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Volume 7: Medicines and Cosmetics
9.72 On 7 March 1991, SEAC held its seventh meeting and discussed a paper about tallow. Mr Murray had replaced Dr Pickles as DH secretary to SEAC the previous September. Dr Pickles continued to attend SEAC as an observer for the next few meetings, however, until she was succeeded in that role by Dr Wight in September 1991. The minutes of the meeting include the following: . . . C TALLOW (SEAC 7/2) 6. The Committee was grateful for the very helpful paper produced by Mr Lawrence. The Committee was reassured by the evidence that the protein content of tallow was very low and that MAFF did not believe that tallow derived from specified offals was likely to reach the food chain. The Committee would be grateful for a further note about the real scope for leakage of such material into human food. They would also welcome a note on the use of bovine material in non-food preparations such as cosmetics. On the basis of the available evidence, it was not appropriate to offer specific advice on tallow. 9.73 Mr Lowson's follow-up note to the this meeting included the following: (iii) Non-food uses of bovine material. The Committee asked for a note on the use of bovine material for cosmetics in particular, although it might make sense to cover all the non-food uses that we can think of (harp strings, tennis rackets etc). I think that all that is required is a factual note about the range of uses, and quantities, together with an assessment of possible risk factors. It looks to me like a job for Dr Pickles. 1 9.74 Having been allocated this task, Dr Pickles asked Mr Maslin about the status of the research into non-food uses of bovine by-products highlighted as a priority in the June 1989 Tyrrell Report: Who is doing the study identified in the Tyrrell report A1d? Your Ministers have claimed all the 3 star projects are being taken forward. The MAFF summary chart gives this item as being done by 'DTI, MAFF, Industry'. Please let me know how it is going on and who are the relevant contacts. 2
9.75 Enquiries about the audit were made within MAFF. In response to Dr Pickles's note to Mr Maslin of 25 March 1991, Mr Bradley minuted Mrs Stephanie Townsend (Animal Health (Disease Control) Division) on 8 April saying, 'My notes suggest action on Ald (Tyrrell Report) to be a joint DOH/MAFF responsibility. Within MAFF my notes suggest that commodities divisions have had some responsibility but I cannot identify which.' Mr Bradley provided 'off the top of my head' a provisional list of non-food uses: - those for medicinal product manufacture either as an ingredient of the final product (eg, insulin) or in preparation of it - media for culture - those for laboratory diagnosis - bacteriological media - lung - for surfactant production - use in SIDS - blood vessels, heart valves, pericardium - surgery - skin for collagen for use in artificial casings (could be eaten but mainly used to 'contain') - bone for gelatin manufacture - wide usage incl. food - tendon & catgut for surgery - catgut for tennis racquets and stringed musical instruments - tallow in industry in non-medicinal ointments in cosmetics - gangliosides (from brain) for cosmetics and biologicals - in Europe lymph nodes extracts for human treatment - RBC [red blood cells] for human treatment - cadavers and eyes etc for dissection in Vet Schools and Schools (eyes) - hoof & horn meal - gardening) - bone meal - " ) or a combination - blood meal - " ) - hides for leather goods - hair ? for brushes, upholstery - check: horn for export as aphrodisiac? 3 9.76 Mr Maslin answered Dr Pickles in a minute dated 23 April 1991: I apologise for not coming back to you earlier but we have been trying to find out what has happened to this study. From our papers it would seem that there has been no 'study' initiated. The reference 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. That said we clearly need to decide where to go from here. As a starting point I attach a copy of a list that Chris Rogers, our meat trades adviser, did last year of outlets for material from slaughterhouses. Most of these however are for food use or the hide market. I also enclose a minute from Ray Bradley giving some other uses. I suggest the best way forward might be to prepare a list as requested by the Tyrrell Committee and seek their views on any uses that should be considered further. We could then check with other sources whether we have missed any while we seek more information on those Tyrrell is interested in. 4 9.77 Dr Pickles replied to Mr Maslin the next day: 1. I find your response quite unsatisfactory. 2. When we were discussing last year with Mr Gummer and MAFF officials were writing into a speech that all essential research was being funded, I pointed out this *** project identified by the Tyrrell research committee was not being taken forward. Mr Gummer's response was that it should be immediately so that he could give Parliament what they wanted to hear and what he wanted to say. I have asked about the project several times since and been reassured. You now tell me that nothing has happened. 