testbiotech

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 MON88705 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:

• opinion on safeguard clause invoked by Luxembourg on Amflora potato EH92-527-1 (http://www.efsa.europa.eu/en/efsajournal/pub/2874.htm),
• opinion on the prolongation of prohibition of the placing on the market of GM oilseed rape GT73 for import, processing and feed uses in Austria (http://www.efsa.europa.eu/en/efsajournal/pub/2876.htm),
• opinion on the prolongation of prohibition of the placing on the market of GM oilseed rape Ms8, Rf3 and Ms8 x Rf3 for import, processing and feed uses in Austria (http://www.efsa.europa.eu/en/efsajournal/pub/2878.htm),
• opinion on safeguard clause invoked by Greece on GM maize MON 810 (http://www.efsa.europa.eu/en/efsajournal/pub/2877.htm).

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).

News

On 10 May, the European Parliament voted against granting discharge of the European Food Safety Authority (EFSA) budget for the year 2010. By doing so, it adopted a report from its Committee on Budgetary Control criticising EFSA very harshly for conflicts of interest and revolving door cases (http://www.testbiotech.org/en/node/661).

On 8 May, just two days before the vote, Diána Bánáti, Chair of the EFSA Management Board, had resigned with immediate effect. She will take up a professional position at the International Life Sciences Institute (ILSI). Diána Bánáti had been subject to criticism since September 2010 because she was Board Member of ILSI Europe. After leaving ILSI, she was re-elected as chair of EFSA’s Management Board in October 2011. Now she is returning to ILSI Europe, which is funded by food industry and agrochemical companies (http://www.testbiotech.org/en/node/656).

EFSA wrote a letter to ILSI explaining that according to its new regulations on independence, experts from ILSI are excluded from various working levels at EFSA:
"Regarding the classification of ILSI involvement as a category V activity “ad hoc or occasional consultancy”, EFSA’s new rules explicitly exclude the involvement of scientific experts participating in scientific work related to services provided to products, their development and/or assessment methods carried out on behalf of trade associations or other bodies with an interest in this subject matter, such as ILSI."
http://www.efsa.europa.eu/en/press/news/120516a.htm

Obviously, in a reaction to the pressure from the EU Parliament, EFSA then decided to postpone the nomination of new experts for several scientific panels. The nominations, which were scheduled for 8 May, will now take place on 27 June.

In a letter to the EU ombudsman in regard to the case of Suzy Renckens, EFSA admitted for the first time that it had not taken the necessary action to stop revolving doors (http://www.testbiotech.org/en/node/650). EFSA states that “regrettably” the authority did not follow up the relevant information. Further, the authority acknowledges that it has strengthened internal rules in response. More information on the case of Suzy Renckens at: http://www.testbiotech.org/en/independence.

Testbiotech published a new backgrounder “MON88017 'Roundup Rootworm Maize' - ready for cultivation?” (http://www.testbiotech.de/node/639) warning that the insecticide producing genetically engineered maize MON88017 might help pest insects become even more harmful. Researchers in a US laboratory have shown that the pest insects, known as corn rootworm, may not only become resistant to the insecticide producing maize plants, but the development of the larvae can be speeded up and fertility higher. Thus, commercial cultivation of these plants could result in helping the pest insects that are also known as the 'one billion dollar bug', to spread even quicker in the fields.

Votes

On 2 May, the SCFCAH voted on the application of soybean MON87701xMON89788 (http://ec.europa.eu/food/committees/regulatory/scfcah/modif_genet/ag0205...). No decision was reached. The case will now be forwarded to the appeal committee.

New Opinions

On 11 April, EFSA published a scientific opinion on the annual monitoring report by Monsanto on the cultivation of GM maize MON 810 in 2010. The GMO panel notes shortcomings in the methodology for Case- Specific Monitoring (CSM) and General Surveillance (GS), but does not identify adverse effects on the environment, human and animal health due to maize MON810 cultivation during the 2010 growing season.
http://www.efsa.europa.eu/en/efsajournal/pub/2610.htm

On May 21, EFSA published a scientific opinion on a request from the European Commission related to the emergency measure notified by France on genetically modified maize MON 810 (http://www.efsa.europa.eu/en/efsajournal/pub/2705.htm). According to the opinion, the GMO Panel found no scientific evidence, in terms of risk to human and animal health or the environment, that would support the notification of an emergency measure.

