1.Seralini at European Parliament: More heavy criticism of EFSA
2.EU citizens demand transparency and independent science on GMOs
1.Seralini at European Parliament: More heavy criticism of EFSA
GMO Seralini, May 29 2013
http://gmoseralini.org/meps-keep-gmo-petitions-alive-more-heavy-criticism-of-efsa/
At a meeting of the European Parliament’s Petitions Committee on 27th May 2013, MEPs maintained their assault on EFSA and DG-SANCO (the Commission’s Directorate for Health and Consumers) and decided to keep two Petitions from Dr Brian John alive for further assessment and negotiation. One of these Petitions dates from 2008, and the other from 2010. Both of them deal with the failure of EFSA and DG-SANCO to prioritise the public health of European citizens in their assessments and approvals for GMO crops and products that enter the food chain.
Watch the Full Petitions Committee Meeting here
http://www.europarl.europa.eu/ep-live/en/committees/video?event=20130527-1500-COMMITTEE-PETI
[only seems to works with some PCs]
The ongoing criticisms of MEPs relate to EFSA’s pro-industry bias, its failure to treat public health issues as the number one priority, its failure to operate in a totally transparent fashion, and its susceptibility to influence from ILSI and other organizations with strong links to the biotechnology industry. The scandals associated with the conflicts of interest among EFSA officials and board members is a recurring theme.
Dr John was unable to attend the Committee meeting on this occasion, but MEPs were addressed by Prof Gilles-Eric Seralini, whose long-term feeding study on rats fed with GM maize NK603 and with traces of Roundup herbicide in their water supplies was published in September 2012. That study, which showed that the animals in the test groups suffered severe toxic effects, was minutely scrutinized by EFSA and by a group of representatives from member states — something which has never been done with previous industry-funded studies which purportedly demonstrated “no harm”. The Petitioner has accused EFSA and DG-SANCO of bias and selective scrutiny. He also says thay have been involved in a conspiracy to discredit Seralini and to defend their previous assumptions about the safety of all approved GMO varieties of maize, including those made to be tolerant to Roundup herbicide. At the last Petitions Committee meeting (in December 2012) MEPs appeared very sympathetic to that reading of the situation.
In his brief talk Prof Seralini described his experiment and his main findings. He also made a direct assault on the GMO regulatory deficiencies within Europe, and he accused EFSA of quite deliberately failing to examine Roundup toxicity and thereby placing the public at risk. (This point was reinforced because in their presentations which followed, Per Bergman from EFSA and Ladislav Miko from DG-DSANCO referred several times to “glyphosate” and not once to “Roundup.” ) Prof Seralini also said that EFSA had an apparent willingness to believe Monsanto data, whether they had examined it or not, and that the organization had connived in keeping Monsanto’s raw data away from public scrutiny. He also said there were powerful vested interests at work both within the EFSA board and its GMO Panel. Finally he accused EFSA of making fundamentally flawed assessments of herbicide-resistant GMO products on two grounds:
1. He said that EFSA failed to examine the real toxicity of Roundup because they depended on old test data from glyphosate, and did not look at the “active principals” in Roundup which make it much more toxic. This placed the public at risk from Roundup residues on plant products.
2. He said that EFSA accepted the use of “historical control norms” as comparators in GMO assessment studies, even though that practice is scientifically indefensible in that it rolls together control group data from many studies and masks the toxic effects that might be picked up in properly conducted laboratory experiments. Again, this allows potentially dangerous GMO products through the net, with a likelihood of damage to the public health.
His overall message was that EFSA depended for its assessments on fraudulent or incomplete data which received inadequate scrutiny; that it often hid behind “commercial confidentiality” rules in failing to apply proper scrutiny; and that it was strongly biased against long-term feeding studies on GMOs for reasons that can only be guessed at. In short, EFSA practises bad science. At the end of Prof Seralini’s address, a number of MEPs broke etiquette by applauding.
Per Bergman from EFSA responded and sought to defend EFSA from the heavy criticism of the Petitioner, Prof Seralini and many others. He simply repeated the EFSA story of how the response to the Seralini paper had been organized, confirming that it was carefully orchestrated in conjunction with just six member states whose representatives had chosen to express their views. He referred to the “multidisciplinary task force” and to EFSA’s Advisory Forum, but made no attempt to address a key criticism from the Petitioner, namely that those chosen to undertake and orchestrate the review process were themselves heavily compromised by their previous involvement in the approvals process for NK603 and other RR crops and products, which they had declared as being safe. Bergman spoke several times about glyphosate, but failed to respond to Prof Seralini’s criticism about a failure to assess the toxicity of Roundup. He also referred to the Seralini study, not for the first time, as a carcinogenicity study, which it patently was not. Finally he said that the EFSA review process had determined that Seralini and colleagues had not demonstrated real toxic effects from Roundup and NK603 maize; that no conclusions could be drawn about the safety or otherwise of the products in question; and that therefore no action was required.
