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.

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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Bio x AI: Policy Recommendations for a New Frontier

Artificial intelligence (AI) is likely to yield tremendous advances in our basic understanding of biological systems, as well as significant benefits for health, agriculture, and the broader bioeconomy. However, AI tools, if misused or developed irresponsibly, can also pose risks to biosecurity. The landscape of biosecurity risks related to AI is complex and rapidly changing, and understanding the range of issues requires diverse perspectives and expertise. To better understand and address these challenges, FAS initiated the Bio x AI Policy Development Sprint to solicit creative recommendations from subject matter experts in the life sciences, biosecurity, and governance of emerging technologies. Through a competitive selection process, FAS identified six promising ideas and, over the course of seven weeks, worked closely with the authors to develop them into the recommendations included here. These recommendations cover a diverse range of topics to match the diversity of challenges that AI poses in the life sciences. We believe that these will help inform policy development on these topics, including the work of the National Security Commission on Emerging Biotechnologies.

AI tool developers and others have put significant effort into establishing frameworks to evaluate and reduce risks, including biological risks, that might arise from “foundation” models (i.e., large models designed to be used for many different purposes). These include voluntary commitments from major industry stakeholders, and several efforts to develop methods for evaluations of these models. The Biden Administration’s recent Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence (Bioeconomy EO) furthers this work and establishes a framework for evaluating and reducing risks related to AI. 

However, the U.S. government will need creative solutions to establish oversight for biodesign tools (i.e., more specialized AI models that are trained on biological data and provide insight into biological systems). Although there are differing perspectives among experts, including those who participated in this Policy Sprint, about the magnitude of risks that these tools pose, they undoubtedly are an important part of the landscape of biosecurity risks that may arise from AI. Three of the submissions to this Policy Sprint address the need for oversight of these tools. Oliver Crook, a postdoctoral researcher at the University of Oxford and a machine learning expert, calls on the U.S. government to ensure responsible development of biodesign tools by instituting a framework for checklist-based, institutional oversight for these tools while Richard Moulange, AI-Biosecurity Fellow at the Centre for Long-Term Resilience, and Sophie Rose, Senior Biosecurity Policy Advisor at the Centre for Long-Term Resilience, expand on the Executive Order on AI with recommendations for establishing standards for evaluating their risks. In his submission, Samuel Curtis, an AI Governance Associate at The Future Society, takes a more open-science approach, with a recommendation to expand infrastructure for cloud-based computational resources internationally to promote critical advances in biodesign tools while establishing norms for responsible development.

Two of the submissions to this Policy Sprint work to improve biosecurity at the interface where digital designs might become biological reality. Shrestha Rath, a scientist and biosecurity researcher, focuses on biosecurity screening of synthetic DNA, which the Executive Order on AI highlights as a key safeguard, and contains recommendations for how to improve screening methods to better prepare for designs produced using AI. Tessa Alexanian, a biosecurity and bioweapons expert, calls for the U.S. government to issue guidance on biosecurity practices for automated laboratories, sometimes called “cloud labs,” that can generate organisms and other biological agents.

This Policy Sprint highlights the diversity of perspectives and expertise that will be needed to fully explore the intersections of AI with the life sciences, and the wide range of approaches that will be required to address their biosecurity risks. Each of these recommendations represents an opportunity for the U.S. government to reduce risks related to AI, solidify the U.S. as a global leader in AI governance, and ensure a safer and more secure future.

An evidence-based approach to identifying and mitigating biological risks from AI-enabled biological tools

Richard Moulange & Sophie Rose

Both AI-enabled biological tools and large language models (LLMs) have advanced rapidly in a short time. While these tools have immense potential to drive innovation, they could also threaten the United States’ national security.

AI-enabled biological tools refer to AI tools trained on biological data using machine learning techniques, such as deep neural networks. They can already design novel proteins, viral vectors and other biological agents, and may in the future be able to fully automate parts of the biomedical research and development process.

Sophisticated state and non-state actors could potentially use AI-enabled tools to more easily develop biological weapons (BW) or design them to evade existing countermeasures . As accessibility and ease of use of these tools improves, a broader pool of actors is enabled.

This threat was recognized by the recent Executive Order on Safe AI, which calls for evaluation of all AI models (not just LLMs) for capabilities enabling chemical, biological, radiological and nuclear (CBRN) threats, and recommendations for how to mitigate identified risks.

Developing novel AI-enabled biological tool -evaluation systems within 270 days, as directed by the Executive Order §4.1(b), will be incredibly challenging, because:

To achieve this, it will be important to identify and prioritize those AI-enabled biological tools that pose the most urgent risks, and balance these against the potential benefits. However, government agencies and tool developers currently seem to struggle to:

Some frontier AI labs have assessed the biological risks associated with LLMs , but there is no public evidence of AI-enabled biological tool  evaluation or red-teaming, nor are there currently standards for developing—or requirements to implement—them. The White House Executive Order will build upon industry evaluation efforts for frontier models, addressing the risk posed by LLMs, but analogous efforts are needed for AI-enabled biological tools.

Given the lack of research on AI-enabled biological tool evaluation, the U.S. Government must urgently stand up a specific program to address this gap and meet the Executive Order directives. Without evaluation capabilities, the United States will be unable to scope regulations around the deployment of these tools, and will be vulnerable to strategic surprise. Doing so now is essential to capitalize on the momentum generated by the Executive Order, and comprehensively address the relevant directives within 270 days.

Recommendations

The U.S. Government should urgently acquire the ability to evaluate biological capabilities of AI-enabled biological tools via a specific joint program at the Departments of Energy (DOE) and Homeland Security (DHS), in collaboration with other relevant agencies.

Strengthening the U.S. Government’s ability to evaluate models prior to their deployment is analogous to responsible drug or medical device development: we must ensure novel products do not cause significant harm, before making them available for widespread public use.

The objective(s) of this program would be:

  1. Develop state-of-the-art evaluations for dangerous biological capabilities 
  2. Establish Department of Energy (DOE) sandbox for testing evaluations on a variety of AI-enabled biological tools
  3. Produce standards for performance, structure and securitisation of capability evaluations
  4. Use evaluations of the maturity and capabilities of AI-enabled biological tools to inform U.S. Intelligence Community assessments of potential adversaries’ current bio-weapon capabilities

Implementation 

Lead agencies and organizations

They should coordinate with other relevant agencies, including but not limited to the Department of Defense, and the National Counterproliferation and Biosecurity Center.

The benefits of implementing this program include: 

Leveraging public-private expertise. Public-private partnerships (involving both academia and industry) will produce comprehensive evaluations that incorporate technical nuances and national security considerations. This allows the U.S. Government to retain access to diverse expertise whilst safeguarding the sensitive nature of dangerous capability evaluations contents and output—which is harder to guarantee with third-party evaluators.

Enabling evidence-based regulatory decision-making. Evaluating AI tools allows the U.S. Government to identify the models and capabilities that pose the greatest biosecurity risks, enabling effective and appropriately-scoped regulations. Avoiding blanket regulations results in a better balance of the considerations of innovation and economic growth with those of risk mitigation and security.

Broad scope of evaluation application. AI-enabled biological tools vary widely in their application and current state of maturity. Subsequently, what constitutes a concerning, or dangerous, capability may vary widely across tools, necessitating the development of tailored evaluations.

A Global Compute Cloud to Advance Safe Science and Innovation

Samuel Curtis

Advancements in deep learning have ushered in significant progress in the predictive accuracy and design capabilities of biological design tools (BDTs), opening new frontiers in science and medicine through the design of novel functional molecules. However, these same technologies may be misused to create dangerous biological materials. Mitigating the risks of misuse of BDTs is complicated by the need to maintain openness and accessibility among globally-distributed research and development communities. One approach toward balancing both risks of misuse and the accessibility requirements of development communities would be to establish a federally-funded and globally-accessible compute cloud through which developers could provide secure access to their BDTs.

The term “biological design tools” (or “BDTs”) is a neologism referring to “systems trained on biological data that can help design new proteins or other biological agents.” Computational biological design is, in essence, a data-driven optimization problem. Consequently, over the past decade, breakthroughs in deep learning have propelled progress in computational biology. Today, many of the most advanced BDTs incorporate deep learning techniques and are used and developed by networks of academic researchers distributed across the globe. For example, the Rosetta Software Suite, one of the most popular BDT software packages, is used and developed by Rosetta Commons—an academic consortium of over 100 principal investigators spanning five continents. 

Contributions of BDTs to science and medicine are difficult to overstate. There are already several AI-designed molecules in early-stage clinical trials. BDTs are now used to identify new drug targets, design new therapeutics, and construct faster and less expensive drug synthesis techniques. There are already several AI-designed molecules in early-stage clinical trials.

