Board meeting minutes: 6 July 2004

1. The Chair informed Board members that apologies had been received from Andrew Miller and Vernon Sankey.

2. The Chairman reminded Board members of their obligation to declare interests before discussion of relevant items.

3. There were no items raised for discussion under Any Other Business.

(Paper FSA 04/07/01)

4. Minutes of the meeting held on 13 May at the Ramada Jarvis Hotel, Inverness were considered and confirmed as an accurate record of the meeting.

5. In considering matters arising and the table of follow up action the following issues were raised:

• Index 217: An information note on the mapping exercise to identify nutrition initiatives was currently being prepared for circulation to the Board.
• Index 197: An information note on the progress that had been made in taking forward the recommendations of the Waste Food Task Force was also currently being prepared for circulation to the Board.
• Index 218: The Chairman informed Board members that the report on the outcome of the enquiry into allegations of re-labelling, re-packaging and extending date marks on fresh chicken, which had been shown as a completed action, had not yet been published. The report would be available on the FSA's website shortly.

6. One Board member, referring to paragraph 13 of the minutes (about re-packaging of chicken), asked whether any other substantive replies from supermarkets had been received. The Chief Executive informed Board members that responses had now been received from all the major supermarkets and that this would be covered in the report that was due to be issued shortly.

Bovine Spongiform Encephalopathy (BSE) Testing Failures Inquiry
7. The Chair informed Board members that, following the announcement at the meeting in Inverness of five failures to enforce the testing of casualty cattle aged between 24 and 30 months for BSE, a much larger number of failures had come to light, details of which had been placed on the FSA's website and reported to the Board in correspondence. The Board had agreed that an external inquiry into the reasons for this should be set up as a matter of urgency.

8. The Chairman informed Board members that Patrick Wall from University College, Dublin had agreed to chair an independent Steering Group that would oversee the investigation. Dr Wall was a medical doctor and a veterinarian; he had also been Chief Executive of the Food Safety Authority of Ireland. The other two members of the Group were: Barbara Saunders, a consumer affairs consultant who had previously served on the FSA's Food Advisory Committee; and Peter Jinman, past president of the British Veterinary Association and a current member of the Spongiform Encephalopathy Advisory Committee (SEAC).

9. The proposed terms of reference for the investigation were:

• To investigate:
  • the reasons for the Meat Hygiene Service (MHS) and Department of Agriculture and Rural Development (DARD) failure to ensure that animals were tested in accordance with the instructions issued
  • why these failures were not identified earlier
• To make recommendations to improve the robustness of the testing arrangements so as to minimise the likelihood of this, or a similar problem, recurring
• to make a report to the FSA Board and DARD by the end of September 2004.

10. The Chair informed Board members that the FSA Chief Executive would attend meetings of the Steering Group as an observer, as would a representative from the Department for Environment, Food and Rural Affairs (Defra). The FSA Chief Executive informed Board members that the Steering Committee had met earlier that day for the first time and had agreed its terms of reference, which were broadly the same as the Chair had outlined, and which would be published shortly on the FSA's website. The Steering Group had agreed to appoint the FSA's independent auditors (Panel, Kerr and Foster (PKF)) to lead the investigation; they would be taking advice from experts with Local Authority audit experience as well as from a veterinary expert.

11. Some Board members were concerned that the investigation would be too narrow in its focus and sought reassurance that it would include other potential areas where similar issues of professional judgement might arise. They also sought assurance that the systems failure that had precipitated this investigation had been dealt with and that the procedure for deciding the programme of FSA audits of MHS performance had been suitably adjusted. The Chief Executive assured Board members that, although the inquiry would concentrate on identifying the reasons for the failures, the Steering Group was keen to ensure that the investigation should establish whether these failures had implications for other areas of the MHS's functions. The auditors would also be visiting slaughterhouses to monitor the effectiveness of the procedures that had already been put in place to address the systems failures.

