Between Reason and Will: Can Regulation Be Responsive?

Vesco Paskalev Presentation for Workshop Socializing Economic Relationships - New Perspectives and Methods for Analysing Transnational Risk Regulation Oxford, CSLS, April, 2010 In the present paper I will argue that the problem of disagreement is embedded in the structure of rational decision making at a collective level. This was already done by Philip Pettit, who offered a model for collectivising reason. Further to him, I will emphasise that the collectivising reason leads to systematic frustration of popular will, i.e. rationality is always achieved at the expense of democracy (understood as responsiveness to popular will). This problem I term rationality gap. I suggest that there are three ways by which contemporary polities mitigate this structural problem first, by identification with our common reason, second by trust in the decisionmaking authority, and third, by persuasion by scientific arguments. In practice, the three methods are merged into a single rational discourse in the public sphere which eventually aligns (partially) the collective reason and popular passion. Yet, in increasing number of areas and loci of contemporary decision-making, esp. in cases of administrative regulation, none of these happens. When the policy choices are made at a level lower than that of the responsible politicians, and on issues, which are not sufficiently salient to be discussed beyond the specialised circles of stakeholders, an insurmountable rationality gap arises. Paradoxically, the more technical and the less politicised the issue is, the bigger the frustration of popular will is likely to be. I make a case-study of the recent authorisation of a genetically modified potato for cultivation in EU, by a decision-making process which paid particular attention to scientific argumentation, yet the controversy remained and threatens the regulatory regime itself. I suggest that for such cases, where closing of the rationality gap is not possible, we can employ another form of responsiveness, namely inclusion of the stakeholders considerations in the set of premises relevant for the decision.

1. Collectivising Reason
Philip Pettit has offered a way to understand reasoned decision-making by public authorities which I believe to be very useful to understand administrative regulation and which point to a way to solve its difficulties with democratic accountability and responsiveness.1 He identified the following dilemma: when a group of people has to

The core argument is in PHILIP PETTIT & WLODEK RABINOWICZ, Deliberative Democracy and the Discursive Dilemma, 35 Nous (Supplement: Philosophical Issues, 11, Social, Political, and Legal Philosophy) (2001). hereinafter Discursive Dilemma, and PHILIP PETTIT, Depoliticizing Democracy, 17 Ratio Juris (2004). hereinafter Depoliticizing Democracy.
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take a reasoned decision on certain issue there are two possibilities. First, its members can assess the relevant factual premises independently, reach their own conclusions and then, on the basis of these individual conclusions, determine the common decision on the issue. Alternatively, they can assess the premises together, e.g. vote on each of the relevant premises,2 and then, on the basis of the common judgement of the premises, the conclusion is drawn by application of the rules of formal logic (esp. modus ponens). Pettit shows that socially aggregating the conclusion-judgement gives us a different result from socially aggregating the premise-judgement.3 The persistence of the difference between the outcomes of the two processes can be illustrated by the following example. Let us suppose that a panel of three members has to decide on the permission for cultivation of a genetically modified potato and that among them there is wide agreement that there are three relevant premises the availability of which warrants the positive decision. These are P1 whether the GM potato is as safe as the conventional one, P2 whether the potatos resistance to certain antibiotics has no implications to the public health policy and P3 whether there is uncertainty in the laboratory tests made to establish the former two. However members beliefs on each of the premises differ according to the following Matrix 1: Members P1: Potato safe? A B C Collective beliefs: No Yes Yes Yes P2: Potato jeopardising antibiotic use? Yes No No No P3: Science certain? Individual conclusions:

Yes Yes No Yes

No Yes No ?

Apparently there is a majority believing that the two positive premises are present and the one negative is absent, therefore, if the panel decides by voting independently on each of the premises, the potato shall be authorised. However, if the panel does not decide on each of the premises separately, but each of the members makes up his or her own mind whether the potato should be licensed for cultivation or not, there is a majority of individual voters against licensing. Thus, the result in the bottom-right cell will differ depending on whether the mode of decision-

In Pettits examples this determination is done by voting, but the distinction applies to a more general case with other methods like consensus, drawing lots, expert opinion, etc. 3 Discursive Dilemma, p. 273.
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making is premise-centred (PCM) or conclusion-centred (CCM). Indeed, the presence of this contradiction depends on the actual distribution of members beliefs on premises, however in the complex policy-making of today there certainly are sufficient number of cases when various majorities of citizens believe the premises are obtained, yet a majority opposes the decisions which logically follows from these premises.4 Note that the panel may even have the two opposite views in the same time an official collective opinion that the GM potato is welcome, and personal views of all5 members that it is not. I will revisit this state of schizophrenia and the ways to deal with it latter in section 3. The difficult choice between the two processes Pettit calls discursive dilemma and notes that:
going the conclusion-driven way means adopting a course that is inconsistent with the premises endorsed by the group and going the premise-driven way means adopting a course that a majority individually reject. Going the first way means sacrificing collective rationality for the sake of responsiveness to individuals, going the second means sacrificing responsiveness to individuals for the sake of collective rationality. 6

and also:
Let a group individualise reason, and it will ensure responsiveness to individuals in its collective view on each issue but it will run the risk that the views will be irrational. Let a group collectivise reason, and it will ensure the rationality of the collective views maintained but run the risk of adopting a view on one or another issue that is unresponsive to the views of individuals on that issue.7

While advocating for PCM (i.e. collectivising reason in his terms) Pettit acknowledges that in this way responsiveness to individuals wills, (i.e. to their aggregation as popular will), will be obstructed - that is why we have a dilemma. He shows that the contradiction between the results of the premise-centred and conclusion-centred process is logical necessity rather than institutional contingency.

Note that CCM permits for many incompletely theorised agreements (which many consider to be essential for democracy) as it allows to each member to for different reasons (and strike a bargain). The PCM instead is likely to expose and disrupt such agreements. On the other hand, PCM may induce agreements between people who disagree on the conclusions, but share beliefs as per the relevant premises. Arguably this will be the case when the judgement on certain premises is dependent on external evidence. 5 Not in the example given above, yet if all of the premises are positive and cumulatively lead to a conclusion, it is quite possible that every single member is against the conclusion because one of the premises does not obtain, yet a majority is formed behind each of the premises and therefore in PCM the collective adopts the conclusion even though all of the members individually believe the opposite should be the case. 6 Ibid., p. 274. 7 Ibid, p. 277. See also PHILIP PETTIT, Collective Persons and Powers, 8 Legal Theory (2002).p. 450 for a similar restatement of the dilemma.
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There is a trade-off between responsiveness to individual wills and collective rationality, and he accepts that the lost responsiveness is a price worth to be paid for the rationality gains. Pettit actually goes a little further than this and maintains that it is the collective rationality which matters for the democratic self-governance and not the responsiveness to wills formed by individualised reasoning: for people to be empowered in relation to democratic majorities and democratic elites they must be able to ask after the reasons that support the decisions [which is possible] only so far as the democratic bodies in question operate in a deliberative mode8. There must be a commitment in the different arms of government to justifying whatever decisions are taken by reference to the considerations that are relevant.9 Thus, on his account the democracy is a system of government where the branches have good reasons for their actions, and not as government according to the popular will as it is commonly perceived.10 On his republican understanding of freedom as nondomination, citizens should be free from arbitrary interferences i.e. any such interferences must be for good reasons and it matters less whether they implement the will of any majority. Note that this corresponds to the common notion of accountability of the government, i.e. to be able to explain and justify its decisions only phrased differently. This model is in my view suitable to justify the contemporary administrative state, and possibly to avoid the problems of non-delegation doctrine, of lengthy accountability lines, independence of agencies, deference to expertise, etc. This is not to say that all administrative decision-making is done in PCM, probably there are many counter-examples and it is not my goal to pursue that here. Yet, it is apparent that the cannons of judicial review, the requirements to explain and justify, to base decisions on scientific arguments and sound reasons etc, can be understood in terms of ways to collectivise reason (as opposed to majoritarian institutions, which respond to individual preferences). Pettit himself does say anything on administrative law as a way to achieve collectivised reasoning, yet he calls for depoliticization of certain issues and areas of decision-making and emphasises the role of contestatory institutions such as constitutional courts, consultative bodies11 and arms-length appointments12 which are to ascertain governance according to democratically

