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Volume 7: Medicines and Cosmetics
9. Consideration of an audit of the uses of cattle tissues
1995
A review of MAFF TSE research recognises the need for an audit trail

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A review of MAFF TSE research recognises the need for an audit trail

9.100 During February and March 1995 a review took place of all MAFF-funded research and development in relation to TSEs. The main review meeting took place over four days, 13-16 February 1995. 1 At this meeting contractors gave presentations to four external referees (Professor Almond, Dr Hueston, Dr Kimberlin and Dr Ridley), representatives from Animal Health Policy Division and the CSG. Two follow-up meetings were held without the contractors on 3 and 13 March 1995. 2

9.101 By 23 March, Dr Kate Brown had prepared a draft paper summarising the outcome of the TSE review for the R&D Committee. 3 She sent the draft to Mr Meldrum, Mr Haddon, Dr Shannon, Mr Taylor, Mr Eddy, Dr Matthews, Mr Bradley and Dr MacOwan, and asked for any amendments or comments by 3 April. In her covering minute Dr Brown said that it was proposed to send the paper, without the referee summaries, to all those who had attended the review. The attached draft identified (at paragraph 3 of the executive summary) an audit trail of cattle and sheep tissues from slaughter to end point products as one of seven new areas in which a need for work was identified. Paragraph 1.4.6 of the draft stated:

1.4.6 Audit trail for cattle and sheep tissues
Recent experience in trying to determine the fate of products derived from bovine and ovine tissues, such as gelatine, had highlighted the need for an 'audit trail' to find out what products were derived from cattle and sheep carcasses. This would be suitable for IYSC [In Year Service Contract] and possible collaboration with Food Science Division would be sought. 4

9.102 On 3 April 1995, Dr Matthews provided comments to Dr Brown on her draft summary of the review. He included comment on paragraph 1.4.6 (audit trail):

Having raised this area in the wash-up meeting, and still being concerned about the lack of clarity which makes policy making and future epidemiology of human disease very difficult, I suspect that this area of work could be contained in-house without even using IYSC funding. A small team of VOs appropriately briefed should be able to carry out this sort of investigation. 5

9.103 By 12 April 1995, Dr Brown had prepared a second draft of the paper summarising the outcome of the TSE review. In her covering minute to Mr Meldrum, copied to Mr Haddon, Dr Shannon, Mr K Taylor, Mr Eddy, Dr Matthews, Mr Bradley and Dr MacOwan, she said that she had tried to incorporate the comments and suggestions received from Mr Haddon, Mr Eddy, Dr Matthews and Mr Bradley. She asked for any further comments by 28 April 1995. Para 1.4.6 of the draft now stated:

1.4.6 Audit trail for cattle and sheep tissues
Recent experience in trying to determine the fate of products derived from bovine and ovine tissues, such as gelatin, had highlighted the need for an 'audit trail' to find out the final destination and use of every product derived from cattle and sheep. This will be an Animal Health Veterinary Group study co-ordinated by the policy division with possible collaboration with Food Science Division. 6

9.104 Dr Matthews provided his comments on the revised draft on 18 April:

. . . 2. Not wishing to slow down the process of distributing the summary any more than is necessary, I do wonder if we should help both ourselves and contractors by attempting to prioritise areas of work. Given that we have only a limited amount of money to spend, it would make sense to seek proposals on those areas that are most urgent. At the very least, if contractors are to spend valuable time in preparing proposals, they should be aware that funding in some areas is likely to take priority over others. . . . 7

9.105 On 24 April 1995, Dr Brown sent Dr Matthews a draft executive summary of the TSE review. 8 Dr Brown's draft listed the new areas for study identified by the review in order of priority from 1 to 13. The audit trail of cattle and sheep tissues from slaughter to end point products was second on the list.

