Board meeting minutes: 15 September 2005

Friday 14 October 2005

Four Seasons Hotel, London

Present:
Dame Deirdre Hutton, Chair
Julia Unwin, Deputy Chair
Sati Ariyanayagam
Richard Ayre
Chrissie Dunn
Maureen Edmondson
Michael Gibson
Ann Hemingway
Valerie Howarth
Iain MacDonald
Graeme Millar
Christopher Pomfret
Nelisha Wickremasinghe

Officials attending:
Jon Bell – Chief Executive
Clair Baynton – Head of NFAS Division (item 5 only)
Diane Benford – Head of Toxicology of Food
Chemicals Branch (item 5 only)
Catriona Stewart – Official Control Regulation &
Implementation Team (item 6 only)
Steve Wearne – Head of Strategy & Regulation Division (item 7 only)
Chris Lawson – Chief Executive, Meat Hygiene Service (item 8 only)
Neil Martinson – Director of Communications (item 8 only)
Alan Harvey – Head of TSE Division (item 8 only)
Sue Johns – Private Secretary to the Chair

Chair's Introduction

1. The Chair welcomed all observers attending the open Board meeting and invited the Deputy Chair to introduce the meeting. The Deputy Chair reminded those attending the meeting and watching the webcast that the FSA Board discussed policy issues at its open meetings to meet its commitment to transparency and accessibility. There would be an opportunity for questions immediately after the formal session and those watching the webcast could also send questions to the Board.

2. The Chair noted that apologies had been received from Sandra Walbran and 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.

Item 1 - Minutes of the Meeting on 15 August 2005, Congress Centre, London
(FSA 05/09/01)

4. The Board agreed the Minutes of the meeting held on 15 August 2005 at the Congress Centre, London, as an accurate record.

Item 2 - Actions Arising

5. In considering matters arising and the table of follow up actions, the Chair noted that in the table of follow up actions there was an incorrect reference to 'the illegal dyes task force' and asked that this be corrected to read 'food incidents task force'.

Item 3 - Chair's Report

Over Thirty Months (OTM) Rule

6. The Chair reminded Board members that, following Patrick Wall's report on whether a reliable BSE testing regime had been designed, trialled and would be able to operate across the UK, the Board had met on 15 August 2005 to discuss the FSA's advice to Government in the light of this and other evidence. During that discussion, the Board had agreed to recommend proceeding with rule change subject to a number of pre-requisites being met. The Chair had subsequently written to the Deputy Prime Minister setting out the FSA's advice in full.

7. The Chair then informed Board members that the Government had announced that morning that they had accepted the FSA's advice. A communications strategy was being developed in partnership with a number of other government departments and the Implementation Review Group would, as the Board had agreed, monitor the rule change implementation and provide regular reports to the Board. Alan Harvey, head of TSE Division, would be available to answer any questions that arose from the BSE controls discussion later in the meeting.

FSA appointment to EFSA Panel on Contaminants in the Food Chain

8. The Chair congratulated Diane Benford, Head of the FSA's Toxicology of Food Chemicals Branch, on her appointment to the European Food Safety Authority's (EFSA) Panel on Contaminants in the Food Chain (CONTAM).

Item 4 - Chief Executive's Report

HACCP implementation

9. The Chief Executive informed Board members that the work in catering businesses to implement HACCP in England and Wales was progressing well. A pack for small businesses - 'Safer Food Better Business' - had been produced and would be available free of charge. Local Authorities were being supported in a variety of ways with the provision of:

• a framework for using the Safer Food Better Business Pack
• free training courses
• a grant package amounting to
  10 million over three years, the first tranche of which had been announced on 8 September and the second tranche of which would be awarded early in 2006

10. He noted that the aim of this initiative was to increase consumer protection by improving food hygiene standards. Board members welcomed the package, especially the practical approach that had been adopted. They noted that it was particularly accessible to small and medium sized businesses, as easy to understand language had been used.

11. Bearing in mind it was unlikely that there would be full penetration of the industry by January 2006, the question was raised as to what action would be taken against businesses that had not fully complied with the new requirements. The Chief Executive responded that every effort was being made to reach all businesses and that, as now, enforcement authorities would be encouraged to take proportionate enforcement action either in the form of advice and guidance to businesses on how to fulfil their duties or, if public health was being put at significant risk, more stringent action.

