OTM Testing Stakeholder Meeting: 7 December 2004

1. David Statham welcomed everyone to the meeting. He explained that the meeting had been arranged for two reasons. The first was to update stakeholders on the current position of the OTM rule, following the Government announcement the previous week of the start of a managed transition towards replacing the OTM rule with a robust system for BSE testing. The Government announcement had stated that the final switch from the OTM rule to testing would only happen when the FSA has advised Ministers that a robust testing system was in place. The Agency had therefore set up an independent group to advise on the robustness of the proposed testing system. This is under the chairmanship of Patrick Wall, Professor of Food Safety in the Centre for Food Safety at University College, Dublin and former Chief Executive of the Food Safety Authority of Ireland.

2. The second part of the meeting would involve Patrick Wall explaining the work the group is doing, particularly the initial advice to be presented to the FSA Board on Thursday, 9 December. Stakeholders were informed that they were welcome to attend the Board meeting, and feedback on the independent group's initial advice would also be welcome.

3. Alan Harvey commenced his presentation by thanking Members of the Agency OTM Rule Review Team for their work on the review. David Carruthers, Adrienne Conroy, Irene Hill and Jill Wilson were mentioned. Alan Harvey also mentioned that many of those that were present that afternoon had been involved in earlier stakeholder meetings, culminating in the advice that was delivered to Ministers in July 2003.

4. A brief history of the BSE epidemic in the UK was presented, from the peak year in1992, when 37,000 cases were diagnosed, to the steep decline to 611 in 2003 and diagnosis of only 186 cases up until mid-November of the current year. Alan Harvey acknowledged that there are still uncertainties. For instance, the number of cases born after the reinforced feed ban (BARB) currently stands at 101.

5. The UK BSE position had improved very significantly in relation to other EU countries, compared with the 1990s. Alan Harvey explained that it had been estimated that the additional risk due to a change to the OTM rule over the next five years was less than one hundred thousandth compared to the past. He spoke about new information that had emerged in the past 12 months about prevalence of vCJD and the effect of this on the projected number of vCJD cases. The best estimate of vCJD cases arising from OTM rule change over the next 60 years, attributable to infection in the next five years is 0.5. The worst case scenario is 2.5 cases. This is based on SEAC advice, which was to use the pessimistic assumption that vCJD prevalence in the UK human population is three out of 12,000. This translates to an underlying vCJD epidemic of between 5,000 and 20,000 cases, which is much higher than the 152 cases to date.

6. The trend in the number of cases is downwards although the possibility of further peaks in the epidemic cannot be ruled out. In looking at the numbers, various options had been worked through by Health Protection Agency statisticians, including an exponential rise, plateauing, or a downward trend. Although there were no certainties, a downward trend (the so-called quadratic model) represented the best 'fit'.

7. Alan Harvey stated that the Agency considered that on the basis of the arithmetic, it would be appropriate to change the OTM rule, subject to robustness of the testing system. The key BSE controls are the Feed Ban, which essentially turned off the source of the infection, and SRM Controls, which research indicates remove 99% of potential infectivity. The testing regime offers a further measure of protection. It has been estimated that a 1% failure in the testing regime would not add significantly to the risk but would have a huge impact on public confidence. The FSA has therefore advised that no change should take place until a robust testing system is in place.

8. John Godfrey from Foodaware stated that he was interested in the graph showing the trend in vCJD deaths, which Alan had shown during his presentation. He wanted to know whether there had been any statistical review of whether the quadratic model or plateau model gave a 'better fit'. The narrative suggests that the quadratic model was the best fit although the possibility of more peaks could not be ruled out.

9. David Rutledge from Livestock and Meat Commission, Northern Ireland asked what the underlying vCJD epidemic would be, based on the 152 cases to date as opposed to the prevalence data, if the quadratic curve was followed. Alan Harvey stated that he did not know the exact number but it would be in the region of a few hundred.

10. John Taylor from the National Federation of Meat and Food Traders asked whether there had been any comparison between the number of vCJD cases in the UK and number of cases in the rest of the EU. The answer was that there had been seven cases in France, two cases in the Republic of Ireland and one in Italy. The panel was not aware of any other cases in Europe.

11. Tim Lobstein from the Food Commission asked about confidence in the assumptions that had been made and whether sporadic CJD may be attributable to BSE. Alan Harvey replied that the assumptions were peer-reviewed by SEAC and modelling was adjusted to take account of assumptions. He stated that SEAC regarded the sporadic CJD hypothesis as speculative although they did draw attention to uncertainties.

12. Peter Mills from the Human BSE Foundation asked whether modelling had been adjusted for secondary infection through blood products. Alan Harvey replied that modelling was for the level of increased risk attributable to OTM rule change through food-borne exposure. The possible additional risk that might arise through person to person transmission had not been taken into account.

13. Patrick Wall presented this item. He is Chair of the group and is assisted by Mrs Barbara Saunders, Peter Jinman, Professor Peter Lind and Dr Geoff Spriegel. In addition, the group gets assistance from staff from the FSA, Defra, DARD and MHS. Patrick Wall stated that the group had only had three meetings so far but a lot of work had taken place.

