Volume 7: Medicines and Cosmetics
9. Consideration of an audit of the uses of cattle tissues
1990
Publication of the Tyrrell Report
Consideration of Tyrrell proposal A1d by SEAC
The first SEAC meeting: A1d 'remains high priority'
A meeting with Mr Gummer
Correspondence from Dr Pickles
The fourth meeting of SEAC

Publication of the Tyrrell Report

9.38 The Tyrrell Report was published on 9 January 1990. The accompanying written Parliamentary Answer said that all of the urgent and high-priority projects were either in progress or preparatory work was in hand. ¹

9.39 Shortly beforehand Dr Pickles provided a background briefing on the Report for the DH Parliamentary Under-Secretary, Mr Roger Freeman. MAFF were taking the lead on the publication handling. Dr Pickles said that those who needed to act on its recommendations had access to pre-publication copies, and that much of the high-priority work was already in progress. She added that the only high-priority topics that fell to DH were A2a (monitoring of CJD cases) and C2a (measurement of BSE infectivity in bovine serum albumin (BSA) and foetal calf serum (FCS)). ²

9.40 In March, Mr Lawrence asked Dr Pickles, Mr Bradley and Dr MacOwan to comment on a draft chart which he had prepared detailing progress on the Tyrrell Report's research recommendations. ³ The draft chart indicated that proposal A1d was 'in progress' and was funded by 'DOH and Industry'. ⁴ Commenting on the draft chart, Dr Pickles said in relation to A1d:

this is not in progress as far as I know. Nor would I expect DH to be in the lead, rather than MAFF (looking after the suppliers) or DTI (looking after trade more generally). ⁵

Consideration of Tyrrell proposal A1d by SEAC

9.41 On 6 April 1990, Dr Pickles minuted Mr Lowson about the agenda for the first meeting of SEAC. Dr Pickles asked whether they were going to raise the 'relatively minor matters' of possible routes to man overlooked previously, such as the use of bovine ingredients in cosmetics, and the dissection of eyeballs. She offered to put together very brief papers on these. ⁶

9.42 In early April, Mr Lawrence circulated an amended version of his chart indicating the status of all the Tyrrell Committee's research proposals. ⁷ The chart now said that A1d (Item 22 on his chart) was '[n]ot being undertaken at the present time', but still indicated that it would be funded by 'DOH/Industry'. ⁸ In his covering minute dated 11 April 1990, Mr Lawrence said:

Hilary Pickles mentioned Item 22 and why DOH should [not] be regarded as the main sponsor. It is also down as a high priority which is not yet under way. Ministers are sure to pick this up. Perhaps a starting point would be for us to identify what materials leave an abattoir and for what use. I am therefore copying this to Keith Baker and Chris Rogers for advice where we should go for this information. Should we, for instance, talk to the Abattoir Owners Association? ⁹

9.43 On 12 April 1990, Dr Pickles sent Mr Lowson a draft paper for SEAC entitled, 'Routes of Possible Transmission of BSE to Man', which was intended to 'challenge the committee about possible routes of transmission to man that may have been overlooked'. ¹⁰ In the paper she pointed out that the audit of cattle and sheep tissues recommended in paragraph A1d of the Tyrrell Report had yet to be commissioned and that a sponsoring body had yet to be found. In the event, Dr Pickles's paper was not put to SEAC as a result of concerns expressed by Mr Meldrum (see Chapter 8).

9.44 By 18 April 1990, Mr Chris Rogers, the Meat Trade Adviser responsible for providing MAFF's Beef Division, and other Divisions in Livestock Group, with technical advice on meat trade matters, had prepared a list of outlets for material from slaughterhouses as suggested in Mr Lawrence's minute of 11 April 1990. He described the list as 'fairly complete . . . although some will no doubt have been changed due to regulations or industry concerns about the risks of BSE'. He set out the various items as follows: ¹¹

a) Carcass meat.

b) Edible offal including heads

1. Offal to distribution as food or as pet food

2. Heads to boners, residue to renderers

3. Head meat - cheeks, lips to manufacturers

4. Cauls to dress lamb carcasses

c) Guts for use in casings

d) Glands and guts for pharmaceutical uses

e) Blood

1. for use in food as black pudding

2. for use in pet foods

3. for drying - incorporation in fertilisers and animal feeds

4. for inclusion in rendering and eventually as meat and bone meal

5. disposal by spreading on land

f) Rumen/Reticulum and feet for production of tripe and calves foot jelly

g) Sheep's paunch, beef tripes, melts for direct sale to dog breeders for dog feeding. Lights (lungs) for cat food.

h) Anything not disposed of elsewhere into the skip for the renderer.

i) Hides and skins to hide market for salting and selling on to tanner - fellmonger. The fellmonger buys in sheep skins, removes wool and sells wool and pelts - latter to tanners.

j) Collagen casings made from inner layer of cattle hide.

