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
Extent to which DH reviewed the Southwood Report
Extent to which MAFF reviewed the Southwood Report

3.63 MAFF took the lead in preparing papers for members of the Cabinet on the publication and handling of the Southwood Report.

3.64 Mrs Attridge's minute of 15 February (see paragraph 3.32) put in question the reasoning behind the baby food recommendation in the Southwood Report. On the one hand, no adequate reason had been given for thinking liver and kidney were not safe for babies; on the other hand, if it were not safe for babies, why was it nonetheless safe for adults? The Southwood Report itself gave no explanation as to why manufacturers were advised not to include offal in baby food, nor why this recommendation was aimed at manufacturers only (as opposed to anyone feeding offal to babies) and why no precautionary measures were considered necessary in respect of the consumption of offal by children and adults.

3.65 Mrs Attridge's suggestion that the Government response to the baby food recommendation should be to say that the matter was being referred to the CMO was agreed by the CMO himself. ¹ Up to this point it does not appear that the matter had received consideration by the DH Secretary of State, Mr Kenneth Clarke.

3.66 Mr Clarke is an astute politician and we believe that, when he learned what was proposed in relation to the Southwood baby food recommendation, he at once concluded that it was politically untenable.

3.67 He told us that in the Cabinet meeting which took place on 23 February he expressed the view that:

The Government would be in serious difficulty if we turned round and said we do not believe this is based on adequate evidence and we are not going to issue any warnings on baby food. ²

3.68 When asked whether the Government could not have taken further advice before reaching a decision on policy, Mr Clarke retorted:

I would regard that as pretty pathetic if I had had to put that up - to say we are publishing the Southwood Report, the Government is making no recommendations, it is taking no action, it is going to have some more work done. I would have loved to have been in the Opposition if some Minister [had made a] half-baked statement of that kind. You do have to make your mind up what you are going to do. We had no sensible advice that we should not take the action recommended by Southwood on baby foods. People would have had our guts for garters if we said we were going away to commission some more work. ³

3.69 Mr Clarke told us that he anticipated that some of his Cabinet colleagues would resist publishing the Southwood Report and accepting the baby food recommendation because it would make sensational headlines if it were not handled extremely carefully. ⁴ The problem was how to persuade the Cabinet that the best course was to put out the Report on baby food. He told us that before the Cabinet meeting he had gone round to try to persuade other members of the Cabinet of this in order to get a few allies in advance. One ally that he recruited was Mr MacGregor, who supported him in urging that the Report should be accepted and published. ⁵

3.70 We asked Mr Clarke about the reference in the minutes of the Cabinet meeting to the CMO advising him that morning that it would not be right to do other than accept the Southwood Working Party's findings. Sir Donald Acheson had not told us about this meeting and Mr Clarke suggested that he had probably forgotten about it. ⁶ Mr Clarke himself did not have a clear recollection of the meeting. He told us that the discussion came to the conclusion that the CMO 'could not possibly give me advice that we should set aside the recommendation on baby foods and do nothing about baby foods whilst a further review took place'. ⁷

3.71 In a Supplementary Statement Sir Donald said this about his meeting with Mr Clarke on the morning of the Cabinet meeting:

As far as the discussion with Kenneth Clarke on 23 February 1989 is concerned, all I am able to remember is that he approached me on the issue of offals in baby foods and advised me that there was concern about the baby food suggestion (it was not a recommendation) for presentational reasons. He asked me whether I thought that the Working Party could be persuaded to remove the suggestion from its Report before publication. I advised him that it would be inappropriate, and indeed improper, for me to try to persuade the Working Party to remove a conclusion from its Report for presentation reasons [see paragraph 65 of my earlier statement WS 251A]. The Inquiry have also heard from Kenneth Clarke in oral evidence that I told him that I could not advise him to reject the suggestion relating to baby food. ⁸

