Volume 6: Human Health, 1989-96
3. Introduction of the ban on Specified Bovine Offal
Discussion of the extent of the Government review of the Southwood Report
Adequacy of review of the Southwood Report
Some comments with hindsight

Adequacy of review of the Southwood Report

3.102 In the course of the discussion in Cabinet, one Minister is recorded to have remarked that it was unsatisfactory that policy decisions should in effect be put into the hands of specialised experts. ¹ The terms of reference of the Working Party were widely drawn, enabling it to advise on both the risks posed by BSE to humans and animals and on measures that should be taken to address those risks. The Report was to be published and, because of the public interest in its subject, the Government was under pressure to do so promptly. There was little time to consider its recommendations before publication. Once it was published the Government had, as Mr Clarke recognised, little alternative but to accept its recommendations unless very good reason could be demonstrated for not doing so. Mr MacGregor made the same point to us and observed that he did not have a lengthy period in which to carry out a scientific analysis of the reasoning of the Working Party. ²

3.103 We accept that the Government could not be seen to question recommendations in the Southwood Report without being able to demonstrate good reason for so doing. We also accept that the pressure to publish the Report may not have permitted adequate time for review before publication. We are in no doubt, however, that whether before or after publication the Departments concerned needed to review the Report so as to satisfy themselves that the reasoning underlying its recommendations was clear and supported the recommendations. This was accepted by Mr Clarke (see paragraph 3.91). Sir Derek Andrews also accepted that it was part of the responsibility of Government on receiving the Southwood Report to consider whether there were any reasons for wanting to question the advice in it and that, for this purpose, it was necessary to know the reasons for the advice. ³ Where Government acts on the basis of expert advice it needs to be in a position to explain the reasons underlying that advice and to review, as time passes, whether these reasons remain valid.

3.104 In recommending measures to address the possible risks posed by BSE to human health, the Southwood Working Party drew the line between the clinically sick animal, calling for the draconian measure of slaughter and destruction, and the subclinically infected animal, in respect of which its advice was that all tissues could go into the food chain. But the line was not clear-cut. As noted at paragraph 3.80, concerns held by the Working Party about the safety of certain tissues of clinically healthy animals were demonstrated by the recommendation that manufacturers of baby food avoid ruminant offal and thymus. In a written statement Mr Cruickshank summarised the position as follows:

. . . the recommendation on baby foods seemed to make good sense when it was received; when difficulties with it emerged, a way was quickly found of avoiding these difficulties without calling into question the Working Party's advice as a whole (in which we still had complete confidence). ⁴

3.105 In our view, paragraph 5.3.5 of the Report raised questions as to the reasoning of the Working Party which needed exploring. This fact was highlighted when Mrs Attridge drew attention to the baby food recommendation. The removal of liver and kidney from the recommendation left the questions unanswered. DH and MAFF needed to review the reasoning of the Working Party in order to be satisfied that their recommendations on risk management appeared sound.

3.106 Later in the story Dr Pickles was to inform Mr Cockbill (Head, Food Standards Division, MAFF) that the justification for excluding offal from baby food and not all food was 'based on uncertain data'. ⁵

3.107 How should the review of the Southwood Report have been brought about? Mr Meldrum told us that, so far as doubts about the baby food recommendation were concerned, he was not in the lead, it was a matter for Mrs Attridge and the DH. ⁶ He said that it was clearly the responsibility of Mrs Attridge to ask the question 'if there is a need to take out these "high risk" tissues from baby food, why not take them out from the food of adolescents?'. ⁷ He emphasised that, while he would have done his best to assist Mrs Attridge if asked, this area was not his responsibility. He did not have responsibility for assessing risk to human health. That was for the CMO, assisted in this instance by the Southwood Working Party. ⁸

3.108 Mr Capstick told us that the question of the implications for adults of the baby food recommendation was primarily a matter for DH, but that to some extent it fell within Mrs Attridge's area of concern. ⁹