Dame Sheila McKechnie Memorial Award
12. The Chairman announced that, following her death earlier this year, the FSA had decided to commemorate the life and work of Dame Sheila McKechnie, Director of the Consumers' Association, by setting up an annual award for a local food project. The decision had been taken with the consent and support of her partner, Alan Grant. The award would promote work with disadvantaged groups, which had been a personal crusade of hers. The award would be considered by a panel consisting of an FSA Board member, someone with knowledge of a local food project, and Jon Snow, the TV presenter and a personal friend of Dame Sheila, who had agreed to chair the panel. Information about the award would be published on the FSA's website shortly.
Action: Neil Martinson

Folic Acid
13. The Chief Executive reminded the Board that it had last discussed the issue of fortification of flour with folic acid at its meeting in May 2002. Following that discussion, Health Ministers had been advised that the Board did not recommend mandatory fortification of flour with folic acid, but wished to review emerging evidence on the impact of flour fortification on vitamin B12 deficiency in older people, and its potential beneficial effects for other groups as it became available from overseas. In June this year, Melanie Johnson MP, Parliamentary Under Secretary of State for Public Health, had written to the FSA accepting this advice and had indicated that she would be content for the Scientific Advisory Committee on Nutrition (SACN) to review the new evidence. SACN had since established a sub group to consider when and how to re-visit the risk assessment undertaken by the Committee on Medical Aspects of Food and Nutrition Policy (COMA) in the light of the emerging evidence. The sub group would meet for the first time in September. In response to a question from one Board member, the Chief Executive confirmed that the FSA was not funding any specific new research in this area but was, as previously agreed, gathering evidence from countries that had already taken steps to fortify food.

Undiagnosed Encephalomyelitis in Ruminants
14. At the previous closed meeting the Chief Executive had informed Board members that a new neurological condition in cattle, with symptoms apparently similar to that of infection by the polio virus, had recently been reported. The FSA had been working closely with the Health Protection Agency (HPA), which was leading the investigation into these undiagnosed cases in a number of sheep and cattle. A group of experts convened by the HPA had met on 21 June to assess the likely cause or causes of these cases and any potential risk to public health. The FSA had attended the meeting as an observer. The group had considered the available evidence on a total of twenty nine apparently similar cases that had occurred over the past ten years and its assessment of that evidence had been published in a statement on 28 June. The FSA's own independent Advisory Committee on the Microbiological Safety of Food (ACMSF) had considered the expert group's findings and had decided to wait until the investigation had been completed before considering whether the condition had zoonotic potential.

15. Further investigation of one sample from a heifer had detected an enterovirus: a common gut virus that had the ability, occasionally, to cause neurological illness. This could account for the symptoms observed in the heifer and had therefore been considered to be the cause of the illness in that case. Further tests on other cases were underway, but this would take three months to complete. The Chief Executive explained that enteroviruses were commonly found in both human and animal populations, but that this type of virus had not been found to cross species barriers. He confirmed that none of the meat from the infected animals had entered, or would enter, the food chain as the symptoms were quick to develop and obvious to spot.

New Advice on Oily Fish
16. The Chief Executive reminded Board members of the recent publication of the FSA's new advice on the consumption of oily fish, which had received wide media coverage. Following a risk assessment, it had been possible to give advice to consumers on the health benefits of oily fish while at the same time setting clear limits for maximum consumption. He wished to record the FSA's thanks to the British Heart Foundation for their support and the endorsement of the FSA's advice. The Chair of the Scottish Food Advisory Committee (SFAC) noted that the publication of the new advice had coincided with the Royal Highland Show and that feedback from members of the public attending had been very positive.

(Papers FSA 04/07/02, FSA 04/07/03 & FSA 04/07/04)

17. The Chair welcomed the Deputy Director, FSA Northern Ireland to the table to present the report of the Northern Ireland Advisory Committee in the absence of a Northern Ireland Board member, pending the appointment of Michael Walker's successor. The Chair informed Board members that the reports were being taken at this point in the meeting to allow the views of the three countries' Advisory Committees on the promotion of foods to children to be heard in advance of the Board discussion of this issue (Agenda item 5). The Chair also welcomed Rosemary Hignett, Head of Food Labelling and Standards Division, to the table; she would be introducing the paper on food promotions and children's diets.

Wales
18. The Chair of the Welsh Food Advisory Committee (WFAC) advised Board members that she had nothing to add to the tabled report. WFAC had discussed the food promotions and children's diets consultation at its May meeting, had concluded that the proposed action plan was not vigorous enough and wished to see more active targeting and less monitoring. These concerns had now been addressed in the revised plan that the Board was to discuss later under Agenda item 5. WFAC had been keen to see key alliances established, especially where partners could influence outcomes, and had affirmed the proposal to identify good role models to promote healthier foods, but noted the potential risks of that strategy.