Other

On 2 April, EFSA published its annual report of the EFSA Scientific Network for Risk Assessment of GMOs for 2011 (http://www.efsa.europa.eu/en/supporting/pub/260e.htm).

EFSA published a call for tender: Review of the strategies for the comprehensive food and feed safety and nutritional assessment of GM plants per se (CFT/EFSA/GMO/2012/04). http://www.efsa.europa.eu/en/tenders/tender/cftefsagmo201204.htm. For the first time the authority is starting to work on the details how to perform a risk assessment that is not based on the comparative approach.

On 30 May, the GMO Panel might adopt opinions for the following applications (http://www.efsa.europa.eu/en/events/event/120530-a.pdf):

• Application for authorisation of genetically modified Soybean 40-3-2 for Cultivation submitted under Regulation (EC) No 1829/2003 by Monsanto (EFSA-GMO-NL-2005-24) (EFSA-Q-2005-251)
• Application for authorisation of genetically modified maize MIR162 for food and feed uses, import and processing submitted under Regulation (EC) No 1829/2003 by Syngenta (EFSA-GMO-DE-2010-82) (EFSA-Q-2010-00972)
• Application for authorisation of genetically modified Soybean MON87705 for food and feed uses, import and processing submitted under Regulation (EC) No 1829/2003 by Monsanto (EFSA-GMO-NL-2010-78) (EFSA-Q-2010-00165)
• EFSA environmental risk assessment guidance on genetically modified animals (EFSA-Q-2011-00919)

EFSA published an event report regarding a workshop on key allergens and compositional analysis in the allergenicity assessment of genetically modified plants which was held on 21st March 2012 (http://www.efsa.europa.eu/en/supporting/pub/289e.htm).

News

Testbiotech filed a comment on EFSA's opinion on Syngenta maize GA21 for cultivation see http://www.testbiotech.de/node/606

Votes

On 17 January 2012, the Appeal Committee set up under Regulation (EC) No. 182/2011 voted on four genetically engineered soy events:

• Roundup Ready soybean 40-3-2 produced by Monsanto, which has been made tolerant to the herbicide glyphosate;
• Basta Soybean A5547-127 produced by Bayer CropScience, which has been made tolerant to the herbicide glufosinate;
• Bt-Soybean MON87701 produced by Monsanto, which is the first transgenic soybean on the market that produces an insecticidal protein; and
• Optimum GAT Soybean 356043 produced by DuPont/Pioneer, which has been made tolerant to two different herbicides, glyphosate and ALS-inhibitors

Testbiotech and Friends of the Earth, Europe, wrote a letter to MS, exposing deficiencies in risk assessment of EFSA: http://www.testbiotech.org/en/node/603

The applications did not attain a majority vote. Member states voted as follows:

on soybean MON87701 (Monsanto)

• in favour: Cz, Dk, De, Es, Est, Fin, Ir, Mal, NL, Port, Ro, Svk, Swe, UK
• against: Au, Be, Cyp, Gre, Hu, Lat, Lith, Lux, Pol, Sln
• abstained: Bu, It, Fr

on soybean DP356043 (Pioneer)

• in favour: Cz, Dk, De, Es, Est, Fin, Ir, Mal, NL, Port, Ro, Svk, Swe, UK
• against: Au, Bu, Cyp, Gre, Hu, Lat, Lith, Lux, Pol, Sln
• abstained: Be, It, Fr

on soybean A5547-127 (Bayer CropScience)

• in favour: Cz, Dk, De, Es, Est, Fin, Ir, Mal, NL, Port, Ro, Svk, Swe, UK
• against: Au, Cyp, Fr, Gre, Hu, Lat, Lith, Lux, Pol, Sln
• abstained: Be, Bu, It,

on soybean 40-3-2 (Monsanto)

• in favour: Cz, Dk, De, Es, Est, Fin, Ir, Mal, NL, Port, Ro, Svk, Swe, UK
• against: Au, Cyp, Gre, Hu, Lat, Lith, Lux, Pol,
• abstained: Be, Bu, Fr, It, Sln

It is likely that the EU Commission will now authorise these events.