Pettit equates PCM with deliberative mode of governance but in this paper I will avoid using the latter term. 9 Ibid., p. 282. 10 See the discussion in his Discursive Dilemma, p. 280. 11 An example of such is a depoliticized forum, at arms length from parliament, which can
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offer guidelines on what sort of activities amongst those offending against most peoples moral ideals ought to be legalised . and how they ought to be regulated. This body could represent different sectors of popular opinion and professional expertise and would be able to take a long-term view ., Depoliticizing Democracy, p. 56-7.
12

See Depoliticizing Democracy, p. 63.

persuasive reasons.13 These publicly supported reasons which should ground the decisions in the depoliticized model apparently correspond to the premise-centred decisions in the collectivised reasoning model. On the other hand, empowering majoritarian institutions and CCM are, pace Kenneth Arrow, the same thing. Thus, although PCM, depoliticization and administrative regulation are not identical, they are very closely interconnected. They are all ways to achieve collective rationality, and responsiveness to the individual wills of citizens concerned is not just something well worthy to be sacrificed, it appears to be almost irrelevant. What Pettit initially presents as dilemma is solved, conclusively, in favour of one of the available options. It should be noted, that the discursive dilemma is not another guise of the science/democracy dichotomy that Elisabeth Fisher had persuasively advised us to abandon.14 On the contrary, PCM decision-making model shows how even if individual decision-makers are all informed by science and responsive to citizens in equal degree, disagreements or inconsistencies of the decisions may persist. Further, it shows that even in a panel of three people, the collective decision (if taken in PCM) may diverge from the majority view, and this divergence is not a matter of ignorance and prejudice of the layman as some commentators argue.15 The suggested model of reasoned decision-making (RDM) model actually explains away the dichotomy science/democracy as both experts and citizens can take decisions in either PCM or CCM way.16 Actually, I believe that the RDM framework allows us to integrate into the decision making all relevant concerns matters of science, of anxiety, etc., but before recommending the PCM as solution to this regulatory problems, I find the RDM model to be a very powerful explanatory tool. First, it shows a problem with democratic deficit inherent in any system for collective rationality, and in depoliticized regulation in particular. Next, RDM model can be adapted to the more complex situations as risk regulation in cases of uncertainty. Further, it can be used to demonstrate how the concerns of variety of players on various loci can be integrated meaningfully in a system of transnational governance. Finally, it may be used to illustrate the enabling conditions of (dis)agreement based on rational argumentation and scientific experiments.

Depoliticizing Democracy, p. 53 and also p. 58. ELIZABETH FISHER, Risk regulation and administrative constitutionalism (Hart. 2007). hereinafter Risk Regulation. 15 CASS R. SUNSTEIN, Risk and reason : safety, law, and the environment (Cambridge University Press. 2002). 16 The scientific community is by no means united on most matters of risk regulation and this will be illustrated with a case study of GMOs.
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2. Rationality Gap
There are two problems arising when collective will yields to collective rationality17 collective will is systematically constrained and the responsibility for policy choices is lost. The latter should be apparent, and I will not discuss it here. Suffices to say that in the context of administrative regulation the means to compensate for the loss of political responsibility is accountability, which will be discussed again in the last section. As for the former, Pettit acknowledges that the decision, resulting from a premise-centred and depoliticised process, will be such that a majority individually reject.18 Constraints to popular will are easy to justify by references to Rousseau, Condorcet, Burke, Madison and even Polybius,19 to name but few. Almost all classics of democratic theory actually seek to constrain popular will for the sake of common good, human rights, principles of justice, etc. Yet all of them had also the notion that the binding decisions are in some ways responsive to the wills of citizens. What is perhaps more important is that even when formal decision-making authority collectivises reason, it does not crowd out the individual reasoning. On the contrary, often the reasoning continues at individual or other levels and reaches contrary results. The collectivised reasoning at the EU level apparently does not prevent the simultaneous process of collectivising reason at national level; actually the EU competes with the member states for reaching conclusions and when the states are first they tend to guard the conclusions on their national interests against argumentative challenges. In a transnational context similar competitions can happen in variety of levels and places. In this way, any system which operates in PCM will systematically yield decisions which contradict the will of the majority (the majorities against each of these decisions may be different). The reasoned decisions, even when produced by the ideal system of collective reasoning or supported by the best available argumentation, will be accepted by citizens even when they accept the legitimacy of the decision-making system as a whole. In other words, Pettits conception is elitist collectivising reason is indeed the best mean to attain the common good yet they contradict to the preferences of majority of the citizens; this is acknowledged but seems of little concern to him. That is how governing elites in many European states are perceived as alienated from citizens and in turn this brings about the surprising success of populist politicians.20

For the remaining of the paper I will use the somewhat misleading shortcuts collective will or popular will for the aggregated individual conclusions through CCM decision-making. Similarly, collective reason will stand for the outcome of PCM decision-making. 18 Deliberative Dilemma, p. 274. 19 See PHILIP PETTIT, Democracy, Electoral and Contestatory, in NOMOS: Designing democratic institutions (Ian Shapiro & Stephen Macedo eds., 2000)., at p. 139, which invokes Polybiuss pejorative term ochlocracy for empowering the unconstrained popular will. 20 It appears that elites secretly dream of a system that will deprive irresponsible voters of the power to undermine rational politics as Ivan Krastev has aptly put it, and At the same time, most citizens
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Similarly, there is often contempt against certain administrative regulations, even if they are produced by sophisticated consultation process and are supported by the best scientific evidence. The opposition to GMO is perhaps the best example, but there are many others in less salient areas as well. All this may appear trivial, indeed the tension between collective rationality and popular will is by no means novel discovery; what I am arguing here is that the contradiction is inherent in the very process of reasoned decision-making and not merely contingent failure of certain mundane institution. The contradiction is not pathology, but the norm. I will call it rationality gap and I think it is present in all democratic institutions, as they all collectivise reason to certain extend. It may be present even in majoritarian institutions, such as the panel modelled above, and becomes more acute in the more obscure regulatory bodies. Pettit has somewhat inadvertently showed how the rationality gap appears; in the next section I am exploring how the gap may be mitigated if not closed. Where such mitigating mechanisms are absent or inadequate the gap becomes more visible. This is usually the case of administrative regulation, and this is even more so in the EU regulation where the gap is also known as democratic deficit. In the last section of this paper I will discuss how can we live with the gap for cases as risk regulation where collective reasoning clearly should be preferred to responsiveness to will.

