GMO Authorisations in EU - Amflora case study

7/30/2019 GMO Authorisations in EU - Amflora case study

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Between Reason and Will: Can Regulation Be Responsive?

Vesco Paskalev

Presentation for Workshop Socializing Economic Relationships - New Perspectives and

Methods for Analysing Transnational Risk RegulationOxford, 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 decision-

making 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

1 The core argument is in PHILIP PETTIT & WLODEK RABINOWICZ, Deliberative Democracy and the

Discursive Dilemma, 35 Nous (Supplement: Philosophical Issues, 11, Social, Political, and LegalPhilosophy) (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 commonjudgement 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 GMpotato 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?

P2: Potato

jeopardising

antibiotic use?

P3: Science

certain?

Individual

conclusions:

A No Yes Yes No

B Yes No Yes Yes

C Yes No No No

Collective

beliefs:

Yes No Yes ?

Apparently there is a majority believing that the two positive premises are presentand 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-

2

In Pettits examples this determination is done by voting, but the distinction applies to a moregeneral case with other methods like consensus, drawing lots, expert opinion, etc.3Discursive 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 thesepremises.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 meanssacrificing 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.

4

Note that CCM permits for many incompletely theorised agreements (which many consider to beessential 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 beempowered 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 non-

domination, citizens should be free from arbitrary interferences i.e. any suchinterferences 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 apparentthat 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

8 Pettit equates PCM with deliberative mode of governance but in this paper I will avoid using the

latter term.9Ibid., 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

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.


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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, theyare 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 withdemocratic 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.

13Depoliticizing Democracy, p. 53 and also p. 58.14 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 authoritycollectivises 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 majoritiesagainst 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

17 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 andpopular 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 mitigatingmechanisms 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 toalleviate 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 thepremises 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 basisof 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.


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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?

Individual

conclusions:

A: Yes Yes No No

B: Yes No Yes No

C: No Yes Yes No

Collective

beliefs:

Yes Yes Yes ?

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 thepremises. 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 beliefswith 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 mightinvolve practising modus ponens letting the premises dictate the conclusion or modus tollens

keeping the conclusion and revising one or more of the premises.


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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 asalignment 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 technicalexpertise, 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:

24 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?

P3: Science

certain?

Individual

conclusions:

A No 0 Yes Yes

B 0 0 Yes Yes

C 0 Yes No No

Advisory

body

Yes No 0 0

Collectivebeliefs:

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 fromboth 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 decision-

making 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 dueto 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 premise-

centred 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 methodincreasingly 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

28 Bruce Lyons, in the Op.cit, p. 53.29

TYLOR COWEN & ROBIN HANSON,Are Disagreement Honest at http://hanson.gmu.edu/deceive.pdf., atp. 29.30 With the other being the problem of scale. See PARKINSON..


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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 UnionIn 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 recentauthorisation 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. Theopinion of the public should also be taken into account34 however this is interpreted

31 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 theEFSA 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 StandingCommittee 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 furtherinformation. 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 EFSAis 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

35 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 decisionssubmitted 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 metwith 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 isfar 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 healthand 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

41 LEE., p. 68.42 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 andfeed 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 exchangecould 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

48 Id., recital 24.49 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 themarket 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 canbe 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 environmentP9 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

54 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 possiblespread 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 thearea. 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 tobe 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 parsimoniousapproach, 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. 1163 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 ourregulatory 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 thoseproducts 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

64 It is just an assumption that in case of insufficient evidence, science should err on the side of non-

existence 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. 2967 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 theacquis. 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 arealready 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 minorimportance.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 theadoption 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

70 EFSA Opinion 2004, p. 13.71 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 RiskManagement 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 EFSAsown 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 justemphasised 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

76 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 resistancegenes 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 inthe 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 considerationby 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 thatthe 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:

ARMG

widespread in

nature

P2:

Antibiotics

concerned

important?

P3:

Horizontal

gene transfer

likely?

C:

Safe to use?

EFSA Yes No* No Yes

EMEA Yes Yes n/a n/a

80 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 otherthan safety were more important for the authorisation, but were excluded from consideration by the

current regulation.


