Select Committee on European Union Seventh Report


PART 2: WITNESSES' VIEWS AND THE COMMITTEE'S OPINIONS

Status, structure and powers of the Authority

STATUS, STRUCTURE AND ACCOUNTABILITY

41. Various options for the status and structure for the Authority were proposed in the James et al Report.[20] The Commission has followed the report's recommendation in favour of an "interinstitutional office"—a body with a legal existence and personality separate from the current Community institutions, with a status similar to that of the European Anti-Fraud Office (OLAF) (White Paper, paragraph 39). Professor James pointed out that full equivalence to OLAF could not be achieved without major legislative change, and that the Commission was focusing on what could in practice be achieved in the immediate future (Q 18). Other models considered were: (i) an improved scientific analysis capability within a Commission directorate general (the basis of which has been partially—or in the opinion of some witnesses sufficiently—achieved by the reorganisation of the old DG XXIV into the new DG SANCO, with transfer of responsibility for the relevant scientific committees (see paragraphs 6 and 62); (ii) a separate Commission service reporting to the "SANCO" Commissioner; and (iii) an independent agency, such as the European Environment Agency or the European Agency for the Evaluation of Medicinal Products (EMEA).

42. Professor Lang suggested that for the EFA to work well, it must have the following features: "an independent board, independence from the food industry, an independent scientific base, a policy of openness, new blood in the staff, clear and revisable principles of working, routine dialogue with consumers, a long-term and clear strategy, and consistency" (p 34). CEG did not think that paragraph 41 of the White Paper, despite its heading ("Independence"), adequately addressed the question of independence. Besides the features mentioned by Professor Lang, they would wish the EFA's board to include members with consumer and environment backgrounds, which in this respect would make the Authority more akin to the UK Food Standards Agency than an agency of the Commission. Appointments should be ratified by the European Parliament (p 63). Ms Jeanette Longfield (Sustain) suggested that the EFA's governing body should have representation from relevant environmental and public health units from within the Commission, in order to institutionalise the close links which the Authority needed to maintain with the various Commission services (Q 134).

43. Dr Caroline Jackson MEP argued strongly that the EFA should be accountable to the Parliament: "it remains very much the creature of the Commission, but in such a sensitive field MEPs will be very interested in a continuous dialogue with it, and will want to insist on a degree of democratic accountability....In so far as the new Authority gathers together the existing scientific committees, MEPs would, in the name of openness and accountability, expect to have a much more open and frequent dialogue with them than has been the case so far." She referred to the Parliament's right to nominate two board members of the European Environment Agency, and considered that it should have a similar power in relation to the EFA.[21] CA was of the same view: "it is important...that the Authority is ultimately accountable to the European Parliament and to Member States" (p 94).

44. Commissioner Byrne told the Sub­Committee that, in addition to the EFA's board (the composition of which remained to be decided), he had in mind the establishment of a consultative committee made up of heads of national agencies and their equivalents. He agreed it was essential that the EFA enjoyed the full confidence of the European Parliament. It might be appropriate to build in a requirement for the chief executive of the Authority attend plenary sessions or meetings of the relevant committee to give a report (which he suggested should be annual, rather than more frequently, although that would be for negotiation) and to answer questions. He did not feel it would be appropriate for the EFA to have to answer to the Parliament on specific assessments, as opposed to general systems; nor did he favour the Parliament being given powers to requisition work from the Authority and its scientific committees (which he felt would be "unwieldy"). Only the Commission and the Authority should have powers of initiative, although there was no reason why the Parliament could not ask the EFA to initiate actions. He added that Members of the European Parliament were only part of the EFA's constituency—"it would speak direct to the people".[22]

OPINION

45. We do not disagree with the Commission's choice of institutional status for the EFA, which we think is consistent with the necessarily close relationship between the Authority, DG SANCO and other Commission directorates-general. We note the various suggestions that have been made about board membership and other management arrangements. These are not dealt with in the White Paper and we do not feel it is necessary to express a view at this stage, except to say that if the Authority is to acquire a reputation for independence and authoritative science, the membership of its board and committees, and its management structure and style, must be such as to command the confidence of the whole spectrum of interests concerned with the food chain, including consumers and environmental groups.

46. We agree with MEPs that close links, both formal and informal, between the EFA and the European Parliament are essential to support the Parliament's role as co-legislator with the Council, even if that stops short of formal accountability, and that the Parliament and its committees should have the right to call in representatives of the Authority to assist them in their deliberations. It is important that the Authority should develop its relationship with the Parliament in a positive and constructive manner, and avoid the kind of reactive stance which is sometimes a feature of the Commission's dealings with MEPs.