3. Solutions of the Rationality Gap Problem

Despite the persistent contradiction between the decisions yielded by simultaneous PCM and CCM processes, the rationality gap is not always acute. There are ways to alleviate the problem, and to find a way to achieve both collective reasoning and responsiveness to public opinion in the same time. I see three possible ways out: community, trust, persuasion. Community The first way is by appealing to collective identity or to bonds of solidarity and many authors have already emphasised it, esp. in the case of EU. The logic is simple: solidarity provides citizens with a separate reason to accept the outcome of the PCM decisions of their government, even when following their own beliefs about the premises they have desired the opposite.21 Cass Sunstein noted that in the cases when the group matters for its members once they hear what others believe, they adjust their positions in the direction of the dominant position.22

are convinced that they have the right to vote but not the right to influence decision-making. See The Populist Moment, in Eurozine, 18 September 2007, first published in Critique & Humanism 23 (2007). 21 Compare with Pettit, who notes that the identification [of group members] with one another will support a wish to reach agreement on a set of antecedently agreed set of considerations on the basis of which to justify particular judgements. (PETTIT, Collective Persons and Powers.) p. 448. 22 CASS R. SUNSTEIN, The Law of Group Polrization, 10 Journal of Political Philosophy (2002).p. 179.

Consider the example of a family deciding whether to buy a car. The family has three members (e.g. two parents and one sufficiently mature child) and the relevant premises are P1 whether the car is needed by the family, P2 whether the purchase is economically wise and P3 whether the increase of the carbon footprint of the family is acceptable. The beliefs are distributed according to the following Matrix 2: Family members P1: Car necessary? P2: Car affordable? P3: Carbon footprint negligible? No Yes Yes Yes Individual conclusions:

A: B: C: Collective beliefs:

Yes Yes No Yes

Yes No Yes Yes

No No No ?

Again there are apparent majorities supporting each relevant premise and therefore a family which is collectivising reason will decide on each premise and then following modus ponens will have to buy the car even though the individual will of each member is against the purchase. Unlike the panel members in the first model, here each member of the family has commitment to treat the car purchase as our decision. Therefore, he or she may be inclined to revise his or her beliefs on the premises. C may just figure out new usages for the car and change position on P1. B may still believe it is too expensive, but start to consider it a well deserved luxury. After seeing the happiness the purchase brought to the family, A may also relax his environmentalist zeal. Similarly in large groups who share sufficient sense of solidarity, the citizens may be prompted by the common decision of their nation to revise their initial individual beliefs about the premises (or at least the relevance of some premises and the evaluations standards). In other words, the solidarity-grounded acceptance of certain conclusion will lead them to practice modus tollens and eventually align their beliefs with the conclusions. Thus the individuals are likely to practice modus tollens, while the community practices modus ponens.23 The most telling example of the latter is Britons overall opposition to the Iraqi war, which within a week changed to overall support, once the decision of their government became final (i.e. the war started). There is nothing original in pointing at community as a solution, it is a truism that such bonds are necessary to make the outvoted minority accept the will of the

23

For a concise explanation of the terms see Pettit, Discursive Dilemma, p. 277: In short, it might involve practising modus ponens letting the premises dictate the conclusion or modus tollens keeping the conclusion and revising one or more of the premises.

majority.24 My claim is only slightly different: when solidarity exists, the discontent majority is expected to accept the outcome of collective reasoning. Thus, by means of common identity, the discursive dilemma is sometimes bridged and the PCM and CCM decisions may be aligned. When this is the case the frustration of the common will and the related deficit are avoided. Arguably, the success of community as alignment mechanism is the principle explanation why the nation states collectivise reason but usually do not suffer apparent democratic deficit. Trust The second way out of the dilemma, which is the most relevant for administrative regulation is by fiduciary delegation. Giandomenico Majone offers useful distinction of two logics of delegation agency relationship and fiduciary (i.e. trust) relationship.25 On many issues citizens do not have any preferences and opinions (lacking expertise or interest or both), and they are happy to delegate to someone who is authorised not to implement their preferences, but to take a decision he thinks best for them. This is apparently the case of delegation to expert bodies, and Majone maintains that this is the reason why states have delegated some powers to the EU. However elements of such relationship are always present, including in the parliamentary representation. What immediately comes to ones mind is Burkes claim that Your representative owes you his judgment; and he betrays, instead of serving you, if he sacrifices it to your opinion.26 To illustrate how fiduciary delegation works, we can use a version of the RDM model. Let us use the matrix of GMO licensing example, but instead of the panel now have a council of 3 ministers, advised by a singular consultative body. Most ministers, lacking sufficient technical expertise, do not form any position to premises P1 and P2 but still may have own views on P3. That is why they may delegate the decision on P1 and P2 to a consultative body and decide personally on P3 as in the following Matrix 3:

Habermas is among the latest to have made that claim, with regard to distributive decisions, but I think it is equally relevant for any decisions. 25 GIANDOMENICO MAJONE, Two Logics of Delegation: Agency and Fiduciary Relations in EU Governance, 2 European Union Politics (2001). 26 EDMUND BURKE, Speech to the Electors at Bristol at the Conclusion of the Poll I (pp. 446-8. ed., Henry G. Bohn, 1854 The Works of the Right Honourable Edmund Burke. Volume I (), pp. 446-8. ed. 1774).
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Ministers

P1: Potato safe?

P2: Potato jeopardising antibiotic use? 0 0 Yes No

P3: Science certain?

Individual conclusions:

A B C Advisory body Collective beliefs:

No 0 0 Yes

Yes Yes No 0

Yes Yes No 0

Yes

No

Yes

Yes

In the areas of delegation (as per P1 and P2) the opinion of the advisory body substitutes the indifference (0) and even (if it is really trusted one) trumps the opposing beliefs of the ministers. In the areas outside the delegation (P3), the body does not express any opinion and ministers make the final conclusion, on the basis of their own predominant view on P3 and bodys decision on P1 and P2. Thus the rationality gap is closed in the bottom-right corner we have a Yes resulting from both PCM and CCM decision. Note that the recourse to a trustee will successfully avoid rationality gap only if ministers have not formed own opinion on the premises (0 prevail in P1 and P2), or if they trust the body to such an extent that ministers A and C reverse their own opinions on P1 and P2 respectively). I believe this is uncontroversial account of delegation, the only novelty is to suggest that ministers, and ultimately the citizens, may delegate not only in case they lack expertise, but also in order to avoid rationality gap i.e. even if they have the time and resources to form own opinion they still might prefer to delegate to the consultative body. (This is one reason to use consultative and not regulatory bodies). Persuasion The third possible way is by reliance to scientific expertise, or what might be called pure rationality. Ideally, as long as the relevant premises for government decisionmaking concern different states of the world, scientific evidence and expertise brought in by some of the deliberators may prompt rational people to change their beliefs. The Bayesian theory is instructive how people use new information to update their beliefs about these premises27 and there are many rational choice theorists who

27

See SHAUN HARGREAVES HEAP, The Theory of choice : a critical guide (Blackwell. 1992)., p. 15.

