Volume 7: Medicines and Cosmetics
9.
Consideration of an audit of the uses of cattle tissues
Consideration of an audit into the fate of cattle tissues: a chronology
1988/89
Early consideration of an audit
Consideration of the fate of cattle tissues by MAFF prior to Tyrrell
The Tyrrell Report
Early consideration of an audit
9.9 Dr Pickles told us that 'a broad analysis' of some of the ways in which BSE might be transmitted to humans through bovine material was carried out before the first meeting of the Southwood Working Party in June 1988. 1 She said that this broad analysis was reflected in the answer she gave to one of the 20 questions tabled by Sir Richard Southwood about BSE at a preliminary meeting on 19 May 1988. Question 15 of these asked:
What are the theoretical routes to man of parts/products cattle, especially dairy cattle, before and after slaughter? 2
9.10 Dr Pickles's answer included the following:
surface contact with outer-hide: cowhands, vets, slaughtermen, tanners, leather workers
surface contact with udders/milk: cowhands/dairy men
surface contact with blood, flesh, brain: slaughtermen, butchers, cooks
aerosol inhalation of blood: slaughtermen?
inoculation of blood: vets during needlestick injuries
surface contact via saliva, semen, placenta, blood and amniotic fluid during calving: cowhands, vets
surface contact with misc products: workers in various industries eg rendering, some pharmaceuticals
ingestion of milk, offal and meat: general public
indirectly through another species: general public via pets
inoculation/administration via licensed medicinal products or 'food supplements': bovine insulin in diabetics, perhaps in other pharmaceuticals too 3
9.11 Dr Pickles provided six additional questions and answers concerning the possible risk of BSE for humans. As part of her answer to one of the questions concerning who would be most at risk from infection with BSE, she asked:
Do we know what other potentially infectious bovine products are used, eg in the cosmetic industry? Can we draw up a flow chart of the final destination of all bovine parts? 4
9.12 Dr Pickles's suggestion was picked up at the first meeting of the Southwood Working Party on 20 June 1988. The minutes of that meeting record a discussion about background papers, including some relating to the answers to the 20 questions posed by Sir Richard Southwood and supplemented by Dr Pickles. The points emerging from that discussion included:
(b) it would be useful to have an 'epidemiological flow chart' (to determine what bovine material is used for). 5
9.13 In the event, no such analysis was carried out at this time, and it emerged again in June 1989 as a high-priority research proposal in the Tyrrell Report. 6 We trace below the story of what became of this proposal thereafter.
Consideration of the fate of cattle tissues by MAFF prior to Tyrrell
9.14 Mr Lowson suggested to us 'that something approaching an audit trail was carried out at an early stage by MAFF'. 7 He referred us to a minute from Dr Matthews to Mr Kevin Taylor dated 12 June 1989. The subject of the minute was the conclusions of a meeting held on 9 June with representatives of the Health and Safety Executive (HSE) and DH about occupational groups who needed guidance on BSE risks in handling cattle and carcasses. 8 Matters identified as relevant to this included:
. . . a need for a background paper on all processes that a bovine animal/carcass undergoes in the abattoir, with a breakdown if possible on the destination and handling methods for by-products. This is largely because of the anticipated ban on use of certain bovine offals in human food and the need to assess risks at all stages of carcass dressing or handling products. 9
This minute was copied to Mr Meldrum, Mr Crawford, Mr Kyle, Mr Lowson, Mr D Taylor, Mr Jenkinson, Mr Lawrence and Mr Maslin.
9.15 Responding to Dr Matthews's minute on 15 June 1989, Mr David Taylor sent Mr Kevin Taylor a summary, prepared by Mr Hutchins, of the procedures involved in slaughtering and dressing animals. 10 It annexed a list of the main uses of the by-products. Mr Hutchins noted that the summary would not cover every eventuality, but should deal with the majority of uses: 11
CONTENT OF BY-PRODUCTS OF BOVINE SLAUGHTER
9.16 This reply was copied to Mr Fry and Mr Hutchins. Mr Lowson told us that he does not recall what use was made of this information after that date. 12 A copy of the list appears to have been sent to the HSE and matters to have rested there.
