By Lynn L. Bergeson and Carla N. Hutton
 
On April 25, 2023, the Council of the European Union (EU) announced that it approved the conclusions on the opportunities of the bioeconomy in light of current challenges, with special emphasis on rural areas. Using biomass to produce food, materials, and energy can help boost rural communities, increase competitiveness, and combat many of the challenges facing the EU. According to the press release, in their conclusions, ministers “highlighted the key role that the bioeconomy could play in achieving the environmental and climate goals under the European Green Deal, while also making the EU more competitive, helping it transition away from fossil-fuel dependency, and strengthening food security in the wake of Russia’s war of aggression against Ukraine.” The ministers also stressed the importance of promoting research and innovation and improving alignment between scientific advances and industry policy. The press release states that the conclusions will provide political guidance for the European Commission (EC) and EU member states on developing the potential of the bioeconomy in Europe.
 
While the Council of the EU welcomed the EC’s progress report on the implementation of the EU Bioeconomy Strategy, ministers put forward a number of recommendations intended to help boost the potential of the bioeconomy in Europe. In particular, they called on the EC to:

• Better integrate bioeconomy into all policies and ensure policy coherence;
• Facilitate knowledge transfer toward less developed regions and rural areas; and
• Update the EU Bioeconomy Strategy and associated action plan and carry out an in-depth assessment of actions being taken at the EU level.

Ministers also noted that the bioeconomy was an integral aspect of the reformed Common Agricultural Policy (CAP) and invited the EC to follow up on how EU member states had incorporated it into their national strategic plans.

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By Lynn L. Bergeson and Carla N. Hutton
 
President Joseph Biden’s September 12, 2022, Executive Order (EO) creating a National Biotechnology and Biomanufacturing Initiative directs the U.S. Department of Commerce’s (DOC) Bureau of Economic Analysis (BEA) to assess “the feasibility, scope, and costs of developing a national measurement of the economic contributions of the bioeconomy.” As reported in our March 30, 2023, blog item, BEA released a March 2023 report on Developing a National Measure of the Economic Contributions of the Bioeconomy that assesses the feasibility of measuring the economic contributions of the U.S. bioeconomy. The report also includes an assessment of what is needed to measure these contributions better and more accurately.
 
According to the report, in the case of the bioeconomy, researchers, potential data users, and other stakeholders have different (and competing) ideas of how the bioeconomy should be defined and which industries should be included or excluded. The report states that these different ideas can be summarized into three distinct visions for the bioeconomy:

• Biotechnology: The biotechnology vision focuses on emerging industries and products enabled by innovation in the life sciences, particularly in genetic engineering; in this vision, established industries such as agriculture and forestry are typically not included;
• Bioresources: The bioresources vision focuses on understanding the flow of biological resources, such as biomass and biofuels, through the economy; in this vision, the agriculture and forestry industries are included as foundational components of the bioeconomy; and
• Bioecology: The bioecology vision focuses on the contributions of the bioeconomy to sustainability and the environment; this vision may specifically exclude some products or industries, such as genetically engineered crops.

The report states that it finds that developing a comprehensive bioeconomy satellite account encompassing all concepts of the bioeconomy appears technically feasible. The report notes that “[s]uch a broad approach would roughly correspond to similar efforts by the European Union (EU) and other international organizations but would not address data users’ preferences for an account more focused on a specific vision of the bioeconomy.” The report states that “[d]eveloping a consistent, ongoing bioeconomy satellite account broken down along the lines of specific visions of the bioeconomy, such as biotechnology, is likely infeasible at this time due to both a lack of existing data on which to base such an account and a lack of consensus on practical measurement definitions.”

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By Lynn L. Bergeson and Carla N. Hutton
 
That National Academies of Sciences, Engineering, and Medicine (NASEM) hosted an October 2022 workshop on successes and challenges in biomanufacturing. The workshop brought together biomanufacturing stakeholders across industry, academia, and government with expertise across diverse fields, including United States-based and international speakers. According to NASEM, discussions spanned the breadth of biomanufacturing contexts and applications, including bioindustrial and biopharmaceutical manufacturing. NASEM’s Proceedings of a Workshop-in Brief provides a high-level summary of the topics addressed at the workshop. Topics covered include:

• Biomanufacturing for Sustainability and a Circular Bioeconomy;
• Regulation and Standards;
• Biomanufacturing Workforce Development and Education;
• Economic Considerations and Challenges in Biomanufacturing;
• Biomanufacturing Ecosystems and Partnerships;
• Translating Lessons from Different Biomanufacturing Sectors;
• Modeling, Data, Analysis, and Process Control;
• Biomanufacturing Platform Development; and
• Biomanufacturing Infrastructure and Tools for Scaling.