Unfortunately, these same BDTs can be used for harm. They may be used to create pathogens that are more transmissible or virulent than known agents, target specific sub-populations, or evade existing DNA synthesis screening mechanisms. Moreover, developments in other classes of AI systems portend reduced barriers to BDT misuse. One group at RAND Corporation found that language models could provide guidance that could assist in planning and executing a biological attack, and another group from MIT demonstrated how language models could be used to elicit instructions for synthesizing a potentially pandemic pathogen. Similarly, language models could accelerate the acquisition or interpretation of information required to misuse BDTs. Technologies on the horizon, such as multimodal “action transformers,” could help individuals navigate BDT software, further lowering barriers to misuse.

Research points to several measures BDT developers could employ to reduce risks of misuse, such as securing machine learning model weights (the numerical values representing the learned patterns and information that the model has acquired during training), implementing structured access controls, and adopting Know Your Customer (KYC) processes. However, precaution would have to be taken to not unduly limit access to these tools, which could, in aggregate, impede scientific and medical advancement. For any given tool, access limitations risk diminishing its competitiveness (its available features and performance relative to other tools). These tradeoffs extend to their developers’ interests, whereby stifling the development of tools may jeopardize research, funding, and even career stability. The difficulties of striking a balance in managing risk are compounded by the decentralized, globally-distributed nature of BDT development communities. To suit their needs, risk-mitigation measures should involve minimal, if any, geographic or political restrictions placed on access while simultaneously expanding the ability to monitor for and respond to indicators of risk or patterns of misuse.

One approach that would balance the simultaneous needs for accessibility and security would be for the federal government to establish a global compute cloud for academic research, bearing the costs of running servers and maintaining the security of the cloud infrastructure in the shared interests of advancing public safety and medicine. A compute cloud would enable developers to provide access to their tools through computing infrastructure managed—and held to specific security standards—by U.S. public servants. Such infrastructure could even expand access for researchers, including underserved communities, through fast-tracked grants in the form of computational resources.

However, if computing infrastructure is not designed to reflect the needs of the development community—namely, its global research community—it is unlikely to be adopted in practice. Thus, to fully realize the potential of a compute cloud among BDT development communities, access to the infrastructure should extend beyond U.S. borders. At the same time, the efforts should ensure the cloud has requisite monitoring capabilities to identify risk indicators or patterns of misuse and impose access restrictions flexibly. By balancing oversight with accessibility, a thoughtfully-designed compute cloud could enable transparency and collaboration while mitigating the risks of these emerging technologies.

Recommendations

The U.S. government should establish a federally-funded, globally-accessible compute cloud through which developers could securely provide access to BDTs. In fact, the Biden Administration’s October 2023 “Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence” (the “AI EO”) lays groundwork by establishing a pilot program of a National AI Research Resource (NAIRR)—a shared research infrastructure providing AI researchers and students with expanded access to computational resources, high-quality data, educational tools, and user support. Moving forward, to increase the pilot program’s potential for adoption by BDT developers and users, relevant federal departments and agencies should take concerted action in the timelines circumscribed by the AI EO to address the practical requirements of BDT development communities: the simultaneous need to expand access outside U.S. borders while bolstering the capacity to monitor for misuse.

It is important to note that a federally-funded compute cloud has been years in the making. The National AI Initiative Act of 2020 directed the National Science Foundation (NSF), in consultation with the Office of Science and Technology Policy (OSTP), to establish a task force to create a roadmap for the NAIRR. In January 2023, the NAIRR Task Force released its final report, “Strengthening and Democratizing the U.S. Artificial Intelligence Innovation Ecosystem,” which presented a detailed implementation plan for establishing the NAIRR. The Biden Administration’s AI EO then directed the Director of NSF, in coordination with the heads of agencies deemed appropriate by the Director, to launch a pilot program “consistent with past recommendations of the NAIRR Task Force.”

However, the Task Force’s past recommendations are likely to fall short of the needs of BDT development communities (not to mention other AI development communities). In its report, the Task Force described NAIRR’s primary user groups as “U.S.-based AI researchers and students at U.S. academic institutions, non-profit organizations, Federal agencies or FFRDCs, or startups and small businesses awarded [Small Business Innovation Research] or [Small Business Technology Transfer] funding,” and its resource allocation process is oriented toward this user base. Separately, Stanford University’s Institute for Human-centered AI (HAI) and the National Security Commission on Artificial Intelligence (NSCAI) have proposed institutions, building upon or complementing NAIRR, that would support international research consortiums (a Multilateral AI Research Institute and an International Digital Democracy Initiative, respectively), but the NAIRR Task Force’s report—upon which the AI EO’s pilot program is based—does not substantively address this user base.

In launching the NAIRR pilot program under Sec. 5.2(a)(i), the NSF should put the access and security needs of international research consortiums front and center, conferring with heads of departments and agencies with relevant scope and expertise, such as the Department of State, US Agency for International Development (USAID), Department of Education, the National Institutes of Health, and the Department of Energy. The NAIRR Operating Entity (as defined in the Task Force’s report) should investigate how funding, resource allocation, and cybersecurity could be adapted to accommodate researchers outside of U.S. borders. In implementing the NAIRR pilot program, the NSF should incorporate BDTs in their development of guidelines, standards, and best practices for AI safety and security, per Sec. 4.1, which could serve as standards with which NAIRR users should be required to comply. Furthermore, the NSF Regional Innovation Engine launched through Sec. 5(a)(ii) should consider focusing on international research collaborations, such as those in the realm of biological design.

Besides the NSF, which is charged with piloting NAIRR, relevant departments and agencies should take concerted action in implementing the AI EO to address issues of accessibility and security that are intertwined with international research collaborations. This includes but is not limited to:

The AI EO provides a window of opportunity for the U.S. to take steps toward mitigating the risks posed by BDT misuse. In doing so, it will be necessary for regulatory agencies to proactively seek to understand and attend to the needs of BDT development communities, which will increase the likelihood that government-supported solutions, such as the NAIRR pilot program—and potentially future fully-fledged iterations enacted via Congress—are adopted by these communities. By making progress toward reducing BDT misuse risk while promoting safe, secure access to cutting-edge tools, the U.S. could affirm its role as a vanguard of responsible innovation in 21st-century science and medicine.

Responsible and Secure AI in Production Agriculture

Jennifer Clarke

Agriculture, food, and related industries represent over 5% of domestic GDP. The health of these industries has a direct impact on domestic food security, which equates to a direct impact on national security. In other words, food security is biosecurity is national security. As the world population continues to increase and climate change brings challenges to agricultural production, we need an efficiency and productivity revolution in agriculture. This means using less land and natural resources to produce more food and feed. For decision-makers in agriculture, the lack of human resources and narrow economic margins are driving interest in automation and properly utilizing AI to help increase productivity while decreasing waste amid increasing costs.

Congress should provide funding to support the establishment of a new office within the USDA to coordinate, enable, and oversee the use of AI in production agriculture and agricultural research. 

The agriculture, food, and related industries are turning to AI technologies to enable automation and drive the adoption of precision agriculture technologies. The use of AI in agriculture often depends on proprietary approaches that have not been validated by an independent, open process. In addition, it is unclear whether AI tools aimed at the agricultural sector will address critical needs as identified by the producer community. This leads to the potential for detrimental recommendations and loss of trust across producer communities. These will impede adoption of precision agriculture technologies, which is necessary to domestic and sustainable food security.

The industry is promoting AI technologies to help yield healthier crops, control pests, monitor soil and growing conditions, organize data for farmers, help with workload, and improve a wide range of agriculture-related tasks in the entire food supply chain

However, the use of networked technologies  approaches in agriculture poses risks. AI use could add to this problem if not implemented carefully. For example, the use of biased or irrelevant data in AI development can result in poor performance, which erodes producer trust in both extension services and expert systems, hindering adoption. As adoption increases, it is likely that farmers will use a small number of available platforms; this creates centralized points of failure where a limited attack can cause disproportionate harm. The 2021 cyberattack on JBS, the world’s largest meat processor, and a 2021 ransomware attack on NEW Cooperative, which provides feed grains for 11 million farm animals in the United States, demonstrate the potential risks from agricultural cybersystems. Without established cybersecurity standards for AI systems, those systems with broad adoption across agricultural sectors will represent targets of opportunity.

As evidenced by the recent Executive Order on the Safe Secure and Trustworthy Development and Use of Artificial Intelligence and AI Safety Summit held at Bletchley Park, there is considerable interest and attention being given to AI governance and policy by both national and international regulatory bodies. There is a recognition that the risks of AI require more attention and investments in both technical and policy research. 