Sudan I

12. The Chief Executive advised Board members that the FSA had been informed that Sudan I had been found in a particular batch of the food colouring Sunset Yellow. The occurrence had been a by-product of the Sunset Yellow production process (not a deliberate adulteration) and was not, therefore, illegal as current EU regulations allowed for up to 5% of 'subsidiary colours' formed in this way to be present in the final product. However, not all batches appeared to be contaminated in this way, so the company importing the Sunset Yellow had given an undertaking to ensure that, in future, no batches would be sold for food use where Sudan I was detected using the HPLC method, which had a limit of detection of 0.5 ppm.

13. FSA officials intended to raise the issue of the specification at a forthcoming meeting with the Commission and Member States and to seek a change such that the presence of Sudan I would no longer be permitted.

14. A question was raised as to why products containing Sunset Yellow from that batch had not been withdrawn when, in the previous adulteration incident, products containing similarly low levels had been. The Chief Executive confirmed that expert advice on Sudan I was that it was a potential genotoxic carcinogen and that the incidence of such substances should be kept as low as reasonably achievable (the ALARA principle). In the adulteration incident, where Sudan I had been added deliberately and illegally, a zero level of Sudan I was achievable, hence those products had been withdrawn. However, when present as a by-product of a manufacturing process, Sudan I should be kept as low as reasonably achievable.

15. The Chief Executive went on to remind Board members that, during the earlier spice adulteration incident, the FSA had agreed to be the rapporteur for the EU-wide work on the development and evaluation of the specifications for the EU methods of analysis. This work was progressing well and earlier this month samples of contaminated materials had been sent to those participating in the trials. However, in preparing the test materials, a lack of homogeneity had been identified. As a result, consideration was being given to the drawing up of a sampling protocol for the future testing of contaminated material.

Contamination of Allied Bakery Products

16. The Chief Executive informed Board members that the FSA had been notified of the deliberate contamination of products made at the Allied Bakeries' Orpington plant, which supplied the south east of England. No other plants were involved. The police had been carrying out a covert investigation for some time, but recently the type of contamination had changed from readily identifiable, unpleasant but non-hazardous objects (such as chewing gum and pieces of paper) to more serious contaminants such as drawing pins and sewing needles. Hence the company had issued a press notice warning consumers to be vigilant if they were purchasing Kingsmill sliced loaves in the south east of England. The company had declined interviews with the media and the FSA had taken these opportunities to inform the public. Board members suggested:

• that consumers in the local area should be reminded to check loaves that they might have bought earlier and then frozen
• that in this situation, parents should be especially careful, for example when making sandwiches for children

and asked the Executive to consider how best to get these messages across.

17. The Chief Executive noted that, although there had been five reported incidents of needles etc, approximately 2.5 million loaves were made each week at the plant. He agreed to keep the Board updated on any further developments.

Avian Influenza (AI)

18. The Chief Executive informed Board members that the FSA had been assured by the Department for Environment, Food and Rural Affairs (Defra) that emergency plans to contain any outbreak of AI in poultry in the UK had been drawn up. He informed Board members that there was no evidence that AI could be contracted by humans through the consumption of an infected bird. He noted that those most at risk of contracting the virus were likely to be farm workers in close contact with live infected birds affected by the highly pathogenic form of the disease. He advised Board members that there were two strains of the flu, one virulent and one more benign. The highly pathogenic strain was easier to identify, because the affected birds became ill and died very quickly. Birds that had not already died would be slaughtered on farm, and would not enter slaughterhouses or the food chain. The less virulent form was more difficult to identify because the affected birds just became unwell.

Antibiotic Resistant E. Coli

19. The Chief Executive advised Board members that there had been recent press reports of an antibiotic resistant form of E. Coli entering the country through imported foods. He noted that there was no evidence to support this but that the FSA would be consulting the Advisory Committee on Microbiological Safety in Foods about the potential for this organism to be transported in food and the likely level of any associated risks.

