NOTE: EFSA, the body that gives expert opinions to the European Commission on the safety of GMOs and pesticides, has just issued a positive opinion on Bayer's new herbicide-tolerant soybean for food and feed uses in the EU (see TestBiotech report below).

Our earlier post today featured a new report drawing attention to conflicts of interest at EFSA.

EFSA is heavily populated by affiliates of the International Life Sciences Institute (ILSI), which 'helps' regulators design regulatory frameworks for GMOs, pesticides, and chemicals.

TestBiotech here demonstrates how ILSI influenced the risk assessment of a GM soy by EFSA. The report says EFSA drew evidence on the GM soy's safety from the handy ILSI database, set up to provide regulators with ready-made comparisons of GM and non-GM plants (no prizes for guessing that this is about showing "substantial equivalence").
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EFSA GMO Watch June 2011
TestBiotech
Special edition: Bayer's Basta Beans: Soybean A5547-127 (Bayer CropScience)
 
In May 2011 EFSA published a new opinion [on] Bayer's herbicide resistant soy A5547-127 for uses in food and feed:

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 and questionable data from industry such as the ILSI [International Life Sciences Institute, industry-funded group] 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 exploration of the metabolom of the plants and changes in the plants´ gene activity or of pleiotrophic effects
*No exploration of DNA traces in animal tissue after feeding
*No investigation of impact on the composition of the microorganisms in the intestines
 
In conclusion, Testbiotech suggests the rejection of EFSA's opinion.
 
Documents and 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-Homepage-Liste_der_18_Pestizide.pdf <http://www.greenpeace.de/fileadmin/gpd/user_upload/themen/umweltgifte/BMELV-Homepage-Liste_der_18_Pestizide.pdf>
 
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 <http://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/questionsListLoader?panel=GMO