This recognition dovetails with an increase in emphasis on the use of automation and AI in agriculture to enable adoption of new agricultural practices. Increased adoption in the short term is required to reduce greenhouse gas emissions and ensure sustainability of domestic food production. Unfortunately, trust in commercial and governmental entities among agricultural producers is low and has been eroded by corporate data policies. Fortunately, this erosion can be reversed by prompt action on regulation and policy that respects the role of the producer in food and national security. Now is the time to promote the adoption of best practices and responsible development to establish security as a habit among agricultural stakeholders. 

Recommendations

To ensure that the future of domestic agriculture and food production leverages the benefits of AI while mitigating the risks of AI, the U.S. government should invest in institutional cooperation; AI research and education; and development and enforcement of best practices.

Recommendation: An Office should be established within USDA focused on AI in Production Agriculture, and Congress should appropriate $5 million over the next 5 years for a total of $25 million for this office. Cooperation among multiple institutions (public, private, nonprofit) will be needed to provide oversight on the behavior of AI in production agriculture including the impact of non-human algorithms and data sharing agreements (“the algorithmic economy”). This level of funding will encourage both federal and non-federal partners to engage with the Office and support its mission. This Office should establish and take direction from an Advisory body led by USDA with inclusive representation across stakeholder organizations including industry (e.g., AgGateway, Microsoft, John Deere), nonprofit organizations (e.g., AgDataTransparent, American Farmland Trust, Farm Bureaus, Ag Data Coalition, Council for Agricultural Science and Technology (CAST), ASABE, ISO), government (e.g., NIST, OSTP), and academia (e.g., APLU, Ag Extension). This advisory body will operate under the Federal Advisory Committee Act (FACA) to identify challenges and recommend solutions, e.g., develop regulations or other oversight specific to agricultural use of AI, including data use agreements and third-party validation, that reduces the uncertainty about risk scenarios and the effect of countermeasures. The office and its advisory body can solicit broad input on regulation, necessary legislation, incentives and reforms, and enforcement measures through Requests for Information and Dear Colleague letters. It should promote best practices as described below, i.e., incentivize responsible use and adoption, through equitable data governance, access, and private-public partnerships. An example of an incentive is providing rebates to producers who purchase equipment that utilizes validated AI technology. 

To support development of best practices for the use of AI in production agriculture, in partnership with NIH, NSF, and DOD/DOE, the proposed Office should coordinate funding for research and education on the sociotechnical context of AI in agriculture across foundational disciplines including computer science, mathematics, statistics, psychology, and sociology. This new discipline of applied AI (built on theoretical advances in AI since the 1950s) should provide a foundation for developing best practices for responsible AI development starting with general, accepted standards (e.g., NIST’s framework). For example, best practices may include transparency through the open source community and independent validation processes for models and software. AI model training requires an immense amount of data and AI models for agriculture will require many types of data sets specific to production systems (e.g., weather, soil, management practices, etc.). There is an urgent need for standards around data access and use that balance advances and adoption of precision agriculture with privacy and cybersecurity concerns.   

In support of the work of the proposed Office, Congress should appropriate funding at $20M/year to USDA to support the development of programs at land-grant universities that provide multidisciplinary training in AI and production agriculture. The national agricultural production cyberinfrastructure (CI) has become critical to food security and carbon capture in the 21st century. A robust talent pipeline is necessary to support, develop, and implement this CI in preparation for the growth in automation and AI. There is also a critical need for individuals trained in both AI and production agriculture who can lead user-centered design and digital services on behalf of producers. Training must include foundation knowledge of statistics, computer science, engineering, and agricultural sciences coupled with experiential learning that provide trainees with opportunities to translate their knowledge to address current CI challenges. These opportunities may arise from interagency cooperation at the federal, state, and local  levels, in partnership with grower cooperatives, farm bureaus, and land-grant universities, to ensure that training meets pressing and future needs in agricultural systems.

BioNETWORK: The Internet of Distributed Biomanufacturing

Summary

The future of United States industrial growth resides in the establishment of biotechnology as a new pillar of industrial domestic manufacturing, thus enabling delivery of robust supply chains and revolutionary products such as materials, pharmaceuticals, food, energy. Traditional centralized manufacturing of the past is brittle, prone to disruption, and unable to deliver new products that leverage unique attributes of biology. Today, there exists the opportunity to develop the science, infrastructure, and workforce to establish the BioNETWORK to advance domestic distributed biomanufacturing, strengthen U.S.-based supply chain intermediaries, provide workforce development for underserved communities, and achieve our own global independence and viability in biomanufacturing. Implementing the BioNETWORK to create an end-to-end distributed biomanufacturing platform will fulfill the Executive Order on Advancing Biotechnology and Biomanufacturing Innovation and White House Office of Science and Technology Policy (OSTP) Bold Goals for U.S. Biotechnology and Biomanufacturing.

Challenge and Opportunity

Biotechnology harnesses the power of biology to create new services and products, and the economic activity derived from biotechnology and biomanufacturing is referred to as the bioeconomy. Today, biomanufacturing and most other traditional non-biomanufacturing is centralized. Traditional manufacturing is brittle, does not enhance national economic impact or best use national raw materials/resources, and does not maximize innovation enabled by the unique workforce distributed across the United States. Moreover, in this era of supply chain disruptions due to international competition, climate change, and pandemic-sized threats (both known and unknown), centralized approaches that constitute a single point of attack/failure and necessarily restricted, localized economic impact are themselves a huge risk. While federal government support for biotechnology has increased with recent executive orders and policy papers, the overarching concepts are broad, do not provide actionable steps for the private sector to respond to, and do not provide the proper organization and goals that would drive outcomes of real manufacturing, resulting in processes or products that directly impact consumers. A new program must be developed with clear milestones and deliverables to address the main challenges of biomanufacturing. Centralized biomanufacturing is less secure and does not deliver on the full potential of biotechnology because it is: 

Single point failures in centralized manufacturing are a root cause of product disruptions and are highlighted by current events. The COVID-19 pandemic revealed that point failures in the workforce or raw materials created disruptions in the centralized manufacturing, and availability of hand sanitizers, rubber gloves, masks, basic medicines, and active pharmaceutical ingredients impacted every American. International conflict with China and other adversarial countries has also created vulnerabilities in the sole source access to rare earth metals used in electronics, batteries, and displays, driving the need for alternate options for manufacturing that do not rely on single points of supply. To offset this situation, the United States has access to workforce, raw materials, and waste streams geographically distributed across the country that can be harnessed by biomanufacturing to produce both health and industrial products needed by U.S. consumers. However, currently there are only limited distributed manufacturing infrastructure development efforts to locally process those raw materials, leaving societal, economic, and unrealized national security risks on the table. Nation-scale parallel production in multiple facilities is needed to robustly create products to meet consumer demand in health, industrial, energy, and food markets. 

The BioNETWORK inverts the problem of a traditional centralized biomanufacturing facility and expertise paradigm by delivering a decentralized, resilient network enabling members to rapidly access manufacturing facilities, expertise, and data repositories, as needed and wherever they reside within the system, by integrating the substantial existing U.S. bioindustrial capabilities and resources to maximize nationwide outcomes. The BioNETWORK should be constructed as an aggregate of industrial, academic, financial, and nonprofit entities, organized in six regionally-aligned nodes (see figure below for notional regional distribution) of biomanufacturing infrastructure that together form a hub network that cultivates collaboration, rapid technology advances, and workforce development in underserved communities. The BioNETWORK’s fundamental design and construction aligns with the need for new regional technology development initiatives that expand the geographical distribution of innovative activity in the U.S., as stated in the CHIPS and Science Act. The BioNETWORK acts as the physical and information layer of manufacturing innovation, generating market forces, and leveraging ubiquitous data capture and feedback loops to accelerate innovation and scale-up necessary for full-scale production of novel biomaterials, polymers, small molecules, or microbes themselves. As a secure network, BioNETWORK serves as the physical and virtual backbone of the constituent biomanufacturing entities and their customers, providing unified, distributed manufacturing facilities, digital infrastructure to securely and efficiently exchange information/datasets, and enabling automated process development. Together the nodes function in an integrated way to adaptively solve biotechnology infrastructure challenges as well as load balancing supply chain constraints in real-time depending on the need. This includes automated infrastructure provisioning of small, medium, or large biomanufacturing facilities, supply of regional raw materials, customization of process flow across the network, allocation of labor, and optimization of the economic effectiveness. The BioNETWORK also supports the implementation of a national, multi-tenant cloud lab and enables a systematic assessment of supply chain capabilities/vulnerabilities for biomanufacturing.

s a secure network, BioNETWORK serves as the physical and virtual backbone of the constituent biomanufacturing entities and their customers, providing unified, distributed manufacturing facilities, digital infrastructure to securely and efficiently exchange information/datasets, and enabling automated process development.

