By Lynn L. Bergeson and Carla N. Hutton
 
As reported in our September 13, 2022, blog item, on September 12, 2022, President Joseph Biden signed an Executive Order creating a National Biotechnology and Biomanufacturing Initiative (NBBI) to accelerate biotechnology innovation and grow America’s bioeconomy across multiple sectors in industries such as health, agriculture, and energy. On December 20, 2022, the White House Office of Science and Technology Policy (OSTP) published two requests for information (RFI) related to the NBBI. In the first one, OSTP, on behalf of the primary agencies that regulate the products of biotechnology -- the U.S. Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) -- requests relevant data and information, including case studies, that may assist in identifying any regulatory ambiguities, gaps, inefficiencies, or uncertainties in the Coordinated Framework for the Regulation of Biotechnology, particularly with regard to new and emerging biotechnology products. 87 Fed. Reg. 77900. According to the RFI, the information provided will inform regulatory agency efforts to improve the clarity and efficiency of the regulatory processes for biotechnology products. The RFI includes the following questions:

1. Describe any ambiguities, gaps, inefficiencies, or uncertainties regarding statutory authorities and/or agency roles, responsibilities, or processes for different biotechnology product types, particularly for product types within the responsibility of multiple agencies.
    
   1. Describe the impact, including economic impact, of these ambiguities, gaps, inefficiencies, or uncertainties.
       
2. Provide any relevant data or information, including case studies, that could inform improvement in the clarity or efficiency (including the predictability, transparency, and coordination) of the regulatory system and processes for biotechnology products.
    
3. Describe any specific topics the agencies should address in plain language on the regulatory roles, responsibilities, and processes of the agencies.
    
4. Describe any specific issues the agencies should consider in developing a plan to implement regulatory reform, including any updated or new regulations or guidance documents.

5. Describe any new or emerging biotechnology products (e.g., microbial amendments to promote plant growth; food plants expressing non-food substances or allergens from non-plant sources) that, based on lessons learned from past experiences or other information, the agencies should pay particular attention to in their evaluation of ambiguities, gaps, or uncertainties regarding statutory authorities and/or agency roles or processes.

6. Describe any new or emerging categories of biotechnology products on the horizon that the regulatory system and processes for biotechnology products should be preparing to address. Describe any specific recommendations for regulating these new or emerging categories of biotechnology products to guide agency preparations.

7. What is the highest priority issue for the agencies to address in the short term (i.e., within the next year) and in the long term.

OSTP, EPA, FDA, and USDA will host a virtual public listening session on January 12, 2023. The virtual listening session will allow OSTP, EPA, FDA, and USDA to hear, firsthand, from stakeholders who wish to provide feedback on any of the seven questions outlined in the RFI. Comments are due on or before 5 p.m. (EST) February 3, 2023. More information on the Coordinated Framework for the Regulation of Biotechnology is available in our January 9, 2017, memorandum.
 
The second RFI seeks public input on how advances in biotechnology and biomanufacturing can help achieve goals that were previously out of reach and what steps can be taken to provide the right research ecosystem, workforce, data, domestic biomanufacturing capacity, and other components to support a strong bioeconomy. 87 Fed. Reg. 77901. OSTP invites input from interested stakeholders, including industry and industry association groups; academic researchers and policy analysts; civil society and advocacy groups; individuals and organizations that work on biotechnology, biomanufacturing, or related topics; and members of the public. OSTP seeks responses to one, some, or all of the following questions:

Harnessing Biotechnology and Biomanufacturing Research and Development (R&D) to Further Societal Goals

1. For any of the four categories outlined above (health, climate and energy, food and agriculture, and supply chain resilience):
    
   1. What specific bold goals can be achieved through advances in biotechnology and biomanufacturing in the short term (five years) and long term (20 years)? In your answers, please suggest quantitative goals, along with a description of the potential impact of achieving a goal. Listed below are illustrative examples of quantitative goals:
       
      1. Develop domestic bio-based routes of production, including the entire supply chain, for X percent of active pharmaceutical ingredients.
          
