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Volume 5: Animal Health, 1989-96 6.89 The possibility that semen could transmit BSE required MAFF officials to think carefully about AI policy. AI was used in cattle breeding on a significant scale when BSE emerged. About 1.9 million inseminations were performed across all breeds in the UK in 1986. Modern techniques allow semen to be collected from AI bulls, diluted, frozen and then stored, possibly for years, in plastic tubes or 'straws' until required. Further, a single, potentially BSE-infective, bull could be used for many thousands of inseminations. Vol. 12: Livestock Farming should be consulted for further details about the UK AI industry. 6.90 On 8 March 1988 Mr Bradley minuted the CVL Director, Dr William Watson, about a BSE-suspect bull which had been slaughtered. Mr Bradley advised that he had asked whether semen was available and that the CVL should have a plan to secure semen from suspect bulls for a transmission study. 1 6.91 A paper on the CVL's BSE research and development programme, forwarded by Dr Watson to Mr Meldrum on 9 September 1988, noted that: The risk of transmission of BSE via semen is of particular interest to AI organisations. Knowledge of this risk is important to maintain or re-instate the export of semen. Determination of this risk is dependent on the development of a suitable animal model in which to assay the BSE agent, but there is also the problem of proving zero risk. The design of an experiment to fulfil a given objective or set of objectives requires further thought and possibly discussions with the AI organisations. Plans have been made to obtain semen, under suitable conditions, from clinically suspected bulls. Give the current incidence of BSE, a maximum of one affected bull is likely to occur each year . . . 2 6.92 In October 1988 an exchange of minutes, initiating discussion of AI policy, took place between MAFF officials. Mr Robin Bell of the Animal Welfare, Exports and Veterinary Resources Section in the Veterinary Field Service (VFS), informed Mr Kyle, Assistant Chief Veterinary Officer (ACVO) responsible for notifiable diseases, that he supported a proposal that action be taken to prevent the distribution of BSE-confirmed bulls' semen. However, he pointed out that there was no evidence that BSE could be transmitted via semen. Since at that time the offspring of confirmed BSE cases were left untouched, he also queried whether it would be logical to ban the use of semen from BSE-confirmed bulls. Against this, Mr Bell noted that MAFF would be criticised if such semen was allowed to be used, when its role in the transmission of BSE was still unknown. 3 6.93 Mr Kyle agreed that semen from BSE-confirmed bulls should not be allowed to be distributed, and sought Mr Meldrum's endorsement. Mr Meldrum suggested to Mr Bell that he seek the industry's views - in particular, AI veterinarians. 4 6.94 Mr Bell reported to Mr Kyle that veterinarians whom he had spoken to thought that semen from bulls with confirmed BSE should not be used until the results of transmissibility tests were available. 5 Thus, on 9 November 1988, Mr Kyle recommended to Mr Meldrum that the approval of bulls in which BSE was confirmed should be suspended, and the distribution of their semen should be prevented. He also recommended that bulls that were not suspected of BSE, but whose dams were confirmed, should not be allowed to enter the AI network. 6 6.95 Mr Meldrum replied two days later, and suggested that a move in the direction proposed 'must be carefully assessed with particular reference to the best means of public presentation in view of the extreme sensitivity of BSE at the present time'. He also said that he would like to consult with the Neuropathogenesis Unit (NPU), and requested that a paper be prepared for a BSE research and development meeting on 17 November 1988. 7 6.96 Mr Bell provided the background information Mr Meldrum sought on 16 November 1988. At that stage BSE had been confirmed in one bull in the AI network, and one case was under investigation. Soon after bulls enter the AI centre, about 1,000 semen straws are collected, most of which are used for progeny testing. Progeny testing, which involves assessing the merit of the offspring produced using the semen, takes about four or five years, during which time the bull enters 'lay off'. Mr Bell noted that the majority of potential BSE cases would emerge while a bull was in 'lay off', and before a significant number of straws had been stored. At that time, there was no requirement for bulls entering AI centres to originate from BSE-free farms. Mr Bell posed a number of 'unanswered questions':