Ladislav Miko for DG-SANCO repeated the line that the Commission had absolute faith in the integrity and competence of EFSA, and stated that the Commission accepted its findings on the Seralini study. That having been said, he conceded that the Seralini study had raised serious issues that had to be addressed if the concerns of the European public were to be allayed. He announced two major developments:
1. The completion of new Guidelines for the GMO assessment process, making it obligatory for all new GMOs to undergo 90-day feeding studies and for 2-year studies to be undertaken if there were any indications of negative health effects. (He did not address a complaint of the Petitioner that this Regulation is still hidden from public scrutiny, so that nobody currently knows what it looks like in detail, and which rules EFSA is working to.)
2. There will be a long-term animal feeding study on another GMO, funded by the EU, with an open call for bids in the near future. It would be open to Prof Seralini and his team to submit a bid for this work.
Mr Miko also insisted that EFSA operated in a totally transparent fashion, and said that all of the data on NK603 had been made publicly available in exactly the form determined by Monsanto when it submitted its original assessment dossier. (This is interesting, since it was clearly in such a form that neither the Seralini team nor EFSA could have subjected it to proper scrutiny / statistical analysis. On that basis, what assurances could EFSA have had that the Monsanto conclusions bore any relation to its data sets?) He also stated that glyphosate was currently subject to a long-term safety review, once again ignoring Prof Seralini’s point that scrutiny should be given to Roundup, not glyphosate………
In the debate that followed not a single MEP said anything supportive of either EFSA or the Commission. The Petitioners were commended for their persistence, and speaker after speaker referred to conflicts of interest within EFSA, to public disquiet about Monsanto and its attempts to exert greater and greater control of the food supply, to failings in the GMO assessment process, and to undue influence within EFSA from ILSI and other biotechnology organizations. Several MEPs called for a truly independent assessment of the risks associated with GMOs to be conducted not by EFSA but by a Scientific Committee with no vested interests and incorporating truly independent scientists. They said that public health must be the top priority at all times. The Commission was also criticised for its sudden realisation that long-term feeding studies now needed to be done; why had the EC not commissioned this work years ago, as requested by many consumer groups and NGOs? Overall, the feeling was that there were still serious doubts about the safety of GMOs and associated herbicides, and that caution had to be employed. The final speaker urged that the Precautionary Principle MUST be used here, where public health was at risk.
In his concluding comments Prof Seralini repeated that EFSA had persistently refused to assess the effects of Roundup residues in GMO products, in breach of its obligations. He also outlined some of the difficulties faced by himself and his colleagues in seeking to complete their experiment in conditions of great secrecy, and in achieving publication in the face of concerted attack from GMO proponents in France and elsewhere. He did not directly complain about this campaign of victimisation and vilification, but he made it perfectly clear to MEPs that EFSA was rather too close for comfort to various organizations and individuals whose activities have very little to do with science.
At the end of the session, the Chair thanked Prof Seralini and the Petitioner, and stated that it was the intention of the Committee to keep both Petitions alive in view of the fact that many issues had still not been resolved by either EFSA or DG-SANCO. She also admitted that the scientific issues were difficult for the Petitions Committee to deal with on its own, and that support might now be sought from the Agriculture Committee in giving them close scrutiny.
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2.EU citizens demand transparency and independent science on GMOs
The Greens/EFA, May 29 2013
http://gmo.greens-efa.eu/gmo-authorisations-9932.html
Professor Gilles-Eric Séralini was invited on Monday 27th May to the session of the PETI Committee that discussed 3 petitions related to GMOs, in particular to debate the persisting conflicts of interest and industry influence that affect European policy making and decision taking. At the heart of the matter is the way EFSA conducts risk assessments of GMOs.
Even though there have been some improvements within EFSA recently, under the impulse of EFSA's Executive Director, Catherine Geslain-Lanéelle, and thanks to constant pressure by the Greens/EFA group, civil society and citizens, these improvements fall short of the "revolution" that is needed in the risk assessment of GMOs, both in terms of the methodology, the origin and transparency of the data that are used as well as the range of scientists that are represented in EFSA's scientific panels. Also, the new implementing regulation for the risk assessment of GMOs for food and feed that the Commission adopted last February contains serious flaws.
Séralini testified in the European Parliament on the follow-up of his 2-years toxicological study on rats published last September in the peer reviewed scientific journal Food and Chemical Toxicology, which provoked a furore among GMO proponents and the biotech industry. Séralini explained a few of his main concerns on the assessment of GMOs and their associated pesticides, among them the most sold herbicide in the world, Round-up, from Monsanto (also the seed producer of Round-up Ready crops, such as soya, corn, and cotton).
