FAIRFAX AGRICULTURAL MEDIA’s Canberra Bureau Chief, Colin Bettles, requested a response to the European Food Safety Authority’s final evaluation of the paper by Séralini et al.
Read SFF Director, Scott Kinnear’s response below:
The EFSA position is to be expected given the initial findings and the general observation that we at SFF make of FSANZ and other food regulatory agencies, specifically that their foremost task is to protect the industry that they regulate, by legalising products with scant and unsatisfactory safety testing at the direct expense of public health and safety.
Some comments about EFSA:

1. EFSA says in its press release “The Authority’s final review reaffirmed its initial assessment that the authors’ conclusions cannot be regarded as scientifically sound because of inadequacies in the design, reporting and analysis of the study as outlined in the paper. Consequently, it is not possible to draw valid conclusions about the occurrence of tumours in the rats tested.”

EFSA ignores the biochemical tests that Seralini et al did. They do not deny the tumours or that the tumours may be caused by either Roundup or the GMO rather they say that there is insufficient evidence to assure the causation. When you have an adverse effect and then require public scientists to prove causation, you effectively erect a hurdle in favour of the commercial interests of the product.

2. EFSA says in the press release “EFSA’s analysis has shown that deficiencies in the Séralini et al. paper mean it is of insufficient scientific quality for risk assessment. In addition, several national organisations were independently mandated by Member States to assess this study. These reviews have demonstrated a consensus among  a significant part of the EU risk assessment community that the conclusions of Séralini et al. are not supported by the data in the published paper. We believe the completion of this evaluation process has brought clarity to the issue.”

EFSA did no scientific analysis, it only reviewed the data. EFSA has not presented contrary scientific findings from experiments but has only served to cast doubt on the causative link between Roundup, NK603 and the adverse effects recorded in Seralini et al. Before issuing this opinion, why did they not do some science of their own???

3. EFSA says a consensus has formed between EFSA and Member States. While the Member States conclude as well that for the moment the Seralini et al paper is not sufficient to change their minds, they are not entirely dismissive of the work or the findings. In fact, if you read the one from Belgium, they say “one expert felt this…”  “two experts noted that…” A. The individual opinions from the member states are themselves not peer-reviewed to the same standard as the Seralini paper itself! B. They are speaking in minority terms on each quibble, even if the majority overall agree that the paper is not suitable for changing the opinion of the agency on safety. C. They are not any more expert than the peer-reviewers of Seralini’s paper or the scientists of ENSSER that have reached different conclusions. Even the member states most often say that the problem is one of PROVING the cause and needing more animals to do so, they do not DENY that there is an adverse effect. Only that you cannot prove to their normative standard that the cause was the GMO or Roundup. Good scientists would react with data.

Look at the Member State reports in Annex 1. From Belgium: Annex 1: Minority opinion · Considering the uncertainties on long term effects of GM maize NK603 on health, we ask for a reassesment of the advice of the BAC on the initial dossiers of the maize NK603, regarding effects on human and animal health, using the same critical analysis that was applied by the BAC’s experts to the Seralini et aI, study: Jean-Claude Gregoire, Damien Winandy, Lucette Ffandroy and Philippe Baret”

These scientists want the same kind of robust re-evaluation on those dossiers as Seralini et al were subject to here. They do not believe that this one-sided criticism of only Seralini gives the right overall assessment of the state of the science of risk assessment of GMO and herbicides.

The overall French conclusion is similar to what EFSA says in that the Germans won’t change their minds just because of Seralini et al’s findings. However, if you read deeper, they say, “This study is unique in that over this long period and using several doses, it tests both a GMP cultivated with and without treatment by a plant protection product and the complete plant protection formulation by itself. In this respect, no equivalents have been found in the literature. It is also distinctive in that it monitors a large number of blood and urine parameters and the authors indicate that it was undertaken in a GLP environment.”

“This study is commendable for having addressed novel issues.”

“Nevertheless, the ECEAG experts note the lack of studies on the potential effects of long-term exposure to various glyphosate-based formulations and the limited number of studies that have addressed the long-term effects of consuming GMOs.”

In the end the French came to this conclusion of uncertainty over the controversy that has erupted:

“However, whether current assessment methods can detect potential long-term effects and the plausibility of these effects are subjects of controversy in the scientific community. Given that there are so few studies documenting these effects, it is difficult to overcome this controversy. The ECEAG deems that these issues should be debated, especially in regard to the growing and foreseeable complexity (GM stacked events) of genetically-modified plants. The ECEAG experts therefore feel that it is necessary to deliberate further on whether the scientific principles for evaluating safety should be revised and this deliberation should be based on all the studies that have been conducted on a national level, particularly by ANSES, but also on an international level.”

In other words, their main conclusion was that the Seralini et al study was sufficiently robust as to create doubt in their minds that this herbicide and NK603 are safe on existing evidence. New protocols and new evidence supporting safety are warranted.

“Thus, more generally speaking, ANSES calls for more public funding on the national and European levels for broad-scope studies to consolidate scientific knowledge on insufficiently documented health risks. In light of the needs for studies and research highlighted by the ECEAG, ANSES recommends: – more research on the potential health effects associated with the long-term consumption of GMOs or long-term exposure to plant protection products. This research should focus in particular on the issue of exposure to GMOs and to residues of associated plant protection preparations. These studies should be conducted using public funds and based on precise research protocols that address specific questions (investigated effects, monitored parameters, research methodology, number and nature of animals studied, complexity of the GMO, type of exposure, etc.). ANSES is prepared, along with other partners, and particularly other European health agencies, to work toward defining the general principles for these study protocols; – and more broadly speaking, fostering research on the health issues associated with chronic exposure to xenobiotics (active substances, co-formulants), their mixtures and their potential interactions, especially regarding their effects when combined with GMOs.”

Likewise, the Germans also emphasise what was unique to Seralini et al and the inability to dismiss the relevance of those findings. “However, the BfR is aware of certain co-formulants, in particular surfactants from the group of polyethoxylated alkyl amines (POEA, often designated as tallow amines), that might affect the toxicity of glyphosate containing herbicides. The toxic effects are in some cases more severe compared to studies with the active ingredient. Therefore, the results of the study performed by Séralini’s group could provide an experimental contribution to the elucidation of the possible influence of formulants on long-term effects of plant protection products.”They also say more work is needed. They don’t dismiss Seralini, they deny that it was sufficient alone to change their minds.
Thus in summary, there is a controversy surrounding what is the best science for risk assessment for GMO’s and crop protection chemicals. Key member states are calling for reviews on the GMO and crop protection product assessed by Seralini et al and on the science used to conduct risk assessments. Thus Seralini et al’s work has had a significant beneficial effect. We hope that it is replicated using larger sample sizes to satisfy the criticisms and that this is publicly funded and conducted urgently to rule out the possibility of causation. This is consistent with the recommendations that Seralini et al made in their study.

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