Strategic Investments the U.S. Should Make in the Bioeconomy Right Now

In 2023, the U.S. bioeconomy generated 643,992 domestic jobs and contributed $210.4 billion to the U.S. GDP, establishing it as a significant economic force. This impact is largely due to its broad and diverse scope. While the U.S. bioeconomy does not have a consensus definition, nearly all versions of the definition include biotechnology as a central driver. Consequently, a wide range of industries are encompassed within the bioeconomy (Table 1). Previous administrations, including the previous Trump Administration, have championed and advanced biotechnology and biomanufacturing. The Biden Administration released the Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy (Bioeconomy EO) focused on expanding domestic biomanufacturing capacity, streamlining regulations for biotech products, and expanding market opportunities. With a new chapter ahead of us, the United States is presented with incredible challenges and opportunities in the face of China’s dominance in this space.

However, the broad scope of the U.S. bioeconomy also presents significant challenges. While there is general consensus on the types of industries relevant to the bioeconomy, there is no definitive agreement on which should be included or excluded, resulting in certain sectors within an industry being classified as part of the bioeconomy even if the industry as a whole is not. This lack of clarity creates confusion which could result in missed opportunities for ongoing development and support programs that these industries could benefit from. Furthermore, this ambiguity fosters the creation of artificial silos, hindering cross-sector communication and potentially causing a loss of valuable collaborative capabilities. This lack of clarity additionally complicates the measurement of the bioeconomy’s economic contributions, leaving valuable opportunities for growth and development underexplored due to an inability to identify sectors that require further investment.

The Bioeconomy EO made significant strides in understanding the U.S. bioeconomy, but substantial growth remains. A key lesson learned is the need for a common, consensus-based definition and lexicon to improve communication across sectors, as agencies like the DOD, USDA, and DOE often struggle to talk across sectors without a shared language. NIST’s Bioeconomy Lexicon, last updated in February 2025, remains incomplete, with important terms like continuous fermentation still undefined. Additionally, there is a growing need for standards and metrics, and continued investment in NIST’s initiatives, which are essential to build a unified strategy that maximizes the bioeconomy’s full potential.

Despite these difficulties, the U.S. bioeconomy continues to demonstrate resilience and growth, particularly as we enter the next technological revolution driven by advancements in artificial intelligence, biotechnology, advanced manufacturing, and sustainable development. This underscores the critical need for investment across all levels of the U.S. bioeconomy. By making strategic investments in the bioeconomy now, the U.S. can position itself to capitalize on future innovations and advancements, unlocking the projected growth potential, which is expected to reach $400 billion by 2030. Investment in the U.S. bioeconomy not only promotes economic growth but also yields broader benefits, like fostering job creation, driving development of new technologies that enhance the quality of life, providing resilience to long-term prosperity, and staking out significant competitive advantage at the global scale. Overall, the U.S. bioeconomy represents a powerful force with immense potential, one that must be recognized and leveraged further.

Investment in the Bioeconomy Drives Regional Development 

Given the vastness of the U.S. bioeconomy, a top-down approach alone will not be enough to drive the rapid growth needed for global competitiveness. A bottom-up approach, led by regional efforts, is essential for fostering growth and innovation across the country. Combining both approaches can boost the national GDP, stimulate regional economies, and create jobs. Regional programs like the EDA Tech Hubs, NSF Biofoundries, and U.S. Manufacturing Institutes like BioMADE and NIIMBL are already supporting localized bioeconomies, or micro-bioeconomies, tailored to specific resources and technologies.

While federal initiatives are important, it is equally important to assess their effectiveness. Understanding the return on investment from these programs is essential, not just for local micro-bioeconomies, but for their broader impact on the U.S. economy. For example, BioMADE has seen significant budget increases, including a $450 million boost in 2023, but its 2024 allocation of $75 million across 65 projects raises questions about fund distribution. As BioMADE supports more projects, further evaluation is needed to determine how effectively it is utilizing resources to advance U.S. biotechnology and biomanufacturing.

Ultimately, it will be essential for stakeholders in the U.S. bioeconomy to closely examine regional programs and assess their effectiveness. A comparative analysis of funding across different programs, agencies, and performance metrics will be necessary to ensure these investments are delivering tangible benefits and are aligned with broader bioeconomy goals. One key lesson from the Bioeconomy EO is that the U.S. must acknowledge that we can do more and that we have not yet done enough. The U.S. bioeconomy is still in its early stages, with significant room for growth and improvement. If the federal government and regional entities do not continue investing in this crucial sector, the nation will face serious economic, social, and global challenges in the future. Failing to act will only stifle progress and allow global competitors to surpass the U.S. in production, manufacturing, skill development, and resource acquisition. To ensure the U.S. bioeconomy thrives, sustained investment, decisive action, and a unified national and regional strategy are essential. 

What Areas of the U.S. Bioeconomy Still Need Development?

The bioeconomy EO focused on many different components of the bioeconomy to grow and foster, but despite the EO’s best efforts, not all areas have developed to the same degree. Several areas still require further development, investment, and strategy to safeguard and grow portions of the U.S. bioeconomy.

One important area is Supply Chain Resiliency. In March 2024, the USDA published a report aimed at creating a more resilient biomass supply chain, in accordance with the deliverable in section 5C of the bioeconomy EO. Biomass is an important component of the U.S. bioeconomy but the bioeconomy supply chain encompasses much more. Resiliency should extend to ensuring that all material and intellectual inputs and outputs in the U.S. bioeconomy are safeguarded against disruptions, such as those experienced during the COVID-19 pandemic, and built to last. The pandemic exemplified our reliance on products made outside of the U.S. to keep our biomanufacturing ecosystem functioning, such as the need for single-use plastics or specific biological inputs for vaccine production. In light of this, achieving true resilience requires building a flexible, global supply chain to ensure access to diverse biological resources and the ability to rapidly adapt to global market demands, rather than relying solely on a U.S.-centric model. Establishing stockpile agreements and treaties will be key to ensuring the bioeconomy’s supply chain can withstand unforeseen challenges.

Another important aspect is Bio-Based Product Procurement. The bioeconomy EO included several deliverables focused on bio-based procurement, such as identifying procurement challenges, producing annual fiscal reports, and creating new procurement programs within different agencies. However, despite the emphasis on these issues, little has been published beyond a USDA report that offers generic recommendations to address challenges. These recommendations, such as measuring the bioeconomy and coordinating carbon intensity labels, fail to address the real difficulties that have hindered bio-based procurement at the federal level.

Additionally, Workforce Development & Bioliteracy is crucial for the success of the U.S. bioeconomy. To fully capitalize on the potential of the bioeconomy, a skilled workforce is required. While the OSTP has released an action plan to boost the bioeconomy workforce, further investment and coordination are necessary to meet the bioeconomy’s needs. The U.S. manufacturing sector has been the backbone of the economy since the industrial revolution, and transitioning to biomanufacturing offers the opportunity to create new jobs and bring substantial economic growth to regions across the country. However, this shift requires significant workforce development reforms, including reassessing immigration policies to ensure that the best global talent is attracted to the U.S., further strengthening the economy.

Strategic Next Steps for the U.S. Bioeconomy and the New Administration

To strategically foster the growth of the U.S. bioeconomy and remain globally competitive, the new administration must not only prioritize the development of currently underdeveloped areas within the bioeconomy but also establish the foundational infrastructure necessary for long-term success. A crucial first step would be establishing a clear and adaptable definition of the U.S. bioeconomy. This would help not only in measuring its progress but also in defining which sectors and sub-sectors fall under its umbrella. 

Additionally, the administration should focus on regional development through the creation of micro-bioeconomies, which would diversify and strengthen the national bioeconomy. Implementing a bottom-up approach allows regions to tailor their strategies to local strengths, like existing industries, academic institutions, or workforce capacities, while aligning with broader federal priorities. This could involve reskilling and redeploying existing manufacturing capacity into biomanufacturing, leveraging local resources, talent, and infrastructure. These efforts would not only support economic growth and job creation at the regional level, but also enhance national resilience by decentralizing production and fostering innovation across the nation.

To support this regional strategy, the federal government must provide a comprehensive national framework based on clear goals and achievable metrics. For instance, a target such as increasing the production of bio-based products by 50% by 2050 for domestic consumption could help coordinate efforts across various agencies and set a clear path for growth. Furthermore, the federal government should focus on providing the necessary infrastructure for biotechnology and biomanufacturing development, not only physical infrastructure, such as processing facilities and biomanufacturing plants, but also intangible infrastructure like workforce development, talent enhancement, financial mechanisms, and intellectual property creation. The Trump administration could also lead in advancing bio-based material production and green chemical production through novel biotechnologies. These efforts would not only benefit American consumers by providing sustainable alternatives to essential products but would also strengthen national security and defense positions.
The Trump administration presents significant opportunities to advance the bioeconomy, but it must also carefully navigate the wide-ranging activities the sector encompasses. Policy changes, particularly cuts to funding for scientific research and development, could have unintended consequences that hinder progress. While some repealed executive orders may not have directly affected the sector, reductions in funding for science and education are likely to create ripple effects, such as a shortage of trained workers or disruptions in the supply chain, which could trigger cascading negative impacts. Therefore, thoughtful and strategic decision-making is crucial to ensuring the bioeconomy reaches its full potential.

While the U.S. has made significant advancements and remained a global leader in biotechnology over the past decade, the next four years will be critical in determining whether it can sustain that leadership. According to the National Security Commission on Emerging Biotechnology, China has prioritized biotechnology and, by extension, the bioeconomy for the past 20 years and is rapidly advancing toward dominance in the field unless the U.S. takes decisive action. Meanwhile, the Netherlands recently announced an investment of approximately €1.3 billion to expand its biotechnology sector, with the goal of becoming a global leader by 2040. This growing international investment signals rising global competition, and the U.S. must strengthen its bioeconomy to stay ahead. The Trump administration  does not need to start from scratch; it can build on the accomplishments of its first term and the progress made since.

The Emerging Reach of the Bioeconomy

On Tuesday, 4/8/25, the bipartisan National Security Commission on Emerging Biotechnology (NSCEB) released their findings on how the U.S. can support and bolster the emerging bioeconomy sector. This sector, which includes biotechnology and biomanufacturing, is increasingly important to scientists working across disciplines – and will continue to shape the economic fortunes of regions across the country. 

FAS looks forward to dissecting, advancing, and advocating for the Commission’s report. FAS has been active and influential in this sector and has worked with various stakeholders and experts to advance evidence-based policy recommendations to boost the U.S. bioeconomy (more below). While the report provides an essential starting point to grow and secure our biotechnology and biomanufacturing enterprise, it will be important to advocate for the recommendations found within it, but also to add and refine recommendations to meet the ever evolving U.S. bioeconomy. 

FAS is especially enthusiastic about the recommendations that emphasize prioritizing and advancing biotechnology at the national level, ensuring the U.S. maintains its innovation edge. We also strongly support the recommendations aimed at scaling biotechnologies and biomanufacturing by fostering private sector growth and leveraging various financial mechanisms. These recommendations are crucial in addressing some of the most urgent challenges facing the U.S. bioeconomy and will serve as a vital step toward establishing a dynamic and adaptable national strategy for the sector. See our policy statement for more details.

Cautious and Enthusiastic Interest

While FAS is optimistic of the impact that this report can have, it is also important for FAS to be cautious around national security issues due to our 80 year old legacy. FAS began in response to how new technologies (nuclear) could be used for war (nuclear weapons). Today we remain watchful of technologies with the potential of misuse. FAS team members involved with national security take an understandably cautionary approach. The confluence of technology and access mean that there is risk associated with bio-products, too. “This opportunity must also be balanced with a clear-eyed understanding that increasing economic competition, heating geopolitics, and advancing life sciences capabilities may change how countries and other actors view the utility of globally repugnant capabilities such as biological weapons.” said Yong-Bee Lim, Associate Director of Global Risk at the Federation of American Scientists.