As a secure network, BioNETWORK serves as the physical and virtual backbone of the constituent biomanufacturing entities and their customers, providing unified, distributed manufacturing facilities, digital infrastructure to securely and efficiently exchange information/datasets, and enabling automated process development.

Plan of Action

Congress should appropriate funding for an interagency coordination office co-chaired by the OSTP and the Department of Commerce (DOC) and provide $500 million to the DOC, Department of Energy (DOE), and Department of Defense (DOD) to initiate the BioNETWORK and use its structure to fulfill economic goals and create industrial growth opportunities within its three themes

  1. Provide alternative supply chain pathways via biotechnologies and biomanufacturing to promote economic security. Leverage BioNETWORK R&D opportunities to develop innovative biomanufacturing pathways that could address supply chain bottlenecks for critical drugs, chemicals, and other materials. 
  2. Explore distributed biomanufacturing innovation to enhance supply chain resilience. Leverage BioNETWORK R&D efforts to advance flexible and adaptive biomanufacturing platforms to mitigate the effects of supply chain disruptions. 
  3. Address standards and data infrastructure to support biotechnology and biomanufacturing commercialization and trade. Leverage BioNETWORK R&D needed to enable data interoperability across the network to enable scale-up and increase global competitiveness. 

To achieve these goals, the policy Plan of Action includes the following steps: 

1. Congress should appropriate $10 million to establish an interagency coordination office within OSTP that is co-chaired by the DOC. This fulfills the White House Executive Order and CHIPs and Science mandates for better interagency coordination among the DOE, DOC, DOD, National Institute of Standards and Technology (NIST), and the National Science Foundation (NSF). 

2. Congress should then appropriate $500 million to DOC and DOE to fund a biomanufacturing moonshot that includes creating the pilot network of three nodes to form the BioNETWORK in regions of the U.S. within six months of receiving funding. This funding should be managed by the interagency coordination office in collaboration with a not-for-profit organization whose mission is to build, deploy, and manage the BioNETWORK together with the federal entities. The role of the not-for-profit is to ensure that a trusted, unbiased partner (not influenced by outside entities) is involved, such that the interests of the taxpayer, U.S. government, and commercial sectors are all represented in the most beneficial way possible. The mission should include education, workforce development, safety/security, and sustainment as core principles, such that the BioNETWORK can stand alone once established. The new work to build the network should also synergize with the foundational science of the NSF and the national security focus of DOD biotechnology programs.

3. Continued investment of an additional $500 million should be appropriated by Congress to create economic incentives to sustain and transition the BioNETWORK from public funding to full commercial operation. This step requires evaluation of concrete go/no-go milestones and deliverables to ensure on-time, on-budget operations have been met. The interagency coordination office should work with DOC, DOE, DOD, and other agencies to leverage these incentives and create other opportunities to promote the BioNETWORK so that it does not require public funding to keep itself sustainable and can obtain private funding.   

Create a Pilot Network of Three Nodes

To accelerate beyond current biomanufacturing programs and efforts, the first three nodes of the BioNETWORK should be constructed in three new disparate geographic regions (i.e., East, Midwest, West, or other locations with relevant feedstocks, workforce, or component infrastructure) to show the networking capabilities for distributed manufacturing. The scale of funding required to design, construct, and deploy the first three nodes is $500 million. The initiation and construction of the BioNETWORK should commence within six months. The DOE should lead the initiation and deployment of the technical construction of the BioNETWORK through Theme 2 of their Biomanufacturing goals, which “seeks alternative processes to produce chemicals and materials from renewable biomass and intermediate feedstocks by developing low-carbon-intensity product pathways and promoting a circular economy for materials.” Each node should create regional partnerships that have four entities (a physical manufacturing facility, a cell programming entity, an academic research and development entity, and a workforce/resource entity). All four entities will contain both physical facilities such as industrial fermentation and wet lab space, as well as the workforce needed to run them. On top of the pilot nodes, a science and technology/engineering integrator of the system should be identified to coordinate the effort and lead security/safety efforts for the physical network. Construction of the initial BioNETWORK should be completed within two years. 

Achievement of the BioNETWORK goals requires the design plan to:

The BioNETWORK construction milestones should fulfill the White House OSTP bold goals through new capabilities delivered via distributed manufacturing infrastructure: 

Full Network: Plan for Sustainability 

Congress and executive branch agencies establish economic incentives for commercial entities, state/local governments, and consumers of bioindustrial manufacturing products to create commercialization pathways that enhance local economies while also supporting the national network. These include tax credits, tax breaks, low interest loans, and underwritten loans as a starting point. To facilitate tech transition, unique lab-to-market mechanisms and proven tools to address market failure and applied technologies gaps should be used in conjunction with those in the Inflation Reduction Act. This includes prize and challenge competitions, market shaping procurement or loan programs, and streamlined funding of open, cross-disciplinary research, and funding at the state and local levels. 

A new public-private partnership could coordinate across multiple efforts to ensure they drive toward rapid technology deployment and integration. This includes implementing a convertible debt plan that rewards BioNETWORK members with equity after reaching key milestones, providing an opportunity for discounted buyout by other investors during rounds of funding, and working with the federal government to design market-shaping mechanisms such as advance market commitments to guarantee purchase of a bioproduction company’s spec-meeting product. 

Additionally, the BioNETWORK should be required to expand the repertoire of domestic renewable raw materials into a suite of high-demand, industry-ready products as prescribed in the DOC’s goals in biomanufacturing. This will ensure all regions have support for commercial goods and can automatically assess domestic supply chain capabilities and vulnerabilities, and are provided compensatory remediation on demand. The full BioNETWORK consists of six nodes—aligned to each of the major geographic regions and/or EDA regions in the United States—which have unique raw materials, workforce, infrastructure, and consumption of products that contribute to supporting the overall network functionality. The full BioNETWORK should be active within five years of project initiation and be evaluated against phased milestones throughout. 

Conclusion

Networked solutions are resilient and enduring. A single factory is at risk of transfer to foreign ownership, closure, or obsolescence. The BioNETWORK creates connectivity among distributed biomanufacturing physical infrastructure to form a network with a robust domestic value chain. Today’s biomanufacturing investments suffer from the need to vertically integrate due to lack of flexible capacity across the value chain, which raises capital requirements and overall risk. The BioNETWORK drives horizontal integration through the network nodes via new infrastructure, connecting physical infrastructure of the nodes within the system. The result is a multi-sided marketplace for biotechnology innovation, products, and commercialization. 

The federal government should initiate a new program and select performers within the next six months to begin the research, development, and construction of the first three nodes of the BioNETWORK. Taking action to establish the BioNETWORK ensures that the United States has the necessary physical and virtual infrastructure to grow the bioeconomy and its international leadership in biotechnology. The BioNETWORK creates new job opportunities for people across the country where training in biotechnology expands the skill sets of people with broad-spectrum applicability from trades to advanced degrees. The BioNETWORK drives circular economies where raw materials from rural and urban centers enter the network and are transformed into high-value products such as advanced materials, pharmaceuticals, food, and energy. The BioNETWORK protects U.S. supply chain resiliency through distributed manufacturing and links regional development into a national capability to establish biomanufacturing as a pillar of economic and technological growth for today and into the 22nd century.

Frequently Asked Questions
How is this idea different from the regional technology and innovation hub program within the EDA and the Biofoundries program at the NSF or other recent government-funded hubs?

Establishment of the BioNETWORK scales, connects, and networks the impact of a hub and tailors it to the needs of bioindustrial manufacturing, which requires regional feedstocks and integration of small-, intermediate-, and large-scale industrial fermentation facilities scattered across the United States to form an end-to-end distributed biomanufacturing platform. Similar to the goals of the EDA hub program, the BioNETWORK will accelerate regional economic activity, workforce development, and re-establishment of domestic manufacturing. Leveraging activity of the EDA and NSF Biofoundries program is an opportunity for coordination across the interagency.

What infrastructure needs to be built to achieve this?

Retrofitting existing small-, intermediate-, and large-scale biomanufacturing facilities/plants is necessary to construct the connected BioNETWORK. This includes new/modified fermentation equipment, scale-up and purification hardware, software/communications for networking, transportation, load-balancing, and security infrastructure.

What is needed to ensure the BioNETWORK is enacted within five years?

Clear, measurable intermediate milestones and deliverables are required to ensure that the BioNETWORK is on track. Every three months, key performance metrics and indicators should be used to demonstrate technical functionality. Planned economic and workforce targets should be established every year and tracked for performance. Adjustments to the technical and business plans should be implemented if needed to ensure the overarching goals are achieved.

What does success look like if the BioNETWORK program is enacted? What does failure look like?