3.109 Mrs Attridge was head of the Emergencies, Food Quality and Pest Control Group. In a written statement she referred to the division of responsibilities in respect of food between DH and MAFF laid down by the Whetnall Report (see paragraph 3.344 and Chapter 4). The matters on which MAFF had the lead included meat hygiene and the composition of food. Her Group was not concerned with meat hygiene. It was, however, concerned with composition of food. In relation to BSE her Group advised on labelling aspects, consumer perceptions and Single European Market issues. ¹⁰ Mrs Attridge said that her Group was concerned with the baby food recommendation inasmuch as its impact might reduce the nutritional value of baby food. It was not concerned with the wider question of whether adult food might be rendered unsafe if it contained the types of offal that were not safe for babies. ¹¹ It was for the CMO, for the veterinary side and for others to look at the wider issues. ¹² In particular, it was the Animal Health Group and the State Veterinary Service which were responsible for animal diseases that could affect humans. ¹³

3.110 Paragraph 5.3.5 of the Southwood Report addressed the problems of risk evaluation and management in relation to potentially infective tissues in subclinicals. This was a human health problem and thus of direct interest to DH. It was also, it seems to us, a problem of direct interest to the Animal Health Group (AHG) at MAFF, in that it arose out of a potential zoonosis, and to Mrs Attridge's Group, as it raised questions as to the safety of the components of food. The issues raised required input from veterinarians and we believe that they fell within the area of responsibility of the CVO.

3.111 Mrs Attridge is to be commended for first drawing attention at a senior level to the problems raised by the baby food recommendation. These problems had been identified by Dr Woolfe, who shares in that commendation. We consider, however, that Mrs Attridge should have continued to urge the need to review the reasoning behind this recommendation after liver and kidney had been withdrawn from its ambit. The Report still did not answer the question why no precautionary steps were advisable to address the possible risk to children and adults from eating tissues that were considered potentially hazardous to babies.

3.112 We have considered whether Mr Cruickshank should have seen that steps were taken to ascertain the answer to this question. He told us that veterinary colleagues had advised him that young calves were more susceptible to BSE than older ones and that it seemed reasonable to expect that if any humans were at risk from BSE, the risk would be greatest for babies. He commented that the Working Party did not consider that the risks presented by material from subclinically infected animals were sufficiently serious to justify any action in relation to adults, but he considered that this did not mean it was unreasonable to propose certain very limited action in relation to the category of humans for whom the risk was greatest.

3.113 We do not consider that this reasoning should have satisfied Mr Cruickshank that there was no need to obtain a more specific explanation of the Working Party's reasoning. If MAFF was to base its policy on a distinction between babies and other humans, and between clinically affected and subclinically infected animals, it needed to know the precise premises which the Working Party believed justified those distinctions for two reasons. First, so that it could decide whether the Working Party's conclusions were soundly based on those premises; secondly, so that it could keep those premises under review.

3.114 Mrs Attridge had recommended referring the baby food recommendation to the CMO, commenting, 'This would enable us to assess more fully what the actual risks are' ¹⁴ (see paragraph 3.32). Mr Cruickshank has described to us the problem raised by Mrs Attridge as 'a loose end in the Report' in respect of which he had agreed that the CMO should be asked to give further consideration. He suggested that the option of getting the CMO's advice was closed off by the CMO's decision not to give such advice. We do not understand that there was any refusal on the part of the CMO to help to explore the question 'Why baby food and not hamburgers?' DH was not asked to address that question. It is one that we consider Mr Cruickshank should have pursued.