The report details the importance of safeguarding the biotechnology and biomanufacturing enterprise to remain competitive at the global scale, especially with China (recall the recent semiconductor shortages). However, “it’ll be important to balance both innovation capabilities and risk as we work towards ensuring that the U.S. bioeconomy is a priority area for both the Nation and for National Security.” said Nazish Jeffery, Bioeconomy Policy Manager at the Federation of American Scientists.

Bioeconomy Presents Significant Opportunities

Still, FAS continues advocating and promoting this area with great enthusiasm. The nascent bioeconomy is more than just leading edge biology meets computational gains. There are a myriad of scientific, economic, and social benefits to be had by leveraging this new industry.

No one at FAS knows this better than Nazish Jeffery, who spearheaded efforts to understand this moment. For more than two years she has worked with biologists, technologists, policymakers and biotechnology companies to investigate how the U.S. can maintain competitiveness while distributing economic rewards equitably domestically.

FAS sponsored policy sprints, which are open calls for participants in academia and industry to submit and develop actionable policy memos that address a particular issue or sector. The goal is to infuse diverse perspectives and expertise into policy that improves lives for all Americans. Since the start of the Commission’s investigations, FAS has sponsored policy sprints on topics such as the intersection of biology and artificial intelligence, as well as a sprint soliciting ideas to grow the bioeconomy sector itself. 

This emerging technology sector brought in $210 billion into the U.S. economy in 2023, and is projected to grow to $400 billion by 2030. The economic potential of the bioeconomy is significant; policymakers should promote and work in partnership with industry to continue development in distributed regions across the U.S. to invigorate innovation and enable job creation. This opportunity must also be balanced with a clear-eyed understanding that increasing economic competition, heating geopolitics, and advancing life sciences capabilities may change how countries and other actors view the utility of globally repugnant capabilities such as biological weapons.

FAS interviewed, worked with, or sought input from numerous academics, technologists, bio-industry leaders, elected representatives, and organizations, to understand the full spectrum of the value chain and push forward the best ideas.

FAS invites you to take a look at what possibilities lay ahead, presented below.

Bioeconomy Policy Sprint

The FAS Bioeconomy Sprint produced actionable policy memos to strengthen the bioeconomy in concert with outside expertise, including:

Bioeconomy x AI Policy Sprint

Artificial intelligence continues to develop exponentially; these recommendations can scale alongside AI and deliver substantial benefits:

Additional Bioeconomy Research

Given the ongoing cost curve declines of compute, increased access to data, and growing interest in this emerging sector, FAS continues to investigate a range of related topics. Some recent work includes:

FAS will continue to work in this important area. Ongoing work related to the U.S. bioeconomy will be regularly updated here: https://fas.org/initiative/bioeconomy/

Position on National Security Commission on Emerging Biotechnology Final Report: Charting the Future of Biotechnology

The Federation of American Scientists supports the National Security Commission on Emerging Biotechnology’s Final Report and the Recommendations contained within it.

Charting the Future of Biotechnology delivers 49 recommendations to foster the growth of the biotechnology and biomanufacturing sector within the U.S. bioeconomy. Implementing the recommendations outlined in this report will strengthen the U.S. bioeconomy by establishing a unified national strategy that fosters innovation in biotechnology, ensures our continued global competitiveness, and delivers significant economic and societal benefits to the nation.

FAS is particularly excited by these recommendations:

These recommendations have the potential to address key challenges within the U.S. bioeconomy, including the lack of a coordinated strategy, commercialization barriers, workforce shortages, and supply chain vulnerabilities.

“FAS applauds the NSCEB’s deep investigation of unlocking U.S.-led biotechnology in the Fourth Industrial Revolution. We look forward to bringing FAS’s unique and effective approach of policy entrepreneurship to realize the promise of these capabilities while reducing the risks of misuse,” said Yong-Bee Lim, Associate Director of Global Risk at the Federation of American Scientists.

“The National Commission on Emerging Biotechnology report developed 50 recommendations to address the major challenges currently facing the U.S. bioeconomy: a lack of strategy and coordination across the federal government, difficulties in scaling biotechnology innovations, and the need for a trained workforce for the future. These recommendations aim to de-risk the biotechnology sector, thereby enabling private sector investment in critical biotechnology and biomanufacturing initiatives. Ultimately, these efforts will foster continued growth, secure the U.S. bioeconomy, and lead to the creation of new jobs and further economic growth.”” said Nazish Jeffery, Bioeconomy Policy Manager at the Federation of American Scientists. “It will be important to continue advocating, refining, and adding additional recommendations in order to realize the full value that this report offers.”

For more information contact Nazish Jeffery, FAS Bioeconomy Policy Manager, njeffery@fas.org.

Understanding the U.S. Bioeconomy: Agency Perspectives

The U.S. bioeconomy—defined by the National Institute of Standards and Technology (NIST) as “economic activity derived from the life sciences, particularly in the areas of biotechnology and biomanufacturing, including industries, products, services, and the workforce” and valued by some at ~$1 trillion—has been a major focus of policy development over the past few years. These policy advances include the White House Executive Order on “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy” (Bioeconomy EO), the CHIPS & Science Act, and the Inflation Reduction Act (IRA). In March 2024, the Office of Science and Technology Policy (OSTP), announced the launch of the National Bioeconomy Board (NBB). The board will “partner across the public and private sectors to advance societal well-being, national security, sustainability, economic productivity, and competitiveness through biotechnology and biomanufacturing,” highlighting the Biden Administration’s commitment to future-proofing an economically sustainable U.S. bioeconomy. 

Despite these advances, the vast intersectionality inherent to the bioeconomy (e.g., with health, clean energy, national security, climate change, economic development) poses unique challenges for the U.S. government. This complexity makes it difficult for the various agencies to coordinate and even more difficult for the general public to understand the government’s approach to the bioeconomy. Nonetheless, to maintain the continued growth within the bioeconomy that has resulted from these policy advances, it will be imperative to clarify a strategic vision that coordinates and publicizes governmental efforts that support the burgeoning U.S. bioeconomy.

The NBB can play an important role in promoting this strategic vision. As directed by the Bioeconomy EO, the interagency through the Executive Office of the President set up the NBB to promote interagency coordination and collaboration on the bioeconomy. The NBB is co-chaired by OSTP, the Department of Commerce (DOC), and the Department of Defense (DOD), and nine other agencies make up the entirety of the board. Other agencies not represented on the NBB itself, including the Environmental Protection Agency (EPA), work with the NBB through various working groups and play an integral role. 

To understand the range of governmental priorities for the bioeconomy, the overarching strategy, the work underway, the various programs within the agencies, and the role of environmental sustainability, our team at the Federation of American Scientists (FAS) spoke with key agencies represented on the NBB to collect their perspectives.

The perspectives summarized below demonstrate that the agencies align bioeconomy-related initiatives to their varied mission areas and, through the NBB and other interagency activities, are working together to develop a shared vision. However, the summaries also show the diversity in focus that informs how agencies approach the bioeconomy. The agency views encompass the broader bioeconomy landscape, including biotechnologies from commodity fuels and agriculture to individualized therapeutics, and biomanufacturing solutions from biomass production to final product. This range highlights both the important role that each agency plays in supporting the U.S. bioeconomy as well as the challenge in coordinating their activities and programs across the federal government.

Approach

In order to collect perspectives from the agencies represented on the NBB around the U.S. bioeconomy, FAS conducted semi-structured interviews with key NBB officials from the OSTP, DOC, DOD, Department of Energy (DOE), Department of Health and Human Services (HHS), and the U.S. Department of Agriculture (USDA) from May 2024 through June 2024. With the exception of USDA, all agency interviews were conducted over Zoom and answers were documented by note-taking. All summaries have been reviewed by agency representatives to confirm consent and validity. The USDA perspective was summarized using publicly available reports and have also been confirmed for validity by an agency representative.

Perspectives from these agencies on the Bioeconomy EO deliverables, bioeconomy-related programs, coordination, goals, hurdles, and the role of environmental sustainability are summarized below. The full list of questions used in the semi-structured interviews can be found in Appendix A.

Agency Perspectives

Office of Science & Technology Policy

For OSTP’s perspective, FAS conducted a semi-structured interview with Dr. Sarah Glaven, principal assistant director for biotechnology and biomanufacturing.

The Office of Science & Technology Policy plays an important role in interagency coordination for topics, like the bioeconomy, that cut across many different agencies, and is one of the co-chairs for the NBB. In adherence with the Bioeconomy EO, OSTP has coordinated interagency efforts and published several reports on the bioeconomy: Bold Goals for U.S. Biotechnology and Biomanufacturing, Building the Bioworkforce of the Future, and Visions, Needs & Proposed Actions for Data for the Bioeconomy Initiative. They are currently working with interagency groups on several activities, including one that recently published a report, in conjunction with USDA and other agencies, that recommended revisions to the North American Industry Classification System (NAICS) and the North American Product Classification System (NAPCS) to better capture economic activity related to the bioeconomy. The creation of the NBB itself fulfills directives from both the Bioeconomy EO as well as the CHIPS & Science Act, which called on OSTP to establish a coordination office on these topics. Currently, due to a lack of funding, OSTP is not an official coordinating office but will function to coordinate activities through the NBB. 

According to OSTP, the Bioeconomy EO reflects the whole-of-government approach that will be needed to support the bioeconomy. For the near term, OSTP plans to show the value and utility of the NBB, execute policy from the Bioeconomy EO, prioritize specific actions from the resulting Bioeconomy EO reports, highlight significant investments, and produce a report on the NAICS and NAPCS codes. In the long term, OSTP hopes that the NBB will become a sustainable government entity that drives a clear national strategy to move the bioeconomy forward and enables the United States to work collaboratively with global partners. 

A key challenge is measuring the bioeconomy. It is difficult to prioritize, strategize, or advocate for additional resources in the absence of baseline economic metrics to track impact or estimate the potential return on investment. Ultimately, OSTP believes it is important to clarify the definition of the bioeconomy in order to create measurements and classifications.

A challenge for OSTP is continuity as it experiences staff turnover and administration changes. However, the NBB and coordination of the bioeconomy portfolio will be well positioned to persist, in part by relying on the NBB’s co-chairs. Also, the Bioeconomy EO allowed OSTP to create principal and assistant director positions for the bioeconomy portfolio, which can help ensure that it remains a high priority. At OSTP, this portfolio sits within the Industrial Innovation Group, which also houses coordination efforts for semiconductors and clean energy. OSTP leadership understands the importance of the bioeconomy and is keen to see the intersections of biomanufacturing with other initiatives, like the DOE’s Earth Shot programs and other clean energy initiatives. 

On the issue of environmental sustainability and the bioeconomy, OSTP highlights efforts by DOE to push for sustainable aviation fuels and USDA’s sustainable biomass supply chain framework as initiatives that are setting the pace for sustainability. There is also an opportunity to consider how biomanufacturing and biosynthesis fit into the broader sustainable chemistry landscape.

Department of Commerce

For DOC’s perspective, FAS conducted a semi-structured interview with Dr. Christopher Szakal, acting director, program coordination office at the National Institute of Standards and Technology.

The Department of Commerce is one of the NBB co-chairs. DOC is sector-agnostic and is interested in the bioeconomy as a way to support the broader economy, remain competitive, and solve broader challenges, such as those related to supply chain resilience. In response to the Bioeconomy EO, the DOC has released the bioeconomy lexicon from NIST and the Feasibility Study for measuring the bioeconomy from the Bureau of Economic Analysis. It has also participated in several interagency activities, including development of OSTP’s Bold Goals report and USDA’s Biomass Supply Chain report, as well as ongoing working groups focusing on updating systems for measuring economic activities (e.g., the NAICS and NAPCS codes) and on biological data and cybersecurity. Separate from the executive order, the Inflation Reduction Act provided significant investments for the Economic Development Administration in biotechnology-related regional technology hubs. Other ongoing activities at DOC in support of the bioeconomy include efforts to support biotechnology and biomanufacturing standards development at NIST, supply chain analyses at the International Trade Administration, work at the Bureau of Industry and Security and at the Patent and Trademark Office to ensure a safe and fair market, and the Workforce Development Strategy.

