"GMO expertise: assessment process turns its back on science"
[Note from GM-Free Cymru: In quite a detailed Report Inf'OGM describes a new analysis done on the Draft Implementing Regulation, and comes to the same conclusion as many other NGOs -- namely that EFSA and the Commission are seeking, through this document, to water down the GM assessment process, leaving far too much discretion at the door of EFSA to do comfortable deals with GM applicants which will -- more often than not -- do away with any requirement for toxicological testing. All that will be required is that EFSA and the applicant will have to agree on this absurd thing called "substantial equivalence." As Dr Jacquemart points out, this is not a scientific assessment at all, and will allow GM crops to be authorised on the basis of assessments that are based upon assumptions and assurances rather than on proper investigations of toxicity. We agree with Dr Jacquemart that this indicates that EFSA is in effect turning its back on science, much to the delight of the biotechnology lobby which sees all regulation of GM products as anathema. the Draft Implementing Regulation MUST be stopped before it is brought into law -- and we are now quite hopeful that it WILL be stopped, since many NGOs, national governments and even the European Parliament do seem to be fully aware of what is going on.]
This is the material from inf'OGM -- apologies for the poor translation from the French, but you will get the general idea.........
The issue of GMOs is trapped in conflictual controversies which largely hide the core of the problem, this sphere beyond the technical realm is conditioning our future. In order to solve the technical issue so as to move onto more interesting and important things, Inf'OGM has gone through some cases with a fine-tooth comb and compared the positions of experts when acting in a scientific capacity and when they are acting in the capacity of experts, so as to demonstrate their contradictions. Particularly, the European Food Safety Authority (EFSA), which had been asked for several years about the harmlessness of maize MON810, finally answered but avoided the question, thus implicitly admitting its failures. Concretely this means: selecting data, only keeping those which were favourable to industrialists, having statistical tests with such weak power that one could hardly see anything (which is what is done when one does not WANT to see anything), statements devoid of scientific bases, dishonest answers from EFSA to elected politicians and ministers who were concerned about these anomalies, the conclusion of safety based on "the weight of evidence", which means that no data really allows this conclusion to be drawn, a test developed by Monsanto and imposed by ILSI which was to show that, if it were applied in this field and following EFSA's logic, it would be very unlikely for cholera to be pathogenic for humans, in other words nothing but "Sound Science", which is how European experts like to describe what they do. Inf'OGM says "you emphasize science, then do it properly by following its basic rules". In the meantime, activists will focus on something else, which they were too distracted to focus on due to the debate being pigeon-holed in the health question, wanted by the industry and some politicians. In its conclusion, Inf'OGM reminds us that now what is really at stake involves the change to the cultural and ethical context currently underway.
The full report can be downloaded here: http://www.infogm.org/spip.php?article5313
An open letter to civil society's organisations involved in the GMO debate
Concerning the new GMO risk assessment guidelines, the new European Commission [1] proposal could lead to no assessment at all if GMOs are declared substantially equivalent to a comparator.
Following the unanimous EU council's vote, on December 2008, to improve the GMO risk assessment, EFSA was mandated to update its guidelines. Three years of work and talks later, the European Commission has sent an implementing regulation draft, based on EFSA's opinion [2]. This is crucial as we will see.
Those new guidelines for the GMO risk assessment do propose some improvements to the existing guidelines. But those improvements will never concretely come into force. In the last version, the conduct of toxicological and nutritional assessment are subjected to the highlighting of biologically relevant difference between the components composition of the GMP (meaning fatty acids, amino-acids...) and its non GM comparator. It is to be stressed here that such a substantial equivalence is claimed in all the authorisation request files, even if based on non scientifically valid analysis but validated as such by the european experts [3].
The guidelines' wording [4] ?
Paragraph 1.4, in its main part of general meaning, states :
« The toxicological impact of any changes resulting from the expression of introduced genes or any other type of genetic modification [...] shall be assessed ». Quotation "any changes resulting" induces that, if substantial equivalence is shown, nothing's to be assessed. This Inf'OGM's reading is discussed by other persons. According to them, this sentence defines the obligation to conduct a compositional comparison analysis. For others, it defines the need to establish the nature of further tests to be done, depending on the results of this analysis. It has to be considered that this sentence concerns the toxicological analysis and not the compositional ones. But most important, such an unclear statement read by other NGOs is not to be maintained in the regulation supposedly reinforcing risk assessment, except if there's an hidden will. Additionally to this :
1) Guidelines are also stating that :
« The applicant shall consider the need of toxicological testing based on the outcome of the molecular and comparative analysis referred to in Section 1.2 and 1.3, namely the differences identified between the genetically modified product and its conventional counterpart, including intended as well as unintended changes ».
