b'Ag Groups Support USDAs Proposed Biotech FrameworkOrganizations and associations look forward to a vastly different approach when it comes to how plant breeding innovations are regulated, but as the old saying goes, the devil is in the details. Julie Deering jdeering@issuesink.comIN EARLY JUNE,the U.S.Under the proposed rule, developers Department of Agriculture (USDA)would have the option to make a self-released its proposed rule regarding thedetermination as to whether his or her movement and release of genetically-engi- GE plant belongs to one of the categories neered (GE) organisms relating to genelisted under 340.1(b) or (c) and is exempt editing and plant breeding innovation.from the regulations.The rules, originally established in 1987,For those GE plants that must havent been updated since. The USDAsundergo a regulatory status review, Animal and Plant Health InspectionAPHIS will in combination and individu-Service (APHIS) released proposals inally evaluate the plant pest risk based on 2008 and again in 2017, both of whichthree elements: the basic biology of the were withdrawn due to concerns sub- plant prior to modification, the trait that mitted during the comment period. Ifresulted from the genetic modification completed, this would mark the firstand the plant-trait-mechanism of action.comprehensive revision of the regulationThe public had until Aug. 5 to submit in nearly four decadesa great deal hascomments for consideration in the final changed since then. rule. Organizations from the American The USDA aims to provide a clear,Seed Trade Association (ASTA) to the predictable and efficient regulatory path- National Sunflower Association submitted way for innovators, facilitating the devel- Sec. Sonny Perdue says the USDA seeks tocomments and letters of support, repre-opment of new and novel geneticallyallow innovation where there isnt risk. senting their constituents.engineered organisms that are unlikely toThe American Seed Trade Association pose plant pest risks. Need to Know appreciates that USDAs proposal rec-The proposed framework is a differentUnder the proposed rule, developersognizes that some applications of gene approach altogether. According to thewould have the option of requesting aediting result in plant varieties that are docket (APHIS-2018-0034), the regula- permit or a regulatory status review ofessentially equivalent to varieties devel-tory efforts would focus on the propertiesa GE plant that has not been previouslyoped through more traditional breed-of the GE organism itself rather than ondetermined to be nonregulated. ing methods and treats these varieties the method used to produce it. Furthermore, the proposed rule wouldaccordingly.With this approach, Secretary ofexempt GE plants with plant-trait-mech- However, in its letter to the Alan Agriculture Sonny Perdue says USDAanism of action (MOA) combinations thatPearson, APHIS Biotechnology seeks to allow innovation when there is noAPHIS has already evaluated and foundRegulatory Services assistant deputy risk present. to be unlikely to pose a plant pest risk. administrator, ASTA recommends 16/ SEEDWORLD.COMOCTOBER 2019'