By nature, DOC keeps a broad perspective and tries to understand how the bioeconomy intersects with other parts of the economy and how technological developments may impact progress. There are important intersections of the bioeconomy with artificial intelligence (AI) and with data security, and policy development in these other areas will have implications for the bioeconomy. For example, the October 2023 Executive Order on AI called for significant new requirements for providers of synthetic nucleic acids to conduct biosecurity screening, which will have implications for biotechnology and biomanufacturing. NIST is tasked with developing standards for this new policy. The intersectional nature of the bioeconomy requires coordination both within the DOC and across the U.S. government. A key challenge is the need for sustained funding because coordination requires time and effort. 

On environmental sustainability, the DOC prioritizes the market and what U.S. companies will find profitable in both the near term and the long term. Elevating sustainability has been challenging because there is uncertainty in how sustainability is measured. Additionally, market drivers have been inconsistent relative to the level needed to address the uncertainty. DOC is looking to utilize the NBB to help provide clarity on how to achieve more consistent market forces in support of sustainability to drive growth of the bioeconomy. 

Department of Defense

For DOD’s perspective, FAS conducted a semi-structured interview with Dr. Peter Emanuel, senior research scientist, bioengineering at U.S. Army Combat Capabilities Development Command.

The Department of Defense is one of the NBB co-chairs. In September 2022 (before the Bioeconomy EO was announced), DOD announced a $1.2 billion investment in biomanufacturing. In March 2023, DOD released a Biomanufacturing Strategy, which was informed by both the National Defense Authorization Act for Fiscal Year 2023 and the Bioeconomy EO. In support of this strategy and the investments made by DOD, the Department’s Defense Production Act Investments (DPAI) Office published an open Request for Information that sought input from industry on biomanufactured products and process capabilities that could help address defense needs. Significant additional investments in biomanufacturing are likely to be forthcoming.

The bioeconomy portfolio is a tiny portion of the overall programmatic budget for DOD. Previously, the DOD’s interest in biology and biotechnology was limited to military medicine and chemical and biological defense, but the department is increasingly focused on nonmedical biomanufacturing applications and believes that they will be key for ensuring national security. The department also acknowledges the importance of workforce development and the need for standardization and infrastructure for the bioeconomy and strongly supports these areas. This commitment can be seen with DOD’s large investments in 2020 in BioMADE, a Manufacturing Innovation Institute focused on creating a sustainable, domestic end-to-end bioindustrial manufacturing ecosystem. 

In the future, DOD hopes to take advantage of biomanufacturing’s potential to support defense objectives beyond just medical countermeasures and other human health-related advances, such as production of bio-based materials, chemicals, and foods. However, DOD faces challenges both internally and externally in communicating the full potential of the bioeconomy and biomanufacturing for DOD. 

On environmental sustainability, DOD believes that economic and environmental sustainability for the bioeconomy go hand-in-hand. For example, a company that could make chemicals without waste would have a significant economic advantage and would support environmental sustainability. Historically, DOD has seen significant costs due to polluted sites, and so understands the value of cleaner products and processes. In addition, DOD is investing in different technologies that would valorize waste streams.

Department of Energy

For DOE’s perspective, FAS conducted a semi-structured interview with Dr. Valerie Reed, director, Bioenergy Technologies Office.

The Department of Energy has many goals for advancing the bioeconomy, with the common denominator being to decarbonize America’s transportation and fuel sectors and to build resilient clean energy for generations to come. In response to the Bioeconomy EO, the DOE contributed to the OSTP Bold Goals report and was tasked to work with other agencies to write reports on National Security Recommendations for Federal Procurement (forthcoming) and best practices for cyber security documentation. Furthermore, DOE also played a large role in an upcoming biotechnology and biomanufacturing report mandated by the Bioeconomy EO. Outside of the direct requirements from the EO, the DOE plays a crucial role in supporting industrial biotechnology through additional reports and their involvement in ongoing interagency activities. For example, the Billion Ton Report provides a comprehensive assessment of biomass availability today and how to sustainably produce more than one billion tons of biomass per year to meet the demand for sustainable aviation fuel production. 

DOE’s bioeconomy efforts are concentrated within the Bioenergy Technologies Office (BETO) and the Office of Science. BETO aims to utilize biomass for sustainable and renewable fuel and chemical production, while the Office of Science supports fundamental research that enables the bioeconomy, including synthetic biology and thermochemical conversion. Under the Inflation Reduction Act and CHIPS & Science Act, significant support was given to bioenergy solutions and clean energy demonstrations, including DOE tax incentives aimed at carbon reduction in fuel production.

In the short term, DOE is focused on prioritizing the use of biomass for Sustainable Aviation Fuel (SAF) and marine fuel production, as well as supporting renewable diesel and ethanol for medium- and heavy-duty vehicles. Long-term goals include transitioning to electrification using biomass, achieving substantial SAF production by 2035 through the SAF Grand Challenge, and scaling up the production of specific chemicals by 2035 as part of the industrial decarbonization strategy. Additionally, in coordination with the USDA, there are focused efforts to increase cultivation of purpose-grown energy crops.

One of the major hurdles the DOE currently faces, and may continue to face in the future, is ensuring sustained funding levels that support ongoing development. Currently, biomass is seen as an expensive feedstock. While the IRA provided an initial policy bridge, it is essential to establish a longer-term incentive to meet market demand, like the 40B (SAF production) and 45Z (clean fuel production) tax credits. 

On environmental sustainability, the DOE is very focused on goals for decarbonization of transportation and fuels, including replacing petroleum-based products with sustainable biomass solutions and conducting life cycle assessments (LCAs) to measure sustainability impacts throughout the supply chain. DOE created the GREET Model for LCAs, which was updated recently, to reduce ambiguity and to help standardize the process for measuring carbon emissions. Additionally, DOE’s Clean Fuels and Products Earthshot is an important cross-agency collaboration that supports accelerating bio-based fuels and chemicals production and decarbonizing both the fuel and chemical industry.

Department of Health & Human Services

For HHS’s perspective, FAS conducted a semi-structured interview with Dr. Lyric Jorgenson, associate director for science policy and the director of the Office of Science Policy at the National Institutes of Health (NIH), and Dr. Julia Limage, director, Office of Strategy, Policy, and Requirements in the Administration for Strategic Preparedness and Response (ASPR).

The Department of Health & Human Services has two representatives on the NBB, one from NIH and one from ASPR. HHS has a broad mission in support of human health, and many of its programs could be considered part of the bioeconomy. However, the Bioeconomy EO outlined a set of priorities that called for additional focus at HHS on advances specific to biotechnology and biomanufacturing, many of which were included in the OSTP Bold Goals report. The EO also tasked HHS with leading the establishment of a Biosafety and Biosecurity Innovation Initiative; a strategic plan for this initiative will be available soon. Another area of intersection of HHS and the Bioeconomy EO is on the regulatory side: the Food and Drug Administration worked with USDA and EPA to provide updates on the regulatory system as deliverables for the EO. Many of the activities related to the EO draw on interagency working groups and other ongoing activities—for example, the work toward pandemic preparedness and biodefense, as well as collaborations between NIH and NSF on health-relevant research.

In the near future, HHS will focus on advancing biotechnologies such as multi-omic medicine, gene editing, and other therapeutics tailored to individual patients. Biomanufacturing and scale-up is another key focus to increase speed and availability of key medicines. In regards to public health, the COVID pandemic highlighted the need for fast and secure biomanufacturing for vaccine production. The Biomedical Advanced Research and Development Authority (BARDA) in ASPR has made significant investments in biomanufacturing for this reason. ASPR also has an Office of Industrial Base Management and Supply Chain to support domestic biomanufacturing in case of public health emergencies.

For HHS, activities related to the bioeconomy directly and unambiguously support the department’s mission and will continue to be prioritized. A key challenge for HHS is the need for sustained funding, especially for coordination, which requires time and effort above and beyond programmatic work. To be effective, activities initiated by the Bioeconomy EO will need to be funded. Some HHS activities, including some related to biomanufacturing of medical countermeasures, were funded with COVID supplemental funding that will soon run out.

On environmental sustainability, HHS has not had any significant focus. However, there have been efforts to decrease the use of single-use plastics and equipment in research and public health activities.

United States Department of Agriculture

For USDA’s perspective, FAS gathered information from publicly available reports and documents, with guidance and direction from Herrick Fox, USDA’s bioeconomy coordinator in the Office of the Chief Economist, and Greg Jaffe, senior advisor in the Office of the Secretary.

The Bioeconomy EO tasked USDA with a wide range of deliverables, and USDA has released many related reports and products that reflect its bioeconomy-related priorities. One set of deliverables focuses on biomass and feedstocks, and supports the strategic vision outlined for agriculture in OSTP’s Bold Goals report. This includes the report on Building a Resilient Biomass Supply—A Plan to Enable the Bioeconomy in America, along with an Implementation Framework. USDA also has a long-standing focus on bio-based products, including support of the BioPreferred Program, a program created by the 2002 Farm Bill to increase the purchase of bio-based products and reauthorized in the 2018 Farm Bill. Their recent Economic Impact Analysis of the U.S. Biobased Products Industry report summarizes the status of bio-based products, an important component of the bioeconomy.

USDA also plays a central role in regulating biotechnology products, and the Bioeconomy EO called for updates to the regulatory system. In response, USDA (along with the FDA and the EPA) conducted stakeholder outreach, which is summarized in a report on Ambiguities, Gaps, and Uncertainties in Regulation of Biotechnology Under the Coordinated Framework. USDA also released a Plan for Regulatory Reform under the Coordinated Framework for the Regulation of Biotechnology and produced an updated Coordinated Framework website. Activities to improve coordination across the three major regulatory agencies are ongoing.

Unlike most federal departments and agencies, most programs and activities at USDA have a link with the life sciences, including those that support food and fiber, forests and grasslands, and other natural resources, as well as the manufacturing of numerous bio-based products and biofuels from these resources and the R&D and infrastructure that supports it. From USDA’s perspective, the department has served the bioeconomy since its founding in 1862. This broad focus provides many opportunities for strategic partnerships with other parts of the U.S. government working on the bioeconomy, and there are many different ways that USDA can contribute to the NBB.

On environmental sustainability, USDA has demonstrated its commitment to developing a circular bioeconomy, which is reflected in its Biomass Plan, and in its support for bio-based products and sustainable agriculture initiatives.

Conclusion

The agencies that make up the NBB highlight the complex nature of the U.S. bioeconomy and the various sectors that fall under it. Nevertheless, despite this complexity, the NBB is providing a whole-of-government approach to enable agencies to better support the burgeoning U.S. bioeconomy. The work underway is underpinned by the agencies’ priorities and programmatic expertise, but comes together to build the foundational base needed to support and grow the U.S. bioeconomy. Each agency also has a focus on environmental sustainability, with some, like DOE, DOD, and USDA, having a stronger focus due to their direct connections with the environment. Finally, agencies also agree on the need for more data on the bioeconomy’s impact as the different sectors evolve and the need for sustained funding to promote coordination, which takes time and effort beyond just programmatic work.

Appendix A. Interview Questions

  1. In response to the September 2022 Bioeconomy EO, your agency has produced some reports and other deliverables on the bioeconomy.
    • Are we missing any deliverables? Are there any other reports or activities that are already completed or still to come in response to the EO?
  1. Are there programs or other deliverables relevant to the bioeconomy that your agency has pursued under the Inflation Reduction Act or the CHIPS & Science Act?
  1. Are there other activities within your agency that you believe support the bioeconomy? Is the bioeconomy broader than what was captured by the EO and these other efforts?
  1. What does your agency hope to achieve in the foreseeable future and in the more distant future regarding the U.S. bioeconomy?
    • Are these goals related to the OSTP Bold Goals Report or other deliverables for the Bioeconomy EO?
    • To what extent will this progress be prioritized within your agency? How central to your agency is progress in the bioeconomy – now and into the future?
  1. What are the major hurdles your agency currently faces or may face in the future in reaching these goals?
  1. How does your agency tackle the issue of creating an environmentally sustainable bioeconomy and/or a circular bioeconomy?
    • Are there any initiatives in place currently or coming up in the near future that speak towards this?

