Andrew Nicholas Birch

Scientific opinion on an application by Dow AgroSciences LLC (EFSA‐GMO‐NL‐2012‐106) for the placing on the market of genetically modified herbicide‐tolerant soybean DAS‐44406‐6 for food and feed uses, import and processing under Regulation (EC) No 1829/2003

Abstract Soybean DAS‐68416‐4 was developed by Agrobacterium tumefaciens‐mediated transformation to express the aryloxyalkanoate dioxygenase‐12 (AAD‐12) protein, conferring tolerance to 2,4‐dichlorophenoxyacetic acid (2,4‐D) and other related phenoxy herbicides, and the phosphinothricin 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 soybean DAS‐68416‐4 and its conventional counterpart, except for ‘days to 50% flowering’. The compositional analysis identified no differences requiring further assessment, except for an increase (up to 36%) in lectin activity in soybean DAS‐68416‐4. Such increase is unlikely to raise additional concerns for food/feed safety and nutrition for soybean DAS‐68416‐4 as compared to its conventional counterpart and the non‐GM reference varieties. There were no concerns regarding the potential toxicity and allergenicity of the two newly expressed proteins, and no evidence that the genetic modification might significantly change the overall allergenicity of soybean DAS‐68416‐4. Soybean DAS‐68416‐4 is as nutritious as its conventional counterpart and the non‐GM reference varieties. There are no indications of an increased likelihood of establishment and spread of occasional feral soybean DAS‐68416‐4 plants, unless these are exposed to the intended herbicides. The likelihood of environmental effects resulting from the accidental release of viable seeds from soybean DAS‐68416‐4 into the environment is therefore very low. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of soybean DAS‐68416‐4. The GMO Panel concludes that the information available addresses the scientific comments of the Member States and that soybean DAS‐68416‐4, as described in this application, is as safe as its conventional counterpart and the tested non‐GM reference varieties with respect to potential effects on human and animal health and the environment in the context of the scope of this application.

Response to Kruse-Plass et al. (2017) regarding the risk to non-target lepidopteran larvae exposed to pollen from one or more of three Bt maize events (MON810, Bt11 and 1507)

We respond to the paper of Kruse-Plass et al. (Environ Sci Eur 29:12, 2017), published in this journal, regarding the risk to non-target lepidopteran larvae exposed to pollen from one or more of three Bt maize events (MON810, Bt11 and 1507). We emphasise that what is important for environmental risk assessment is not the number of pollen grains per se, but the degree of exposure of a NT lepidopteran larva to Bt protein contained in maize pollen. The main text of this response deals with general issues which Kruse-Plass et al. have failed to understand; more detailed refutations of each of their claims are given in Additional file 1. Valid environmental risk assessment requires direct measurement of pollen on leaves at varying distances outside a source field(s); such measurements reflect the potential exposure experienced by an individual larva on a host plant. There are no new data in the Kruse-Plass et al. paper, or indeed any data directly quantifying pollen on actual host-plant leaves outside a maize field; only data gathered within or at the edge of maize crops were reported. Values quoted by Kruse-Plass et al. for deposition on host plants outside the field were estimates only. We reiterate the severe methodological criticisms made by EFSA [Relevance of a new scientific publication (Hofmann et al. 2016) for previous environmental risk assessment conclusions and risk management recommendations on the cultivation of Bt-maize events MON810, Bt11 and 1507. EFSA Supp Publ; EN-1070, 2016], which render this estimation procedure unreliable. Furthermore, criticisms of EFSA (EFSA J 2015(13):4127, 2015) and of EFSA [Relevance of a new scientific publication (Hofmann et al. 2016) for previous environmental risk assessment conclusions and risk management recommendations on the cultivation of Bt-maize events MON810, Bt11 and 1507. EFSA Supp Publ; EN-1070, 2016] made by Kruse-Plass et al. are shown in Additional file 1 to be without foundation. We therefore consider that there is no valid evidence presented by Kruse-Plass et al. to justify their conclusions.

Guidance on allergenicity assessment of genetically modified plants

Abstract This document provides supplementary guidance on specific topics for the allergenicity risk assessment of genetically modified plants. In particular, it supplements general recommendations outlined in previous EFSA GMO Panel guidelines and Implementing Regulation (EU) No 503/2013. The topics addressed are non‐IgE‐mediated adverse immune reactions to foods, in vitro protein digestibility tests and endogenous allergenicity. New scientific and regulatory developments regarding these three topics are described in this document. Considerations on the practical implementation of those developments in the risk assessment of genetically modified plants are discussed and recommended, where appropriate.

