EFSA GMO Newsletter September/October/November 2012

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News

Testbiotech took part in a conference organized by civil society organisations in Parma because of the 10th anniversary of EFSA. Testbiotech published a backgrounder paper summarizing some findings on conflict of interests: http://www.testbiotech.de/node/736

The controversy over a study that found significant health effects in rats fed with glyphosate tolerant maize NK603 (by Monsanto) has dominated the scientific discourse on GMOs during the last few weeks. EFSA published a preliminary review of the Séralini study in October (http://www.efsa.europa.eu/en/efsajournal/pub/2910.htm). EFSA found that the study was of “insufficient scientific quality for safety assessment”. Testbiotech published several comments and a backgrounder on the case.

In a new backgrounder, Testbiotech shows that the European Food Safety Authority (EFSA) uses double standards in assessing scientific publications (http://www.testbiotech.de/node/725). According to the Testbiotech analysis, the authority applies differing standards to assess risks of genetically engineered plants and EFSA´s findings appear to be influenced by assumptions.

Testbiotech further pointed to the fact, that the discussion about the French study reveals several deficits in the current risk assessment procedures (http://www.testbiotech.org/en/node/714). Amongst others:
EFSA does not request any feeding studies using genetically engineered plants to investigate health effects if health risks are not already evident.
EU regulations request the monitoring of effects on health once the genetically engineered plants have been authorised. As this monitoring is non- existent at the moment, data for long term effects are missing.
There are severe conflicts of interests at the EFSA and other national state authorities.

The European Court of Auditors (ECA) recently published a report on the “Management of conflict of interest in selected EU Agencies”. None of the four EU agencies assessed - one being the European Food Safety Authority (EFSA) - have adequate policies in place. Revolving doors at EFSA are explicitly mentioned in the report. One of the deficiencies identified is a lack of clear, transparent and consistent policies and procedures concerning a breach of trust by experts or staff members (http://www.testbiotech.org/en/node/717).

In October, EU Health Commissioner Dalli stepped back from his position for alleged fraud. Testbiotech's concern that the EU Commission might use this power gap to push forward decisions before a new Commissioner has been appointed and properly introduced to his job (http://www.testbiotech.org/en/node/719) became reality just a few days later when the Commission gave a green light for the market authorisation of maize MIR162. Testbiotech is asking for impending decisions to be halted and a reorganization of the Commissioner’s tasks. Testbiotech urges putting any decisions on further market authorisations and a planned Implementation Regulation that deals with new standards for risk assessment of genetically engineered plants on hold.

Testbiotech submitted a comment (http://www.testbiotech.org/en/node/728) on the EFSA opinion concerning an application for market approval of genetically modified herbicide tolerant oilseed rape Ms8, Rf3 and Ms8 × Rf3 for food from Bayer, which was published on 26 September (http://www.efsa.europa.eu/en/efsajournal/pub/2875.htm).

Votes

On 10 September, the Standing Committee on genetically modified food and feed & environmental risk discussed the draft Commission Implementing Decision authorising the placing on the market of maize MIR162. As usual, no qualified majority could be reached. On 27 September, the Appeal Committee was also unable to reach a decision concerning MIR162.

New Opinions

On 15 of November, the GMO Panel published an opinion concerning market authorisation of drought tolerant Maize MON 87460 which expresses the cold shock protein B (CspB) from Bacillus subtilis and neomycin phosphotransferase II (NPTII) from Escherichia coli to reduce yield loss under water-limited conditions (http://www.efsa.europa.eu/en/efsajournal/pub/2936.htm).

On 30 October, the GMO Panel published an opinion concerning market authorisation of soybean MON87705 by Monsanto (http://www.efsa.europa.eu/en/efsajournal/pub/2909.htm). The soybean is engineered to be tolerant towards herbicides containing glyphosate. Further, the plant's fatty acid profile is changed. Oleic acid is increased, whereas proportions of linoleic acid and palmitic acid are decreased.

On 25 October, EFSA published an opinion updating the risk assessment conclusions and risk management recommendations on maize 1507. This assessment was undertaken after the EU Commission had asked for the inclusion of new scientific data that was not considered by EFSA in an update of the environmental risk assessment for maize 1507 that was published in 2011 (http://www.efsa.europa.eu/en/efsajournal/pub/2429.htm). In its latest opinion, the GMO Panel found that none of the publications reported new information that would invalidate the previous conclusions on the safety of maize 1507.

On 25 October, The GMO Panel published an opinion addressing the safety assessment of plants developed by using Zinc Finger Nucleases (http://www.efsa.europa.eu/en/efsajournal/pub/2943.htm).
EFSA states that the main difference between the SDN-3 t(Zinc finger) technique and transgenesis is that the insertion of DNA is more targeted to a predefined region of the genome. It can therefore, minimise hazards associated with the disruption of genes and/or regulatory elements in the plant. EFSA considers SDN-3 techniques to lead to fewer changes in the genome than those occurring with most mutagenesis techniques. According to EFSA, changes are of the same type as those produced by conventional breeding.

In September, the GMO Panel published four opinions on safeguard clauses that were invoked by EU Member states for import or cultivation:

In all cases, scientific evidence presented by Member States was rejected by the GMO Panel.

New Authorisations

On October 18, the EU Commission authorised market approval for maize MIR162 by Syngenta. The EFSA risk assessment had been criticised by Testbiotech recently (http://www.testbiotech.org/node/687).