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Scientific opinion on an application by Monsanto (EFSA‐GMO‐NL‐2013‐114) for the placing on the market of a herbicide‐tolerant genetically modified cotton MON 88701 for food and feed uses, import and processing under Regulation (EC) No 1829/2003


Naegeli, Hanspeter; Birch, Andrew Nicholas; Casacuberta, Josep; De Schrijver, Adinda; Gralak, Mikołaj Antoni; Jones, Huw; Manachini, Barbara; Messéan, Antoine; Nielsen, Elsa Ebbesen; Nogué, Fabien; Robaglia, Christophe; Rostoks, Nils; Sweet, Jeremy; Tebbe, Christoph; Visioli, Francesco; Wal, Jean‐Michel; Poeting, Annette; Álvarez, Fernando; Broll, Hermann; Ramon, Matthew (2017). Scientific opinion on an application by Monsanto (EFSA‐GMO‐NL‐2013‐114) for the placing on the market of a herbicide‐tolerant genetically modified cotton MON 88701 for food and feed uses, import and processing under Regulation (EC) No 1829/2003. EFSA Journal, 15(3):e04746.

Abstract

Cotton MON 88701 was developed through Agrobacterium tumefaciens-mediated transformation to express the dicamba mono-oxygenase (DMO) protein, conferring tolerance to dicamba, and the phosphinothricin N-acetyltransferase PAT protein, conferring tolerance to glufosinate ammonium-based herbicides. The molecular characterisation data and bioinformatics analyses did not identify issues requiring further assessment for food/feed safety. The agronomic and phenotypic characteristics tested revealed no relevant differences between cotton MON 88701 and its conventional counterpart. Since complete compositional results were reported for only three sites, the EFSA Panel on Genetically Modified Organisms (GMO Panel) is not in the position to complete the assessment of the compositional analysis. Moreover, as no 28-day toxicity study in rodents on the MON 88701 DMO protein was provided, the GMO Panel is not in the position to complete the safety assessment of this protein in cotton MON 88701. Consequently, the GMO Panel cannot complete the toxicological, allergenicity and nutritional assessment of food/feed derived from cotton MON 88701. The safety assessment identified no concerns regarding the potential toxicity and allergenicity of the PAT protein newly expressed in cotton MON 88701. Considering the routes of exposure and limited exposure levels, the GMO Panel concludes that cotton MON 88701 would not give rise to safety concerns in the event of accidental release of viable seeds into the environment. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of cotton MON 88701. In conclusion, in the absence of an appropriate comparative assessment and an appropriate assessment of the MON 88701 DMO protein, the GMO Panel is not in a position to complete its food/feed risk assessment of cotton MON 88701. The GMO Panel concludes that the cotton MON 88701 is unlikely to have any adverse effect on the environment in the context of the scope of the application. (C) 2017 European Food Safety Authority.

Abstract

Cotton MON 88701 was developed through Agrobacterium tumefaciens-mediated transformation to express the dicamba mono-oxygenase (DMO) protein, conferring tolerance to dicamba, and the phosphinothricin N-acetyltransferase PAT protein, conferring tolerance to glufosinate ammonium-based herbicides. The molecular characterisation data and bioinformatics analyses did not identify issues requiring further assessment for food/feed safety. The agronomic and phenotypic characteristics tested revealed no relevant differences between cotton MON 88701 and its conventional counterpart. Since complete compositional results were reported for only three sites, the EFSA Panel on Genetically Modified Organisms (GMO Panel) is not in the position to complete the assessment of the compositional analysis. Moreover, as no 28-day toxicity study in rodents on the MON 88701 DMO protein was provided, the GMO Panel is not in the position to complete the safety assessment of this protein in cotton MON 88701. Consequently, the GMO Panel cannot complete the toxicological, allergenicity and nutritional assessment of food/feed derived from cotton MON 88701. The safety assessment identified no concerns regarding the potential toxicity and allergenicity of the PAT protein newly expressed in cotton MON 88701. Considering the routes of exposure and limited exposure levels, the GMO Panel concludes that cotton MON 88701 would not give rise to safety concerns in the event of accidental release of viable seeds into the environment. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of cotton MON 88701. In conclusion, in the absence of an appropriate comparative assessment and an appropriate assessment of the MON 88701 DMO protein, the GMO Panel is not in a position to complete its food/feed risk assessment of cotton MON 88701. The GMO Panel concludes that the cotton MON 88701 is unlikely to have any adverse effect on the environment in the context of the scope of the application. (C) 2017 European Food Safety Authority.

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Item Type:Journal Article, refereed, original work
Communities & Collections:05 Vetsuisse Faculty > Institute of Veterinary Pharmacology and Toxicology
Dewey Decimal Classification:570 Life sciences; biology
Language:English
Date:March 2017
Deposited On:28 Jan 2018 16:45
Last Modified:19 Feb 2018 10:13
Publisher:European Food Safety Authority (EFSA), Parma
ISSN:1831-4732
OA Status:Hybrid
Free access at:Publisher DOI. An embargo period may apply.
Publisher DOI:https://doi.org/10.2903/j.efsa.2017.4746

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