3. Do you really want to come clean in front of the next meeting of the Tyrrell committee, or do you want more time to prepare your case? 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. 5 9.78 Mr Lowson, who was copied Dr Pickles's minute, responded to her on 26 April 1991: I entirely agree that it is not satisfactory that this item on the Tyrrell shopping list should not have received the attention it deserved. . . . As to why this has happened, Alan Lawrence and I both have a clear memory that at the briefing meeting with Mr Gummer for the House of Commons BSE debate last May you were kind enough to raise with him the question of what was happening about this study and then agreed to go away and draft a protocol as quickly as possible. 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. Clearly as this is a human health issue we need proposals from you about how the job should be done that we can discuss and look forward to seeing them. 6 9.79 In reply, Dr Pickles said: 1. We discussed briefly your note of today's date and agreed that we now did not have time to bring this to the next Tyrrell meeting. 2. I agree that to satisfy Mr Gummer that the matter was being taken forward I said I would be thinking about the protocol that afternoon since there was no professional from MAFF present at the time who could volunteer instead. But the tables provided thereafter by MAFF indicated that 'DTI, MAFF and Industry' was carrying this forward and in correspondence with Mr Maslin I made it clear it was not really my responsibility. 3. Irrespective of what should have happened, how do we take this forward? Would the right approach be to provide a paper for Tyrrell and put our own attempt at a list in, and ask them whether a formal study should be commissioned? If so, who would pay? The money will be trivial. Is it DTI, MAFF, HSE, DH or the 'agriculture' industry? Or do we quietly drop the idea of a study and hope none of them remember the Tyrrell research report (some chance!). 7 9.80 We have not seen a response to this letter or any continuation of correspondence on this point. However, on 2 May 1991, Mr Lowson wrote to Dr Tyrrell regarding the agenda for the next meeting of the Tyrrell Committee. He stated: Third, I am afraid that we have not made much progress on the question of the non-food uses of bovine material. We may be able to table some basic information, but only I think for a preliminary discussion. 8 9.81 The eighth meeting of SEAC took place on 10 May 1991. The minutes of the meeting record: K NON-FOOD USES OF BOVINE MATERIAL 21. MAFF would circulate to members a list of such uses that had been drawn up in consultation with the slaughtering industry. It would make sense in addition to seek from the cosmetics industry an indication of whether they used bovine material. 9 9.82 Following the meeting, Mr Lowson circulated a minute entitled, 'Tyrrell Committee: 10 May: Follow-up', which included the following: 10 (iv) Non-food uses of bovine material: Could Mr Rhodes please tidy up the list that was faxed to me during the Committee meeting and send it to members. It was agreed that information should be sought from the cosmetics industry about whether they use bovine material and I suggest that Mr Murray pursues this. 9.83 The list to which Mr Lowson refers in this minute appears to have been the same as that provided by Mr Hutchins in his minute of 15 June 1989. 11 9.84 Shortly afterwards, Mrs Townsend sent Mr Murray of DH a copy of a list of uses of bovine material, at Mr Lowson's request. 12 The list, entitled 'Treatment of By-Products of Bovine Slaughter', was a reformatted version of Mr Hutchins's list of 15 June 1989 and incorporated a few handwritten additions apparently made during the SEAC meeting of 10 May 1991. The list now looked as follows: 13 CONTENT OF BY-PRODUCTS OF BOVINE SLAUGHTER 9.85 At the bottom of the list it was noted, 'The above reflects the position before the specified offals bans and action on licensed medicinal products'. 9.86 Dr Pickles made efforts to ensure that the list was complete. On 29 May 1991, she sent the MAFF list to DH officials at the Medicines Control Agency (MCA), the Medical Devices Directorate (MDD) and ISPA, 14 as well as Mr Lister from HSE and Mr Murray from EHF3. Her covering minute said: The Tyrrell Committee is now into the small print of trying to work out how possibly BSE-infected bovine material might get into humans. I need your help with lateral thinking. MAFF have drawn up the attached list, based on bits collected from slaughterhouses. It does not include placentae, for example. 