NASEM notes that the summary should not be viewed as consensus conclusions or recommendations of NASEM.

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By Lynn L. Bergeson and Carla N. Hutton
 
On March 8, 2023, the U.S. Department of Agriculture (USDA) announced the kickoff of the inaugural National Biobased Products Day and highlighted the accomplishments of people and organizations working to improve sustainability within the federal government. USDA notes that its ongoing work includes the National Institute of Food and Agriculture’s (NIFA) Agriculture and Food Research Initiative programs, which fund research that advances climate-smart agriculture and forestry and strengthens the bioeconomy. USDA states that in line with President Biden’s September 12, 2022, Executive Order (EO) on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy, “these programs develop sources of clean energy and power, biomass systems and high-value biobased products from agricultural feedstocks to foster economic development.” The Bipartisan Infrastructure Law funded innovative new USDA programs such as NIFA’s $9.5 million Bioproduct Pilot Program, which supports research into the benefits of using materials derived from agricultural commodities to manufacture construction and consumer products. USDA notes that the projects have special emphasis on benefits to underserved communities.
 
USDA states that National Biobased Products Day is an annual celebration on March 8 to raise awareness of the benefits of biobased products. The day recognizes the Biden Administration’s commitment to use the vast array of federal resources to combat climate change and help rural communities address its impacts. The day also aligns with President Biden’s Federal Sustainability Plan and EO Number 14057, which focuses on making the federal government carbon-neutral by 2050 and reducing planet-warming greenhouse gas emissions by 65 percent by 2030.
 
A key component of these federal sustainability efforts is USDA’s BioPreferred^® Program, the federal government’s “official advocate and market accelerator for biobased products.” USDA congratulates the four winners of the BioPreferred^® Program’s “Excellence in Procurement Award” for 2022 for reducing their respective agencies’ environmental impact by using biobased products and championing farmers in rural America:

• The U.S. Department of Energy’s (DOE) Y-12 National Security Complex in Oak Ridge, Tennessee;
• Christina Graves with USDA’s Forest Service;
• Brian McCabe with the National Park Service (NPS); and
• Brooke Siegel with the Federal Bureau of Investigation (FBI).

According to USDA, all of these efforts support President Biden’s EO to advance U.S. biotechnology and biomanufacturing. USDA states that it is supporting this effort by providing tools, resources, and scientific research to ensure American farmers and producers remain globally competitive.

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By Lynn L. Bergeson and Carla N. Hutton
 
The Congressional Research Service (CRS) published a CRS report, updated on September 19, 2022, entitled The Bioeconomy: A Primer. The report provides an overview of the bioeconomy, details the efforts of the United States and other selected nations pertaining to the bioeconomy, and offers policy considerations for strengthening the role of the United States in the global bioeconomy. The report does not examine the policies and programs of individual sectors that contribute to the bioeconomy (e.g., biofuels, biomanufacturing, pharmaceuticals, or agriculture), but instead discusses the bioeconomy from a macro level perspective.
 
According to the report, issues for consideration regarding advancement of the U.S. bioeconomy that could be pursued by Congress include:

• Development and Implementation of a National Strategy: The National Academies of Sciences, Engineering, and Medicine (NASEM) and others have recommended that the federal government develop and regularly update a national bioeconomy strategy. As reported in our September 13, 2022, blog item, on September 12, 2022, President Joseph Biden signed Executive Order (EO) 14081 “to coordinate a whole-of-government approach to advance biotechnology and biomanufacturing towards innovative solutions in health, climate change, energy, food security, agriculture, supply chain resilience, and national and economic security.” According to the report, the policies and activities included in the EO appear to respond to NASEM’s recommendation for a more comprehensive vision and approach to advancing the U.S. bioeconomy. If Congress is interested in further supporting the U.S. bioeconomy, it may consider codifying some of the efforts initiated under the EO or establishing an alternative high-level coordination body tasked with developing, implementing, and evaluating a comprehensive U.S. bioeconomy strategy. It could also continue to support a more decentralized framework that encourages sector specific programs and activities related to the bioeconomy. The report states that “[r]egardless of the approach, sustainment of bioeconomy policies and programs across presidential Administrations and Congresses will likely be necessary for maintaining U.S. leadership in the future bioeconomy.” The report acknowledges that ensuring long-term engagement, including the provision of sufficient resources, “is often challenging.”
   
