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.  https://www3.epa.gov/pesticides/chem_search/ppls/062719-00706-20170608.pdf (SmartStax PRO Enlist<sup>TM</sup>). Registration of the SmartStax 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 genome edited ag biotech constructs.  Generation of new biological constructs through the use of genome 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, CRISPR-Cas9 mediated mutagenesis that resulted in enhanced fungal resistance in rice, and delivery of CRISPR-CAS9 into plant tissue using nanotubules.  The U.S. Government is currently devising regulatory approaches to genome editing. This presentation will provide insights as to the latest developments from EPA, FDA, and USDA with regard to regulation of genome edited products.<br/>

EPA registration of dsRNAi plant incorporated protectants: Implications for genome edited products

2019 Fall National Meeting

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