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believe that combining Bayesian learning with objectively based priors effectively eliminates subjectivity.28 Most famously, according to Aumanns Agreement Theorem rational people (who have certain common priors) cannot rationally disagree; if they are rational they a bound to reach agreement. Building on the Agreement Theorem, Cowen and Hanson showed that most disagreements are due to people being dishonest, i.e. disagreements occur when people do not engage in honest truth-seeking and do not abide to the rationality standards that most people heed.29 In the same vein, from the side of the deliberative democrats Parkinson identified that one of the two fundamental obstacles to deliberative democracy is the lack of motivation to engage genuinely.30 Thus, if deliberators are rational and genuine in seeking their common good, with the help of scientific arguments and independent trustworthy expert bodies all will be able to persuade each other on each of the premises; all sides will practice modus ponens and modus tollens until full alignment is reached between the outcome of the conclusion-centred and the premise-centred processes. Thus, in our original GMO licensing example (Matrix 1), the gap between premisecentred and conclusion-centred decisions may be closed by expert evidence, which may lead the participants to align their beliefs on P1 and P2, and less uncontroversially, on P3. Alternatively, if there is some community solidarity, with the growing support for the common conclusion to adopt the policy, the participants may feel tempted to revise their beliefs on the premises. The sense of solidarity is what may make a citizen internalise the common position reached by his group as his own. If he does, he is likely to practice modus tollens to maintain logical consistency, i.e. he may have believed that Pi obtains and therefore C follows, but if he comes to believe that actually not-C obtains, then he will update his original belief, i.e. that Pi does not obtain (this is actually a combination of the first and the third solution). Finally, the citizen may just defer to the opinion of an expert whom she trusts, and update her beliefs according to the expert judgement (she may care to learn the experts reasons and internalise his judgements on the premises, but more often, she will only care to learn his bottom-line, and update her own premise beliefs accordingly). The latter case is the most important for risk regulation as this is the method increasingly used by administration, which in the case of EU relies not so much on the trust in the administrative bodies, but on trust in science. So rationality gap is expected to be closed when discontent citizens are persuaded by scientific evidence to change their beliefs on certain premise. Ideally, science will ascertain everybody to align all the relevant Pis in such a way that the results of collective reasoning and

Bruce Lyons, in the Op.cit, p. 53. TYLOR COWEN & ROBIN HANSON, Are Disagreement Honest at http://hanson.gmu.edu/deceive.pdf., at p. 29. 30 With the other being the problem of scale. See PARKINSON..
28 29

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individual reasoning will coincide. As the following case study of the recent authorisation of a GM potato shows, this is not the case in practice, yet there is precious little evidence for argument driven collectivisation of reason.

4. GMO Regulation in the European Union

In the area of risk regulation the potential of science to overcome different beliefs on the premises and to structure deliberations is greatest. As discussed in the previous section, delegation to objective and trusted expert bodies can substitute potentially controversial political judgements. In the model presented above (Matrix 3) such a body may supervene on the decision on certain premises and remove or reduce the controversy. This was the rationale for the adoption of the current regime of GMO authorisation in EU, which was supposed to be the final settlement of the heated controversy on the issue in the late 90s and a de facto moratorium on any new GM authorisations from 1998 to 2004. In this section I make a case study of the recent authorisation of a GM potato (Amflora), which is the first approval for cultivation since the beginning of the moratorium. The findings do not support the hypothesis that the reliance on one supposedly neutral and scientific body can solve the controversy. Nevertheless, it illustrates how scientific arguments can matter, and how science can structure the debate and push decision-making towards PCM. It also shows that the controversy on the outcome is maintained because of the controversy on the range of relevant premises, rather than on the judgements on each premise, even though the different judgements played their part. Regime The GMO authorisations are governed primarily by the Deliberate Release Directive31 and the Food and Feed Regulation.32 Procedures vary according to the projected use of the GMO,33 but the common pattern, in a nutshell, is the following. The licensing process starts with an application through a national authority, which forwards it (together with its own opinion) to a specialised scientific body - European Food and Safety Agency (EFSA), whose assessment of food and environmental safety is crucial in all cases. The EFSA distributes the dossier to the other member states which may make their own evaluations and submit their opinions to EFSA. The opinion of the public should also be taken into account34 however this is interpreted

Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms OJ L 106/1 (12 March 2001). hereinafter Deliberate Release Directive. 32 Regulation 1829/2003/EC on genetically modified food and feed OJ L 268/1 (22 September 2003). hereinafter Food and Feed Regulation. 33 In theory the Deliberative Release Directive creates regime of mutual recognition, and only in case of disagreement the decision is centralised by comitology and upon an optional advice of EFSA. However, member states always rise and maintain objections, and the Commission always asks the EFSA opinion. 34 Deliberate Release Directive, recital 46 and Article 9.
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to allow public opinion only on the same substantive grounds that are allowed to scientific bodies, which severely limits its influence. EFSA, as most other EU agencies, is not a regulatory authority with powers of its own, but is only an independent source of expert advice.35 If its opinion is positive, the Commission prepares a draft authorisation decision, which is submitted to the Standing Committee on Food Chain and Animal Health (Food Chain Committee) - a regulatory comitology committee. So far the Food Chain Committee has never succeeded in forming a qualified majority neither for nor against any GMO authorisation proposal (thus exhibiting unprecedented failure of cooperation in comitology process)36 and therefore the issue is referred to the Council. In turn, the Council so far has never reached qualified majority to block the decision and in such cases the matter is referred back to the Commission for final decision.37 This decision usually is positive and is justified with the respective positive EFSA opinions, although sometimes the Commission has delayed it and asked EFSA for further information. When the GMO is finally authorised it enjoys the freedom of movement, including cultivation (if the authorisation was for deliberate release) on the territory of any member state. This can be restricted by member states only on the basis of new or additional scientific knowledge, [that the licensed GMO] constitutes a risk to human health or the environment.38 Presently there are only two GMO authorised for cultivation, about a dozen for food and feed and about 6 member states have invoked safeguard clauses. 39 Thus, the GM authorisation procedure is centralised40, although member states have opportunities to engage actively in the process by their own evaluations, which EFSA is legally obliged to take into account, and by the comitology and Council votes. As Maria Lee notes, the regime relies on networking of risk assessors through agency

For more details on EFSA see Regulation 178/2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety OJ L 268/1 (28 January 2002). hereinafter General Food Law Regulation. 36 Pollack and Shaffer quoted a Commission report according to which out of 2 637 draft decisions submitted to the various EU expert committees that year, only eleven of those decisions (less than 0,5 per cent) were referred to the Council for a decision and six of these involved authorisation of GM foods and crops. MARK A. POLLACK & GREGORY SHAFFER, Biotechnology Policy. Between National Fears and Global Disciplines in Policy-making in the European Union (Helen Wallace, et al. eds., 2010). 37 The exception being its decisions from 24 June 2005, 18 December 2006 and 20 February 2007 to block infringement proceedings against member states for bans of authorised GMOs. These decisions in practice suspend the application of the general GM law with respect to these countries. 38 This is the safeguard clause, see Art. 23 of the Deliberate Release Directive. 39 For a more detailed account see MARIA LEE, EU regulation of GMOs : law and decision making for a new technology (Edward Elgar. 2008).; for the most recent development in the area see POLLACK & SHAFFER, ( 40 Recitals 30 and 31 of the Food and Feed Regulation even state the goal of harmonised scientific assessment.
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structures [which invites] national perspectives on risk into the EU system.41 According to Art. 30 of the General Food Law regulation, when different scientific opinions emerge EFSA and member state(s) are obliged to co-operate with a view to either resolving the divergence or preparing a joint document clarifying the contentious scientific issues and identifying the relevant uncertainties in the data.42 Yet, it was met with objections (and unfavourable view from EFSA) against which Austria was unable to defend it and had to withdraw. This is perhaps the clearest requirement for a PCM decision-making one can find in a positive law as not only the disagreements of the final positions, but the differences in all potentially contentious scientific issues (i.e. on all relevant premises) shall be identified, and sought to be resolved. If the Food Chain Committee were to decide by member states voting on each of these points of disagreements, it would be the ideal implementation of the model discussed above and this is why I have chosen this area to study. Indeed, my first case study evidenced some argument based exchanges, yet it seems what happens is far below these expectations.43 It seems that the EFSA alone is in the driving seat, making the final decision on the basis of its own beliefs for each of the premises. This mode is apparently supported by the Commission, which has always been deferential to EFSAs conclusions, rather than engaging with the premises they are based on.44 Since 2004, the Commission has always followed EFSAs recommendation, and no objection coming from a member state assessment succeeded to convince it in the opposite. The authorisation decision for the Amflora demonstrated that once again. The substantive criteria for authorisation are the absence of risks to human health and the environment, whether direct or indirect, immediate or delayed, which the deliberate release or the placing on the market of GMOs may pose.45 These risks may have different expressions in different cases, for example possible development of antibiotic resistance and possible development of insecticide resistance. The application of these criteria should be conditioned by the precautionary principle46 and by consideration of the cumulative effects47 (with regard to earlier

