Volume 1: Findings and Conclusions
6. Protecting human health
Introduction of the ban on Specified Bovine Offal (SBO) in human food
Government response to the Southwood Report
The decision to introduce the human SBO ban
Preparation of the Regulations

536 We have seen that the Southwood Working Party drew a sharp distinction between the possible risk to those who ate food derived from a cow with clinical signs of BSE and the risk from eating food derived from a cow incubating the disease, but not yet showing clinical signs (a 'subclinical'). Clinically ill cattle had to be destroyed. The tissues of a subclinical were not regarded by the Working Party as likely to be sufficiently infective to pose a threat - except perhaps to babies. ¹

537 With hindsight, we can see just how dangerous it can be to eat some of the tissues of a subclinical, at least for cattle, where no species barrier is involved. On 8 August 1988 compulsory slaughter and destruction of all cattle showing signs of BSE was introduced. Some 40,000 cattle born since that date have contracted BSE and lived to develop the clinical signs. A multiple of that figure will have been infected but slaughtered before clinical signs developed. The vast majority of those cases are likely to have been infected as a result of eating feed contaminated by very small quantities of infective tissues of subclinicals. These had been through the rendering process. We have seen above how this material got into cattle feed.

538 Since 13 November 1989, the tissues of subclinicals most likely to carry infectivity should not have been fed to humans. On that day a ban on using them for human food was introduced ('the human SBO ban'). The introduction of that ban at a time when most considered it highly unlikely that BSE could be transmitted to humans was one of the most far-sighted measures introduced in response to BSE - or it would have been had it been introduced as a result of foresight. As we shall see, however, the process that led to its introduction was haphazard rather than the result of rigorous risk evaluation. Mr MacGregor, who was responsible for the measure that Mr Meldrum described to us as 'inspirational', was at pains to emphasise to us that scientific considerations were not the primary factor which motivated him. Did it matter that the process was haphazard? We think that it did. First, it meant that the process was protracted. Second, it contributed to a failure to emphasise the importance of the measure, which detracted from the rigour of its implementation. In this chapter we shall describe how the policy decision to introduce the human SBO ban came to be taken, the reasons that were given for that decision and the manner in which it was translated into statutory Regulations.

Government response to the Southwood Report

539 Good government does not blindly follow the advice of scientific experts. Before doing so, it must evaluate the advice to make sure that it appears sound. In the case of the Southwood Report this was not easy. The Working Party had not expressed their reasons for concluding:

• that all clinically sick animals should be destroyed;
• that the risk that BSE posed to humans was remote;
• that manufacturers of baby food should exclude certain bovine offal; and
• that no measures were justified to prevent others from eating offal from subclinicals.

540 Nor had the Working Party made it plain that they were attempting to apply the ALARP principle.

541 Dr Hilary Pickles had the lead for DH in relation to BSE. She had been DH secretary to the Southwood Working Party and had drafted some of the most important parts of their Report. She wrote to Sir Donald Acheson on 6 February 1989 saying that the Report should be with him in a day or two. She commented:

In my view DH can be very pleased with the way the report has turned out. Sir Richard and his team are to be congratulated.

542 Dr Pickles did, however, inform Sir Donald of one concern that was not reflected in the Report. She was worried about the safety of bovine-based vaccines. Sir Donald minuted Dr E L Harris, the Deputy CMO, to ask him to look into this. Sir Donald told us that he also asked Dr Harris to conduct a complete review of the Southwood Report. Dr Harris has died, so we could not ask him about this, but our analysis of the evidence set out in vol. 6: Human Health, 1989-96 has satisfied us that Sir Donald's recollection is at fault here. He should have ensured that the Report was reviewed by his Department, but he did not do so. No doubt he placed confidence in the views of Dr Pickles. She was someone who inspired confidence. But because of her involvement she was not in a position to review the Report.

543 Sir Donald forwarded a copy of the Southwood Report to the Secretary of State for Health, Mr Kenneth Clarke, on 9 February. He commented:

I regard it as a thorough study of the subject with sound and balanced conclusions.

He also expressed the view that, with one possible exception: ²

Every reasonable step has been taken to minimise any theoretical risk of transmission by destruction of affected cattle.

Sir Donald said nothing about the baby food recommendation.

544 When Mr Lawrence, MAFF's secretary to the Working Party, presented the Report to MAFF Ministers, he identified in a covering note a number of areas of interest to MAFF. One of these was the baby food recommendation. He sent a copy of his note, together with the Report, to 'interested Divisions within the Department'. Mr MacGregor raised the question of baby food at a meeting with Sir Richard Southwood a few days later. Sir Richard commented that the point in the Report in relation to baby food was not a specific recommendation, but a counsel of 'extreme prudence'.

