Scientific opinion on insect resistant GM cotton 281-24-236 x 3006-210-23 for food and feed uses, import and processing

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Article
GMO, cotton (Gossypium hirsutum L.), 281-24-236, 3006-210-23, 281-24-236 x 3006-210-23, insect resistant, risk assessment, food and feed safety, environment, import and processing, Regulation (EC) No 1829/2003
First published in the EFSA Journal
15 June 2010
Adopted
26 May 2010
Type
Opinion of the Scientific Committee/Scientific Panel
Abstract

This scientific opinion reports an evaluation of a risk assessment for placing on the market of insect resistant genetically modified (GM) cotton (Gossypium hirsutum L.) 281-24-236 x 3006-210-23 (Unique Identifier DAS-24236-5 x DAS-21Ø23-5) for food and feed uses, import and processing. The GM cotton 281-24-236 x 3006-210-23 has been produced by conventional crossing between lines of the single cotton events 281-24-236 and 3006-210-23. The cotton 281-24-236 x 3006-210-23 expresses combined traits encoded by cry1F in event 281-24-236 and by cry1Ac in event 3006-210-23, both genes conferring resistance to certain lepidopteran pests. Both single events contain pat genes used as a selectable marker. The structure of the inserts in the single cotton events was retained in the stack 281-24-236 x 3006-210-23. Expression levels of Cry1Ac, Cry1F and PAT proteins were demonstrated to be comparable to those of the respective single events. The results of comparative analyses indicated that cotton 281-24-236 x 3006-210-23 and its respective single events are compositionally, agronomically and phenotypically equivalent to its conventional counterpart, except for the expression of Cry1Ac, Cry1F and PAT proteins. The safety assessment identified no concerns regarding toxicity and allergenicity of cotton 281-24-236 x 3006-210-23. A feeding study on broiler chickens confirmed the nutritional equivalence of this GM cotton to its conventional counterpart and two commercial non-GM cotton varieties. The intended uses of cotton 281-24-236 x 3006-210-23 exclude cultivation within the European Union. The environmental risk assessment is therefore restricted to the indirect exposure through manure and faeces mainly from animals fed with cotton products of 281-24-236 x 3006-210-23 and with the accidental release into the environment of cotton 281-24-236 x 3006-210-23 grains during transportation and processing. There are no indications of increased likelihood of establishment or survival of feral cotton plants. If accidental spillage and subsequent release into the environment of cotton 281-24-236 x 3006-210-23 seeds occur, cotton 281-24-236 x 3006-210-23 plants would have a selective advantage only under infestation of target pest species or in presence of glufosinate-ammonium herbicides, which are not commonly used on cultivated cotton or in most areas where the GM cotton might be spilled. In conclusion, the EFSA GMO Panel considers that information available for cotton 281-24-236 x 3006-210-23 addresses the scientific comments raised by Member States and that the cotton 281-24-236 x 3006-210-23 as described in this application is as safe as its conventional counterpart and other appropriate comparators with respect to potential effects on human and animal health and the environment in the context of its intended uses. The EFSA GMO Panel concludes that cotton 281-24-236 x 3006-210-23 is unlikely to have any adverse effect on human and animal health and the environment, in the context of its intended uses.

Panel members at the time of adoption
Hans Christer Andersson, Salvatore Arpaia, Detlef Bartsch, Josep Casacuberta, Howard Davies, Patrick du Jardin, Gerhard Flachowsky, Lieve Herman, Huw Jones, Sirpa Kärenlampi, Jozsef Kiss, Gijs Kleter, Harry Kuiper, Antoine Messéan, Kaare Magne Nielsen, Joe Perry, Annette Pöting, Jeremy Sweet, Christoph Tebbe, Atte Johannes von Wright, and Jean-Michel Wal.
Panel on Genetically Modified Organisms
Contact
GMO [at] efsa.europa.eu
doi
10.2903/j.efsa.2010.1644
EFSA Journal 2010; 8(6):1644 [32 pp.].
Question Number
On request from
the Competent Authority of the Netherlands on an application (EFSA-GMO-NL-2005-16) submitted by Dow AgroSciences
Print on demand
Number of Pages
32