EFSA -- hypocrisy, double standards and dodgy dealing on Seralini paper
There's an old saying that goes like this: "When you are in a hole that is too deep to climb out of, for God's sake stop digging!" EFSA is obviously unaware of it, for having got itself into a frightful pit on virtually everything to do with GMOs, over many years, it just cannot resist making matters worse. If it keeps going like this, the sides of the pit will simply cave in, and EFSA will be buried without trace. No bad thing, you might think, and GM-Free Cymru would agree with you........
When the paper by Seralini and his team (1) was published on 19th September 2012, showing that both GM maize NK603 and Roundup herbicide had dramatic negative effects on the health of rats during a two-year feeding trial, EFSA should of course have welcomed the new research, put an instant moratorium on all pending GMO applications in the pipeline, and asked for further research in order to verify or falsify the results of the French team. That would have been entirely appropriate, given that EFSA is required at all times to be mindful of the Precautionary Principle and to treat as its highest priority the protection of public health. But no -- it immediately launched into a damage limitation exercise, on the basis that the Seralini study suggested very strongly that all of its previous assessments of GMOs, and its long-standing assumption that all GMOs are safe, were fundamentally flawed. So in order to save face, and to protect the interests of the GM industry, EFSA launched a grubby little campaign designed to discredit Seralini and his team and to suggest that their research results had no scientific relevance. It set up a "rebuttal unit" involving a group of senior EFSA employees and headed by Andrew Chesson, who was involved in 1998 in the campaign of vilification directed at Arpad Pusztai and in 2003 in the original granting of approval for NK603 on the grounds that it was perfectly safe. So there was not even the slightest pretence of impartiality or objectivity in the EFSA deliberations, and this has received widespread criticism from all sides (2). To make matters worse, EFSA convened a "teleconference" with a number of trusted allies from Belgium, Denmark, France, Germany and the Netherlands to coordinate "scientific critiques" of the Seralini paper and to ensure that there were no "dissenting voices" at a European level. Unfortunately for EFSA, the minutes of this meeting were leaked on a Dutch government web site............ (3) Conspiracy or cockup? Who can tell?
All that came on top of recent scandals over EFSA's cosy working relationships with the GM industry by which staff move back and forth and maintain very close working links -- even to the extent of the industry helping to draft EFSA guidelines on GMO assessments and regulatory mechanisms. As a result of these tight and potentially corrupt links with industry, Commissioner John Dalli has been forced to resign, as has Diana Banati, head of EFSA's management board (4). There is an ongoing investigation into improper influence exerted within the EFSA GMO Panel by long-standing Chairman Harry Kuiper, on behalf of the lobby group ILSI. Revolving doors, blatant lobbying, conflicts of interest -- all in evidence, giving rise to perfectly natural suspicions of corruption and scientific fraud. EFSA has been rapped over the knuckles several times by the European Parliament, and most recently it even deferred approval of the EFSA budget as a signal of its extreme concern over the management and running of the organization.
Is EFSA corrupt, thick-skinned or just plain stupid? It's difficult to say -- but that reviled body has now proceeded to make matters even worse by demonstrating its total incompetence in scientific matters. First, it made a series of rather snooty remarks, on the record, about the scientific inadequacies of the Seralini study, and claimed that in its initial assessment, EFSA found the paper "of insufficient scientific quality to be considered as valid for risk assessment." In short, said EFSA, the Seralini conclusions were not "scientifically sound." (5) That sort of arrogance attracts attention, if nothing else, and so Testbiotech has now conducted an assessment of EFSA's own scientific procedures employed in the course of assessing GMO applications for approval. Not surprisingly, Testbiotech has concluded that none of the research documents considered by EFSA as describing chronic feeding studies with genetically engineered plants "have met the standards being used by EFSA to criticize the research of Seralini et al., 2012". Furthermore, " Seralini's research was conducted using comparatively higher scientific standards." In other words, EFSA was being hypocritical in the extreme, employing double standards and hoping to get away with it..............
