After years of study and regulatory review, the U.S. EPA, in 2017, registered a dsRNAi plant incorporated protectants (PIP) construct for general commercial use as an insecticide to protect crop plants (SmartStax PRO EnlistTM). Registration of the SmartStax PRO EnlistTM dsRNAi product may be a significant milestone in how EPA regulates this new generation of genetically engineered crop protection products. This presentation will address whether EPA’s registration of a dsRNAi product for commercial use has implications for possible regulation by EPA of gene edited ag biotech constructs. In developing its safety assessment framework for RNAi products, EPA held two FIFRA Scientific Advisory Panel (SAP) meetings. The first meeting (January 28, 2014), considered questions related to the risk assessment framework that EPA’s Office of Pesticide Programs (OPP) would apply to RNAi products. On September 27-28, 2016, EPA held a second SAP to address issues related to the SmartStax PRO EnlistTM RNAi pesticide product. The findings and recommendations of these two SAP panels informed EPA’s regulatory decision on SmartStax PRO EnlistTM. Generation of new biological constructs through the use of gene editing is occurring at a fast-accelerating pace. A cursory review of the literature reveals that recent genome editing advances relevant to crop protection include: generation of canker-resistant citrus varieties through use of CRISPR-Cas9 editing, development of powdery mildew resistant tomato using CRISPR-Cas9, enhancement of powdery mildew resistance in wheat using CRISPR-Cas9, and CRISPR-Cas9 mediated mutagenesis that resulted in enhanced fungal resistance in rice. The question is what type of regulatory oversight will EPA require of such pesticidal gene edited constructs. This presentation will provide insights as to what the regulation of dsRNAi constructs may portend for the regulatory framework that EPA will apply to gene edited products.

EPA registration of dsRNAi Plant Incorporated Protectants: Implications for gene edited products

256th National Meeting (2018)

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