9.106 The next day Dr Matthews sent a minute to Dr Brown, in which he referred to the summary of the TSE review she had sent by email the previous day. 9 Dr Matthews said that, given the delay and the urgent need to supply contractors with a summary, he was commenting on behalf of the CVO, Mr Taylor and Mr Eddy in relation to the supplementary list arising out of the review. He listed the new studies in 'approximate order of priority' placing the audit trail at the bottom of the list. He continued:

Having suggested that we should prioritise I now wish that I hadn't bothered. This list bears no resemblance to the one agreed with Mr Eddy. In redrafting, it became clear that either some areas of high priority cannot proceed because of the need to await further results from the current research, or the outcome of lower priority work not yet started . . .
In addition, I have moved the audit trail of cattle and sheep tissues to the bottom of the list not because I regard it of low priority, but because I believe that this type of applied study could be done within the SVS with guidance from perhaps CVL. It is similar to the first review of the rendering industry carried out by John Wilesmith, where the field work was largely done by VOs. 10

9.107 By 1 May 1995, a final draft of the TSE Review Report had been completed and was circulated to a large number of recipients. The paper said that in general the research programme met policy needs and was of a 'high quality' but identified new areas of work. Among these was the need for an 'audit trail' of cattle and sheep tissues:

1.4.6 Audit trail for cattle and sheep tissues
Recent experience in trying to determine the fate of products derived from bovine and ovine tissues, such as gelatin, had highlighted the need for an 'audit trail' to find out the final destination and use of every product derived from cattle and sheep. This will be an Animal Health Veterinary Group study co-ordinated by the policy division with possible collaboration with Food Science Division. 11

9.108 It appears, however, that no action was taken to carry out an audit before late 1995. Mr Eddy told us:

From recollection, at some point after May 1995 and before December 1995, it became clear to us that MAFF would not be able to undertake this work internally and that we would have to seek outside consultants. My recollection is that this was a combination of:-
(i) the very heavy pressure of work falling on the Department on BSE at that time;
but more importantly:
(ii) a recognition that we would be crucially dependent on interviews with those who were in the Food Industry at the time and that whilst it was important that people would feel free to speak openly, some might be reluctant to do so to Government Officials if this could result in them or their employers being identified as having breached food regulations which applied before the SBO ban. 12

9.109 A discussion of research priorities was on the agenda for SEAC's twenty-second meeting of 23 November 1995. 13 However, the minutes of the meeting record that this was not discussed due to lack of time. 14

9.110 On 29 November 1995, Mr Eddy sent a minute to Mr Meldrum, Mr Haddon, Mr Taylor, Dr MacOwan, Mr Bradley, Dr Matthews, Dr Brown and Dr Render regarding BSE research priorities. He said:

I am not sure whether it is sensible to have an early meeting to discuss BSE research priorities. The SEAC was due to discuss research priorities at its meeting on 23 November, but because the discussion on other issues was prolonged far beyond the expected time, this has been deferred to a meeting yet to be arranged in January. 15

9.111 MAFF held an internal meeting to discuss research priorities on 22 December 1995. Dr Brown prepared a note listing points of discussion for the meeting. 16 Appendix 1 to the note included a table entitled 'Further requirements arising from ongoing studies and new initiatives and facilities identified at the TSE Review'. Under the entry for the audit recommendation, it said, 'I understand that this has been completed and would be most grateful if a copy could be provided to me.' A handwritten note next to this reads, 'R&D MLC Pratt, Baker SVS [illegible], P. Soul, MHS, KB to put minute'. 17 We understand this to refer to Mr Pratt of the MLC, Mr Baker, Assistant CVO in the SVS, Mr Soul, the Director of Operations at the MHS, and Dr Brown ('KB').

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1 YB95/2.13/2.1-2.18

2 YB95/2.27/7.1-7.2; YB95/3.13/1.1-1.2

3 YB95/3.23/3.1

4 YB95/3.24/9.6

5 YB95/4.03/3.1

6 YB95/4.12/5.1-5.7

7 YB95/4.18/2.1-2.2

8 YB95/4.25/3.1-3.2

9 YB95/4.25/1.1-1.3

10 YB95/4.25/1.3

11 YB95/5.1/3.9 para. 1.4.6

12 S109D Eddy para. 7

13 YB95/11.23/10.1

14 YB95/11.23/1.13

15 YB95/11.29/18.1

16 YB95/21.12/14.1

17 YB95/12.22/17.4

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