A major outcome of the BioNETWORK program is that biomanufacturing in the United States becomes on par with the other traditional pillars of manufacturing such as chemicals, food, and electronics. Workforce retraining to support this industry leads to new high-paying jobs as well as new consumer product sectors and markets with new avenues for economic growth. Failure to deploy the BioNETWORK leaves the United States vulnerable to supply chain disruption, little to no growth in manufacturing, and out competition by China and other peer nations that are investing in and growing biotechnology.


Secondary milestones include key performance indicators, including increased capacity, decrease in production time, robustness (more up time vs. down time), cheaper costs, better use of regional raw materials, etc.

Wins, Gaps, & Looking Forward in the U.S. Bioeconomy

September should be considered National Bioeconomy Month. This past September marked the one year anniversary of the 2022 Presidential Executive order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy (affectionately known as the Bioeconomy EO). SynBioBeta celebrated the occasion by organizing a Bioeconomy Product Showcase on Capitol Hill that highlighted many different companies within the bioeconomy and proudly boasted bipartisan support in attendance. FAS wrapped up the month by hosting a Bioeconomy & Biomanufacturing Hill Day and Dinner on September 28th, 2023. We brought in some of our subject matter experts to talk in-depth about their Day One Memos and other contributions with key members of Congress.

Highlights Hill Day & Dinner

From our subject matter experts
Coordinating the U.S. Government Approach to the Bioeconomy
Policy memo
read more
Accelerating Biomanufacturing through a Grand Challenge
Policy memo
read more
Strengthening the U.S. Biomanufacturing Sector Through Standardization
Policy memo
read more
Maintaining Progress and Growing US Biomanufacturing
Interview
read more
Federation of American Scientist Bioeconomy experts standing in front of the Hart Senate Office Building sign
Team FAS on the Hill

Dr. Nazish Jeffery, Dr. Sarah Carter, Dr. Allison Berke, Dr. Chris Stowers, and Dr. Sarah Richardson representing the Federation of American Scientists at the Bioeconomy & Biomanufacturing Hill Day and Dinner

Next Year is Critical for the Bioeconomy

In a short timespan, several federal agencies have pushed the needle forward in terms of the U.S. bioeconomy, however there is no shortage of work left in order to achieve a “Sustainable, Safe, and Secure” bioeconomy. For the next year, we would like to see an updated definition of the U.S. bioeconomy that accounts and specifies sectors that are and are not part of the bioeconomy and takes sustainability as its main priority. In addition, the National Institute of Standards and Technology (NIST) should update the Bioeconomy Lexicon and prioritize setting standards for biomanufacturing that utilizes a sector to sector approach instead of an overarching standards approach to ensure that innovation is not stifled by standards that do not allow for the flexibility needed in the biotech space. 

Additionally, it will be vital for the federal government to enact a true framework for the U.S. bioeconomy by creating a coordinating office housed in OSTP that works with the various federal agencies focused on the bioeconomy and provide support to publish the reports directed by the Bioeconomy EO on time. Furthermore, in order to achieve products, goods, and services that are sustainable, secure, and safe, it will be essential for the coordinating office to gather public opinions in order to help shape and influence our bioeconomy.

Increased congressional involvement is also necessary to address key challenges the bioeconomy currently faces, such as the inability to measure the bioeconomy and the challenge that companies within the bioeconomy face (such as incomplete knowledge on processes relating to creating a startup, scaling goods and serves, and navigating the regulatory system). The BEA should be directed by Congress to create a satellite account to measure the U.S. bioeconomy and Congress should mandate a public-private driven landscape analysis on the current financial situation of the U.S. bioeconomy in order to be able to identify the gaps in financing the sector currently faces. 

There is no doubt that the bioeconomy has potential to grow, but it needs a solid framework to stand upon. Implementing some or all of these ideas will not only lead to a prosperous bioeconomy, but it will also create one that is resilient, sustainable, and secure.

“The US needs to lean into an old strength”: Maintaining Progress and Growing US Biomanufacturing

The U.S. bioeconomy has been surging forward, charged by the Presidential Executive Order 14081 and the CHIPS and Science Act. However, there are many difficult challenges that lay ahead for the U.S. bioeconomy, including for U.S. biomanufacturing capabilities. U.S. biomanufacturing has been grappling with issues in fermentation capacity including challenges related to scale-up, inconsistent supply chains, and downstream processing. While the U.S. government works on shoring up these roadblocks, it will be important to bring industry perspectives into the conversation to craft solutions that not only addresses the current set of issues but looks to mitigate challenges that may arise in the future.

To get a better understanding of industry perspectives on the U.S. bioeconomy and the U.S. biomanufacturing sector, the Federation of American Scientists interviewed Dr. Sarah Richardson, the CEO of MicroByre. MicroByre is a climate-focused biotech startup that specializes in providing specialized bacteria based on the specific fermentation needs of its clients. Dr. Richardson received her B.S. in biology from the University of Maryland in 2004 and a Ph.D. in human genetics and molecular biology from Johns Hopkins University School of Medicine in 2011. Her extensive training in computational and molecular biology has given her a unique perspective regarding emerging technologies enabled by synthetic biology.

FAS: The U.S. Government is focused on increasing fermentation capacity, including scale-up, and creating a resilient supply chain. In your opinion, are there specific areas in the supply chain and in scale-up that need more attention?

Dr. Sarah Richardson: The pandemic had such an impact on supply chains that everyone is reevaluating the centralization of critical manufacturing. The United States got the CHIPS and Science Act to invest in domestic semiconductor manufacturing. The voting public realized that almost every need they had required circuits. Shortages in pharmaceuticals are slowly raising awareness of chemical and biomedical manufacturing vulnerabilities as well. The public has even less insight into vulnerabilities in industrial biomanufacturing, so it is important that our elected officials are proactive with things like Executive Order 14081.

When we talk about supply chains we usually mean the sourcing and transfer of raw, intermediate, and finished materials — the flow of goods. We achieve robustness by having alternative suppliers, stockpiles, and exacting resource management. For biomanufacturing, an oft raised supply chain concern is feedstock. I can and will expound on this, but securing a supply of corn sugar is not the right long-term play here. Shoring up corn sugar supplies will not have a meaningful impact on industrial biomanufacturing and should be prioritized in that light.

Biomanufacturing efforts are different from the long standing production of consumer goods in that they are heavily tied to a scientific vendor market. As we scale to production, part of our supply chain is a lot of sterile plastic disposable consumables. We compete with biomedical sectors for those, for personal protective equipment, and for other appliances. This supply chain issue squeezed not just biomanufacturing, but scientific research in general.

We need something that isn’t always thought of as part of the supply chain: specialized infrastructural hardware. This  may not be manufactured domestically. Access to scale up fermentation vessels is already squeezed. The other problem is that no matter where you build them, these vessels are designed for the deployment of canonical feedstocks and yeasts. Addressing the manufacturing locale would offer us the chance to innovate in vessel and process design and support the kinds of novel fermentations on alternate feedstocks that are needed to advance industrial biomanufacturing. There are righteous calls for the construction of new pilot plants. We should make sure that we take the opportunity to build for the right future.

One of the indisputable strengths of biomanufacturing is the potential for decentralization! Look at microbrewing: fermentation can happen anywhere without country-spanning feedstock pipelines. As we onboard overlooked feedstocks, it may only be practical to leverage them if some fermentation happens locally. As we look at supply chains and scale up we should model what that might look like for manufacturing, feedstock supply chains, and downstream processing. Not just at a national level, but at regional and local scales as well.

There are a lot of immediate policy needs for the bioeconomy, many of which are outlined in Executive Order 14081. How should these immediate needs be balanced with long-term needs? Is there a trade-off?

Counterintuitively, the most immediate needs will have the most distant payoffs! The tradeoff is that we can’t have every single detail nailed down before work begins. We will have to build tactically for strategic flexibility. Climate change and manufacturing robustness are life or death problems. We need to be open to more creative solutions in funding methods, timeline expectations; in who comes to the table, in who around the table is given the power to affect change, and in messaging! The comfortable, familiar, traditional modes of action and funding have failed to accelerate our response to this crisis.

We have to get started on regulation yesterday, because the only thing that moves slower than technology is policy. We need to agree on meaningful, aggressive, and potentially unflattering metrics to measure progress and compliance. We need to define our terms clearly: what is “bio-based,” does it not have petroleum in it at all? What does “plant-based” mean? What percentage of a product has to be renewable to be labeled so? If it comes from renewable sources but its end-of-life is not circularizable, can we still call it “green”?

We need incentives for innovation and development that do not entrench a comfortable but unproductive status quo. We need to offer stability to innovators by looking ahead and proactively incubating the standards and regulations that will support safety, security, and intellectual property protection. We should evaluate existing standards and practices for inflexibility: if they only support the current technology and a tradition that has failed to deliver change, they will continue to deliver nothing new as a solution. 