The Importance of Standards for the U.S. Bioeconomy & National Security: A Conversation with Congressman Jake Auchincloss

The U.S. bioeconomy, the sector of the economy that is touched by biology, is valued at ~$1 trillion and predicted to grow to over $30 trillion in the next two decades. With such enormous potential, ensuring the U.S. bioeconomy’s continued economic growth and global leadership has become a matter of importance for national security. Despite this massive potential, the U.S. bioeconomy, and specifically the biomanufacturing industry, is currently limited by the lack of standards in place for the sector. 

The need for standards within the biomanufacturing sector has been discussed at length by experts, and the U.S. government has acknowledged and prioritized the establishment of standards by creating a National Standards Strategy for Critical and Emerging Technologies. Both the CHIPS & Science Act of 2022, and the Visions, Needs, and Proposed Actions for the Data for the Bioeconomy Initiative (2023), highlight the need for standardization as critical to the advancement of our domestic biomanufacturing sector. Furthermore, the National Security Commission on Emerging Biotechnology (NSCEB), a commission tasked with reviewing advancements in biotechnology and its nexus with national security, stated in their interim report the importance of creating standards for this sector as a matter of national security.

Most recently, The Select Committee on Strategic Competition between the United States and the Chinese Community Party (Select Committee on the CCP), held a hearing, “Growing Stakes: The Bioeconomy and American National Security”, that focused on the threats posed by adversaries in the industry. During the hearing, Congressman Jake Auchincloss (D-MA, 4th District), entered into the record a bipartisan letter that contained recommendations around developing and implementing standards for the bioeconomy that urged action from the National Institute of Standards and Technology (NIST). 

To get a better understanding of how Congress and the Select Committee on the CCP view the need for standards for the bioeconomy, FAS interviewed Congressman Jake Auchincloss.

FAS: In your opinion, why does creating standards for biotechnology and biomanufacturing boost economic competitiveness and national security? What benefits does this pose for different regions across the nation?

Congressman Auchincloss: Standards are important in every industry to solve coordination and collective action problems, and the government plays a critical role in establishing them so that markets can work more effectively. Standards provide concrete benchmarks for individuals and companies within American industry, all of whom need a stable environment to make long-term investments. This sentiment is echoed in the National Security Commission on Emerging Biotechnology’s interim report which has noted that “biomanufacturing faces barriers to innovation because of…lack of standardization.” 

With standardization, more time can be spent innovating, researching, and building instead of compensating for uncertainty due to a lack of definitions that carry the weight of the federal government. Establishing standards will only increase productivity. As I stated in the letter I entered into the record during the Select Committee on the CCP’s hearing around the bioeconomy, “standardization will help advance industrial biomanufacturing, create a more resilient and dynamic supply chain, and establish a durable, competitive U.S. bioeconomy. In turn, strengthening the U.S. bioeconomy will improve Americans’ well-being, promote well-paying jobs, and create a competitive and advantageous U.S. science and technology enterprise to achieve our national and societal goals.”

What is the role of international collaboration in creating standards for biotechnology and biomanufacturing in light of increased tensions with China?

International collaboration is critical to the success of biotechnology, but we must ensure we are working with reliable and responsible partners. For the U.S. to remain a leader in the bioeconomy, the U.S. must ensure its domestic standards become the international benchmark. 

As we standardize the bioeconomy, we must also set standards for ethical intent and conduct. As such, there are some companies whose loyalty does not side with responsible science. We shouldn’t partner with companies like BGI, whose technologies have clear ties to the CCP’s repression and ongoing ethnic cleansing of its Uyghur communities. The increased tensions are a direct result of President Xi Jinping’s disregard for human rights, and excluding the CCP from projects that could be weaponized against their own people is the correct response.

Where does the U.S. bioeconomy stand in comparison with China or other countries?

China isn’t currently ahead but they are neck-and-neck with the U.S. because of the rate at which they are investing in their domestic bioeconomy. That’s already showing up in their patent and publication volume. The CCP’s R&D investment in biotechnology increased from $26 million USD in 1986 to $99 million USD in 2005. From 2008 to 2020, their investments increased to $3.8 billion USD. China’s spending on research and development overall climbed 10.3 percent to 2.44 trillion Chinese yuan ($378 billion USD) in 2020, according to the nation’s National Bureau of Statistics. Further, according to the health care information company IQVIA, China was the world’s second-largest national biopharmaceutical market in 2017, worth $122.6 billion USD. 

Via Rhodium Group

The 117th Congress and Biden Administration edged science and technology funding upwards, but Republicans have proposed slashing federal R&D funding. We are moving in the wrong direction with this self-defeating approach. Congress must prioritize basic science: the curiosity-driven, peer-reviewed research that the private sector won’t fund and the public sector under-funds. We can start by expanding NIH funding and fully appropriating the $170 billion Science portion of the Chips and Science law that was authorized throughout the next ten years.

NIST has been directed to create standards and metrology for the U.S. bioeconomy through the FY24 appropriation bills, the FY25 Presidential Budget, the Bioeconomy EO, and from the letter that you submitted into the record during the hearing “Growing Stakes: The Bioeconomy & American Security.” Given all these priorities, what needs to happen in order for NIST to fulfill their directives for the bioeconomy?

There needs to be continued pressure applied to ensure NIST is prioritizing this important work. Congress can further support NIST by appropriating more funding for them to achieve the work laid out in front of them, as I have advocated during the current appropriations process.

The recent AI EO also directs NIST with many different tasks. Is the AI EO overtasking NIST and making bioeconomy related efforts an afterthought for them?

The AI EO can be implemented simultaneously with standardization efforts, if NIST is appropriately resourced. But those who think that AI is more important than biotech are wrong, and should not point NIST in that direction. Care should be taken not to duplicate work unnecessarily, but all of these tasks assigned to NIST will take time and labor. Again, NIST needs to be adequately funded to do all the work it is being asked to do.

In the letter, you suggest NIST collaborate with Manufacturing USA institutes, NIIMBL & BioMADE. However, in the Department of Commerce’s FY25 budget request, they ask for $37M for the Manufacturing USA program, the same amount that they have received since FY23. Should Congress prioritize and raise funding levels for programs like Manufacturing USA and why would this be important for ensuring a competitive edge for the U.S. bioeconomy?

Absolutely. Many federal R&D programs are continuously underfunded, even as they are tasked with more responsibilities. The programs we fund reflect our priorities. We need to be prioritizing science, technology, and centers of excellence for manufacturing to gain that competitive edge. Increasing funding would give these agencies and programs the resources they need to set standards and increase R&D. That’s why I sent a letter to the House Committee on Appropriations asking for a 10 percent increase above FY24 enacted funding levels for NIST, Manufacturing USA, and the Manufacturing Extension Partnership.

Lastly, in your opinion, what potential does the U.S. bioeconomy have that we are not capitalizing on and what would you like to see occur for the U.S. bioeconomy in the next year.

I would like to see standardization, or at least the beginning of standardization, within the next year. With standardization for industrial biomanufacturing in place, the U.S. bioeconomy will be able to reach new heights and enable our talented citizens to delve deeper into their research without being hindered by the lack of baseline definitions. Fully appropriating the $170 billion that was authorized for the Science portion of CHIPS and Science would be the step in the right direction to maintain U.S. innovation and competitiveness in biotechnology and biomanufacturing. Furthermore, we need state capacity and funding for R&D; which includes the staffing and programming for regulation and standardization and also the funding for peer-reviewed basic research. Finally, we need to expand the productive capacity of the bioeconomy through workforce development compacts that bring together employers, educators, and trade associations together; through skilled immigration pathways; and through technology-agnostic tax credits that are transferable for R&D and biomanufacturing. In the next year, I am working towards legislation that advances all of these different components to strengthen and secure the U.S. bioeconomy.

The Federation of American Scientists values diversity of thought and believes that a range of perspectives — informed by evidence — is essential for discourse on scientific and societal issues. Contributors allow us to foster a broader and more inclusive conversation. We encourage constructive discussion around the topics we care about.

The U.S. Bioeconomy needs biomass, but what is it and how do we use it?

In the quest for sustainable energy and materials, biomass emerges as a key player, bridging the gap between the energy sector and the burgeoning U.S. and regional bioeconomies (microbioeconomies). Despite often being pigeonholed as fuel for energy production, biomass holds far-reaching potential that extends beyond combustion. Identifying sustainable biomass feedstocks that are easily accessible and consistent in their makeup could be a game-changer to help regions unlock their bioeconomy potential and support scientific innovations toward more environmentally sustainable materials and chemicals.

Biomass is defined as “any organic matter that is available on a renewable or recurring basis, including agricultural crops and trees, wood and wood residues, plants, algae, grasses, animal manure, municipal residues, and other residue materials” by the Foundation for Food & Agriculture Research (FFAR). Biomass has mainly been viewed by the public as a source of energy through burning or for chemical conversion into biofuels, encouraged by federal incentive programs, including those from the United States Department of Agriculture (USDA) and the Department of Energy (DOE). However, aside from burning or conversion for biofuel, biomass can undergo a complex process of chemical or biological breakdown and be transformed into various building block components that can be used for a wide range of biotechnology applications.

Once the biomass is broken down into its functional components it can be used as a feedstock, which is a “resource used as the basis for manufacturing another product. [Often], . . . a source of carbon to produce an array of chemicals.” For example, lignocellulosic biomass, plant or plant-based materials not used for food, can be hydrolyzed into sugars, which serve as precursors for bio-based chemicals and materials. This allows for new, environmentally sustainable chemicals for use in biotechnology and biomanufacturing applications, thus positioning biomass as a cornerstone resource of the U.S. bioeconomy. In addition to biochemical production, biomass, and feedstock are used in the bioeconomy in bioplastics and biomaterials. To push the U.S. bioeconomy toward environmental sustainability, it is critical to begin building programmatic and physical infrastructure to harness biomass, which is ultimately converted into feedstock using biotechnology applications and used in the biomanufacturing process to create everyday materials for the public.

Not All Biomass is Used for Energy, or Sustainably Produced

While biomass holds promise as a renewable energy source, not all biomass is used for energy, and not all of it is sustainable. Corn is a consistent poster child of the biomass and biofuel industry as a sustainable way to power combustion engines. Yet, the growth of corn relies heavily on the extensive use of fertilizers and pesticides, which can lead to soil erosion, water pollution, and habitat degradation. Depending on how a company conducts its Life Cycle Assessment and Carbon Intensity of its supplies, corn may not truly represent an environmentally sustainable biomass solution.

However, it is tough to beat the productivity of corn and its ability to be used for various biomass and atmospheric carbon capture applications. For example, corn stover, the byproduct stalks and leaves leftover from harvest, can be broken down into biochar for reuse in soil nutrient replenishment and is excellent for carbon sequestration from the atmosphere. Carbon sequestration is the “storage of carbon dioxide (CO2) after it is captured from industrial facilities and power plants or removed directly from the atmosphere”. One California-based company, Charm, is harvesting the leftover corn leaves, husks, and stalks and breaking them down into bio-oil which is stored deep underground in EPA-regulated wells. This bio-oil now contains sequestered carbon from corn crops and locks it away for thousands of years thus allowing a simple, and effective, way to use farm waste materials as carbon sequestration machines. This corn stover may otherwise have been burned or left to rot, releasing its carbon into the atmosphere.

As the DOE Bioenergy Technology Office puts it:

“Crops can serve as a carbon sink, capturing CO2 from the atmosphere. During CO2 fermentation, some of this recycled CO2 can be harnessed for various applications, such as carbon capture and storage, where it can be compressed or stored underground. The convergence of lower input costs, improvement of ethanol production, and CO2 management showcases a sector poised to contribute to a sustainable and prosperous future.”

Read more

While corn remains the leader of the biomass pack for usage in atmospheric carbon capture, it is necessary to begin broadening the biomass portfolio into other crops, both conventional and not, that can offer similar carbon capture and biomass benefits for industrial energy and feedstock use. The introduction of more sustainable biomass inputs, like waste hulls from almond crops, winter oilseed crops, or macro/microalgae, might be the key to introducing options for industries to use for their biomanufacturing processes. To make the U.S. bioeconomy more environmentally sustainable, it will be necessary to prioritize the use of biomass that is sustainable for the creation of bio-based products. To achieve this, policymakers and industry leaders can come together to understand the physical infrastructure needed to support the processing and utilization of sustainable biomass.

