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Message From: Sent: To: Subject: Beck, Nancy [/0=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=168ECB5184AC44DE95A913297F353745-BECK, NANCY] 3/23/2018 4:44:01 PM Matthews, Keith [KMatthews@wileyrein.com]; Bolen, Derrick [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=lffc58b0468c4deca51a8bad735b7d95-Bolen, Derr] RE: CAST Releases New Issue Paper: "Regulatory Barriers to the Development of Innovative Agricultural Biotechnology by Small Businesses and Universities" Thanks Keith! Nancy B. Beck, Ph.D., DABT Deputy Assistant Administrator, OCSPP P: 202-564-1273 M:[ Ex. 6 Personal Privacy (PP) } heck.nancy@epa.gov From: Matthews, Keith [mailto:KMatthews@wileyrein.com] Sent: Friday, March 23, 2018 11:56 AM To: Beck, Nancy <Beck.Nancy@epa.gov>; Bolen, Derrick <bolen.derrick@epa.gov> Subject: Fwd: CAST Releases New Issue Paper: "Regulatory Barriers to the Development of Innovative Agricultural Biotechnology by Small Businesses and Universities" Nancy, Thanks again for taking the time to speak with our Committee this morning. I know how busy you are, and for us to get an hour and a half of your time is greatly appreciated. Forwarded below is the CAST announcement yesterday of the release of the biotech regulations paper. Best regards Keith Keith Matthews Wiley Rein LLP Sent from mobile device, please excuse typographical errors. Begin forwarded message: From: Council for Agricultural Science and Technology <msly@cast-science.org> Date: March 22, 2018 at 10:24:35 EDT To: kmatthews@wileyrein.com Subject: CAST Releases New Issue Paper: "Regulatory Barriers to the Development of Innovative Agricultural Biotechnology by Small Businesses and Universities" Reply-To: msly@cast-science.org Having trouble viewing this email? Click here Sierra Club v. EPA 18cv3472 NDCA Tier 12 ED 002061 00051057-00001 D I I B fW f fS W |i amers to the eveiopmen ilR f gricultural Biotechnolog a ll Businesses and t.'nivc March 22, 2018, Council for Agricultural Science and Technology, Ames, Iowa Sierra Club v. EPA 18cv3472 NDCA Tier 12 ED 002061 00051057-00002 The scientific community is overwhelmingly positive about biotech plant breeding and the benefits for farmers, consumers, and the environment. But the authors of this paper demonstrate that the current process-based U.S. biotechnology regulatory system is a barrier to such agricultural innovation. The regulatory system needs to be adjusted, or "public, academic, and small business entities will continue to be frustrated in using these safe tools to deliver useful products." This report examines the current U.S. regulatory system for genetically engineered (GE) crops, compares it with those of major trading partners, and considers the effects it has on agricultural biotechnology. In theory, scientifically sound regulations serve the public good by assuring safety while not stifling innovation. But current regulations are sometimes based on spurious, undocumented risks- onerous, expensive regulations discourage innovation, especially in small businesses and universities. - _Downl,oad, this CAST Issue Paper Led by Task Force Chair Alan McHughen, these experts or show that despite foundational contributions requiring considerable public resource commitments for GE crop innovation and development, academic institutions and small private entities have been almost entirely excluded from the agricultural biotechnology market. This issue paper explains the problem by examining several key topics: * the history of GE or genetically modified development and regulations * evidence that genetic engineering in plants is safe and beneficial the need for better record keeping and communication about management and practices the problem of inconsistent and costly regulations-by U.S. and international agencies poor regulatory practices that hinder production and commerce-and lead to trade disputes * unfair labeling practices that influence consumer perceptions and negatively affect research and development-especially for academic institutions and small businesses Unreasonable barriers result in biotech innovation projects that have been slowed down or shelved. Regulations need to align with the stated public policy goal of reasonably assuring safety--in a way that is commensurate with the degree of risk posed. Otherwise, public, academic, and small business entities will continue to be frustrated in using these safe and beneficial tools. The 35-year history of public and small private investment in agricultural biotechnology will continue to be squandered. This CAST Issue Paper (IP59) and its companion Ag quickCAST are available online at the CAST website, along with many of CAST's other scientific publications. CAST Issue Papers, Commentaries, and Ag quickCASTs are FREE. Task Force Authors: Alan McHughen (Chair), University of California, Riverside Kent j. Bradford, University of California, Davis Sierra Club v. EPA 18cv3472 NDCA Tier 12 ED 002061 00051057-00003 Neal Carter, Okanagan Specialty Fruits Inc, Dennis Eriksson,. Swedish University of Agricultural Sciences Elizabeth Grabau, Virginia Tech Elizabeth Hood, Infinite Enzymes Wayne Parrott, University of Georgia Jeff Wolt, Iowa State University Contacts: Alan McHughen-Phone: 951-827-7532; Email: aianmgc&citrus. ucr.edu Kent Schescke-Phone: 515-292-2125, ext. 231; Email: kschescke# cast-science.ora CAST is an international consortium of scientific and professional societies, companies, and nonprofit organizations. Through its network of experts, CAST assembles, Interprets, and communicates credible, balanced, science-based information to policymakers, the media, the private sector, and the public. w w w x a st"Seieiieeoyg Council for Agricultural Science and Technology, 4420 West Lincoln Way, Ames, IA 50014 SafeUnsubscribeTM kmatthews@wilevrein.com D D Forward this emaii \ Update Profile | About our service provider Sent by mslv@cast-sdence.orQ in collaboration with Sierra Club v. EPA 18cv3472 NDCA Tier 12 ED 002061 00051057-00004 Try it free today NOTICE: This message (including any attachments) from Wiley Rein LLP may constitute an attorney-client communication and may contain information that is PRIVILEGED and CONFIDENTIAL and/or ATTORNEY WORK PRODUCT. If you are not an intended recipient, you are hereby notified that any dissemination of this message is strictly prohibited. If you have received this message in error, please do not read, copy or forward this message. Please permanently delete all copies and any attachments and notify the sender immediately by sending an e-mail to Information@wileyrein.com. Sierra Club v. EPA 18cv3472 NDCA Tier 12 ED 002061 00051057-00005