3.115 We have also considered whether this was a question that Mr Meldrum should have pursued. Mr Meldrum was adamant that it was not. He accepted that where advice of a scientific committee was given in an animal health context he would want to know the reasons for that advice and to look at its soundness and its applicability. In oral evidence, however, he said that it was not his responsibility to review the reasoning of the advice given in paragraph 5.3.5 of the Southwood Report; that responsibility devolved on Mrs Attridge's Group and on DH. ¹⁵ We cannot accept this argument. In correspondence with the Inquiry, Mr Meldrum accepted that the CVO had a responsibility for ensuring that relevant veterinary matters were drawn to the attention of the CMO, and for providing information and advice to him on veterinary matters based on which he could form an opinion on food safety. Even on this narrow view of the CVO's responsibility, it was in our view necessary for Mr Meldrum to consider whether there were any veterinary issues relevant to the advice given by the Southwood Working Party. The distinction drawn by the Southwood Working Party between animals showing clinical symptoms of BSE and infected animals in the subclinical state raised issues that clearly fell within the province of the veterinarian.

3.116 When, as a result of public pressure, the question arose as to the adequacy of the precautionary measures recommended by the Working Party, it was to Mr Meldrum that Mr MacGregor turned for advice. As we record below, Mr Meldrum told us that it was at that stage that it became clear that the baby food recommendation lacked some logic. The illogicality would have been identified earlier if, as we believe he should, Mr Meldrum had considered whether there were any veterinary issues relevant to the advice given by the Southwood Working Party. He would have found that a review was needed in order to ascertain, and assess the soundness of, the reasoning of the Working Party in relation to the risks to the human food chain posed by cattle incubating BSE. Even on the limited view of his responsibilities which he has advanced, Mr Meldrum should have realised that there was a need for such a review.

3.117 Before moving on, we wish to refer in a little more detail to submissions made on behalf of Mr Meldrum about the role of the CVO. The following is an extract from those submissions:

Mr Meldrum had a responsibility as CVO for ensuring that relevant veterinary matters were drawn to the attention of the Chief Medical Officer, and for providing information and advice to him on veterinary matters based on which he could form an opinion on food safety.

During his tenure as CVO, Mr Meldrum was never asked, and would not have expected to be asked, to give advice to the CMO on the assessment of any risk to human health arising from BSE or any other zoonoses or potential zoonoses.

Once any such veterinary matters have been drawn to the attention of the CMO (whether by the CVO or his colleagues within MAFF), which occurred on a number of occasions only some of which were related to BSE, the CVO has fulfilled his duty. It is then entirely within the responsibility of the CMO and those who share in the CMO's responsibility for the assessment of food safety and human health, as to how those veterinary matters, together with all other relevant information in the CMO's possession, are taken into account. The ultimate decision as to what, if any, the human health risks might be and any judgement on the adequacy of the assessment by which the decision is reached, is within neither the responsibility nor the capability of the CVO.

3.118 We have had, and we still have, great difficulty in practice between drawing the line between 'advising on veterinary matters' and 'advising on the assessment of any risk to human health arising from a zoonosis'. It is one thing to say that 'the ultimate decision' on human health risks was for the CMO and another to say that it was never part of the CVO's duty to give advice about risks to human health.

3.119 In this context we can draw attention, without leaving the confines of this chapter, to occasions on which Mr Meldrum's advice on veterinary matters was couched in terms of risk to human health. The preparation of the human SBO Order required identification of those tissues which should be proscribed because of their potential infectivity. This was a joint task of MAFF and DH. Mr Meldrum's advice was repeatedly provided in the form of evaluation of whether a particular tissue would pose a risk to human health: eg,

• In the preparation of black tripe the mucosa is likely to be removed and for that reason abomasum should not present a human health hazard when used as either black tripe or casings (see paragraph 3.433).
• We suggest that we can separate types of offal for practical purposes on the basis that those with macroscopically visible lymphoid tissues would be banned while others would be excluded (see paragraph 3.460).
• The intestines contain significant amounts of lymphoid tissue and are thus a 'risk' organ. However, in the processing of casings for sausage manufacture the lymphoid tissue in the mucosa is removed when the intestines are scraped, cleaned and washed. On this basis we have concluded that we could not justify a ban on intestines so processed for use as casings (see paragraph 3.493).
• We conclude that the human health risk from casings is extremely low particularly in view of the fact that so little intestinal tissue is used for casings, that the product is fully cooked and we believe that it is common practice for the casings to be discarded at the table (see paragraph 3.508).
• The risk to man is extremely remote since the calves would not have been fed meat and bone meal (see paragraph 3.528).