New authorisations

In December 2011, the Commission authorised Syngenta stacked maize events which combine insect- resistant traits with herbicide tolerance for usage in food and feed:

• MIR604 x GA21,
• Bt11 x MIR604 and
• Bt11 x MIR604 x GA21

Further authorisations was awarded to the genetically engineered stacked cotton event produced by
Dow AgroSciences for use in food and feed with insect resistance (Cry1F and Cry1Ac) and tolerance to glufosinate:

• DAS 281-24-236 x 3006-210-23

News
EFSA held a workshop on independence and the scientific decision making process on 12 October 2011 in Brussels. The results can be found at http://www.efsa.europa.eu/en/events/event/111012.htm

Testbiotech filed a letter (http://www.testbiotech.de/node/573) to Member States before the meeting of the standing committee SCFCAH on 14 November on the market authorisation of two genetically engineered soybeans tolerant to herbicides (http://ec.europa.eu/food/committees/regulatory/scfcah/modif_genet/index_...). The applications did not achieve a majority. Member states voted as follows:

on soybean A5547-127
• in favour: Bel, Cz, Dk, De, Est, Ire, Es, NL, Port, Ro, Svk, Fin, Swe, UK
• against: Gre, Fr, Cyp, Lat, Lith, Lux, Hun, Au, Pol, Sln
• abstained: Bul, It, Mal

on soybean 40-3-2
• in favour: Bel, Cz, Dk, De, Est, Ire, Es, NL, Po, Ro, Svk, Fin, Swe, UK
• against: Gre, Cyp, Lat, Lith, Lux, Hun, Au, Pol
• abstained: Bul, Fr, It, Sln, Mal

These applications now for the first time will be examined by a new procedure involving the Appeal Committee set up by Regulation (EC) No. 182/2011. A decision can be expected during January 2012.

New opinions and guidance
EFSA published an updated version on post-market monitoring of MON810 without proposing case specific monitoring http://www.efsa.europa.eu/en/efsajournal/pub/2376.htm

EFSA is of the opinion that pollen from MON810 in honey does not pose any risk: http://www.efsa.europa.eu/en/efsajournal/pub/2434.htm

EFSA published a new opinion on MON80807 for cultivation (http://www.efsa.europa.eu/en/efsajournal/pub/2428.htm). This is the first opinion published under the new Guidance for environmental risk assessment. The maize produces an insecticidal toxin (Cry3Bb1) and is tolerant to glyphosate. Deadline for comments is 10 December, please see: http://ec.europa.eu/food/food/biotechnology/gmo_authorisation_en.htm

Furthermore EFSA published opinions on subcombinations of MON80934x1507xNK603 and MON89034x1507xMON88017x59122. These are additional informations as requested by the Commission.

Others:
EFSA will hold a workshop on GMOs on 29 November: http://www.efsa.europa.eu/en/events/event/111129.htm

The EU Commission and EFSA answered Testbiotech's letter on the authorisation of MON 89034 × MON 88017 maize (Monsanto), GHB614 (Bayer) and the renewal of the application for maize 1507 (Pioneer) (http://www.testbiotech.de/node/501)

Testbiotech does not consider this answer (see: http://www.testbiotech.de/sites/default/files/CAB16_1114101113_001.pdf) to be adequate and will come up with further analysis during the coming weeks.

News
Testbiotech and GeneWatch, UK filed a formal request for an internal review of the EU Commission´s decision according Article 10 of Regulation (EC) No. 1367/2006 to withdraw market authorisation for maize MON89034XMON88017 (http://www.testbiotech.de/node/526).

New opinions and guidance
EFSA published its opinions on food and feed for

• Soybean MON87701 (Monsanto, produces the insecticidal protein Cry1Ac), http://www.efsa.europa.eu/en/efsajournal/pub/2309.htm
• Soybean 356043 (Pioneer, herbicide tolerance to glyphosate and ALS-inhibiting herbicides)
  http://www.efsa.europa.eu/en/efsajournal/pub/2310.htm

Both crops inherit unintended changes in plant compounds. See media release Testbiotech http://www.testbiotech.org/en/node/531. Comments can be sent to the following address until 27 August 2011: http://ec.europa.eu/food/food/biotechnology/gmo_authorisation_en.htm

Further, EFSA has published new guidance for the post market monitoring of environmental risks http://www.efsa.europa.eu/en/efsajournal/doc/2316.pdf. According to a letter from the Commission of 5 July, the new guidance will be used to update and effect EFSA´s opinion issued for the following applications relevant to the cultivation of genetically engineered plants:
Maize 1507, maize Bt11, soybean 40-3-2, sugarbeet H7-1. Publication will be within the next few weeks (see last EFSA-GMO_Newsletter).

