Industrial BiotechnologyVol. 19, No. 2 EditorialFree AccessDeveloping Supportive Bioeconomy PoliciesRebecca CoonsRebecca Coonsexecutive editor, Industrial Biotechnology, New Rochelle, NY, USSearch for more papers by this authorPublished Online:17 Apr 2023https://doi.org/10.1089/ind.2023.29310.editorialAboutSectionsPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail The Biden Administration is keeping its foot on the gas in terms of building an American bioeconomy. The White House has announced “bold goals and priorities” that include meeting 30% of US chemical demand with biobased routes in 20 years and developing processes to convert biobased feedstocks into recyclable polymers that can displace more than 90% of today's plastics. The goals—released in a March report from the White House Office of Science and Technology Policy (OSTP)—are the next step in fulfilling a September 2022 executive order (EO) earmarking $2 billion to biobased development. “The chemicals sector is the largest industrial GHG emitter with over 20% of industrial emissions, a significant portion of which may be eliminated using biomanufacturing and sustainable biomass resources,” says OSTP. “Chemicals, materials, and products can be derived from more sustainable, bio-based resources and produced in less carbon-intensive ways that promote broader reuse in a circular bioeconomy.” Use of biobased feedstocks and bioprocessing routes can also stabilize commodity chemical prices and avoid supply chain disruptions, OSTP says.The OSTP report—entitled Bold Goals for US Biotechnology and Biomanufacturing: Harnessing Research and Development to Further Societal Goals—includes individual sections authored by the Department of Energy, the Department of Agriculture, the Department of Commerce, the Department of Health and Human Services, and the National Science Foundation and interim steps on the way to achieving the broader goals. In 20 years, OSTP calls for the collection and processing of 1.2 billion metric tons of conversion-ready, purpose-grown plants and waste-derived feedstocks and utilization of over 60 million metric tons of exhaust gas CO2 suitable for conversion to fuels and products—all while minimizing emissions, water use, and habitat conversion, among other sustainability concerns. In 7 years, the goal is to produce 3 billion gallons of sustainable aviation fuel with at least a 50% (stretch 70%) reduction in GHG lifecycle emissions relative to conventional aviation fuels, with production then rising to 35 billion gallons in 2050. OSTP has also set a five-year target to produce over 20 commercially viable bioproducts with 70-plus percent reduction in life-cycle GHG emissions compared to current production practices.“Achieving these goals will require significant prioritization of R&D investments and efforts across the U.S. government, as well as actions from the private sector and state, local, and tribal governments,” OSTP says. The goals will also offer an opportunity to leverage the US's unique national strength in agriculture. “The United States has an unparalleled ability to grow, harvest, store, and transport agricultural products on a massive scale. While this productivity is most evident for grain and oilseed crops, the potential exists to expand agricultural production of purpose-grown crops for bioenergy and bioproducts.”The Department of Defense, which was allocated $1.2 billion under the EO, concurrently released its Biomanufacturing Strategy, while the Department of Commerce's Bureau of Economic Analysis issued a report on the feasibility of measuring the economic contributions of the US bioeconomy. Other deliverables dictated by the EO are in development, including a plan to expand training and education opportunities for the biotechnology and biomanufacturing workforce; a report on data needs for the bioeconomy; a national strategy for expanding domestic biomanufacturing capacity; and actions to improve biotechnology regulation clarity and efficiency.In this issue of Industrial Biotechnology, Rina Singh, PhD, Executive Vice President of IB's partner association Alternative Fuels & Chemicals Coalition (AFCC), emphasizes the tremendous potential of biobased development to reshape and strengthen the US economy and deliver on the country's global climate obligations, but also acknowledges the challenges and long timelines required to transform supply chains. “For biotechnology to achieve its full potential critical gaps must be filled and the realities of timelines to significant commercialization recognized,” Singh writes. “Policymakers should recognize the realities of bringing products to market—including extensive time and resources.”To date, there are very few successful companies in the industrial biotechnology sector and those that do have significant commercial scale have taken 15–20 years to achieve success, Singh writes. “The concern is that while expectations for the bioeconomy are high, the reality is that it will be some 15 years to achieve commercial and environmental impact. Political support will wane, investment will dry up and we will not achieve the potential for biology to drive economic growth