Could it possibly get any worse? Well, actually, yes. The final revelation for today involves the spat between EFSA and the Seralini team over the release of full data sets for specialist scrutiny. EFSA has gone onto the record as demanding to see Seralin's full data sets which underpin the findings of the paper published in 19th September. Seralini, in response, has refused to supply those to EFSA unless and until EFSA releases into the public domain all the data sets on which its own approval of NK603 is based. (These have previously been kept away from public scrutiny -- except for heavily censored information released for short periods following formal requests.) Seralini has also said that he will only release his data if he is given an assurance that it will be scrutinized by fully independent scientists who had nothing to do with the original NK603 consent. In a highly publicised more at the beginning of this week, EFSA said that all of its data sets had now been sent to Seralini, and they demanded reciprocation. "Excellent!" said many NGOs. "That shows that EFSA is at last being more transparent and cooperative, as a result of years of pressure." But yet again all is not quite as it seems (7). The Seralini team has discovered, on looking at the released data, that it does not include the biological data relating to blood and tissues which can be subjected to detailed analysis. EFSA claims to have "given researchers access to all available data relating to its evaluation of genetically modified NK603 corn from 2003 and 2009." Note these words: ".....ALL AVAILABLE DATA." What on earth does that mean? Does it mean that the GMO Panel has other data, but that it is not available because Monsanto refuses to allow it to be made public? Or does it mean that EFSA has never seen, or been in possession of, any data other than that which has been sent to the Seralini team? If the former, it means that EFSA is being downright dishonest and disingenuous, by withholding data while pretending that it has passed all of it over. And if the latter, it means that EFSA has issued positive assessments of NK603 in 2003 and 2009 by taking Monsanto's research findings on trust, without scrutinizing them properly or even asking for raw data from feeding studies. Even more seriously, EFSA might have been hoodwinked by fraudulent or incompetent science -- meaning that a GMO product they now assume to be safe might actually be dangerous. (8)
Incompetence, vested interests, secrecy, evasion, revolving doors, scientific bias............. the list of EFSA crimes grows ever longer. For how much longer do we have to put up with these idiots at the heart of the European regulatory system, who are supposed to be looking after public health?
NOTES
(1) Séralini, G-E., E. Clair, R. Mesnage, S. Gress, N. Defarge, M. Malatesta, D. Hennequin, J. Spiroux de Vendômois. 2012. Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize. Food Chem. Toxicol.
(2) Double standards from EU food watchdog Friends of the Earth Europe, October 5 2012 http://www.foeeurope.org/EFSA-sidelines-GM-maize-food-safety-fears-051012
http://www.greenpeace.org/eu-unit/en/News/2012/EFSA-rat-study/
GMOs: EFSA breaches basic ethical code Corinne Lepage MEP Le Nouvel Observateur 7 October 2012 Article in French: http://bit.ly/QWjizy http://www.arc2020.eu/front/2012/10/mep-slams-efsa-bias/
(3) https://zoek.officielebekendmakingen.nl/blg-187499.html
(4) http://www.testbiotech.org/en/node/631
http://www.gmwatch.org/latest-listing/51-2012/14315
http://www.gmwatch.org/latest-listing/51-2012/13910
http://www.combat-monsanto.co.uk/spip.php?article764
(5) EFSA publishes initial review on GM maize and herbicide study EFSA Press Release 4 October 2012 http://www.efsa.europa.eu/en/press/news/121004.htm
(6) The European Food Safety Authority: Using double standards when assessing feeding studies Christoph Then A Testbiotech background, 30 October 2012 http://www.testbiotech.de/sites/default/files/the%20double%20standards%20of%20EFSA_0.pdf
(7) GM: Team Seralini accuses EFSA [of a con trick] Europe1.fr with AFP, October 26 2012 http://www.europe1.fr/France/OGM-l-equipe-Seralini-accuse-l-EFSA-1289019/
(8) Monsanto sleight-of-hand in its NK603 maize study? - research analyst Friday, 26 October 2012 http://www.gmwatch.org/index.php?option=com_content&view=article&id=14359:monsanto-sleight-of-hand-in-its-nk603-maize-study-research-analyst
1.EFSA hands Seralini data on NK603 corn but gets nothing in return
2.Team Seralini accuses EFSA of a con trick
3.EFSA delays final review of GM corn study to mid-November
NOTE: Gilles-Eric Seralini has said from the start that he is reluctant to hand over more information about his recently published study on the impact of NK603 GM maize and Monsanto's herbicide Roundup unless the regulators release - ideally on a public website - all the health and environmental risk studies on GMOs and Roundup, including all the details of the blood analyses performed during mammalian tests, so that all the scientists, journalists and citizens who wish to can compare the details of Seralini's study with the studies that led to the European Food Safety Authority's market approvals of these products.