19. WFAC members had agreed that action in schools was key, but that a 'whole school' approach was required, i.e. every aspect of food, from what was available for children to eat in school/home/shops to what was being taught, was vital. Finally, WFAC members had also noted that there was a role of pastoral care for the schools inspection service.

Scotland
20. The Chair of the Advisory Committee for Scotland (SFAC) informed Board members that the Committee had discussed the consultation on food promotions and children's diets and had submitted a formal response. SFAC members had not been convinced that the reliance on voluntary action and codes of practice would be sufficient to drive through the changes which were needed, and had felt that the legislative route would be more effective. SFAC had also agreed that the use of sign-posts or a traffic light system on foods should be scientifically based. SFAC members had also agreed that vending machines in schools should not sell 'unhealthy' foods, that the Office of Communications (Ofcom) should be invited to do more than just 'note' the initiatives set out in the action plan, and that there was a need for a joined-up Government approach in taking these actions forward.

Northern Ireland
21. The Deputy Director FSA Northern Ireland informed Board members that he had nothing to add to Michael Walker's final report as Chair of the Advisory Committee for Northern Ireland (NIAC). He told Board members that NIAC had met with the Consumer Council and the Ulster Farmers Union to discuss the issue of food promotions and children's diets and that there had been a lively and constructive debate. The proposed action plan in the FSA's consultation document had been discussed at NIAC in April and members had agreed that it was an appropriate way to take the issue forward.

22. However, they were of the opinion that there was a unique Northern Ireland dimension to the issue. The Department for Education in Northern Ireland had a significant influence with over ninety per cent of school children being provided with meals from 'in-house' catering facilities. NIAC members had agreed that simple and 'easy-to-action' guidance should be prepared for school principals / teachers / governors giving advice on healthy options for vending machines.

23. NIAC members had strongly supported the proposed action to encourage more advertising of healthier foods and were content to adopt a statutory approach should voluntary options fail. Finally, NIAC members recognised the influential role of parents and noted that they also needed to be informed, advised and supported.

(Paper FSA 04/07/05)

24. The Chair invited Rosemary Hignett to introduce the paper. She informed Board members that the paper summarised the responses to the public consultation on the draft Action Plan and the consequent proposals for revisions, as set out in Annex 1. The paper also described the work undertaken to gather the views of young people, gave details of the opinion of the FSA's Consumer Committee and described recent developments in the UK and other countries since the Board discussion in March of this year. Rather than go into the detail, she proposed to draw out three general points from the consultation exercise.

25. The first concerned the likely effectiveness of the proposed Action Plan, which all had agreed was an important issue. Many respondents had supported the emphasis on voluntary initiatives, although it was recognised that, in certain circumstances (for example where EU regulations required it), a statutory approach would have to be adopted. However, many responses from the public health/consumer group sector had suggested that a voluntary approach would not work and that statutory action was necessary. Many industry responses, on the other hand, had reflected their view that the Action Plan was 'over-interventionist' and had not been based on evidence that it would work in practice. The view the FSA had taken had been that a voluntary approach had not been tried in the current climate; and with only sparse evidence to support the effectiveness of legislative action, any approach was essentially 'untried' at this time. The revised Action Plan in Annex 1 therefore emphasised voluntary initiatives and the active encouragement of a multifaceted approach working across schools, the media and the food industry. It was, however, proposed that specific agreed targets should be introduced and that progress against them should be carefully monitored.

26. The second point to emerge from the consultation was that a number of industry responses had disagreed in principle with any approach based on differentiating between food high in fat, salt and/or sugar and 'healthier' options. Others, particularly the public health sector and consumer groups, had strongly supported such a distinction. Common across this spectrum of responses, however, had been the concern that this differentiation would be difficult to establish in practice. The FSA was currently funding work to develop definitions for these categories. This was being taken forward by an expert group, including stakeholders. Although it still had some way to go, progress was being made.

27. The third point concerned the lack of responses from ethnic groups, despite the consultation package having been circulated to a large number of these. The paper therefore proposed that, during implementation of the Action Plan, particular attention should be paid to assessing the needs and views of ethnic groups.