      2. Utilize X tons of sustainable biomass annually as input to biomanufacturing processes to displace Y percent of U.S. petroleum consumption.
         ​
   2. What R&D is needed to achieve the bold goals outlined in (a), with a focus on cross-cutting or innovative advances? How would the government support this R&D, including through existing federal programs, creation of new areas of R&D, and/or development of new mechanisms?
       
   3. How else can the government engage with and incentivize the private sector and other organizations to achieve the goals outlined in (a)?
       
2. Public engagement and acceptance are of critical importance for successful implementation of biotechnology solutions for societal challenges. How might social, behavioral, and economic sciences contribute to understanding possible paths to success and any hurdles? What public engagement and participatory models have shown promise for increasing trust and understanding of biotechnology?

Data for the Bioeconomy

3. What data types and sources, to include genomic and multiomic information, are most critical to drive advances in health, climate, energy, food, agriculture, and biomanufacturing, as well as other bioeconomy-related R&D? What data gaps currently exist?

4. How can the federal government, in partnership with private, academic, and non-profit sectors, support a data ecosystem to drive breakthroughs for the U.S. bioeconomy? This may include technologies, software, and policies needed for data to remain high-quality, interoperable, accessible, secure, and understandable across multiple stakeholder groups.

Building a Vibrant Domestic Biomanufacturing Ecosystem

5. What is the current state of U.S. and global biomanufacturing capacity for health and industrial sectors, and what are the limits of current practice?

6. What can the federal government do to expand and scale domestic biomanufacturing capacity and infrastructure? What level of investment would be meaningful, and what incentive structures could be employed?

7. What are barriers that must be addressed to enable better domestic supply chains for biomanufacturing (e.g., feedstocks, reagents, consumables)?

8. How can the federal government partner with state and local governments to expand domestic biomanufacturing capacity, with a particular focus on underserved communities?

Biobased Products Procurement

9. What are new, environmentally sustainable biobased products that the federal government could purchase through its BioPreferred Program? How can the federal government incentivize development of new categories of sustainable biobased products?

   Biotechnology and Biomanufacturing Workforce

10. How can the U.S. strengthen and expand the biotechnology and biomanufacturing workforce to meet the needs of industry today and in the future? What role can government play at the local, state, and/or federal level?

11. What strategies and program models have shown promise for successfully diversifying access to biomanufacturing and biotechnology jobs -- including those involving Historically Black Colleges and Universities (HBCU), Tribal Colleges and Universities, and other Minority Serving Institutions? What factors have stymied progress in broadening participation in this workforce?

Reducing Risk by Advancing Biosafety and Biosecurity

12. What can the federal government do to support applied biosafety research and biosecurity innovation to reduce risk while maximizing benefit throughout the biotechnology and biomanufacturing life cycles?
     
13. How can federal agencies that fund, conduct, or sponsor life sciences research incentivize and enhance biosafety and biosecurity practices throughout the United States and international research enterprises?

 Measuring the Bioeconomy

14. What quantitative indicators, economic or otherwise, are currently used to measure the contributions of the U.S. bioeconomy? Are there new indicators that should be developed?

15. How should the North American Industry Classification System (NAICS) and the North American Product Classification System (NAPCS) be revised to enable characterization of the economic value of the U.S. bioeconomy? Specifically, which codes or categories do not distinguish between functionally identical biobased and fossil fuel-based commodities?

International Engagement

16. What are opportunities for the U.S. government to advance R&D, a skilled workforce, regulatory cooperation, and data sharing for the bioeconomy through international cooperation? Which partnerships and fora are likely keys to advance these priority areas?
     
17. What risks are associated with international biotechnology development and use, and how can the U.S. government work with allies and partners to mitigate these risks?

Comments are due on or before 5:00 p.m. (EST) on January 20, 2023.