If the EFSA would do this, Seralini has said he will reciprocate, although he has also said that if his work is to be evaluated fully and fairly it needs to be assessed by an independent group of scientists who, unlike the EFSA, are untainted by conflicts of interest and by past regulatory decisions that Seralini's research challenges.
Seralini's desire for full disclosure is not only about transparency, but also about making sure that like is compared with like, so that a double standard cannot be applied where the EFSA can identify apparent weaknesses in Seralini's research that might equally apply to studies that the EFSA has fully accepted.
There is, in fact, good evidence that the EFSA has already in its preliminary rejection of Seralini's work applied just such a double standard. There is also evidence that Seralini's research has used comparatively higher scientific standards than research the EFSA has accepted as supporting the safety of Monsanto's products.
http://www.gmwatch.org/index.php?option=com_content&view=article&id=14372
http://www.gmwatch.org/latest-listing/51-2012/14288
Now, according to two of the articles below (items 1 and 3) the EFSA has moved things forward by giving Seralini's team access to all the available information relating to its evaluation of Monsanto's NK603 maize from 2003 and 2009. The articles say that despite the EFSA's full disclosure of this information Seralini has not reciprocated.
However, the French article that we've translated below (item 2) tells a very different story. According to one of Seralini's co-authors, when they dug into the information that the EFSA had provided, they discovered that "there is no biological data (analyses of blood and tissues) on which you can work. This is really a con trick."
If that is the case, then the question that arises is, has the EFSA claimed it is making a full disclosure while actually retaining critical information about the studies that it used to approve Monsanto's products? And, if so, why? What has it got to hide?
Or, on the other hand, has the EFSA done what it says and fully disclosed all the information that was used in its approval process for Monsanto's products? Because if so, this would suggest something still more disturbing, that the EFSA never had access to the information that would be necessary to evaluate the studies fully.
That would in turn raise the question as to why the EFSA is demanding that kind of depth of information from Seralini. That question also applies to all those pro-GM scientists and commentators who have also been demanding full disclosure from Seralini but who have never made the same demand about the data relating to the applications for GM approvals.
Such a double standard would only make sense if people are intent on finding fault with one type of study - the type that raises concerns about Monsanto's products, while nodding through the other.
Either way, Seralini's goal of the complete release of all the details of the health and environmental risk studies on GMOs and Roundup, including his own, remains the only sensible way forward. As Seralini has also requested, this information should be made available on a public website where everyone can see the basis of regulatory discussions and decision making. --- --- 1.EFSA hands Seralini data on NK603 corn but gets nothing in return Agra-Net, October 30 2012 [subscription required for full article]
http://www.agra-net.com/portal2/ptcn/home.jsp?template=newsarticle&artid=20018000533&pubid=ag100
The European Food Safety Authority last week gave French toxicologist Gilles-Eric Seralini all the available data that the agency used to assess Monsanto's NK603 biotech corn variety in 2003 and 2009, but EFSA says the controversial researcher has yet to hand over more information on his study design and methodology.
