title: Ecological risk assessment for DvSnf7 RNA: A plant-incorporated protectant with targeted activity against western corn rootworm.
abstract: MON 87411 maize, which expresses DvSnf7 RNA, was developed to provide an additional mode of action to confer protection against corn rootworm (Diabrotica spp.). A critical step in the registration of a genetically engineered crop with an insecticidal trait is performing an ecological risk assessment to evaluate the potential for adverse ecological effects. For MON 87411, an assessment plan was developed that met specific protection goals by characterizing the routes and levels of exposure, and testing representative functional taxa that would be directly or indirectly exposed in the environment. The potential for toxicity of DvSnf7 RNA was evaluated with a harmonized battery of non-target organisms (NTOs) that included invertebrate predators, parasitoids, pollinators, soil biota as well as aquatic and terrestrial vertebrate species. Laboratory tests evaluated ecologically relevant endpoints such as survival, growth, development, and reproduction and were of sufficient duration to assess the potential for adverse effects. No adverse effects were observed with any species tested at, or above, the maximum expected environmental concentration (MEEC). All margins of exposure for NTOs were >10-fold the MEEC. Therefore, it is reasonable to conclude that exposure to DvSnf7 RNA, both directly and indirectly, is safe for NTOs at the expected field exposure levels.
authors: Global Regulatory Sciences, Monsanto Company, 800 North Lindbergh Boulevard Creve Coeur, MO, 63167, USA. Electronic address: pamela.m.bachman@monsanto.com.
authors: Pamela M
authors: PM
authors: Bachman
authors: Global Regulatory Sciences, Monsanto Company, 800 North Lindbergh Boulevard Creve Coeur, MO, 63167, USA.
authors: Kristin M
authors: KM
authors: Huizinga
authors: Global Regulatory Sciences, Monsanto Company, 800 North Lindbergh Boulevard Creve Coeur, MO, 63167, USA.
authors: Peter D
authors: PD
authors: Jensen
authors: Global Regulatory Sciences, Monsanto Company, 800 North Lindbergh Boulevard Creve Coeur, MO, 63167, USA.
authors: Geoffrey
authors: G
authors: Mueller
authors: Global Regulatory Sciences, Monsanto Company, 800 North Lindbergh Boulevard Creve Coeur, MO, 63167, USA.
authors: Jianguo
authors: J
authors: Tan
authors: Global Regulatory Sciences, Monsanto Company, 800 North Lindbergh Boulevard Creve Coeur, MO, 63167, USA.
authors: Joshua P
authors: JP
authors: Uffman
authors: Global Regulatory Sciences, Monsanto Company, 800 North Lindbergh Boulevard Creve Coeur, MO, 63167, USA.
authors: Steven L
authors: SL
authors: Levine
mesh_terms: D000818:Animals; D001517:Coleoptera / Q000235:genetics* / Q000472:pathogenicity; D019295:Computational Biology; D003198:Computer Simulation; D018556:Crops, Agricultural / Q000235:genetics / Q000469:parasitology / Q000633:toxicity*; D030541:Databases, Genetic; D004781:Environmental Exposure; D059022:Food Safety; D030841:Food, Genetically Modified / Q000469:parasitology / Q000633:toxicity*; D018506:Gene Expression Regulation, Plant; D054884:Host-Pathogen Interactions; D006801:Humans; D019055:No-Observed-Adverse-Effect Level; D010572:Pest Control, Biological / Q000379:methods*; D030821:Plants, Genetically Modified / Q000235:genetics / Q000469:parasitology / Q000633:toxicity*; D034622:RNA Interference; D012330:RNA, Double-Stranded / Q000235:genetics / Q000633:toxicity*; D018570:Risk Assessment; D013045:Species Specificity; D013997:Time Factors; D018675:Toxicity Tests / Q000379:methods*; D003313:Zea mays / Q000235:genetics / Q000469:parasitology / Q000633:toxicity*
chemical_list: D012330:RNA, Double-Stranded
keywords: DvSnf7; Ecological risk assessment; GE crop; MON 87411; Non-target organism; RNAi