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By Lynn L. Bergeson and Carla N. Hutton
 
EuropaBio announced on November 14, 2022, a new cross-sectoral Biomanufacturing Platform. EuropaBio states that the Platform has the mission to represent biomanufacturing at the highest policy levels in Europe and to ensure that it is visible and recognized within the industrial strategy and Europe’s green and digital transitions. The Platform will address the policy and wider frameworks through which biomanufacturing is delivered. EuropaBio states that together with members and stakeholders, the Platform will address how economic growth, employment, and resilience are achieved through policy, legal frameworks, and regulation at the European Union (EU) and national levels. Platform activities will build an economic evidence base for biomanufacture across sectors; reflect policy priorities from EuropaBio’s Healthcare, Industrial Biotechnology, and National Association Councils; and build case studies to demonstrate diversity and impact of biomanufacture.
 
The Biomanufacturing Platform will host its first policy summit on March 15, 2023, in Brussels. The summit will set the vision for Europe’s global innovation, competitiveness, and sustainability through the lens of biomanufacturing and set a baseline for its understanding and recognition within policy.

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By Lynn L. Bergeson and Carla N. Hutton
 
On November 21, 2022, the U.S. Government Accountability Office (GAO) published a Science & Tech Spotlight on biorecycling of plastics. Biological recycling, or biorecycling, is an emerging technology that uses microbes, such as bacteria or fungi, to break down plastic into its basic components for reuse. GAO states that research suggests that biorecycling of plastics could help promote a circular economy in which plastic waste is continuously reincorporated into new products. According to GAO, entities seeking to engage in biorecycling could face a “complicated legal landscape” that may pose a challenge for the emerging technology. At the federal level, depending on the specifics of the process, aspects of biorecycling or the wastes that may result from that process might be governed by statutes such as the Toxic Substances Control Act (TSCA), the Resource Conservation and Recovery Act (RCRA), and the Microbial Products of Biotechnology Rule. In addition, states, tribal organizations, municipalities, and other stakeholders, including nonprofit organizations, businesses, and other entities, can also play important roles in regulating or supporting recycling in the United States.
 
Opportunities from biorecycling of plastics include:

• Economic, environmental, and health gains. Biorecycling of plastics could help promote a circular economy by turning waste into more useful products while reducing dependence on fossil fuels for new plastics. Emerging recycling methods could help mitigate the negative health effects of incinerating plastic waste; and
• Processing efficiency. Biorecycling does not require the same level of sorting for plastic waste compared with mechanical recycling, thereby saving time and money. It also consumes less energy than mechanical and some chemical recycling methods.

GAO identified the following challenges:

• Implementation costs. Recycling plastics is generally more expensive than creating new plastics. Further, companies may face high start-up costs to develop a biorecycling facility;
• Limited applicability. The enzymes researchers have identified are currently limited to degrading only a few types of plastic; and
• Knowledge gaps. Research is needed to address the unintended consequences of biorecycling. For example, researchers have not assessed the risks engineered enzymes might pose if released into the environment.

According to GAO, policy context and questions include:

• What aspects of biorecycling could be prioritized to help reduce the accumulation of plastic waste and its economic and environmental effects?
• To what extent do current laws and regulations appropriately address concerns regarding the industrial use of engineered enzymes for biorecycling, while still allowing for their development?
• What steps could the federal government, states, municipalities, and other stakeholders take if they want to support or implement effective policies for biorecycling of plastic waste?

GAO states that it meets Congressional information needs in several ways, including by providing oversight, insight, and foresight on science and technology issues. GAO notes that it also provides targeted assistance on specific science and technology topics to support Congressional oversight activities and provide advice on legislative proposals.

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By Lynn L. Bergeson and Carla N. Hutton
 
On November 1, 2022, the U.S. Environmental Protection Agency (EPA) announced 26 Safer Choice Partner of the Year award winners, recognizing their achievements in the design, manufacture, selection, and use of products with safer chemicals. The awardees represent a wide variety of organizations, including small- and medium-sized businesses, women-owned companies, state and local governments, non-governmental organizations, and trade associations.
 