In a statement issued Oct. 22, EFSA says that, after receiving a written request from the Caen University professor, the agency had that same day given him access to all the available data used in the two evaluations, EU Food Law reports. --- --- 2.GM: Team Seralini accuses EFSA [of a con trick] Europe1.fr with AFP, October 26 2012
http://www.europe1.fr/France/OGM-l-equipe-Seralini-accuse-l-EFSA-1289019/
English translation by GMWatch
On Friday CRIIGEN, the research institute on GMOs of which Professor Gilles-Eric Seralini is a key member, accused the European Food Safety Authority (EFSA) of "bad faith", in response to the agency which on Monday lamented Seralini's refusal to send his raw data. "We deplore the bad faith of the EFSA," the members of the Committee for Research and Independent Information on Genetic Engineering (CRIIGEN) wrote in a statement. CRIIGEN directed the financing of the researcher's controversial study on the GM maize NK603 and Roundup, published in September.
Prof. Seralini's team had requested the publication of the data on which the EFSA had based its authorizations of Monsanto's NK603 [GM maize] and Roundup, the most widely used herbicide in the world, before transmitting their own data. On Monday, while criticizing Criigen's lack of cooperation, the European agency [EFSA] said it had decided to make available to the researcher all the elements that led to the granting of the authorizations. But "when you peel back [dig into] the records only made available to us since Monday, [you discover] there is no biological data (analyses of blood and tissues) on which you can work. This is really a con trick," said Dr Joel Spiroux, the chairman of CRIIGEN and coauthor of the [Seralini] study. --- --- 3.EFSA Delays Final Review of Genetic Corn Study to Mid-November Michael Haddon
www.nasdaq.com/article/efsa-delays-final-review-of-genetic-corn-study-to-mid-november-20121030-01256
LONDON--The European Food Safety Authority said Tuesday its final assessment of a study which alleges a genetically engineered corn made by Monsanto Co. (MON) causes cancer will be published in mid-November, later than originally planned.
The EFSA, the European Union's risk assessment body for food and feed safety, said it had changed the date of its second assessment from the end of October to allow it to fully consider critiques of the University of Caen's research paper that have been carried out by member states including Belgium, Denmark, France, Germany and the Netherlands.
Earlier this month the EFSA's initial assessment labeled the paper "of insufficient scientific quality to be considered as valid for risk assessment" and said its conclusions weren't "scientifically sound." However, it also requested additional information from the study's authors related to experimental design, reporting and analysis of findings to help inform its final assessment.
The university study found that rats fed for two years on Monsanto's genetically modified NK603 corn, or exposed to the company's Roundup brand glyphosate weedkiller used with the corn, developed more tumors and other severe diseases than a control group fed regular, non-GM corn.
The study also found that rats exposed to Roundup exhibited more disease symptoms than the test group.
The researchers recommended conducting more studies to evaluate toxic effects of genetically modified crops on humans, especially when combined with a weedkiller. NK603, which Monsanto sells as Roundup Ready corn, is resistant to the weedkiller. Monsanto markets the two products together as a weed-control strategy for farmers.
Last week the EFSA said it had given researchers access to all available data relating to its evaluation of genetically modified NK603 corn from 2003 and 2009 following a written request by Professor Gilles-Eric Seralini, the author of the controversial study.
The EFSA added that it had also repeated its previous request for further information in letters sent to Mr. Seralini on Oct. 4 and Oct. 18, but had received no documentation.
Proof that EFSA used double standards to attack Seralini
Tuesday, 30 October 2012 15:42
NOTE: The following are extracts from an important new report that shows in detail how the European Food Safety Authority (EFSA) used double standards to attack Seralini's paper. We recommend reading the report in full. It is only 14 pages in length including all the references and is very clearly written, and is accessible to the non-specialist. It also includes a useful table (page 11) directly comparing the different aspects of Seralini's study with other studies that EFSA has accepted without problem to support the approval of GM foods.
EXTRACTS: ...we believe that none of [the studies discussed in this briefing] describing chronic feeding studies with genetically engineered plants have met the standards being used by EFSA to criticize the research of Seralini et al., 2012. The comparison with the studies reviewed by Snell et al. (2011) shows that Seralini's research was conducted using comparatively higher scientific standards.
