You are here:
Human health and ecological risk assessments for SmartStax PRO (MON 89034 x TC1507 x MON 87411 x DAS-59122-7), a plant-incorporated protectant intended to control corn rootworm through ribonucleic acid (RNA) interference
Citation:
Human health and ecological risk assessments for SmartStax PRO (MON 89034 x TC1507 x MON 87411 x DAS-59122-7), a plant-incorporated protectant intended to control corn rootworm through ribonucleic acid (RNA) interference.
Impact/Purpose:
Earlier this year, EPA received applications from Monsanto Company and Dow AgroSciences, LLC, requesting registration of commercial release RNAi PIPs expressing DvSnf7 dsRNA and known by the name SmartStax PRO. SmartStax PRO also expresses several Bt insecticidal Cry proteins.
Description:
The use of RNA interference (RNAi) gene silencing technology, particularly RNAi for pesticidal purposes to control macroorganism pests, is a relatively recent innovation. Post-transcriptional silencing of gene function is a very rapid process where double-stranded RNA (dsRNA) directs sequence-specific degradation of a RNA. As EPA anticipated receiving pesticide applications based on RNAi technologies and identified the need to better understand the scientific issues concerning the assessment of the risks to human health and the environment that RNAi technologies pose, it convened a January 28, 2014, Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP). This FIFRA SAP provided EPA with scientific advice regarding the framework for assessing RNAi pesticide products. On October 29, 2015, EPA registered MON 87411, a corn plant-incorporated protectant (PIP) for seed increase/breeding purposes only and not for commercial release, with a time limitation of 2 years and a per-season acreage cap of 15,000 acres. In addition to Bacillus thuringiensis (Bt) Cry3Bb1 protein, MON 87411 expresses DvSnf7 dsRNA. Upon consumption by corn rootworm (CRW), the insect's RNAi machinery recognizes DvSnf7 dsRNA, resulting in down-regulation of the targeted DvSnf7 gene and leading to CRW mortality. EPA will present the human health risk assessment conducted for DvSnf7 dsRNA, as expressed in SmartStax PRO, and will consider the fate of ingested dsRNA and the potential for impacts on gene expression and the immune system. The action of a RNA interference construct relies upon some level of sequence homology with the target gene transcript; however, the fidelity of the sequence match may vary in some instances. EPA will discuss the role that bioinformatic analysis may play in understanding and predicting possible off-target effects within the host genome, as well as in predicting nontarget effects as part of the ecological risk assessment. EPA will also present an ecological risk assessment for DvSnf7 dsRNA, as expressed in SmartStax PRO, and will include descriptions of environmental fate and nontarget exposure, data reviewed in support of the risk assessment, risk characterization and description, and uncertainties. The charge to the panel will request expert opinion on completeness of the data set and uncertainties related to the risk conclusions.
URLs/Downloads:
Peer Review Plan (PDF, NA pp, 40 KB, about PDF)Human Health and Ecological Risk Assessments for SmartStax PRO
Revised Addendum to Environmental Risk Assessment (PDF, NA pp, 1530 KB, about PDF)
Response to the Transmission of Meeting Minutes of the September 27-28, 2016 FIFRA SAP (PDF, NA pp, 227 KB, about PDF)
FIFRA Scientific Advisory Panel Minutes No. 2016-02,RNAi Technology: Human Health and Ecological Risk Assessments for SmartStax PRO (PDF, NA pp, 2638 KB, about PDF)
CHARGE TO THE SEPTEMBER 27-28, 2016 FIFRA SCIENTIFICADVISORY PANEL (PDF, NA pp, 100 KB, about PDF)