3.120 It is not our task, in the abstract, to delineate the duties of the CVO in relation to advice given about risk to human health from a zoonosis. We recommend, however, that this is a topic which should be explored between MAFF and DH, with input from both the CMO and the CVO so that no misapprehension can arise in the future.

3.121 Mr Andrews received a copy of Mrs Attridge's minute of 20 February, though not that of 15 February (see paragraphs 3.38 and 3.32). Thus he was alerted to the problems arising out of the baby food recommendation, including Mrs Attridge's comment that MAFF would be asked why action should be taken on baby food but not other food. He told us that he believed that any uncertainties about the reasoning underlying the Southwood Report would have been clarified in inter-departmental discussions:

The issue did of course come out in the very detailed discussions over a period of, I do not know, a fortnight, between officials in the Ministry of Agriculture and officials in the Department of Health, and of course there were discussions at ministerial level. These issues were pretty thoroughly explored and discussed. I was not involved in all those discussions but I was aware that they were going on. The records do not show everything that happened during this period of time, but I have no doubt that by the time the Southwood Report was published, insofar as there was a need to clarify the thinking behind any particular pieces of the Report, that would have come out in the discussions between officials. ¹⁶

3.122 It must have been clear to Mr Andrews that such discussions had not resolved the reasoning behind the baby food recommendation, for right up to the morning of the Cabinet meeting the plan was that this should be referred to the CMO for advice. The problem about liver and kidney was resolved, but the question remained outstanding as to why babies needed protection against the residual types of offal, but adults did not. We consider that Mr Andrews should have raised with Mr MacGregor the need to see whether there was a satisfactory answer to this question.

3.123 Mr MacGregor had, however, already been alerted by Mrs Attridge to concerns which included the fact that questions would be asked as to why action should be taken on baby food but not on food for adults. He had concluded that 'a considerable amount of further thought' needed to go into the matter (see paragraphs 3.39 and 3.40) While the major cause for concern was the removal of liver and kidney from the diet of babies, the wider question of 'Why babies and not adults?' also needed to be pursued, and he should have seen that it was.

3.124 Mr MacGregor has asked whether there was anywhere he could have turned to for a review of the Report. We have already indicated that the first step would have been to ascertain the reasoning of the Working Party. Mr Lawrence and Dr Pickles could have assisted with this, and veterinary issues would then have been identified. The Central Veterinary Laboratory (CVL) would then have been an obvious source of advice.

3.125 We have considered whether criticism should attach to Mr Lawrence or Mr Capstick for failure to point out the need for a review of this aspect of the Southwood Report. We have concluded that it should not. This initiative was properly to be sought at a higher level than Mr Lawrence. Mr Capstick was promoted Deputy Secretary in January 1989. He had a very wide portfolio and told us that in his first 10 or 11 months he had nothing to do with, and knew nothing about, BSE. ¹⁷

3.126 We turn to DH. We consider first the position of Sir Donald Acheson. Our first concern is that he had not himself obtained a satisfactory explanation from Sir Richard Southwood of the distinction between the possible dangers posed by clinical and subclinical victims of BSE.

3.127 On 24 November 1988 Sir Donald met Sir Richard and Mr MacGregor and MAFF officials. ¹⁸ One of the topics discussed was the possible risk involved in eating brains from subclinically infected cattle. Sir Richard indicated that he was not persuaded that it was necessary to ban the use of cattle brains in food, though it might be appropriate to impose a labelling requirement. When Sir Donald gave evidence he was asked whether Sir Richard explained the reason for responding so differently to ox-brain in a clinical animal and in a subclinical animal.