28. In conclusion, Annex 1 tracked the proposed changes to the Action Plan and it was suggested that progress should be reviewed after two years, with regular updates being provided to the Board in the interim.

29. The Chair thanked Rosemary for her clear and concise introduction and Board members congratulated her and her team on an excellent paper. Board members noted that the ability to form effective partnerships was crucial to the successful delivery of the Action Plan. In addition, partnerships between the FSA and other Government departments, especially Health and Education, were important in maintaining a consistent message across government.

30. Board members noted that industry responses to the plan had been, at best, mixed and recognised. Therefore. that a particular effort would be needed to form productive partnerships with the different industry sectors to ensure its delivery. Board members discussed the advantages and disadvantages of trying to achieve the targets through voluntary initiatives rather than legislative action. Several members expressed concern about waiting two years before there was a formal review of progress. However a majority felt that two years was a realistic review date, provided that regular interim updates were made available as and when there were specific issues to report. One Board member suggested that, during that time, the opportunity should be taken to identify the legislative action that might be needed should a voluntary approach be seen to be failing.

31. Board members acknowledged the role of schools and education in taking the action plan forward. They also affirmed the views of NIAC that the role of parents was also key. They agreed that the FSA should work, in partnership with others as appropriate, to develop clear and simple advice for parents and those who work with children, for example educators and health professionals. One Board member noted the comments of the FSA's Consumer Committee in paragraph 9 of the paper and recalled that the provision of nutrition information during the training of health professionals had been discussed previously. Another Board member felt that failure to make information easily accessible would further disadvantage those who were most vulnerable.

32. Board members recognised that the role of school principals, teachers, governors, teaching assistants and catering staff in bringing about a change in children's diets and their attitude to food was vital. Some Board members expressed some concern about the fact that resource implications, including over burdening educators, might undermine the practicality of the action plan, while others noted that, with the right information and support, a real impact could be made. In particular, encouraging more children to take school meals could provide an opportunity to change the pattern of children's eating habits.

33. Board members also noted that there was a need to improve public procurement. This not only applied to schools but also to other institutions that had the responsibility to care and provide for children, especially those in care. The provision of free, safe drinking water in schools should also be a priority and not just left as an option in a vending machine. Experience from pilot schemes in schools throughout the UK had shown that replacing items in vending machines with well thought through 'healthy' options (most successfully implemented through consultation with the pupils) could maintain the profits that some schools relied on. Examples, and advice gained as a result, of experience with such schemes should be made widely available to all those in education. One Board member noted that, while much had been made of the food served in schools, little attention had been paid (in the paper or other similar reports) to promoting the enjoyment of food. That involved looking at issues like the time allowed for eating, the environment in which the food was eaten and the scope this provided for social interaction, and how the food was presented.

34. Board members acknowledged that the work currently being undertaken by the Office of Communications (Ofcom) was also vitally important in ensuring that this issue moved forward. Rosemary Hignett informed Board members that Ofcom was currently compiling a large volume of information prior to going to public consultation later this year.

35. One Board member noted that a proposed traffic light labelling scheme was due to be piloted by Tesco in September and asked what was being done to ensure that such initiatives were properly co-ordinated across the industry and the UK. Rosemary Hignett assured Board members that the Executive would be actively encouraging consistency of approach in the development of such schemes and a meeting had been arranged for later this month with industry representatives to take this forward. Some Board members were concerned that industry concerns about the action plan had not been sufficiently highlighted in the paper. In response, the Chief Executive expressed the view that the food industry was keen to be part of the solution to the problem of helping people to improve their diets and he had recently had a very encouraging meeting with representatives from the Food and Drink Federation at which he had suggested setting up a seminar at which nutritionists from industry and academia could consider the nutritional evidence which could underpin such action. This had been warmly welcomed.
Action: Jon Bell/ David Statham

36. The suggestion, made by some respondents to the consultation, that the proposal to remove confectionery products, snacks and soft drinks from checkouts should only apply to supermarkets was not supported by some Board members. They noted that the proposal disregarded those in low income groups living on large housing estates who generally use local corner shops for their main shopping. Rosemary Hignett noted this concern, but pointed out that several of the respondents had voiced serious doubts about the practical implications for small stores of implementing such a proposal.

