several young people - the latter being particularly significant because up until then the disease had almost invariably struck down its victims late in life. A distinguished scientist questioned the safety of beef offal. These events received wide media coverage. The CMO and the Secretary of State for Health each responded with public assurances that it was safe to eat beef. 101 The first two months of 1996 saw the CJD Surveillance Unit and SEAC concerned at an increasing number of young victims of CJD. On 16 March SEAC advised the Government that a new variant of CJD had been identified in young people and that the most likely explanation was that these were linked to exposure to BSE before the introduction of the SBO ban in 1989. A series of urgent meetings of Ministers and then of the Cabinet ensued, and SEAC's advice was sought as to further precautionary measures. 102 On 20 March 1996 the Government announced the likelihood that the recent cases of CJD in young people had resulted from exposure to BSE before 1989 and stated its intention to adopt further precautionary measures in accordance with SEAC's advice. These were that carcasses from cattle aged over 30 months must be deboned and that the use of MBM in feed for all farm animals would be banned. These measures proved inadequate to reassure the public and, within two weeks, were replaced with a total ban on cattle over the age of 30 months being used for human food or animal feed. 103 By 20 March 1996 approximately 160,000 cattle affected by BSE had been slaughtered. In addition about 30,000 cattle suspected of BSE, but not confirmed to have the disease, were slaughtered. These figures can be compared with over 3.3 million cattle slaughtered and destroyed under the Over Thirty Month Scheme in the period from March 1996 to the end of 1999. 104 This brief narrative has concentrated on events that have been most in the public eye. As we explained above, we shall also cover in later chapters of this volume precautionary measures taken in areas which, while important, did not come to the attention of the general public. These include medicines, cosmetics and occupational health. 105 The Report of an Inquiry such as this inevitably focuses on the areas where things went wrong. It is those areas that government and the public are most anxious to have thoroughly explored. For this reason we think it desirable to give at the outset an overview of why things happened in the way that they did. 106 Why initially a cow or cows developed BSE will probably never be known. Why the early case or cases began a chain of transmission that ended with hundreds of thousands of cattle becoming infected is now clear. It was because of the practice of rendering cattle offal, including brain and spinal cord, to produce animal protein in the form of meat and bone meal (MBM), and including MBM in compound cattle feed. This resulted in the recycling and wide distribution of the BSE agent. 107 Many have expressed the view that it was not surprising that a practice as unnatural as feeding ruminant protein to ruminants should result in a plague such as BSE. Had BSE emerged soon after this practice was introduced, there might have been force in this reaction. However, the practice of feeding MBM to animals in the UK dates back at least to 1926, when it was given statutory recognition in the Fertilisers and Feedingstuffs Act of that year. It is a practice which has also been followed in many other countries. It was recognised that it was important that the rendering process should inactivate conventional pathogens. Experience had not suggested that the practice involved any other risks. In these circumstances we can understand why no one foresaw that the practice of feeding ruminant protein to ruminants might give rise to a disaster such as the BSE epidemic. Accusations have been made both against the Government and against renderers of causing BSE by relaxing rendering standards. As we shall explain, changes in rendering practices and regulatory requirements are unlikely to have made any substantial difference. 108 There were a number of factors that made it inevitable that, whatever measures were taken in response to its emergence, BSE would be a tragic disaster:
109 These factors had the following consequences:
110 Given the practice of pooling and recycling cattle remains in animal feed, this sequence of events flowed inevitably from the first cases of BSE. It was inevitable that, whatever measures were taken, many thousands of cows would succumb to the disease in the years to come. It was inevitable that if humans were susceptible to the disease, some would be infected with it before its existence was even suspected. 111 The measures that were taken in response to the emergence of BSE greatly reduced the scale of the disaster. The MBM component of feed was diagnosed as the vector responsible for the disease with commendable speed, and the ruminant feed ban was a swift and appropriate response. That ban reduced the rate of infection by 80 per cent overnight and established a diminishing trend which would, ultimately, have resulted in the eradication of the disease. Unhappily, as the cases born after the ban were to demonstrate, there were shortcomings in formulating and carrying out both the ruminant feed ban and the animal SBO ban, which should have provided a second line of defence against infection of cattle feed. These shortcomings had serious consequences. Over 41,000 cattle that developed clinical signs of BSE in the years that followed were infected after the ruminant feed ban came into effect. Many more must have been infected but slaughtered before the signs developed. When the link between BSE and the new variant of CJD became apparent in March 1996, the Government was unable to demonstrate that the source of infection had been completely cut off. Had they been able to do so, some of the drastic measures that followed might have been avoided. The reasons for these shortcomings receive detailed consideration in our Report. 112 There is a popular misconception that the Government did nothing to protect the public against the risk BSE might pose to human health until the likelihood of transmissibility was demonstrated in 1996. It is important to emphasise that the most significant measures to protect human health were taken at a time when the likelihood of transmissibility to humans was considered to be remote. Those were the compulsory slaughter and destruction of sick animals introduced in August 1988 and later, in November 1989, the human SBO ban, which was intended to remove from the human food chain those parts of apparently healthy cattle most likely to be infective if the animals were incubating BSE. At the same time steps were taken to ensure that bovine ingredients of medicines came from BSE-free sources. 113 These were vitally important measures. For a period of nearly ten years continuous consideration was given to addressing the possibility that BSE might be transmissible to humans, although few believed that there was any likelihood of it. This is a matter for commendation. 114 Yet again, however, there were shortcomings: shortcomings which led to delay in introduction of the precautionary measures, and shortcomings in formulating and carrying out the ban. Despite the SBO ban, some potentially infective bovine tissues continued to enter the human food chain. The reasons for these shortcomings also receive detailed consideration in our Report. 115 The other casualty of the BSE story has been the destruction of the credibility of government pronouncements. Those responsible for public pronouncements - or at least some of them - were aware of the possibility that humans might have become infected before the slaughter policy and the SBO ban were introduced. They saw no reason to draw attention to this. They believed that the measures taken had effectively removed the 'theoretical risk' of infection. They were concerned that the public should not be misled by scaremongers or the media into believing that it was dangerous to eat beef when this was not the case. Ministers and, on occasion, the Chief Medical Officers, made statements about the safety of beef which were intended to reassure the public. Insofar as these statements were believed, many clearly treated them as assurances that BSE posed no danger to human beings. In the case of some, there was a growing scepticism as the media reported cases of possible human victims of BSE which were then challenged by the Government. When on 20 March 1996 it was announced that cases of new variant CJD were probably attributable to contact with BSE before precautionary Regulations were introduced, the reaction of the public was that they had been misled, and deliberately misled, by the Government. 116 We have examined with care the public pronouncements that were made about the risks posed by BSE, and have concluded that allegations of a government 'cover-up' of the risks posed by BSE cannot be substantiated. There were, however, mistakes in the way risk was communicated to the public, and there are lessons to be learned from these. 117 As we go through the story we shall describe in greater detail what happened and how it came to happen in the way it did. We shall consider the response to BSE of the individuals principally concerned in the story. At the end of this volume we shall review what went right and what went wrong, before turning to the lessons to be learned from the BSE story. 1 For statistics, see vol. 16: Reference Material 2 S9 Anderson para. 1 |
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