Volume 1: Findings and Conclusions
9. Potential pathways of infection
Consideration of an audit of the uses of cattle tissues
The Tyrrell recommendation
Reasons for this outcome
Where responsibility lay

1052 The last part of vol. 7: Medicines and Cosmetics deals with a topic that concerned not just medicines and cosmetics, but also many other industries and activities where BSE posed a threat. This was the need to establish all the ways in which cattle tissues were used, in order to ensure that BSE infection was not spread by unrecognised routes.

1053 We consider it was a top priority to prepare an overview of this kind. A proper understanding of all the ways in which cattle tissues were used was fundamental to the planning of suitable measures to stop the disease from spreading. Those responsible for action in each area of concern needed to be contacted and the risk assessed. The industries and groups of workers involved stretched far beyond the ambit of MAFF. Coordination of measures and ensuring they covered all the ground was going to be important. Various pieces of safety legislation might have to be deployed. Many Departments and public bodies would be involved in enforcing and monitoring individual activities. Once action had been taken, the map of identified pathways could be used to monitor the situation, and ensure new information was relayed to those who needed to know it.

1054 However, a comprehensive overview exercise was not carried out. Gaps in knowledge were still causing problems seven years after the need for an overview was identified. This led to new proposals within MAFF for a research study. The term 'audit trail' was applied to it, a convenient description we have used here.

1055 What follows is a condensed account of what happened. The fuller story and analysis can be found in vol. 7: Medicines and Cosmetics, Chapter 9.

The Tyrrell recommendation

1056 The Southwood Working Party in 1988 had agreed with Dr Pickles that it would be useful to have an epidemiological flowchart to determine what bovine material was used for. They followed up the most pressing issues they had identified, but did not themselves prepare an overview of all uses.

1057 The matter was picked up in the Tyrrell Report on research into TSEs a year later, in June 1989. This had an item as follows:

Item A1d More detailed investigation into the fate of bovine (and ovine) tissues and products that could lead to infection being spread by as-yet-unrecognised routes.

Some uncertainty remains as to whether all the possible routes of transmission from bovine (and ovine) tissues to other species have been considered and appropriate action taken. Small scale users of bovine products, such as the cosmetic industry, may not be covered by the present regulations and guidelines. There are no formal proposals for work of this sort and consideration should be given as to whether such a study should be commissioned *** [ie, three-star, top priority]

1058 Along with the other three-starred items, A1d was approved by Ministers for immediate action. MAFF had divided all the recommended projects into two tables. Table 1 contained items to be wholly funded by MAFF; Table 2 listed the remainder, to be jointly funded or to fall entirely to others. The audit and cosmetics item, captioned 'Spread of infection by unrecognised routes', was listed in Table 2. The wording was vague: 'Those routes currently considered important are being pursued. Scientific progress may reveal the need for further action. This issue is of importance also to DH.'

1059 There had meanwhile been a meeting with the HSE in June to follow up the Southwood recommendation on occupational risk. This was attended by Dr Matthews, a veterinarian in MAFF. After the meeting he asked Mr Hutchins, a Senior Veterinary Officer in MAFF's Meat Hygiene Veterinary Section, for a background paper listing the destinations of slaughterhouse products. The object was to help identify workers at risk. Mr Hutchins promptly produced a businesslike list of raw by-products, processed by-products and their use. MAFF officials were at this stage heavily engaged in deciding which tissues needed to be covered by the proposed SBO ban. They did not seek to trace any further the fate of the items identified in the list or to contact other Departments that might have an interest in them.

1060 In March 1990 Mr Lawrence of MAFF's Animal Health Division drew up a progress chart of where each of the Tyrrell proposals now stood. This revealed that nothing had been done about the audit since Ministers had agreed it the previous August. Cosmetics, as we have seen, were being tackled, thanks to Mr Roscoe at DTI.

1061 Faced with this awkward situation, Mr Lawrence turned to the MAFF Meat Trade Adviser, Mr Chris Rogers, for advice about outlets for slaughterhouse material. Mr Lawrence appears to have been unaware of the list prepared by Mr Hutchins. Mr Rogers identified many of the same items, adding his own observations. One of these concerned a different sort of by-product, namely slaughtering and rendering waste. We return to that later in this chapter.

1062 In May, while being briefed for a Parliamentary Debate on BSE, the MAFF Minister, Mr Gummer, learned that the audit had not yet been set in hand. He instructed that it should go ahead forthwith and that MAFF should fund it. Some confusion and misunderstandings then ensued about whose job it was to draft the protocol for the work. The details appear in Volume 7.

1063 The upshot was several more months of inaction. SEAC was told on 2 July 1990 that the project had not been followed up, but that MAFF was seeking information from slaughterers about where bovine tissues went so as to provide the basis for a comprehensive picture of the products in which they might be used. It appears that MAFF officials were taking a narrow view of what was required. A few days later, Mr Lowson told Dr Kenneth MacOwan, who managed the MAFF research budget, that MAFF had kicked this off through an enquiry at slaughterhouses to establish what happened to the whole range of bovine tissues, and that pending the results of this enquiry he would not see a need to direct resources to the item.

1064 Thereafter matters gathered dust until March 1991, when SEAC called for a paper on non-food uses of bovine materials and MAFF set about updating its progress chart. Dr Pickles queried the assertion in the MAFF chart that DTI, MAFF and industry had the item in hand. The dust was blown away with a vengeance. It was now revealed that nothing had been done. Mr Maslin told Dr Pickles:

From our papers it would seem that there has been no 'study' initiated. The references to 'DTI, MAFF, Industry' was I assume included in the summary chart in the early days and has simply been perpetuated in later charts. Alan Lawrence recalls that this was a matter raised with Mr Gummer before the BSE Parliamentary debate last year. It seems however that this area has fallen through the cracks.