14. The group was tasked with making recommendations to the FSA on a robust testing regimen for OTM cattle. They have not been asked to re-open the risk assessment that FSA advice had been based on or make any comments on previous risk assessments.

15. Patrick Wall explained that the task had been divided into six stages as follows:
a) Outline the components of the system - a wish list;
b) Suggest approach for assessing performance;
c) Agree appropriate field trials of testing system;
d) Review recommendations in light of field trials;
e) Make a recommendation 'for' or 'against' the introduction of testing; and
f) If the OTM rule is replaced by testing, evaluate and audit of the first six months of the testing system and make recommendations on improvements, if indicated.

16. Patrick Wall stated that a previous group had looked at failures to test casualty animals that should have been tested. He stated that there could not be a move to testing OTM cattle until the failures that were identified have been rectified. Action plans are currently in place to rectify the failures.

17. Patrick Wall mentioned that other EU Member States have testing systems in place so the UK is not trying to do the impossible. He outlined the areas of the system as being:

• Identification - both of animals to be tested and animals to be excluded from the food chain
• Abattoir process
• Vertebral column removal

18. Patrick Wall stated that 15% of the boning process would be supervised by the MHS and there would be severe sanctions for non-compliance, for example loss of approval to remove SRM vertebral column.

19. Plant Staff, MHS Staff in plants, MHS internal audit, FSA external audit and EU FVO audit would all have a role in controls.

20. Patrick Wall concluded his presentation by stating that we have an obligation not to waste good food, an obligation to spend taxpayers' money wisely and an obligation to protect consumer health. Introducing a change to the OTM Rule is dependent on satisfactory trials. He stated that the work of the independent group is in progress and comments from the audience could be included in the group's deliberations.

21. Sue Davies from 'Which?' had two issues. She first expressed surprise that plant staff would be collecting samples rather than the MHS ' which she thought could give rise to a potential conflict of interest. Her second question related to the huge focus on this issue now, before the go-ahead for rule change. She wanted to know how pressure to ensure testing would be robust would be maintained afterwards. In answer to the first question, Patrick Wall stated that MHS staff would supervise the sampling and if there were no test result, the carcase would be treated as being positive. The proposal for plant staff to conduct sampling is not set in stone so can be reviewed if necessary.

22. Sue Davies stated that, given the history of non-compliance, it would give greater reassurance if the MHS was conducting sampling. Trust in the Meat Industry has eroded due to past identified failures. Patrick Wall stated that there were explanations for past failures but no excuses. There had been unclear guidelines relating to the testing of animals aged 24-30 months. The situation would be different when every animal has to be tested and as previously indicated, the change to the OTM Rule will not take place until identified failures have been rectified. Peter Jinman added that there would be very few positives. An abattoir could operate for many years without any positives. However, the system must be robust enough to slot in when a positive case is discovered.

23. Sue Dibb from the National Consumer Council asked what sanctions would be applied for non-compliance, how non-compliance would be monitored, what is the definition of satisfactory trials and who would pay for testing? Patrick Wall replied that animals going into the food chain must have tested negative for BSE and the vertebral column must be removed. 100% compliance is required. There will be a 15% check by MHS staff of removal of vertebral column and discovery of non-compliance will result in the loss of approval to process OTM carcases. In field trials, plant staff must be able to identify, individually or in a batch, all parts of the tested animals, which have to be retained until the test result has been received, otherwise they cannot be involved in handling OTM cattle. Frances Radcliffe from Defra, responding to the question on cost, stated that Defra would continue to pay for laboratory tests and the cost of MHS supervision of the system. Abattoirs would pay the cost of transporting samples to the laboratory.

24. Nancy Robson of the FSA Consumer Committee asked whether checks and controls on imported beef would be as stringent as those for domestically produced beef. David Statham stated that this was an important point as the UK is currently considered to be acting illegally for not allowing the free movement of goods within the EU. If the move to testing goes ahead, we will need to allow the entry of tested OTM beef from the rest of the EU. The only guarantee will be the same one the UK can offer other EU Member States: that controls and testing are being applied. For imports from outside the EU, there is reliance on checks and controls in other countries and the Food and Veterinary Office (FVO) monitors the situation.

25. Doug Ward of UK Renderers Association wanted to know whether there had been any assessment of the effect of removing less SRM, as is the case in 'moderate risk status' countries, given that current SRM controls removes 99% of potential infectivity. Alan Harvey replied that head meat and cheek meat could potentially come back onto the market but no analysis had been carried out. The application for 'moderate risk status' is separate from the OTM rule but at best guess it would not be significant.

26. Doug Ward also asked whether the independent group had addressed the value of rendering animal by-products. The answer was no, as this was not within the group's remit. Alan Harvey stated that for the export market and SRM controls, nothing was enshrined in tablets of stone. There is no guarantee that the definition of SRM would stay the same. For instance, some might argue that cheek meat should not be allowed back into the food chain. David Statham stated that there were no plans for any SRM changes for the foreseeable future. Doug Ward stressed that there was a question that needed to be answered because animals that test positive for BSE would arrive at the renderers' either as SRM or, if the SRM rules change, as clean material. Three separate lines might therefore be needed to cater for OTMS, SRM and clean material.