• Investment in Research and Development (R&D): According to the report, many experts call for increased federal investment in R&D to maintain U.S. leadership in the bioeconomy. In general, experts highlight the life sciences, computing and information sciences, engineering, and biotechnology for increased support, and many also emphasize the convergence of such disciplines. Beyond investments in basic and applied research in areas deemed critical to advancing the bioeconomy, some call for improvements in bioeconomy-related R&D infrastructure, including biomanufacturing platforms and pilot facilities. The report states that Congress may find that a more holistic view of its investments in and oversight of biological research, infrastructure, and data is necessary. At least 25 federal agencies and departments support biological R&D, and the jurisdiction of such agencies spans multiple congressional committees, making coordination, oversight, and coherence of bioeconomy policies and investments more challenging.
   
• Promotion of Regional Efforts: The report states that to have ready access to biological resources (e.g., crops, forests), implementation of many aspects of the bioeconomy will occur at the regional scale and involve rural communities. According to the report, policies to encourage the development of bioeconomy clusters and regions, including resources for planning and the creation of networks that facilitate collaboration between diverse stakeholders, including firms from divergent sectors and small businesses, are common. The report notes that it is unclear if existing programs and efforts to support regional innovation and technology-based economic development, including in rural areas, are sufficient to advance the bioeconomy. Congress may examine the size, scope, effectiveness, and synergy of existing programs, in addition to creating new programs or modifying existing programs to promote regional bioeconomy efforts.
   
• Creating a Market for Biobased Products: The report states that an analysis by the Organization for Economic Cooperation and Development (OECD) found that bioeconomy-related policies focus primarily on supply-side or technology push measures (i.e., support for R&D and demonstration efforts). According to the report, OECD emphasized the importance of public procurement in helping to create a market for biobased products and recognized the U.S. Department of Agriculture’s (USDA) BioPreferred Program “as the most advanced effort in this regard.” Despite the relative success of the program, NASEM identified some areas for improvement, including updating the reporting mechanisms involved in the federal procurement of biobased products, setting procurement targets, and increasing funding for the program to enable increased awareness and standardized reporting.
   
• Developing a Bioeconomy Workforce: According to the report, “[t]here is broad consensus that access to a skilled workforce is essential to advancing the bioeconomy,” and “it is also clear that bioeconomy education and training should be multidisciplinary in nature.” As noted by OECD, “the long-standing conundrum of multidisciplinary education is the need for both breadth and depth to graduate people with problem-solving abilities,” however. Additionally, according to OECD, the bioeconomy workforce needs more undergraduates than doctorates. The report states that Congress may examine federal investments in bioeconomy training, education, and workforce development and the progress of the federal government in attaining the goals outlined in its strategic plan on science, technology, engineering, and mathematics (STEM) education.
   
• Public Engagement and Acceptance: The report states that due to the significance of public acceptance, a number of countries are pursuing public engagement and awareness activities and policies. In a 2017 study, NASEM recommended that federal agencies invest in new methods of understanding the ethical, legal, and societal implications (ELSI) of future biotechnology products. Congress may conduct additional oversight on federal efforts to enhance public awareness and acceptance of biobased products and services and may also consider the level of resources allocated toward ELSI-related research across federal agencies, as well as the coordination of such efforts.
   
• International Collaboration: According to the report, most bioeconomy-related policies and strategies are focused at the national level with some exceptions (e.g., the European Union (EU)). In the United States, some states, such as Maine and Michigan, have engaged in bilateral collaborations. The report states that Congress “may examine the state of international collaboration on the bioeconomy and the need for congressional direction in this regard.”
   
• Sustainability and Creating a Circular Economy: A number of nations, especially those in the EU, are increasingly connecting their bioeconomy strategies and policies to action plans associated with creating a more sustainable and circular economy. Many countries see a connection between the bioeconomy and a circular economy as a means to address a number of the Sustainable Development Goals (SDG). Congress may consider the degree to which U.S. bioeconomy policies and activities can or should be tied to and aligned with achieving the SDGs. Additionally, while the use of waste material as a feedstock is central to a circular economy, there are often challenges to its use. Congress may examine any regulatory impediments or other barriers to creating a circular economy.