37. In drawing the discussion to a close, the Chair asked whether Board members had any specific comments about the Action Plan. One Board member had previously noted that it contained a good deal of narrative and requested that it therefore be supplemented by a tabulated summary of the targets and their milestones/deadlines so that the effectiveness of the various activities could be tracked more easily.
Action: Rosemary Hignett

38. The Chair summarised the main points raised in the discussion. The Board had:

• noted the results of the consultation on the Action Plan
• noted the work already underway on the definition of high fat, sugar or salt and 'healthier' options
• discussed and agreed the revised Action Plan, with the proviso that the role of, and advice to, parents and health professionals be included; and emphasised the need to involve schools, young children and those responsible for vulnerable children
• agreed to give consideration to the possibility of legislative action and to review progress in implementation of the Action Plan after two years, with regular updates in the interim, including an update after the White Paper on Public Health had been published
• requested that a tabulated version of the Action Plan be prepared.

Action: Rosemary Hignett

(Paper FSA 04/05/04)
[Prior to the discussion of this item Michael Gibson declared an interest as a primary producer and butcher, which he considered sufficient to warrant his exclusion from the discussion of this issue. The Chairman agreed that this was a material interest and that Michael Gibson should not participate in the discussion and determination of this issue. Michael Gibson thereupon left the table for this item. Chrissie Dunn declared an interest as a non-Executive Director of a meat marketing company. The Chairman considered that this was not a material interest and that Chrissie Dunn should participate in the discussion and determination of the issue.]

39. The Chairman invited Alan Harvey to introduce the paper. Alan noted that, in July 2003, the Board had given advice to Ministers on the future of the OTM rule, as follows:
'A move to replace the OTM rule by BSE testing of all OTM cattle going through UK abattoirs was justified on the grounds of the public health risk in relation to food and proportionality.'

This advice had been subject to Ministers satisfying themselves that a satisfactory testing regime could be put in place. He went on to explain that paragraph 1 of the Executive Summary of the present paper had inadvertently over simplified the Board's previous conclusions as it implied that the FSA had positively advocated OTM rule change. In fact the FSA was not an advocate for change in this particular issue. The word 'should' in line 2 of the first paragraph of the Executive summary of the paper ought, therefore, to be replaced by the word 'could'.

40. The paper reminded Board members that the present controls on specified risk material (SRM) removed more than 99% of infectivity. It went on to set the scene for what had prompted the original review – a steep and steady decline over recent years in reported BSE cases and the fact that, in 2001, BSE testing had been successfully introduced elsewhere in the EU. However, subsequent to the Board's original advice, rural affairs departments had decided that no cattle born before August 1996 would enter the food chain because of the potential difficulty in tracing their cohorts as required under the regulation.

41. Alan Harvey drew Board members' attention to the recent critical Public Accounts Committee report on cattle movements and the identification of livestock. Livestock identification, or 'cattle passports' as they were more commonly referred to, were important in establishing the correct age of the animal. It was important that this system should work reliably because of the need to prevent animals born before August 1996 entering the food chain should a decision be taken to move from OTM rules to testing.

42. The first section of the paper concluded at paragraph 21 with a new proposal to set up an independent group to oversee the testing scheme. It recommended that Ministers should not change from the OTM rule until this independent group had advised that the necessary arrangements had been made to put in place a robust testing system.

43. In paragraph 24, the paper turned to the important question of the risk assessment. This section considered the likely number of variant Creutzfeldt-Jakob Disease (vCJD) cases that would result from past food-borne exposure to BSE, and then predicted the number of additional vCJD cases that might arise from removing the OTM rule. A year ago, the only evidence available on which to predict the future size of the vCJD epidemic had been the number of cases reported to health departments. Estimates had then suggested the likely maximum figure to be no more than a few hundred. However, with an uncertain incubation period and no diagnostic test, there had been no way of knowing how many people might be incubating the disease so experts have arrived to an upper estimate of 5000. More evidence was now available with the publication of the findings of a survey of twelve thousand human tonsil and appendix samples. Although the survey sample size had been small, the implications from the findings had been that the total epidemic could be significantly higher than the case data suggest.