545 The baby food recommendation was, however, causing concern to MAFF officials, in particular to Dr Mark Woolfe of the Food Science Division, who considered that identification of babies as a high-risk category did not appear to have been 'well thought out', and to Mrs Attridge, the head of Emergencies, Food Quality and Pest Control Group. Mrs Attridge was concerned because her responsibilities included the composition of food, and cow's liver and kidney were a valuable source of nutrition for babies. She was concerned that the baby food recommendation was based not on consideration of all the relevant science, but on 'poorly substantiated speculation'. Although Mrs Attridge's concern was that the baby food recommendation might result, without good reason, in the removal from babies of valuable nutrition, she commented in minutes to Mr Cruickshank, the Under Secretary in charge of the Animal Health Group, that MAFF would be asked why action should be taken on baby food but not on other food.

546 At a Cabinet meeting on 23 February to discuss the response to the Southwood Report, there was lively debate about the baby food recommendation. Mr Clarke, supported by Mr MacGregor, urged that the Report should be published and the baby food recommendation accepted. Other Ministers were concerned that publication of the recommendation would lead to a baby food scare. The decision was taken that the Report should be published after Mr MacGregor and Mr Clarke had prepared, with the help of the CMO, a clear and accurate statement of the Government's response to the baby food recommendation.

547 After the Cabinet meeting Sir Richard Southwood was contacted by Sir Donald Acheson. Sir Richard said that the baby food recommendation should only be treated as applying to brain, spinal cord, spleen, intestine and thymus, and not to heart, liver and kidney. This took the heat out of the situation. None of the former types of offal was included in manufactured baby food. The recommendation would not be likely to give rise to a boycott of baby food.

548 On 27 February 1989 the Southwood Report was published. In a written announcement, Mr MacGregor explained that none of the types of offal, which were the subject of the baby food recommendation, were used in the manufacture of baby food, but that as a precautionary measure he intended to make it illegal for anyone to sell baby food containing such products in the future.

549 No one in either DH or MAFF gave thought to the question that Mrs Attridge had warned would be raised. If these types of offal could not safely be fed to babies, why was it safe to feed them to children and adults? This important question was one that any thorough departmental review of the Southwood Report should have addressed. Another, linked, question that needed to be addressed was why the Working Party were so concerned about animals showing clinical signs of BSE, but not concerned, at least so far as safety of food was concerned, with the subclinicals.

550 We have already rejected Sir Donald Acheson's evidence that a full review of the Report was carried out by Dr Harris. Mr Clarke told us that in his Department there had been a very great deal of copious review, correspondence and discussion about the Report, which would have included the questions raised above, although he could not now remember the details of these. He also referred to an 'amazing quantity of exchanges' going on between his Department and Mr MacGregor's. We did not accept this evidence. As Secretary of State for Health, Mr Clarke needed to be in a position to answer the question 'If offal is not safe for babies, why is it safe for adults?' He should have ensured that his Department reviewed the Report and provided an answer - if there was one. He did not.

551 At Prime Minister's Questions on 28 February, Mr John Evans, from the Opposition benches, asked Mrs Thatcher:

If, as appears likely to the Secretary of State for Health, BSE is a threat to humanity, why not ban the use of this offal for all human consumption? If according to the Minister of Agriculture, it is not a danger, why was it banned for babies?

She replied:

We set up a committee of experts under Professor Southwood. We published the report in full. We referred it to the Chief Medical Officer of Health and we accepted the recommendations of both, precisely. There is no point whatsoever in setting up a committee of experts, in having a Chief Medical Officer of Health, in receiving their advice and then not accepting it. We would rather accept their advice than that of the hon. Gentleman.

Her Secretary of State for Health would not have been in a position to give a more informative reply.

552 What of MAFF? Dr Woolfe and Mrs Attridge had directed attention to the questions raised by the baby food recommendation, and are to be commended for this. But after the Cabinet meeting the questions were not pursued. We have concluded that there were a number of officials who should have made sure that the outstanding questions were answered. First of all, we think that Mrs Attridge herself, being concerned for composition of food, should have pursued the question of 'why should we take action on baby food and not on hamburgers', which was one that she had raised earlier. We consider that Mr Cruickshank should have taken steps to find out why the Southwood Working Party had drawn a distinction between babies and others, and between clinical and subclinical animals. We think that Mr Meldrum should have pursued these questions. The former distinction involved consideration of analogies with matters within the expertise of the veterinarians, such as the apparent susceptibility of calves to BSE. The latter was quite plainly a matter of veterinarian expertise.

553 Mr Andrews, the Permanent Secretary, had received a copy of one of the minutes in which Mrs Attridge raised the question of why action should be taken on baby food and not other food. He should have raised with Mr MacGregor the need to have an answer to this question. Mr MacGregor himself had been alerted to Mrs Attridge's concerns and should have seen that the question of 'why babies and not adults' was pursued.