3. The more unusual and perhaps hazardous uses of by product material are more likely to occur in the medium to small local slaughterhouses which will be more difficult to locate but the hazard is likely to be localised and on a small scale.

4. I had assumed that tallow from renderers was sterilised but if meat and bone meal may be a source of infection of cattle high grade tallows used in cosmetics, tooth paste, soap may represent a possible hazard although it seems unlikely. Higher grade fats are often rendered at lower temperature for food use as suet or dripping but presumably these are no different to meat in terms of risk.

5. There may be a hazard from disposal of tankage - material intercepted from the drainage system which in some cases years ago was disposed of with blood by spreading on land but should now be better controlled. Solids will probably go to be rendered and liquid treated in the effluent system.

6. I am not sure if any of this will add to the store of knowledge so am not copying it more widely. If I can be of help in any further enquiries let me know but RHMAs and VOs in divisions making routine visits to non-EC approved slaughterhouses are in the best position to find unusual things.

The first SEAC meeting: A1d 'remains high priority'

9.45 SEAC met for the first time on 1 May 1990. ¹² The Committee considered Mr Lawrence's table summarising research work being undertaken. In relation to item 22 (project A1d), the minutes record:

MAFF and DOH would consider how to carry this work forward - it remains high priority. ¹³

9.46 On future work, the item 'Possible transmission routes to man that might have been overlooked' was identified. ¹⁴

9.47 The next day Dr Pickles sent a minute to Mr Lowson, copied to Mr Bradley and Mr Brown of DH's Food Hygiene and Safety Branch, enclosing the first draft of the minutes of the SEAC meeting on 1 May 1990. Dr Pickles said, in relation to action identified:

. . . You and I are both looking into commissioning item 22 on the research paper. . . . ¹⁵

9.48 On the same day Mr Lawrence sent to MAFF Ministers, and circulated among MAFF officials, an updated version of his chart. This version of the chart said that proposal A1d was in progress with advice being 'given by DTI to trade associations', and indicated that it would be funded by 'DoH/DTI/MAFF/Industry'. ¹⁶ The reference to trade associations appears to relate to the DTI correspondence with the Cosmetics, Toiletries and Perfumery Association (CTPA) chronicled in Chapter 8.

9.49 On 3 May 1990, Dr Pickles sent a minute to Dr Dastgir of DH's Research Management Division:

. . . in relation to item 22 on the chart, the committee [SEAC] were not pleased to hear that we had yet to agree who would commission this work. The secretariat were left to sort it out. It is 'soft' research, so we cannot look to research councils. The money would be very small. I suggest we find it ourselves. Provided you assure me you can do that, and tell me how much might be available - a few £k at most - then we can talk together and with MAFF about putting together a protocol. I think the draft can be put together in house, but later we would need some expert advice too. ¹⁷

9.50 On the same day, Dr Pickles sent a minute to Mr Burton of DH Procurement Directorate (PD). ¹⁸ She attached a copy of her minute to Dr Dastgir and noted that SEAC was 'cross' that nothing was being done about item A1d. She asked whether PD had funds which might be used to commission the work, adding that they could hope to share the costs with MAFF.

9.51 On 9 May 1990, Mr Lowson sent Dr Pickles his comments on her draft minutes of the first SEAC meeting. ¹⁹ In relation to follow-up action, he said that he would pursue a number of additional points which he thought fell to him, including 'arrange for Alan Lawrence's table on research work to be updated periodically'. He added, 'You and I will need to discuss how to carry forward work on unrecognised modes of BSE transmission . . .'