3.128 Sir Donald replied that on some occasion, and he could not say whether or not it was at the meeting on 24 November, Sir Richard told him that titres of scrapie rose very steeply a very short time before the animal became sick. Quite apart from the uncertainty as to when Sir Donald received this information, it does not seem to us that it sufficed to justify taking no precautionary measures against the risk from eating ox-brain from a subclinical animal. When it was pointed out to him that the information he described would raise a question about dealing with the animals that were being slaughtered just before they became sick, Sir Donald said:

Well, it depends how many animals are slaughtered just before they become sick. Honestly I never considered that. It seemed to me it was reasonable, in the circumstances of the way he described it to me, that - at the time, in the light of knowledge at the time and in the light of the fact that nvCJD had not occurred, that it was quite reasonable for him to pursue the policy that he did or to advise on it. In any case I go back to my opening statement, and say that I was a generalist; and I did not enter into discussions with expert advisers, except to inform myself. And I would not have regarded myself as in a position to advise the acknowledged experts - very rare - experts in this disease - to change their advice. ¹⁹

In all the other things I had a consultant adviser to whom I could turn when it came to evaluating the report. But in the case of the Southwood Report I did not have one. So my own evaluation of these things was the only thing I could rely on, apart from my colleagues in the Department, of whom Ed Harris and Hilary Pickles were the obvious people. ²⁰

We are satisfied that Sir Donald Acheson was not given, and should have sought, a clear explanation for the distinction between clinically affected and subclinically infected animals.

3.129 This leads to our second concern, which is Sir Donald's failure to have the Southwood Report reviewed. For the reasons that we have given, we find that he did not do so. He should have done, and should not have commended the Report to Mr Clarke in the terms in which he did without a review.

3.130 After Sir Donald had commended the report to Mr Clarke, MAFF's concerns about the baby food recommendation led Dr Pickles to offer to 'seek the appropriate information and advice - including from Sir Richard . . . and put forward a paper on what information and opinions are available'. Sir Richard's clarification that 'offal' did not include liver and kidney still left outstanding the question of why the remaining types of offal posed no threat to humans. This Sir Donald should have pursued.

3.131 In April 1989 Dr Pickles was to list a number of questions related to food 'that might be regarded as still being unresolved' for possible consideration by the Richmond Committee (see paragraph 3.177). Significantly these included:

Should the ban of offal in baby food be extended to include (i) pancreas (sweetbread), oxtail (rich in peripheral nerves) and possibly even liver and kidney and/or (ii) to all processed food for human use or even (iii) to a total ban on sale for human consumption of some beef offal?

3.132 Sir Donald was opposed to reopening matters covered by the Southwood Report in the absence of new developments as this would imply a lack of confidence in the Working Party's conclusions (see paragraph 3.179). The problem with this approach was that the reasoning underlying those conclusions had not been reviewed.

3.133 Turning to Mr Clarke, we consider that, as Secretary of State for Health, he needed to be in a position to answer the question 'If offal is unsafe for babies, why is it safe for adults?' Because there had been no review of the Working Party's reasoning, he was not in a position to do so. DH's position was reflected by the Prime Minister's response to Mr Evans on 28 February. We noted in our narrative section that Mr Evans asked why, if bovine offal were not a danger, it was banned for consumption by babies. We quote the response:

The Prime Minister: 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. ²¹

3.134 Mr Clarke should have ensured that the reasoning of the Southwood Report was ascertained and reviewed. He was taking a close personal interest in BSE and, in these circumstances, we do not consider this criticism falls to be shared by his junior Minister, Lord Freeman.

