22 Mar 2010 – The Guidance introduces new principles and concepts for environmental risk assessment of genetically modified plants (GMP ERA), in the first place the principle of the “comparative safety assessment” as a reformulation of the “concept of substantial equivalence”. Further, the Guidance foresees to use the “concept of familiarity” as upstream decision-making instrument for the GMP ERA.
Both concepts have been judged as not appropriate for GMP ERA by many experts and decision makers und thus have not been recognised in the two major legally binding frameworks, the Directive 2001/18 and the Cartagena Protocol on Biosafety.
Based on the mandate given by the European Commission, this Guidance had to be developed and updated in four clearly described points in order to better implement the EU GMO legislation – not fundamentally alter it. EU legislation defines that each GMO has to be assessed through an ERA without an upstream screening and decision-making instrument as suggested by the EFSA Guidance. EU legislation as well as Codex Alimentarius Guidelines rejects the concept that the test on substantial equivalence can serve as safety assessment in itself – as it would be the case if the concept of comparative safety assessment should be applied in future by EFSA.
ENSSER beleaves that this alteration of the GMP ERA process will lead to a situation in which risk assessors make use of the obsolet “concept of familiarity” to declare significant differences between a GMP and its parents as “irrelevant” before an ERA on exactly these differences is conducted. With this approach, EFSA proceeds with its repeatedly criticised efforts to implement the EU regulations under its own interpretation. In contrast to the many useful deliberations and recommendations given in the chapters on scientific and technical issues, the sections on principles and concepts fail to provide sound guidance how to operationalise them with regard to their normative and scientific challenges. In this context, it is especially regretful that EFSA has not satisfactory fulfilled the given mandate with regard to the “identification of the EU geographic regions where GM plants may be released and the selection of representative receiving environment(s) which reflect the appropriate meteorological, ecological and agricultural conditions”.
In this context, ENSSER has noted with interest that Commissioner John Dalli in his speech “GMOs: towards a better, more informed decision-making process” on March 17, 2011, did not support the suggestion of EFSA to introduce a “comparative safety assessment” in conjunction with the “concept of familarity” but stressed that all differences between the GMO and its comparator will be subject to a risk assessment.
ENSSER urges decision makers, experts, and stakeholders to engage in a sound discussion on both, the appropriate principles and concepts as well as the appropriate scientific and technical approaches for GMP ERA. There need to be given sufficient time for these debates to avoid any hasty decisions aiming at transforming the Guidance into a legally binding document for the entire EU. ENSSER and its members are dedicated to engage in any transparent and open processes to debate the future of the EU GMO risk assessment system.
The key recommendations to EFSA are:
• Deletion of Chapter 2.1 and abandonment of the concept of “comparative safety
assessment” and the “concept of familiarity”
• Adherence to Directive 2001/18 general principle comparison of GMO with the most appropriate comparator (eg. the parental organisms) in ERA
• Establishment of scientific criteria to interprete statistically significant differences in unintended effects
• Rewriting of Chapter 2.2 giving a comprehensive overview about approaches to problem formulations
• Adding a chapter on methodological and institutional approaches for normative elementsof ERA as problem formulation, selection of protection goals, or ecological/biological relevance.
The key recommendations to the European Commission and the Member States are:
• Ensuring participatory and open processes including all relevant stakeholders to establish these normative elements of the e.r.a. process prior to new applications for GM plant market approvals
• New applications for GM plant market approval can only be accepted when the new e.r.a. concepts and procedures are established and implemented.
ENSSER also proposes to convene expert rounds to discuss the key concepts and provisions of the Guidance during the process of revision and before approval by EU Member States. ENSSER finally suggests that the processes and elements of the new Guidance should be tested in hands-on courses by relevant stakeholders during the process of revision and before approval by EU Member States. Such testing will be proposed by ENSSER as activitiy in the application for the FP7 Project “GM crops in the EU – systematically assessing environmental and economic impacts”.