44. The Risk Assessment Group (RAG) had been reconvened to consider the implications of the new data and SEAC had considered the issue twice. In addition, the FSA had asked Imperial College to model an approach factoring in the new survey information using a different risk assessment methodology which had met with SEAC's approval. At its second meeting, SEAC had supplemented its membership with four additional experts to provide what the SEAC Chair had described as 'on-line peer review' of the work carried out by Imperial College. It was the FSA's intention to publish the risk assessment on its website in the near future.
Action: Alan Harvey / Neil Martinson

45. SEAC had taken the precautionary view that, because of the incompatibility of the two sets of data, a cautious approach should be taken and the higher numbers predicted from the use of the tonsil/appendix survey should be used as the basis for the calculations. Paragraph 34 of the paper onwards reflected the outcome of the revised risk assessment. The paper described a realistic worst case that 2.5 extra vCJD cases could arise over the next 60 years if the OTM rule were to be replaced with BSE testing. By contrast, the best estimate was less than one case. The tabled note (annexed to these minutes) summarised the pessimistic assumptions, agreed by SEAC, that had been adopted to cover those issues for which quantitative estimates of risk could not be made.

46. In paragraphs 43 and 44, the paper mentioned the option of deferring a decision on replacement of the OTM Rule by testing until 2006, when it was possible that more might be known about the prevalence of vCJD arising from a wider survey of human tonsils which was now underway. However, the FSA had been informed that there was no guarantee that further data would be available by that date.

47. The paper concluded by inviting the Board to agree that the current analysis of risk continued to provide a basis on which to recommend that a move to a system of testing of animals born after August 1996 was justified.

48. Board members were unanimous in their congratulations to Alan Harvey for his thorough and clear introduction and to him and his team for an excellent paper on an extremely technical subject. The Chair invited Board members to seek factual clarifications.

49. One Board member, recognising the need to retain public confidence if the change from the OTM rule to BSE testing were to go ahead, noted the possible impact of a failure in the testing system. Alan Harvey replied that the independent group would wish to ensure that all elements of a robust testing system had been put in place to minimise such failures. Another Board member was concerned about the robustness and accuracy of the tests and was informed that, for clinical cases, the testing method was known to be accurate. Prior to the onset of clinical symptoms, there was some uncertainty about when positive cases could be identified by testing. There was some evidence to show that BSE testing had given a positive result five months prior to the onset of the disease, hence the assumption used in the risk assessment, that the test was effective only at three months prior to onset, was considered (by SEAC) to be a cautious one. The Chair suggested that the evidence supporting the OTM risk assessment that had been considered by the Board last year should be provided to those Board members who had been appointed since those discussions had taken place.
Action: Alan Harvey

50. One Board member sought an explanation of the cases that had arisen in cattle born after the feed ban had been introduced but which had gone on to develop BSE (so called BARB cases). The reasons for these cases remained unclear, but the most likely cause was that there had been a small ongoing risk from animal feed cross-contamination, despite the controls that had been put in place. The possibility of maternal transmission had already been ruled out. However, in the risk assessment it had been assumed that BARB cases would continue to occur at the current low level.

51. The Deputy Chair, noting that paragraph 19 of the paper stated that officials from all three Government departments involved (the FSA, DH and Defra) had agreed to the proposal to set up an independent group to oversee testing implementation, asked if these arrangements had been confirmed. Alan Harvey replied that nothing had yet been confirmed in writing.

52. One Board member questioned the use of the term 'best estimate' in paragraph 36 of the paper. Alan Harvey explained that this was the central or most likely estimate. Responding, the Board member then questioned the range of 0.5 – 2.5 quoted in paragraph 39 of the paper. If 0.5 were the central estimate, the range must start below that. Alan Harvey agreed; the most optimistic estimate of additional cases caused by the change from the OTM rule was vanishingly small, in fact very close to zero.

53. One Board member asked for clarification concerning paragraph 38 of the paper. As it stood, this suggested that SEAC had reservations about the modelling that had been used in 2003. Would these same, or similar, reservations reoccur in the future? Alan Harvey explained that, when the modelling had been carried out in 2003, the size of the epidemic (based on the case data alone) had been pessimistically assumed to be 5000. The new tonsil/appendix survey of twelve thousand samples had given three positive results. That data in turn had provided the basis for a more statistically robust estimate. SEAC had taken the most pessimistic scenario (that all three 'positive' results were genuinely positive) and had scaled the estimate up over the whole population.

