European Commission White Paper on Food Safety Memorandum by 18 February 2000 Arpad Janos Pusztai 6 Ashley Park North Aberdeen AB10 6SF In response to the invitation by Sub-Committee D to submit written evidence concerning their inquiry into the European Commission's White paper on Food safety (COM(99)) this is my submission of evidence to the Royal Society of Edinburgh. Is there a need for a European Food Authority? There is a clear need for a European Food Authority with wide powers to monitor the food supply to ensure the health of European consumers. As set out in the White Paper, the food safety policy needs to be based on a comprehensive, integrated "farm to table" policy approach. This can only be delivered by an European Food Authority with the necessary powers to monitor and ensure food safety at every level within this chain of production to consumption. Many of the principles of this approach are set out with admirable clarity in the White Paper. Unfortunately, although the White Paper is full of high ideals, it becomes rather short on concrete details as how to achieve these. In addition, some of the contentious issues concerning the quality, independence, reporting and transparency of the scientific advice and the related issue of the application of the precautionary principle will need considerable clarification. From the information described in Chapter 3 and detailed under Research it becomes clear that "to expand the scientific knowledge base with regard to food safety", apart from a not closely defined but "adequate" financial resource to initiate ad hoc research in response to food emergencies, the Commission envisages that the FSA will rely mainly on the Fifth Framework Programme for Research in which problem-solving R & D projects on food safety are carried out on the basis of multi-annual work programmes as indirect actions (shared cost actions) and direct actions by the Commission Joint Research Centre. Unfortunately, most of the research in the EU, including that in the Fifth Framework Programme is "mission oriented" and set up and run in combination with a near compulsory industrial participation. This, by the definition, reduces choice of topics to that in which the industry is interested and the possibility of more academic, speculative themes can only be second best. Although the EU research programmes are supposed to be pre-market, most industrial partners are less than keen to discuss and share the results of the research generated with scientists not participating in the action or publish them. Accordingly, the science basis of these actions may become too narrow and necessarily restricted for the Community and the FSA to obtain maximum benefit. Independence and transparency It is not very reassuring that the Commission will only in future examine the "range of options to ensure that the Authority strikes the correct balance in terms of independence and accountability". In my opinion reliance on an almost compulsory industrial participation raises the real danger that, even if everything is done to satisfy the criteria of transparency, the public may not necessarily see them independent and transparent. Without the provision of a credible mechanism that how a level playing field for all stakeholders can be achieved by giving more details it is difficult not to come to the conclusion that these high ideals may be only words without much substance in them. This is of particular importance in connection with the evaluation of the suitability and acceptability of new foods, including those generated by genetic engineering. In my opinion it is therefore mandatory that a number of academic research programmes should be set up for exploring new methods of genetic transformation of both plants and animals and for the evaluation of their safety without industrial involvement. There is an urgent need to establish robust and transparent scientific methods for both health and environmental risk assessments. If it stretched the financial resources of the Commission, it might be necessary to use a part of the ad hoc funds at the disposal of the FSA for such a purpose. Indeed, it is essential that this part of the programme is proactive and not simply a response to food emergencies. There is already an emergency in the public's lack of confidence and acceptance of GM-food and this will need to be addressed after consultation with interested public groups, religious bodies, consumers by independent EU research work carried out by scientists who are not financed by industry. Their results need to be transparently reported and published if the overall EU objective of improving health protection and restoring confidence in the EU's Food Safety Policy is to be achieved. Excellence Although the selection of the head of the Authority and the quality of the personnel will be of paramount importance in the quality of the operation of the whole FA the White Paper is again somewhat short on detail about the size of the Authority and what sort of specialists they want to recruit. The "revolving door" approach the US FDA is often accused of will have to be avoided if for nothing else but for the sake of transparency. This may not be so easy as not many "suitably qualified specialists" are available, particularly without ties to the food industry. The tasks and flow of information for formulating policy within the Authority Information gathering and analysis needs obviously to be one of the main tasks of the Authority as it is correctly described in the White Paper. However, communication must be a two-way process and it is not clear whether such a mechanism will exist. Moreover, in my opinion it is particularly not clear how the FSA can draw on the results of shared cost actions for formulating their policy. As most of the time it would be regarded unacceptable and even unethical by the scientists doing the research work to use their results obtained in shared cost and other programmes before they are published and/or possibly patented, the delays from the "bench to the FSA" may amount to years rather than days or even weeks. Considerable thought should be given to establish in detail the best and fastest routes of communications between individual scientists, FSA and industry. It is not acceptable only to say that scientific advice "must be provided in a timely and reliable manner to those responsible for taking decisions to protect consumer health" without setting up a reliable and workable mechanism. No Committee has ever come up with a novel idea and therefore the active scientist must be put in the middle of this process. The spatial and temporal distance between the actual scientists generating data in the laboratories and the scientific administrators sitting on the Scientific Steering Committee which coordinates the scientific opinions provided by the Sectoral Scientific Committees needs to be bridged by workable solutions. This is particularly so as the sectoral committee members are likely to spend only a fraction of their time in Brussels. If members of these Committees are chosen "following rigorous assessment of their scientific excellence" the White Paper and the Commission attempts to square the circle unless it is made clear what criteria they will use for defining scientific excellence. When looked at objectively and dispassionately, the only way that a sufficiently close contact can be maintained between working scientists actually providing the data and Sectoral Committee members is if the Committee members are actually the scientific leaders of the groups and/or the heads of the institutions engaged in the work. This will ensure that both of those directing and also the directed scientists can keep each other "in the picture" and have a smooth and instant flow of information between between them that is necessary to directly channel the information from the bench to the Scientific Steering Committee. Clearly, this is the only way acceptable to the individual working scientist in which the necessity of publishing his/her data can be reconciled with releasing them in confidence to the FSA and to be used for policy making without undue delays. Unfortunately, this will expose members of the FSA and the Committees to the possible accusation of corruption that by "sitting close to the fire" they channel most of the research money to their own Institutes. It is therefore imperative that democratic accountancy is built into the system with frequent, not less than 3-yearly, scientific evaluation of the working and effectiveness of the Sectoral and Steering Committees and the Institutes under their direction/leadership by ad hoc Committees consisting of outside and unconnected eminent scientists. My summary responses to the Objectives of a European Food Authority: * Within the provisions of the White Paper the guidelines are not sufficiently well- thought out and do not guarantee that the FA will "be guided by the best science". The heavy reliance on the Fifth Framework shared cost actions, particularly as the compulsory industrial participation in them narrows their scientific scopes. Moreover, most of the scientists in these programmes are connected to and financed by industry. The lack of clear routes of scientific communication between the Authority and the individual scientist will make it impossible for the Authority to draw on up-to-date and unpublished scientific information and data leading to unacceptable delays in their actions. * As it is envisaged in the White Paper, the Authority will have difficulties to "be independent of industrial and political interests". What is even more important it will not be seen as such by the public if the guidelines in the White Paper will be put in practice. * There is no mechanism decribed in the White Paper for the Authority how to "be open to rigorous public scrutiny". * This will depend on the quality of its personnel and how they can obtain the best scientific advice from working scientists, particularly as this flow of information is not guaranteed by within the provisions of the White Paper . * Hopefully, this may be achieved, particularly if rivalries can be avoided and proper routes of lines of communications can be set up. Unfortunately, the White Paperis rather short on detail as how to achieve these. Finally, one of our main principles which ought to override all other considerations: no effort should be spared to try to avoid that the European Food Authority will turn into an unwieldy, massive, bureocratic and non-democratic institution rubber-stamping the sometime questionable actions and activities of the industry and political lobbies. ??