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Greenpeace n/a Yes n/a No

Commission Yes Yes 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 hardpressed 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 isthe 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 And also of the member states even though they on this decisional stage they are only observers.82 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 reasonfrustrates 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 byEFSA, 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 caseswhere the rationality gap cannot be closed, we can still confer legitimacy to decision-

making 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 asthey 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 individualconclusions) 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 suchnone 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 realdifference 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

84 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 non-

scientific 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. 5686 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 fromnot 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 takedifferent 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 thebasis 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 asCass 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,

88 It should be noted that the premise integration I advocate does not mean legislative harmonisation

of premises, but inclusion.


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References

PHILIP PETTIT & WLODEK RABINOWICZ,Deliberative Democracy and the DiscursiveDilemma, 35 Nous (Supplement: Philosophical Issues, 11, Social, Political, and LegalPhilosophy) (2001).

PHILIP PETTIT,Depoliticizing Democracy, 17 Ratio Juris (2004).

PHILIP PETTIT, Collective Persons and Powers, 8 Legal Theory (2002).

ELIZABETH FISHER, Risk regulation and administrative constitutionalism (Hart. 2007).

CASS R.SUNSTEIN, Risk and reason : safety, law, and the environment (CambridgeUniversity Press. 2002).

PHILIP PETTIT,Democracy, Electoral and Contestatory, in NOMOS: Designing democraticinstitutions (Ian Shapiro & Stephen Macedo eds., 2000).

SAMANTHA BESSON & JOS LUIS MART, Deliberative democracy and its discontents

(Ashgate. 2006).JOHN PARKINSON, Deliberating in the Real World: Problems of Legitimacy in DeliberativeDemocracy (2006).

PETER MAIR, Popular Democracy and the European Union Polity European GovernancePapers.

ANDREAS FOLLESDAL & SIMON HIX, Why There is a Democratic Deficit in the EU: AResponse to Majone and Moravcsik, 44 Journal of Common Market Studies (2006).

CASS R.SUNSTEIN, The Law of Group Polrization, 10 Journal of Political Philosophy (2002).

GIANDOMENICO MAJONE, Two Logics of Delegation: Agency and Fiduciary Relations in EUGovernance, 2 European Union Politics (2001).

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).

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

TYLOR COWEN & ROBIN HANSON,Are Disagreement Honest athttp://hanson.gmu.edu/deceive.pdf.

Directive 2001/18/EC on the deliberate release into the environment of genetically modifiedorganisms OJ L 106/1 (12 March 2001).

Regulation 1829/2003/EC on genetically modified food and feed OJ L 268/1 (22September 2003).

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 offood safety OJ L 268/1 (28 January 2002).

MARK A.POLLACK & GREGORY SHAFFER,Biotechnology Policy. Between National Fears andGlobal Disciplines in Policy-making in the European Union (Helen Wallace, et al. eds.,2010).

MARIA LEE, EU regulation of GMOs : law and decision making for a new technology(Edward Elgar. 2008).


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JANE HOLDER, et al., Environmental protection, law and policy : text and materials(Cambridge University Press 2nd ed. 2007).

EFSA, Opinion of the Scientific Panel on GMO on a request from the Commission related tothe 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 Cof Directive 2001/18/EC from BASF Plant Science The EFSA Journal (2006).

EFSA, Opinion of the Scientific Panel on GMO on the use of antibiotic resistance genes asmarker genes in genetically modified plants The EFSA Journal (2004).

Critically Important Antibacterial Agents for Human Medicine for Risk ManagementStrategies of Non-Human Use. Report of a WHO working group consultation. (2005).

EMEA, Committee for Medicinal Products for Veterinary Use And Committee For MedicinalProducts For Human Use Presence of the ARMG nptII in GM plants for Food and Feed Uses ,EMEA/CVMP/56937/2007 (2007).

EFSA, Statement of the Scientific Panel on GMO on the safe use of the nptII antibiotic

resistance marker gene in genetically modified plants (2007).

EFSA, Statement of EFSA on the consolidated presentation of opinions on the use ofantibiotic resistance genes as marker genes in genetically modified plants, The EFSA Journal(2009).

JENS STEFFEK & MARIA PAOLA FERRETTI,Accountability or Good Decisions? TheCompeting Goals of Civil Society Participation in International Governance, 23 GlobalSociety (2009).

Documents

GMO Authorisations in EU - Amflora case study