The Biotechnology Innovation Organization (BIO) is pleased to respond to the U.S. Department of Agriculture’s (USDA) Solicitation of Input from Stakeholders on Agricultural Innovations. BIO applauds USDA for taking a proactive approach and seeking information about facilitating the transformative breakthroughs for agriculture to meet the challenges of the 21st Century and increase agricultural production by 40 percent while cutting the environmental footprint by 50 percent. Achieving this goal and addressing the challenges of climate change and inequality in society, will require the rapid development and deployment of biology-based technologies throughout the agricultural supply chain. It will require USDA and the federal government to establish supportive policies and regulations, provide robust funding for research and development, modernize infrastructure, support all farmers and ranchers, and build public support of new technologies. We urge the Administration to seize the opportunity to expand on this American leadership, by acting and supporting the pro-innovation technologies and policies we outlined in our comments. We look forward to our continued partnership in this critical endeavor.  

July 30, 2020 Re: Docket No. FDA–2019-D-5799: FDA’s Public Meeting, Modernizing the Food and Drug Administration’s Data Strategy. Dear Sir/Madam: The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments regarding FDA’s Public Meeting, Modernizing the Food and Drug Administration’s Data Strategy. BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO’s members develop medical products and technologies to treat patients afflicted with serious diseases, to delay the onset of these diseases, or to prevent them in the first place. When discussing “data” throughout this letter, BIO takes a broad definition as laid out in FDA’s Technology Modernization Action Plan (TMAP), “…the data that is collected during the routine care of patients, coupled with traditional clinical trial evidence, will be used to generate steady improvements in future patient care. Other data types, such as genomic or toxicology data, and output from medical devices, are a part of the data ecosystem. Data-informed technologies, such as distributed ledger solutions like blockchain, will be critical to support FDA’s track-and-trace priorities.” We support FDA’s efforts to modernize its data strategy to ultimately transform the way data is shared, analyzed, and utilized for regulatory purposes. It will be important to keep in mind, however, as FDA considers these advancements that just as it will take FDA time to implement appropriate IT infrastructure and capabilities to enable these modernizations, industry will need time to implement compatible technologies and processes as well. FDA’s engagement with stakeholders, including industry, in these cases is critical and should, most importantly, allow for flexibility, optional adoption by industry…

New innovations capable of advancing plant breeding, such as gene editing, have immense potential to improve agriculture and food production. Researchers are exploring genetic innovations aimed at increasing agricultural productivity; improving environmental sustainability outcomes; providing consumers safer and more nutritious products; and reducing food waste, among many other benefits. However, the future of many of these innovations relies on the existence of a science-based, risk-appropriate regulatory system – one that is consistent across domestic regulatory agencies and internationally – and does not impose unnecessary burdens to market access. FDA has a critical role to play in shaping this regulatory framework by clarifying the agency’s approach to plants derived from these new techniques under its 1992 guidance on Foods Derived from New Plant Varieties. To obtain an outcome that best supports regulatory consistency, we urge FDA to issue this clarifying guidance as expeditiously as possible.