Our respondents, eight current or former members of the EFSA GMO panel, focus on defending the EFSA's environmental risk assessment (ERA) procedures. In our article for EMBO reports, we actually focused on the proposed EU GMO legislative reform, especially the European Commission (EC) proposal's false political inflation of science, which denies the normative commitments inevitable in risk assessment (RA). Unfortunately the respondents do not address this problem. Indeed, by insisting that Member States enjoy freedom over risk management (RM) decisions despite the EFSA's central control over RA, they entirely miss the relevant point. This is the unacknowledged policy—normative commitments being made before, and during, not only after, scientific ERA. They therefore only highlight, and extend, the problem we identified.
The respondents complain that we misunderstood the distinction between RA and RM. We did not. We challenged it as misconceived and fundamentally misleading—as though only objective science defined RA, with normative choices cleanly confined to RM. Our point was that (i) the processes of scientific RA are inevitably shaped by normative commitments, which (ii) as a matter of institutional, policy and scientific integrity must be acknowledged and inclusively deliberated. They seem unaware that many authorities [,,,] have recognized such normative choices as prior matters, of RA policy, which should be established in a broadly deliberative manner “in advance of risk assessment to ensure that [RA] is systematic, complete, unbiased and transparent” []. This was neither recognized nor permitted in the proposed EC reform—a central point that our respondents fail to recognize.
In dismissing our criticism that comparative safety assessment appears as a ‘first step’ in defining ERA, according to the new EFSA ERA guidelines, which we correctly referred to in our text but incorrectly referenced in the bibliography [], our respondents again ignore this widely accepted ‘framing’ or ‘problem formulation’ point for science. The choice of comparator has normative implications as it immediately commits to a definition of what is normal and, implicitly, acceptable. Therefore the specific form and purpose of the comparison(s) is part of the validity question. Their claim that we are against comparison as a scientific step is incorrect—of course comparison is necessary. This simply acts as a shield behind which to avoid our and others' [] challenge to their self‐appointed discretion to define—or worse, allow applicants to define—what counts in the comparative frame. Denying these realities and their difficult but inevitable implications, our respondents instead try to justify their own particular choices as ‘science’. First, they deny the first‐step status of comparative safety assessment, despite its clear appearance in their own ERA Guidance Document []—in both the representational figure (p.11) and the text “the outcome of the comparative safety assessment allows the determination of those ‘identified’ characteristics that need to be assessed […] and will further structure the ERA” (p.13). Second, despite their claims to the contrary, ‘comparative safety assessment’, effectively a resurrection of substantial equivalence, is a concept taken from consumer health RA, controversially applied to the more open‐ended processes of ERA, and one that has in fact been long‐discredited if used as a bottleneck or endpoint for rigorous RA processes [,,,]. The key point is that normative commitments are being embodied, yet not acknowledged, in RA science. This occurs through a range of similar unaccountable RA steps introduced into the ERA Guidance, such as judgement of ‘biological relevance’, ‘ecological relevance’, or ‘familiarity’. We cannot address these here, but our basic point is that such endless ‘methodological’ elaborations of the kind that our EFSA colleagues perform, only obscure the institutional changes needed to properly address the normative questions for policy‐engaged science.
Our respondents deny our claim concerning the singular form of science the EC is attempting to impose on GM policy and debate, by citing formal EFSA procedures for consultations with Member States and non‐governmental organizations. However, they directly refute themselves by emphasizing that all Member State GM cultivation bans, permitted only on scientific grounds, have been deemed invalid by EFSA. They cannot have it both ways. We have addressed the importance of unacknowledged normativity in quality assessments of science for policy in Europe elsewhere []. However, it is the ‘one door, one key’ policy framework for science, deriving from the Single Market logic, which forces such singularity. While this might be legitimate policy, it is not scientific. It is political economy.
Our respondents conclude by saying that the paramount concern of the EFSA GMO panel is the quality of its science. We share this concern. However, they avoid our main point that the EC‐proposed legislative reform would only exacerbate their problem. Ignoring the normative dimensions of regulatory science and siphoning‐off scientific debate and its normative issues to a select expert panel—which despite claiming independence faces an EU Ombudsman challenge [] and European Parliament refusal to discharge their 2010 budget, because of continuing questions over conflicts of interests [,]—will not achieve quality science. What is required are effective institutional mechanisms and cultural norms that identify, and deliberatively address, otherwise unnoticed normative choices shaping risk science and its interpretive judgements. It is not the EFSA's sole responsibility to achieve this, but it does need to recognize and press the point, against resistance, to develop better EU science and policy.
- Copyright © 2012 European Molecular Biology Organization