New consultations:
EFSA launched a call for comments on risk assessment of food and feed from genetically modified animals including animal health and welfare aspects: http://www.efsa.europa.eu/en/consultations/call/110810.htm

In May 2011 EFSA published a new opinion Bayer´s herbicide resistant soy A5547-127 for uses in food and feed, http://www.efsa.europa.eu/de/efsajournal/pub/2147.htm. Testbiotech provides a short analysis of EFSA´s opinion:

Soybean A5547-127, is part of the so-called LibertyLink system which is mainly followed by Bayer CropScience. The plants are tolerant to herbicides with the active ingredient glufosinate (brand names Liberty or Basta). The soybean was originally developed by the German company, Agrevo (created through the merger of the chemical companies Hoechst and Schering, in operation from 1994 to 1999). Agrevo later became Aventis until Bayer aquired the company in 2002. Soybean A5547-127 was first approved in the USA in 1998. In contrast to Monsanto's RoundupReady plants, the commercial success of the LibertyLink system was only minor. Nevertheless, soybean A5547-127 was approved for commercial cultivation in Brazil in 2010. It is evident that the reintroduction of this very old event in the market is closely connected to the emergence of weeds that are resistant to Monsanto's herbicide Roundup (active ingredient glyphosate). The LibertyLink system can be offered by industry as an alternative in growing genetically engineered plants.

Glufosinate use in soybean A5547-127 is highly relevant to human and animal health because the substance is regarded as highly toxic (EFSA 2005). According to the German Agricultural Ministry, glufosinate will be phased out in the EU in 2017 for reasons of reproductive toxicity (BMELV 2009). Furthermore, it has been shown that the metabolite of glufosinate (called NAG) produced by the transgenic plant can be reconverted into the pesticide itself by gut bacteria, leading to increased health risks for animals and consumers (Bremmer & Leist 1997). Both factors concerning glufosinate are not covered by EFSA risk assessment.

The soybeans showed several significant changes in their composition and agronomic performance compared to isogenic lines. There were no targeted investigations (such as a stress test under defined environmental conditions) to determine genetic stability and to explore if certain environmental conditions can trigger higher variations in compositions and performance.

Despite all the known risks associated with these genetically engineered soybeans, no feeding studies with the whole plants were performed to investigate health effects related to toxicology, immunology and reproduction. Instead only a 14 day toxicological study on rats (with isolated protein produced by bacteria, not with whole plant) and 42 day nutritional study on chickens (with whole plant but no investigation of health effects) were conducted.

The event shows specific risks and unintended effects:

• plants contain residues from spraying with glufosinate
• the method used to insert the gene sequence has several technical deficiencies e.g. an interruption of the plant´s gene. The gene construct is unintentionally divided into two parts, The insertion of the gene construct results in parts of the DNA with reverse orientation and deletions. Open reading frames are found that can give rise to unintended proteins in the plants
• the plants show significant differences in their composition compared to their counterparts that were not investigated further. Instead it was referred to unspecific data from industry such as the ILSI database.
• soybeans are known to cause allergic reactions. No tests were performed to investigate if new potential allergens are emerging from genetic manipulation
• soybeans are known to produce compounds with hormonal activity. No targeted tests concerning impact on reproductive system were performed.
• these soybeans will be fed and might be eaten by mixing them with other genetically engineered plants. No tests were performed on potential accumulated effects such as interaction between the plants and other factors.

Overview of some shortcomings of EFSA opinion:
• No assessment of pesticide residues
• No assessment of metabolites of glufosinate produced by the transgenic plant
• No detailled investigation of changes in composition and agronomic performance
• No targeted investigation concerning potential new allergens or impact on the reproductive system
• No feeding studies concerning health effects with the whole plant
• No assessment of combinatorial effects when used with other genetically engineered plants in food and feed
• No assessment of possible pleiotropic effects
• No exploration of the metabolom of the plants and changes in the plants´ gene activity
• No exploration of DNA traces in animal tissue after feeding

In conclusion, Testbiotech suggests the rejection of EFSA´s opinion.

Documents und publications:
BMELV, Bundesministerium für Ernährung, Landwirtschaft und Verbraucherschutz (2009) Neue Bewertungskriterien für Wirkstoffe in Pflanzenschutzmitteln. www.greenpeace.de/fileadmin/gpd/user_upload/themen/umweltgifte/BMELV-Hom...