6.97 The minutes of the BSE research and development meeting, held in Mr Meldrum's office on 17 November 1988, do not record any discussion about the transmission of BSE via semen. 9
6.98 The proposal to ban the distribution of semen from BSE-positive bulls, and to prevent the progeny of BSE-confirmed cows from entering AI centres, was discussed when Mr Kyle and Mr Kevin Taylor, veterinary Head of the Notifiable Diseases Section, met NFU and NCBA representatives on 5 December 1988. 10 On the same day, in view of the discussions, Mr John Wilesmith, Head of Epidemiology at the CVL, informed Mr Taylor of 'what the [Milk Marketing Board] and Avoncroft Cattle Breeders have in mind on this subject'. He understood that semen from the offspring of affected dams and bulls born in the same cohort as affected animals, would not be used by either body in their AI operations. 11 6.99 Mr Taylor subsequently reported to Mr Meldrum that the discussion with NFU and NCBA representatives was inconclusive, with both organisations wanting more time to consider their reactions. However: The balance of feeling at the meeting was, however, strongly in favour of banning the use of stored semen, at least until semen had proved not to be a vehicle of transmission. Opinion was divided on whether any ban should be voluntary or affected by legislation, the NFU arguing for the former. On the [question of allowing the male progeny of affected cows to be used for AI] attitudes were more clearly influenced by financial considerations, NCBA in particular talking of 'massive compensation'. All present understood the arguments and were reluctant to see the progeny of affected cows used for AI in case a genetic susceptibility was eventually proven. NCBA asked about legal implications, and asked for time for discussion and thought before giving a definite opinion. 12 6.100 Two weeks after the meeting, Mr Kershaw-Dalby, of the NCBA, wrote to Mr Meldrum to inform him of the NCBA's considered position: 1. Any semen stocks from bulls which become infected with BSE should be destroyed and any stocks held by breeders should be traced by the bull owners and an offer to replace this with semen from an alternative bull made. 2. If the dam or surrogate dam (recipient of an embryo) of a bull active in an AI stud becomes infected with BSE then the bull should be removed from service and all semen stocks withdrawn from sale. The bull will have a market value for slaughter and there should be no compensation required. 13 6.101 Mr Kershaw-Dalby commented that the unanimous opinion of those that he had consulted within the industry was that no risk of spreading BSE should be taken. 14 Mr Meldrum replied on 10 January 1989, and informed Mr Kershaw-Dalby that MAFF was obtaining legal guidance on various aspects of dealing with AI, and that the NCBA's input would be helpful 'when we establish firm policy lines'. 15
6.102 Meanwhile, Mr Bell had minuted Mr John Suich, Head of the Animal Health Division, explaining the three areas in which MAFF required legal advice:
6.103 Mr Bell said that the legal advice was required by the end of January 1989, so that MAFF's policy could be announced at the time of the publication of the Southwood Report in February. 17 6.104 Mr Suich forwarded Mr Bell's minute to Mr Alan Lawrence, Animal Health Division, BSE and Related Issues, on 11 January 1989, asking him to seek the Legal Department's advice. However, he suggested that whatever the legal advice: I think we need to give the whole matter very careful thought before we proceed. All the other restrictions and safeguards which we have introduced have been on the advice of the Southwood Working Party. Should we not put the question of AI to the Working Party also? . . . There have already been various suggestions, especially in connection with public health, that measures should be taken to guard against the possible risk of infection being transmitted from animals in which clinical BSE is not apparent. So far we have said that we do not consider this necessary and have pointed to the fact that the Southwood Working Party has made no recommendation that we should. If we take decisions on AI which might seem to imply that there is a risk of infection from clinically healthy cattle we will need to be able to explain convincingly why the nature of the risk from AI is greater or different. 