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, The applicant should obtain information on glyphosate use for highway maintenance, and, if such use is confirmed, produce results concerning possible persistence of cotton plants in these specific conditions. Those information are essential for monitoring and GM

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S. Heuberger, C. Ellers-kirk, B. E. Tabashnik, C. , and Y. , Pollen-and Seed-Mediated Transgene Flow in Commercial Cotton Seed Production Fields, PLoS ONE, vol.5, 2010.

J. Hofs and B. Hau, Etude des flux de gènes entre le cotonnier cultivé et les espèces voisines dans les agrosystèmes sud africains, 2006.

D. Llewellyn, C. Tyson, G. Constable, B. Duggan, S. Beale et al., , 2007.

, Containment of regulated genetically modified cotton in the field, Ecosystems & Environment, vol.121, pp.419-429

P. Kareiva, W. Morris, and C. M. Jacobi, Studying and managing the risk of crossfertilization between transgenic crops and wild relatives, Molecular Ecology, vol.3, pp.15-21, 1994.

J. Lançon and C. Klassov, Mise au point sur graines de coton (G. hirsutum L.) d'une methode de germination en laboratoire, Coton Et Fibres Tropicales, vol.43, pp.311-317, 1988.

A. Messéan, F. Angevin, M. Gómez-barbero, K. Menrad, and E. Rodríguez-cerezo, New case studies on the coexistence of GM and non-GM crops in European agriculture, 2006.

. Oecd, Consensus document on the biology of cotton ENV/JM/MONO(2008)33, Series on harmonisation of regulatory oversight in biotechnology, 2008.

C. Pannetier, J. Hofs, E. Montes, F. Eber, O. Coriton et al., Evidence of unreduced gamete production from interspecific crosses between G. herbaceum and G. hirsutum, 2009.

G. Roberts, S. Kerlin, and M. Hickman, Controlling volunteer cotton -a guide for integrated management of weeds in cotton, p.6, 2002.

, Step 3: Exposure characterization

, It would therefore be advisable to monitor transport routes, under procedures to be specified, especially if their edges are treated with glyphosate, as in France. Special attention should be paid to farms using whole seed for animal feed

, The HCB Scientific Committee notes that, by and large, the literature cited is old and should be replaced by more recent work

. Kay, Yet transformation events have been observed to occur directly or indirectly in soil although not necessarily with DNA from transgenic plants. Moreover, in field conditions transfer could take place within plants that are healthy, 2001.

A. Pontiroli, A. Rizzi, P. Simonet, D. Daffonchio, T. M. Vogel et al., , 2009.

, Visual evidence of horizontal gene transfer between plants and bacteria in the phytosphere of transplastomic tobacco, Appl Environ Microbiol, vol.75, pp.3314-3322

, The applicant refers (page 132) to only 4 weed taxa for cotton-growing in Spain: Solanum negrum, Abutilon teophrasti, Medicus and Cyperus spp

, This practice is now being abandoned for economic and environmental reasons (waste). The current list of cotton weeds in Spanish agrosystems is lengthier, 1981.

, There are two groups requiring particular attention in terms of glyphosate resistance: -Species and genera with glyphosate-resistant biotypes in non-European countries (Amaranthus spp., Digitaria spp., Echinochloa spp., Poa spp, Sorghum halepense), -Species with glyphosate-resistant biotypes in Spain (Lolium multiflorum, L. rigidum)

. González-torralva, So far there is no literature covering some of the new invasive species introduced into Spain that have glyphosate-resistant biotypes (Conyza canadense, C. bonariensis, C. sumatrensis), but there ought to be a review of the possible presence of these species in cotton crops, since they are a problem in (olive and peach) orchards in the south of Spain, 2012.

, The commercial management regime for the GHB614 cotton varieties is the same as for conventional cotton

A. Albajes, is too recent for any valid conclusions to be drawn. Information about other crops can serve only as guidance: 'A study performed with HT maize in Spain concluded that significant changes in heteropteran predator densities from moderate alterations in weeds arising from the deployment of herbicide-tolerant corn varieties are not expected, No studies exist on effects of glyphosate management on above-ground invertebrates in cotton crops. The study by Albajes et, 2011.

. Price, Potential environmental impacts of GHB614 cultivation on weed shifts and the selection of weed communities composed of more tolerant or resistant species', page 134), resistance existed in some species before the introduction of GMPs (Heap, 2013): Plantago lanceolata in South Africa and Lolium rigidum in Australia and in France, where no GMPs have been introduced. In the United States, on the other hand, where MON01445-2 was introduced in 1995, a number of species have developed glyphosate resistance subsequently. This is the case for three species of Amaranthus spp, As regards the potential impact of GBH614 on development of glyphosate resistance, 2000.

, This information (Devos et al., 2008) is valid for maize but not for cotton. The HCB Scientific Committee therefore asks the applicant to provide information relevant to cotton-growing. In addition, specific information on changes in the composition of weed species should be supplied, since repeated glyphosate use in cropping systems leads, 2008.

, As for hazard characterisation, the risk is not low, contrary to what the applicant states (page 136), since introduction of GHB614 and its herbicide package can accelerate selection of glyphosate-resistant weeds

, The HCB Scientific Committee regrets that there is no mention of the power of the tests used in this section which doesn

Y. Devos, M. Cougnon, S. Vergucht, R. Bulcke, G. Haesaert et al., Environmental impact of herbicide regimes used with genetically modified herbicide-resistant maize, Transgenic Research, vol.17, pp.1059-1077, 2008.