Item 5 - Food Supplements Directive: Maximum Safe Levels of Vitamins and Minerals in Supplements (FSA 05/09/02)

20. The Chair welcomed Clair Baynton and Diane Benford to the table.

21. Clair Baynton introduced the paper. She reminded Board members that the Food Supplements Directive had been agreed in 2002 and had been applied across Member States since 1 August 2005. The Directive listed vitamins and minerals, and different forms of these, which could be used in food supplements in the EU and included provision for setting maximum levels.

22. By way of background Clair Baynton advised Board members that:

• in the UK, the Expert Group on Vitamins and Minerals (EVM) had published a report in May 2003 on safe upper levels for vitamins and minerals, which the Board had previously discussed
• the European Commission's Scientific Committee for Food (SCF) and more recently the EFSA had also been considering safe upper levels (SUL) for vitamins and minerals and a number of opinions had been published over the past 5 years
• the approach taken by the EVM had been based on an assessment of the available toxicological data on each vitamin and mineral and estimates of dietary intake of UK consumers obtained from the National Diet and Nutrition Survey (NDNS), taking into account those who consume high levels of vitamins and minerals in their diets. The EVM recommended SUL or guidance levels for both total nutrient intake and supplement intake
• the SCF and EFSA had also used toxicology data to establish SULs applicable to total nutrient intakes comparing the known intakes as well as comparing levels in different Member States where this information is available. Unlike the EVM, they had not distinguished between dietary or supplement use unless there had been a specific concern about the supplement
• although data was available on SULs, the challenge would be agreeing harmonised levels for vitamins and minerals across Europe given the variation in diets between Member States and the different attitudes to food supplements

23. Clair Baynton asked the Board to agree that the FSA's advice to Health Ministers on the setting of maximum safe levels of vitamins and minerals in food supplements in EC legislation should be that such levels should be based on scientific risk assessment, and then to consider which of the three proposed options the FSA should recommend as the UK policy objectives.

Option One
Proposed that a level could be established across the EC based on an overall amount determined by EFSA taking into account the highest dietary intake for each vitamin and mineral across Member States. The benefit of this option was that it would be in line with the single market intention behind the Directive. For some Member States, where supplements containing higher levels of vitamins and minerals were already on sale, the agreed level might restrict consumer choice

Option Two
Proposed establishing a level that could be used in trade across the EC but which took into consideration that consumer choice might be restricted in some Member States. A two tier approach was therefore proposed where, in addition to the level established for trade across the EC, separate levels could be set in individual Member States. The benefit of this option was that trade would be permitted across the EC and consumer choice in the UK would be increased above that provided in Option One. However, products currently on sale in the UK where a single dose exceeds the overall maximum level would not be permitted.

Option Three
Followed the same approach as Option Two, except single dose supplements that exceeded these levels would be allowed to be sold at the discretion of the Member State provided they carried additional advice on the possible side effects of high doses. This approach recognised that taking of supplements was a matter of personal choice. This option provided the UK consumer with an equivalent situation to the current market.

24. The following issues were raised in discussion:

• The paper did not discuss the issue of safe levels for children; how much was known about safe levels of dosage for them? Diane Benford accepted that this was a difficult area and that little research had been undertaken in this area. She noted that in some cases children could have higher nutritional needs as they were growing
• It was acknowledged that, regardless of the limit set, if a consumer wanted to take a higher dosage they could either do so by purchasing a high level single dosage from another source (e.g. internet sites) or by taking multiple lower dose pills. It was important to ensure that appropriate advice could be made available to consumers
• There needed to be more data on how many high dosage products were available, and what market share was attributable to products that might be affected by one or more of the three options, and what percentage of the population took such products. Clair Baynton suggested that the FSA could explore commissioning a survey to scope these issues
• The side-effects did not seem to be particularly severe although the counter argument was that it would seem perverse in some respects to be arguing for a policy that allowed consumers potentially to harm themselves by taking single high dosage supplements. Diane Benford noted that there was no direct evidence that people were being harmed but those taking very high doses might be at risk and the FSA had a duty to advise them
• The arguments did not appear to take into account the range of diets within the UK, such as the minority ethnic groups, and the increasing occurrence of so called 'fortified foods'. Nor did they reflect potential extra requirements, for example during pregnancy and old age. Diane Benford explained that data from the NDNS, through which many of the intake assessments had been informed, did allow many of these factors to be taken into account
• The complexity of the situation should not be overlooked. The recent advice published on vitamin A illustrated the challenge communicating the potential risks might pose
• It was noted that in setting SULs the remits of the EVM and the EFSA committees were different. Diane Benford noted that this reflected the different terms of reference and that the texts of their opinions were actually very similar. She added that failure to use the EVM advice might lead to an over precautionary approach

