GM Free Cymru

GM soy applications fail to meet EU legal requirements

Comment from GM-Free Cymru:

This letter from Testbiotech and NABU was sent to the member states on 9th November, warning them that the data provided in connection with two applications for marketing (Part C) consents for two varieties of GM soy were defective and probably illegal -- in spite of the fact that EFSA has recommended approvals. The authors of the letter argue that EFSA has failed in its duty to apply the law as it stands, and that the marketing applications should be rejected. In the event, the vote on 14 November failed to obtain a qualified majority, and the matter will now be decided by the new Appeal Committee set up by Regulation (EC) No. 182/2011. The voting was 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

Note that as usual, the UK voted in line with the EFSA recommendation, emphasising yet again that the Westminster government is slavishly following its policy of supporting GM applications regardless of their legality and regardless of the direct and indirect health and safety issues surrounding the cultivation of these soy crops. And as for the Precautionary Principle, which is enshrined in the Directives and Regulations, the UK never did understand that at all........

Note that environmental issues are supposed to be considered here -- and that means that the Westminster government is supposed to represent the views of the other 3 partners in the "GM Concordat." Were Scotland, Northern Ireland and Wales consulted prior to these two votes? Almost certainly not.....

Letter to EU Member States concerning the vote on genetically engineered soybean 40-3-2 (Monsanto) and A5547-127 (Bayer CropScience) 9.11.2011

Dear representatives of the Member States

We are writing to you to make you aware of a complicated legal situation concerning the vote to be taken on the continued marketing of soybean RR 40-3-2 (Monsanto) and market authorisation of A5547-127 (Bayer CropScience). Its authorisation would not be in line with current EU legislation on pesticides and genetically engineered organisms.

(1) REGULATION (EC) NO 396/2005 Necessary data for setting and assessing the maximal residue levels (MRL) for glyphosate and glufosinate stemming from cultivation on these soybeans under the specific and recent agricultural conditions in countries like US, Brazil or Argentina are missing. Trials should have been performed, taking into account the specific agricultural practice in these countries. But so far the presence of pesticide residues stemming from plant protection practice in most relevant countries, and their cumulative and synergistic effects, have not been determined.

(2) DIRECTIVE (EC) NO 2001/18, REGULATION (EC) NO 1829/2003 The risk assessment does not fulfill the high standards of protection of human health as foreseen in the EU Regulation. For example significant changes in the composition of the plants were not assessed sufficiently, possible impact on immune system or the reproductive system were not investigated by empirical data. Although health risks are known from the usage of glyphosate and glufosinate and its metabolites produced in the plants, no specific monitoring of health effects are proposed by EFSA. Also no measures to imply general surveillance are foreseen as legally required. We therefore kindly urge you to reject these market applications and the opinions of EFSA because they do not meet the legal requirements for the protection of consumer health within the European market.

With kind regards,

Christoph Then, Testbiotech Steffi Ober, Naturschutzbund (NABU), info@testbiotech.org, Tel: 0049 15154638040 Tel. + 49 (0)30.28 49 84-1612 Steffi.Ober@nabu.de

PS: Regarding the discussion about the risk assessment of “SmartStax” maize (Monsanto) we kindly ask you to take into account a recent report by Testbiotech, Then, C., Bauer-Panskus, A., 2011, How industry and EFSA have been systematically undermining the risk assessment of ‘SmartStax' http://www.testbiotech.de/sites/default/files/PR%20Testbiotech-SmartStax_2.pdf

Testbiotech Background to the letter to EU Member States concerning the vote on genetically engineered soybean 40-3-2 (Monsanto) and A5547-127 (Bayer CropScience)

(1) Pesticide regulation and its interplay with risk assessment of genetically engineered plants

Where pesticide residues are concerned, the data that are necessary to assess the actual risks stemming from the usage of these plants under the specific conditions of cultivation in the originating countries such as Brazil, Argentina are completely missing, also from the US recent data taking are lacking into account changed agricultural practise due to the rise of herbicide resistant weeds. Some of the relevant questions – such as residues and metabolites and possible synergies are quite specific for genetically engineered plants and have to be investigated in detail even if the pesticide itself is approved within the EU. The necessary interplay between risk assessment of genetically engineered plants and the pesticide regulation was omitted completely in EFSA's current opinions. Recent publication of EFSA (EFSA 2011) on Pesticide Residues gives no data on glufosinate. On glyphosate, 462 samples are mentioned, in nearly 10% residues were detected, details on imported soybeans are not given.