554 In short, there was at MAFF, as at DH, a team failure to subject the Southwood Report to a proper review in order to evaluate whether the unexplained differences in approach to the food risks posed by BSE had explanations that appeared to be sound.

The decision to introduce the human SBO ban

555 In the months that followed the publication of the Southwood Report, a number of influences combined to drive MAFF towards the decision to introduce a ban on using for human food those types of offal that were most likely to carry BSE infectivity.

556 In the first place there was the public reaction to the Report. This started with a broadcast on the day the Report was published from Dr Helen Grant, a consultant neuropathologist at Charing Cross Hospital in London, who commented on the risk posed by cattle brains that were going into the human food chain. In an article in The Guardian on 2 March 1989, she suggested that the Government was concentrating on baby food 'to divert the public from thinking about other foods and thus to imply that they are safe, which they are not'.

557 In May three articles appeared in The Times, suggesting that sausages and meat pies were a risk to health and that the Government should ban the use in food of potentially infected organs. On 24 May the Woman's Farming Union issued a press release calling for a ban on the inclusion of brain and spinal cord in products for human consumption. This theme was taken up the next day by delegates when Mr MacGregor attended the Conservative Women's Conference. On the same day the Bacon and Meat Manufacturers' Association advised its members to exclude bovine pancreas, brain, intestine, spinal cord and spleen from their products. The Meat and Livestock Commission (MLC), which was being advised by Dr Kimberlin (whom we have already met as a witness to the Southwood Working Party ³ and a member of the Tyrrell Committee and SEAC), ⁴ wrote to Mr MacGregor urging him to introduce a general ban on the use of bovine offal for human consumption for the sake of public perception.

558 The Parliamentary Secretary at MAFF, Mr Donald Thompson, had started his working life in his father's butchery business. He told us that he had all along been worried about the brains of subclinical animals entering the human food chain. In March he made the suggestion that cull cows might be excluded from the human food chain. This received short shrift from MAFF officials, but Mr Thompson returned to the charge, seeking advice on removing brains and certain other types of offal of cull cows from the human food chain, a measure that he subsequently supported. We commend him for this.

559 From the middle of 1988 the pet food industry had begun to address the possible infectivity of bovine raw materials incorporated in pet food. In July 1988 Pedigree Master Foods commissioned Dr Kimberlin to advise on whether their raw materials might carry the BSE agent. What he had to tell them they considered to have wider significance and they offered to share the information with MAFF. On 16 May 1989 Pedigree Pet Foods invited Mr Meldrum and other MAFF officials to meet Dr Kimberlin. Dr Kimberlin gave Mr Meldrum details of the advice that he had given to Pedigree, including the categorisation of offal into four categoriesof risk. The highest was brain and spinal cord and the next consisted of ileum, lymph nodes, proximal colon, spleen and tonsil. ⁵ Mr Meldrum told us that it was clear to him that Dr Kimberlin thought it a good idea to keep the more infective offal out of the human food chain. He left the meeting converted to this viewpoint. Dr Kimberlin's analysis had added a huge amount to his knowledge. We wish to commend Pedigree for their initiative in seeing that this information was provided to MAFF.

560 Meanwhile MAFF officials had been preparing draft Regulations and a consultative paper in respect of the proposed ban on offal in baby food. Mr Andrews warned Mr MacGregor that this would lead to pressure to extend the ban to all human food. Mr MacGregor was already under pressure in Parliament from Mr Ron Davies, the Opposition spokesman on Agriculture, to do just this. Mr MacGregor then met with Mr Meldrum. Mr Meldrum told him of what he had learned from Dr Kimberlin. This did not persuade Mr MacGregor that the Southwood Working Party's assessment of risk was unsound. He told us that what it did was to provide him with 'a scientific underpinning for the selection of tissues if Ministers were to adopt a policy to further reduce the remote risk of transmission of BSE to humans'. He told us, 'I had some concern about this. Most of the scientists were telling me that this concern was unjustified, but there was just beginning to emerge some body of scientific opinion that there may be something in it, so it had the merit of dealing with that risk, if there was a risk.'

561 Within days Mr MacGregor had decided to go ahead with a ban. He told us that his reasons for this decision were:

• He wished to reassure the public.
• It was easier to introduce a general ban than a baby food ban.
• It would deal with any clinical animals that might slip through the net.
• It would deal with any risk from tissues from subclinical animals.

562 There was one practical difficulty. It was desirable to get Sir Richard Southwood's approval to this course. This called for diplomacy as MAFF proposed to go beyond the measures that his Working Party had advised.

