THIRD WORLD NETWORK BIOSAFETY INFORMATION SERVICE
Dear Friends and colleagues,
RE: EFSA Opinion of Bayer’s GM Soy Questioned
In May 2011, EFSA (European Food Safety Authority), the body that gives expert opinions to the European Commission on the safety of GMOs and pesticides, published a new opinion of Bayer Cropscience’s herbicide resistant soybean A5547-127 for use in food and feed in the EU.
Soybean A5547-127 is part of the so-called LibertyLink system that is genetically engineered to be tolerant to the herbicide glufosinate (brand names Liberty or Basta).
EFSA was overall positive on soybean A5547-127 and concluded that it is phenotypically and agronomically not different from its conventional counterpart.
However, according to Testbiotech, an independent organization that assesses the impact of biotechnology, the event shows specific risks and unintended effects to human and animal health.
In the analysis below it points out some of the shortcomings of the EFSA assessment and called for the opinion to be rejected.
With best wishes,
Third World Network
131 Jalan Macalister,
10400 Penang,
Malaysia
Email: twnet@po.jaring.my
Website: www.biosafety-info.net and www.twnside.org.sg To subscribe to other TWN information lists: www.twnnews.net
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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 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.
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.
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)article_818147, 1-28. [27 pp.] doi:10.2903/j.efsa.2011.2147.
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