27. Frances Radcliffe stated that it was necessary to be clear on what should or should not be SRM and we need to make sure the industry is aware. The Commission needs to be asked how they foresee the future definition of SRM. Alan Harvey added that there is a prescribed SRM list for countries with 'high risk status'. Countries with 'moderate risk status' have a reduced SRM list. We cannot be sure what the Commission will do in future. David Statham noted that further discussion was needed to address details of this issue. It would appear that the implications for renderers have not been fully taken on board.

28. John Godfrey was concerned that the removal of vertebral column might result in central nervous tissue being spread. Could spinal cord to be removed while still within vertebral column, as he believed was the case in Portugal? Adrienne Conroy responded by saying that there were devices available for the removal of spinal cord with the vertebral column but there was scepticism about the effectiveness of such devices and their acceptability to the Commission. John Godfrey added that there were parameters abattoirs had to adhere to, when severing heads, to limit the spread of central nervous material. It was also mentioned that in some EU countries, carcases are split off-centre, to reduce the chance of spreading central nervous material.

29. Tim Lobstein of the Food Commission asked what would happen when an inconclusive test result is obtained. Patrick Wall answered that samples that give inconclusive results have to be re-tested. If no result is obtained and the animal cannot be re-tested, this would be equivalent to a positive result and the protocol for positive results would be activated.

30. Barbara Saunders returned to the question about satisfactory trials, asked by Sue Dibb earlier in the meeting. She stated that the meetings of the independent group had thus far been focused on the steps involved in processing animals from farm to fork. The issue of trials will be addressed at their next meeting. As for the structure and criteria for determining what is satisfactory, an audit regime in abattoirs and cutting plants has been looking at criteria that will need to be met for plants to be able to handle OTM cattle at all. David Statham added that audit arrangements are being revamped. At present, the MHS has its own internal audit system and there is also the FSA external audit. There will be a new Audit Team within the Agency by April next year, which will provide a very rigorous system in addition to the internal system. The FVO audit is also a key component.

31. Peter Soul from Defra returned to the question about the procedure for removing spinal cord. He stated that France used pressure at one end and suction at the other. There is also the Oval Saw. The cost and benefits of these options need to be considered, bearing in mind the animals come from populations with low BSE risk.

32. On the question of animal by-products, Peter Soul stated that there would be a continuing disposal scheme for cattle born before 1 August 1996 and it will be necessary to continue to treat that stream separately for audit purposes. Other streams are Categories 1, 2 and 3 animal by-products. If the definition of SRM is revised, increased SRM from additional OTM vertebral column will balance this out. Under animal by-products, it is necessary to maintain different streams for disposal of OTMS cattle and other animal by-products.

33. Doug Ward asked whether vertebral column would be removed from cattle over 12 months of age. Alan Harvey replied that vertebral column is SRM at 30 months in the UK at present, although 12 months in the rest of the EU. He was aware that there might be a requirement to harmonise controls for exports to the EU. This is an issue that needs to be discussed with the Commission, as the removal of vertebral column at 30 months is related to the Feed Ban, not the OTM rule.

34. John Taylor expressed concern that with a removal of the OTM rule, better breeds of beef would come back onto the market but it would not be possible to have T-bone steaks from such animals. He wanted to know whether the same health mark was to be used throughout the meat industry. Alan Harvey stated John Taylor's remark about the health-mark would be noted. Members of the public need to be aware that OTM beef is not inferior to UTM beef. Finishing at 30 months requires intensive rearing. David Statham added that the aim is to give consumers choice. If all issues of concern have been addressed and consumers want to eat beef on the bone, we should be able to allow them to do so. This equates to giving consumers choice as well as ensuring food is safe.

35. Tim Lobstein asked for reassurance that there would be good accountability from Professor Wall's team and that the group was completely independent. Patrick Wall was able to give assurance that the group had no vested interest in the beef industry and the interests of consumers would come first. If the group says the testing system is robust, it will be robust. David Statham added that all deliberation would be in the public arena. The FSA has an open agenda and discussion will be rigorous. A change to the OTM rule will only occur if this can be done safely. The independent group will not allow the change to be made if it is unsafe and the FSA Board will not advise Government to change the rule if the report of the group indicates that it cannot be done. Peter Jinman added that protection of public health is a very important part of being a Veterinary Surgeon.

36. There being no further questions, David Statham drew the meeting to a close by stating that it was not the end of the consultation process, as there would be further stakeholder meetings. He added that if anyone needed further reassurance, the Agency would be happy to have meetings with different groups about their particular concerns. He also stated that it was vitally important for everyone to engage throughout the process so encouraged everyone to come along to other stakeholder workshops, to which they are invited. David Statham concluded by thanking everyone for attending.