1. EFSA criticised by auditors over conflicts of interest

2. EFSA on health effects of interaction between GMOs and herbicides

NOTE: The European Court of Auditors has slammed the European Food Safety Authority (EFSA) for its inadequate management of conflicts of interest which it says is "not robust enough."

The Court – the independent audit institution of the European Union, whose job it is to examine whether the EU's monies are being used in accordance with the rules – found serious shortcomings in the policies and procedures followed by EFSA.

The problems included EFSA not screening thoroughly the declared conflicts of interests of the scientists it appointed. EFSA, for instance, failed to do anything about a conflict of interest involving two experts reviewing food substances relevant to a company that they were simultaneously providing professional advice to. The Court's report also criticises the presence of industry figures on EFSA's management board.

The Court's findings come as no surprise. Earlier this year the European Parliament postponed approval of EFSA's budget in the light of all the problems over conflicts of interest at the agency.

In fact, EFSA and its GMO Panel have been riven with such conflicts for years. And in May of this year the Chair of EFSA's Management Board, which should be taking the lead in tackling the problem, was forced to quit because of her own flagrant industry links.

Disturbingly, all the concern over conflicts of interest at EFSA didn't stop the European Commission earlier this year from nominating a food industry lobbyist and former Monsanto employee to become a member of EFSA's Management Board.
http://www.testbiotech.org/en/node/631

The resulting controversy made the Commission back down over that nomination, but there has long been similar controversy over EFSA's GMO panel. At one point Friends of the Earth Europe reported that a member of the GMO panel had direct financial links with the biotech industry while several others had indirect ones. FOEE even found that two members of the GMO panel had appeared in promotional videos for the biotech industry.

FOEE also reported that several members of the GMO panel, including its then chair, had also been involved in a project tasked with agreeing procedures that would "facilitate market introduction of GMOs in Europe, and therefore bring the European industry in a competitive position." As part of this, the chair of the GMO panel sat on a working group for the project alongside staff from Monsanto, Bayer and Syngenta. EFSA, of course, is supposed to be "the independent voice of science" guiding EU institutions.

EFSA claims it has made changes that are putting its house in order. But the scepticism about this has only been increased by EFSA's rapid rebuttal of the Seralini paper.

The concerns centre on the fact that EFSA seems to be applying standards to Seralini's study that it fails to apply to the far less adequate studies underlying its own GM crop approvals, and also that EFSA appears to be trying to stifle debate and sweep the Seralini study under the carpet rather than seeking further investigation of the issue. In addition, both of the peer reviewers overseeing EFSA's preliminary response to Seralini's paper have also been accused of suffering conflicts of interest of one sort or another.
http://www.gmwatch.org/index.php?option=com_content&view=article&id=14296

As a result, Corinne Lepage MEP, the former French Environment Minister who heads up the board of Seralini's institute, is now calling for the executive director of EFSA, Catherine Geslain-Laneelle, to resign.
http://www.gmwatch.org/index.php?option=com_content&view=article&id=14286

For Lepage, what adds to the sense that something is seriously awry at EFSA is the fact that the criticisms contained in EFSA's response do not read like carefully considered opinions but like a rapidly assembled copy/paste job of points already circulated by others, and which largely fail to stand up to serious scrutiny.

This is well exemplified by what happened at a recent EFSA press conference (item 2), where apparently EFSA's Geslain-Laneelle "recalled the EFSA's preliminary review of Seralini's study, which was released last week, that the Sprague-Dawley strain of rats used in the experiments has been shown to be susceptible to developing tumours spontaneously, particularly as they grow older, making it difficult to interpret the results [of Seralini's study]." (item 2 below)

But although this claim has been widely made, the Sprague-Dawley (SD) rat is not only routinely used by industry in its studies to gain approval for GM foods, it is also used in *long-term* toxicity and carcinogenicity tests performed by Monsanto on glyphosate to gain marketing approval for it in the EU. And the European Network of Scientists for Social and Environmental Responsibility (ENSSER) reports that the National Toxicology Program of the U.S. Department of Health and Human Services uses the same strain of rat as Seralini in its 2-year studies, uncontested. They also found from a "brief, quick and still preliminary literature search of peer-reviewed journals" that SD rats were also used:

• in 36-month studies by Voss et al. (2005);
• in 24-month studies by Hack et al. (1995), Klimisch et al. (1997), Minardi et al. (2002),

Soffritti et al. (2006) and Gamez et al. (2007);

• in 18-month studies by Lee et al. (2010); and
• in 12-month studies by Perry et al. (1981), Conti et al. (1988), Morcos & Camilo (2001), Flamm et al. (2003) and Gutierrez et al. (2011).

