testbiotech

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".

At the beginning of December, the GMO Panel launched a public consultation of the draft scientific opinion on the assessment of allergenicity of GM plants and microorganisms and derived food and feed. The public consultation will be open for a period of 2 months, untill 31 Janurary 2010. The document can be found here. After the open consultation a summary report of the comments will be prepared.live sex
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At its plenary meeting scheduled on 27 and 28 Janury 2010 EFSA GMO Panel is likely to adopt a scientific opinion on the establishment of area free of cultivation of genetically modified organisms (GMOs) in the Portuguese autonomous region of Madeira.

Background: In May 2009 the Republic of Portugal informed the European Commission about its intention to declare the autonomous region of Madeira as an area free of the cultivation of varieties of GMOs. The draft Decree of Portugal wants to prohibite the introduction of plant or seed propagating material containing GMOs into the territory of Madeira. The ban includes all GMO varieties authorised under Directive 2001/18/EC and Regulation 1829/2003.tabela

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.

The EU is split on genetically engineered plants. Only one genetical engineered plant is authorized for cultivation in the EU and even that is banned in several countries. Relatively few GM events are imported as food/feed. The risk assessment if the EFSA GMO Panel is under continuous criticism. But still the daily work of the EFSA goes on and more and more GMO applications are assessed. This is why EFSA GMO Watch was set up to monitor the workings of the EFSA GMO Panel.