In examining the manner in which EFSA has assessed GM maize applications in Europe prior to giving its "favourable assessments" and recommending approvals, the authors of this paper make it clear that the requirements of the relevant Directives (particularly Directive 2001/18/EC) have not been met. There is too much dependence upon the assurances of the applicants; too little questioning as to the effects of the genetically modified plant as a whole (as distinct from the effects of "surrogate proteins"); poor assessments of the likely levels of exposure and risk in the field; a haphazard and inconsistent approach to the methods of risk evaluation and monitoring that should be employed; and a cavalier attitude to the effects of associated herbicides on the environment, in the case of herbicide tolerant crops. Other things too. Not exactly a ringing endorsement of EFSA's methods -- and it can be argued that EFSA has consistently and deliberately flouted the legal requirements placed upon it in the Directives. If that is the case, are the GM crop consents already issued actually legal?
by Marion Dolezel, Marianne Miklau, Angelika Hilbeck, Mathias Otto, Michael Eckerstorfer, Andreas Heissenberger, Beatrix Tappeser and Helmut Gaugitsch
Environmental Sciences Europe 2011, 23:33 doi:10.1186/2190-4715-23-33
The prevailing controversies on the potential environmental risks of genetically modified organisms [GMOs] still fuel ongoing discussions among European Union [EU] member states, risk assessors, applicants and scientists, even several years after the commercial introduction of GMOs. The disagreements mainly derive from the current risk assessment practice of GMOs and differences in the perceived environmental risks. Against this background, the aim of this study was to scrutinize the current practice of environmental risk assessment [ERA] of several GMO applications currently pending for authorisation in the EU.
We analysed the data presented for three assessment categories of the ERA of genetically modified [GM] maize applications for cultivation in the European Union: the agronomic evaluations and the assessments of the effects of GM maize on target organisms and of its potential adverse effects on non-target organisms.
Major shortcomings causing considerable uncertainties related to the risk assessment were identified in all three categories. In addition, two principles of Directive 2001/18/EC are largely not fulfilled - the consideration of the receiving environment and the indirect effects, as mediated, e.g. by the application of the complementary herbicide in the case of herbicide-tolerant GM maize.
We conclude that the current practice of ERA does not comprehensively fulfil the scientific and legal requirements of Directive 2001/18/EC, and we propose improvements and needs for further guidance and development of standards. The recommendations address likewise applicants, risk assessors as well as decision makers.
From the evaluation of the data presented for the three assessment categories in GM maize applications, we conclude that there is a need for an improvement of the ERA and its data base if cultivation is envisaged. This requires a broader ERA concept that includes a thorough exposure analysis and the scientific evaluation of the whole GMP at different containment levels guided by testable risk hypotheses. Risk conclusions should be based on relevant data specifically generated for and using the GM event in question. Basic information on the agronomic characteristics and the efficacy of the GMP as well as its environmental behaviour must be provided for the ERA. The corresponding herbicide and its agronomic and environmental consequences also need to be taken into account. Such an approach would significantly strengthen the risk conclusions and their credibility.
Careful attention ought to be paid to the consideration of relevant data obtained from different European environments. Here, guidance for the selection of representative locations for field trials assessing the agronomic and environmental characteristics of the GMP is urgently needed. There is also a strong need for the development of standards with respect to the test designs, methods and parameters to achieve a common approach for specific assessments, e.g. the evaluation of the efficacy of the GMP against its target organism. Such standards could significantly improve the ERA without overruling the case-by-case approach.
The aforementioned shortcomings have led to considerable dispute among EU MS, in particular regarding the data gaps and uncertainties in the ERAs. Nevertheless, the presented data were frequently considered sufficient in EFSA GMO panel opinions and the GMP declared safe with respect to potential effects on the environment. This apparent discrepancy in the perception of environmental risks can only be resolved if a common understanding of how an ERA should be performed and which scientific data should be included will be achieved. In our view, the addressed suggestions would significantly improve the quality of the ERAs of GM maize applications and hence fulfil the requirements of Directive 2001/18/EC. EFSA has recently made an important step forward in updating the guidance on ERA in collaboration with all stakeholders . This updated guidance is now under scrutiny by the MS.