EPA encouraged applicants for the 2022 awards to show how their work advances environmental justice, bolsters resilience to the impacts of climate change, results in cleaner air or water, or improves drinking water quality. According to EPA, many of the organizations being recognized are working to reduce greenhouse gas (GHG) emissions and combat the climate crisis. For example, several winners offer products with concentrated formulas that reduce water consumption and plastic use. This practice also lowers GHG emissions by reducing the amount of product that must be transported.
 
EPA states that additionally, many awardees increased access to products with safer chemical ingredients in underserved and overburdened communities. For example, one nonprofit winner conducted targeted outreach in both English and Spanish to promote safer cleaning techniques and products, including Safer Choice-certified products, in food trucks. Many of these businesses are owned and operated by immigrant entrepreneurs. Another winner made its Safer Choice-certified product line more accessible to lower income shoppers by offering affordable prices and making these products available at retailers that often serve low-income communities.
 
In early 2023, EPA intends to build on this work by announcing a grant opportunity for projects that can increase supply and demand for safer, environmentally preferable products such as those certified by the Safer Choice program or identified by EPA’s Environmentally Preferable Purchasing program.
 
The 2022 winners include:

• American Cleaning Institute, District of Columbia;
• The Ashkin Group, LLC, Channel Islands Harbor, California;
• Bona US, Englewood, Colorado;
• Case Medical, Bloomfield, New Jersey;
• Church & Dwight Co., Inc., Ewing, New Jersey;
• Clean Safety & Health in Food Trucks (CleanSHiFT) Team, Seattle, Washington;
• The Clorox Company, Oakland, California;
• Colgate-Palmolive, New York, New York;
• Design for the Environment Logo Redesign Coalition: Environmental Defense Fund, The Natural Resources Defense Council, The Clorox Company, The Procter & Gamble Company, and Reckitt;
• Dirty Labs Inc., Portland, Oregon;
• ECOS, Cypress, California;
• Grove Collaborative, San Francisco, California;
• The Hazardous Waste Management Program, Seattle, Washington;
• Holloway House, Inc., Fortville, Indiana;
• The Home Depot, Atlanta, Georgia;
• Household & Commercial Products Association, District of Columbia;
• Jelmar, LLC, Skokie, Illinois;
• Lemi Shine, Austin, Texas;
• LightHouse for the Blind and Visually Impaired, San Francisco, California;
• Mother Africa, Kent, Washington;
• Novozymes North America, Raleigh, North Carolina;
• The ODP Corporation, Boca Raton, Florida;
• The Procter & Gamble Company, Cincinnati, Ohio;
• PurposeBuilt Brands, Gurnee, Illinois;
• Sensitive Home, Greenbrae, California; and
• Solutex, Sterling, Virginia.

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This week’s All Things Chemical^® podcast will be of interest to readers of the B&C^® Biobased and Sustainable Chemicals Blog. This episode features a conversation between Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (B&C^®) and Dr. Claire Skentelbery, Director General, EuropaBio -- The European Association for Bioindustries. Many know Claire from her prior role as Director General of the Nanotechnology Industries Association, where she energized that Brussels-based trade association to new and exciting heights. Claire has brought her considerable scientific, science policy, and trade association management skills to EuropaBio at an exciting time, as biotechnology is widely recognized to be a pivotal component of the European Union’s (EU) commitment to sustainability. Lynn and Claire cover a lot of territory in this conversation and discuss evolving perceptions of biotechnology in the EU, how biotechnology is advancing the EU’s commitment to sustainability and circularity, and what’s next for biotech advocacy in the EU.

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By Lynn L. Bergeson and Carla N. Hutton
 
The California Department of Toxic Substances Control (CDTSC) invites stakeholders to two external engagement sessions, on November 1 and November 3, 2022, to share their perspectives on an actionable definition of sustainable chemistry. CDTSC states that stakeholders’ participation and expertise can help refine a draft, consensus definition and set of criteria for sustainable chemistry. According to CDTSC, the draft definition and criteria were developed over the past six months by a 20-person Expert Committee on Sustainable Chemistry (ECOSChem) that includes representatives from industry, academia, and governmental and non-governmental organizations, including a representative from the Safer Consumer Products Program (SCP). The charge of ECOSChem is to establish “an ambitious, actionable definition and criteria for sustainable chemistry that can enable effective government policy, inform business and investor decision making, enhance chemistry education, and spur the adoption across all supply chains of chemicals that are safer and more sustainable.” More  information about the project is available in a background document.
 