Some comments with hindsight

3.135 It is time to ask a 'what if' question. What if MAFF and DH had sought and ascertained details of the reasoning underlying the Southwood Report? What if they had been given the list of factors that the Working Party told us led to their decision not to recommend the banning of ox-brain? What if it had been made clear to them that, when describing the risk as remote, the Working Party intended to indicate that precautionary measures should be taken to reduce the risk as low as reasonably practicable (ALARP)? DH and MAFF would then have appreciated that the recommendations that distinguished between tissues from clinical and subclinical animals were based on analogies with slender scientific evidence relating to scrapie. They would have appreciated that in considering practicable precautionary measures there might be relevant matters of which the Working Party was unaware. ²²

3.136 Had the assistance of CVL been sought by way of review of the Working Party's conclusions, Mr Raymond Bradley (Head of Pathology Department, CVL) might have produced the advice that he was to provide to Dr William Watson (Director of CVL, July 1986-March 1990) ²³ in April and which may not, it seems, have reached a wider audience:

It is quite clear that in an infected animal in the late pre-clinical phase . . . lymphoreticular tissues [and] certain other tissues including some endocrines and gut plus CNS [central nervous system] are highly likely to be infected to a high titre of significance to humans if the agent is transmissible to them . . .

It is a big step to take to try to eliminate certain items from the food chain. However it would be relatively simple to reduce risks considerably by sending for rendering or incinerating specified easily identifiable organs . . . ²⁴

3.137 Government would then have been in a position to take an informed policy decision as to whether to take additional precautionary measures to those proposed by the Working Party.

3.138 In the event there was public concern raised as to the risks posed by tissues from subclinicals and no convincing answer could be found to assuage that concern. The result was the decision in June 1989 to introduce the SBO ban. We shall shortly explore the course of events that led to that decision. The manner in which it was reached was haphazard and led many to believe that the ban was not a precaution with a sound scientific base. This impression might have been avoided and several precious months saved had the Southwood Report been reviewed by the two Departments to which it was made.

3.139 Before concluding our discussion of the extent to which the Southwood Report was reviewed by Government, we record that two glosses were placed on the Report in Government publicity.

3.140 On 27 February MAFF and DH issued a joint news release setting out 'The Government's Response to the Southwood Report on BSE'. This took the form of a written reply by Mr MacGregor to a Parliamentary Question. It included the following information on the contents of the Report:

The Report concludes that the risk of transmission of BSE to humans appears remote and it is therefore most unlikely that BSE will have any implications for human health. It points out that the related disease scrapie in sheep has been present in the UK for over 200 years and there has been no evidence of transmission to man. The Report also concludes that from present evidence it is likely that cattle will prove to be a 'dead-end host' for the disease agent. However, the Working Party point out that if their assessment proves incorrect the implications would be serious. ²⁵

3.141 We note the removal of the word 'extremely' which had qualified the word 'serious' in the Report.

3.142 The news release continued:

The Working Party have greatly welcomed the speed with which the Government acted to ban the use of the animal feed rations in question and also to implement their interim recommendations. These measures include the compulsory slaughter of cattle suspected of having BSE and the removal from the food chain of their milk and carcasses. The Working Party believe that the risks as at present perceived would not justify special labelling requirements for products containing either bovine brains or spleen. The Report suggests, however, that manufacturers of baby foods should avoid the use of bovine thymus and offal. Sir Richard Southwood has confirmed that the term 'offal' as it is used in the Report (as defined in the Regulations quoted) refers to brain, spinal cord, spleen and intestines (tripe). The Chief Medical Officer is satisfied that none of these, nor thymus, are used in the manufacture of baby foods and advises that mothers ought not to feed these materials to infants of say under 18 months. As a precautionary measure I am however taking steps to ensure through secondary legislation that it will be illegal for anyone to sell baby food containing such products in future. ²⁶

3.143 Dealing with the Government's response, the news release stated:

Although the risk of transmission to humans is very remote there are several further actions the Government proposes to take as a matter of extreme prudence in response to the other recommendations in the Report. These add up to a comprehensive response to all the Working Party recommendations. ²⁷

3.144 We note the addition of the adverb 'very' to the description 'remote' used in the Report.

3.145 The news release went on to deal with steps taken in response to the Report by the Committee on Safety of Medicines (CSM), the Veterinary Products Committee and the Health and Safety Executive (HSE). Finally, it referred to CJD surveillance, research and the ruminant feed ban.