18 6.105 On 16 January 1989 Mr Meldrum responded to Mr Suich's minute of 11 January 1989, saying that he did not favour an approach to the Southwood Working Party, because: I am fully aware that if we made such an approach he would suggest that legislation should be enacted to impose a ban on the use of semen from affected bulls and a ban on the introduction of bulls from affected dams into an AI centre. 19 6.106 He concluded that before reaching a final view and obtaining the support of Ministers, it would be helpful to get the legal advice requested by Mr Bell. 20 Mr Cruickshank, Head of the Animal Health Group, endorsed these views the following day. 21 6.107 In a statement to the Inquiry, Mr Meldrum explained why he was against referring the AI issue to the Southwood Working Party: I believed that to add a further issue at that time on which the Southwood Working Party would need to fully and properly consult, consider and advise, would have held up delivery of the final report which was urgently awaited by Ministers. 22 6.108 On 24 January 1989 Miss D Wood of the Legal Department provided the legal advice sought. On a general basis, she advised that 'if MAFF decides to err on the side of caution but there is some scientific evidence of genetic susceptibility to support the restrictive measures taken, it is unlikely, in my view, that a civil case for judicial review would succeed'. Further, 'provided MAFF acts reasonably in the general interests of the national breeding stock and to consumers at the end of the food chain there is no particular duty of care owed to any individual breeder, for which he could sue in negligence'. 23 6.109 Mr Meldrum chaired a meeting on 13 January 1989, attended by Mr Kyle, Mr Bell and Mr Suich. For any bull confirmed with BSE, Mr Bell proposed that its licence be suspended, but that its stored semen should not be destroyed, as this would involve paying compensation. Mr Kyle noted that legal advice supported this approach. However, Mr Meldrum felt it could be an over-reaction, since there was no evidence to suggest semen posed a risk. Mr Suich pointed out that such action would be the first taken without expert advice. Mr Meldrum suggested that the advice of Professor John Bourne, Director of the Institute of Animal Health, and Dr Richard Kimberlin be sought. 24 6.110 In relation to the offspring of confirmed cases of BSE, Mr Kyle noted it would be reasonable for MAFF not to licence such a bull, since MAFF risked criticism if it licensed a bull that subsequently affected other herds. Mr Meldrum agreed that such bulls should not be licensed. However Mr Suich pointed out that there was no restriction on breeding from cows whose dams were affected with BSE. Mr Bell queried how MAFF could justify not licensing the offspring of confirmed BSE cases, given Mr Meldrum's previous assertion that there was no evidence that semen posed a risk. Mr Meldrum responded that it would be to protect the AI centre's exports. However Mr Bell thought that this was a commercial decision for the AI centre to make: Mr Meldrum concluded that it would be wise to stop affected bulls going into AI centres and MAFF would probably need to revoke an established bull's licence if its dam was subsequently to become affected. It would, however, be necessary to await advice from NPU and Richard Kimberlin before discussing the matter with the industry and reaching a conclusion. . . . It was agreed that taking action against bulls from the same cohort as BSE-affected cattle would be unjustified. 25 6.111 On 28 February 1989 Mr Meldrum wrote to Dr Kimberlin and Professor Bourne, seeking their 'views on the possibility that BSE might be transmitted in bovine semen'. Mr Meldrum explained that he understood 'there is no evidence to suggest that any of the spongiform encephalopathies have been spread by semen', though there was 'a well recognised inherited susceptibility to Scrapie and there is some speculation as to whether a similar condition occurs with BSE'. He asked for their opinion on the possibility of transmitting BSE via semen collected from a clinically normal bull that subsequently developed BSE, and the probability that semen, from a bull whose dam is confirmed with BSE, was infective. Mr Meldrum concluded: I appreciate that I may be asking you to offer an opinion on the impossible but I would be grateful for your views nonetheless as we need to formulate our policy in this area based on the best available evidence. 