9.52 Mr Lowson told us he could not remember what happened next but said:

I suspect what happened was that I would have consulted colleagues, discovered that in fact the relevant work had been done and was being done in the form of the pieces of paper that we have already spoken about [ie. Mr Hutchins' list of June 1989] and the note which I think Chris Rogers had done in April of 1990, and concluded that we had the basic information. ²⁰

A meeting with Mr Gummer

9.53 On 21 May 1990, a motion on BSE was debated in the House of Commons. ²¹ Before this debate, Mr Gummer held a briefing meeting with Dr Pickles, Mr Lowson and Mr Lawrence. ²² Dr Pickles told us that at this meeting she advised Mr Gummer that the A1d study had not yet been commissioned, to which he replied that it should be started immediately and that MAFF would fund it. She recalled that she then told Mr Gummer that she would start thinking about the protocol straight away. ²³

9.54 Mr Gummer was evidently reassured that all the high-priority projects were therefore under way, and on the evening of 21 May 1990, during the debate in the House of Commons, he said in relation to the Tyrrell Committee's proposals:

Dr Tyrrell identified three categories of research: first, research of top priority. All that is under way. Secondly, he identified research of medium priority: all that is under way, too. We are now working our way through the areas of low priority. Some of them are underway, but some have not even reached the stage of working out the protocols. ²⁴

Correspondence from Dr Pickles

9.55 In early June Dr Pickles sent a number of minutes seeking to chase up project A1d. On 4 June 1990, she provided comments to Mr Lawrence on the MAFF draft memorandum for the House of Commons Select Committee on Agriculture. ²⁵ Annex D of the draft memorandum contained a version of Mr Lawrence's chart, evidently the same as that circulated to MAFF officials on 2 May 1990. Dr Pickles commented:

If item 22(A1d) is now in progress please tell me about it - the advice to trade associations concerned cosmetics only, I think. ²⁶

9.56 Also on 4 June 1990, Dr Pickles minuted Dr MacOwan. In relation to the high- and medium-priority Tyrrell proposals, she said:

Someone has been telling your Ministers it's all underway. If that is the case, I am rather out of touch and would like updating. . . . I need a detailed update on the Tyrrell items A1d, A1e, C1b, C3a, D1c, D1d. As you may know, Tyrrell recently downgraded C2a but as far as I know this work is not underway yet. ²⁷

This minute was copied to Mr Lowson and Dr Dastgir.

9.57 On 7 June 1990, Dr Dastgir sent a minute to Dr Pickles in response: ²⁸

2. The other DH areas of interest identified are - use of bovine materials in pharmaceuticals etc. As you know MAFF have indicated (in A J Lawrence minute 11/4/90 - Spongiform Encephalopathies: Tyrrell Recommended Research item 22) that they consider these should be DH funded research. This item is still outstanding and may have MAFF ministerial support. In view of your briefing to CMO for 20 June Agriculture Select Committee meeting, would you please indicate if there is still a need for research commissions for us in this area. . . . With economies for research funding that are now needed due to pressure on our budgets, this source is worthy of further consideration perhaps by Will. It will be important for RMD to discuss these issues with you further as necessary but RMD requires an urgent response re item 22.

9.58 Dr Pickles replied to Dr Dastgir the next day by way of a handwritten note:

There is an urgent need for this work (no 22) to be commissioned, but Mr Gummer at a meeting with me on 21st May said MAFF would fund it. Please contact your MAFF opposite number to confirm this is actually happening. ²⁹

9.59 On 11 June 1990, Dr Pickles wrote to Mr Bradley about some concerns she had about BSE. Among her concerns was the lack of knowledge about what happened to all parts of cows:

This was raised in the Tyrrell report as A1d. When Mr Gummer found this was still not being attended to, he gave a firm instruction the study should be started and I presume you have this in hand and that MAFF will be providing the funds. Please let me know if you need any help with the protocol. ³⁰

9.60 On 12 June 1990, in a handwritten question on her minute of 4 June 1990 to Dr MacOwan, Mr Lowson queried Dr Pickles's suggestion that someone had been telling Ministers that all the high- and medium-priority Tyrrell work was under way. He wrote: 'Who? Not that I'm aware of.' Mr Lawrence replied to Mr Lowson, also by way of a hand-written note on the same minute:

Remember the meeting with the Minister prior to the BSE Debate in the House. He asked about - in particular he wanted to move on no 22 (in the chart) after she had raised it. I am almost certain that she said that she would start writing a protocol for 22 right away. I am not aware that she has done it. ³¹

9.61 It does not appear to us that Mr Lowson or Mr Lawrence contacted Dr Pickles as a result of this exchange. When he gave oral evidence, Mr Lowson told us:

This is one of the aspects of the untidiness of the way in which this was handled, I think, that no doubt reflects the wide variety of concerns we had at the time, which makes it difficult to follow what was done and at what point we said, 'This work is concluded and that is all we need to worry about'. Having agreed with me quite clearly that it would be for her and me to pursue the next steps on this, Dr Pickles was then writing to Mr Bradley and saying, 'What are you doing about this?', and it does not appear, I do not think, that I saw this correspondence. It may be that at some point, and I just do not remember, I talked to Mr Bradley about this and he said, 'That is all right, I am carrying this forward', but I just do not remember this. But it does, however, reflect that there was another step taken in this job by one of those who you might quite reasonably think was responsible for it. ³²