3.72 Mr Clarke has responded to this evidence in a Supplementary Statement:

I spoke to Sir Donald to make sure I would be on sound ground in telling the Cabinet that we could not reject this part of the Working Party's Report. The advice he gave me was precisely that which I expected he would give. I was not suggesting that he should try to persuade the Working Party to remove the suggestion from their Report. I would have been astonished if he had suggested that we could. I cannot recollect the terms that were used, but it merely confirmed my opinion that he had reviewed the Report and feltstrongly that the baby food suggestion was an integral part of the Report with which he agreed. ⁹

3.73 With recollections of both Sir Donald Acheson and Mr Clarke unclear so long after the event, it is not possible to reach a conclusion about the details of their conversation. What we think is clear is that Mr Clarke sought and obtained Sir Donald's support for publication of the Report and immediate acceptance of its suggestion about baby food rather than deferring that matter for further consideration. We are inclined to think that Mr Clarke persuaded Sir Donald to support his own conclusion that the baby food recommendation should be accepted. Mr Clarke told us that he would have had a last word with Sir Donald before going into Cabinet because he needed to be able to strengthen his argument. It was a discussion that took place for tactical reasons to try to ensure that he was armed with the right arguments for Cabinet. ¹⁰

3.74 In the Cabinet meeting on 23 February Mr Clarke encountered the resistance that he had anticipated. His colleagues were concerned that the baby food recommendation would result in supermarkets sweeping all baby food off their shelves and a tremendous panic about what was being fed to babies. They had in mind the consequences of previous food scares in respect of listeria in cheese and salmonella in eggs. ¹¹

3.75 In the event Mr Clarke's views prevailed. The conclusion was that the Government would publish the Southwood Report and announce that it was acting on its recommendations. The Prime Minister said that the CMO and also Sir Richard and the CVO should be consulted in order to sort out the line that the Government was going to take. The idea was to publish the Report, to act on it and to try to present it in a way which was scientifically accurate and did not cause unnecessary public alarm. ¹²

3.76 As we have noted, on the afternoon of the Cabinet meeting, the CMO phoned Sir Richard Southwood about the baby food point and established that liver and kidney should not be treated as falling within the term 'offal' in the baby food recommendation. Liver and kidney could safely be fed to babies. ¹³

3.77 It was not clear to us whether Sir Richard changed his mind about liver and kidney or whether it had never been the intention of the Working Party that liver and kidney should fall within the recommendation. Mr Cruickshank thought that the Working Party had changed their minds. ¹⁴ Dr Pickles's belief was that the Working Party had never intended that the baby food recommendation should embrace liver and kidney. ¹⁵

3.78 We have difficulty with Dr Pickles's suggestion. In the first place it does not accord with Sir Richard's own evidence (see vol. 4: The Southwood Working Party, 1988-89). Nor does it accord with Sir Richard's actions in the period leading up to the Cabinet meeting: he received a draft of the Q&A brief and amended a sentence stating that internal organs such as liver and kidney 'may carry the agent' to read 'may carry low levels of the agent'. ¹⁶ The probability is, in our view, that Sir Richard was correct when he told us that the Working Party originally intended the baby food recommendation to embrace liver and kidney but subsequently had second thoughts about this. ¹⁷ We do not believe the issue to be one of great importance. It suggests, however, that Mrs Attridge was correct in her conclusion that the status of liver and kidney merited further consideration.

3.79 Once Sir Richard had stated that the baby food recommendation was not intended to apply to liver and kidney, the concerns expressed by members of the Cabinet that the baby food recommendation would lead to a food scare were allayed. The Government was able to reassure the public that the type of offal to which the baby food recommendation related was not, in any event, incorporated in baby food. Thus the recommendation did not cast doubt on the safety of baby food on the shelves of the supermarkets.

3.80 The baby food recommendation had, however, demonstrated that the Working Party had concerns about the safety of certain tissues of clinically healthy animals. The question that Mrs Attridge had identified - if these were not safe for babies why were they safe for adults - remained unanswered. Nor does the contemporary evidence suggest that any explanation was sought, or given, as to why the Working Party had concluded that sick animals should be destroyed but that, the baby food recommendation apart, there was no need for precautionary measures in relation to any of the tissues of animals incubating BSE.