In conclusion, EFSA does not apply OECD standards to sub-chronic, 90-day feeding studies when these are prepared by industry and do not show health effects from consuming genetically engineered foods. In contrast, the OECD standards have been used by EFSA to attack the research of Seralini et al., 2012.
...The results should be taken seriously and used as a starting point for further investigations, as has been proposed by the French food safety and biotechnology authorities (ANSES 2012).
The European Food Safety Authority: Using double standards when assessing feeding studies
Christoph Then A Testbiotech background,
30 October 2012
http://www.testbiotech.de/sites/default/files/the%20double%20standards%20of%20EFSA_0.pdf
Opinions of the authority show a bias in the scientific standards applied to risk assessments of genetically engineered plants
Summary
Recently published research on chronic (long term) animal feeding trials using genetically engineered maize (NK603) and the herbicide Roundup has been harshly criticised by the European Food Safety Authority (EFSA 2012). The research was led by French Professor Gilles-Eric Séralini of Caen University (Seralini et al. 2012) and although it was published in the peer-reviewed journal Food and Chemical Toxicology, the results were criticised by EFSA for not meeting specific scientific standards such as for example set out by the OECD (EFSA 2012a).
However, detailed analysis of former EFSA opinions shows that the authority has not taken a consistent approach when examining such scientific research. On a number of past occasions, EFSA has accepted without question the results from publications, on the risk assessment of genetically engineered plants, that are not in accordance with the scientific standards now being applied by EFSA to criticise the French study.
Unlike Seralini et al. (2012), these earlier studies did not conclude that there were any health impacts from eating genetically engineered plants. This inconsistency suggests that EFSA is 'picking and choosing' when to apply the scientific standards. There also is evidence that the food safety authorities of EU Member States are using similar double standards. For example, the Netherlands Food Safety Authority (NWVA, 2012) referred to a review paper by Snell et al. (2011) in order to refute the findings of Séralini et al. (2012). The review covered 12 chronic feeding studies using genetically engineered plants, and concluded that they did not show any health risks. But an analysis of the studies included in Snell's review shows that none of them met the same scientific standards that are now being applied by NWVA and EFSA to criticise Séralini et al. (2012).
In some respects, the standards used by Séralini et al. (2012) appear to be higher than those of the studies being used by EFSA and NWVA to refute his findings. Seralini's research seems to be the most comprehensive long term health study on genetically engineered plants to date. Also the French national food safety authorities (ANSES, 2012) – despite their criticism - have noted that the range of criteria examined was far wider than other long term studies. Furthermore, the German authorities (BfR, 2012) have pointed out that this research is the only long term study anywhere in the world to assess the health risks of the herbicide formula Roundup. The response to the findings of Seralini et al. should be new experimentation, rather than ad hoc refutations founded in assumption-based reasoning.
By failing to challenge the scientific standard of studies which do not show adverse health effects from genetically engineered crops, while at the same time attacking studies that indicate evidence of harm, European Union authorities such as EFSA are applying double standards and follow a biased approach. The authorities seem to be influenced by the presumption that genetically engineered plants should be regarded as safe and seem to be using the debate on scientific standards to defend their own opinions.
In view of the findings of Seralini et al (2012), the burden of proof should be shifted back to industry. Genetically engineered maize NK603 and the Herbicide Roundup maize cannot be regarded as being safe, so long as their safety is not proven by further investigations.
Further, in view of the debate arising from Séralini et al. (2012), the standards used in recent years for the risk assessment of genetically engineered plants and pesticides should be revised and reshaped, in order to achieve a higher level of protection for consumers and the environment. In addition, independent risk research should be promoted by EU research programs with a much higher priority...
