b'and timing of decisions to avoid trade disruption and to foster agricultural innovation. We encourage countries to implement policies that are risk-proportionate, that encourage scientific innovation without creating unnecessary barriers or unjustifia-bly stigmatizing products of new technologies.In November 2018, the United States joined with 12 other nations to support the International Statement on Agricultural Applications of Precision Biotechnology which was introduced by Argentina at the World Trade Organization (WTO) Committee HOW THE U.S. IS REVISING ITS BIOTECH REGULATIONS. BY: MARCEL BRUINS on the Application of Sanitary and Phytosanitary Measures.We need all the tools available in the toolbox to meet the challenges of global food security; sustainable and resilient agri-culture. Science-based advances in biotechnology have great promise to enhance rural prosperity and improve the quality of life across America and around the globe.ES: HOW DOES THE USDA GO ABOUT ENSURING SUFFICIENT STAKEHOLDER INPUT?FLC:In advance of drafting and publishing the proposed rule, USDA APHIS met with more than 80 organizations, including 17 universities, State Departments of Agriculture, and farmer organizations to seek their views and input. USDA APHIS also sought input from the public by conducting three public hearings across the United States and by publishing a Notice of Intent forUSDA building.public comment. Finally, the proposed rule was open for public comment for 60 days. Internationally, USDA shared rationales, experience and information for potential regulatory changes with U.S. trading partners, like-minded countries and other countries, to garner understanding and support for the proposed updated approach. The WTO was notified of the proposal and comments were invited when it was published. APHIS intends to continue its engagement internationally on the proposed regulatory revisions. ES: IN JUNE 2019, THE USDA PROACTIVELY PROPOSED A RULE. WHAT WERE THE MAIN DIFFERENCES WITH THE CURRENT REGULATIONS?FLC:Some key highlights of the proposed rule are as follows:- To exempt certain categories of modified plants becauseUSDAs Agriculture Research Service National Center for Genetic they could be produced through conventional breeding tech- Resources Preservation National Plant Germplasm System cold storage vault, in Ft. Collins, CO.niques and thus are unlikely to pose a greater plant pest risk than conventionally bred crops, which APHIS has historically not regulated. FLC:We received over 6,150 public comments to the proposed - To exempt modified plants with a plant-trait-mechanismrule. We are in the process of reviewing and considering these of action (MOA) combinations that we have already evaluatedcomments as we prepare the final rule. In the interim, we con-and shown not to present a plant pest risk. Similar plants willtinue to operate under our existing regulation clarified by the subsequently be exempt from regulation. Secretary of Agricultures March 28, 2018, statement that USDA - Set forth a regulatory status review process to determinedoes not plan to regulate plants that could otherwise have been the need for regulatory oversight by appraising the plant pestdeveloped through traditional breeding techniques as long as risk posed by modified plants by evaluating (1) the basic biologythey are not developed using plant pests. of the plant prior to modification; (2) the trait that resulted fromSuch products of biotechnology are likely to pose no greater the genetic modification; and (3) the biochemical mode of actionplant pest risk than their traditionally bred comparators, which conferring the trait. For this purpose, an Initial Review will beAPHIS does not regulate. USDA currently has a system in place, conducted to identify plausible pathways by which a particularthe Am I Regulated? (AIR) process, which allows the interested modified plant could directly or indirectly present a plant pestparties to seek confirmation of regulatory status of a genetically risk through injury, disease, or damage to plants or plant prod- engineered organism from USDA. Guidance for submission, as ucts. If one or more plausible pathways to plant pest risk arewell as AIR letters of inquiry and APHIS responses are avail-identified, a Plant Pest Risk Assessment (PPRA) will be com- able online (https://www.aphis.usda.gov/aphis/ourfocus/bio-pleted to characterize the potential for plant pest risk.technology/am-i-regulated). Since 2011, we have reviewed and responded to over 80 AIR letters of inquiry, of which over 80% ES: WHAT ARE THE NEXT STEPS, AND WHENhave come from academic and small business. Many developers COULD WE SEE THE APPROVAL OF THEhave used this process to inquire on the regulatory status of REVISIONS? genome edited varieties.EUROPEAN-SEED.COMIEUROPEAN SEED I 17'