The ECOSChem process is facilitated and supported by Beyond Benign and the Lowell Center for Sustainable Production (LCSP), who will host two external engagement meetings. CDTSC asks participants to register in advance for the November 1, 2022, meeting or the November 3, 2022, meeting. During the meetings, the Project Team will introduce the project and the draft definition and criteria (15 minutes). Participants will then move into small groups organized by sector that will be moderated by ECOSChem members (45 minutes), followed by a wrap-up session where key input will be shared with the large group with time for discussion (30 minutes). Discussion materials for these meetings will be sent out on October 31, 2022.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Department of Agriculture’s (USDA) Biotechnology Risk Assessment Research Grants (BRAG) program supports the generation of new information that will assist federal regulatory agencies in making science-based decisions about the environmental effects of introducing genetically engineered organisms. In an October 27, 2022, technical assistance webinar, staff will provide an overview of the program, which is jointly administered by USDA’s National Institute of Food and Agriculture (NIFA) and Agricultural Research Service (ARS), and discuss details included in the fiscal year (FY) 2023 Request for Applications (RFA). NIFA plans to invest $5.5 million in this funding opportunity, which supports applied and/or fundamental research relevant to environmental risk assessment, including biological risk, and the federal regulatory process. Applications may be submitted by any U.S. public or private research or educational institution or organization. The closing date for grant applications is January 19, 2023. Registration for the webinar is required.

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By Lynn L. Bergeson and Carla N. Hutton
 
As reported in our September 13, 2022, blog item, on September 12, 2022, President Joseph Biden signed an Executive Order (EO) 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.” The White House hosted a Summit on Biotechnology and Biomanufacturing on September 14, 2022. According to the White House fact sheet on the summit, federal departments and agencies, with funding of more than $2 billion, will take the following actions:

• Leverage biotechnology for strengthened supply chains: The Department of Health and Human Services (DHHS) will invest $40 million to expand the role of biomanufacturing for active pharmaceutical ingredients (API), antibiotics, and the key starting materials needed to produce essential medications and respond to pandemics. The Department of Defense (DOD) is launching the Tri-Service Biotechnology for a Resilient Supply Chain program with a more than $270 million investment over five years to turn research into products more quickly and to support the advanced development of biobased materials for defense supply chains, such as fuels, fire-resistant composites, polymers and resins, and protective materials. Through the Sustainable Aviation Fuel Grand Challenge, the Department of Energy (DOE) will work with the Department of Transportation and the U.S. Department of Agriculture (USDA) to leverage the estimated one billion tons of sustainable biomass and waste resources in the United States to provide domestic supply chains for fuels, chemicals, and materials.
   
• Expand domestic biomanufacturing: DOD will invest $1 billion in bioindustrial domestic manufacturing infrastructure over five years to catalyze the establishment of the domestic bioindustrial manufacturing base that is accessible to U.S. innovators. According to the fact sheet, this support will provide incentives for private- and public-sector partners to expand manufacturing capacity for products important to both commercial and defense supply chains, such as critical chemicals.
   
• Foster innovation across the United States: The National Science Foundation (NSF) recently announced a competition to fund Regional Innovation Engines that will support key areas of national interest and economic promise, including biotechnology and biomanufacturing topics such as manufacturing life-saving medicines, reducing waste, and mitigating climate change. In May 2022, USDA announced $32 million for wood innovation and community wood grants, leveraging an additional $93 million in partner funds to develop new wood products and enable effective use of U.S. forest resources. DOE also plans to announce new awards of approximately $178 million to advance innovative research efforts in biotechnology, bioproducts, and biomaterials. In addition, the U.S. Economic Development Administration’s $1 billion Build Back Better Regional Challenge will invest more than $200 million to strengthen America’s bioeconomy by advancing regional biotechnology and biomanufacturing programs.
   