LEE., p. 68. An recent example of such resolving of differences was a study on long term effects of GM maize on rats, commissioned and presented in the Food Chain Committee by Austria. See the minutes from the proceedings of EFSA GMO panel on 3-4 December and of the Food Chain Committee on 16 December 2008 and 19 October 2009 respectively. 43 Once again I have to note that I still have not researched the positions of the national authorities and especially whether their considerations played any part in the deliberations during the comitology. 44 Another reason, besides the Commissions deference to the EFSA conclusion, is the exclusion of certain premises member states consider relevant, which stiffens their position on the premises which remain relevant. 45 Article 2, para 8 of the Deliberate Release Directive. 46 There is explicit reference to it in recital 8 of the Directive. 47 Id., recital 19.
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authorisations) and the scale of the projected release48. The Food and Feed Regulation requires further that the product should not be nutritionally disadvantageous to consumer, and should not have adverse effects on human and animal health or the environment.49 These are the narrow and, the exclusive grounds on which the authorisations are to be decided; the Deliberate Release Directive and the Food and feed Regulation leave out quite a number of other considerations, which are relevant to member states and stakeholders, like adverse effects on conventional and organic farming, coexistence and contamination, market need and available alternatives, industrial policy, ethics, respect for nature, sustainable development, economic and technological dominance, impact on third countries, consumer choice, regional economy, regional environment, traditional culture, etc.50 The regulatory regime, as well as the established practice of the Commission, (supported by the Pfizer doctrine of the ECJ) is aptly described by Maria Lee as science must be fought with more science.51 Within this very narrow framework, still some premise-centred exchange could be recognised during the saga of the latest authorisation. A case study52: Amflora Amflora is a starch potato, genetically modified for higher content of amylopectin, which is used mostly in the paper industry. It is not intended for human and animal consumption, but some by-products (i.e. pulp) can be used for feed, and inadvertent and technically unavoidable amounts in food cannot be excluded. The application for its cultivation was launched as early as 1996, and in 2003 it was updated as per the new Deliberate Release Directive through the Swedish national authorities (where it is intended to be grown). In 2005 the applicant (BASF) filed also an application under the Food and Feed Regulation, through the British authorities with regard to the inadvertent food and feed use. The assessment of the Swedish authority found Amflora to be safe, in a language worth quoting: the result of the risk assessment does not call for risk management actions. The potential risks are very small and connected with certain unlikely changes of the potato and effects that have not been anticipated in the risk assessment.53 For the unknown unknowns54 the proposed

Id., recital 24. Food and Feed Regulation, art. 4, para 1. 50 See JANE HOLDER, et al., Environmental protection, law and policy : text and materials (Cambridge University Press 2nd ed. 2007). for a comprehensive account of the considerations that are important for different stakeholders. 51 Id., p. 86. 52 This are only very preliminary findings, on the basis only of published documents. The opinions of the national authorities, which were submitted and supposedly taken into account by EFSA and the Food Chain Committee, are not yet obtained, so what is actually the most important part of the case study is still missing. 53 Assessment report of the Swedish Competent Authority on the placing on the market according to notification C/SE/96/3501.
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monitoring plan which constitutes a system fit to detect the potential occurrence of unanticipated events that might lead to adverse effects on human health, animal health and the environment55 was considered sufficient. The Commission distributed the application to the other member states and asked EFSA to opine whether there is any scientific reason to believe that placing on the market of the genetically modified potato is likely to cause any adverse effect on human health or the environment.56 Some of the member states also delivered opinions, raising various concerns which EFSA took care to address.57 In particular, member states raised and maintained objections to the placing on the market of the products in terms of molecular characterisation, allergenicity, toxicity, an inadequate monitoring plan and the detection method of the product. EFSA addressed the concerns issue by issue, i.e. its opinion listed a number of premises relevant for the conclusion (all of them were scientific only) and judged all of them unlikely to present any risk. With regard to the PCM model discussed here, these concerns can be formalised as the following premises: P 1 stability of DNA structure P 2 nutritional value equivalence with conventional potatos P3 toxicity P4 allergenicity P5 possible plant spill-over in nature P6 possible gene spill-over to bacteria (horizontal transfer) P7 adverse effects on the plant-associated organisms P8 spread of antibiotic resistance into environment P9 safety in environments other than Swedish This so established set of relevant premises seems to adequately reflect the substantive criteria in the positive law, and seemingly was accepted58 as framework

This is the epistemological jargon for the things that we do not conceive at the time of decision that may be relevant. The respective state of mind is referred to as ignorance, in contrast to uncertainty which denotes the state of not knowing only the probability of a consequence known to be possible. 55 Id. 56 EFSA, Opinion of the Scientific Panel on GMO on a request from the Commission related to the notification (Reference C/SE/96/3501) for the placing on the market of GM potato EH92-527-1 with altered starch composition, for cultivation and production of starch, under Part C of Directive 2001/18/EC from BASF Plant Science The EFSA Journal (2006)., published in The EFSA Journal (2006) 323, 1-20, hereinafter EFSA Opinion 2005. Actually there were two opinions, with almost identical content for the purposes of the Deliberate Release Directive and of the Food and Feed Regulation respectively. All references below will be to the opinion pursuant to the Deliberate Release Directive. 57 As noted, presently I have not obtained the evaluations of member states and in the discussion rely only on the summaries of these issues in the EFSA opinion itself. 58 Perhaps accepted is not the right word, as many participants would consider many other premises relevant and more important, and would not accept such a limited set. What I mean however, that all
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of the decision-making. In December 2005 EFSA answered all of the above unequivocally and concluded that the information available for the potato [Amflora] addresses the outstanding questions raised by the Member States and considers that [it] is unlikely to have an adverse effect on human health or the environment in the context of its proposed uses."59 From these, only P8 - the possible spread of antibiotic resistant genes from Amflora into the environment became a point of major controversy to be discussed bellow. The EFSA Opinion 2005 contains several caveats about the limits of the current state of knowledge, which is not surprising, given that the effects of an invention are being assessed i.e. we are on the borderlines of our knowledge and all probabilities are uncertain. In the beautiful phrase of Maria Lee, everything that we know about the GMOs lies in the shadow of ignorance, the prospect of harm that we have not even thought of.60 Indeed, several unexpected traits and effects have been observed by the studies, yet EFSA concluded that none of them were unusual in the area. For example some member states were concerned by a study of rats fed on Amflora, some of which exhibited increased number of cysts. To this EFSA responded that: Thyroid cysts occur commonly in rats, while their frequency varies during ageing [therefore their] slightly increased incidence in male [rats] fed transgenic potato is likely to be due to natural variability and does not trigger a further assessment.61 EFSA seemingly did its best to account for ignorance and to assess every effect imaginable (certainly imaginable only in our present state of knowledge), with the most outstanding example being: the hypothetical ORF4 protein showed a high degree of similarity with two proteins that are not known to be toxic or allergenic.62 Another example is EFSAs opinion on allergenicity: the panel concluded that there is no evidence for any, but noted that A weight of evidence approach is recommended, taking into account all of the information obtained with various test methods, since no single experimental method yields definitive evidence for allergenicity.63 It is striking that despite its acknowledgment of the limits of knowledge on some issues, EFSA never even mentioned the precautionary principle. More often than never it took the lack of evidence for adverse effects as certainty for absence of such effect. In the area of science the Razor of Ockham may justify such parsimonious approach, but risk management is to be governed by precaution, not by parsimony.

participants framed their arguments according to these premises, and even Greenpeace played by the rules. 59 EFSA Opinion 2005. 60 LEE., p. 29. 61 EFSA Opinion 2005, p. 10. Emphasis added, note how much this scientific assessment sounds like moral judgement. 62 EFSA Opinion 2005, p. 11 63 EFSA Opinion 2005, p. 11, emphasis added.