Bremmer, J.N. and Leist, K.-H. (1997) Disodium-N-acetyl-L-glufosinate; AE F099730 - Hazard evaluation of Lglufosinate produced intestinally from N-acetyl-L-glufosinate. Hoechst Schering AgrEvo GmbH, Safety Evaluation Frankfurt. TOX97/014. A58659. Unpublished. (see FAO publication on www.fao.org/ag/agp/agpp/pesticid/jmpr/Download/98/glufosi3.pdf)

EFSA (2005) Conclusion regarding the peer review of the pesticide risk assessment of the active substance glufosinate. EFSA Scientific Report 27, 1-81. doi:10.2903/j.efsa.2005.27r. http://www.efsa.europa.eu/en/efsajournal/doc/27r.pdf

EFSA (2011a) Scientific Opinion on application (EFSA-GMO-NL-2008-52) for the placing on the market of herbicide tolerant genetically modified soybean A5547-127 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Bayer CropScience. The EFSA Journal (2011); 9(5):2147, 1-28. [27 pp.] doi:10.2903/j.efsa.2011.2147. http://www.efsa.europa.eu/de/efsajournal/pub/2147.htm

EFSA (2011b) Application EFSA-GMO-NL-2008-52 (soybean A5547-127) Comments and opinions submitted by Member States during the three-month consultation period, accessed via http://registerofquestions.efsa.europa.eu/roqFrontend/questionsListLoade...

News:
EFSA and the Commission invited to hearings on risk assessment of genetically engineered plants as well as on the choice of the comparator. Testbiotech was amongst the speakers. Documented at http://ec.europa.eu/food/food/biotechnology/index_en.htm
http://www.efsa.europa.eu/en/events/event/gmo110331.htm

Our homepage has documentation of all docs filed by Testbiotech on EFSA's guidance within the last few months http://www.testbiotech.org/en/node/467

Testbiotech also signed a joint letter from several NGOs being sent to the Commission (http://www.testbiotech.de/node/500)

Testbiotech wrote letter to the Euoropean Commission urging market authorisation not be given for new applications such as a Bt maize with a triple stack (MON 89034 × MON 88017 by Monsanto), cotton GHB614 (Bayer) as well as maize 1507 (Pioneer). All applications are for import. (http://www.testbiotech.de/node/501)
see also: http://www.testbiotech.org/node/458

On request of the European Parliament, the Commission asked the European Court of Auditors to come up with a report on EU agencies:
http://www.europeanvoice.com/article/imported/european-court-of-auditors...

Happy New Year to all our readers. Thank you for your continued support - our newsletters will be keeping you up to date on our activities throughout 2011!

This is a special edition on Monsanto´s renewal application for the Roundup Ready variety of soybean (soybean 40-3-2).

In December 2010, EFSA published a favourable opinion on the renewal application for authorising imports into the European Union (http://www.efsa.europa.eu/en/scdocs/scdoc/1908.htm). This product is hugely important, especially for the European livestock industry. Millions of tons of soybean 40-3-2 are imported into the EU every year.

The GMO panel upheld its previous findings and confirmed that “soybean 40-3-2 is as safe and nutritious as the conventional counterpart and other commercial soybean varieties.”

For the following reasons Testbiotech disagrees with the GMO panel’s approach and findings:
EFSA did not sufficiently assess the specific risks associated with the genetic engineering method
EFSA did not take into account the necessary interplay between risk assessment in genetically engineered plants and the risk assessment of pesticides
EFSA dismissed relevant publications indicating certain health risks without proper reasoning and did not assess other relevant studies

1) News
The Ombudsman has responded to the EFSA’s answer concerning the Dr. Suzy Renckens’ case. He has asked for more information about Dr. Renckens’ tasks, projects, her meetings with industry and the circumstances of her move to industry. In a new time frame, the Ombudsman has now given the EFSA until 30 November to answer questions. The Ombudsman’s reaction shows that so far the answers from EFSA do not settle the conflicts of interest involved in this case (for more information see http://www.testbiotech.org/en/node/354). New problems for EFSA have arisen in the case of Prof. Diana Bánáti, a member of the management board acting in parallel with the ILSI, International Life Science Institute (http://www.gmwatch.org/latest-listing/1-news-items/12527-efsa-chair-in-c...). The ILSI is an international pro industry expert group that publishes studies in cooperation with companies such as Monsanto. Their aim is to achieve lower standards in risk assessment (see for example Glenn, 2008, Nutritional and Safety Assessments of Foods and Feeds Nutritionally Improved through Biotechnology Case Studies by a Task Force of the ILSI International Food Biotechnology Committee, http://apjcn.nhri.org.tw/server/APJCN/Volume17/vol17suppl.1/229-232S13-1...
ILSI claims that their projects are influencing the work of EFSA – contrary to the statements of Diana Bánáti (http://www.ilsi.org/FoodBioTech/Pages/NutritionalandSafetyAssessments.aspx).