The crosscutting nature of the bioeconomy, in addition to the diversity of potential benefits associated with its growth and advancement, offer a number of reasons for increased congressional interest in bioeconomy policies. The crosscutting nature of the bioeconomy also poses potential challenges to effective policymaking, including the harmonization of policies and coherent governance. Moreover, it likely means that the growth and success of the U.S. bioeconomy will depend, in part, on effective public-private partnerships in research, innovation, education, and workforce development. Transitioning to a biobased economy would take sustained commitment, including balancing short-term actions and long-term planning, removing barriers to such a transition, and creating the opportunity for radical innovation. Congress may decide there is no need to reorganize or group together federal activities, including some long-standing efforts, under a bioeconomy framework. It may decide to pursue bioeconomy-related policies through new or existing sector-specific focused efforts, or it may decide current policies and activities are sufficient. Regardless, other countries are adopting policies and strategies to advance their bioeconomies. Such efforts have the potential to challenge U.S. leadership in biotechnology and other bioeconomy-related sectors that many view as critical to national security and economic competitiveness.

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By Lynn L. Bergeson and Carla N. Hutton
 
On September 12, 2022, President Joseph Biden signed an Executive Order creating a National Biotechnology and Biomanufacturing Initiative “that will ensure we can make in the United States all that we invent in the United States.” On September 14, 2022, the White House will host a Summit on the National Biotechnology and Biomanufacturing Initiative during which cabinet agencies will announce a wide range of new investments and resources that will allow the United States to harness the full potential of biotechnology and biomanufacturing and advance the President’s Executive Order.
 
According to a White House fact sheet, the initiative will accelerate biotechnology innovation and grow America’s bioeconomy across multiple sectors in industries such as health, agriculture, and energy. It will “drive advances in biomanufacturing that substitute fragile supply chains from abroad with strong chains at home, anchored by well-paying jobs in communities all across America.” It will improve food and energy security, and promote agricultural innovation while mitigating the impacts of climate change.
 
Specifically, the initiative will:

• Grow Domestic Biomanufacturing Capacity: The initiative will build, revitalize, and secure national infrastructure for biomanufacturing across America, including through investments in regional innovation and enhanced bio-education, while strengthening the U.S. supply chain that produces domestic fuels, chemicals, and materials.
   
• Expand Market Opportunities for Biobased Products: The fact sheet notes that the U.S. Department of Agriculture’s (USDA) BioPreferred Program “is the standard for sustainable procurement by government agencies, both providing an alternative to petroleum-based products and supporting good-paying jobs for American workers.” The initiative will increase mandatory biobased purchasing by federal agencies and ensure that the Office of Management and Budget (OMB) and USDA regularly publish progress assessments. The fact sheet states that doing so “will provide specific directions to industry about gaps in biobased product options, leading to the creation of new products and new markets.” Together, the initiative will grow and strengthen the BioPreferred Program, increase the use of renewable agricultural materials, and “position American companies to continue to lead the world in bio-innovation.”
   
• Drive Research and Development (R&D) to Solve Our Greatest Challenges: According to the fact sheet, focused government support for biotechnology can quickly produce solutions, “as seen with the first-of-their-kind mRNA vaccines during the COVID-19 pandemic.” This initiative directs federal agencies to identify priority R&D needs to translate bioscience and biotechnology discoveries into medical breakthroughs, climate change solutions, food and agricultural innovation, and stronger U.S. supply chains.
   
• Improve Access to Quality Federal Data: Combining biotechnology with massive computing power and artificial intelligence can produce significant breakthroughs for health, energy, agriculture, and the environment. The Data for the Bioeconomy Initiative will ensure that biotechnology developers have streamlined access to high-quality, secure, and wide-ranging biological data sets that can drive solutions to urgent societal and global problems.
   
• Train a Diverse Skilled Workforce: The United States is facing a shortage of relevant talent spanning all levels, from community college to graduate school. The initiative will expand training and education opportunities for all Americans in biotechnology and biomanufacturing, with a focus on advancing racial and gender equity and support for talent development in underserved communities.
   
• Streamline Regulations for Products of Biotechnology: Advances in biotechnology are rapidly altering the agricultural, industrial, technological, and medical products landscape, which can create challenges for developers and innovators. The initiative will improve the clarity and efficiency of the regulatory process for products of biotechnology so that valuable inventions and products can come to market faster without sacrificing safety.
   