9.62 On 14 June 1990, Mr Smith (in Research Management Division of DH) wrote to Dr Pickles following up the exchange between Dr Dastgir and Dr Pickles of 7 and 8 June 1990. In relation to A1d he said:

I have confirmed with MAFF (Mr Lawrence's office) that MAFF/DTI are to fund [A1d]. They will send me the latest version of the list of projects showing this. ³³

9.63 Mr Bradley replied by letter dated 17 June 1990 to Dr Pickles's letter of 11 June. He stated in relation to A1d:

I have not got far with this. Where do fetal calves, placenta and uteri go and are any uses made of lymph nodes? Cosmetics, ointments, oils, indeed anything that is used on the skin (it could have a lesion) could present an increased hazard. I have some concern over mesenteric lymph nodes though they are not eaten, though DOH/MAFF agreed earlier there was no need to include them in the offal ban. This is one to discuss in Committee. ³⁴

9.64 On 21 June 1990, Dr MacOwan sent a minute to Mrs Attridge, copied to Mr Lowson, Dr Shannon and Miss Ainsworth (CSG), attaching a briefing on where things stood with the MAFF funded projects and the Tyrrell Committee recommendations. His covering minute referred to project A1d:

I understand that there is concern on the Tyrrell Committee recommendation A1d on pharmaceuticals and cosmetics. This has never been considered a primary responsibility of MAFF although collaboration with the principals (DOH and industry) was anticipated.

I suspect the VMD approach will be to avoid or selectively reduce use of bovine tissues in medicinal products for animals. Presumably the authorities responsible for human medicinal products and cosmetics have taken similar action. ³⁵

9.65 On 22 June 1990, Mr Otley (head of the Food Safety Branch of DH, EHF3) provided a background briefing for the DH Permanent Secretary prior to the Agriculture Select Committee hearing scheduled for 27 June 1990. This was copied to, among others, Dr Pickles. Annexed to the submission was a memorandum prepared by MAFF for the Agriculture Select Committee, which included a revised version of Mr Lawrence's table of research projects. Proposal A1d (Item 22) was now listed as funded by DTI, MAFF and Industry, and the table stated that the project was:

In progress. Advice given by DTI to trade associations in relation to cosmetics. Investigations under way to determine other outlets for bovine and ovine tissues. ³⁶

9.66 Also on 22 June, Dr MacOwan replied to Dr Pickles's minute of 4 June 1990. He copied his reply to Mr Lowson, Mr Bradley and Mr Lawrence. He enclosed an update on the Tyrrell items to which Dr Pickles had referred. In relation to project A1d, under the heading 'Funded by', the table stated 'DOH/DTI/MAFF'. Under the heading 'Current Position' the table stated 'Advice being given by DTI to trade associations'. ³⁷

9.67 Dr MacOwan's chart was different from the one in the MAFF memorandum circulated by Mr Otley on the same day. It appears to us that the latter was the more up to date.

9.68 On 25 June 1990, Dr Pickles sent a note to Dr Metters which set out 'examples of difficulties in MAFF, BSE research'. ³⁸ The note was headed 'AREAS OF RESEARCH falling to MAFF to fund, and where delays and difficulties have been experienced'. At point 5 the note listed the audit as an area of research where progress was 'uncertain or delayed, in spite of the importance'. ³⁹

The fourth meeting of SEAC

9.69 The fourth meeting of SEAC was held on 2 July 1990. During the discussion of matters arising from earlier meetings, the Committee noted that

investigation of unrecognised routes of infection had not been initiated (1st meeting para. 3.3). MAFF have now sought information from slaughterers as to the destinations of bovine tissues, which will provide the basis of a comprehensive picture of the products in which they might be used. ⁴⁰

9.70 On 12 July 1990, Mr Lowson sent a minute to Dr MacOwan, who had sought his views about further transmission studies in mice. He said that Dr Tyrrell had

identified the need for research into possible unpredicted routes of transmission. We have kicked this off in Animal Health Division through an enquiry at slaughterhouses to establish what happens to the whole range of bovine tissues. Pending the results of this enquiry I would not see a need to direct resources to this item. ⁴¹

9.71 The subject was not addressed again for nine months until SEAC asked for a note on non-food preparations.