Meeting Agricultural Sustainability Goals by Increasing Federal Funding for Research on Genetically Engineered Organisms

Summary

Ensuring the sustainability and resiliency of American food systems is an urgent priority, especially in the face of challenges presented by climate change and international geopolitical conflicts. To address these issues, increased federal investment in new, sustainability-oriented agricultural technology is necessary in order to bring greater resource conservation and stress tolerance to American farms and fields. Ongoing advances in bioengineering research and development (R&D) offer a diverse suite of genetically engineered organisms, including crops, animals, and microbes. Given the paramount importance of a secure food supply for national well-being, federal actors should promote the development of genetically engineered organisms for agricultural applications. 

Two crucial opportunities are imminent. First, directives in the Biden Administration’s bioeconomy executive order provide the U.S. Department of Agriculture (USDA) a channel through which to request funding for sustainability-oriented R&D in genetically engineered organisms. Second, renewal of the Farm Bill in 2023 provides a venue for congressional legislators to highlight genetic engineering as a funding focus area of existing research grant programs. Direct beneficiaries of the proposed federal funding will predominantly be nonprofit research organizations such as land grant universities; innovations resulting from the funded research will provide a public good that benefits producers and consumers alike. 

Challenge and Opportunity

The resiliency of American agriculture faces undeniable challenges in the coming decades. The first is resource availability, which includes scarcities of fertile land due to soil degradation and of water due to overuse and drought. Resource availability is also vulnerable to acute challenges, as revealed by the impact of the COVID-19 pandemic and the Russian-Ukraine war on the supply of vital inputs such as fertilizer and gas. The second set of challenges are environmental stressors, many of which are exacerbated by climate change. Flooding can wipe out an entire harvest, while the spread of pathogens poses existential risks not only to individual livelihoods but also to the global market of crops like citrus, chocolate, and banana. Such losses would be devastating for both consumers and producers, especially those in the global south. 

Ongoing advances in bioengineering R&D provide technological solutions in the form of a diverse suite of genetically engineered organisms. These have the potential to address many of the aforementioned challenges, including increasing yield and/or minimizing inputs and boosting resilience to drought, flood, and pathogens. Indeed, existing transgenic crops, such as virus-resistant papaya and flood-tolerant rice, demonstrate the ability of genetically engineered organisms to address agricultural challenges. They can also address other national priorities such as climate change and nutrition by enhancing carbon sequestration and improving the nutritional profile of food. 

Recent breakthroughs in modifying and sequencing DNA have greatly enhanced the speed of developing new, commercializable bioengineered varieties, as well as the spectrum of traits and plants that can be engineered. This process has been especially expedited by the use of CRISPR gene-editing technology; the European Sustainable Agriculture Through Genome Editing (EU-SAGE)’s database documents more than 500 instances of gene-edited crops developed in research laboratories to target traits for sustainable, climate-resilient agriculture. There is thus vast potential for genetically engineered organisms to contribute to sustainable agriculture. 

More broadly, this moment can be leveraged to bring about a turning point in the public perception of genetically engineered organisms. Past generations of genetically engineered organisms have been met with significant public backlash, despite the pervasiveness of inter-organism gene transfer throughout the history of life on earth (see FAQ). Reasons for negative public perception are complex but include the association of genetically engineered organisms with industry profit, as well as an embrace of the precautionary principle to a degree that far exceeds its application to other products, such as pharmaceuticals and artificial intelligence. Furthermore, persistent misinformation and antagonistic activism have engendered entrenched consumer distrust. The prior industry focus on herbicide resistance traits also contributed to the misconception that the technology is only used to increase the use of harmful chemicals in the environment. 

Now, however, a new generation of genetically engineered organisms feature traits beyond herbicide resistance that address sustainability issues such as reduced spoilage. Breakthroughs in DNA sequencing, as well as other analytical tools, have increased our understanding of the properties of newly developed organisms. There is pervasive buy-in for agricultural sustainability goals across many stakeholder sectors, including individual producers, companies, consumers, and legislators on both sides of the aisle. There is great potential for genetically engineered organisms to be accepted by the public as a solution to a widely recognized problem. Dedicated federal funding will be vital in seeing that this potential is realized.

Plan of Action

Recommendation 1: Fund genetically engineered organisms pursuant to the Executive Order on the bioeconomy.