25. The Chair asked Board members which option would be most appropriate for the Executive to pursue. The following comments were made in discussion:

• The current situation provided consumers with the freedom to choose, Option Three maintained that choice but ensured that consumers were informed about the potential risks
• There was no evidence that Options One or Two would disadvantage the consumer and there was a need to ensure consistency when introducing new legislation. Currently the dangers of exceeding the SUL for some fat soluble vitamins was not fully understood, although recent data on risks associated with high Vitamin A intake was clear. Option Three may imply to some consumers that exceeding SULs of these types of supplements was safe
• There was no guarantee that the UK would be able to influence the European Commission and pursue Option Three to a successful conclusion. The Chief Executive noted that no proposals had yet been received from the Commission. There were precedents for national considerations to be taken into account and derogations allowed. However, he accepted that a coherent case to underpin the proposal for a two tier system would be needed

26. The Chair summed up noting that:

• the majority of Board members preferred Option Three. However it should be noted that this was a novel regulatory approach and that robust arguments would be needed to support it
• Option Three would ensure there was an opportunity to provide consumers with advice on adverse effects
• due to the variability in people's diets (in the UK between age groups and communities, and between EU Member States) there was less attraction in taking into account the levels of vitamins and minerals contributed by the diet
• the process should be kept under review in the light of fresh evidence
• a survey should be undertaken to provide a better evidence base in relation to market share
• further research should be undertaken to identify intakes through the diet for consumers, including children

Action: Clair Baynton

Item 6 - EU Regulation on Official Feed and Food Controls – Application in the UK
(FSA 05/09/03)

[Prior to the discussion of this item Michael Gibson declared an interest as a primary producer and butcher. The Chair, with the agreement of the Board, considered that this was not a material conflict of interest and that Michael Gibson should participate in the discussion and determination of this issue]

27. The Chair welcomed Catriona Stewart to the table to introduce this paper.

28. Catriona Stewart explained that the paper was concerned with the application in the UK of the feed and food elements of the new EU Regulation on official controls. This EU Regulation was different to the generality of feed and food law that the FSA dealt with as it sets out requirements not for feed and food businesses but rather for the competent authorities and the enforcement authorities responsible for organising and undertaking enforcement checks of businesses.

29. The regulation was directly applicable in the Member States and for the most part consolidated existing rules for controls set out in sector specific legislation. It also updated these rules and extended them in some areas such that adjustments were needed to UK enforcement arrangements to ensure that these were consistent with the new Regulation. The paper provided a summary of the range of proposed application measures including both legal and administrative measures.

30. The Chair noted that the Board was being asked to agree the proposal and the approach as a basis for seeking Ministerial agreement. She drew the Board's attention to the analysis in appendix C of the paper, and asked Board Members whether they had any concerns with any of the analyses or recommendations.

31. The Chair noted that no concerns had been raised and that the Board was content with the proposal and the approach as a basis for seeking Ministerial approval. She drew Board members' attention to paragraph 5 of the paper, which set out the potential risks.

Item 7 - Consultation by the Department of Trade and Industry on Proposals for the Formation and Functions of a Consumer and Trading Standards Agency
(FSA 05/09/04)

32. The Chair welcomed Steve Wearne to the table to introduce this paper.

33. Steve Wearne explained that the regulatory landscape had changed considerably over the past few months and was continuing to change. There had been a number of developments, including proposals for forming new national thematic regulators which, in themselves, could change the balance between central and local enforcement agencies. One of the main drivers of this change was the implementation by Government of the recommendations of the Hampton review . One of the most significant recommendations was for the establishment of a new Consumer and Trading Standards Agency (CTSA), for which the Department of Trade and Industry (DTI) had now issued proposals for public consultation.