We need to get on good footing with workforce development, as well. A truly multidisciplinary effort is critical and will take a while to pull off; it takes at least a decade to turn a high school student into a scientist. I only know of one national graduate fellowship that actually requires awardees to train seriously in more than one discipline. Siloing is a major problem in higher education and therefore in biomanufacturing. What passes for “multidisciplinary” is frequently “I am a computer scientist who is not rude to biologists” or “our company has both a chemical division and an AI division.” A cross-discipline “bilingual” workforce is absolutely critical to reuniting the skill sets needed to advance the bioeconomy. Organizations like BioMADE with serious commitments to developing a biomanufacturing workforce cannot effectively address the educational pipeline without significantly more support.

Hand holding petri dish with bacterial striations.

MicroByre is working to advance alternatives to substrates currently favored by the bioeconomy.

When we emphasize the collection of data — which data are we talking about? Is the data we have collected already a useful jumping off point for what comes next? Are the models relevant for foreseeable changes in technology, regulation, and deployment? For some of it, absolutely not. As every responsible machine learning expert can tell you, data is not something you want to skimp or cheap out on collecting or curating. We have to be deliberate about what we collect, and why. Biases cannot all be avoided, but we have to take a beat to evaluate whether extant models, architecture, and sources are relevant, useful, or adaptable. A data model is as subject to a sunk cost fallacy as anything else. There will be pressure to leverage familiar models and excuses made about the need for speed and the utility of transfer learning. We cannot let volume or nostalgia keep us from taking a sober look at the data and models we currently have, and which ones we actually need to get.

What are the major pain points the biomanufacturing industry is currently facing?

Downstream processing is the work of separating target molecules from the background noise of production. In purely chemical and petrochemical fields, separation processes are well established, extensively characterized, and relatively standardized. This is not the case in industrial biomanufacturing, where upstream flows are arguably more variable and complex than in petrochemicals. Producers on the biomedical side of biomanufacturing who make antibiotics, biologics, and other pharmaceuticals have worked on this problem for a long time. Their products tend to be more expensive and worth specialized handling. The time the field has spent developing the techniques in the urgent pursuit of human health works in their favor for innovation. However, separating fermentation broth from arbitrary commodity molecules is still a major hurdle for a bioindustrial sector already facing so many other simultaneous challenges. Without a robust library of downstream processing methods and a workforce versant in their development and deployment, new industrial products are viewed as significant scaling risks and are funded accordingly.

There is fatigue as well. For the sake of argument, let us peg the onset of the modern era of industrial biomanufacturing to the turn of the latest century. There have been the requisite amount of promises any field must make to build itself into prominence, but there has not been the progress that engenders trust in those or future promises. We have touted synthetic biology as the answer for two and a half decades but our dependence on petroleum for chemicals is as intense as ever. The goodwill we need to shift an entire industry is not a renewable resource. It takes capital, it takes time, and it takes faith that those investments will pay off. But now the chemical companies we need to adopt new solutions have lost some confidence. The policy makers we need to lean into alternative paths and visionary funding are losing trust. If the public from whence government funding ultimately springs descends into skepticism, we may lose our chance to pivot and deliver.

The right investment right now will spell the difference between life and death on this planet for billions of people.

This dangerous dearth of confidence can be addressed by doing something difficult: owning up to it. No one has ever said “oh goody — a chance to do a postmortem!”. But such introspective exercises are critical to making effective changes. A lack of reflection is a tacit vote for the status quo, which is comfortable because we’re rarely punished for a lack of advocacy. We should commission an honest look at the last thirty years — without judgment, without anger, and without the need to reframe disappointing attempts as fractional successes for granting agencies, or position singular successes as broadly representative of progress for egos. 

Biomanufacturing is so promising! With proper care and attention it will be incredibly transformative. The right investment right now will spell the difference between life and death on this planet for billions of people. We owe it to ourselves and to science to do it right — which we can only do by acknowledging what we need to change and then truly committing to those changes.

Corn sugar tends to be the most utilized biomass in the bioeconomy. What are the issues the U.S. faces if it continues to rely solely on corn sugar as biomass?

History shows that low-volume, high-margin fine chemicals can be made profitable on corn sugar, but high-volume, low-margin commodity chemicals cannot. Projects that produce fine chemicals and pharmaceuticals see commercial success but suffer from feedstock availability and scaling capacity. Success in high-margin markets encourages people to use the exact same technology to attempt low-margin markets, but then they struggle to reduce costs and improve titers. When a commodity chemical endeavor starts to flag, it can pivot to high-margin markets. This is a pattern we see again and again. As long as corn sugar is the default biomass, it will not change; the United States will not be able to replace petrochemicals with biomanufacturing because the price of corn sugar is too high and cannot be technologically reduced. This pattern is also perpetuated because the yeast we usually ask to do biomanufacturing cannot be made to consume anything but corn sugar. We also struggle to produce arbitrary chemicals in scalable amounts from corn sugar. We are stuck in an unproductive reinforcing spiral. 

Even if commodity projects could profit using corn sugar, there is not enough to go around. How much corn sugar would we have to use to replace even a fifth of the volume of petroleum commodity chemicals we currently rely on? How much more land, nitrogen, water, and additional carbon emissions would be needed? Would chemical interests begin to overpower food, medical, and energy interests? What if a pathogen or natural disaster wiped out the corn crop for a year or two? Even if we could succeed at manufacturing commodities with corn sugar alone, locking out alternatives makes the United States supply chain brittle and vulnerable.

Gloved hands holding petri dish showing light green bacterial striations.

MicroByre is working to advance alternatives to substrates currently favored by the bioeconomy.

Continued reliance on corn sugar slows our technological development and stifles innovation. Specialists approaching manufacturing problems in their domain are necessarily forced to adopt the standards of neighboring domains. A chemical engineer is not going to work on separating a biomass into nutrition sources when no microbiologist is offering an organism to adopt it. A molecular biologist is not going to deploy a specialized metabolic pathway dependent on a nutrition source not found in corn sugar. Equipment vendors are not going to design tools at any scale that stray from a market demand overwhelmingly based on the use of corn sugar. Grantors direct funds with the guidance of universities and industry leaders, who are biased towards corn sugar because that’s what they use to generate quick prototypes and spin out new start up companies. 

The result of relying on corn sugar is an entrenched field and consequently we might lose our chance to make a difference. Without introducing low-cost, abundant feedstocks like wastes, we run the risk of disqualifying an entire field of innovation. 

What does the U.S. need to do in order for other biomass sources to be utilized beyond corn sugar? Are there ideas (or specific programs) that the U.S. government could supercharge?

Federal agencies must stop funding projects that propose to scale familiar yeasts on corn sugars to produce novel industrial chemicals. We must immediately stop funding biomass conversion projects meant to provide refined sugars to such endeavors. And we must stop any notion of dedicating arable land solely to corn sugar solely for the purposes of biomanufacturing new industrial products. The math does not and will not work out. The United States must stop throwing money and support at such things that seem like they ought to succeed any minute now, even though we have been waiting for that success for 50 years without any meaningful changes in the economic analysis or technology available.

Ironically, we need to take a page from the book that cemented petroleum and car supremacy in this country. We need to do the kind of inglorious, overlooked, and subsequently taken for granted survey of the kind that enabled the Eisenhower Interstate System to be built. 

We need to characterize all of the non-corn feedstocks and their economic and microbial ecosystems. We need to know how much of each biomass exists, what it is composed of, and who is compiling where. We need to know what organisms rot it and what they produce from it. We need to make all of that data as freely available as possible to lower the barriers of entry for cross-disciplinary teams of researchers and innovators to design and build the logistical, microbiological, chemical, and mechanical infrastructure necessary. We need to prioritize and leverage the complex biomasses that cannot just be ground into yeast food. 

We need to get the lay of the land so – to use the roadway analogy – we know where to pour the asphalt. An example of this sort of effort is the Materials Genome Initiative, which is a crosscutting multi-agency initiative for advancing materials and manufacturing technology. (And which has, to my chagrin, stolen the term “genome” for non-biological purposes.) An even more visible example to the public is a resource like the Plant Hardiness Zone Map that provides a basis for agricultural risk assessment to everyone in the country.

The United States needs to lean into an old strength and fund infrastructure that gives all the relevant specialties the ability to collaborate on truly divergent and innovative biomass efforts. The field of industrial biomanufacturing must make a concerted effort to critically examine a history of failed technical investments, shake off the chains of the status quo, and guide us into true innovation. Infrastructure is not the kind of project that yields an immediate return. If venture capital or philanthropy could do it, they would have already. The United States must flex its unique ability to work on a generational investment timeline; to spend money in the very short term on the right things so as to set everyone up for decades of wildly profitable success — and a safer and more livable planet.