26 6.112 Dr Kimberlin replied on 3 March 1989, stating that 'I have been dreading the question of infectivity in semen! It is difficult enough with scrapie but the widespread use of AI in cattle makes the problem even more tricky to assess'. Dr Kimberlin discussed the current knowledge in relation to scrapie, and then turned to BSE: [W]e have two major unknowns. As I have already advised, it is absolutely essential to assess the occurrence of maternal transmission of BSE . . . The other unknown is whether or not genetic factors control BSE. The fact that there is no evidence yet does not rule out a genetic effect. 27 6.113 Dr Kimberlin then considered: . . . what I can only call the 'perceived' risks as opposed to the estimated risks. Since it is conceivable that in future BSE might have to be controlled by sire selection, there is a case for banning now the use of semen from positive bulls and high risk bulls. To do otherwise might appear illogical and the ban could always be lifted in the face of real evidence that maternal spread of BSE infection does not occur. 28 6.114 Dr Kimberlin concluded that it was difficult to discuss 'such a complex issue' by letter, and that he may not have explained himself adequately. Thus, he offered to discuss the issues further in person. 29 Following a meeting with Mr Meldrum, Dr Kimberlin wrote to him again on 16 March 1989 regarding the infectivity of semen. Dr Kimberlin compared the theoretical risks associated with natural service compared to AI. He noted that in natural service, the total ejaculate would be around 6 ml. Only about 20 µl (microlitres) would be used per cow for AI. Dr Kimberlin thought that 'Regardless of what assumption one makes about the localisation of infectivity in semen, the theoretical risks associated with AI will be lower by a factor of about 300; say 10-2'. He set out a calculation of the theoretical risk of semen, and continued: This simple calculation again shows that semen presents a low risk to the cattle population . . . The important point is that the risk from natural service would be around . . . 100 times higher than from AI. In other words, AI would be safer than natural service and this could be used as an argument for not taking action against BSE positive AI bulls; provided of course, that it is not overruled by the 'perceived risks'. 30 6.115 Mr Meldrum replied to Dr Kimberlin on 20 March 1989, thanking him for his comments and adding: Quite clearly this issue is extremely complex and I conclude that although the risks appear very slight, particularly with AI, we need to assess these risks extremely carefully considering not only the technical issues but also the perception of any such risks. 31 6.116 Professor Bourne replied to Mr Meldrum on 5 April 1989. He noted that 'semen collected from a clinically-normal bull which later develops the disease has a low but finite probability of containing pathogen. It can be argued that this likelihood increases during the period leading up to the onset of clinical signs'. He suggested: . . . the most sensible course of action is to regard BSE as cattle scrapie, and follow the guidelines laid down by MAFF for the management of scrapie in sheep. Hence the progeny of a BSE-affected dam would be culled and its tissues and secretions destroyed . . . It is difficult to quantify the risk of transmission and [it is] a matter of opinion what constitutes an acceptable risk in this situation. 32
6.117 Mr Meldrum put a submission to Mr Donald Thompson, Parliamentary Secretary, on 19 July 1989. The proposed action on which his agreement was sought, was:
6.118 On 28 July 1989 Mr Meldrum was informed that Mr David Curry, who had succeeded Mr Thompson as Parliamentary Secretary a few days earlier, had agreed to these proposals. 34 MAFF officials then met cattle breeding and other farming group representatives on 12 September 1989 to discuss the proposals. A number of issues were discussed, but the proposals were not altered. 35 6.119 On 31 January 1990 Mr Richard Gregg, Branch C of Animal Health Division, wrote to repesentatives of cattle breeding associations, the Milk Marketing Board (MMB), BVA, Meat and Livestock Commission (MLC), NFU and the Royal College of Veterinary Surgeons (RCVS) confirming MAFF's policy on AI. 36 He noted that the arrangements as agreed at the meeting on 12 September 1989 would be 'implemented forthwith, until scientific evidence shows conclusively whether or not bovine semen is a vehicle for BSE transmission'. The policy was:
6.120 Mr Gregg also stated that compensation would not be payable where approval was suspended. 38 6.121 On 26 March 1990 Mrs Sylvian Sadowski, Branch C of the Animal Health Division, minuted Miss Wood about the AI policy. She explained that the requirement on bull owners, to certify that dams of bulls entering AI centres were BSE free, was causing difficulty. The MMB was 'unhappy' about signing declarations for bulls they purchased as calves and then submitted for AI approval up to one year after purchase. The MMB claimed it had no knowledge of the dam's history in the intervening period and had reservations about going back to the breeder to find out. MAFF also found it difficult to adequately check all the declarations because its various systems did not provide sufficient information. 39 6.122 Mrs Sadowski canvassed problems with cattle identification. She said: I am concerned that if we license a bull born of an infected dam because we have been unable to retrieve information previously notified by the dam's owner, MAFF may be open to criticism and possible claims for compensation if any semen collected became valueless or, if semen proves to be infectious, infection in other herds was traced to semen from the bull . . . In the light of the background, I would be grateful if you could consider our position, in particular whether MAFF would be liable if it approved a bull which was subsequently found to be worthless because of its BSE background. 40 6.123 Miss Wood advised on 28 March 1990 that MAFF would be so liable, and that the position was 'serious': You have been notified by the dam's owner that the dam has become infectious. You cannot retrieve that information in all cases: that is negligence. You have breached your duty of care to ensure that that information is notified to the people who need to know. You have already publicly stated that you will be checking whether or not a dam or surrogate dam has been reported as a BSE case and owners of bulls are entitled to expect that you have carried out those checks thoroughly and to rely on that check when they purchase bulls. 41 6.124 Mrs Sadowski replied on 11 April 1990 that 'we see no alternative to telling the Industry that the BSE records were not originally set up in a manner that allows us to trace bulls' dams or surrogate dams with certainty and that while we will do our utmost to check each case, we can offer no cast iron guarantees'. MAFF would try to improve its checking procedures and thus would be using its 'best endeavours' with the information it had available. Mrs Sadowski suggested it was reasonable for MAFF to require the same of the industry and therefore require them to sign the declaration on the application form. If they did not then MAFF should be able to refuse approval. 42 6.125 Miss Wood agreed that if MAFF 'do all that a reasonable government department could be expected to do in the forseeable circumstances, then [it] will not have failed in [its] duty of care and will be able to rebut any claim for negligence'. However, she did not see how calf owners could be asked to furnish information about dams or surrogate dams that develop BSE quite some time after they had purchased the calf. 43 6.126 Mrs Sadowski and Miss Wood exchanged minutes again, with the result being that MAFF would only require owners to sign a declaration that the bull's dam was BSE free 'to the best of my knowledge'. 44 Mr Gregg conveyed this proposal to Mr Merson of the MMB on 14 May 1990. 45 6.127 Once the AI policy was implemented, MAFF continued to investigate whether BSE could be transmitted via semen. One method used was an epidemiological study to track the offspring, produced during progeny testing, of AI bulls. On 16 April 1992 Mr Wilesmith wrote to Mr K Taylor about two AI bulls that had been confirmed with BSE. Mr Wilesmith had obtained the details of their offspring. In addition, similar information had been supplied for offspring of two unaffected bulls of the same age, which had been progeny tested in the same counties as the confirmed bulls. The progeny were above the age at which BSE could be expected to occur. Mr Wilesmith advised: There is no indication of an excess risk [of contracting BSE] for the progeny of affected bulls. Perhaps more importantly the incidence [of BSE] in progeny . . . is not at variance with that observed in the general epidemic for this age group. As we have discussed in the past these analyses are rather slight with respect to determining the risks that semen from BSE affected bulls may carry as the two affected bulls were most likely infected in calfhood. However, there is no evidence from this analysis that the semen from the two bulls considered resulted in the transmission of infection to their progeny. The more difficult aspect of this analysis is the risk of infection for the dams, the recipients of the semen. However, no case of BSE has been reported in these recipients. 46 6.128 On 27 April 1992 Mr Meldrum informed Mr Sadler of the United Kingdom Renderers' Association (UKRA) that in practice, when a bull approved for AI purposes was confirmed as having BSE, the following occurred:
6.129 On 21 September 1993 Mr Bell revisited MAFF's AI policy in correspondence with Mr K Taylor. He noted: It was decided that this policy would apply until there was scientific evidence to show conclusively whether or not bovine semen is a vehicle for BSE transmission. Legal advice was that any legal challenge to have a suspension lifted would be based on whether MAFF had acted unreasonably in suspending approval. If MAFF acted with caution because of uncertainty of scientific knowledge, such a challenge would be unlikely to succeed. Our policy is still supported by AI centres, but we have had several queries from owners of semen to have the suspension lifted. In the light of the report which MAFF presented to OIE in May 1992, we therefore need to assess whether the policy can continue. 48 6.130 Mr Bell explained that the report to the Office International de Epizooties (OIE) had concluded that semen from BSE-affected bulls was non-infective, and thus placed doubt on the current policy from a legal perspective. Mr Bell thought it needed to be decided whether the report would persuade a court to conclude that MAFF would be acting unreasonably if it continued to suspend the use of semen from BSE-affected bulls. Before he sought further legal advice, Mr Bell asked Mr Taylor to advise on the scientific status of the report to OIE, and in particular, 'Does it constitute the conclusive scientific evidence under which we could discontinue our present policy?' Mr Bell suggested that one possible relaxation would be to allow the use of semen from a BSE-confirmed bull in the owner's own herd. 49 6.131 Mr Taylor responded on 4 October 1993, and said the 'recommendations of the OIE Animal Health Code are unequivocal: semen can be traded safely, and no conditions are recommended'. After considering the arguments, Mr Taylor judged that 'prudence dictates that if there was no pressure for change none should be offered'. He suggested that if there was pressure for change, semen collected after clinical signs appeared should be prohibited from use, while restrictions on semen produced before signs appeared could be relaxed. However, users of the semen should be informed that it originated from a bull that had subsequently developed BSE. Finally, Mr Taylor suggested that if MAFF was to consider changing its policy, the issue should be referred to SEAC. 50 6.132 Mr Thomas Eddy, Head of Animal Health (Disease Control) Division, was copied Mr Taylor's minute, and on 25 October 1993 he informed Mr Bell that he agreed with Mr Taylor and that if a change was to be considered it would be sensible to obtain SEAC's views. He continued: I have to say that I am somewhat reluctant in policy terms to be seen to be relaxing restrictions on BSE at this stage. There remains quite a ground swell of feeling that our restrictions do not go far enough and although we have been robust in defending the current position, I am not sure that Ministers would be comfortable in starting to roll back the status quo yet. 51 6.133 It appears that SEAC did not consider this issue. MAFF's AI policy in relation to BSE-affected bulls has not changed since this time. 1 YB88/3.8/2.1 2 YB88/9.9/2.12 3 YB88/10.17/4.2 4 YB88/10.17/4.2 5 S184 Meldrum para. 125 6 YB88/11.11/5.1 7 YB88/11.11/5.1 8 YB88/11.16/4.1 9 YB88/11.17/3.1-3.5 10 S184 Meldrum para. 144 11 YB88/12.05/4.1 12 YB88/12.7/5.1 13 YB88/12.19/3.1 14 YB88/12.19/3.1 15 YB89/1.10/4.1 16 YB89/1.06/4.1 17 YB89/1.06/4.1 18 YB89/1.11/4.1 19 YB89/1.16/2.1 20 YB89/1.16/2.1 21 YB89/1.17/11.1 22 S184E Meldrum para. D24 23 YB89/1.24/7.1-7.2 24 YB89/1.13/4.3 25 YB89/1.13/4.4 26 YB89/2.28/1.1-1.2; YB89/2.28/2.1-2.2 27 YB89/3.3/5.2 28 YB89/3.3/5.3 29 YB89/3.3/5.4 30 YB89/3.3/5.6 31 YB89/3.20/6.1 32 YB89/4.05/5.1 33 YB89/7.19/6.1 34 YB89/7.19/12.3 35 YB89/9.29/11.1 36 The letter was also circulated widely within MAFF and representatives of WOAD, DANI and DAFS 37 YB90/01.31/17.1-17.2 38 YB90/1.31/17.2 39 YB90/03.26/9.1 40 YB90/03.26/9.1-9.2 41 YB90/03.28/5.1 42 YB90/04.11/13.1 43 YB90/04.18/7.1 44 YB90/05.02/17.1; YB90/05.10/15.1 45 YB90/05.14/18.1 46 YB92/04.16/3.1 47 YB92/4.27/2.1 48 YB93/9.21/8.1 49 YB93/9.21/8.2 50 YB93/10.04/7.3 51 YB93/10.25/2.1 |
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