34. He noted that the paper focussed on the functions proposed for the CTSA that had potential direct impact on the FSA. These were:

• consistency of inspection and enforcement by the Trading Standards service
• a co-ordinated performance framework for the Trading Standards service
• priority setting for Trading Standards

35. He further explained that the Executive was not proposing a way forward, but had summarised each proposal and identified the risks and benefits for each and was asking the Board whether the FSA should formally respond to the consultation on the proposals, and seeking a steer on the issues that should be covered in that response.

36. The Chair reminded Board members that they had been briefed on this topic at the closed meeting on the 14 September. This briefing had included confidential information about our understanding of the positioning of other organisations.

37. The discussion was broken into four distinct areas:

• Responding to the public consultation
• Consistency of inspection and enforcement
• A co-ordinated performance framework
• Priority setting

Responding to the public consultation

38. On the question of whether the FSA should make a formal response, it was agreed that:

• there should be a response, which should take into account and reflect the FSA�s initial response to the Hampton review
• the response from the FSA should remain high level and strategic as many details, including the position of the devolved administrations, were yet to be resolved

Consistency of inspection and enforcement

39. On the question of consistency of inspection and enforcement, the following points were raised in discussion:

• option 3 envisaged the CTSA taking on some of the current role of Local Authorities, which raised concerns regarding the potential loss of local expertise
• the consultation document presupposed that centralisation automatically brought about consistency, but experience of centralisation in other spheres indicated this was not always the case
• the Hampton report had noted the inconsistency of funding of the Home Authority Principle , but there was no discussion in the proposals of whether, if the funding issue were resolved, the current system would deliver what all stakeholders sought

40. In summarising the discussions on this second area, the Chair noted that:

• the Board on the whole favoured option 2
• if funding to deliver the Home Authority Principle was the issue, then this should be addressed directly
• the model of separating policy from enforcement had served the FSA well, and our experiences might inform proposals for the CTSA
• there were issues pertinent to the devolved countries that were yet to be resolved

A co-ordinated performance framework

41. On the question of a co-ordinated performance framework for the Trading Standards Service, the following comments were made in discussion:

• the FSA had, through considerable hard work, developed a robust Local Authority performance framework that worked. There was now the danger that this could get subsumed into a larger framework, which might not be as effective
• there was a risk, in attempting to co-ordinate the work in this way, that the administrative burden on Local Authorities could be considerably increased, which would appear to be against the spirit of the Hampton review
• there needed to be a framework which would smooth out inconsistencies between Local Authorities and provide minimum standards

42. In summarising the discussion on this third area, the Chair noted that the FSA�s response to this consultation should:

• draw heavily on the FSA's experience of making powers analogous to those proposed for the CTSA work in practice without being burdensome and overbearing
• emphasise that a collaborative and outcome focussed approach worked best
• ask what organisational evidence underpinned DTI's proposals

Priority setting

43. On the question of priority setting for Trading Standards, the following points were made in discussion:

• the FSA should not object to a collaborative approach to setting priorities but the mechanism proposed for deciding priorities was not consistent with its independence from Ministers
• the response should set out a clear argument as to why independence had benefited consumers and consumer confidence and a further well-developed argument that the CTSA should also be independent
• the response should address the need to consider what would happen if the priorities set were not consistent with FSA priorities to protect consumers

44. In summarising the discussions on this fourth area, the Chair noted that the FSA�s response to the consultation should

• recognise the potential benefits to LAs and the public from co-ordinating priorities for LA regulatory services
• argue that the CTSA should be constituted as an independent body, as this degree of independence would provide benefits for consumers
• note that, if Ministers sought to set priorities that the FSA believed would reduce consumer protection, the Board would discuss the issue at an open meeting, and any subsequent FSA advice to Ministers would be published in the usual way

45. The Chair concluded by noting that:

• the Board had agreed that the FSA should respond to the consultation and that the draft response should be cleared with Board members in correspondence, and the response should be placed on the FSA's website

Action: Steve Wearne

Item 8 - BSE Controls: Changing the over thirty month (OTM) rule – progress report
(INFO 05/09/01)

[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 Chair agreed that this was a material conflict of interest and that Michael Gibson should not participate in the discussion and determination of this issue. Michael Gibson left the table for this item.]

