NOTE from GM-Free Cymru: This Open Letter and the ENSSER [European Network of Scientists for Social and Environmental Responsibility] comments on the new EFSA Guidance constitute a polite but nonetheless very strong criticism of what EFSA is proposing to do. As we and many others have suggested, EFSA is seeking to speed up and simplify the assesment and approvals process, while pretending to be tightening it up.
 
Furthermore, ENSSER also homes in on the great extra discretion which EFSA wants to give itself in deciding what evidence it wants to assess from applicants for GM consents. This extra discretion is underpinned by "new principles and concepts" as outlined in the letter and elaborated in the comments published on the ENSSER web site. As we have pointed out in our 2 petitions to the EU Petitions Committee, this comes very close to a change in POLICY relating to GM assessment principles -- this is not anything that EFSA has any right to dabble in, and we would argue that it is illegal.

ENSSER letter to DG SANCO
http://www.ensser.org/fileadmin/files/ENSSER_letter_ERA_guidance.pdf

ENSSER comments on EFSA Guidance on the Environmental Risk Assessment of Genetically Modified Plants
http://www.ensser.org/fileadmin/files/ENSSER_comments_ERA_giudance.pdf
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[Letter from ENSSER]

Berlin, 22 March 2011

[to] Karin Nienstedt
European Commission
Health and Consumers Directorate-General
Safety of the Food Chain
Biotechnology

Dear Ms. Nienstedt,

The European Network of Scientists for Social and Environmental Responsibility (ENSSER) is engaged in the European and international biosafety debate since its foundation in 2009. ENSSER is actively participating in the current discussion on the reform of the EU GMO risk assessment process. Several of its members study and develop the issues, specifically GMO risk research and risk assessment, since more than a decade.

We would like to follow the invitation of the European Commission to study and comment on the current version of the EFSA Guidance on the environmental risk assessment of genetically modified plants of November 2010. While our first comment on the draft Guidance of March 2010 concentrates on scientific and technical issues, the new comments focus on the underlying principles and concepts presented in the Guidance chapters 2.1 and 2.2 and are contained in the annex to this letter.

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 believes that this alteration of the GMP ERA process will lead to a situation in which risk assessors make use of the obsolete "concept of familiarity" to declare significant differences between a GMP and its parents as "irrelevant" before an ERA on exactly these differences is conducted.(1) 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 th
 e
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. (2)

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:
Ӣ Deletion of Chapter 2.1 and abandonment of the concept of "comparative safety assessment" and the "concept of familiarity"
Ӣ Adherence to Directive 2001/18 general principle comparison of GMO with the most appropriate comparator (eg. the parental organisms) in ERA
Ӣ Establishment of scientific criteria to interprete statistically significant differences in unintended effects
Ӣ Rewriting of Chapter 2.2 giving a comprehensive overview about approaches to problem formulations
Ӣ Adding a chapter on methodological and institutional approaches for normative elements of ERA as problem formulation, selection of protection goals, or ecological/biological relevance.
The key recommendations to the European Commission and the Member States are:
Ӣ 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
Ӣ 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".

Sincerely yours,
Angelika Hilbeck, Chairperson of European Network of Scientists for Social and Environmental Responsibility (ENSSER)

NOTES

1   As explained for example in a recent publication of an EFSA GMO Panel member: "The outcome of this comparative safety assessment allows the identification of those differences and hence characteristics that need to be assessed for their biological/ecological relevance in terms of adverse effects to the environment, regardless of whether they were intended or unintended, and will thus further structure the ERA." (Bartsch 2011)

2  John Dalli Commissioner for Health and Consumer Policy: GMOs:  towards a better, more informed decision-making process Debate on GMO Risk Assessment and Management.- Brussels, 17th March 2011 (pdf:
http://europa.eu/rapid/pressReleasesAction.do?reference=SPEECH/11/187&format=HTML&aged=0&language=EN ;
video stream: http://scic.ec.europa.eu/str/index.php?sessionno=4cb811134b9d39fc3104bd06ce75abad , 28:40 min)

Attachment:
ENSSER Comments on the EFSA Guidance on the Environmental Risk Assessment of Genetically Modified Plants
http://www.ensser.org/activities/projects/reforming-the-gmo-approval-system/

ENSSER e.V. Postfach 1102 D-15832 Rangsdorf  phone: +49 (0) 33 708 /  93 99 62
fax:  +49 (0) 33 708 / 93 99 61
email: This email address is being protected from spambots. You need JavaScript enabled to view it.
URL: http://www.ensser.org
Dr. Angelika Hilbeck, Chairperson