9.17 The Tyrrell Committee submitted its Interim Report (the Tyrrell Report) to MAFF and DH in June 1989 (see vol. 2: Science). The Report's proposals included the following at paragraph 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. *** 13
9.18 Each of the Report's research proposals was given a star rating according to the priority afforded to it by the Committee. Research Proposal A1d was given three stars: the highest rating.
9.19 The Report arrived while MAFF was in the thick of difficult official level negotiations with the Treasury about its annual bid for research resources within the public expenditure research cycle. MAFF sought extra resources for BSE and salmonella. The Treasury was seeking further cuts in the MAFF 'baseline', ie, total current research programme, to implement the Government's decision to cut MAFF domestic expenditure (see Volume 2).
9.20 On seeing the Report, the Minister, Mr MacGregor, sent a minute to Mr Andrews (Permanent Secretary, MAFF), in which he said how 'struck' he was by 'how much more work needs to be done interdepartmentally on this to draw the threads together before any decisions can be taken'. 14 The minute was copied to Mr Meldrum, among others, who then suggested that the 'way forward would be for Dr Shannon, Dr MacOwan (both CSG 15), Dr Watson (CVL), Professor Bourne and myself to meet to consider the Tyrrell recommendations and to agree which projects should be recommended for support.' 16
9.21 Mr Andrews agreed with Mr Meldrum's suggestion (with the exception of including Professor Bourne). He believed that 'it would be difficult to decide not to fund any of the research that Tyrrell regards as of high priority, especially those marked in the Report with three or two stars'. 17 He asked for a note to be prepared setting out the following for each of the research areas given three or two stars in the Report: 18
- If the work was already in hand, where it was being carried out and what funding was being devoted to it;
- If the work was not already in hand, what funding was needed; to what extent it would be proper for the industry to fund it and who might do so; and, if it was most appropriate for the Government to fund, on whose budget it might fall: MAFF, Department of Education and Science (DES) or the Medical Research Council (MRC).
9.22 Mr Andrews wrote to Sir Donald Acheson the following day to tell him about the work he had put in hand. He added, 'We shall clearly want to talk all this through with you and agree the way forward. I am asking my people to be in touch with yours about this.' 19
9.23 Sir Donald had meanwhile already submitted a copy of the Report to the Secretary of State for Health, commenting that the work recommended was going to be laborious, time-consuming and expensive. 20 He recommended going along with what the MAFF Minister, Mr MacGregor, proposed over handling since 'the difficult issues are after all his, most notably adequacy of research funding by MAFF for the CVL and for AFRC [Agriculture and Food Research Council]'. 21
9.24 On 29 June 1989, Dr MacOwan drafted a minute to Mr Andrews's private secretary, following meetings with Mr Meldrum, Dr Watson and Dr Shannon. He attached a table, which he said aligned the research proposals in the Tyrrell Report with those in the MAFF Public Expenditure Survey (PES) submission on BSE and salmonella, and indicated for which projects industry, Department of Education and Science (DES) or MAFF funds should be sought. 22 The entry for project A1d was that advice should be sought from the Tyrrell Committee.
9.25 On the following day Dr Shannon sent Mr Andrews an amended version of Dr MacOwan's minute. 23 On the copy we have of that minute, the suggestion in the table that advice should be sought from the Tyrrell Committee has been amended in manuscript to read:
Those routes currently considered important are being pursued. Scientific progress may reveal the need for further action. The issue is of importance also to DH. 24
9.26 On 12 July 1989, Mr Maslin minuted Mr Lowson answering some questions he had raised on the Tyrrell Report, in particular concerns expressed by the Minister about a lack of forewarning with regard to its recommendations. 25 In relation to the Report's proposals Mr Maslin said:
The great majority of the work recommended by Tyrrell is either completed, under way or already the subject of research proposals by MAFF and the AFRC. Of those that have been classed as having top priority only the following are new suggestions not already raised by Southwood:
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.