46. The Chair welcomed Alan Harvey, Chris Lawson and Neil Martinson to the table.

47. Alan Harvey explained that the paper was an update on progress since the August Board meeting. He reminded the Board that, in her report earlier in the meeting, the Chair had referred to her letter to the Deputy Prime Minister and he noted that a copy of that letter was attached as Annex A to the paper now being discussed. As well as setting out the FSA's advice, the paper also set out the pre-requisites the Board had identified as being necessary before implementation. He advised the Board he had received assurances that all of these were being taken forward and would be met.

48. He reminded the Board of the Government's announcement earlier that morning that it was accepting the FSA's advice. The Government had also announced that the expected date for the change from the OTM rule to BSE testing was 7 November 2005. The Communication Strategy, included in the paper, anticipated that this date would be the implementation date. Board members were reminded that, at their August meeting, they had been informed that, while a legal coming-into-force date would need to be specified, it would not mean that everything would happen on that first day. The plan was that critical mass, in terms of abattoirs handling OTM testing, would nonetheless be achieved as quickly as possible. Defra had provided assurance that the current OTMS scheme, involving OTM animals being purchased for destruction, would continue alongside the new regime for the time being.

49. Alan Harvey reminded Board members that the FSA's role would be to provide oversight and scrutiny of implementation of the new regime, which would be taken forward by rural affairs Departments. This oversight role would be fulfilled by the Implementation Review Group (IRG), whose draft terms of reference were attached at Annex B to the paper. The Group would report to the FSA Board. Its membership would include one consumer representative and one meat industry representative. It had also been proposed that the MHS should be observers on this group rather than full members as had been originally proposed.

50. The Chief Executive added that, while Alick Simmons (the FSA's Veterinary Director and Head of Meat Hygiene and Veterinary Division) would attend in that capacity, it was considered that a separate non-executive member of the MHS Board should also be included in the membership. Alan Harvey undertook to pursue the identification of a suitable nominee in consultation with the Chair of the MHS Board and the MHS Chief Executive.

51. The Chair thanked Alan Harvey for his introduction and asked for comments from Board members, which are noted below.

• There was agreement that the MHS should attend as observers on the IRG. The question was then raised as to whether DARD should have member or observer status. The Executive agreed to reflect, but it was recognised that while DARD acted as a delivery agent, its presence would be necessary, alongside Defra, because of its policy responsibilities
• The key messages should make clear the continued emphasis on the need for risk-based and proportionate consumer protection, consistently with the risk assessment underlying previous Board discussions and the FSA advice to Ministers
• Considerable work had already been undertaken with regard to engaging consumers and other stakeholders over the past five years. At each stage explanations had been given as to the FSA's position. Further work was now underway, together with other Government Departments, to ensure that the key messages about the safeguards that would be in place and the thoroughness of ongoing BSE controls were made widely available
• Assurance was given that the rule change would not occur unless all the pre-requisite conditions had been met. It was confirmed that, as implementation was taken forward, should the IRG have cause for concern, it should have a duty to alert the Board immediately. The terms of reference of the IRG would be amended to provide for this

52. The Chair summed up noting:

• the Board was content with the progress so far
• the Board had agreed the IRG's terms of reference, subject to the necessary amendment
• that the Board would be alerted immediately in the event of serious problems being encountered with implementation
• membership of the IRG would now be finalised in the light of the Board's conclusions

Action: Alan Harvey

Item 9 - Reports from Chairs of Advisory Committees
(FSA 05/09/05, FSA 05/09/06, FSA 05/09/07)

53. The reports from the Chairs of the Advisory Committees were noted and the Chair invited the Chairs of the Advisory Committees to comment on their reports

54. The Chair of the Scottish Food Advisory Committee informed the Board that the open meeting due to take place in October had now been moved to November in order to involve as many stakeholders as possible.

55. The Chair of the Northern Ireland Food Advisory Committee (NIFAC) informed the Board that the Minister had agreed the two new members of NIFAC – Dr Alexandra McGarel and Professor Jack Pearce. The process to replace a further five members in 2006 was now starting.

56. The Chair of the Welsh Food Advisory Committee informed the Board that she was currently working on ensuring a smooth handover to the new Chair in the New Year.

Any Other Business

57. There were no other business items raised.

Date of next meeting

58. The next scheduled open meeting would be held in Belfast on 13 October.