2. We have already identified use of bovine lymphoid in cosmetics as a topic worthy of attention. We are well aware of the use of bovine serum albumen and fetal calf serum in laboratory studies (as well as pharmaceuticals). Are you aware of any other uses of bovine materials not listed here? Even if there seems no direct contact of the product with humans at the end of the road, there may be concerns for the workers handling the material, so news of anything else you can think of (however minor the use) would be appreciated. Material used in licensed medical products is controlled separately, so need not concern us here. 3. If you can respond by 14 June, so much the better. Please copy to anyone else who might have bright ideas on this. 15 9.87 Mrs Shersby copied Dr Pickles's minute to Dr Purves, Dr Matthews, Mr Sloggem and Mrs Baker. 16 9.88 Dr Raine of MCA replied on 29 May commenting that the MAFF list appeared 'pretty exhaustive'. 17 She suggested adding materials used in some surgical and other devices. 9.89 On 17 June 1991, Dr Pickles sent a minute to Mr Lowson, attaching a paper on use of bovine material in non-food products, and asking whether this was the sort of thing they were proposing to put before the Committee. 18 9.90 Mr Lowson thought the draft paper was perfectly adequate to focus SEAC's thoughts on the issues. 19 He noted that Mr Bradley had suggested two further items involving lungs and brains, and that he believed that there might be yet further items, such as placenta, which Mr Bradley believed was used in cosmetics. 9.91 Two papers were considered at the ninth SEAC meeting on 28 June 1991, one prepared by Dr Pickles on non-food uses of bovine material generally, and one by Mr Murray dealing specifically with cosmetics. We consider Mr Murray's paper in Chapter 8 on cosmetics. Dr Pickles's paper referred to recommendation A1d and said that, although no formal study had been undertaken, a list had been drawn up. Attached to the paper was the MAFF list entitled, 'Treatment of by products of bovine slaughter'. In relation to the list Dr Pickles's paper asked: (1) Is this list complete? (2) Do these uses of bovine material, or others not listed, present any risks to the public health or health and safety of workers concerned? 20 9.92 On consideration of Dr Pickles's and Mr Murray's papers, SEAC was of the view that, although in general it appeared that no problems arose, several points should be pursued. These included: - investigate whether any specified bovine offals going for industrial use and hence exempt from sterilisation and staining regulations were likely to end up in products (e.g. cosmetics) which might come into contact with human tissues . . . 21 9.93 After the meeting, Mr Lowson asked Mr Lawrence to investigate this point. 22 9.94 Mr Lawrence prepared a note on exemptions from the Meat (Staining and Sterilisation) Regulations during August. He outlined existing controls on the movement of SBO and summarised the state of play in relation to the pharmaceuticals and cosmetics industries. The only other use he identified was that of small intestine in tennis rackets and musical instruments. He concluded: In view of the legislative controls and the guidance which has been issued to manufacturers of pharmaceuticals it is not considered that products derived from sbos will come into contact with human tissues. Guidance has also been issued in relation to cosmetic use and we have no reason to believe that the major manufacturers have not followed the advice given. However in order to obtain as definitive a picture as possible it is considered advisable to check with the trade association to see if this is the case and whether there are small companies who are not members and may not therefore be aware of the advice given. A further check could also be made through the abattoir owners as to the destination of by-products. 23 9.95 Mr Lawrence's paper was included in the materials for SEAC's meeting of 6 September 1991. 24 The minutes record no discussion of it and it appears that no action was taken on Mr Lawrence's suggestion to check through abattoir owners. 9.96 Also tabled at this meeting was a draft of SEAC's Interim Report on Research. In the section reviewing research in progress, the draft report said: The other epidemiological studies listed in the interim report are not progressing at present. The fate of bovine tissues [A1d] is being examined in-house in MAFF and DH however. 25 1 YB91/3.7/3.1-3.2 2 YB91/03.25/9.1 3 YB91/4.8/5.1-5.2 4 YB91/04.23/4.1-4.2. This minute was copied to Mr Lowson, Mr K Taylor, Mr Murray, Mr Lawrence, Mr Bradley and Dr Matthews 5 YB91/04.24/7.1 6 YB91/4.26/4.1 7 YB91/04.29/1.1 8 YB91/5.2/6.1 9 YB91/5.10/9.8 10 YB91/5.13/3.1 11 YB89/6.15/7.4-7.5 12 YB91/5.22/1.1-1.3 13 SEAC 8/11 14 The Pathology and Blood Transfusion Services Branch of the Inspectorate of Anatomy; Scientific Services; Pathology 15 YB91/5.29/8.1 16 YB91/6.3/3.1 17 YB91/6.17/5.1-5.2 18 YB91/6.17/6.1 19 YB91/6.19/6.1 20 SEAC 9/2A p. 1 21 YB91/6.28/2.1-2.7 at 2.7 22 YB91/7.3/3.1-3.2 23 SEAC 10/13 para. 7 24 YB91/9.6/2.1 25 SEAC 10/10 p. 5 |
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