FORMAL POWERS

47. As paragraph 33 of the White Paper acknowledges, the EC Treaty would not, unless amended, permit the Authority to be given risk management, i.e. regulatory, powers. The proposal therefore is for an independent, advisory body, without regulatory or enforcement powers, which would be retained by the Commission and Member States. On a number of occasions (e.g. at the launch of the White Paper on 12 January 2000 and in an address to the European Parliament on 18 January) Commissioner Byrne has reiterated the Commission's view that it is "neither appropriate nor feasible" to devolve risk management to the Authority, believing that decisions in the risk management area "should properly remain the preserve of the Commission, Parliament and Council, exercising fully democratic and accountable prerogatives". In view of the European Parliament's enhanced role in the legislative process following the Amsterdam Treaty, he felt that to give a risk management role to the EFA at this stage (emphasis added) would be a "retrograde step" and mean "dilution of democratic accountability".[23] We discuss the division of responsibility for risk assessment, communication and management in paragraphs 79-93.

48. Witnesses who were not wholly opposed to the EFA in principle did not in the main dissent from the Commission's choice of institutional structure, or at least had no strong views, and most accepted (or positively argued) that the Authority's role should be essentially advisory; enforcement and infraction proceedings should be left to the Member States and the Commission (e.g. BRC, FDF, the Dairy Industry Federation and LACOTS/LGA, pp 42, 72, 96, 104). Both Monsanto and Novartis, however, argued that the EFA should having binding decision-making powers, e.g. in relation to safety evaluations of biotechnology products and regulatory compliance of commercialised products (pp 107, 110). The British Hospitality Association felt that to give the EFA regulatory powers would put it in conflict with national agencies; without such powers, however, there was little to justify the EFA as a free-standing body, and (in common with the Provision Trade Federation) they would prefer its proposed functions to be kept within the Commission (pp 87-8).

49. The Association of Public Analysts argued strongly for a wholly independent authority, with executive and regulatory powers along the lines of those of the UK Food Standards Agency and answerable to the European Parliament. The Association was reluctant to see the EFA established as a purely advisory body and therefore felt that amendment of the Treaty was essential (p 83). Novartis felt that the model of the United States Food and Drugs Administration (USFDA) deserved careful examination (p 112). Scientists for Labour felt that the White Paper fell far short of expectations raised by President Prodi that the EFA should be modelled on the USFDA: with a purely advisory role, the EFA risked having its advice ignored by national governments. They recognised the political constraints, but argued that the Authority should at least be given adequate resources to develop safety criteria and to carry out inspections to ensure compliance with regulations (p 117).

50. Professor Lang, whilst conceding that other countries' experience of food agencies and policies could be valuable, said he would be wary of borrowing directly. In particular, he disagreed with those who favoured the USFDA as a model, though felt the EFA could usefully draw on the US Centers for Disease Control (CDC) in Atlanta and on the joint Australia-New Zealand Food Authority[24] (QQ 111, 114; p 35). Professor James felt that the CDC could point the way to a system of health and nutrition data gathering which Europe at present lacked (Q 5).

OPINION

51. Without ruling out the possibility of future Treaty change, we accept that for the present the EFA should not have formal powers of regulation and enforcement. In any case we would regard it as politically unrealistic to propose giving such powers to a relatively unknown quantity such as the EFA, which has yet to emerge as a firm legislative proposal before it can even start to build a track record which might justify entrusting it with more powers. This can only serve to underline the inescapable responsibilities for enforcement which lie with the Council, the Commission and the Member States.

52. The EFA's activities should therefore reinforce and add distinct value to the way in which the Commission and Member States apply their own powers of regulation and enforcement, paying particular attention to the need to achieve consistency across the EU. The Authority's role would thus go further than simply collecting, monitoring and publishing data, in that it would make a direct input to risk management and policy-making by virtue of its scientific expertise and through its freedom to give independent advice to the Commission on its own initiative.

Role and scope of activities

A PROACTIVE ROLE

53. Even when it is accepted that the EFA should not have regulatory or enforcement powers, a number of questions arise on the range and scope of its advisory role, and how they are to be organised. Among those witnesses who favoured the establishment of the EFA, there was general agreement that its role and activities should include taking a strategic overview of food safety issues, acting as a centre of scientific excellence, resolving scientific disputes on objective criteria, co­ordinating and commissioning of research, advising the Commission and Member States, making proposals for new policy initiatives, monitoring developments and practices throughout the EU and advising on their effectiveness, and actively and openly communicating its findings to the Community institutions, national and local authorities, industry, the professions, non-governmental organisations (NGOs) and the general public. In Professor Lang's words, it should have "a total food chain remit" (Q 119).

