EFSA

13 May 2009

For the third time the EU Commission handed the Amflora dossier back to the EFSA in 2008. This time not only the GMO panel but also the Biohazard panel are asked about their opinion. And after months EFSA announced that they would need more time to come to a conclusion because two of their experts have a different opinion then the rest.
Somehow that shouldn't really surprise anybody. "Risk assessment" is not a hard science but - as the term says - an assessment without strict tick boxes to decide what's safe or not. And over the years scientists came to different assessment of using the antibiotic marker gene nptII in GM crops in general and in the GM potato Amflora.
BASF considered it safe, so did the EFSA GMO panel, while experts in some EU member states did not. In 2007, EMEA concluded that assumptions of the GMO panel on how the antibiotics in question were used were wrong.
What should surprise however, is that after years of giving scientific opinions, the EFSA has apparently no mechanism to allow for different opinions in its panels.

6 December 2008

According to a German newspaper report there will be no Amflora cultivation in 2009. In May 2008, the EU Commission had requested an additional opinion from the EFSA after memberstates did not find a qualified majority to approve or reject BASF's application to cultivate the GM ptotato in Europe. Concerns were raised repeatedly about the antibiotic resistance marker gene nptII in Amflora, that among others concerns antibiotica used as a last resort for multi-resistant tuberculosis.
But a closer look at the Draft Decision by the EU Commission also shows that the EU Commission came to a very different conclusion about risks and risk management of Amflora cultivation. While the EFSA stated that they agreed with BASF that no case-specific monitoring was needed, the EU Commission drafted a decision in which case-specific monitoring was requested to monitor effects on potato feeding animals on and around the fields - an issue the EFSA had not even considered in its review of the application. (More details in the German report EU-Risikomanagement.)
Already in 2008 2008, BASF had sued the EU Commission for unduly delaying a decision. A new EFSA opinion was expected on 15 December, but now will only be published in March 2009 - too late for planting in 2009, independent of what the outcome of this new opinion will be.

5 December 2008

On 4 December 2008, the EU environmental ministers decided that there needs to be a better system to assess the risks of GM crops. They cam to the conclusion that it would be especially important to study long-term effects, and that EFSA should pay more attention to the concerns raised by EU member states.

GM crops producing pesticides should be assessed in a similar way as chemical pesticides. Currently there are no clear rules for the kind of studies used to assess long-term effects. While agrochemicals needs to be tested on three different type of animals over periods as long as two years, there are no comparable rules for GM crops. As a result companies can decide for themselves what they want to test how and most pesticide producing GM crops are only tested on one animal (rats) for as little as 90 days.

The environmental ministers also want companies to make all their information about a GMO public. In principle that's already the case now, but companies often declare parts of the documents as 'confidential business information', accessible only for the authorities. In some cases this included the actual sequence of the inserted DNA or the setup of feeding studies - making it impossible for third parties to scrutinize the presented results.
In addition, the environmental ministers want to make it possible for regions in Europe to declare themselves as GM-free, however only on a voluntary basis.
The decisions of the ministers still has to be implemented by the European Commission and by the EFSA.

5 December 2008

Christoph Then & Antje Lorch. Study for Hiltrud Breyer (MEP) Bündnis 90/Die Grnen. December 2008.

An assessment of statements and decisions by the EU Commission shows that the EU Commission repeatedly points to the independence of the EFSA instead of taking up the responsibility to assess and control the work of the EFSA. So far the Commission usually hides behind the EFSA opinions and in practice even leaves the power to take decisions to the EFSA even though this is in contradiction to the EU regulation. In other cases however, like the cultivation of Bt11, 1507 maize and Amflora, at least some parts of the EU Commission disagree with the EFSA opinion.

5 December 2008

Christoph Then & Antje Lorch, 2008. Studie im Auftrag von Hiltrud Breyer, MEP, Bündnis 90/Die Grünen.

Die Auswertung von Stellungnahmen und Entscheidungen der EU-Kommission führt vor Augen, dass die EU-Kommission sich mit Verweis auf die Unabhängigkeit der EFSA ihrer Aufgabe entzogen hat, klare Vorgaben für deren Arbeit zu machen, die EFSA-Angaben zu prüfen und zu kontrollieren. Sie hat sich bisher hinter den Gutachten der EFSA versteckt und im Endeffekt Entscheidungsgewalt auf die EU-Lebensmitelbehörde verlagert, obwohl dies laut entsprechenden EU-Vorschriften nicht möglich ist. In einigen Fälle jedoch, z.B. bei den Zulassungsanträgen zum Anbau von Bt11, 1507-Mais und Amflora, widerspricht zumindest ein Teil der EU-Kommission den Gutachten der EFSA.

10 November 2008

For the third time now the EFSA has given a positive opinion on the two maize events Bt11 and 1507.
In November 2007, Environmental Commissioner Dimas had proposed that an approval for cultivation for these Bt-maize events should not be given. In May 2008 the Commission send the two notifications back to the EFSA with the explicit question to review eleven scientific studies that had come out since the EFSA gave its last opinion. Now on 29 October 2008, the EFSA once more gave an opinion - and once more it is positive.
How can it be that over years now the Competent Authorities of several memberstates as well as the DG Environment sees risks in the cultivation of these Bt maize - but the EFSA simply maintains their position that everything is fine? Do the members of the GMO Panel have such a completely different view on what makes a risk?

1 August 2008

The European Food Safety Authority (EFSA) responsible for the environmental risk assessment of GMOs - or more accurately: reponsible for reading the papers submitted by companies who want to import or cultivate their GM crops in the EU - invites comments on its updated Guidance Document of the Scientific Panel on Genetically Modified Organisms (GMO)for the risk assessment of genetically modified plants and derived food and feed.
Deadline is 21 September, and details are availabe at the EFSA website

1 February 2007

A. Lorch, GID 180 Februar 2007.

On 20 February 2007, the EU Environmental Ministers are supposed to decide on an application by BASF for the cultivation of a genetically modified potato. BASF seems to be optimistic that this application will be approved: the company already registered in January more then 150 hectares in the German states Brandenburg and Mecklenburg-Vorpommern for commercial cultivation. But somehow nobody seems to raise this issue, nobody seems to oppose it. Five good reasons to act against the approval of BASF's GM potato Amflora.

1 February 2007

A. Lorch, GID 180 Februar 2007.

Bei der EU liegt ein Zulassungsantrag von BASF für den Anbau einer gentechnisch veränderten Kartoffel vor, über den die EU-UmweltministerInnen am 20. Februar entscheiden sollen. Die BASF scheint zuversichtlich, hat sie doch bereits Mitte Januar über 150 Hektar für den Anbau in Brandenburg und Mecklenburg-Vorpommern angemeldet. Und dennoch regt sich kein Sturm der Entrüstung, geht kaum jemand auf die Barrikaden. Fünf gute Gründe, sich dennoch gegen die Zulassung der BASF-Gentech-Kartoffeln zu engagieren.

10 December 2006

Edited version of comments submitted to EFSA's 'Open consultation on Starch potato EH92-527-1', December 2006.

BASF applied for approval for the cultivation of the GM starch potato Amflora, as well as for its use as food and feed. Even though the application does not include any sufficient information to evaluate its environmental and food/feed safety, the EFSA gave a positive opinion.

EFSA

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5 May 2009

ifrik: EFSA announced that it needs another month to discuss the opinions of scientists who see risks in growing GM potato #Amflora

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