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Volume 7: Medicines and Cosmetics
9. Consideration of an audit of the uses of cattle tissues
Introduction
The need for an audit
What happened

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The need for an audit

9.1 Cattle products were used in a huge range of ways. We annex to this chapter an illustrative list of uses we have compiled from evidence received by the Inquiry. If animals supplying raw materials were diseased, the ultimate user of the product might be exposed to the infective agent. So too might those collecting and processing raw materials (an occupational risk). Infected waste, 1 discarded as without value, might pass through other pathways into the wider environment.

9.2 Effective action to counter health risks from BSE therefore needed to draw on a proper understanding of all the possible routes of transmission to humans and between animals. Dr Pickles's initial paper in May 1988 for the Southwood Working Party suggested that a 'flow chart of the final destination of all bovine parts' should be drawn up. 2 When MAFF seven years later attempted to fill the gaps in its knowledge about the fate of products derived from cattle and sheep tissues, it described what was needed in terms of an 'audit trail'. 3 When such an audit was finally commissioned out, those who carried it out wrote:

This audit is needed in order to explore the potential routes of exposure to materials that may have contained BSE to determine which were most likely to be implicated and, in particular, to check that no routes have been overlooked. Such information is crucial to understanding the aetiology of the disease and ensuring that all possible precautions are taken to avoid further infection. 4

We use the term 'audit' in that sense in this chapter.

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What happened

9.3 By spring 1988, MAFF had identified recycled ruminant protein in feedstuffs as a critical likely route of BSE transmission and had given preliminary thought to veterinary medicinal products using bovine material. In relation to human food, they were considering destroying diseased animals. DH, on learning of BSE, added human medicinal products to the list of concerns. During 1988, the Southwood Working Party concentrated on what they saw as the most pressing concerns. These were milk, meat, pharmaceuticals derived from bovine materials, and occupational risk (see vol. 4: The Southwood Working Party, 1988-89). By the time the Working Party reported in 1989, it had alerted all concerned to the need for action in these areas.

9.4 However, the Southwood Working Party had not attempted a comprehensive overview. Although the Working Party had at their first meeting agreed with Dr Pickles that it would be useful to have an 'epidemiological flowchart' to determine what bovine material was used for, this was not followed up by anyone or referred to in its report in February 1989.

9.5 The need for work to be done on this was picked up and highlighted by the Consultative Committee on Research into Spongiform Encephalopathies (the Tyrrell Committee) as Item A1d in its Interim Report in June 1989, with a three-star (top priority) rating. Senior officials, Ministers and the Spongiform Encephalopathy Advisory Committee (SEAC) all subsequently agreed that the two- and three-star proposals should be put in hand, and public statements were made that this had been done. However, the protocol for item A1d still had not been drafted two years later. In April 1991, a SEAC request for a paper revealed that follow-up had 'fallen through the cracks' between MAFF and DH. A year later in April 1992, the SEAC Interim Report on Research stated, on the basis of MAFF assurances that work was in hand 'in-house', that all high-priority studies had been started. Thereafter the topic appears to have disappeared from view for the next three years.

9.6 It was resurrected in a review of MAFF research involving outside scrutineers in February 1995. The recommended work was not, however, commissioned until June 1996. The report presented in 1997 did not attempt to trace all uses, but concentrated on food materials. It also attempted to estimate how many people might have been exposed to risk via various pathways while these remained open.

9.7 The Tyrrell recommendation A1d in 1989 about considering a study of possible unrecognised transmission routes had cited cosmetics as an example. We have discussed in the previous chapter how that particular route, having been identified, was dealt with. In the present chapter we concentrate on the different and wider exercise of the audit itself. As we shall see, reports sometimes confused the two.

9.8 We set out first the detailed chronology of events. We go on to identify what was needed and some of the factors that contributed to why, as one witness put it, 'this matter was not handled tidily'. We conclude by discussing whether the response was adequate.

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1 Refer to Chapter 9 of Volume 14

2 YB88/5.19/2.19

3 YB95/3.24/9.6

4 IBD5 tab 17 p. 1

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