54. The White Paper (at paragraph 50) says that "the Authority will be expected to take a proactive role in developing and operating food safety monitoring and surveillance programmes", and Commissioner Byrne has said on several occasions that he envisages the EFA having "a comprehensive information gathering and surveillance function".[25] BEUC commented that too much of the available information about what went on in Member States was anecdotal; the EFA could therefore play a valuable role in pulling it together on a consistent basis. In order to carry out monitoring and surveillance effectively, the EFA might need an express power to require the production of data, although it would be premature at this stage to argue for a Treaty change for this purpose. Dr Caroline Jackson MEP suggested it was necessary to ask the question—if only to expose an issue which the White Paper failed to address—whether the EFA should have powers of entry and inspection itself.[26]

55. The need for standardisation of scientific approaches and statistical methodology was stressed by the Royal Society of Edinburgh (p 115). The NFU considered that ensuring harmonisation of food safety standards and thereby their consistent enforcement across the EU should be the main purpose of the EFA (p 55). Both CEG and Novartis suggested that the EFA should be given specific responsibility for advising when the degree of scientific uncertainty warranted the application of the Precautionary Principle (pp 63, 111) (see paragraphs 85 and 87). Novartis saw EFA as a potentially useful forum for systematic involvement of stakeholders—regulators, consumers and producers (p 111).

56. The Soil Association stressed the need for the EFA to adopt a proactive approach in identifying potential dangers to both public health and the environment and in developing viable alternatives for producers, strongly advocating a strategy for tackling food safety issues through agricultural policy rather than regulation. It feared, however, that elaborate and expensive inspection, monitoring and surveillance networks across the EU might adversely affect small and medium-scale food producers, many of whom used organic methods; it cited the recent regulatory changes affecting small abattoirs as an example of what could happen (p 118-9).

57. The view that the EFA should not simply be a source of advice, to be consulted as required, but should be able to make recommendations on its own initiative was expressed by several other witnesses. For example, CA said it was essential that the Authority could "determine its own mandate and pursue areas which it considers to be problematic without direction coming first from the Commission in its role as risk manager. Without this flexibility it is extremely unlikely that the strategic approach and rapid response...can be achieved" (p 93). It followed from this that the Authority must have access to the information which it needed for preparing its advice and opinions, with the right to require the production of data, even if it did not have formal powers to enforce its requests. The Commission's own powers to insist on reports and data from Member States under the various EC Directives could be used to back up the EFA's needs.

58. Commissioner Byrne confirmed to the Sub­Committee that it was essential for the EFA to be provided with all relevant data on which to frame its advice and opinions. It would have the right to ask for any information it needed for this purpose, and it would be the Commission's function to ensure that the information was available—if necessary by insisting that Member States provide it.[27]

OPINION

59. It is most important that the EFA should be proactive in offering advice and in recommending action, based on its assessments of the adequacy of systems in place in the Member States. The need for better and more consistent implementation, enforcement and monitoring of food safety laws has been stressed by many witnesses; and to this end Chapter 3 of the White Paper emphasises the importance of a comprehensive and effective EU-wide monitoring and surveillance system. The precise role of the EFA is not clearly spelled out. Enforcement would not be a function of the Authority, as currently envisaged, but it could highlight failures to enforce. In order to do so, it would depend on having an adequate information (and indeed audit) system into which it could tap.

60. The White Paper expressly states that the EFA is to have an information system but does not clarify how that information system is to work. The surveillance system envisaged by Commissioner Byrne implies either an independent mechanism for collating data (which would be disproportionately expensive) or that the EFA should have access as of right to Member States' surveillance schemes, with a particular responsibility for integrating and assessing data. We favour the latter option, and would add that the Authority must be in a position to obtain relevant data from Member States, backed as necessary by the Commission's own powers to require the production of information.

61. In this context, the EFA's credibility will depend on the Commission's willingness to act on its advice and to ensure proper enforcement; otherwise the Authority will be seen as being somehow responsible for the Commission's failure to act. The White Paper proposals do not provide an adequate response to the complaints about inadequate and inconsistent compliance with food safety requirements across the EU. We recommend that when the Commission brings forward its proposals for establishing the EFA it should specify precisely how surveillance is going to be conducted on a Community-wide basis and how the EFA is going to play its part in assessing compliance with food regulations, either directly or via the Food and Veterinary Office.[28]

"THE SCIENTIFIC POINT OF REFERENCE FOR THE WHOLE UNION"

62. Paragraph 116 and the concluding passage of the White Paper's executive summary state the Commission's belief that "the establishment of a new Authority, which will become the scientific point of reference for the whole Union, will contribute to a high level of consumer health protection, and consequently will help to restore and maintain consumer confidence". In common with all the witnesses, we see this as perhaps the most important aspect of the Commission's proposals. The recent and continuing reorganisation of DG SANCO and the ideas explored in the James et al Report are particularly relevant (paragraph 6).