This data gap is also evident from recent publications. For example Kleter et al (2011) explain: "While residue data from experimental studies have been used to establish the residue tolerances for the herbicide–crop combinations described above, it would be interesting to compare these tolerances with what is actually measured in the field, i.e. in commercially produced foods. No measurement of the herbicides of interest in the particular crop foods in question is apparently carried out by the centralised or federal pesticide residue monitoring programmes of the EU, the United States and Canada."

Also EFSA (2011 b) states in a letter to the EU Commission:

“The risk assessment with the purpose of setting maximum residue levels (or import tolerances) in imported commodities falls within the scope of Regulation (EC) No 396/2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin. Residue trials would need to be performed according to the agricultural practice relevant to the herbicide tolerant crops and an evaluation of the consumer safety is a prerequisite for the setting of any higher maximum residue level necessitated by that use.” EFSA´s letter (EFSA, 2011 b) reflects the need for EU Regulation (EC) No 396/2005 to be obeyed when it comes to the risk assessment of herbicide tolerant events. For example Recital 26 of this Regulation reads:

“For food and feed produced outside the Community, different agricultural practices as regards the use of plant protection products may be legally applied, sometimes resulting in pesticide residues differing from those resulting from uses legally applied in the Community. It is therefore appropriate that MRLs are set for imported products that take these uses and the resulting residues into account provided that the safety of the products can be demonstrated using the same criteria as for domestic produce.”

Since relevant data concerning the actual residue loads stemming from cultivation in countries like Brazil and Argentina, where these soybeans are allowed to be cultivated, are missing completely, the risk assessment of these products is flawed. From the aspect of consumers' safety this is not acceptable:

· Glufosinate use in transgenic plants is problematic, the substance is regarded as potentially causing health effects (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). Plants contain residues from spraying with herbicide formulations and their metabolites. Furthermore, it could be shown that the metabolite of glufosinate (called NAG) produced by the transgenic plants can be partially reconverted into the pesticide itself by gut bacteria, leading to increased health risks for animals and consumers (Bremmer & Leist 1997).

· Several experts warn that a toxicity has to be expected in glyphosate higher than anticipated so far (Antoniou, et al., 2010; Benachour, et al., 2007; Paganelli et al., 2010; PAN AP 2009). In this context, the additive POEA also has to be taken into account as it is even more toxic than glyphosate in these plants. In 2010, German authorities even prohibited the usage of certain glyphosate formulations with a high content of POEA for the production of animal feeds in order to avoid a risk of toxins being passed through the food chain (BVL, 2010). The GMO panel decided to leave these questions concerning the risk assessment of residues from spraying to EFSA´s pesticide panel. In parallel, there is an ongoing EU process which is reviewing glyphosate under the pesticide regulation. Results are expected in 2012 but have been postponed (see EU Commission, 2002; Antoniou et al., 2011). Thus, the risk assessment of Roundup Ready soybeans suffers on two quarters – in the work of the GMO panel and the European pesticide regulation.

These aspects also have to be taken into account by post market monitoring, as legally required. Monitoring health effects has to include the risks associated with the spraying of glufosinate and glyphosate formulations and their residues in the plants. This is also underlined by the fact that a significant proportion of consumers seem to bear a substantial load of pesticide residues in their blood. As EFSA (2011c) writes in a letter to the European Commission (DG Sanco), which asked for an opinion on the publication by Aris & LeBlanc (2011):

“From the consumer health perspective, the observations described by the authors on the presence of glyphosate and glufosinate in non-pregnant women blood (5% and 18% of the subjects, respectively) and of 3-MPPA in non-pregnant women, pregnant women and the fetal cord blood are not unexpected. It is known that pesticides are generally well absorbed by the gastrointestinal tract and that an exposure to the two herbicides investigated through the consumption of food commodities is plausible.”