3.81 Despite the lack of contemporary evidence, we were assured by witnesses from DH that a review was carried out to check that the recommendations of the Southwood Working Party appeared to be soundly based. We turn to consider that evidence.

Extent to which DH reviewed the Southwood Report

3.82 After we had raised with Sir Donald Acheson the question of whether the Southwood Report was reviewed by DH, he submitted a written statement which included the information that an independent evaluation of the Report was carried out for him personally, at his request, by 'the relevant DCMO [Deputy Chief Medical Officer], Dr Ed Harris'. ¹⁸ Later in his statement he expanded on this:

In my time in the civil service (1983-1991) there was no established procedure within DH to subject the work of an independent expert committee to critical or independent review other than that undertaken as a matter of course by appropriate members of my staff. In this case, as Dr Pickles had been personally involved in drafting the Southwood Report, I asked my colleague the late Dr Ed Harris, CB, who was the Deputy Chief Medical Officer accountable to me for communicable disease, medicines and medical equipment and pharmaceuticals (including vaccines and blood products) and international health, to evaluate it for me . . . Although no relevant papers have yet come to light, I have a clear recollection that Dr Harris' evaluation was favourable and that he had no substantive criticisms. ¹⁹

3.83 We have referred to the limited instructions given by Sir Donald Acheson to Dr Harris on 9 February 1989 in relation to bovine-based vaccines (see paragraph 3.24). Dr Pickles described this as a request 'not so much to look at medicines but to speed up the action that should have been taken by the Medicines Division'. ²⁰ Apart from this, she could not remember any review of the Southwood Report by Dr Harris. She did not recall him asking her about the factors which led to the Working Party reaching its decision. ²¹ Dr Metters had no recollection of Dr Harris being asked to evaluate the Southwood Report, although he commented 'it does not surprise me in the least that Donald asked Ed to look at the medicines aspect'. ²²

3.84 Mr Clarke had no recollection of Dr Harris carrying out a review. ²³

3.85 We cannot accept that Sir Donald Acheson's recollection that he sought and obtained a review of the Southwood Report from Dr Harris is correct. Had he done so we think it almost inconceivable that there would not have been some indication of this in the contemporary documents. Nor is it likely that neither Dr Pickles, nor Dr Metters, nor Mr Clarke would have any recollection of such a review.

3.86 It seems to us that had Dr Harris carried out a review of the Southwood Report he would almost certainly have asked for some assistance from Dr Pickles in identifying the reasoning behind the Working Party's approach to the potential hazards posed by clinically affected and subclinically infected animals.

3.87 On the central issue of the risk posed by BSE to man, the Working Party had not set out the reasoning behind a number of conclusions and recommendations:

• The risk posed by BSE to humans was 'remote'.
• Clinically affected animals should be slaughtered and their carcasses destroyed.
• No precautionary measures were justified in relation to the risk posed to adults and children from eating tissues of subclinically infected animals.
• Manufacturers of baby food should avoid the use of ruminant [NOTE: not bovine] offal and thymus.

3.88 To review the Southwood Report it was necessary to ascertain the reasons for these conclusions and recommendations and then to consider their validity.

3.89 Dr Pickles had suggested to the CMO steps that she could take to assist in a review of the baby food recommendation (see paragraph 3.41). Had Dr Harris reviewed the Report, we would have expected him to seek such assistance. In the event he did not approach Dr Pickles and she was not aware of any review carried out by him.

3.90 On the first occasion that he gave evidence, Sir Donald commented that the Working Party were the best people in the country to make a judgement and that in the end one had to accept that judgement. ²⁴ Our conclusion is that, while Sir Donald sought limited assistance from Dr Harris in relation to medicines, he did not ask him to carry out a full review of the Report.