Biomass in Carbon Accounting

A contentious issue in biomass utilization revolves around carbon accounting, particularly concerning the differentiation between biogenic and fossil fuel carbon. Biogenic carbon originates from recently living organisms and is part of the natural carbon cycle, while fossil fuel carbon is derived from the remains of extinct carbon-rich plants and animals that decomposed as they were compressed and heated in the ground. When burned, this fossil fuel carbon is released into the atmosphere, contributing to greenhouse gas emissions. The current carbon accounting frameworks often conflate these distinctions, leading to misconceptions and controversies surrounding biomass utilization’s carbon neutrality claims. Addressing this ambiguity is crucial for aligning policy frameworks with scientific realities and ensuring informed decision-making in biomass utilization. As microbioeconomies grow, any confusion about biogenic versus fossil fuel carbon could become another barrier to entry for burgeoning bioeconomy opportunities.

Environmental and Economic Impacts

All across rural America, local economic developers are seeing more biomass conversion projects come to their communities, which offers the chance to boost economic revenues from turning biomass into energy, fuel, or feedstock and creates a broad spectrum of jobs for the area. To capitalize on this, increased bioliteracy on how growing biomass could offer additional financial support for farmers, provide energy to heat communities, and become feedstock for the biotechnology and biomanufacturing industry is critical. The more we activate and connect parts of America that are not located in existing high-density technology hubs, the better prepared these communities will be when biomass projects look to settle in those places. For example, woody biomass was emphasized throughout the DOE 2023 Billion Ton report as an important biomass source for fuel and energy production, yet the process of getting the timber and woody biomass out of the forest and into processing facilities is slow to launch due to concerns over environmental impacts.

While environmental impacts are valid and of great concern in some ecosystems around the U.S., harvesting wood waste and timber in areas that are primed for increased forest fire risk might be a sustainable option for protecting forest ecosystems while also benefiting the community for energy and heat concerns. The USDA Wildland Fire Mitigation and Management Commission discussed the need for further research into forest biomass to understand how it can generate profit for communities with otherwise waste materials while also mitigating fire risk. One recommendation stated the need for “Increase[d] resources for programs to help private landowners dispose of woody biomass”. Although several programs assist landowners in this effort, there are still significant expenses involved. These costs may discourage landowners from conducting fuel reduction activities, leading them to either burn the material, which can harm air quality, or leave it on the land, potentially worsening wildfire severity in case of an outbreak. There’s a necessity for initiatives supporting the disposal of biomass, including wood chipping, hauling, and its utilization. These initiatives could receive support from USDA Rural Development and should explore ways to encourage landowners to sustainably harvest their woody biomass for both financial incentives and for reducing wildfire risk.

Billion Ton Report Recommendations

According to the 2023 DOE Billion-Ton Report, the U.S. used 342 million tons of biomass for energy and bio-based chemicals in 2022. The top biomass source for biofuels is corn, with the U.S. producing nearly 150 tons per year of corn that is converted to ethanol. Whereas ~140 million tons of forestry/wood and wood waste (woody biomass) are used for heat and power purposes. However, many other types of biomass exist and are used for various purposes including transportation or industrial and electrical power. Below is an abbreviated list, based on the Billion-Ton Report, of common biomass examples and some of their uses.

The recent Billion Ton report makes it clear that the U.S. has plenty of available biomass for use in the production of biofuel, heat/energy, and bio-based products, and that further utilization of biomass in these applications and in biotechnology and biomanufacturing industries could be a way forward to mitigate climate change and improve sustainability of the U.S. bioeconomy. To change the mindset of biomass as more than corn grown for biofuel, it will take a concerted effort by the federal agencies involved in funding biomass use projects, like the DOE, USDA, National Science Foundation, and the Department of Defense, to communicate to farmers that growing biomass can be profitable. It will also take a joint effort from the federal government and local governments to build pilot and commercial scale facilities to begin processing diverse biomass.

Overall, there is immense promise in connecting biomass growers, processors, and bio-powered industries. It allows the players in the U.S. bioeconomy to think critically about their waste outputs and how to harness biomass as the key to unlocking a future where all communities, be they rural or urban, benefit from our national bioeconomy. You can learn more about biomass use in biotechnology and biomanufacturing at our upcoming webinar May 1st at 10 AM ET.

Bold Goals Require Bold Funding Levels. The FY25 Requests for the U.S. Bioeconomy Fall Short

Over the past year, there has been tremendous momentum in policy for the U.S. bioeconomy – the collection of advanced industry sectors, like pharmaceuticals, biomanufacturing, and others, with biology at their core. This momentum began in part with the Bioeconomy Executive Order (EO) and the programs authorized in CHIPS and Science, and continued with the Office of Science and Technology Policy (OSTP) release of the Bold Goals for U.S. Biotechnology and Biomanufacturing (Bold Goals) report. The report highlighted ambitious goals that the Department of Energy (DOE), Department of Commerce (DOC), Human Health Services (HHS), National Science Foundation (NSF), and the Department of Agriculture (USDA) have committed to in order to further the U.S. bioeconomical enterprise.

However, these ambitious goals set by various agencies in the Bold Goals report will also require directed and appropriate funding, and this is where we have been falling short. Multiple bioeconomy-related programs were authorized through the bipartisan CHIPS & Science legislation but have yet to receive anywhere near their funding targets. Underfunding and the resulting lack of capacity has also led to a delay in the tasks under the Bioeconomy EO. In order for the bold goals outlined in the report to be realized, it will be imperative for the U.S. to properly direct and fund the many different endeavors under the U.S. bioeconomy.

Despite this need for funding for the U.S. bioeconomy, the recently-completed FY2024 (FY24) appropriations were modest for some science agencies but abysmal for others, with decreases seen across many different scientific endeavors across agencies. The DOC, and specifically the National Institute of Standards and Technology (NIST), saw massive cuts in funding base program funding, with earmarks swamping core activities in some accounts. 

There remains some hope that the FY2025 (FY25) budget will alleviate some of the cuts that have been seen to science endeavors, and in turn, to programs related to the bioeconomy. But the strictures of the Fiscal Responsibility Act, which contributed to the difficult outcomes in FY24, remain in place for FY25 as well.

Bioeconomy in the FY25 Request

With this difficult context in mind, the Presidential FY25 Budget was released as well as the FY25 budgets for DOE, DOC, HHS, NSF, and USDA. 

The President’s Budget makes strides toward enabling a strong bioeconomy by prioritizing synthetic biology metrology and standards within NIST and by directing OSTP to establish the Initiative Coordination Office to support the National Engineering Biology Research and Development Initiative. However, beyond these two instances, the President’s budget only offers limited progress for the bioeconomy because of mediocre funding levels.

The U.S. bioeconomy has a lot going on, with different agencies prioritizing different areas and programs depending on their jurisdiction. This makes it difficult to properly grasp all the activity that is ongoing (but we’re working on it, stay tuned!). However, we do know that the FY25 budget requests from the agencies themselves have been a mix bag for bioeconomy activities related to the Bold Goals Report. Some agencies are asking for large appropriations, while some agencies are not investing enough to support these goals:

Department of Energy supports Bold Goals Report efforts in biotech & biomanufacturing R&D to further climate change solutions

The increase in funding levels requested for FY25 for BER and MESC will enable increased biotech and biomanufacturing R&D, supporting DOE efforts to meet its proposed objectives in the Bold Goals Report.

Department of Commerce falls short in support of biotech & biomanufacturing R&D supply chain resilience

One budgetary increase request is offset by two flat funding levels.

Department of Agriculture falls short in support of biotech & biomanufacturing R&D to further food & Ag innovation

Human Health Services falls short in support of biotech & biomanufacturing R&D to further human health

National Science Foundation supports Bold Goals Report efforts in biotech & biomanufacturing R&D to further cross-cutting advances

* FY23 amounts are listed due to FY24 appropriations not being finalized at the time that this document was created.

Overall, the DOE and NSF have asked for FY25 budgets that could potentially achieve the goals stated in the Bold Goals Report, while the DOC, USDA and HHS have unfortunately limited their budgets and it remains questionable if they will be able to achieve the goals listed with the funding levels requested. The DOC, and specifically NIST, faces one of the biggest challenges this upcoming year. NIST has to juggle tasks assigned to it from the AI EO as well as the Bioeconomy EO and the Presidential Budget. The 8% decrease in funding for NIST does not paint a promising picture for either the Bioeconomy EO and should be something that Congress rectifies when they enact their appropriation bills. Furthermore, the USDA faces cuts in funding for vital programs related to their goals and AgARDA continues to be unfunded. In order for USDA to achieve the goals listed in the Bold Goals report, it will be imperative that Congress prioritize these areas for the benefit of the U.S. bioeconomy.

Regulations, funding, and knowledge gaps: Challenges and opportunities in bringing agricultural biotechnology to market

Innovations in agriculture will play an increasingly important role in America’s quest to ensure resilient and sustainable production of food, medicine, and bioenergy products. Biotechnology, spurred by advances such as cheap sequencing, offers a realm of possibilities for novel agricultural inputs, such as more targeted pesticides that are less toxic and less likely to cause tolerance, less carbon-intensive alternatives to fertilizers, and more climate-resilient crop varieties. 

However, research and development of new agricultural biotech products can be expensive and time-consuming, due to the large physical scale and long timelines of field trials. At the same time, federal funding for agriculture research has historically paled in comparison to funding for defense, energy, and human health. For example, in 2022, the NIH’s R&D budget was more than 16 times that of the USDA’s. 

The Biden administration has demonstrated its recognition of the need to accelerate research and development in agricultural biotechnology, featuring it prominently in 2022’s Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy. Additionally, a bill to expand authorization of funding for a moonshot USDA research grant program, AgARDA (Agriculture Advanced Research and Development Authority), has broad bipartisan support. At the same time, there has been a commensurate increase in private funding. 

While this multi-front surge in enthusiasm and investment is welcome, many challenges remain in translating money, ideas, and laboratory results to the field and the market, including communication between the various stakeholders in agricultural biotechnology R&D. To better understand industry priorities and potential barriers to progress, we spoke to members of the executive team of Fall Line Capital (FLC), a venture capital (VC) and private equity firm that invests in food/agriculture startups. Fall Line’s investments include new biopesticides (Greenlight, Micropep), functional microbes (Pluton, Wild Microbes), and new equipment (Guardian Agriculture, Rantizo, LUMO), in addition to managing a farmland portfolio. As lifelong farmers as well as agriculture technology (agtech) investors, Clay Mitchell and Scott Day offer a multifaceted perspective on the current landscape.

We then outline actions for government actors that can address the challenges identified in our interview, in three key areas: regulatory oversight, federal R&D funding, and bioliteracy.

Q: What can the U.S. government do to provide a supportive landscape for new agricultural biotechnology?

Fall Line Capital: I think the biggest hurdles are regulatory. If the government wants to be truly supportive and innovative, it should be working to revamp the convoluted regulatory environment. The current system wasn’t designed to handle all the new technology being developed with novel mechanisms of action, so hurdles to creating and commercializing stifle innovation even more than they did in the past. 

Looking at new technology like RNA– and micropeptide-based pesticides, it’s been a difficult process to get those products registered, even though they should be embraced: compared to conventional pesticides, they have the potential to be highly specific to the target organism and minimally toxic to non-target organisms. During GreenLight’s discussions with the EPA to register their RNAi biopesticide for tackling invasive potato beetles, the EPA seemed to understand that this sort of technology is the future, but movement through the registration approval process was slow nevertheless; the application sat there for five 5 years. There were dozens of other biological pesticide product applications, and the EPA had to give every application the same level of scrutiny, even if many were obviously ineffective. There’s pressure to register more biological products as a prominent alternative to traditional chemical products, despite generally low efficacy. This clutters up the process, and the EPA was already short-staffed after extensive attrition during COVID. 