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In light of that it should be noted that if parsimony does govern science64 then the division between risk assessment and risk management appears to be particularly inept. A parsimonious expert will conclude his assessments that no risk is likely, and therefore there will be no need for risk management at all. This is precisely what the Swedish national authority concluded.65 This is how, as Maria Lee observed our regulatory systems generally discount ignorance,66 and this is how in cases of apparent uncertainty, precautionary principle is not even triggered. Yet, given the regulatory framework in force, the judgements on the relevant premises are left to EFSA, and EFSAs opinion is entirely dependent on science, scientific parsimony included. The certainty of was disputed se, and Indeed, some national authorities disputed EFSAs estimations on the premises listed above and presented studies with different results. On 9 March 2006 the Council criticised EFSA and asked safety assessment [to] take greater account of the possible long-term consequences of the use of those products and scientific research should be intensified in this context and recommended the need for coordination between all the bodies concerned, particularly the Commission, the European Food Safety Authority and the competent national authorities.67 That is why a technical meeting between members of EFSA and of national authorities was held on 19 June 2006 and according to Commissioner Dimas All Member States confirmed that, based on information available at the current time, the corresponding EFSA opinion satisfactorily addressed their scientific objections.68 Thus, with the ignorance discounted, all but one of EFSAs judgements on the premises were accepted (at least as far as the Commission was concerned69). The one exception was antibiotic resistance. Amflora potato contains nptII an antibiotic resistance marker gene (ARMG). ARMGs are introduced during the process of genetic modification to distinguish the cells with successful modification

It is just an assumption that in case of insufficient evidence, science should err on the side of nonexistence rather than on that of existence of consequences, which would justify EFSAs approach; here is not the place to delve into philosophy of science. 65 See note 53, p. 15. 66 LEE., p. 29 67 Press release from the 2713th Council Meeting (Environment), 9 March 2006, 6762/06 (Presse 58), http://www.consilium.europa.eu/uedocs/NewsWord/en/envir/88721.doc (accessed 10 April 2010). 68 Commissioner Dimas answering a written question by Alyn Smith, MEP (E-0769/2007) http://www.europarl.europa.eu/sides/getAllAnswers.do?reference=E-2007-0769&language=EN (accessed 9 April 2010), emphasis added. 69 Member states remained far from convinced as evidenced by the failure of the Food Chain Committee and the Council to adopt any decision and also by the GMO regime change initiated by the Commission (see below). Yet, this does not necessarily contradict Dimas view member states could have accepted the scientific issues to be settled, but maintained their opposition because they considered other premises to be relevant, which however were not allowed into consideration by the acquis. In my future research I will test this hypothesis, esp. what issues were raised by member states in the Food Chain Committee.
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from the rest. The nptII confers resistance to kanamycin, neomycin and several other antibiotics, which according to EFSA were of limited use in human and veterinary medicine.70 This assessment was based on its own conclusion in a previous opinion on ARMG use in general, where the EFSA classified the ARMG in three groups, putting the nptII in group I ARMG which are safe to use because (1) these genes are already widespread in nature anyway and (2) because they confer resistance to antibiotics which have no or only minor therapeutic relevance in human medicine and only restricted use in defined areas of veterinary medicine.71 Quite unfortunately for our potato, the World Health Organisation (WHO) issued a report, in which it classified kanamycin and neomycin as critically important antibacterials.72 Greenpeace brought the issue to the attention of the Commission, and the Commission mandated the European Medicines Agency (EMEA) to opine on the importance of these drugs.73 In 2007 EMEA concluded that kanamycin and neomycin are valuable antibiotics and cannot be classified as of no or minor importance.74 The Commission asked again the EFSA, which in a Statement from 2008 agreed that kanamycin and neomycin are important, yet repeated its original conclusion that nptII is safe to use, because its horizontal transfer (from the plant to bacteria) was very unlikely, and it was widespread in nature anyway.75 Following that, the Commission proposed to authorise the Amflora for food and feed use through the comitology. The Food Chain Committee failed to reach qualified majority on 10 October 2007 and the decision was referred to the Council, which also failed to obtain majority on 18 February 2008. In the meantime Greenpeace filed a legal brief from a London QC, arguing that the adoption of authorisation decision will be unlawful. The argument was developed on the new classification of the antibiotics: if kanamycin and neomycin can no longer be considered as antibiotics of minor importance, the gene which transfers resistance to

EFSA Opinion 2004, p. 13. EFSA, Opinion of the Scientific Panel on GMO on the use of antibiotic resistance genes as marker genes in genetically modified plants The EFSA Journal (2004). Hereinafter ARMG Opinion, p. 11. 72 World Health Organisation, Critically Important Antibacterial Agents for Human Medicine for Risk Management Strategies of Non-Human Use. Report of a WHO working group consultation. (2005). 73 In the meantime the Commission proceeded with the authorisation pursuant to the Deliberative Release Directive, proposing approval through the comitology, which on 19 December 2006 failed to reach decision and the matter was referred to the Council, which also failed on 16 July 2007. This cleared the way for Commission approval of deliberative release and marketing, but it withheld it until the controversy pursuant to Food and Feed Regulation continued. 74 EMEA, Committee for Medicinal Products for Veterinary Use And Committee For Medicinal Products For Human Use Presence of the ARMG nptII in GM plants for Food and Feed Uses, EMEA/CVMP/56937/2007 (2007)., hereinafter EMEA Opinion, at p. 2. It also indicated few other misgivings in the EFSA opinion, esp. noting that the occurrence of kanamycin resistance, which was judged as widespread by EFSA actually varies substantially between countries and species. 75 EFSA, Statement of the Scientific Panel on GMO on the safe use of the nptII antibiotic resistance marker gene in genetically modified plants (2007).
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them cannot be classified in group I (safe to use) of the EFSA Opinion 2004, but in group II (to be used only in field trials) or group III (to be avoided, irrespective of considerations about the realistic value of the treat).76 The Deliberate Release Directive does require identifying and phasing out ARMGs in GMOs which may have adverse effects on human health and the environment.77 Thus, from the EFSAs own Opinion 2004 follows that ARMG conferring resistance to important antibiotics are to be considered as not safe for human health, and as nptII confers resistance to so classified antibiotics, it should be considered as having adverse effect under the directive, and accordingly phased out in authorised GMOs, and not authorised at all if found in new ones. Although Councils failure to act had cleared the way for Commission to authorise the Amflora alone, in May 2008 it asked EFSA yet again for a consolidated opinion on the Amflora safety78 and EFSA repeated its conclusions once again. This time there were two (out of twenty) panel members dissenting. One of the dissents just emphasised that only the current state of the knowledge indicates that the antibiotic resistance genes are safe, and if this turns out to be different the consequences on health and environment are unknown. The other noted that even though the probability of horizontal gene transfer is low, given the magnitude and multitude of exposures from the foreseen use of GM plants with [ARMG] it appears the cumulative probability of transfer could range from unlikely to high.79 With this final reassurance, the new Baroso Commission, in one of the first acts after its formal inauguration, adopted two decisions (pursuant the Deliberative Release Directive and the Food and Feed Regulation) which authorised Amflora to be cultivated, marketed, and used as food and feed throughout the Union. The saga illustrates that the Commission was very careful deciding this sensitive and salient issue, (indeed, it abstained from deciding when it could) but kept within the range of relevant premises established conservatively by EFSA. It took note of the divergent opinions, but all it did was to ask EFSA to reconsider and possibly change its position, rather than forming own position. Eventually it deferred to EFSAs conclusion, which was probably anticipated by the other participants, so the struggle