(2) On regulation concerning genetically engineered organisms

In comparison with its conventional counterparts, many significant differences in the compositional analysis and the agronomic performance were found in these plants but these were not investigated further. For example in the RR soy 40-3-2 plants the lignin content is affected (Zobiole et al., 2010a and 2010b). Instead references were made to unspecific and questionable ‛historical' data from the industry unrelated to the actual field trials, e.g. the ILSI database. Since it is not sufficiently clear under which specific conditions these additional historical data were generated, this kind of comparison inevitably contains major uncertainties (Hilbeck et al., 2011). As a result, the assumption of substantial equivalence is based not on data, but mostly on statistical tricks and data manipulation.

Soybeans are known to cause severe allergic reactions. The newly introduced gene construct might for example enhance an immune response to these endogenous plant protein(s). Furthermore, soy beans are known to produce compounds with hormonal activity. The content of these compounds might be changed by interference with the newly introduced gene constructs. Despite these known risks to human health, no feeding studies were conducted with the plants from Bayer to investigate the potential negative impact on human and animal health. Some of the studies performed with soy RR 40-3-2 revealed effects that should have been investigated further ( Malatesta et al., 2002a, 2002b, 2003, 2005, 2008). Instead EFSA dismissed the findings due to methodological issues without discussing their substance. In Bayer´s plants no empirical investigations were performed concerning allergies or other impacts on the immune system. No endocrinological studies were performed to investigate potential impacts on the reproductive system

Also the risk assessment of possible accumulated effects is missing completely. These plants will be fed and might be eaten by mixing them with other genetically engineered plants. Tests have to be performed on potential accumulated effects such as combinatorial or accumulated effects. No plan for surveillance as required by European regulation was made available such that would allow identification of particular health impacts that might be related to the use of these genetically engineered plants in food and feed.

In conclusion, the requirements of current EU legislation are not met and the applications should be rejected.

References:

Antoniou, M., Brack, P., Carrasco, A., Fagan, J., Habib, M., Kageyama, P., Leifert, C., Nodari, R. O., Pengue W., 2010, GM Soy: Sustainable? Responsible?, GLS Bank & ARGE gentechnikfrei, http://www.gmwatch.eu/?option=com_content&view=article&id=12479
Antoniou, M., Habib, M., Howard, C.V., Jennings, R.C., Leifert, C., Nodari, R. Robinson, C., Fagan, J., 2011, Roundup and birth defects - Is the public being kept in the dark? Earth Open Source, June 2011
Aris, A & LeBlanc, S (2011) Maternal and fetal exposure to pesticides associated to genetically modified foods in Eastern Townships of Quebec, Canada. Reproductive Toxicology, 31(4):528-33.
Benachour, N., Siphatur, H., Moslemi, S., Gasnier, C., Travert, C., Seralini, G. E., 2007, Time- and dose-dependent effects of Roundup on human embryonic and placental cells, Arch Environ Contam Toxicol 53:126-33.
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
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) BVL (2010) www.bvl.bund.de/DE/04_Pflanzenschutzmittel/05_Fachmeldungen/2010/psm_anwendungsbestim mungen_tallowamin-Mittel.html
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, 2010, EFSA Panel on Genetically Modified Organisms (GMO); Scientific Opinion of the Panel on Genetically Modified Organisms on applications (EFSA-GMO-RX-40-3-2) for the renewal of authorisation for the continued marketing of
(1) food containing, consisting of, or produced from genetically modified soybean 40-3-2;
(2) feed containing, consisting of, or produced from soybean 40-3-2;
(3) other products containing or consisting of soybean 40-3-2 with the exception of cultivation, all under Regulation (EC) No 1829/2003 from Monsanto.
EFSA Journal 2010;8(12):1908, [1-38]. doi:10.2903/j.efsa.2010.1908. Available online: www.efsa.europa.eu/efsajournal.htm European Food Safety Authority (EFSA 2011): 2009 EU Report on Pesticide Residues.
EFSA Journal 2011; 9(11):2430. [226 pp.] doi:10.2903/j.efsa.2011.2430. Available online: www.efsa.europa.eu/efsajournal
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) Letter to DG Sanco, 19. August 2011, Ref PB/HF/AFD/mt (2011) 5881859 Request for an analysis of the Testbiotech letter concerning applications for authorisation of maize MON89034xMON88017, cotton GHB614 and renewal of maize 1507. EFSA (2011c)
Letter to DG Sanco, 19. August 2011, Ref PB/HF/AFD/mt (2011) 5863329 Request for advice from DG Sanco to analyse the articles on residues associated with GMO/ maternal and fetal exposure in relation to a previous statement from 2007 ...” European Commission Peer Review Programme, 2002, Glyphosate Review Report Rapporteur Member State: Germany, www.ec.europa.eu/food/plant/protection/evaluation/existactive/list1_glyphosate_en.pdf
Hilbeck A.,Meier M.,Römbke J.,Jänsch S.,Teichmann H.,Tappeser B., (2011) Environmental risk assessment of genetically modified plants concepts and controversies.E ‐ nvironmentalSciences Europe.2011;23(13). Kleter, G.A., Unsworth J.B., Harris C.A. (2011) The impact of altered herbicide residues in transgenic herbicide-resistant crops on standard setting for herbicide residues, wileyonlinelibrary.com, DOI 10.1002/ps.2128 Malatesta, M., Caporaloni, C., Gavaudan, S., Rocchi, M.B.L., Serafini, S., Tiberi, C., Gazzanelli, G., 2002a, Ultrastructural morphometrical and immunocytochemical analyses of hepatocyte nuclei from mice fed on genetically modified soybean. Cell Structure and Function, 27, 173-180.
Malatesta, M., Caporaloni, C., Rossi, L., Battistelli, S., Rocchi, M.B.L., Tonucci, F., Gazzanelli, G., 2002b, Ultrastructural analysis of pancreatic acinar cells from mice fed on genetically modified soybean. Journal of Anatomy, 201, 409-415.
Malatesta, M., Biggiogera, M., Manuali, E., Rocchi, M.B.L., Baldelli, B., Gazzanelli, G., 2003, Fine structural analyses of pancreatic acinar cell nuclei from mice fed on genetically modified soybean. European Journal of Histochemistry, 47, 385-388.
Malatesta, M., Tiberi, C., Baldelli, B., Battistelli, S., Manuali, E., Biggiogera, M., 2005, Reversibility of hepatocyte nuclear modifications in mice fed on genetically modified soybean, European Journal of Histochemistry, 49, 237-241.
Malatesta, M., Boraldi, F., Annovi, G., Baldelli, B., Battistelli, S., Biggiogera, M., Quaglino, D., 2008, A long-term study on female mice fed on a genetically modified soybean: effects on liver ageing. Histochemistry and Cell Biology 130,967-977.
Matthews D., Jones H., Gans P., Coates St., Smith L.M.J., 2005, Toxic secondary metabolite production in genetically modified potatoes in response to stress. Journal of Agricultural and Food Chemistry, 10.1021/jf050589r.
Paganelli, A., Gnazzo, V., Acosta, H., López, S. L., Carrasco, A. E., 2010, Glyphosate-based herbicides produce teratogenic effects on vertebrates by impairing retinoic acid signalling. Chem. Res. Toxicol., August 9. pubs.acs.org/doi/abs/10.1021/tx1001749 PAN AP, Pesticide Action Network Asian Pacific, 2009, Monograph on Glyphosate, www.panap.net/en/p/post/pesticides-info-database/115 Zobiole, L. H., S., Bonini, E. A., Oliviera, R.S., Kremer, R. J., Ferrarese-Filho, O., 2010a, Glyphosate affects lignin content and amino acid production in glyphosate-resistant soybean, Acta Physiol Plant, 32:831–837 Zobiole, L.H., Oliveira, R.S., Viesentainer, J.V., Kremer, R.J., Bellaloui, N., Yamada, T. 2010B, Glyphosate affects seed composition in glyphosate-resistant soybean. Journal of Agricultural and Food Chemistry. 58:4517-4522.