63. The FDF felt that the EU system of scientific committees, assisted by an expert secretariat, whether or not forming part of a new authority, should be the only source of scientific opinion and risk assessment for the Commission. It could draw on information from any appropriate sources, but should itself be the judge of its admissibility and be answerable for the resultant opinion (p 74). Professor James suggested that part of the EFA's added value would lie in its ability to resolve differences between experts in different Member States, and that this could help the process of levelling up, rather than levelling down, of standards (Q 7).

64. The need for transparency, impartiality and independence was stressed throughout the evidence, for example by CCFRA (p 90), BMA (p 89) and the Royal Society of Edinburgh (p 115) and all those who gave oral evidence. CEG and the Soil Association suggested that, in order to preserve the EFA's objectivity and independence, it was critical that any research submitted to the Authority (or to other bodies carrying out food safety analyses) should clearly identify the persons engaged in the research, with details of their qualifications, funding and any affiliations with the pharmaceutical, food or biotechnology industries (Q 213, pp 63, 120). Ms Wheatley suggested that it was important to keep the licensing of veterinary products separate from surveillance of adverse effects (pp 121-2).

65. The White Paper's twin aspirations of independence and excellence would not, in the FDF's view, be met if "independence" was interpreted in way that excluded the relevant expertise of industrial scientists—a view that was echoed by Novartis (pp 74, 112). CEG agreed that since much of the leading scientific expertise in food technology resided in the food industry itself, it was appropriate to take full account of it, subject to the safeguards outlined above (Q 213, p 63). CA and Professor James, among others, suggested that, in order to ensure the highest quality and the right balance of expertise, it might be necessary in some areas to appoint scientists from outside the EU. CA also stressed that committees should be provided with relevant data and that there should be an effective peer review system (Q 20, p 95).

66. The Co­op considered that the scientific committees should be the core of the Authority, which should ensure that each committee allocated appropriate amounts of time to relevant areas of work. It was unsatisfactory that, according to paragraph 25 of the White Paper, so many of the committees' opinions since the internal reorganisation had been evaluation of individual substances; a proactive, five-year rolling programme was needed (p 49). BEUC pressed for greater transparency in the committees' proceedings, arguing that all data provided to them and all submissions by them to the Commission and Council should be published. Mr Coleman (Director-General SANCO) confirmed that committees' reports and the data on which they relied, together with the formal minutes of their meetings, were published; but argued that publication of working papers and notes of discussions would be counterproductive and inhibit their proceedings. He found the criticisms of lack of transparency difficult to understand; complainants needed to be more precise.[29]

67. CA suggested that it would help to ensure transparency if there were consumer representatives on the scientific committees (pp 93, 95), although this was doubted by BEUC, who felt it would create pressure for parity of representation from industrial interests. CEG pointed out that relations with national scientific advisory committees were also important. In the experience of CEG members serving on UK national scientific advisory committees there was a lack of openness between the Commission and the national committees; the result could be duplication and poor co­ordination of scientific work (p 64). FDF felt that many of the shortcomings of the existing arrangements for scientific advice were due to inadequate resourcing of the secretariat and administrative support services for the committees, which the Commission could remedy without the need to create the EFA (Q 251).

68. Professor Raymond Baker, Chief Executive of the Biotechnology and Biological Sciences Research Council (BBSRC), stressed the importance of ensuring that proper use was made of UK scientific expertise through the EU advisory committees. He and Dr Gasson (Institute of Food Research) felt that there was scope for closer interaction between national and EU committees on regulatory issues and that this would have the same beneficial effect in accelerating scientific advance and international co­operation as EU-funded research programmes (QQ 68, 80, 90, 94). Mr Barti Synge (Scottish Agricultural College) added the comment that the experience of scientists, such as those of the College, who were directly involved in technology transfer though the provision of advice to farmers or the food industry, could enhance the value of interaction with expert committees, in terms of more informed research programmes and better communication to the "coal face" (Q 84). Professor Baker's response to the question whether he thought that the BSE crisis might have been handled better if the EFA had already been in existence was that the Food Standards Agency would have had much more impact than a European Authority, because of the high level of national competence and the fact that the problem was, at the time, confined to the UK. He felt the UK should be cautious about ceding national protection arrangements to the EFA (Q 97).