On the basis of the "substantial equivalence" analysis that the EU is pushing forward as the key of the assessment procedure, the applicant is therefore to decide for himself if toxicological analysis are to be conducted or not. Reducing the assessment procedure to the comparison of a few components and phenotypic exams would therefore be the answer to the assessment reinforcement requested by the European Ministers of Environment. As if an architect was considering two buildings identical because the number of bricks was almost the same in each one.
2) Previous texts or statements make clear the intend to push forward substantial equivalence.
In a previous version of the proposed regulation published in 2009 [5], the European commission wrote "The applicant shall include a 90-day feeding study in rodents [6] [...] : (a) In case the composition of the GM plant is modified substantially, the testing program shall include at least a 90-day feeding study in rodents […], If there are indications or remaining uncertainties regarding the potential occurrence of unintended effects, based on the preceding molecular, agronomical, phenotypical and/or compositional analysis" (page 43).
About substantial equivalence, it is written that "the outcome of this assessment shall determine whether animal feeding trials with the whole food and feed shall be performed" (page 44).
During an EFSA's GMO panel meeting with european NGOs [7] on GMOs environmental assessment guidelines, the authority's presentation stated that if substantial equivalence was shown, no further assessment would be necessary.
Concerning the actual regulation proposal discussed, NGOs are therefore not over interpreting. It is clearly the expression of EFSA's and / or European Commission's will to reduce GMOs risk assessment to the sole substantial equivalence, quoted with different words (comparative analysis of the composition).
EFSA provides a concrete example with GHB614 cotton files, when justifying the lack of toxicological analysis according to ongoing guidelines : "On the basis of the comparative analysis the EFSA GMO Panel concluded that cotton GHB614 is compositionally and agronomically equivalent to the non-GM comparator and other conventional cotton varieties except for the introduced trait. In addition, this analysis as well as the molecular characterisation provided no indications of unintended effects of the genetic modification. According to the EFSA GMO Panel guidance document, animal safety studies with the whole food/feed are not required (EFSA, 2006a)".
Inf'OGM's and other NGOs reading of the discussed regulation is therefore confirmed by EFSA's policy as showing the importance given to substantial equivalence.
Changing the ongoing guidelines into a regulation as proposed is to finalise such a dynamic. Guidelines are not mandatory for the applicants. Those last ones are still responsible for the assessment analysis provided. A regulation is legally binding. Applicants following the regulation are therefore not anymore responsible in case of troubles arising later, even if the initial risk assessment was insufficient. The European union will be responsible for this.
The writing will be the only thing left, legally binding, no matter the reading or will presented by the European commission or EFSA.
It is now up to the civil society's organisations to make them heard, if such a need was acted.
Dr. Frédéric Jacquemart Inf'OGM's chair
Inf'OGM's contact : Eric Meunier Inf'OGM 2 b, rue Jules Ferry – 93100 Montreuil France
Courriel : eric@infogm.org Tél : 01 48 51 65 40
NOTES:
[1] Also designated as an EFSA proposal
[2] « Sanco/12462/2011 rev. 2 (pool/e1/2011/12462/12462r2-en.doc) [...](2012) xxx draft, Commission implementing regulation (EU) No .../.. of XXX on applications for authorisation of genetically modified food and feed in accordance with Regulation (EC) No 1829/2003 of the European Parliament and of the Council and amending Regulations (EC) No 641/2004 and (EC) No 1981/2006 » disponible sur infogm.org/spip.php?rubrique837
[3] Read also « Expertise des OGM : l'évaluation tourne le dos à la science » ed. Inf'OGM, 2012 (english version to come by beginning of 2013.
[4] Read also Inf'OGM's analysis of octobre the 24th, 2012 : « Are toxicological analysis still mandatory according to the proposed regulation from EC to Member states on GMP's risks assessment ? » downloadable on infogm.org/spip.php?rubrique837
[5] http://members.wto.org/crnattachments/2010/tbt/eec/10_0030_00_e.pdf
[6] Meaning subchronic toxicology analysis.
[7] Among which France Nature Environnement for France