563 On 6 June Mr MacGregor had a meeting with his officials, to which Dr Jeremy Metters of DH was invited, in order to prepare for a meeting with Sir Richard Southwood the following day. Sir Donald Acheson had got wind of what was afoot and was unhappy about it, fearing that it might raise concerns about the safety of vaccines. He briefed Dr Metters to resist the move, at least for the time being. Dr Metters was Senior Principal Medical Officer in DH who had recently become involved in BSE matters. In August he became Deputy CMO. Dr Metters raised the concern about the vaccines at the meeting, but reported that this 'cut little ice' with MAFF officials. Mr MacGregor did not refer at the meeting to Dr Kimberlin's analysis of the infectivity of tissues in subclinical animals. He left those present with the impression that his motive for the ban was simply a wish to allay the public concern which had developed.

564 On the next day the meeting reconvened with Sir Richard Southwood. Dr Pickles was also present. When told of the proposed ban, Sir Richard made the point that the scientific evidence had not changed, but accepted the 'political necessity for action'. Mrs Attridge then made a suggestion about presentation. As she reported later:

1. Professor Southwood maintained his position that there was no scientific evidence to support the belief that offal presented a human health hazard (DOH Dr Metters did not dissent).
2. The Minister maintained his view that presentationally something had to be done to allay public concern.
3. The CVO pointed out that the easiest way to ensure any ban was operated was to remove offal (brains, spinal cord, spleen, tonsils, thymus) that were to be covered in the baby food regulations at the slaughterhouse.
4. I suggested that the way to proceed was to say that the Minister considered the easier and more enforceable way to implement the Southwood recommendation on baby foods was to remove the offal at slaughterhouses and there it would be dyed and used for fertiliser and that the Minister would thereby not be appearing to contradict the scientific evidence in the Southwood report by taking more comprehensive action than recommended and there would be no need to proceed with consultations under the Food Act.

565 To those unaware of the potential infectivity of subclinical animals, Mrs Attridge's suggestion on presentation must have seemed attractive. If there was no scientific justification for the ban, it would do no harm to suggest that its introduction was no more than an administratively convenient way of introducing the ban on baby food. The vice of this presentation was, however, that it suggested that the ban was unnecessary. It would not encourage those who had to implement the ban to take it seriously. Unfortunately, Mr MacGregor agreed to Mrs Attridge's suggestion as to how the ban should be presented.

566 The presentation of the ban suggested by Mrs Attridge was widely disseminated. When Mr Lowson was preparing a briefing for incoming Ministers in July after a reshuffle, he included it as the reason for the decision to introduce the SBO ban. We were concerned about this, for he did not mention what he thought to be the true reason, namely to allay public anxiety as to the risk from subclinical animals. But given the pressure of time within which such briefings have to be prepared, and their ephemeral nature, we think it would be wrong to criticise Mr Lowson's draftsmanship. Mr Gummer, Mr Maclean and Mr Curry all told us that Ministers do not place great weight on such briefings, but Mr Gummer subsequently passed on the presentation. At a meeting with UKASTA in October 1989, and again before the Agriculture Committee in 1990, he emphasised that the ban went beyond what the Southwood Working Party had advised was necessary, but was introduced as a practical way of giving effect to their baby food recommendation. Mr Lawrence included the presentation as the reason for the ban in the submission to Mr Gummer that he prepared in November 1989 seeking approval of the terms of the draft Regulations. This submission was widely circulated within MAFF, DH and the Territorial Departments.

567 In his press release announcing the ban, Mr MacGregor referred to the Government's undertaking to implement the Southwood baby food recommendation. He then added:

In working out the details, I have concluded that a better way of dealing with this would be to ensure that the relevant types of bovine offals should be rejected at the slaughterhouses for all cattle so that they cannot be used for human consumption in any way . . . This approach also deals with a separate problem, namely ensuring that if there is any risk that there are cattle incubating the disease but not showing clinical symptoms which are not being slaughtered and destroyed, their offals do not enter the food chain either.

568 This at least referred to the subclinical animals, but in terms that suggested that there was no more than a risk that some of these might go for slaughter. In fact this was inevitably happening on a substantial scale.

569 How far the presentation, which played down the importance of the human SBO ban, influenced people's attitudes we shall never know. We had evidence from many sources, however, of a perception that the ban was not really necessary as a public health measure. We do not criticise Mrs Attridge for her suggestion, made in ignorance of the science that underpinned the ban, nor those who repeated what Mr MacGregor had agreed should be the public presentation of the reason for the ban. Mr MacGregor is to be commended for introducing a ban which was to prove such a vital element in guarding against the risk that BSE posed to humans. However, he should not have agreed to a presentation which played down the importance of the ban as a protection for human health.