• Advance Biosafety and Biosecurity to Reduce Risk: The initiative will prioritize investments in applied biosafety research and incentivize innovations in biosecurity to reduce risk throughout the biotechnology R&D lifecycles.
   
• Protect the U.S. Biotechnology Ecosystem: The initiative will protect the U.S. biotechnology ecosystem by advancing privacy standards and practices for human biological data, cybersecurity practices for biological data, standards development for bio-related software, and mitigation measures for risks posed by foreign adversary involvement in the biomanufacturing supply chain.
   
• Build a Thriving, Secure Global Bioeconomy with Partners and Allies: According to the fact sheet, the initiative advances international cooperation to leverage biotechnology and biomanufacturing to tackle the most urgent global challenges -- from climate change to health security -- and to work together to ensure that biotechnology product development and use aligns with our shared democratic ethics and values, and that biotechnology breakthroughs benefit all citizens.

The White House has posted a transcript of the press call announcing the Executive Order.

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By Lynn L. Bergeson

On May 15, 2020, U.S. Senators Cory Gardner (R-CO), Kirsten Gillibrand (D-NY), Ed Markey (D-MA), and Marco Rubio (R-FL) introduced the Bioeconomy Research and Development Act of 2020, creating a federal research initiative to ensure continued United States leadership in engineering biology. The National Engineering Biology Research and Development Initiative would focus on the advancement of societal well-being, national security, sustainability, and economic productivity and competitiveness. It would accomplish these goals through:

• Advancement of areas of research at the intersection of biological, physical, chemical, data, and computational sciences;

• Advancement of areas in biomanufacturing research;

• Support of social and behavioral sciences and economics research that advances the field of engineering biology;

• Improvement of the understanding of the engineering biology;

• Support of risk research;

• Development of novel tools and technologies to accelerate scientific understanding and technological innovation in engineering biology;

• Expansion of the number of researchers, educators, and students with engineering biology training;

• Acceleration of the translation and commercialization of engineering biology research and development by the private sector; and

• Improvement of the interagency planning and coordination of federal government activities related to engineering biology.

According to Senator Rubio, the Bioeconomy Research and Development Act of 2020 has been endorsed by a number of leading research institutes, including the Biotechnology Innovation Organization (BIO), a Biobased and Renewable Products Advocacy Group (BRAG^®) member.

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By Lynn L. Bergeson

On September 10, 2019, the U.S. Office of Science and Technology Policy (OSTP) announced in the Federal Register a request for information (RFI) on the U.S. bioeconomy. Calling for input from all interested parties on the U.S. bioeconomy, OSTP’s RFI aims to inform notable gaps, vulnerabilities, and areas to promote and protect in the bioeconomy that may benefit from federal government attention. Input from the public is welcome, including those with capital investments, those performing innovative research, and those developing enabling platforms and applications in the field of biological sciences. Of particular interest to OSTP are suggestions of areas of greatest priority within the bioeconomy. Comments are due on or prior to October 22, 2019.

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By Lynn L. Bergeson

The Maine Technology Institute (MTI) announced on December 14, 2018, a request for proposals (RFP) for Maine’s Forest Resources. Managed by Biobased Maine on behalf of MTI, the RFP for the Emerging Technology Challenge aims to deploy a forest industry technology in Maine, where forest biomass is used in the production of a value-added product for sale. MTI is a “publicly funded, nonprofit corporation with the core mission to diversify and grow Maine’s economy by encouraging, promoting, stimulating, and supporting innovation and its transformation into new products, services and companies, leading to the creation and retention of quality jobs in Maine.” In support of the industrial biotechnology growth across the globe, MTI wishes to ensure that Maine is part of the bioeconomy. Eligible candidates must have submitted information to MTI’s request for information (RFI) in July 2018, and must submit RFP applications by January 25, 2019. MTI will award up to $1.5 million in grants for one or multiple projects. For further information on how to apply, please click here.

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By Lynn L. Bergeson

On December 5, 2018, the United Kingdom (UK) published a policy paper titled “Growing the Bioeconomy, Improving Lives and Strengthening Our Economy: A National Bioeconomy Strategy to 2030.” As the UK strives to double its bioeconomy value by 2030, four main goals are outlined as part of the strategic plan:

• Capitalize the research, development, and innovation base;
• Maximize productivity and potential from existing bioeconomy assets;
• Deliver real, measurable benefits for the UK economy; and
• Create the right societal and market conditions to allow innovative biobased products and services to thrive.

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