It is noteworthy that the Deliberate Release Directive requires identifying and phasing out antibiotic resistance markers in GMOs which may have adverse effects on human health and the environment. (Art. 2, para 2) Thus, on PCM reading, from the EFSA Opinion 2004 follows that ARMG conferring resistance to important antibiotics are to be considered dangerous for human health, and as Kanamycin is classified as important by EMEA, the respective ARMG resistant to it should be classified as dangerous and phased out in authorised GMOs, and banned if found in new ones. 77 Deliberate Release Directive, Art. 2, para 2. 78 Greenpeace interpreted this as a huge vote of no confidence in the EUs approval system. 79 EFSA, Statement of EFSA on the consolidated presentation of opinions on the use of antibiotic resistance genes as marker genes in genetically modified plants, The EFSA Journal (2009). Appendix D. The numbers he provides for this probabilities are quite scary.
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was to undermine the premises on which EFSAs conclusion was based. Notably, the Commission consciously avoided to venture in arguments on broader grounds, such as questioning the certainty of science per se or need to apply the precautionary principle. The most apparent exhibit of this was that it took the decision under a written procedure on 2 March 2010, which precluded the possible deliberations in the college meeting. Broader considerations were probably discussed on the college meeting held the next day, 3 March 2010, when it decided to introduce quickly changes of the GMO regime which [should] guaranteed that any decision adopted was based entirely on independent scientific advice, in particular that of the European Food Safety Authority, and at the same time respected the choices made by Member States on whether or not to authorise GMO crops on their territory.80 As reason for this the commissioners mentioned mainly subsidiarity, thus implicitly acknowledging that for the disagreeing member states premises other than safety were more important for the authorisation, which were excluded from consideration by the existing regulation. Thus, during the whole saga, the Commission felt the heat of the continuing controversy and delayed the authorisation decision until it could; when it finally took it, it felt the need to promise to member states a regime change. The other reason to consider the authorisation decision, and the GMO regulation as a whole as regulatory failure, is that the only occasions when the Council reached qualified majority on anything under this regime was for its decisions to stop the Commission from prosecuting member states for violation of the GM legislation, thus in effect suspending it. The conclusion which is most interesting for the purposes of the present paper is that the controversy on the Amfloras antibiotic resistance was apparently argument driven, and placed in premise-oriented decision-making framework. It can be formalised in the following Matrix 4: Participants P1: P2: P3: C:

ARMG Antibiotics widespread in concerned nature important? EFSA EMEA Yes Yes No* Yes

Safe to use? Horizontal gene transfer likely? No n/a Yes n/a

MINUTES of the 1907th meeting of the Commission held in Brussels (Berlaymont) on Wednesday 3 March 2010 (PV(2010)1907 final), at p. 23 available at http://ec.europa.eu/transparency/regdoc/ rep/10061/2010/EN/10061-2010-1907-EN-F-0.Pdf, (Accessed on 9 April 2010). The main reason for this that commissioners mentioned was subsidiarity, thus implicitly acknowledging that premises other than safety were more important for the authorisation, but were excluded from consideration by the current regulation.
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Greenpeace Commission

n/a Yes

Yes Yes

n/a No

No ?

According to the EFSA Opinion 2004, all of the three premises are relevant for the conclusion on the safety of nptII and Amflora, P1 being positive, and P2 and P3 negative. Unlike the models discussed above, here the participants do not vote on the premises, but try to change the beliefs of each other,81 and above all, of the Commission, which takes the final decision. The joint forces of EMEA and Greenpeace succeeded in reversing EFSAs belief (or at least its official position) and the asterisked No turned into Yes. Now, if all of the three premises were relevant all the time, both a premise-centred and a conclusion-centred decision-making would lead to negative answer on the safety issue and the Commission would be hard pressed to adopt such decision. Such would be the case if the ARMG opinion was binding law rather than advisory opinion. What happened instead, was that EFSA violated its own earlier opinion and excluded the relevance of P2. It preferred to loose inter-temporal consistency (and perhaps some credibility) in order to maintain its original conclusion. But it was able to do so, not because it had formal power to determine the preference set, but because the Commission was deferential to its determination. If the Commission had chosen to continue to consider P2 as relevant, then it had to refuse authorisation, regardless of EFSAs opposition. Now, the authorisation of Amflora was not a collective decision taken in PCM mode. Yet the process exhibits apparent features of collective reasoning, esp. the efforts to decide on the basis of democratically persuasive reasons as Pettit requires.82 Nevertheless, the deliberations unfolded in a premise-centred structure which made possible the change of EFSAs position on P2 in the first place. In the very limited set of premises relevant for the antibiotic resistance issue, the arguments carried the day and brought about this belief revision. It is preposterous to generalise, but it seems that such exchanges could have happened on any of the other premises identified above. In a conclusion-centred mode, EFSAs initial position on this preference would warrant its positive conclusion on safety without much ado. The latter often is the case when the advice of scientific agencies is taken as the bottom-line. Opening the process to challenges on the premises makes belief-revision possible (although in this case it did not lead to difference in the ultimate result) so if we want to move towards collectivising reason, deference to bottom lines should be avoided. It should be also noted how the actors engagement with the premises prevents deference, and conversely - avoiding deference fosters engagement with the premises.

81 82

And also of the member states even though they on this decisional stage they are only observers. See above, footnote 13.

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The other point that the case study brought home is that even in this overly reliant on science process, science remained uncertain, and that not only risk management but risk assessment remained a matter of judgement. If this is always so, it is natural to require that such judgements are made by the politically authorities, such as the Commission, or the representatives of member states in the Food Chain Committee, rather than by reliance on independent expert bodies like EFSA. The final significant thing demonstrated by the Amflora case study was how the range of relevant determines the conclusion. Currently, EFSA had the sole responsibility to determine the range of relevant premises and it did so arbitrarily and narrowly (supported both by law and by Commissions behaviour). In the next section I will discuss the importance of the width of the range of relevant premises.

5. Expansion of the Range of the Relevant Premises

In the first two sections of this paper I have showed how collectivising reason frustrates majority will, which I called rationality gap. In the third section I discussed the ways by which democratic polities may close it. In the fourth section I offered an example of argument driven decision-making in the area of risk regulation in the EU, where the reliance on scientific arguments was supposed to reduce conflict and foster acceptance, yet the conflict remained acute and undermined the GMO regime itself. The Amflora case study showed how despite the very narrow range of relevant premises, all of them believed to be scientifically verifiable and despite the involvement of independent expert body,83 despite the lengthy process taking care to answer all objections of national authorities, despite the reassessments made by EFSA, eventually there was no alignment of beliefs and neither the Food Chain Committee nor the Council could reach any decision at all. In the terms adopted here, the rationalisation of the process maintained a gap, which could not be closed by the science. So if the rationality gap persist, and we still face the discursive dilemma. As Pettit advised, it should be solved in favour of collective reason, i.e. by institutionalising PCM, at the expense of responsiveness to will. Indeed, in the area of risk regulation more than anywhere else we need reason and not passion to carry the day. In this final section I will invert my perspective and will discuss how, in the cases where the rationality gap cannot be closed, we can still confer legitimacy to decisionmaking despite of it. I suggest that the conflict between collective reason and aggregated will does not delegitimize the regulatory institutions if the range of premises considered relevant in the regulatory process is expanded to include the considerations the stakeholders find relevant. This requirement I will call premise

83

Actually Greenpeace and Friends of the Earth accuse EFSA of bias and conflict of interests, but as they are outliers and such accusations were never raised by the member states I will not consider them here.