54. Some Board members were uncertain about the implications of the potentially very long incubation period for vCJD. Alan Harvey explained that it added to the uncertainty about how many people would go on to develop the disease taking into account the absence of a diagnostic test prior to the onset of clinical symptoms. However, the risk assessment had taken this uncertainty into account by assuming that all three 'positive' appendix samples were due to the prion, when the evidence appeared to show that only one of the three had the distinctive signature. DH was leading the investigation into the two other samples, but until they were shown to be otherwise, the assumption made was to treat these as positive test results.

55. In response to the concern about the three 'positive' appendix samples, another Board member pointed out there was no evidence to show that vCJD in humans had necessarily resulted from food borne transmission. Alan Harvey responded that, in mouse experiments, vCJD clearly showed the same profile as BSE in cattle. While there was compelling evidence to suggest that transmission of the infective agent to humans had originally been via infected meat, the actual route remained unproven.

56. One Board member asked about the length of the incubation period for BSE in cattle. Alan Harvey responded that this was about five years. As he had previously stated, there was evidence to show that BSE was detectable by testing some five months in advance of clinical onset.

57. One constant in the risk assessments had been that the relationship between past exposure and future risk remained unchanged. The Chief Executive pointed out that the introduction of effective controls in 1996 had reduced the exposure risk to a minimum in respect of beef from cattle born after that date.

58. One Board member expressed concern about the implications of a change to testing for 'private kills', which were not subject to ante or post mortem inspections and were not required to be tested for BSE, even if they were casualty cattle. Board members were informed that the new TSE regulations meant that meat from private kills could only be consumed by the owner of the animal and no-one else, not even his/her family members. The issue of enforcement of these regulations would not change if the OTM rule was changed .

59. One Board member suggested that, by refusing to allow casualty cattle into the food chain, the risk would appear to be halved and that the UK would be able to move towards new EU measures more quickly. Alan Harvey reminded Board members that all casualty cattle over the age of twenty four months must test negative for BSE before the meat was allowed into the food chain. Cattle suspected of having BSE were not allowed into the food chain under any circumstances.

60. One Board member enquired whether the European Food Safety Authority (EFSA) had indicated that it was likely to review its recent decision to move the UK to a moderate BSE risk category in the light of the new tonsil/appendix information. The Chief Executive informed Board members that, in recent discussions, EFSA had indicated that, if the Board was to continue to recommend that a move to testing would be justified, it would, in due course, review its risk assessment in the light of the new evidence.

61. All Board members indicated their support for the recommendation in paragraph 21. The Chairman therefore then asked for specific comments on the second part of the paper.

62. One Board member expressed concern about imports from third countries, i.e. those outside the EU. The Chairman reminded them that there were some countries that were designated as 'BSE free'. Before meat from any other country could enter the EU they had to abide by EU regulations (and there were missions from the EU to check that they were being properly adhered to) and there were additional checks at the point of entry for SRM material.

63. Board members recognised and acknowledged the real distress of those who suffered from vCJD and the distress of their families. They recalled that a year ago the risk of additional cases had been estimated as very small. Now the likely range, in the light of the new evidence, was 0.5 – 2.5. It might be as low as zero, it could however be as high as two or even three. But the new evidence also suggested that the epidemic could reach as high as 20,000 cases if the three appendix samples had all been correctly identified as positive. Although the FSA was charged with protecting public health, it had to do this in an appropriate and proportionate way. It was an extremely difficult decision to make and though similar decisions had been made previously, the FSA had chosen to come to its decisions openly.

64. The Chair summarised the main points raised and agreed during the discussion. The Board had:

• agreed that the current risk assessment continued to provide a basis on which to recommend that a move to replace the OTM rule by BSE testing of cattle born after August 1996 was justified
• agreed that this advice should be extended by recommending that Ministers should not change the OTM rule until an independent group, reporting to Defra, DH and the FSA, had advised that the necessary arrangements had been made to ensure that all elements of a robust testing system had been put in place
• recognised that all three departments jointly owned this responsibility and should see it through to implementation
• agreed that, before moving to a testing regime, an agreement must have been reached with Defra to provide the necessary additional funding to enable the MHS and DARD to meet the additional enforcement requirements

65. There were no items of other business.

66. The next open meeting would be held on 9 September 2004 in Swansea.