[on EFSA's criticisms of Seralini's research]
...we consider EFSA's statement on this issue [the spontaneous occurrence of tumours in Sprague-Dawley rats, the strain used in Seralini's experiment] to be misleading, particularly the assertion that the spontaneous occurrence of tumours in these rats was "neither taken into account nor discussed in the Seralini et al. (2012) publication." Seralini et al demonstrate two different findings, both an increase in the number of tumours and an earlier onset of tumours in rats fed on the GE plant or the herbicide. Thus the researchers did not just measure the number of tumours over the lifetime of the rats. Further to support their conclusions, Seralini et al. (2012) compared their results to tumour rates in other published studies using this strain of rat. So they do appear to have been aware of the issue, and to have taken it into account.
EFSA's assessment of subchronic feeding studies
EFSA does not request sub-chronic or chronic toxicological feeding studies when assessing the health risks of genetically engineered plants. But in many cases, results from sub-chronic feeding studies are voluntarily provided by product developers.
Séralini et al. (2012) set out in their research to test the value of 90 day sub-chronic feeding trials. Thus they designed their experiment to conform with OECD guideline 408 for 90-day trials, but then extended the length of the test to examine further health impacts which became apparent towards the end of the 90 days period. The researchers used ten animals per group, which is in accordance with OECD Guidelines 408 for subchronic feeding studies.
We are not aware of sub-chronic toxicological feeding studies having been accepted by EFSA with fewer than 10 animals in each test group, as required by OECD (OECD Guideline 408), thus in regard of number of animals, the OECD criteria seem to be fulfilled. However the OECD Guidelines also request at least three dose levels. In other words, genetically engineered plant material should be included in the feed of test animals at low, medium or high concentrations. This allows the study to establish if there is a relationship between the dose and any observed health effect.
Seralini and colleagues did use three different dose levels in their study. In contrast, and despite OECD guidelines, EFSA routinely accepts 90 days studies with only two dose levels of genetically engineered plants in the animal feed. Indeed, when EFSA originally assessed the safety of NK603 maize, the 90 day feeding study submitted by Monsanto used only two dose levels of the genetically engineered maize (Hammond et al. 2004).
So 90-day feeding studies submitted to EFSA by product development companies do not routinely meet OECD guidelines, and yet the results are accepted by EFSA.
The design of sub-chronic feeding studies that have been accepted by EFSA have also not been in accordance with OECD standards in respect of the numbers of test groups used in the trials. In most cases, biotech companies use many more groups for comparison than is required by the OECD guidelines. The OECD Guideline 408 proposes only one group for comparison and a smaller additional ("satellite") group for ensuring quality standards, containing only five animals.
Monsanto's feed trials for NK603 maize (Hammond et al. 2004) used ten groups (per sex) but only two of these groups were fed with the genetically engineered maize NK603. All other groups, fed with various maize varieties (not just the isogenic line), were used for comparison and for additional references. Overall, 80 animals were fed with genetically engineered maize, but their data was compared against that from 320 animals from the reference and control groups. As a result, the statistical noise stemming from the additional reference groups threatens to cause a bias in the interpretation of the data, hiding relevant biological effects and significant differences.
90-day feeding studies, such as that by Hammond et al. (2004), follow standards set by industry. Although the OECD guidelines were not adhered to in these studies, the results were accepted by EFSA. Having accepted several industry-sponsored feeding studies using these standards, including those for genetically engineered maize MON810 and MON863, EFSA published its own guidance on 90-day feeding studies for whole food and feed (EFSA 2011). The standards in EFSA's guidance show little difference to those established by product developers which have a vested interest in the outcome of the risk assessment. In effect, the industry standards were adopted as the official standards of EFSA, with the explanation that OECD standard 408 was not adequate for this type of investigation.
So, the experimental designs used for 90 days feeding studies that are accepted by EFSA are not in compliance with the OECD standards. As a consequence, the findings and the methodology of these 90 day feeding studies have been a matter of controversial debate for years (see for example Spiroux et al., 2009).
In conclusion, EFSA does not apply OECD standards to sub-chronic, 90 day feeding studies when these are prepared by industry and do not show health effects from consuming genetically engineered foods. In contrast, the OECD standards have been used by EFSA to attack the research of Seralini et al., 2012.