Four of these studies had been published in the journal Food and Chemical Toxicology - the same journal that published Seralini's study. http://www.gmwatch.org/latest-listing/51-2012/14288

As Mute Schimpf of Friends of the Earth Europe recently commented: "For the past decade, EFSA has consistently sided with the biotech industry and disregarded health or environment concerns about genetically modified crops. Instead of picking holes in independent, peer-reviewed research, it should be taking public concerns seriously and making long-term safety tests for genetically modified foods compulsory in the EU. The reaction from EFSA shows their double standards. If they had been as thorough with Monsanto's applications as they were with this new research then no GMO would have been approved in the EU." http://www.gmwatch.org/index.php?option=com_content&view=article&id=14270

1. EFSA criticised by auditors over conflicts of interest

Corporate Europe Observatory, October 11 2012

Brussels - The European Court of Auditors (ECA) has sent a highly critical message to four of the EU agencies in a report published today, condemning their failure to manage conflicts of interest adequately.

The Court has carried out an investigation into conflict of interests policies at the European aviation safety agency (EASA), European chemicals agency (ECHA), European food safety agency (EFSA) and the European Medicines agency (EMA). The EASA came out worst in the score report, but significant shortcomings were identified at EMA and EFSA as well.

Nina Holland of Corporate Europe Observatory said:

"This report confirms that there is no effective system in place at the agencies to ban conflicts of interest or to stop staff going through the revolving doors between the agencies and industry. Ongoing conflicts of interest at EFSA and the EMA jeopardise food safety and public health. The agencies have so far failed to take the action which is so badly needed".

The auditors’ report stands in stark contrast to the praise that recently came from Ernst & Young, hired by EFSA to carry out an evaluation of the agency.

Holland added that EFSA for its part was twisting the Court's message by emphasising the observation that EFSA's system to deal with conflicts of interest seems 'more developed' than that of some of the other agencies. She argued that even though EFSA has recently made some changes to its policy and practices, it was not enough to claim that all problems had been solved.

The report also criticises the presence of industry figures on EFSA’s management board. This threat to EFSA’s impartiality, it says, is worsened by the fact that three of these organisations are at the same time represented on the Stakeholder Consultative Platform. This is a clear message to the EU institutions that are about to start a revision of the EFSA founding regulation, where this could be changed.

The ECA report can be found at:http://eca.europa.eu/portal/pls/portal/docs/1/17190743.PDF

Contact: Nina Holland, Corporate Europe Observatory + 31 6 30285042

2. EFSA on health effects of interaction between GMOs and herbicides

Joanna Sopinska, Europolitics, 12 October 2012

Catherine Geslain-Laneelle, executive director of the European Food Safety Authority (EFSA), has admitted that there are two separate legislative tracks in the EU to examine the adverse health effects of diets containing genetically modified organisms (GMOs) and herbicides. At a press briefing, held on 12 October in Brussels, she explained that EU law does not require tests to be conducted on the health effects of the interaction between GMOs and herbicides.

The comment came after the publication, at the end of September, of a study by Gilles-Eric Seralini, which found that rats fed over two years with authorised GM maize NK603 and dosed with the herbicide called Roundup at permitted levels suffered from tumours and died earlier than rats fed a non-GM diet. An earlier test of NK603 maize in rats in a 90-day feeding trial (the current regulatory norm), sponsored by its producer - Monsanto company - showed no adverse effects. Geslain-Laneelle rejected claims that the 90-day feeding trial is not sufficient to estimate the risk and grant the authorisation for use or cultivation of GMOs in the EU.

Several food safety NGOs criticise EU legislation for not requiring long-term feeding trials in the area of GMOs. Referring to Seralini’s study, Geslain-Laneelle pointed to the fact that there were many other studies made on the adverse health effects on cows and sheep of diets containing GM crops, which also lasted two years. She recalled the EFSA's preliminary review of Seralini's study, which was released last week, that the Sprague-Dawley strain of rats used in the experiments has been shown to be susceptible to developing tumours spontaneously, particularly as they grow older, making it difficult to interpret the results.

NEXT STEPS

Geslain-Laneelle confirmed that the EFSA will publish its final review of Seralini’s study by the end of October. To this end, the EU food health watchdog asked Seralini to provide, by 12 October, additional information on his study. The scientist said, however, that he will not release his data until the raw data underpinning the authorisation of NK603 in Europe are also made public. Geslain-Lanéelle referred to this request, underlining that such data are made available on request. At the time when Europolitics went to press, on 12 October, no reply was received by the EFSA from Seralini. "Regardless if we receive additional information from Seralini or not, we would publish our final review," an EFSA spokesman told Europolitics. He explained that the paper will also be based on national reviews. Germany, Belgium, the Netherlands and France are expected to contribute with their own assessments, the spokesman confirmed.