A substantial amount of the innovation is coming from small companies like Greenlight that don’t have the resources (which many of the large incumbent ag companies have) to navigate the current registration programs and protocols, which are spread across multiple agencies involved in regulating biotechnology: the USDA, EPA, and FDA. There needs to be a new concierge resource beyond what the Unified Website for Biotechnology Regulation currently provides, that could direct you to the right office, the right registration process, as well as appropriate funding opportunities and legal resources.

Q: What do you think are currently the most pressing challenges in agriculture?

FLC: Pest resistance continues to be a very serious concern in agriculture, so new and effective control measures need to be continually developed for all pests: weeds, insects, disease. There are two major pests of concern for my own farm in Western Canada. First, herbicide-resistant kochia weed, which has become a huge problem in the last five years all across the world. No one’s sure how exactly it spread so quickly. Second, flea beetles are decimating cruciferous crops. RNAi-based insecticides could be very effective here, if we can achieve sufficient persistence of the insecticide and avoid impacting non-target species.

In terms of challenges to agriculture-based businesses, there’s a lack of funding right now for getting tech to market. Funding for agtech from VC firms fell last year, as it did for most forms of tech. This was  following a very strong period of agtech funding for the previous two years, during which we saw over-investment in several sectors, such as alternative meat and indoor farming. At the same time, agtech companies typically have long timelines to product launch and need more funding than just one VC can provide. Right now, many companies who come to Fall Line for money are just looking for short-term “bridge funding” so they can make payroll and buy time until they can demonstrate enough progress to raise a successful “series” round with good valuation and favorable investment terms. And no one is going public right now.

Q: What are common knowledge gaps for agtech startups regarding farmers’ needs?

FLC: Agtech startups are often centered around a great idea or technology that’s looking for a problem to solve — but it’s hard for a specific technology to meet the needs of a variable problem. Farmers’ needs and priorities (e.g. pests, nutrients, etc.) are incredibly diverse, varying dramatically by crop and location, even from one field to the next on the same farm, or even within the same field. Today, it is very hard to get an accurate understanding of what is needed or desired at the farm level because there is no easy way to connect with growers on a broad scale. Farm papers have diminished in popularity just like mainstream papers, radio has diminished as well. Unless you have the email address or cell phone number of a farmer, it is hard to connect directly with them now, and most farmers don’t like doing surveys of any type anyway — and those that do aren’t that representative of the industry. I think this is why most types of polls are becoming less accurate as it is increasingly more difficult to get a representative sample of opinions. 

Farmers can be hesitant to adopt new technologies, since the risk can be high. And once they’ve been burned once by a product that failed to work as advertised, they’re unlikely to be willing to trust that company, or even that type of product, in the future. For example, last year, North Dakota State University scientists coordinated a large-scale field trial where it showed in a large field trial that most new biological products aimed at improving nitrogen-fixation in non-legume crops were ineffective at increasing yield. In general, the efficacy of biologicals can vary greatly depending on the exact field conditions, making it hard to reliably achieve the advertised result. There’s a huge jump from greenhouse results to field trials, another huge jump from field trials to commercial fields. But when a product’s value is obvious, farmers actually embrace new technology very quickly: both GMO crops and GPS achieved widespread adoption in a very short period of time.

Finally, technology developers should keep in mind that problems can be solved by old or simple technology. When people think about controlled-environment farming, their minds jump to fancy things like vertical farming — but with irrigation and mulch films, you’re 90% of the way there. Simply by adding a mulch film to heat the soil, farmers can greatly extend the growing season in northern climates by a month. This approach allowed us us to substantially increase the yield from our corn fields in Wisconsin.

This conversation illustrates a clear need for change in three key areas:

Federal funding for agricultural R&D

Given the unreliability of private market funding for agricultural biotechnology R&D, which often entails long turnaround times and low margins relative to traditional tech companies, substantial federal funding through research programs such as AgARDA is vital for accelerating R&D. AgARDA, based on the ARPA Advanced Research Projects Agency model, would allow the USDA to support the development of transformative technologies for focus areas of its choosing. However, despite its popularity, AgARDA, which was first authorized in the 2018 Farm Bill for $50 million annually for FY2019-2023, only received $2m in that timeframe. The USDA requested $5m for AgARDA in FY2022 and again in FY2023; it only received $1m each year. By contrast, ARPA-H, the human health equivalent, was authorized in FY2022 and immediately received its full $1 billion authorization, followed by $1.5b in FY2023. 

The USDA has published an implementation framework for AgARDA. Unfortunately, misalignment between USDA and Congress appears to be preventing AgARDA from being fully funded to its authorized levels. Members of the Congressional agriculture committees want the USDA to show that it has made progress with the $2m it has received before they allocate additional funding, namely the appointment of a dedicated director and initiation of a pilot program with calls for grant proposals. However, the USDA has deemed the $2m insufficient to support long-term staff or a formal grant program, especially since the appropriations require annual renewal. The current impasse means that no AgARDA projects have been rolled out, despite the pressing nature of the research priorities identified by the USDA.  

The following steps should be taken for AgARDA to achieve its full potential:

Regulatory oversight

The U.S. regulatory system for biotechnology needs to be a) expanded, with funding for a larger agency staff to process applications quickly; b) updated, to be flexible such that it can accommodate new-to-market technologies; and c) coordinated, to streamline approval processes. 

The National Security Commission on Emerging Biotechnology (NSCEB) addresses these unmet needs in its interim report. First, NSCEB is “considering options to facilitate higher staffing levels”; this should be made a priority. 

Second, concerning regulatory oversight, NSCEB identified three potential paths for improvement:

Of these, the hybrid approach would likely provide the greatest flexibility. In contrast, discrete changes to individual statutes will likely involve slow, piecemeal changes that can easily become outdated again. While a unified regulatory process may be more streamlined, the report’s phrasing creates a sharp binary delineation between biotech and conventional that does not reflect reality. Such a delineation could engender a lot of wasted time debating biotech versus conventional classification for a given product. 

Finally, to address intra- and interagency coordination, the NSCEB presented two Farm Bill amendments that deserve Congressional support: the Biotechnology Oversight Coordination Act and the Agriculture Biotechnology Coordination Act.

Bioliteracy and agricultural education

Market demand and regulations are informed by consumer perceptions, which then impact R&D decisions. For example, fear of consumer and regulatory backlash can dissuade companies from investing in new genetic engineering technology for developing new plant varieties, despite their potential to improve agricultural sustainability. Increased bioliteracy across the American public would help consumers, businesses, and policymakers alike better understand new biotechnologies and engage with the burgeoning bioeconomy. This is a need that the NSCEB has also highlighted. At the K-12 level, improvements could comprise updating science curriculums to include contemporary topics like gene editing, as well as amending civics curriculums to better explain the modern functions of regulatory agencies. In addition, agricultural education can be embedded into biology and earth science curriculums to reconnect the public at large with the realities faced by producers. Similar to computer science literacy improvements through standard setting and funding, bioliteracy can be improved through state-level education initiatives.

The Federation of American Scientists values diversity of thought and believes that a range of perspectives — informed by evidence — is essential for discourse on scientific and societal issues. Contributors allow us to foster a broader and more inclusive conversation. We encourage constructive discussion around the topics we care about.

The U.S. Bioeconomy is Not Yet Sustainable. Here’s What Needs to Change.

The U.S. Bioeconomy can be a slippery thing, but there’s no denying that leaders at the highest levels of industry and politics are paying attention to its potential to boost our economic growth and our technological edge.

Look no further than the White House’s Bioeconomy Executive Order – aimed at shaping a bioeconomy that is “safe, secure and sustainable.” While programs and reports have focused on the ‘safe’ and ‘secure’ aspects of the bioeconomy and economic indicators, environmental sustainability has not had as much momentum. But this isn’t necessarily due to a lack of interest in biobased products at the industrial level.

A novel collaboration between Ford Motor Company and Jose Cuervo® Tequila Company is one example of this growing interest. Agave by-products from tequila production will soon be used to create more sustainable bioplastics for next-generation Ford vehicles. According to the United Nations Environment Programme, 5 billion metric tons of agricultural biomass waste is produced annually. Agriculture by-products, like the waste products from tequila production, are abundant and often underutilized; therefore, finding new processes to incorporate available waste products to create something new and sustainable can help manufacturers embrace more biobased materials. 

But one catch for building an environmentally sustainable national bioeconomy strategy is that not all biobased products or processes in the bioeconomy are – despite the connotations of “biobased” – inherently sustainable. Biobased products do indeed hold enormous promise for promoting economic growth while mitigating environmental challenges. And yet a strategy to ensure that environmental benefits actually get to consumers remains elusive. As the U.S. government grapples with delineating what sectors the bioeconomy does or does not contain –  it must also ask:  What does environmental sustainability mean in a bioeconomy? How should it be measured? Answers to these questions would support efforts to evaluate technologies and projects, prioritize investments, and ultimately improve sustainability.

Circular bioeconomy is a term commonly used to describe sustainability in the bioeconomy and combines two fundamental sustainability principles. First, it embraces the increased use of renewable resources, such as energy, chemicals, and materials, particularly those derived from plants. Second, it focuses on extending the lifecycle of these sustainable materials and products instead of discarding them. 

While the U.S. grapples with defining its bioeconomy and landing on a cohesive approach to  making it sustainable, the European Union (EU) and other international organizations have committed to this circular bioeconomy model (see BOX).

International definitions of the bioeconomy that include sustainability

Sustainability within the context of the European bioeconomy has been defined in many ways, including:

In the definitions above, economic and environmental sustainability inform each other depending on where a bioeconomy is located and what sector of the bioeconomy is being considered, such as biopharmaceutical manufacturing vs. agriculture. For example, sustainability for agriculturally-related bioeconomic products from Spain’s Andalusia region may look very different from sustainability for biopharmaceuticals from Berlin. The regionality differences will inform decisions that drive sustainability in a bioeconomy. 

The United Nations Food and Agriculture Organization (FAO )is creating guidance for developing and implementing sustainable bioeconomy strategies, policies, and programs across the globe The FAO focuses on five key elements of a sustainable bioeconomy: 1) the reduction of carbon emissions, 2) restoring biodiversity, 3) eliminating toxic waste, 4) building rural economies, and 5) reducing food insecurity and malnutrition. The FAO further states that the “development of a sustainable and circular bioeconomy globally is and will be driven by three broad forces:

The EU is currently working towards a sustainable bioeconomy that aligns with the European Green Deal objectives, to build more diverse supply chains that are less dependent on fossil fuels and non-renewable resources. Furthermore, the EU sees the shift towards biobased products and sustainable processes as a way to achieve economic, social, and environmental goals. Establishing an aligned strategy allows for the two independent plans to work in synergy together to promote and advance EU’s goals. Which is further promoted by financial incentives that help EU member countries and municipalities to partake in this overarching strategy. Significant amounts of funding have been invested into the European bioeconomy and more member states of the EU are using tax incentives, grants, loans, and subsidies for biobased products to “provide public financial support to circular bioeconomy projects.” These efforts push the private sector to create more biobased products, but also enable a shift in manufacturing and research development processes to become more sustainable in order to capture additional financial benefits. 

The EU’s intentional inclusion of sustainability as part of their bioeconomy strategy can be attributed to the general acceptance of nature as a societal and economical benefit. This sustainability-forward mindset  informs how the EU seeks to use biotechnology as a tool to fix societal challenges. Furthermore, the sustainability-forward mindset has informed  how natural resources are included as part of their economic evaluations. Preserving their natural resources becomes a priority for them and the EU sees the bioeconomy, and the biotechnology sitting within it, as a means to safeguarding their natural resources. 

The U.S., on the other hand, has a rich history in manufacturing, and takes a more industry-forward approach to promote biomanufacturing and biotechnology as a way to create new biobased products. Any societal challenges that may be alleviated along the way come as a positive byproduct but it is not the primary focus of the U.S. bioeconomy. Inclusion of sustainability in the U.S. bioeconomy gets further stress-tested by the vastness of the U.S. natural landscape and the increasing number of natural disasters that vary from one region to another. For example, the rampant wildfires continue to destroy thousands of acres of forested land on the West Coast and the coastal habitats are lost on the East Coast due to rising ocean levels. This all leads to immense challenges in conserving and protecting these natural resources at a national level, making it hard to establish a coherent environmental sustainability strategy for the U.S. bioeconomy.