• Bring bioproducts to market: DOE will provide up to $100 million for research and development (R&D) for conversion of biomass to fuels and chemicals, including R&D for improved production and recycling of biobased plastics. DOE will also double efforts, adding an additional $60 million, to de-risk the scale-up of biotechnology and biomanufacturing that will lead to commercialization of biorefineries that produce renewable chemicals and fuels that significantly reduce greenhouse gas emissions from transportation, industry, and agriculture. The new $10 million Bioproduct Pilot Program will support scale-up activities and studies on the benefits of biobased products. Manufacturing USA institutes BioFabUSA and BioMADE (launched by DOD) and the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) (launched by the Department of Commerce (DOC)) will expand their industry partnerships to enable commercialization across regenerative medicine, industrial biomanufacturing, and biopharmaceuticals.
   
• Train the next generation of biotechnologists: The National Institutes of Health (NIH) is expanding the Innovation Corps (I-Corps™), a biotech entrepreneurship bootcamp. NIIMBL will continue to offer a summer immersion program, the NIIMBL eXperience, in partnership with the National Society for Black Engineers, which connects underrepresented students with biopharmaceutical companies, and support pathways to careers in biotechnology. In March 2022, USDA announced $68 million through the Agriculture and Food Research Initiative to train the next generation of research and education professionals.
   
• Drive regulatory innovation to increase access to products of biotechnology: The Food and Drug Administration (FDA) is spearheading efforts to support advanced manufacturing through regulatory science, technical guidance, and increased engagement with industry seeking to leverage these emerging technologies. For agricultural biotechnologies, USDA is building new regulatory processes to promote safe innovation in agriculture and alternative foods, allowing USDA to review more diverse products.
   
• Advance measurements and standards for the bioeconomy: DOC plans to invest an additional $14 million next year at the National Institute of Standards and Technology for biotechnology research programs to develop measurement technologies, standards, and data for the U.S. bioeconomy.
   
• Reduce risk through investing in biosecurity innovations: DOE’s National Nuclear Security Administration plans to initiate a new $20 million bioassurance program that will advance U.S. capabilities to anticipate, assess, detect, and mitigate biotechnology and biomanufacturing risks, and will integrate biosecurity into biotechnology development.
   
• Facilitate data sharing to advance the bioeconomy: Through the Cancer Moonshot, NIH is expanding the Cancer Research Data Ecosystem, a national data infrastructure that encourages data sharing to support cancer care for individual patients and enables discovery of new treatments. USDA is working with NIH to ensure that data on persistent poverty can be integrated with cancer surveillance. NSF recently announced a competition for a new $20 million biosciences data center to increase our understanding of living systems at small scales, which will produce new biotechnology designs to make products in agriculture, medicine and health, and materials.

A recording of the White House summit is available online.

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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
 
The U.S. Department of Energy (DOE) Bioenergy Technologies Office (BETO) and the Agile BioFoundry (ABF) will hold a webinar on September 22, 2022, highlighting technologies used by the ABF to accelerate biomanufacturing. According to BETO, the ABF consortium collaborates with industry and academia to develop technologies that enable commercially relevant biomanufacturing of sustainable bioproducts. During the webinar, attendees will hear from ABF scientists on how they use state-of-the-art machine learning, deep learning, testing, and modeling techniques to guide the bioengineering process and speed up bioproduct development.
 
The webinar will feature the following speakers:

• Nathan Hillson, staff scientist at Lawrence Berkeley National Laboratory and the principal investigator of the ABF. Dr. Hillson leads the consortium’s Integrated Design-Build-Test-Learn task;
• Taraka Dale, scientist and principal investigator at Los Alamos National Laboratory and co-lead of ABF’s Host Onboarding and Development task;
• Hector Garcia Martin, staff scientist at Lawrence Berkeley National Laboratory and co-lead of ABF’s Learn subtask, and
• Philip Laible, biophysicist at Argonne National Laboratory and co-lead of ABF’s Learn subtask.

Registration for the webinar is open. 

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