Discussion
On the basis of the studies discussed in this briefing, we believe that none of them describing chronic feeding studies with genetically engineered plants have met the standards being used by EFSA to criticize the research of Seralini et al., 2012. The comparison with the studies reviewed by Snell et al. (2011) shows that Seralini's research was conducted using comparatively higher scientific standards (see table 2).
In this context, it also should be recognised that the OECD Guidelines are not based on a process that can be considered independent from vested interests. For example, the International Life Sciences Institute (ILSI) is mentioned as a source in the OECD Guidelines. ILSI is an institution funded by the food and biotechnology industries. Beyond this, there is a wider issue of whether feeding studies, even if in compliance with the standards of the OECD, are adequate to assess health risks of genetically engineered plants. That is why according to the EU Commission (2012), the current standards will be reviewed within the next few years:
"The requirements regarding animal feeding trials in the context of GMO risk assessments should be reviewed in the light of the outcome of this project expected to be available by the end of 2015 at the latest."
In comparison to other studies, Seralini and colleagues used the most comprehensive criteria to assess health impacts, including a high number of samples and measurement of hormone levels (for more details see Seralini et al,. 2012, table 1). The French food safety authorities have also stated that the investigations in Seralini et al., ( 2012) covered a broader range of criteria than, for example, Sakamoto, et al. (2008). (See ANSES, 2012, table page 15 and also ENSSER, 2012).
Conclusion and recommendations
While there may be some problems with the methods used by Seralini et al. (2012) in their feeding trials, we believe their findings are still very important.
In comparison with previous feeding studies, mentioned by EFSA and NWVA, the research of Seralini et al. (2012) was conducted to higher scientific standards. The results should be taken seriously and used as a starting point for further investigations, as has been proposed by the French food safety and biotechnology authorities (ANSES 2012).
In contrast to their response to Seralini et al. (2012), when assessing applications for the approval of genetically engineered plants, European and national authorities often appear uncritical of the methods used by studies which do not show any adverse effects from the genetically engineered material. For example, the GMO Panel of the European Food Safety Authority has accepted such studies, even when they do not meet the OECD Guidelines for chronic toxicity or carcinogenicity studies.
From this evidence, it appears as if EFSA and some other EU authorities are taking a biased approach and applying differing standards during risk assessment. The outcome of their opinions seems to be influenced by a presumption in favour of the safety of genetically engineered plants.
This feeds a perception of selective evidence-gathering by EFSA, and that it favours the applicants who have a vested financial interest in the marketing of pesticides and genetically engineered plants.
After creating a history of certifying the safety of these products, it could be argued that EFSA and national authorities have a conflict of interest when it comes to reassessing their own conclusions. Indeed, their published statements on the work of Seralini et al. (2012) seem to be an attempt to refute any doubts about the safety of genetically engineered products and to defend previous opinions.
Based on our findings, we make the following recommendations:
The findings of Séralini et al. (2012) should be the subject of further experiment and investigation, rather than being dismissed. Given that consumers could be exposed to some of the relevant products each and every day, a high level of precaution is warranted.
In our view, EFSA has not earned a reputation of credibility for taking a final judgment on the research of Seralini et al. (2012). So we recommend that another scientific body be established on a ad hoc basis to deal with the assessment of this publication. That body should be assembled from appropriate experts free of financial conflicts of interest and independent of past contributions to EFSA decision making.
Genetically engineered maize, NK603 and the herbicide Roundup cannot be regarded as being safe, so long as their safety is not proven by further investigations. In view of the findings of Séralini et al (2012), the burden of proof should be shifted back to the product developer.
In view of the debate arising from the research of Seralini et al. (2012), the standards used in recent years for the risk assessment of genetically engineered plants and pesticides should be revised and reshaped, in order to achieve a higher level of protection for consumers and the environment.
Furthermore, independent risk research should be promoted by EU research programs with a much higher priority.