To successfully achieve environmental sustainability, the U.S. bioeconomy needs a two-pronged approach. The first approach requires incorporating sustainability at the regional level. Due to historic, place-based federal investments throughout the U.S., like the Economic Development Administration (EDA) Tech Hubs or the National Science Foundation (NSF) Regional Innovation Engines, regional bioeconomies, or microbioeconomies, are beginning to form. 

Microbioeconomies utilize a region-specific biobased industries, academic strengths, and support sectors to apply and innovate on various biotechnologies that boost regional economies and mitigate region-specific environmental challenges. Microbioeconomies enable the integration of sustainability into the bioeconomy in a more approachable manner. Taking the lessons learned and major themes that arise from how these microbioeconomies are established and including sustainability in their planning, allows for a roadmap on how to integrate sustainability into the national bioeconomy strategy.

The second approach requires action at the federal level, in other words, a top-down approach to incorporating environmental sustainability into the U.S. bioeconomy.  This approach would require a dedicated effort to build the necessary infrastructure and common language of what sustainability is and how it can exist within the bioeconomy. One way that the federal government can start this process is by driving the convergence of bioeconomy and sustainability programs within federal agencies. By mandating that federally-funded bioeconomy programs and activities include a component of environmental sustainability, the government can spur a new wave of innovation and encourage regional efforts to incorporate sustainability in their microbioeconomies. The federal government can leverage and fortify existing programs to carry out this approach.  For example, the BioPreferred program, housed within the United States Department of Agriculture (USDA), is meant to increase the purchase of biobased products in the U.S. through mandatory purchasing requirements for federal agencies and their contractors; and a voluntary labeling initiative for biobased products. As the recent Bioeconomy Executive Order also highlighted the need to strengthen and expand the BioPreferred program, and implementation of this task can be another step forward in incorporating sustainability into the U.S. bioeconomy.

With historic levels of investments and the push to reduce emissions to tackle climate change, the time is ripe with opportunities for U.S. innovators to bring sustainability into the fold of their manufacturing and R&D processes, products, and services. The U.S can take steps in the right direction by creating financial incentive programs similar to ones implemented by EU member states, incorporating sustainability language into our federal codes, and mandating that federally funded biotechnology research have a sustainability component. These changes will be critically important to both grow a future circular bioeconomy in the U.S. that can simultaneously promote economic growth and help alleviate the impacts of climate change. 

A Matter of Trust: Helping the Bioeconomy Reach Its Full Potential with Translational Governance

The promise of the bioeconomy is massive and fast-growing—offering new jobs, enhanced supply chains, novel technologies, and sustainable bioproducts valued at a projected $4 trillion over the next 16 years. Although the United States has been a global leader, advancements in the bioeconomy—whether it’s investing in specialized infrastructural hardware or building a multidisciplinary STEM workforce—are subject to public trust. In fact, public trust is the key to unlocking the full potential of the bioeconomy, and without it, the United States may fall short of long-term economic goals and even fall behind peer nations as a bioeconomy leader. Recent failures of the federal regulatory system for biotechnology threaten public trust, and recent regulations have been criticized for their lack of transparency. As a result, cross-sector efforts aim not just to reimagine the bioeconomy but to create a coordinated regulatory system for it. Burdened by decreasing public trust in the federal government, even the most coordinated regulatory systems will fail to boost the bioeconomy if they cannot instill public trust.

In response, the Biden-Harris Administration should direct a Bioeconomy Initiative Coordination Office (BICO) to establish a public engagement mechanism parallel with the biotechnology regulatory system. Citizen engagement and transparency are key to building public trust, yet current public engagement mechanisms cannot convey trust to a public skeptical of a biotechnology’s rewards in light of perceived risks. Bioeconomy coordination efforts should therefore prioritize public trust by adopting a new public-facing biotechnology evaluation program that collects data from nontraditional audiences via participatory technology assessments (pTA) and Multi-Criteria Decision Analysis (MCDA/MCDM) and provides insight that addresses limitations. In accordance with the CHIPS and Science Act, the public engagement program will provide a mechanism for a BICO to build public trust while advancing the bioeconomy. 

The public engagement program will serve as a decision-making resource for the Coordinated Framework for the Regulation of Biotechnology (CFRB) and a data repository for evaluating public acceptance in the present and future bioeconomy. 

Challenge and Opportunity 

While policymakers have been addressing the challenge of sharing regulatory space among the three key agencies—Environmental Protection Agency (EPA), Food and Drug Administration (FDA), and USDA—transparency and public trust remain challenges for federal agencies, small to midsize developers, and even the public at large. The government plays a vital role in the regulatory process by providing guidelines that govern the interactions between the developers and consumers of biotechnology. For over 30 years, product developers have depended on strategic alliances between product developers and the government to ensure the market success of biotechnology. The marketplace and regulatory oversight are tightly linked, and their impacts on public confidence in the bioeconomy cannot be separated. 

When it comes to a consumer’s purchase of a biotechnology product, the pivotal factor is often not price but trust. In 2016, the National Academy of Sciences, Engineering, and Medicine released recommendations on aligning public values with gene drive research. The report revealed that public engagement that promotes a “bi-directional exchange of information and perspectives” can increase public trust. Moreover, a 2022 report on Gene Drives in Agriculture highlights the importance of considering public perception and acceptance in risk-based decision-making. 

The CHIPS and Science Act provides an opportunity to address transparency and public trust within the federal regulatory system for biotechnology by directing the Office of Science and Technology Policy (OSTP) to establish a Coordination Office for the National Engineering Biology Research and Development Initiative. The coordination office (i.e., BICO) will serve as a point of contact for cross-sector engagement and create a junction for the exchange of technical and programmatic information. Additionally, the office will conduct public outreach and produce recommendations for strengthening the bioeconomy.

This policy window presents a novel opportunity to create a regulatory system for the bioeconomy that also encompasses the voice of the general public. History of requests for information, public hearings, and cross-sector partnerships demonstrates the public’s capacity—or at least specific subsets of experts therein—to fill gaps, oversights, and ambiguities within biotechnology regulations. 

While expert opinion is essential for developing regulation, so too are the opinions of the general public. Historically, discussions about values, sentiments, and opinions on biotechnology have been dominated by technical experts (for example, through debates on product vs. process, genetically engineered vs. genetically modified organisms, and perceived safety). Biotechnology discourse has primarily been restricted to these traditional, technical audiences, and as a result, public calls to address concerns about biotechnology are drowned out by expert opinions. We need a mechanism for public engagement that prioritizes collecting data from nontraditional audiences. This will ensure sustainable and responsible advancements in the bioeconomy.

If we want to establish a bioeconomy that increases national competitiveness, then we need to increase the participation of nontraditional audiences. Although some public concerns are unlikely to be allayed through policy change (e.g., addressing calls for a ban on genetically engineered or modified products), a public engagement program could identify the underlying issue(s) for these concerns. This would enable the adoption of comprehensive strategies that increase public trust, further sustaining the bioeconomy.

Research shows that public comment and notice periods are less likely to hear from nontraditional audiences—that is, members of underserved communities, workers, smaller market entities, and new firms. Despite the statutory and capacity-based obstacles federal agencies face in increasing public participation, the Executive Office of the President seeks to broaden public participation and community engagement in the federal regulatory process. Public engagement programs provide a platform to interact with interested parties that represent a wide range of perspectives. Thus, information gathered from public engagement could inform future proposed updates to the CFRB and the regulatory pathways for new products. In this way, the public opinions and sentiments can be incorporated into a translational governance framework to bring translational value to the bioeconomy. Since increasing public trust is complementary to advancing the bioeconomy, there is a translational value in strategically integrating a collective perception of risk and safety into future biotechnology regulation. In this case, translational governance allows for regulation that is informed by science and is responsive to the values of citizens, effectively introducing a policy lever that improves the adoption of, and investment in, the U.S. bioeconomy.

The future of biotechnology regulation is an emerging innovative ecosystem. The path to accomplishing economic goals within this ecosystem requires a new public-facing engagement mechanism framework that satisfies congressional directives and advances the bioeconomy. This framework provides a BICO with the scaffolding necessary to create an infrastructure that invites public input and community reflection and the potential to decrease the number of biotechnologies that fail to reach the market. The proposed public engagement mechanism will work alongside the current regulatory system for biotechnology to enhance public trust, improve interagency coordination, and strengthen the bioeconomy. 

Plan of Action

To reach our national bioeconomic policy goals, the BICO should use a public engagement program to solicit perspectives and develop an understanding of non-economic values, such as deeply held beliefs about the relationship between humans and the environment or personal or cultural perspectives related to specific biotechnologies. The BICO should devote $10 million over five years to public engagement programs and advisory board activities that (a) report to the BICO but are carried out through external partnerships; (b) provide meaningful social data for biotechnology regulation while running parallel to the CFRB regulatory system; and (c) produce a repository of public acceptance data for horizon scanning. These programs will inform regulatory decision-making, increase public trust, and achieve the congressional directives outlined in Sec. 10402 of the CHIPS & Science Act.

Recommendation 1. Establish a Bioeconomy Initiative Coordination Office (BICO) as a home office for interagency coordination.

The BICO should be housed within the Office of Science and Technology Policy (OSTP). The creation of a BICO is in alignment with the mandates of Executive Order (EO) 14081, Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure Bioeconomy, and the statutory authority granted to the OSTP through the CHIPS and Science Act. 

Congress should allocate $2 million annually for five years to the BICO to carry out a public engagement program and advisory board activities in coordination with the EPA, FDA, and USDA. 

The public engagement program would be housed within the BICO as a public-facing data-generating mechanism that parallels the current federal regulatory system for biotechnology. 

The bioeconomy cuts across sectors (e.g., agriculture, health, materials, energy) and actively creates new connections and opportunities for national competitiveness. A thriving bioeconomy must ensure regulatory policy coherence and alignment among these sectors, and the BICO should be able to comprehensively integrate information from multiple sectors into a strategy that increases public awareness and acceptance of bioeconomy-related products and services. Public engagement should be used to build a data ecosystem of values related to biotechnologies that advance the bioeconomy.

Recommendation 2. Establish a process for public engagement and produce a large repository of public acceptance data. 

Public acceptance data will be collected alongside the “biological data ecosystem,” as referenced by the Biden Administration in EO 14081, that advances innovation in the bioeconomy. To provide an expert element to the public engagement process, an advisory board should be involved in translating public acceptance data (opinions on how biotechnologies align with values) into policy suggestions and recommendations for regulatory agencies. The advisory board should be a formal entity recognizable under the Federal Advisory Committee Act (FACA) and the Freedom of Information Act (FOIA). It should be diverse but not so large that it becomes inefficient in fulfilling its mandate. Striking a balance between compositional diversity and operational efficiency is critical to ensuring the board provides valuable insights and recommendations to the BICO. The advisory board should consist of up to 25 members, reflect NSF data on diversity and STEM, and include a diverse range of citizens, from everyday consumers (such as parents, young adults, and patients from different ethnic backgrounds) to specialists in various disciplines (such as biologists, philosophers, hair stylists, sanitation workers, social workers, and dietitians). To promote transparency and increase public trust, data will be subject to FACA and the FOIA regulations, and advisory board meetings must be accessible to the public and their details must be published in the Federal Register. Additionally, management and applications of any data collected should employ CARE (Collective Benefit, Authority to Control, Responsibility, Ethics) Principles for Indigenous Data Governance, which complement FAIR (Findable, Accessible, Interoperable and Reusable) Principles. Adopting CARE brings a people and purpose orientation to data governance and is rooted in Indigenous Peoples’ sovereignty.