1065 The chart had confused the follow-up on cosmetics - where DTI had been in touch with the industry - with the wider audit.

1066 By way of response to the situation, Mr Bradley of the CVL provided an 'off the top of my head' set of suggestions about non-food uses. Mr Maslin suggested to Dr Pickles that these and Mr Rogers's list of the previous year might be amalgamated to form the paper sought by SEAC. There ensued a spirited exchange between MAFF and DH about who was to blame for the item falling through the cracks.

1067 In a minute to Dr Pickles, Mr Lowson conceded this ought not to have happened:

I entirely agree that it is not satisfactory that this item on the Tyrrell shopping list should not have received the attention it deserved.

1068 However, he did not accept that the blame lay with MAFF. He had understood Dr Pickles was drafting the protocol, though:

. . . it was a hot afternoon, a long meeting and nobody produced a note so I would not want to be too critical of the fact that nothing seems to have happened as a result. No doubt for our part we should have been more assiduous in trying to find out what was going on.

1069 In response to Mr Maslin's suggestion about the list, Dr Pickles observed:

Of course I could make a start at a 'list' but the purpose of a research study was to investigate more formally as to what actually happens, not what some of us think might happen.

1070 We entirely agree with Dr Pickles's observation. What was needed was a full and accurate picture tracing products through their various handling and processing stages. This was going to extend well beyond the boundaries of MAFF's knowledge.

1071 What in fact happened was that, with a few additions, Mr Hutchins's original list of uses from June 1989 was annexed to a paper by Dr Pickles for the SEAC meeting on 28 June 1991. SEAC was asked to consider if the list was complete and if these uses presented any risks to the public or to workers. SEAC thought that in general no problems arose but was still concerned about some matters. One of these was the risk that unstained and unsterilised SBO might end up in products that could come into contact with humans.

1072 Mr Lawrence prepared a paper reviewing the controls and the guidance on pharmaceuticals. It took an optimistic view that these covered the situation but suggested that a further check could be made through the abattoir owners on the destination of by-products. This suggestion does not appear to have been discussed by SEAC when the paper was tabled in September, nor does it appear to have been followed up. The SEAC interim report on research published in April 1992 said that the fate of bovine tissues had been examined in-house by MAFF and was not progressing as a formally commissioned piece of work.

1073 Thereafter the need for an audit of this kind did not resurface until 1995, when it emerged in the context of a review of MAFF-funded TSE research. The proposed audit was slow in getting off the ground. In February 1996 SEAC advised that it was high priority to carry out the audit and that sheep tissues should be included in the study. The work was commissioned from outside consultants in June 1996 and completed in May 1997.

Reasons for this outcome

1074 Why did the matter turn out this way? Various factors were at work. MAFF thought that what was required could be done in-house by existing staff. No association appears to have been recognised between the risk for workers in identified industries and the risks that might be continuing to be carried in the material itself. There had been some confusion from the start about the status of the study which the Tyrrell Report had identified. Was it truly research or simply a fact-finding exercise? The indeterminate wording of the initial allocation in Table 2 provided no impetus to anyone to move matters forward. Subsequently the compressed reporting in the progress chart of the coupled cosmetics and audit proposals gave a misleading impression about whether action was in hand and who was in the lead.

1075 However, given the importance of doing the work, all these difficulties could undoubtedly have been overcome had the project had a champion. None emerged to press for the work to be done and secure action. This lack of ownership of the project spelt its doom.

Where responsibility lay

1076 We have no doubt that whether or not the Tyrrell Report had listed it as an item, an exercise of this sort was a necessary precursor to an effective government response to BSE. Within MAFF, Animal Health Division, headed by Mr Lowson, was responsible for developing policy on BSE. The role of working up policy proposals and submissions for Ministers, and setting up the arrangements to carry them out, was generally a Head of Division responsibility. It seems to us that Mr Lowson had a responsibility to ensure as far as possible that the development of policy on BSE was properly informed by data from appropriate scientific research and field studies.

1077 The work done by Mr Hutchins and Mr Rogers to compile lists of uses was a good start but no more than that. They did not seek to trace through what happened to the products and what risks might be associated with them. Yet these lists appear to constitute the sum total of the 'in-house work' that SEAC was assured made a full audit premature for the time being. This was scarcely a systematic investigation, nor was it of value without policy action to follow up the clues it offered.

1078 We consider that the need for the work on an overview to be done should have been obvious at the time. Mr Lowson agreed that he needed no special advice from scientists about whether or how to carry out a fact-finding exercise to map all the ways in which cattle products might be used. New though he was in his post, in our view he should have ensured that this matter was promptly and properly addressed.

1079 We considered whether Dr Pickles shared responsibility for this. On reviewing her actions, it seems to us that at each stage she pushed hard for the audit to be carried out. She took independent action in an effort to secure DH funds to break the financing deadlock; and she drew the failure to carry out the project to Mr Gummer's attention, which led directly to his instruction that the work should go ahead. Thereafter she made efforts to get the protocol drafting under way at MAFF. We do not think she could have done more than she did.

1080 We have been at pains to explore what happened to the audit. We see the failure to carry it out as a serious shortcoming in the response to the emergence of BSE. Time and again the story we have explored has shown that in the main the right action was taken, but often more belatedly than it could have been. Some matters, such as the safety of gelatine and tallow which were used for a wide range of different purposes, were dealt with only late in the day. Others, such as waste disposal from slaughterhouses and rendering plants dealing with SBO, were barely identified at all. Where work was put in hand there were often no deadlines. Urgent warnings were delayed while drafts were refined. Some of this could have been avoided if all had been working within a recognised overview and timetable as a framework for tackling matters, under a firm guiding hand.