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integration and I believe it should be the new way to understand the concepts of responsiveness and accountability. In other words the condition for legitimacy of regulation should be that it provides mechanism for ones considerations to be taken into account by institutions, thus making them responsive not to the will of the stakeholders (i.e. their individual conclusions) but to the premises which they consider relevant. This might appear trivial requirement but it is precisely what is not done by the EU regulation of GMO. In the Deliberate Release Directive, as well as just about everywhere else, there already are provisions for public participation however participants may only raise arguments on the limited number of premises allowed to EFSA itself, thus leaving out most of what stakeholders actually find relevant. Thus, when Rebecca Harms, MEP, asked Commission President Barroso whether we need the GM potato that was just authorised he replied with just another statement on its safety and implied that the question of the market and need for GMO is a matter of ideology and as such none of his concern.84 On the suggested account the focus of participation should be moved from the stakeholder to the premises that she considers relevant. This is substantive theory of inclusion, in contrast to the procedural theories of participatory democracy, which usually take participation as value per se, rather than as instrumental to bring in other relevant considerations in the regulatory deliberations. The positive law, including that of the EU often provides for participation, but often this is taken only in procedural sense and that is why so far it has limited or no impact at all as evidenced by a constellation of political scientists.85 Participation may make a real difference if taken to be premise-inclusion rather than stakeholder-inclusion because in all cases of rationalised decision-making the range and structure of the premise set matter, just like the number of available options matters in voting. The antibiotic resistance controversy illustrated how differences in the premise sets warrant different conclusions, but also suggests that the same premise set warrants the same result regardless of the participants86 (unless the participant has a voting power, as per the original PCM model, and not in the more usual regulatory model in Matrixes 3 and 4). Thus, the participation of a stakeholder without inclusion of the premises he considers relevant will hardly make any difference.87 So if Greenpeace considers the

European Parliament, Debates, 9 March 2010, available at www.europarl.europa.eu/sides/getDoc.do ?pubRef=-//EP//TEXT+CRE+20100309+ITEM-010+DOC+XML+V0//EN (Accessed 10 April 2010). 85 Steffek and Ferretti remarkably found that the EU imposes restraints that, in effect, exclude nonscientific arguments and expertise, which paradoxically, appear to be the crucial asset of civil society. JENS STEFFEK & MARIA PAOLA FERRETTI, Accountability or Good Decisions? The Competing Goals of Civil Society Participation in International Governance, 23 Global Society (2009). at p. 56 86 It would not make a difference if the WHO was listed with the same positions as the EMEA. 87 One may ask why is it different to take ones premise into account yet defeat it on the merits from not taking it into account at all. In my view it is like the difference between having a vote and winning it.
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premise GMO needed? for example to be the most relevant, at least in theory it could be persuaded by evidence that in certain case it is to be answered in the positive. If it was not Greenpeaces acquiescence to the outcome is precluded a priori. The exclusion of some premises, which certain constituencies consider relevant from the regulatory process often is more significant than excluding them themselves. This does not mean that every premise considered relevant by a stakeholder should be considered by the regulators. Which premises will be considered is a matter of issue-by-issue and sometimes case-by-case settlement, but it appears that taking premises into consideration is the factor which confers legitimacy to the regulation. Note also that the consideration of ones favourite premise does not mean that its substantial assessment will coincide with his the GMO needed? premise may be included in the decisional framework, still it may be systematically assessed in the positive. Starting from the same trivial observation that deliberating groups, which take different premise sets into consideration reach different conclusions we can notice another major reason to require premise-inclusion. Nations, as well as many other groups which collectivise reason, compete for legitimacy with the EU. Certain premises may be excluded from the EU regulatory regime, but it usually cannot exclude them from consideration on national level. In such cases, despite all persuasive power of the objective science employed by the EFSA and the like, the differences with national regulators and national public opinions will remain. While EFSA/Commission decides on the basis of certain premise set, parallel deliberative processes inevitably take place in the national authorities and stakeholders on the basis of their own, often quite different premise sets. Even if citizens are not involved in any form of institutionalized public deliberation at home, they will form their conclusions in private and still a majority of them may find the outcome of deliberation in Europe frustrating. In other words, when premises are excluded from consideration by the body which collectivises reason, the citizens who hold them may collectivise reason in some independent public spheres, constructed on national, class or cultural basis, or just remain unconvinced, with their individual wills frustrated. Thus, the divergence between citizens opinion on GMO and the decisions of EU is not a deviation, but the norm. It is not a matter of laymens ignorance as Cass Sunstein argues, but of his exclusion.88 The final virtue of the suggested concept of premise integration is that this is a way to subject the collective reasoning to accountability, which will be especially robust as the public will not have to be satisfied that certain decision was justified by some reasons, but will be entitled to ask what was the decision-makers judgement on their reasons. Thus every stakeholder would be able to check whether the premises she considers relevant were taken into account, and whether her participation mattered,

It should be noted that the premise integration I advocate does not mean legislative harmonisation of premises, but inclusion.
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i.e. whether she could have affected the judgement made on these premises and eventually the conclusion.

Conclusion
Pettits model of reasoned decisions (RDM) identified a problem (rationality gap), which is inherent in the logic of collectivised reasoning and is not a matter of institutional design (although the paper sometimes discussed the distinction between PCM and CCM in terms of procedure). I have used this model for better understanding of a practical example of regulation, where the conflict between collective reason and popular demand persists, despite the employment of an expert agency as institutional device to solve the difference. For cases like these, where we have to live with the dilemma, I have suggested that premise integration may be a workable alternative understanding of our concept for responsiveness. I have argued that successful premise integration leads to responsive collective reasoning as it allows the decision-maker to be accountable, accountable not to achieve what people want to see as final result but to what they consider relevant for the conclusion. This may be attenuated version of the common notion of responsiveness with regard to the rationality gap it is as best as we can get in risk regulation. On the other hand, it allows a more robust accountability: if classical notion of accountability is reasonsgiving, premise integration is reason-taking. If accountability was understood just to require some considerations to justify a decision to be given it remains unclear what is so great about justifying it with reasons which some stakeholders do not consider to be the most relevant. On the contrary, inclusion of ones considerations in the range of relevant premises is a substantive difference. If my argument is correct, our attention should turn from interest representation to premise (and argument) consideration, i.e. the question was my group represented should be substituted with the question was my moral consideration taken into account? Ideally, these considerations can be taken into account without participation; the condition for responsive collective reasoning is that all premises which substantial part of the public considers relevant are dully taken into consideration. On this account, it does not matter who participated in the regulatory process (though participation of a trusted NGO may create presumption in favour), what matters is the inclusion of the respective premises. The suggested concept may appear trivial in claiming that the arguments matter, but this may have far-reaching normative consequences, because this claim provides an alternative source of legitimacy of regulatory institutions, without need for their representation and participation in the regulatory process and without need for delegation from and accountability to politically responsible bodies.

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