570 One person who thought that the human SBO ban was an unnecessary precaution was Dr Pickles. She remained of the view that the Southwood Working Party had recommended all that science justified. She suggested that MAFF should be left to introduce the ban on its own. Sir Donald Acheson had by now decided, however, that DH should support the ban. This attitude was shared by Mr Clarke, although his understanding was that MAFF was motivated by a desire to restore consumer confidence rather than by any scientific consideration. Mrs Thatcher approved the ban. She informed us that she did not believe that she would have accepted the need for the ban solely for public reassurance.

Preparation of the Regulations

571 The ban was announced on 13 June 1989. Five months were to pass before it was brought into force. ⁶ The Agriculture Committee criticised this delay. We have considered why it occurred and concluded that it would not be fair to criticise either MAFF or DH for not moving faster. The ban was introduced under the Food Act 1984 and made use of procedures and mechanisms for dealing with unfit meat that were already in place under the Meat (Sterilisation and Staining) Regulations 1982 (MSSR). This made good sense, but it carried with it a statutory obligation to consult. Regulations requiring the removal of tissues from apparently healthy animals on the ground that a small minority would be incubating a disease that carried a remote possibility of transmission to humans were novel. They were quite complex. They carried serious economic consequences for some. We think that consultation was desirable. What took longer than anticipated was the task of identifying which offal should be subject to the ban. This was not due to any lack of diligence, but to the complexity of some of the technical issues that arose. It would have been better to have introduced a ban on those tissues which were known to be high risk and added to them later by amendment, but that is to use hindsight.

572 From the outset it was the intention that the ban should apply to brain, spinal cord, tonsils, spleen, thymus and intestines, which were recognised as high-risk tissues. The principal issues as to the ambit of the ban were whether:

• it should include tripe and rennet;
• it should include mesenteric fat;
• it should include intestines which had been processed to make casings for sausages and other meat products;
• it should apply to tissues of calves under the age of six months.

573 Resolving those issues required research, consultation with the industries involved and discussion between MAFF and DH. All of this took time.

574 Mr Bradley, who had been placed in charge of BSE research work at the CVL, carried out the research. So far as the first three issues were concerned, his task was to ascertain the extent to which lymphoid tissue would remain after the industrial processes that were involved. He set about this task with characteristic diligence.

575 Discussion between MAFF and DH involved Mr Meldrum on the one hand and Dr Pickles and Dr Metters on the other. Mr Meldrum's approach was one of reluctance, without good reason, to countenance extending the ban to the detriment of established sectors of the food industry. This was a proper approach provided that he did not permit concern for the food industry to prejudice the safeguarding of public health. We were conscious of accusations that MAFF had done precisely that, so we scrutinised this part of the story with particular care. We concluded that Mr Meldrum adopted a conscientious and objective approach to his task.

576 Neither Dr Pickles nor Dr Metters believed that there was any justification for the human SBO ban. They saw it as an exercise carried out by MAFF in order to improve public confidence in the safety of beef. We were concerned to see whether this perception led to any lack of rigour on their part in considering what should and what should not be included in the ban. We concluded that it did not. Dr Pickles told us that if Ministers, for all sorts of good reasons, wished to do something that was not strictly necessary, she would support them. Her aim was to ensure that all the bits of offal that might be of concern were removed from the food chain.

577 Mr Gummer was appointed Minister of Agriculture in July, in the course of the preparation of the SBO Regulations. He gave Mr Maclean, one of the new Parliamentary Secretaries, special responsibility for food safety. We are satisfied that Mr Gummer and Mr Maclean gave careful consideration to the terms of the human SBO Regulations. They did not rubber-stamp their officials' proposals, but sought and considered the reasons behind the inclusion or exclusion of various types of offal from the ban.

578 Notwithstanding the diligence that was applied to most aspects of the preparation of the SBO ban, it was inevitable that borderline decisions would be influenced by the general belief that the ban was being imposed as a measure of extreme prudence which went beyond the recommendations of the expert scientists. While those involved made no conscious application of the ALARP principle, the exercise that they were engaged in entailed weighing perceptions of risk on the one hand against the economic consequences of banning particular tissues on the other.

579 We turn to record briefly the decisions that were reached as to the ambit of the ban.

Brain, spinal cord, thymus, spleen and tonsils

580 These 'high risk' tissues were intended to be covered by the ban from the outset. Dr Kimberlin, whose advice was sought by MAFF on the ambit of the ban, advised that the proposed ban on these tissues was well founded.