Indeed, Séralini has shown and insisted on the fact that glyphosate is not the only active ingredient of Round-up, but that there are other toxic components in the widely used herbicide. This is crucial because only glyphosate has been tested for its toxicity (and only in the short term on ten rats). He's accusing EFSA of a blatant lack of transparency as the authority has not been able to make the raw data that it has been used to give its opinion to the EU institutions public, after which the EU authorised the use of the herbicide.
A second major flaw that Séralini addressed comes from what is called the "historical data" of control rats used by the agrochemical industry, which are generally accepted by EFSA. Séralini claims that these data, which are used to detect health impacts, are flawed. This for the simple reason that most of the control groups of rats that have been used the past decades for other scientific experiments were fed with feed that was from GMO origin and/or treated with pesticides (they haven't been fed with organic feed!). Séralini stated that these rats should not be considered as "control groups".
Lastly, he countered criticism on his study for having used too small a number of rats in his 2-year experiment. Séralini reminded the EP of the fact that EFSA's scientific panel on GMOs gave a positive opinion on the Amflora GMO potato with only 5 rats per sex being fed with it in a short term experiment.
Séralini also testified on some behind-the-curtains attempts to have his study discredited. According to Séralini, within a few days to weeks after the publication of his paper, many 'scientific' advocates often linked to the biotech sector tried everything they could to avoid that it could be taken seriously by other experts, scientific publications and the general media. For example, an ex-Monsanto researcher,, Mr Richard Goodman, has just been recruited to the editorial board of the scientific journal that had published the article (Food and Chemical Toxicology), and did exchange communications on how to have the article retracted with Mr. Paul Christou, who happens to be the owner of the patent of the method used to make Round-up Ready soybean! Séralini said that he had been surprised that some commentators linked to the agrochemical industry have been able to comment on the article within one day, although it took the peer reviewers months to assess it.
Green MEP Catherine Grèze applauded the perseverance of the petitioner Brian John and mentioned that the huge world-wide protests against Monsanto, that took place last Saturday, was further proof of the fact that citizens all over the world have serious reservations about the safety of Monsanto products and pesticides as well as GMOs.
Grèze said that doubts about the risks of GMOs will remain as long as the issue of conflicts of interest within EFSA remain unsolved. One can be very concerned when one sees the increasing dominance of the biotech industry on research, scientific careers, expert bodies and even international negotiations, as we see happening in the early discussions around an EU-US free trade agreement (TTIP). These negotiations carry the risk of weakening EU regulations on GMOs and other issues as they are considered by US companies as trade barriers.
EFSA needs to get rid of the remaining conflicts of interest in the authority, to enhance its independence and scope of expertise on GMOs, including changing the risk assessment methodology, of which the design has been heavily influenced by the industry. Grèze also asked why EFSA is still rejecting a long term toxicological study, as the Séralini's article would at least warrant this. It is in fact the only one that has been done on such duration. Séralini already gave his raw data to a ''huissier' who can make it public "for zero euro" as soon as EFSA does the same.
Until there is greater assurance in the quality of the EFSA expertise on GMOs, the widening of the scope of the scientists participating, as well as the range of scientific issues that are assessed, the Greens/EFA group asks for a moratorium on all GMOs.
Another Greens/EFA MEP, Margrete Auken, who's a member of the Committee on Petitions, insisted that EFSA makes all raw data public, in order to allow for a real independent and pluralist expertise.
EFSA and the Commission's answers in the PETI Committee were not very convincing. They explained, for example, that they cannot disclose the data related to Monsanto's Round-up because it was Germany that was in charge of assessing the herbicide. The seeming impossibility to access the raw data used for authorising the herbicide is not very reassuring for EU citizens in any case.
The EC-spokesman acknowledged the importance of transparent data and did announce that, due to the debate after Séralini's study, the EC will launch a two year carcinogenic study in autumn 2013, open to all scientific groups. The design, methodology and involved scientists will be key for such a study be satisfactorily implemented.
However, in general the weakness of the answers by EFSA and the EC did not convince the PETI Committee, for which transparency and citizen participation are of the utmost importance, especially in such a difficult and controversial issue. It calls on EFSA to publish all data that have not yet been published and proposes to hear other competent agencies and parliamentary Committees, in particular the ENVI and AGRI Committees.
It decided to keep the petition open, which will keep the political debate open and pressure both EFSA and the Commission to really put all data on the table.
The Greens/EFA group considered it as a positive outcome that the petition stays "open" and will continue pressing for full transparency and a sound and independent methodology for the now newly announced 2-year toxicological study, to be performed in order to confirm or discard the results from Séralini's study.