Assessment of genetically modified cotton GHB614 × T304‐40 × GHB119 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2014‐122)

The three-event stack cotton GHB614 9 T304-40 9 GHB119 was produced by conventional crossing to combine three single events, GHB614, T304-40 and GHB119. The genetically modified organisms (GMO) Panel previously assessed the three single cotton events and did not identify safety concerns. No new data on the single cotton events that could lead to modification of the original conclusions on their safety were identified. Based on the molecular, agronomic, phenotypic and compositional characteristics, the combination of the single cotton events and of the newly expressed proteins in the three-event stack cotton did not give rise to food and feed safety concern. The GMO Panel considers that the three-event stack cotton GHB614 9 T304-40 9 GHB119 has the same nutritional impact as its comparator and the non-GM reference varieties tested. The GMO Panel concludes that the three-event stack cotton GHB614 9 T304-40 9 GHB119, as described in this application, is nutritionally equivalent to and as safe as its comparator and the non-GM reference varieties tested, and no post-market monitoring of food/feed is considered necessary. In the case of accidental release of viable GHB614 9 T304-40 9 GHB119 cottonseeds into the environment, this three-event stack would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of cotton GHB614 9 T304-40 9 GHB119 seeds. The GMO Panel concludes that cotton GHB614 9 T304-40 9 GHB119, as described in this application, is as safe as its comparator and the tested non-GM reference varieties with respect to potential effects on human and animal health and the environment.

Assessment of genetically modified cotton GHB614 × LLCotton25 × MON 15985 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2011‐94)

Abstract The three‐event stack cotton GHB614 × LLCotton25 × MON 15985 was produced by conventional crossing to combine three single cotton events, GHB614, LLCotton25 and MON 15985. The EFSA GMO Panel previously assessed the three single events and did not identify safety concerns. No new data on the single events that could lead to modification of the original conclusions on their safety were identified. Based on the molecular, agronomic, phenotypic and compositional characteristics, the combination of the single events and of the newly expressed proteins in the three‐event stack cotton did not give rise to food and feed safety or nutritional issues. Food and feed derived from cotton GHB614 × LLCotton25 × MON 15985 are expected to have the same nutritional impact as those derived from the non‐GM comparator. In the case of accidental release of viable GHB614 × LLCotton25 × MON 15985 cottonseeds into the environment, this three‐event stack cotton would not raise environmental safety concerns. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of cotton GHB614 × LLCotton25 × MON 15985. In conclusion, the GMO Panel considers that cotton GHB614 × LLCotton25 × MON 15985, as described in this application, is as safe as the non‐GM comparator with respect to potential effects on human and animal health and the environment.

Assessment of genetically modified soybean MON 87751 for food and feed uses under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2014‐121)

Abstract Soybean MON 87751 was developed through Agrobacterium tumefaciens‐mediated transformation to provide protection certain specific lepidopteran pests by the expression of the Cry1A.105 and Cry2Ab2 proteins derived from Bacillus thuringiensis. The molecular characterisation data and bioinformatic analyses did not identify issues requiring assessment for food and feed safety. None of the compositional, agronomic and phenotypic differences identified between soybean MON 87751 and the conventional counterpart required further assessment. The GMO Panel did not identify safety concerns regarding the toxicity and allergenicity of the Cry1A.105 and Cry2Ab2 proteins as expressed in soybean MON 87751, and found no evidence that the genetic modification might significantly change the overall allergenicity of soybean MON 87751. The nutritional impact of soybean MON 87751‐derived food and feed is expected to be the same as those derived from the conventional counterpart and non‐GM commercial reference varieties. The GMO Panel concludes that soybean MON 87751, as described in this application, is nutritionally equivalent to and as safe as the conventional counterpart and the non‐GM soybean reference varieties tested, and no post‐market monitoring of food and feed is considered necessary. In the case of accidental release of viable soybean MON 87751 seeds into the environment, soybean MON 87751 would not raise environmental safety concerns. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of soybean MON 87751. In conclusion, soybean MON 87751, as described in this application, is as safe as its conventional counterpart and the tested non‐GM soybean reference varieties with respect to potential effects on human and animal health and the environment.

Assessment of genetically modified maize MON 87411 for food and feed uses, import and processing, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2015‐124)