Tripe and rennet

581 Rennet was extracted from the abomasum, the fourth stomach of the cow, and was used for making cheese. One form of tripe was also made from the abomasum. Concern about these products arose from the fact that the abomasum contained significantly more lymphoid tissue than the other stomachs. In relation to lymphoid tissue Mr Bradley proposed a pragmatic test. Lymphoid tissue would be banned only when macroscopically visible, that is, to the naked eye. On this approach, the abomasum and its products did not fall within the ban. This approach was approved by Dr Kimberlin and accepted by Dr Pickles and Dr Metters. Very careful consideration was given to this issue, which involved a question of nice judgement as to where the borderline should be drawn. The decision not to include tripe and rennet in the ban was endorsed by Mr Maclean and Mr Gummer.

Mesenteric fat

582 This was fat that was originally attached to the intestine and which contained lymphoid tissue. It was excluded from the ban on the basis that, in the course of processing, the protein containing the BSE agent would fractionate with the solids rather than with the fat. Similar reasoning had led to the conclusion that tallow need not be subject to the SBO ban. Ministers initially queried the exclusion of mesenteric fat from the ban, but on being given this explanation were satisfied with it.

Casings

583 MAFF officials initially believed that the cleaning of intestines, which were used as sausage casings, would remove all but an insignificant quantity of lymphoid tissue and proposed that casings should be excepted from the ban. Dr Pickles challenged this assumption, whereupon the CVL confirmed that the processing of sausage casings removed lymphoid tissue. This conflicted with information that DH had obtained from a medicinal company in relation to the manufacture of sutures from intestines. Mr Bradley carried out further research, which revealed that lymphoid tissue remained in casings after processing. Mr Meldrum reported this, but suggested that casings could be excluded from the ban because they were only used on black and white puddings, were cooked and were usually discarded at the table. Sir Richard Southwood and Dr Tyrrell were then consulted, and both indicated acceptance of Mr Meldrum's reasoning. Dr Metters expressed continuing reservations, but added that DH was content for MAFF to proceed as it thought fit. Mr Meldrum then had second thoughts. He advised Ministers not to exempt casings and wrote to Dr Metters explaining: 'I believe it is most important that we have a fully agreed position on this most important area.' Ministers accepted Mr Meldrum's advice.

Calves under 6 months of age

584 There were a number of reasons why Mr Meldrum was anxious to exclude offal from calves aged less than six months from the human SBO ban:

• It was not slaughterhouse practice to split the carcass of calves, so a requirement to remove spinal cord would raise practical problems.
• Feed compounders were threatening to boycott SBO-derived MBM. An exemption from the ban in respect of calves might discourage them from this step.
• A ban on SBO from calves would add to the waste disposal problem.
• A ban on SBO from calves might provoke export restrictions. The UK had a large trade in the export of veal calves.

585 There were two arguments that could be advanced to justify an exception from the ban in respect of the offal of calves:

• Calves would have been born after the ruminant feed ban came into operation and therefore should not have been infected from feed. The weakness of this argument was that it was possible - and Mr Meldrum thought it was likely - that calves would be infected with BSE as a result of maternal transmission.
• Analogy with scrapie research suggested that infectivity would not reach the brain or spinal cord of cattle in the first six months of life. This was a cogent argument for exempting brain and spinal cord of calves from the ban. Dr Kimberlin was, however, concerned that the lymphoreticular system (LRS), and in particular the spleen and thymus, might be infective at any age.

586 Dr Metters indicated that DH could not agree to an exemption in relation to calves in the absence of scientific advice justifying this.

587 Mr Meldrum made enquiries of the trade and was informed that spleen and thymus did not enter the human food chain. He passed this information to Dr Kimberlin and to Dr Metters, adding that very few calves were slaughtered in the United Kingdom each year. Dr Kimberlin then reconsidered the issue and indicated that he would be content with an exemption in respect of calves. Sir Richard Southwood and Dr Tyrrell were both consulted, and accepted that Mr Meldrum had demonstrated valid reasons for an exemption in respect of calves. Finally Dr Metters indicated DH agreement to this, adding that the position would have to be reviewed if maternal transmission were established. Ministers accepted advice that offal from calves should be excluded from the ban.

588 The facts that we have outlined above caused us concern. While only 25,000 calves were slaughtered each year in the UK, 250,000 were exported to the Continent to be slaughtered for veal. Furthermore, thymus, or 'ris de veau', was a prized delicacy on the Continent. In such circumstances, to have sought to disguise the risk posed by thymus by exempting calves from the ban, with the motive of protecting our export market, would have been scandalous. We explored our concerns with the witnesses. Dr Kimberlin assured us that his advice had not been influenced by export considerations. He also said that he was not overly concerned about the thymus because scrapie research indicated that thymus was lower risk than other LRS tissues.

589 Sir Derek Andrews summarised the factors which had satisfied him that the exemption in respect of calves was justified:

• The SBO ban was a measure of extreme prudence.
• The risk of transmission to humans was considered remote.
• Calves had not been fed MBM.
• Scrapie research indicated that calves under 6 months would not contain the agent.