while mitigating climate change and reducing impact on the environment. We as an industry cannot afford to repeat the past, using biofuels and cellulosic ethanol as recent examples.”A report from the Boston Consulting Group in this issue of IB echoes this sentiment. “While the potential and the investment to date are real, progress has been uneven,” according to Rothman et al. “The health care and food sectors have seen many of the market successes so far and, for that reason, much of the investment. The chemical and materials industry has generated only a few commercial successes and plenty of tales of technology hubris and market woe.”The reality is, fundamentally transforming supply chains is such a long, expensive, and difficult process that good science, measurable sustainability benefits, and a solid business plan aren't always enough to reach the finish line. The hope is that supportive policy and funding—if thoughtfully applied and distributed—helps more products reach the market. Singh lays out a comprehensive view of the challenge and detailed policy advice to address each hurdle. Among her recommendations, she encourages OSTP to institute policies that provide access to pilot, demo, and first commercial facilities—analogous to what Europe has done with BioBased Europe Pilot Plant and EW Biotech—as well as incentives to “put more steel in the ground” at existing fermentation sites and new locations.This lack of appropriate fermentation capacity has been an emerging topic in the biobased industries, particularly as brand demand and better technology allow more products and processes to take the big steps from bench to pilot to demo. A Synonym report that also appears in this issue has found that the majority of existing fermentation capacity globally does not match the size and configuration needs of biobased products development. “While there is definitely a decent network of bench and pilot scale capacity in the Americas and Europe, Capacitor [fermentation database] users are predominantly seeking and filtering for facilities with technical specifications that don't match the available capacity… This is one of the many mismatches that we've identified between what existing facilities provide and what the users increasingly need. We hope this will help the ecosystem understand which gaps need to be addressed as more facilities come online in the near future.”Singh also suggests workforce development, funding technology development—particularly increased support for basic and relevant applied research—and science-based, risk-adjusted regulations and streamlined regulatory processes. “Dual oversight must be eliminated,” and a reform of the Lautenberg act for biomanufactured substances/materials is essential, Singh writes. “EPA is exhaustively reviewing PMNs [Premanufacture Notices] with a mindset that every chemical in question is unsafe unless proven safe, resulting in EPA asking redundant and/or scientifically inappropriate questions about every PMN submitted, resulting in serious delays (PMNs now take 1-2 years instead of 90 days) and the need for EPA to raise fees (now proposed to go up to $45,000 from $5,000 pre-Lautenberg).”Another report from Singh in this issue—Identifying Ambiguities, Gaps, Inefficiencies, and Uncertainties in the Coordinated Framework for the Regulation of Biotechnology—provides an even deeper dive on how US regulatory policy can improve biotechnology regulation clarity and efficiency as part of The National Biotech and Biomanufacturing Initiative (NBBI). Just one of many steps Singh encourages are “corrective actions in the area of TSCA, FDA and USDA/APHIS” to eliminate the “overly burdensome or duplicative regulatory requirements to advance the commercial introduction of bio-based products.” Among a number of policy recommendations to facilitate the bioeconomy, she suggests the establishment of a single coordinating agency to streamline regulatory clearance approval requirements.These are just a few examples of the many hurdles a biobased process has to overcome from discovery to commercialization. And even though the Biden Administration's ambitious goals and billions in funding show tremendous political will, it is doubtful many industry veterans are expecting smooth sailing from here on out. Political winds are constantly changing, and policies with the best intentions can even turn into impediments. AFCC has been at the forefront of advocating for biobased industries and educating federal agencies on practical and coordinated policy and will ramp up these efforts as various government agencies flesh out their own roles in implementing Biden's bioeconomy vision. I would encourage readers to engage with AFCC during this critical time to help advance policies that take into account the complex and unique needs of industrial biotechnology.FiguresReferencesRelatedDetails Volume 19Issue 2Apr 2023 InformationCopyright 2023, Mary Ann Liebert, Inc., publishersTo cite this article:Rebecca Coons.Developing Supportive Bioeconomy Policies.Industrial Biotechnology.Apr 2023.35-36.http://doi.org/10.1089/ind.2023.29310.editorialPublished in Volume: 19 Issue 2: April 17, 2023PDF download