Abstract Maize MON 87411 was developed to confer resistance to corn rootworms (Diabrotica spp.) by the expression of a modified version of the Bacillus thuringiensis cry3Bb1 gene and a DvSnf7 dsRNA expression cassette, and tolerance to glyphosate‐containing herbicides by the expression of a CP4 5‐enolpyruvylshikimate‐3‐phosphate synthase (cp4 epsps) gene. The molecular characterisation data and bioinformatics analyses did not identify issues requiring assessment for food and feed safety. No statistically significant differences in the agronomic and phenotypic characteristics tested between maize MON 87411 and its conventional counterpart were identified. The compositional analysis of maize MON 87411 did not identify differences that required further assessment except for palmitic acid levels in grains from not treated maize MON 87411. The GMO Panel did not identify safety concerns regarding the toxicity and allergenicity of the Cry3Bb1 and CP4 EPSPS proteins, as expressed in maize MON 87411 and found no evidence that the genetic modification might significantly change the overall allergenicity of maize MON 87411. The nutritional impact of maize MON 87411‐derived food and feed is expected to be the same as those derived from the conventional counterpart and non‐GM commercial reference varieties. The GMO Panel concludes that maize MON 87411, as described in this application, is nutritionally equivalent to and as safe as the conventional counterpart and the non‐GM maize reference varieties tested, and no post‐market monitoring of food/feed is considered necessary. In the case of accidental release of viable maize MON 87411 grains into the environment, maize MON 87411 would not raise environmental safety concerns. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of maize MON 87411. The GMO Panel concludes that maize MON 87411, as described in this application, is as safe as its conventional counterpart and the tested non‐GM maize reference varieties with respect to potential effects on human and animal health and the environment.

Assessment of genetically modified maize 4114 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2014‐123)

Abstract Maize 4114 was developed through Agrobacterium tumefaciens‐mediated transformation to provide protection against certain lepidopteran and coleopteran pests by expression of the Cry1F, Cry34Ab1 and Cry35Ab1 proteins derived from Bacillus thuringiensis, and tolerance to the herbicidal active ingredient glufosinate‐ammonium by expression of the PAT protein derived from Streptomyces viridochromogenes. The molecular characterisation data did not identify issues requiring assessment for food/feed safety. None of the compositional, agronomic and phenotypic differences identified between maize 4114 and the non‐genetically modified (GM) comparator(s) required further assessment. There were no concerns regarding the potential toxicity and allergenicity of the newly expressed proteins Cry1F, Cry34Ab1, Cry35Ab1 and PAT, and no evidence that the genetic modification might significantly change the overall allergenicity of maize 4114. The nutritional value of food/feed derived from maize 4114 is not expected to differ from that derived from non‐GM maize varieties and no post‐market monitoring of food/feed is considered necessary. In the case of accidental release of viable maize 4114 grains into the environment, maize 4114 would not raise environmental safety concerns. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of maize 4114. The genetically modified organism (GMO) Panel concludes that maize 4114 is as safe as the non‐GM comparator(s) and non‐GM reference varieties with respect to potential effects on human and animal health and the environment in the context of the scope of this application.

Assessment of genetically modified maize Bt11 x MIR162 x 1507 x GA21 and three subcombinations independently of their origin, for food and feed uses under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2010‐86)

Abstract In this opinion, the GMO Panel assessed the four‐event stack maize Bt11 × MIR162 × 1507 × GA21 and three of its subcombinations, independently of their origin. The GMO Panel previously assessed the four single events and seven of their combinations and did not identify safety concerns. No new data on the single events or the seven subcombinations leading to modification of the original conclusions were identified. Based on the molecular, agronomic, phenotypic and compositional characteristics, the combination of the single events in the four‐event stack maize did not give rise to food/feed safety issues. Based on the nutritional assessment of the compositional characteristics of maize Bt11 × MIR162 × 1507 × GA21, foods and feeds derived from the genetically modified (GM) maize are expected to have the same nutritional impact as those derived from non‐GM maize varieties. In the case of accidental release of viable grains of maize Bt11 × MIR162 × 1507 × GA21 into the environment, this would not raise environmental safety concerns. The GMO Panel concludes that maize Bt11 × MIR162 × 1507 × GA21 is nutritionally equivalent to and as safe as its non‐GM comparator in the context of the scope of this application. For the three subcombinations included in the scope, for which no experimental data were provided, the GMO Panel assessed the likelihood of interactions among the single events and concluded that their combinations would not raise safety concerns. These maize subcombinations are therefore expected to be as safe as the single events, the previously assessed subcombinations and the four‐event stack maize. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of maize Bt11 × MIR162 × 1507 × GA21 and its subcombinations. A minority opinion expressed by a GMO Panel member is appended to this opinion.

Guidance for the risk assessment of the presence at low level of genetically modified plant material in imported food and feed under Regulation (EC) No 1829/2003

Abstract This document provides guidance for the risk assessment under Regulation (EC) No 1829/2003 of the unintended, adventitious or technically unavoidable presence in food and feed of low level of genetically modified plant material intended for markets other than in the European Union. In this context, the presence at low level is defined to be maximum 0.9% of genetically modified plant material per ingredient. This guidance is intended to assist applicants by indicating which scientific requirements of Annex II of Regulation (EU) No 503/2013 are considered necessary for the risk assessment of the presence at low levels of genetically modified plant material in food and feed.