590 The evidence we received satisfied us that those involved in the decision to exempt offal from calves from the ban were not improperly motivated by a concern to preserve exports and that the exception could be justified on an objective appraisal of such facts as were known at the time.

Mechanically recovered meat (MRM)

591 We now come to a topic which we have identified as a serious flaw in MAFF's precautions to prevent SBO from entering the human food chain. Once all meat had been removed from the carcass, it was often the practice to subject the bare bones to the process of mechanical recovery of meat. High pressure was applied to the bones to separate from them anything that was still adhering. The resultant slurry was used in a range of meat products for human consumption, including lower grade sausages, burgers and pies. The major source of bovine MRM was the spinal column.

592 Spinal cord, together with the brain, was identified as the tissue which contained the highest titre of BSE infection. It had long been the usual practice in slaughterhouses for bovine spinal cord to be removed and sent for rendering as part of the meat-dressing process. That is not to say that it used to be cleanly removed. We received evidence that before the human SBO ban it was common for sizeable sections of spinal cord to be left in the spinal column. In that event it would be sucked out as a constituent of MRM.

593 Once spinal cord was prescribed as an SBO, standards of removal of the spinal cord in slaughterhouses improved. In 1995, however, it was discovered that slaughterhouses were, on occasion, leaving small portions of spinal cord attached to or trapped within the spinal column. We are satisfied that that was a state of affairs which had persisted ever since the human SBO ban was introduced. Portions of spinal cord will have gone into MRM.

594 When the human SBO Regulations were being formulated, peripheral nervous tissue was believed not to be high risk. Since 1996 experiments have shown one respect in which that belief was fallacious. The autonomic nervous system is linked to the central nervous system at junction boxes, consisting of clusters of nerve cells, alongside each vertebral body. These are known as dorsal root ganglia. ⁷ This tissue has now been shown to develop high infectivity between 32 and 40 months after a cow is infected with BSE. Dorsal root ganglia will also have been sucked out by the MRM process.

595 On more than one occasion, consideration was given to the question of whether it was satisfactory to continue the practice of extracting MRM from the spinal column of cattle. Not until late 1995 was it decided that this practice should be banned. The first occasion on which the question arose was when the SBO Regulations were being prepared.

596 In June 1989 a minute circulated within MAFF recording that a slaughterhouse had given up producing MRM from cattle bones because it could not guarantee that all central nervous system (CNS) tissue would be removed from the backbone. This did not stimulate any detailed consideration. Views were expressed that the quantity of CNS material involved was unlikely to be significant. Mr Bradley responded with a warning that the vertebral column might be contaminated with spinal cord and commented, 'Clearly spinal cord must be removed before processing to produce MRM should this be allowed to continue.'

597 The consultation process in relation to the human SBO ban provided further warning of the danger that spinal column would be contaminated with residues of spinal cord. Some of those consulted responded that total removal of the spinal cord was impractical. One pointed out that 'the residual bone treated hydraulically to produce re-claimed meat [would] include spinal cord pieces'.

598 A meeting was held in MAFF on 27 September 1989 to consider the responses to the consultation letter. It was chaired by Mr Cruickshank and attended by, among others, Mr Kevin Taylor, Mr David Taylor, Mr Lowson, Mr Lawrence, Mr Maslin, Mr Wilesmith, Mr Duncan Fry and representatives from the Territorial Departments. Dr Pickles had been given short notice of the meeting and was unable to be present. There was no representation from DH. No witness had any recollection of what transpired in relation to MRM at this meeting. MAFF's note of the meeting recorded:

The proposed ban on specified offals was in itself a measure of extreme prudence, going beyond what Southwood recommended. Though some tissue would be contained in MRM it would be minimal and not present a significant risk. No action should be taken on MRM.

599 Mr Ron Martin, Deputy CVO at the Department of Agriculture for Northern Ireland (DANI), also made a note of the meeting, which recorded the discussion of MRM as follows:

The possible danger raised by several of those consulted was recognised and during discussion there was an expression of the illogicality of what was being done and, in particular, how easy it would be to have to concede the possible dangers of material other than those listed in the proposed ban. It was agreed not to raise it.

600 The issue of MRM was a complex one. In the following year, as we shall see, MAFF prepared a paper on it for consideration by SEAC. The amount of work that went into that paper is illustrative of what was required if the matter was to be properly considered in 1989. To make a reasoned decision about MRM, it was necessary to assess:

• the amount of spinal cord that might be left attached to the spinal column and recovered as MRM; and
• the minimum quantity of spinal cord that might be capable of carrying an infective dose for humans.