3.91 When giving oral evidence Mr Clarke accepted that a careful and thorough review and assessment of the scientific reasoning and conclusions of the Southwood Report should have been carried out by his Department in conjunction with MAFF. He told us that he was satisfied that this had indeed occurred. ²⁵ He painted a picture of a series of meetings involving himself, Mr Freeman, the CMO and other senior and relevant officials which had constituted 'a long and tortuous process' leading to a policy decision on how to respond to the Southwood Report. ²⁶ The meetings were informal and not documented. Mr Clarke was critical of the Inquiry for paying too much attention to documentary evidence:

. . . what is happening is you are wandering through this maze of documents as though you have the picture in front of you. With great respect, you do not seem to have the picture in front of you at all about how the decision was taken. ²⁷

3.92 We were particularly interested to know whether there had been discussion about the reasoning that had led the Southwood Working Party to recommend slaughter and destruction of clinically sick animals but to make no recommendation in relation to subclinical animals. Mr Clarke assured us that such discussion had taken place. He described the process as follows:

This submission has been put in my box covering the Southwood Report, and it sets out some of the background. Next step, the Secretary of State reads the Southwood Report. Next step, we start having some serious discussions about what is in the Report and what we should do about it. It certainly includes, obviously, the advice, the medical and scientific of the officials who are reviewing what the Southwood Report has put to them. Certainly, I cannot claim after over ten years to remember, you know, phrases used, location of meetings, all this kind of thing but it would certainly cover the subject you have just touched upon and quite a lot of others as well. ²⁸

3.93 A little later in his evidence he said that it was his clear recollection that there was a very great deal of copious review, correspondence and discussion. Just because it could not be found in a document did not mean that it did not take place. ²⁹

3.94 So far as interdepartmental discussion was concerned, Mr Clarke said that it seemed to him and to Mr MacGregor that there had been an amazing quantity of exchanges going on between their Departments. ³⁰

3.95 Lord Freeman dealt with the position of Ministers on receipt of the Southwood Report in a written statement to the Inquiry:

When external advice was commissioned, it was not appropriate for Ministers to set in motion a review of that advice unless:

i) Some deficiency in the advice was brought to their attention by officials, once the advice had been considered by those officials;

ii) More unusually, Ministers were themselves in a position to identify some deficiency in the advice received.

In the case of the report of the Southwood Working Party, Ministers expected to listen to and if necessary act upon the advice of the Chief Medical Officer. As a non-scientist, it would have been inappropriate for me to subject a scientific report to detailed scrutiny in an attempt to identify possible deficiencies in that report.

The view of the CMO in relation to the report of the Southwood Working Party was as follows:

'I regard it as a thorough study of the problem with sound and balanced conclusions. On the evidence given in the Report I accept that the risk to man has been extremely small and that (with one possible exception mentioned below) every reasonable step has already been taken to minimise any theoretical risk by destruction of affected cattle . . .'

(Minute dated 9 February 1989 to the Secretary of State, copied to me.) ³¹

I was not aware of any contrary view having been expressed, either by the Chief Medical Officer or by others.

I had every confidence and trust in the Chief Medical Officer. He had always struck me as professional and diligent.

In summary, the Chief Medical Officer had indicated that he was content with the Report and there was no reason for Ministers to dissent from that advice. Nor was there any reason for Ministers to take the view that the Southwood Working Party was not in a position to give authoritative scientific advice. In the circumstances, it would have been inappropriate for a review of the Report to have been set in motion. ³²

3.96 In oral evidence he explained that he was there dealing with a formal review under which a number of officials would be given a specific collective task to take the Report and review it. While that did not take place, there were ongoing informal discussions with the CMO about the issues that had to be dealt with subsequent to the receipt of the Report. ³³ He could not remember whether these discussions included the reasons for distinguishing between clinically affected and subclinically infected animals. ³⁴

3.97 We can readily accept that informal and un-minuted meetings took place within DH between Mr Clarke, Mr Freeman, the CMO and officials. We do not believe, however, that these discussions can have included a reasoned analysis of the baby food recommendation in particular, and the distinction drawn between clinically affected and subclinically infected animals in general. We so conclude primarily because a reasoned discussion would not have been possible without first establishing the reasons why the Working Party had advised as it did. Had these matters been discussed, DH would have been in a position to make a constructive contribution when MAFF drew attention to the problems raised by the baby food recommendation, rather than simply agreeing that the matter should be referred to the CMO.

