Dr. Maria Fedorova DuPont Pioneer

Gene Editing for Crop Improvement The plant does not have desired output The plant does have desired output DELETE SEARCH / REPLACE EDIT The plant has tolerance to drought The plant has high-tolerance to drought The plant is susceptible to disease The plant is resistant to disease Precise, yet flexible, set of tools allowing to make specific, targeted improvements to plant genomes Uses genetic material from the same plant/crop - no DNA from a different species in the end-product Change similarly possible through conventional breeding Targeted mutagenesis

Wide Array of Agricultural Applications CRISPR-Cas Furthers Innovation for Pioneer® Brand Products NEAR-TERM Pioneer® PRODUCT TO MARKET NEXT GEN. WAXY CORN HYBRIDS High amylopectin starch corn Targeted mutation in the same gene as in the current waxy product To market by end of current decade Products, benefits and concepts described herein will not be offered for sale or distribution until completion of field testing and applicable regulatory reviews.

Vision for CRISPR-Cas at DuPont Pioneer

Gene Editing: Challenging Regulatory Paradigms Regulatory policies are still in development in many countries "Living modified organism" means any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology” Challenge: what is the appropriate policy framework to facilitate innovation while protecting human health and the environment?

Available processes or regulatory precedents Regulatory Policies for Gene Editing Available processes or regulatory precedents U.S. (USDA) Canada Argentina Chile Israel Several EU MS New Zealand (EPA) policy in development

Considerations for Regulatory Policies Appropriate, science-based regulatory oversight for plants developed with CRISPR-Cas advanced plant breeding, consistent with plants developed through other plant breeding methods Gene edited plants are indistinguishable from plants that could be produced with conventional breeding tools and have a long history of safe use It is the characteristics of the plant, not the production method, that determines its safety Protecting health and the environment while promoting innovation Science-based, accommodate new evidence and learning Cost effective and commensurate with the risk Transparent, consistently applied and enforced Globally harmonized