. . . 26
9.27 Mr Lowson sent a minute to Mr Cruickshank the following day, in which he noted:
. . . much of the recommended work is already in hand (8 out of 13 top priority projects) while much of that not in hand is not appropriate for MAFF funding. 27
9.28 On 13 July 1989, Mr Andrews held a meeting to discuss Dr Shannon's minute of 30 June. 28 He asked Dr Shannon to divide the two- or three-star projects into those which MAFF would be responsible for funding, and those regarded as falling to others to fund. Dr Shannon submitted revised tables the following day. 29 Project A1d, described as 'Spread infection by unrecognised routes', was listed in Table 2, which was headed, 'Responsibilities of Other Departments (DOH, DES) or Industry Alone or Jointly with MAFF'. Under the heading 'Responsibility/source of funds/action' was the comment, 'Those routes currently considered important are being pursued. Scientific progress may reveal the need for further action. This issue is of importance also to DOH.' 30
9.29 At the 13 July meeting, Mr McIvor of Financial Guidance Division was asked to draft a letter for the Minister to send to the Secretaries of State for Health and for Education and Science seeking their agreement to funding of all the two- and three-star work and to MAFF's proposed breakdown of the work. 31 Mr McIvor circulated a draft on 21 July 1989. 32
9.30 On 28 July, a further meeting took place involving Dr Watson, Dr MacOwan, Mr Bradley, Mr Wilesmith and others to discuss the research and development implications of the Tyrrell Report. Those present considered the tables that had been submitted by Dr Shannon. No mention is made of project A1d in the note of the meeting as it concentrated on the MAFF projects. 33
9.31 Mr Lowson also referred us to a note produced shortly afterwards by Mr Maslin. 34 The note raised questions about certain bovine materials, which had arisen during the preparation of a consultation letter about the contents of a specified bovine offal (SBO) ban. Mr Lowson told us that there was a 'range of discussions' throughout 1989 which 'picked up' the audit issue, some of which arose out of the introduction of the SBO ban:
. . . And the discussion of which tissues should be included in the bovine offal ban inevitably touched upon questions of which tissues went where because that would identify possible routes of exposure of people to the agent.
Of course, what we are looking for here is, as I think the Tyrrell Committee said, outlets that we do not know anything about which might constitute a risk that people might be exposed to the agent, and so as one examined slaughterhouse practices and the use made of specified offal through that period as 1989 went on, one was identifying the kind of area which the Tyrrell Committee presumably had in mind in making its recommendation, while the formal process of thinking about how the Government reacted to the Tyrrell Committee was taking its course. 35
9.32 On 1 August 1989, Mr Gummer (who had succeeded Mr MacGregor as Minister of Agriculture on 24 July 1989) wrote to the Secretary of State for Health, Mr Clarke, about the Tyrrell research proposals:
The programme of research covered by Dr Tyrrell's report is set out in Annex 1. The research programme is divided into 3 categories of urgency and at the Committee's suggestion I have concentrated on the two most urgent categories. In these two categories I have costed in Table 1 those parts of the programme that would fall to me to finance and I have indicated in Table 2 where responsibility for other parts of the programme would appear to fall. In view of the wide public concern about this disease, I see no option for the Government other than to ensure that all the projects in these two higher categories are initiated. Not to do so would lay us open to the criticism that, while we were aware of the potential danger of BSE, we had failed to research into the public and animal health aspects adequately. I consider that in order to keep the initiative, I need to announce urgently that the Government has accepted the findings of the Tyrrell report as regards the projects to which it attaches higher priority, and that we are making money available so that work can begin on the most pressing recommendations that were considered by Tyrrell to be of primary importance.