3.98 On our analysis the response of DH to the receipt of the Southwood Report was as follows:

1. From May 1988 until the summer of 1991 Dr Pickles held lead responsibility in DH for assisting the CMO in matters relating to BSE. Until 1990 there was no administrative branch with parallel responsibilities for BSE in DH, so that Dr Pickles carried that responsibility as well. As the focal point of BSE intelligence she acted to coordinate the exchange of information on BSE throughout DH. ³⁵
2. Sir Donald Acheson explained why he gave Dr Pickles these responsibilities:

Her strong scientific background and credibility together with her record of success in tackling the AIDS crisis, and her remarkable energy and capacity for work made her an ideal candidate. ³⁶

1. Dr Pickles worked closely with the Southwood Working Party. She sat in on their deliberations and wrote much of their Report on the basis of the views that they expressed. She told us how impressive she had found it watching a group of people like the Southwood Working Party debating the question of the potential hazard posed by BSE. ³⁷ Her understanding was that the Working Party considered it a very borderline question whether tissues from subclinicals counted as a real risk for humans or not. She felt that there were good scientific reasons for drawing the borderline between babies and other human beings. The Working Party felt comfortable, looking particularly at the scrapie evidence, and knowing that the highest titres were being removed from the food chain, that the tissues of the incubating animals could remain part of the human diet. ³⁸ The Working Party had given their best judgements on the very limited evidence available at the time. The urgent matter was to try to get some more hard evidence. Nobody could have gone much further at the time with the very limited evidence available. ³⁹
2. Dr Pickles remained firmly convinced that the conclusions of the Southwood Working Party were sound and that tissues of subclinicals represented no risk to human health, until her perception changed a year or more after the Working Party reported. ⁴⁰
3. Dr Pickles's involvement in the drafting of the Report meant, of course, that she was not an appropriate person to review it.
4. Dr Pickles's confidence in the judgement of the Southwood Working Party was reflected in her note of 6 February, which informed Sir Donald that he would receive a copy of the Report in a day or two and commended it to him (see paragraph 3.16).
5. Encouraged by Dr Pickles's approbation, we believe that Sir Donald simply accepted the Southwood Report's recommendations as constituting the best possible advice without seeking to explore the reasoning behind them. Apart from the question of medicines, the recommendations in the Report were considered to be the concern of MAFF rather than DH, and MAFF was left to take the lead in handling the Report. When MAFF raised the problem of the baby food recommendation and especially liver and kidney, Mr Clarke took a political decision that the Report should be accepted, even though the reasoning behind the baby food recommendation was not clear. When Sir Richard Southwood resolved one difficulty by indicating, on 23 February, that the baby food recommendation did not embrace liver and kidney, DH did not further question the implications of the recommendations.

Extent to which MAFF reviewed the Southwood Report

3.99 The circulation of the Southwood Report to 'interested divisions' within MAFF (see paragraph 3.26) invited recipients to provide an initial assessment of the Report's contents. Mrs Attridge drew attention to the baby food recommendation. Her concern was that this would lead to the withdrawal of liver and kidney from the diet of babies although these were nutritious. She was not convinced that there was a sound scientific basis for so doing. Her recommendation was that the matter should be referred to the CMO. She observed that 'this would enable us to assess more fully what the actual risks are'. ⁴¹

3.100 Mr MacGregor rightly observed that this was a good example of MAFF raising questions and analysing the Southwood recommendations. ⁴² When she raised the matter he realised that they had an issue that was quite a problem and they needed to get further advice to sort it out. ⁴³

3.101 However, when on 23 February Sir Richard Southwood stated that the baby food recommendation did not apply to liver and kidney, no further review was carried out as to the reasoning underlying the recommendation. Earlier when discussing the Q&A brief, Mrs Attridge had remarked, 'We will be asked why should we take action on baby food and not on hamburgers . . . ?' ⁴⁴ That question did not receive further consideration at this stage.