The BICO can look to the National Science and Technology Council’s published requests for information (RFI) and public meetings as a model for public engagement. BICO should work with an inclusive network of external partners to design workshops for collecting public acceptance data. Using participatory technology assessments (pTA) methods, the BICO will fund public engagement activities such as open-framing focus groups, workshops, and forums that prioritize input from nontraditional public audiences. The BICO office should use pre-submission data, past technologies, near-term biotechnologies, and, where helpful, imaginative scenarios to produce case studies to engage with these audiences. Public engagement should be hosted by external grantees who maintain a wide-ranging network of interdisciplinary specialists and interested citizens to facilitate activities. 

Qualitative and quantitative data will be used to reveal themes, public values, and rationales, which will aid product developers and others in the bioeconomy as they decide on new directions and potential products. This process will also serve as the primary data source for the public acceptance data repository. Evolving risk pathways are a considerable concern for any regulatory system, especially one tasked with regulating biotechnologies. How risks are managed is subject to many factors (history, knowledge, experience product) and has a lasting impact on public trust. Advancing the bioeconomy requires a transparent decision-making process that integrates public input and allows society to redefine risks and safety as a collective. Public acceptance data should inform an understanding of values, risks, and safety and improve horizon-scanning capabilities.

Conclusion

As the use of biotechnology continues to expand, policymakers must remain adaptive in their regulatory approach to ensure that public trust is acquired and maintained. Recent federal action to boost the bioeconomy provides an opportunity for policymakers to expand public engagement and improve public acceptance of biotechnology. By centralizing coordination and integrating public input, policymakers can create a responsive regulatory convention that advances the bioeconomy while also building public trust. To achieve this, the public engagement program will combine elements of community-based participatory research, value-based assessments, pTA, and CARE Principles for Indigenous Data Governance. This approach will create a translational mechanism that improves interagency coordination and builds public trust. As the government works to create a regulatory framework for the bioeconomy, the need for public participation will only increase. By leveraging the expertise and perspectives of a diverse range of interested parties, policymakers can ensure that the regulatory framework is aligned with public values and concerns while promoting innovation and progress in the U.S. bioeconomy.

Frequently Asked Questions
What is translational governance?

Translational governance focuses on expediting the implementation of regulations to safeguard human health and the environment while simultaneously encouraging innovation. This approach involves integrating non-economic values into decision-making processes to enhance scientific and statutory criteria of risk and safety by considering public perceptions of risk and safety. Essentially, it is the policy and regulatory equivalent of translational research, which strives to bring healthcare discoveries to market swiftly and safely.

Which congressional directives outlined in Sec. 10402 of the CHIPS & Science Act would public engagement support?

The Office of Science and Technology Policy (OSTP) should use translational governance through public engagement as a backbone of the National Engineering Biology Research and Development Initiative. Following the designation of an interagency committee by the OSTP—and once established under the scope of direction outlined in Sec. 10403 of the CHIPS and Science Act—the Initiative Coordination Office should use a public engagement program to support the following National Engineering Biology Research and Development Initiative congressional directives (Sec. 10402):



  • 1) Supporting social and behavioral sciences and economics research that advances the field of engineering biology and contributes to the development and public understanding of new products, processes, and technologies.

  • 2) Improving the understanding of engineering biology of the scientific and lay public and supporting greater evidence-based public discourse about its benefits and risks.

  • 3) Supporting research relating to the risks and benefits of engineering biology, including under subsection d: Ensuring, through the agencies and departments that participate in the Initiative, that public input and outreach are integrated into the Initiative by the convening of regular and ongoing public discussions through mechanisms such as workshops, consensus conferences, and educational events, as appropriate].

  • 4) Expanding the number of researchers, educators, and students and a retooled workforce with engineering biology training, including from traditionally underrepresented and underserved populations.

  • 5) Accelerating the translation and commercialization of engineering biology and biomanufacturing research and development by the private sector.

  • 6) Improving the interagency planning and coordination of federal government activities related to engineering biology.

Why is interagency coordination within biotechnology regulation challenging?

In 1986, the newly issued regulatory system for biotechnology products faced significant statutory challenges in establishing the jurisdiction of the three key regulatory agencies (EPA, FDA, and USDA). In those early days, agency coordination allowed for the successful regulation of products that had shared jurisdiction. For example, one agency would regulate the plant in the field (USDA), and another would regulate the feed or food produced by the plant (FDA/DHHS). However, as the biotechnology product landscape has advanced, so has the complexity of agency coordination. For example, at the time of their commercialization, plants that were modified to exhibit pesticidal traits, specific microbial products, and certain genetically modified organisms cut across product use-specific regulations that were organized according to agency (i.e., field plants, food, pesticides). In response, the three key agencies have traditionally implemented their own rules and regulations (e.g., EPA’s Generally Recognized as Safe, USDA’s Am I Regulated?, USDA SECURE Rule). While such policy action is under their statutory authorities, it has resulted in policy resistance, reinforcing the confusion and lack of transparency within the regulatory process.

How many times has the Coordinated Framework for the Regulation Of Biotechnology (CFRB) been updated?

Since its formal debut on June 26, 1986, the CFRB has undergone two major updates, in 1992 and 2017. Additionally, the CFRB has been subject to multiple memorandums of understanding as well as two executive orders across two consecutive administrations (Trump and Biden). With the arrival of The CHIPS and Science Act (2022) and Executive Order 14081, the CFRB will likely undertake one of its most extensive updates—modernization for the bioeconomy.

Why does the Coordinated Framework for the Regulation of Biotechnology (CFRB) need to be updated?

According to the EPA, when the CFRB was issued in 1986, the expectation was that the framework would respond to the experiences of the industry and the agencies and that modifications would be accomplished through administrative or legislative actions. Moreover, upon their release of the 2017 updates to the CFRB, the Obama Administration described the CFRB as a “flexible regulatory structure that provides appropriate oversight for all products of modern biotechnology.” With this understanding, the CFRB is designed to be iterative and responsive to change. However, as this memo and other reports demonstrate, not all products of modern biotechnology are subject to appropriate oversight. The opportunity loss between addressing regulatory concerns and acquiring the regulations necessary to capitalize on the evolving biotechnology landscape fully presents a costly delay. The CFRB is falling behind biotechnology in a manner that hampers the bioeconomy—and likely—the future economy.

Implementing the Bioeconomy Executive Order: Lessons Learned and Future Considerations

With the U.S. bioeconomy valued at over $950 billion and predicted to steadily increase, the potential for significant economic impact is unmistakable. To leverage this economic opportunity, the 2022 Bioeconomy Executive Order (EO) took a significant step towards addressing the complexities of the bioeconomy and creating a whole-of-government approach. The scope of the EO was vast, assigning around 40 tasks to many different federal agencies, in order to create a national framework to leverage bio-based innovations for sustainable economic growth. 

To track the numerous tasks assigned by the EO, the Federation of American Scientists have put together a living Bioeconomy EO tracker to monitor the progress of these tasks, enhance accountability and to allow stakeholders to stay informed on the state of the U.S. bioeconomy as it evolves. This FAS tracker was inspired by the initial tracker created by Stanford University when the EO was first published.

View the full tracker at the bottom of this post

Preliminary Benefits Made Possible Through the Bioeconomy EO

The Bioeconomy EO was an ambitious attempt at a whole of government approach. One year after its publication and implementation, we now have the opportunity to conduct a preliminary assessment to understand the impact the EO has had on the U.S. bioeconomy to date and to identify areas where there is still room for improvement and growth. 

The Bioeconomy EO has generated a number of tools and reports to guide this emerging economic sector such as the:

The reports created thus far have served to highlight the gaps within the U.S. bioeconomy and have taken the first step in figuring out how to fill in these missing links, such as the Bold Goals report by OSTP that highlights a possible future for the U.S. bioeconomy and The Coordinated Framework for the Regulation of Biotechnology reports that is the first step in addressing challenging regulatory hurdles the biotechnology sector faces. Furthermore, many of these reports have highlighted the need for a “coordination of intergovernmental investments, efforts, and resources” – an ongoing challenge for the U.S. bioeconomy.

The EO assigned around 40 tasks to a few agencies and each of these tasks required a substantial amount of work to be conducted in a short amount of time. A challenge that has been identified as a result of the implementation of the EO is the need to better allocate proper resources needed (e.g., staff, funds, and time) in order to ensure effective implementation. Federal agencies are often under-resourced and staff are overstretched. The additional work that an EO adds to these agencies and their staff can further overwhelm offices and lead to implementation delays or failures. For example, reports such as the Vision, Needs, and Proposed Actions for Data for the Bioeconomy Initiative which involve monumental effort to produce, was not published until December 2023 due to the lack of resources needed to complete this complex task. To ensure successful implementation, future EOs should include realistic resources, guidelines, timetables, and a more specific implementation plan to help agencies deliver on these promising areas.

While the Bioeconomy EO recognized the need for a whole-of-government approach, the foundational pieces that underpin the bioeconomy strategy have yet to be established. Some of these foundational areas include: 

  1. Consensus on the scope of the U.S. bioeconomy
  2. Consensus on how to better measure different aspects of the bioeconomy (i.e. biological resources, biotech, biomanufacturing, and sustainability)
  3. Development of an updated classification system needed to more accurately analyze the U.S. bioeconomy
  4. Increased capacity within federal agencies to properly research and analyze the U.S. bioeconomy
  5. A coordinating body within the federal government to oversee and guide the U.S. bioeconomy
  6. Synergistic interoperability between federal agencies

The Bioeconomy EO was the first step in creating a national framework and strategy for the U.S. bioeconomy and the OSTP Bold Goals Report highlighted and outlined what the U.S. bioeconomy could achieve with such a strategy.To ensure success, prevent future lags in implementation, and to achieve the full potential of the U.S. bioeconomy, future EO’s should ensure that the foundations that are needed to achieve the work are already in place or incorporated as individual tasks that inform implementation. 

Coordinating Efforts of New Programs to Strengthen Future Capabilities 

The Bioeconomy EO and the CHIPS and Science Act of 2022 has spurred many different regional programs to be established (e.g., Economic Development Administration’s Tech Hubs and National Science Foundation Engines and Biofoundries), which demonstrates the regional opportunities the U.S. bioeconomy can create. However, it remains to be seen whether these programs are working in synergy to advance the larger bioeconomy goals and how they are leveraging federal resources through coordination. It will be essential for the U.S. bioeconomy to have a whole-of-government approach, which includes making sure that federal agencies are discussing relevant programs with each other to make sure that there are no redundancies. Future EO’s should help shepherd the execution of these tasks by proposing a coordination framework.

The execution of the Bioeconomy EO this past year has provided valuable insights into the challenges and opportunities associated with such an ambitious executive order. As we reflect on the lessons learned, it is evident that future EOs in similar scale that propose a whole-of-government approach must carefully consider future and existing agency resources to ensure success. For the future success of the U.S. bioeconomy, it will be imperative to establish a body to coordinate efforts, ensure seamless communication, and foster interoperability between agencies. As the Biden-Harris administration continues to pursue actions from this EO in 2024 and beyond, it should focus on creating a national framework that has longevity and success. By incorporating these lessons, the administration could pave the way for sustainable and impactful initiatives that contribute to the continued economic growth and success of the U.S. bioeconomy.

Tracker

The Biorevolution is Underway. Now is the Time for Biology to Harness the Potential of Artificial Intelligence

The Federation of American Scientists (FAS) Makes Five Policy Recommendations to Maximize Opportunity and Minimize Risk at the Intersection of Biology and Artificial Intelligence

Washington, DC – December 12, 2023 – Today the Federation of American Scientists (FAS) released federal policy recommendations to address potential threats AI poses to bioscience and the surging bioeconomy. The five recommendations presented by experts are detailed in these memos:

Read each of these recommendations, plus an introduction from Nazish Jeffery at this link.

ABOUT FAS

The Federation of American Scientists (FAS) works to advance progress on a broad suite of contemporary issues where science, technology, and innovation policy can deliver dramatic progress, and seeks to ensure that scientific and technical expertise have a seat at the policymaking table. Established in 1945 by scientists in response to the atomic bomb, FAS continues to work on behalf of a safer, more equitable, and more peaceful world. More information at fas.org.

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