69. Commissioner Byrne said that he hoped that the proposed consultative committee (paragraph 44) would help to reinforce the climate of co­operation between the Authority and the scientists in Member States and their national agencies. He was determined, however, that the EFA should be the "single voice" on food safety for the EU. He did not wish to see it second-guessed by Member States' agencies. He believed that a lot of the complaints about lack of transparency stemmed from an under-informed press, and assured the Sub­Committee that there was no ethos of secrecy in the Commission.[30]

70. Professor James said that the term "scientific point of reference" had no meaning except on the basis of accumulated experience (Q 20); Professor Lang thought that the history of other agencies suggested it would take time—even 20 years or more—for the new Authority to establish a reputation for scientific excellence and to win the confidence of Member States, national agencies and consumers (Q 110). Mrs Pauline Green and Mrs Freida Stack said it was because of the time it would take for the EFA to build up trust and confidence that the Co­op favoured a relatively small institution, focused on risk assessment, but with a remit broad enough to allow the Authority to look at emerging issues across the spectrum of the food chain (Q 178).

71. Professor James was asked (as Specialist Adviser) what characterised success in organisations of the kind envisaged. In his opinion the only two bodies that stood out in the eyes of the international community were the Swedish National Food Administration and the USFDA. It was clear however, from statements by Commissioner Byrne[31] and others, that the Commission was cautious about the FDA—despite its apparent transparency, authoritative and usually extremely comprehensive scientific analyses together with the huge flow of information—perceiving it as deficient because it was part of the US administration, with politically appointed leaders and answerable to the executive for both the analysis of risk and its management.

OPINION

72. From our consideration of the evidence, we can identify at least six major deficiencies in the current arrangements for scientific advice:

(a) There is no formal interactive process between the Commission's advisory committees and Member States' own expert committees;
(b) There is no formal responsibility for transforming their highly technical reports into meaningful statements for communicating to those other than fellow experts;
(c) There are no formal mechanisms for obtaining and analysing data from Member States; the committees' risk analyses are therefore often theoretical and do not deal with risks that occur in practice;
(d) Although the outcomes of committee analyses (i.e. reports, minutes etc) go on the internet, there is no mechanism for routine involvement with either public interest or industrial groups.
(e) There is minimal scientific and administrative support for the Commission's committees—so much so that the tasks assigned to the committees at present overwhelm them; even if information flows could be improved, the quality of the committees' scientific analyses would continue to be adversely affected by the other deficiencies;
(f)   As a result, the Commission is not always able to bring in the world's best experts because those experts are deterred by the prospect of being engulfed by demands for instant analyses and lengthy reports.

73. Many of these deficiencies are the subject of discussion elsewhere in this Report. One thing is clear—that the EFA must ensure that it identifies the best science from anywhere in the world. Where competing national views and prejudices obscure the science, the Authority must be able to offer a totally objective view. We do not think that this can be achieved by formally decreeing that, in the event of disagreement, the Authority's opinion should prevail: experience of the BSE crisis suggests that this is unlikely to work. It is more a question of the Authority establishing its reputation as an acknowledged "point of reference"; this will take time and will depend crucially on the quality of the scientists which the EFA is able to recruit for the expert committees and of those to whom it turns for advice externally.

74. To bind all this together a scientific secretariat of the highest calibre is needed within the EFA. This secretariat—which must be properly resourced—should be responsible for co­ordinating and commissioning research from around the world, and would ensure that the Authority's advice was firmly based on a consistent and cumulative corpus of knowledge and expertise.


20   See footnote to paragraph 6 Back

21   See p 103. Back

22   Comments made at meeting with Sub­Committee D. Back

23   Quotations from copies of speaking notes provided to Sub­Committee D. Back

24   For a discussion of these and other models, see Lang, T., Millstone E. and Rayner, M. Food Standards and the State: A Fresh Start, Discussion Paper 3, Thames Valley University, Centre for Food Policy, London, April 1997. Back

25   For example in his speech to the European Parliament on 18 January 2000. Back

26   Comments made during informal discussions with Sub­Committee D; see also p 103. Back

27   Comments made at meeting with Sub­Committee D. Back

28   See paragraphs 101-104 below. Back

29   Comments made at meeting with Sub­Committee D. Back

30   Comments made at meeting with Sub­Committee D. Back

31   For instance, when speaking to the European Parliament's Committee on Environment, Public Health and Consumer Policy on 23 February 2000. Back


 
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