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SEPTEMBER 2015 SEEDWORLD.COM 29 tion between the agencies that oversee the approval of bio- tech products ... must be a priority to encourage innovation by improving transparency timeliness and predictability of the regulatory system says Matt OMara acting vice president of BIOs Food and Agriculture Section. According to BIO the coordinated framework has come under criticism in recent years for impeding the timely approval of much-needed and long-reviewed biotech products. However the organization reports that USDA has since implemented new processes to address the issue and similar efforts across all three agencies would prove increasingly beneficial. BIO supports a regulatory system that is timely predictable based upon the best available science and incorporates 20-plus years of experience with the technology OMara says. We look forward to reviewing the proposal in more detail and working with the administration moving forward. Holdren says the goal of this effort is to ensure public confidence in the regulatory system and improve transparency predictability coordination and ultimately efficiency of the bio- technology regulatory system. Under the Radar GE Crops Late last year Alan Bennett director of the Public Intellectual Property Resource for Agriculture at the University of California Davis and colleagues submitted information to the editor of Nature Biotechnology highlighting technologies that did not require full assessment under the existing Coordinated Framework and calling for its reconsideration. In the correspondence Genetically engineered crops that fly under the U.S. regulatory radar Bennett cited that in recent years products emerging from the technology development pipeline are increasingly falling outside the scope of USDAs Animal and Plant Health Inspection Service regulations. The analysis highlights the incongruity of regulation that is based on process rather than product. The authors analyzed the 26 inquires that were made to USDA-APHIS during the past 20 years seeking a determination on regulatory status. They divided the inquiries into five catego- ries based on the final plant product transformation processes or the use of recently developed technologies. These categories were null segregants classic gene delivery systems cisgenics intragenics site-directed nucleases and miscellaneous. Of these 26 inquires only four were determined to be regulated. In their correspondence the authors wrote The fact that the U.S. Coordinated Framework is on the one hand failing to over- see these new product types and on the other overregulating GE crops and technologies with proven track records of safety should be a cause for concern. The United States remains the only country with a case history of challenges and determina- tions on the regulatory status of crops modified using modern technologies and genetic elements. The authors argue that a rational science-based regulatory system should not regulate products based on null segregants because they contain no genetic modification. Similarly they say products generated by site-directed nucleases should not be regulated because they use the natural DNA repair and replication enzymes found in living organisms and result in changes that could be a result of conventional breeding. It is time to build a system of oversight that is product- and science-based the authors wrote. This system should have enough flexibility to evolve with accumulating scientific knowl- edge and new technologies and importantly allow the partici- pation of small companies and public sector institutions to fulfill the range of innovation needed to sustainably meet the next decades agricultural needs. While the end product is yet to be seen and much work has to be done this gives industry an opportunity to educate others about the new breeding techniques being used today and expand the Coordinated Framework with input being gathered from stakeholders and the public. As part of the process to update the Coordinated Framework three public engagement sessions will be held during the next year with the first one to be held in the fall in Washington D.C. Additionally there will be a public notice and comment period before the updated Coordinated Framework is finalized. Stay tuned to SeedWorld.com as the editorial team will follow the process on updating the Coordinated Framework. SW WHAT SHOULD YOU EXPECT FROM THE COORDINATED FRAMEWORK REVIEW First the administration has asked the National Academies of Sciences Engineering and Medicine to conduct an outside independent analysis of the future landscape of the products of biotechnology. Due to the rapidly changing landscape the memorandum calls for an external analysis at least every five years. Second after gathering public input the administration will update the Coordinated Framework to include clearly defined roles and responsibilities of the Environmental Protection Agency Department of Agriculture and Food and Drug Administration in the process. This update is suppose to help clarify which biotechnology product areas are within the authority and responsibility of each agency and outline how the agencies work together to regulate products that may fall under the authorities of multiple agencies. Third to ensure that the federal regulatory system is well-equipped to assess any risks associated with the future products of biotechnology the administration will develop a long-term strategy. This will include performing periodic horizon-scanning of new biotech products coordinating support for the science that informs regulatory activities developing tools to assist small businesses as they navigate the regulatory system and create user-friendly digital tools for presenting the agencies authorities practices and basis for decision-making. WHEREON THE WEB For an expanded version of this article with comments from company representatives visit SeedWorld.comBiotech-Regulatory-Review.