Governance of AI in Bio: Harnessing the Benefits While Reducing the Risks

Artificial Intelligence (AI) has gained momentum in the last 6 months and has become impossible to ignore. The ease of use of these new tools, such as AI-driven text and image generators, have driven significant discussion on the appropriate use of AI. Congress has also started digging into AI governance. Discussion has focused on a wide range of social consequences of AI, including biosecurity risks that could arise. To develop an overarching framework that includes addressing bio-related risks, it will be crucial for Congress, different federal agencies, and various non-governmental AI stakeholders to work together.

Bio Has Already Been Utilizing AI For Decades

Artificial intelligence has a long history in the life sciences. The principles are not new. Turing developed the idea in the 50’s and, by the turn of the century, bioinformaticians (data scientists for biological data) were already using AI in genome analysis. One focus of AI tools for biology has been on proteins. Nearly every known function in your body relies on proteins, and their 3-dimensional shapes determine their functions. Predicting the shape of a protein has long been a critical challenge. In 2020, Alphabet’s DeepMind published AlphaFold 2 as an AI-enabled software tool capable of doing just that. While not perfect, scientists have been able to use it and related tools to predict the shape of proteins faster and even to create new proteins optimized for specific applications. Of course, the applications of AI in biotechnology extends beyond proteins. Medical researchers have taken advantage of AI to identify new biomarkers and leverage AI to improve diagnostic tests. Industrial biotechnology researchers are exploring the use of AI to optimize biomanufacturing processes to improve yield. In other natural sciences, AI can even drive entire courses of experiments with minimal human input, with biological labs in development. Unfortunately, these same tools and capabilities could also be misused to cause harm by actors trying to develop toxins, pathogens, and other potential bio risks.

Proposed Bio x AI Solutions Are Incomplete 

Congress is looking for ways to reduce AI risks, beginning with social implications such as disinformation, employment decision making, and other areas encountered by the general public. These are excellent starting points and echo some concerns abroad. Some Congressional action has also called for sweeping studies, new regulatory commissions, or broadly scoped risk management frameworks (see the AI Risk Management Framework developed by NIST). While some recently proposed bills address AI concerns in healthcare, there have been few solutions for reducing risks specifically related to intersections of AI with biosciences and biotechnology. 

The Biden Administration recently reached agreements with leaders in the development of AI models to implement risk mitigation measures, including ones related to biosecurity. However, all of the current oversight mechanisms for AI models are voluntary, which has generated discussion on how to provide incentives and whether a stronger approach is needed. As the availability of AI models increases and models specific to biosciences and biotechnology become more sophisticated, this question about how to establish enforceable rules and appropriate degrees of accountability while minimizing collateral impact on innovation will become more urgent.

Approaches to governance for AI’s intersections with biology must also be tailored to the needs of the scientific community. As AI-enabled biodesign tools drive understanding and innovation, they will also decrease hurdles for malicious actors seeking to do harm. At the same time, data sharing, collaboration, and transparency have long been critical to advances in biosciences. Restricting AI model development or access to data, models, or model outputs without hampering legitimate research and development will be challenging. Implementing guardrails for these tools should be done carefully and with a solid understanding of how they are used and how they might be misused. Key questions for oversight of AI in bio include:

Now, While the Policy Window is Open

Recently, the National Defense Authorization Act for Fiscal Year 2022 created the bipartisan, intergovernmental National Security Commission on Emerging Biotechnology. The NSCEB has been tasked with creating an interim report by the end of 2023 and a final policy recommendation report by the end of 2024 with recommendations for Congressional action. One of the areas they are looking into is the intersection of AI and biosciences, specifically how AI technology can enable innovation in the biosciences and biotechnologies while mitigating risks. 

The current attention on AI and the upcoming interim report to Congress by the NSCEB provide  an important policy window and acts as a call to action that requires stakeholder input in order to create governance and policy recommendations that enable innovation while mitigating risks. If you are an AI or bio expert within academia, the biotech industry, an AI lab, or other non-governmental organization and are interested in contributing policy ideas, we have just launched our Bio x AI Policy Development Sprint here. Timely, well considered policy recommendations that address the key questions listed above will lead to the best possible implementation of AI in biosciences and biotechnology.

Coordinating the U.S. Government Approach to the Bioeconomy

Summary

The bioeconomy touches nearly every function of the U.S. government. The products of the bioeconomy compete in an international marketplace and include medicines, foods, fuels, materials, and novel solutions to broad challenges including climate and sustainability. The infrastructure, tools, and capabilities that drive the bioeconomy must be safeguarded to maintain U.S. leadership and to protect against misuse. The vast scale of these issues requires a cross-governmental approach that draws on input and engagement with industry, academia, nongovernmental organizations, and other stakeholders across the bioeconomy. 

To achieve a durable and strategic interagency approach to the bioeconomy, the Office of Science and Technology Policy (OSTP) should establish and Congress should fund a Bioeconomy Initiative Coordination Office (BICO) to coordinate strategic U.S. government investments in the bioeconomy; facilitate efficient oversight and commercialization of biotechnology products; safeguard biotechnology infrastructure, tools and capabilities; and serve as a focal point for government engagement with nongovernmental partners and experts. 

Challenge and Opportunity

Executive Order 14081, “Establishing a National Biomanufacturing and Biotechnology Initiative,” was released in September 2022. Since then, OSTP has worked to coordinate this Initiative and has made significant progress with the March 2023 release of “Bold Goals for Biotechnology and Biomanufacturing,” which describes how government agencies will support and benefit from investments in the bioeconomy; an implementation plan is forthcoming. EO 14081 also initiated interagency efforts to better measure and track the bioeconomy, prepare the regulatory system for future biotechnology products, and establish a Biosafety and Biosecurity Innovation Initiative. Although these efforts are laudable, we need a more strategic, longer-term, and outward-facing approach to ensure that the United States remains the world leader in biomanufacturing and biotechnology development. Expert reports over several years, including those from the National Academies, support the formation of strategic coordinating body within the U.S. government that focuses on the bioeconomy and more strategic planning for its investments in these areas.

The CHIPS and Science Act of 2022 provides a critical opportunity for improved interagency coordination. Division B, Title IV calls for the formation of a National Engineering Biology Research and Development Initiative coordinated by an interagency committee, co-chaired by OSTP, and supported by an Initiative Coordination Office (ICO) with a director and full-time staff. This bill stipulates that this coordination office should:

A recent bipartisan letter from Congressman Jake Auchincloss of Massachusetts confirms Congress’s intent that the ICO described in the legislation incorporate the Initiative as described in Executive Order 14081.

An ICO focused on the bioeconomy would be analogous to other congressionally mandated National Coordination Offices that drive effective interagency coordination at OSTP, including those for the U.S. Global Change Research Program (USGCRP), the National Nanotechnology Initiative (NNI), and the Networking and Information Technology Research and Development (NITRD) Program. These offices have several features in common, including:

Now is the time for OSTP to establish and for Congress to fund a durable and well-staffed Bioeconomy Initiative Coordination Office (BICO) that leads ongoing, strategic, interagency coordination across the government to support the bioeconomy. The BICO should not replace current interagency committees and processes. Instead, it should coordinate bioeconomy-related efforts that reach across multiple domains, ensure a durable and long-term approach to the bioeconomy, and serve as a focal point and doorway for U.S. government engagement with industry, academia, and other stakeholders. 

Plan of Action

OSTP should establish the BICO within the next year. Its focus should be on (1) biomanufacturing, including infrastructure and capacity, pre-competitive industry issues (e.g., standards), and workforce; and (2) development and commercialization of biotechnology products, tools, and capabilities, with a particular focus on those developed for nontherapeutic uses. The interagency committee that drives the BICO should be established under the National Science and Technology Council, should be co-chaired by OSTP and the Department of Commerce, and should include as participants every agency listed in EO 14081, including:

Congress should provide an appropriation of at least $4 million per year to ensure funding for at least six full-time employees (director, lead for strategic planning and assessment, lead for regulation, lead for safeguarding, outreach coordinator, and administrator), plus office expenses, events, outreach, and other costs. Absent a specific appropriation from Congress, the BICO should follow the funding model of other congressionally mandated coordination offices, including the USGCRP and the NITRD Coordination Office: each participating agency would contribute a small percentage of its total expenditures on biomanufacturing and biotechnologies to support the BICO.