601 Those present at the meeting were not in a position to provide definitive answers to those questions, but they were in a position to identify that such questions needed to be addressed. They did not identify them. Part of the problem appears to have been that no one took on personal responsibility for addressing the question of whether MRM posed a risk to human health. Responsibility for producing the human SBO Regulations had been shared. MAFF's Meat Hygiene Division had agreed to be responsible for the mechanics of drawing up the Regulations, but considered that the Animal Health Division had retained responsibility for policy. It was the Animal Health Division that had charge of the consultation exercise.

602 Mr Cruickshank said that he relied on the veterinary judgement that MRM was acceptable. Mr Kevin Taylor said that he had no responsibility for matters relating to human as opposed to animal health. Mr Lowson said that his divisional responsibilities were limited to animal health. He also said that the Meat Hygiene Division had taken the lead in preparing the Regulations. Mr Lowson said he had to rely on Mr David Taylor, the SVO dealing with meat hygiene issues. Mr Keith Baker, for whom Mr David Taylor was deputising, told us that it was not for his section to advise on the implications of infective dose for the safety of MRM.

603 We found this evidence confusing and unsatisfactory, bearing in mind that all present on 27 September were participating in an exercise that had only one object - the protection of human health.

604 The decision on MRM depended critically on a combination of knowledge of the processes of carcass-splitting and removal of the spinal cord; knowledge of the processes of extracting MRM; knowledge of standards of operation, inspection and monitoring of abattoirs; and an understanding of what was known, and what was not known, about infective dose in relation to TSEs.

605 No one before or after the meeting of 27 September set about collecting this information and presenting it in a form that would enable an informed policy decision to be taken. There appears to have been a general assumption that, if any spinal cord were to get into MRM it would do so in quantities too small to represent a threat. Some failed to appreciate the extent to which spinal cord might get into MRM. Some seem likely to have made unwarranted assumptions about the minimum effective dose.

606 Consideration of the proposed SBO Regulations was a team exercise and the failure to give rigorous analysis to MRM was a team failure. We believe that this failure is explained in large part, and mitigated, by the general belief that the SBO ban was a measure of extreme caution that went beyond the recommendations of the scientists. In the circumstances it is easy to understand the reaction that if there was a failure on occasion to remove a little bit of spinal cord, it was unlikely to matter. This does not, however, excuse the failure to carry out the rigorous risk evaluation that was required in order to reach a sound decision on policy.

607 The problem posed by MRM should not have been dismissed at the meeting on 27 September 1989. It should at least have been identified as calling for further consideration. However, no witnesses could remember any relevant detail as to the information or views contributed on this subject at that meeting. It would not, in these circumstances, be fair to criticise any individual for the conclusion that was reached. Nor would it be fair to criticise those who placed reliance on that conclusion. We are simply not in a position where it would be fair to allocate blame to any individual for the failure to give rigorous analysis to MRM in 1989.

608 Dr Metters and Dr Pickles of DH received copies of MAFF's note of the meeting on 27 September. They had no knowledge of the nature of MRM. They read the statement that the amount of nervous tissue that it would contain would be minimal, and were content with that.

609 Those who relied upon the outcome of the meeting included Mr Lawrence. He advised Mr Gummer that any nervous tissue in MRM would be minimal and that the ban should not extend to MRM. Ministers questioned this advice. Mr Maclean asked how they could be sure that all abattoirs removed the spinal cord cleanly before MRM production took place. Mr Meldrum reassured Ministers that the risk from MRM was no greater than that in other cases where an exclusion from the ban had been agreed. Mr Meldrum told us that he was not concerned about spinal cord. He believed that any fragments would be removed at the dressing stage. He had concerns about peripheral nervous tissue, but Dr Kimberlin had provided reassurance about this. Mr Meldrum also relied on the conclusions reached at the meeting on 27 September.

610 On this occasion the chance to identify the danger posed by MRM was lost. What would have transpired had that danger been identified? We do not think it likely that it would have led officials to advise, or Ministers to decide, that the practice of extracting MRM from the spinal column of cattle should be banned. Mr Cruickshank told us that officials were conscious that the ban went beyond what the scientists had advised was necessary for the protection of public health, and were apprehensive that action that appeared disproportionate would provoke a judicial review. Had the danger of MRM been recognised, we think that this would have led MAFF to emphasise to slaughterhouse operators and local authorities that it was essential to remove spinal cord in its entirety and to monitor the extent that this was achieved once the ban was in force.

611 In the event, when the ban was introduced, no guidance was given to slaughterhouse operators or to the local authorities who had to enforce it. Nor were any instructions given to the veterinarians in the VFS, whose job it was to monitor the enforcement of the Regulations, that it was important to check that all spinal cord was being removed from carcasses.