EFSA has answered the questions asked by the European Ombudsman concerning the case of Dr. Suzy Renckens. EFSA again states that the authority does not see any problems with the move of the leading member of staff Renckens from its 'GMO panel' to the seed company of Syngenta (which produces genetically engineered plants). Testbiotech and other stakeholders are warning of the conflict of interest in this case. In May 2010, the Ombudsman filed a letter with several questions to EFSA after he was informed by Testbiotech. The Ombudsman now will take a decision on how to proceed with the case (see also: http://www.testbiotech.org/en/node/354).

EFSA has invited Testbiotech and other organisations to a meeting on 29 September 2010 in Parma on the assessment of ecological risks associated with genetically engineered plants (see also: http://www.efsa.europa.eu/en/press/news/gmo20100706.htm).

Following a complaint made by Testbiotech and the Corporate Europe Observatory (CEO) [http://www.testbiotech.org/en/node/354] the European Ombudsman has reacted and forwarded relevant questions to EFSA. EFSA now has to respond by the end of August. Further, on initiative of the Green Party, the European Parliament has adopted a paragraph during its process of budget control stating that the Parliament “urges EFSA to ensure that all former officials, in accordance with Art. 16 of the European Staff Regulations, inform EFSA about taking up new positions outside the institutions. If these activities could lead to a conflict with the legitimate interests of the institution, EFSA must take the appropriate measures".

Members of the EFSA's Stakeholder Consultative Platform met on 1 and 2 December 2009 for the first time since being re-appointed in October. The representatives of 24 EU-wide organisations discussed the following topics: the risk assessment of GMOs, health claims, EFSA's approach on emerging risks and nanotechnology.

Regarding the risk assessment of GMOs Per Bergman, head of the GMO unit, spoke on cooperation in GMO risk assessment and interaction with stakeholders, and explained ongoing updates on GMO risk assessment guidance, such as environmental risk assessment, molecular characterisation and the allergenicity assessment of GM plants
Stakeholder Consultative Platform has been initiated by EFSAs Management Board and is composed of 24 EU-wide organisations working in areas related to the food chain. The platform members meet three times a

On 5 March 2010, EFSA’s GMO Panel has published a draft guidance document for the environmental risk assessment of GM plants and a draft scientific opinion on the assessment of potential impacts of GM plants on non-target organisms.

The draft Guidance Document and the draft scientific opinion are now open for public consultation. The deadline for public comments is 30 April 2010.

On 30. October 2009 the European Commission has authorized the importation of three transgenic maize events: MON88017 and MON89034, both form Monsanto, and 59122 x NK603 from Pioneer Hi-Bred (a Dupont company). The three transgenic events now can legally be imported into Europe over the next 10 years for food and feed uses.
The Commission decision came only ten days after the meeting of the Agriculture and Fisheries Council, where none of the three events had obtained a qualified majority.

Member States voting against an authorisation not only raised safety and political reasons against the three applications but also criticised the favourable EFSA opinions on the three events as not fully satisfactory. As the European agriculture ministers did not find an agreement about the three applications, the ministers forwarded the issue to the European

In its meeting on 27/28 January 2010, the EFSA GMO Panel discussed the peer-reviewed scientific paper concerning effects of GM maize on mammals: "A Comparison of the effects of three GM corn varieties on mammal health" (Vendômois et al. 2009) concerning MON810, MON863 and NK603; and comments from Austria about bioinformatic data of NK603. In both cases the GMO Panel did not see any reason to re-consider their earlier assessments.
In fact the one page statement the GMO Panel concludes that Vendômis et al.'s "claims regarding new side effects indicating kidney and liver toxicity, are not supported by the data provided in their paper." The GMO Panel also dismisses criticism on the experimental design. As the Panel lists in more detail: this is not the first time that peer-reviewed articles bythe scientists of the research institute CRIIGEN have been dismissed in favour of Monsanto's company research.

Shortly after the GMO Panel published its opinion on the renewal of Bt maize MON810, Greenpeace and Friends of the Earth Europe published a joint report criticizing the opinion as 'woefully inadequate.'
In a reaction, EFSA first released a statement clarifying and ratifying some of the mentioned points, and then invited them to a scientific discussion on 2 October 2009.