The office should be tasked with:

Strategic Planning

To maintain U.S. leadership in the bioeconomy, the federal government has made significant investments in biomanufacturing and biotechnology development over many years, and EO 14081 provided an important step toward a more strategic approach to these investments. However, we need a more robust and ongoing structure that incorporates opportunities for assessment of the rapidly changing bioeconomy and iteration of planning activities. The BICO should coordinate a strategic approach that includes:

To generate an accurate National Bioeconomy Assessment and ensure that it captures updated, relevant information, the BICO should actively seek external stakeholder input and engagement that includes academia, industry, manufacturing institutes (such as BioMADE or NIIMBL), state and local governments, nongovernmental organizations, and others. In addition to informing federal investment in the bioeconomy, this ongoing assessment will be valuable for other activities within the BICO by providing insight into the types of novel products that regulators might expect to see and highlighting priority topics for outreach and engagement on safeguarding biotechnology tools and capabilities. If a Living Evidence approach is not feasible, then National Bioeconomy Assessments could be generated in a more traditional format, with publication of updated assessments at regular intervals (e.g., every three years, offset from the strategic planning publication cycle).

A “Single Door Approach” for the Biotechnology Regulatory System

For the bioeconomy to flourish, the biotechnology regulatory system must allow low-risk products to be developed and marketed quickly and efficiently. At the same time, regulatory oversight is essential to identify and limit risks to human health and the environment. The BICO should establish and support a “single door approach” for the biotechnology regulatory system to reduce ambiguities and uncertainties in the system and to better prepare the regulatory agencies for future products. (See FAQs for more information.)

An effective single door approach requires robust interagency coordination that includes OSTP and high-level decision makers from each of the primary regulatory agencies: Environmental Protection Agency (EPA), Food and Drug Administration (FDA), and U.S. Department of Agriculture (USDA). Future biotechnology products will include a wide range of applications in the environment, so governmental entities responsible for environmental protection should also be included in this interagency process, including U.S. Fish and Wildlife Service, the National Marine Fisheries Service, and the Council on Environmental Quality. These groups have rarely engaged on issues related to the use of genetically engineered organisms in the environment but should prepare for this type of decision-making. Representation in this interagency process should include lawyers from the Offices of the General Counsel of EPA, FDA, and USDA who can work together within a reasonable time frame (e.g., three months) to determine which agency should lead when novel products arise. To support this single door approach, the BICO should:

When possible and as experience is gained, the BICO should work with the agencies to distill generalizable principles or summaries of decisions to provide guidance to product developers and the broader bioeconomy on how different types of products are likely to be regulated. 

Safeguarding the Bioeconomy

As the bioeconomy grows, the United States must ensure that its investments are protected and that biotechnology tools and capabilities are not accidentally or intentionally misused. In addition to coordinating discussions among U.S. government agencies on these topics, a key role for the BICO will be to conduct outreach and engagement with the broader bioeconomy community. There are several areas where outreach, particularly to industry partners, will be critical to maintaining U.S. competitiveness and leadership in the bioeconomy. Many industry standards and practices are not well-established, and there are opportunities for the federal government to work with industry partners to protect U.S. assets and keep biomanufacturing and biotechnology development securely within the United States. The BICO, in collaboration with the National Security Council, should facilitate engagement on topics such as:

Safeguarding the bioeconomy also requires a process to better understand the potential for accidental or deliberate misuse of biotechnology tools, services, and capabilities to cause harm, and to support development of resources and best practices to reduce these risks. The BICO should develop an engagement strategy that includes opportunities for public discussion of risks related to misuse and strategies to reduce those risks; a publicly accessible portal for experts outside the government to raise concerns or suggest topics for further scrutiny; and a protected venue in which companies can securely share more sensitive information about business products, interactions, or practices. The BICO will maximize the benefit of this forum by conducting outreach and raising awareness of these opportunities, particularly by targeting industry partners. 

Currently, the U.S. government does not have a venue or forum for multi-stakeholder engagement on risks related to potential misuse of biotechnology tools and capabilities. As the bioeconomy grows, a wide range of tools and capabilities will be developed to make biology easier to engineer, including many enabled by artificial intelligence. Accidental or deliberate misuse of these rapidly expanding capabilities could pose risks that will be difficult to anticipate and mitigate. By establishing a process for ongoing and robust engagement to better understand and manage these risks, the BICO can help address these biosecurity needs.

Conclusion

By establishing the BICO as a focal point for coordination among the interagency community and outreach to the broader bioeconomy, OSTP can ensure a long-term and robust U.S. government commitment to biomanufacturing and biotechnology. This commitment includes a strategic approach to investments that can be tracked over time, improvements to the regulatory system that will enable safe and useful products to be more easily commercialized, and activities and engagement to better safeguard advances in the bioeconomy. With appropriate funding, the BICO will form the foundation for a true cross-governmental approach that will ensure U.S. leadership and competitiveness and will ultimately enable the bioeconomy to flourish.

Frequently Asked Questions
Why should the BICO be established at OSTP instead of another agency? Are there alternatives?

Because OSTP is part of the Executive Office of the President, there is a risk that establishing the BICO at OSTP will make it vulnerable to changes in funding or priorities, particularly during presidential transitions. However, there are several reasons for the BICO to be at OSTP. A critical factor is that the CHIPS and Science Act names OSTP as co-chair for the interagency engineering biology initiative that is described in the Act. Executive Order 14081 also names OSTP as a key point of coordination for U.S. government activities on the bioeconomy. Some aspects of the bioeconomy, particularly the regulation of biotechnology, have been coordinated by OSTP for decades. Furthermore, OSTP plays a key role in multiple science- and technology-rich initiatives that are supported by Coordination Offices, including the USGCRP, NITRD, and NNI.


If it is not feasible for OSTP to establish the BICO, coordination could be established by lead agencies that are committed to supporting the bioeconomy. A model for this type of coordination is the Wildland Fire Leadership Council, which is established by a Memorandum of Understanding among the Secretary of the Interior, Secretary of Agriculture, Secretary of Defense, and Secretary of Homeland Security. However, to capture the full scope of coordination that is needed for the bioeconomy, this approach may require negotiation of multiple MOUs among different sets of government agencies.

Why is a single door approach needed for the biotechnology regulatory system?

Currently, the U.S. government regulates biotechnology products based on the Coordinated Framework for the Regulation of Biotechnology, established in 1986 and most recently updated in 2017. Under this system, agencies regulate biotechnology products based on their product-based authorities (e.g., drugs are regulated by FDA; pesticides are regulated by EPA). However, there are gaps, ambiguities, and uncertainties in the regulatory system that will be compounded by the accelerating pace of biotechnology development, expanding range of applications, and potential novelty of new products. Often, developers of novel products struggle to determine which agency (FDA, EPA, or USDA) has primary responsibility for regulation of their product and can receive conflicting information from the agencies over the course of months or years. Several reports, including from the National Academies and from PCAST, have called for improved interagency coordination and a single door approach to the regulatory system that would enable product developers to contact a single entity within the U.S. government and receive an actionable answer about their product’s regulatory path. Importantly, this approach will not require changes to the underlying statutes that define regulatory authorities or to the regulations that define how these authorities are applied. Instead, it calls for efficient decision-making among the agencies to decide which agency will take the lead for novel products as they arise.

How would the portal for product developers be implemented for the single door approach?

To use the single door approach, product developers would submit basic information about their products for the regulatory agencies to consider. At its simplest, this portal could be a submission system similar to that used by the federal government when requesting information from the public through regulations.gov (though product developer submissions would not be released publicly). A more secure system could be modeled on the Case Management System used for companies to share documents with the Committee on Foreign Investment in the U.S.

What else could the BICO do to improve the biotechnology regulatory system?

A more robust interagency process could also drive efforts to better harmonize regulatory approaches across agencies. For example, in 2017 the National Academies recommended ways the agencies could streamline oversight of familiar and low-risk products while focusing resources on products that are novel or require more complex risk assessments. The BICO should facilitate coordination on these topics, including progress agencies have made since 2017, lessons learned, and opportunities for improvements. The BICO should also conduct horizon scanning activities (e.g., as part of its National Bioeconomy Assessment or in public meetings focused on specific product types) so that regulators can best anticipate novel products and prepare for future decision-making. Expert groups, including PCAST, have also identified a need for training of regulators and opportunities for engagement between regulators and the broader bioeconomy; the BICO will be well-positioned to coordinate these activities.

How would the BICO fit into policy development for DNA synthesis screening?

DNA synthesis is one type of biotechnology for which the risks of misuse are well described, frameworks for reducing risk are already being developed and applied (including the 2010 HHS Screening Framework Guidance and efforts toward international harmonization), and best practices among responsible companies are established. An interagency process to update the Screening Framework Guidance is nearing completion; this process would have benefited from additional opportunities for engagement between the U.S. government and the DNA synthesis industry. The BICO should provide a forum for this type of engagement in support of future policy development.