I am prepared if necessary to limit my announcement to the follow-up work falling to my Department. But I believe that we ought to cover, in a single statement, all the urgent work recommended by Tyrrell including projects that fall to you and John MacGregor to finance. I am writing therefore in part to ask your and John's agreement to my announcement and to confirm that you wish to be associated with it. 36
9.33 The item A1d appeared in Table 2 attached to this letter in the form set out by Dr Shannon on 14 July. 37
9.34 Mr Lowson told us that his Division was involved in agreeing with the CSG the appropriate response to each proposal. 38
9.35 On 3 August 1989, Dr Watson minuted Mr Meldrum. 39 He noted Mr Andrews's view that all of the two- and three-star proposals must be done and was seeking a meeting to discuss two papers prepared by Mr Bradley, which he had attached. The first, 'CVL response and proposals for BSE ** and *** experiments as defined in the interim report of the Tyrrell Committee June 1989 pages 10-21', said of project A1d, 'DOH/DES responsibility'. In Mr Bradley's subsequent note of the meeting, no specific mention was made of project A1d. 40
9.36 On 9 August 1989, the AFRC wrote to the DES enclosing comments of the Institute of Animal Health (IAH) on the MAFF response to the Tyrrell Report contained in Mr Gummer's letter. They said:
The IAH thinks it proper that MAFF should be responsible for funding the research areas A1 and A3 and agrees that there is a DOH interest in area A1d. The area A2 would properly fall to DOH. 41
9.37 No steps were taken to initiate project A1d for the remainder of 1989. It was not considered further up to March 1990, when Dr Pickles challenged a chart incorrectly indicating that the work was in progress (see below). Mr Lowson told us that the matters raised in Mr Gummer's letter of 1 August took some months to resolve as Departments worked on the financing of the research concerned. He said that he did not recall seeing further Ministerial correspondence that disputed the categorisation of, or comments relating to, A1d. 42
1 S115D Pickles para. 4
2 YB88/5.19/2.14
3 YB88/5.19/2.14
4 YB88/5.19/2.19
5 YB88/6.20/2.2
6 S115D Pickles para. 4
7 S104E Lowson para. 7
8 This meeting is discussed further in vol. 6: Human Health,1989-96 in relation to occupational risks
9 YB89/6.12/7.2
10 YB89/6.15/6.1
11 YB89/6.15/7.1-7.6
12 S104E Lowson para. 7
13 IBD1 tab 4 para. A1d
14 YB89/6.15/4.1
15 Chief Scientists Group, the group responsible for the MAFF research budget: DMO1 tab 5 para. 10
16 YB89/6.19/7.1
17 YB89/6.19/6.1
18 YB89/6.19/6.1
19 YB89/6.20/9.1-9.2
20 YB89/6.13/10.1
21 YB89/6.13/10.1
22 YB89/6.29/5.1-5.5
23 YB89/6.30/3.1-3.23
24 YB89/6.30/3.7
25 YB89/ 7.12/1.1-1.2
26 YB89/7.12/1.2
27 YB89/7.13/6.1
28 YB89/7.14/1.1-1.2
29 YB89/7.14/5.1-5.6
30 YB89/7.14/5.5
31 YB89/7.14/1.1
32 YB89/7.21/11.1-11.11
33 YB89/7.28/10.1-10.5; YB89/8.3/10.1-10.3
34 YB89/7.27/2.1-2.2
35 T127 pp. 99-100, incorporating revisions proposed in S104 H Lowson
36 YB89/8.1/3.1-3.10
37 YB89/8.1/3.7
38 T127 p. 103
39 YB89/8.3/6.1-6.11. Mr Meldrum's role is discussed in Chapter 8
40 YB89/8.8/4.1-4.7
41 YB89/8.9/3.1-3.4
42 S104E Lowson para. 9; see also YB89/8.9/4.1-4.3; YB89/8.18/5.1; YB89/9.19/1.1-1.2; YB89/10.2/3.1
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