Despite the importance of agriculture for the nation’s basic survival and the clear impact of agricultural innovation, USDA’s R&D spending pales in comparison to other agencies and other expenditures. In 2022, for example, USDA’s R&D budget was a mere 6% of the National Institutes of Health’s R&D budget, and R&D comprised only 9.6% of USDA’s overall discretionary budget. The Biden Administration’s September 2022 executive order provides an opportunity to amend this funding shortfall, especially for genetically engineered organisms.  

The Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy explicitly embraces an increased role for biotechnology in agriculture. Among the policy objectives outlined is the call to “boost sustainable biomass production and create climate-smart incentives for American agricultural producers and forest landowners.” 

Pursuant to this objective, the EO directs the USDA to submit a plan comprising programs and budget proposals to “support the resilience of the United States biomass supply chain [and] encourage climate-smart production” by September 2023. This plan provides the chance for the USDA to secure funding for agricultural R&D in a number of areas. Here, we recommend (1) USDA collaboration in Department of Energy (DoE) research programs amended under the CHIPS and Science Act and (2) funding for startup seed grants. 

CHIPS and Science Act

The 2022 CHIPS and Science Act aims to accelerate American innovation in a number of technology focus areas, including engineering biology. To support this goal, the Act established a new National Engineering Biology Research and Development Initiative (Section 10402). As part of this initiative, the USDA was tasked with supporting “research and development in engineering biology through the Agricultural Research Service, the National Institute of Food and Agriculture programs and grants, and the Office of the Chief Scientist.” Many of the initiative’s priorities are sustainability-oriented and could benefit from genetic engineering contributions. 

A highlight is the designation of an interagency committee to coordinate activities. To leverage and fulfill this mandate, we recommend that the USDA better coordinate with the DoE on bioengineering research. Specifically, the USDA should be involved in the decision-making process for awarding research grants relating to two DoE programs amended by the Act.

The first program is the Biological and Environmental Research Program, which includes carbon sequestration, gene editing, and bioenergy. (See the Appendix for a table summarizing examples of how genetic engineering can contribute sustainability-oriented technologies to these key focus areas.)

The second program is the Basic Energy Sciences Program, which has authorized funding for a Carbon Sequestration Research and Geologic Computational Science Initiative under the DoE. Carbon sequestration via agriculture is not explicitly mentioned in this section, but this initiative presents another opportunity for the USDA to collaborate with the DoE and secure funding for agricultural climate solutions. Congress should make appropriating funding for this program a priority.

Seed Grants

The USDA should pilot a seed grant program to accelerate technology transfer, a step that often poses a bottleneck. The inherent risk of R&D and entrepreneurship in a cutting-edge field may pose a barrier to entry for academic researchers as well as small agricultural biotech companies. Funding decreases the barrier of entry, thus increasing the diversity of players in the field. This can take the form of zero-equity seed grants. Similar to the National Science Foundation (NSF)’s seed grant program, which awards $200+ million R&D funding to about 400 startups, this would provide startups with funding without the risks attached to venture capital funding (such as being ousted from company leadership). The NSF’s funding is spread across numerous disciplines, so a separate agricultural initiative from the USDA dedicated to supporting small agricultural biotech companies would be beneficial. These seed grants would meet a need unmet by USDA’s existing small business grant programs, which are only awarded to established companies.

Together, the funding areas outlined above would greatly empower the USDA to execute the EO’s objective of promoting climate-smart American agriculture.

Recommendation 2: Allocate funding through the 2023 Farm Bill.

The Farm Bill, the primary tool by which the federal government sets agricultural policy, will be renewed in 2023. Several existing mandates for USDA research programs, administered through the National Institute of Food and Agriculture as competitive grants, have been allocated federal funding. Congressional legislators should introduce amendments in the mandates for these programs such that the language explicitly highlights R&D of genetically engineered organisms for sustainable agriculture applications. Such programs include the Agriculture and Food Research Initiative, a major competitive grant program, as well as the Specialty Crop Research Initiative and the Agricultural Genome to Phenome Initiative. Suggested legislative text for these amendments are provided in the Appendix. Promoting R&D of genetically engineered organisms via existing programs circumvents the difficulty of securing appropriations for new initiatives while also presenting genetically engineered organisms as a critically important category of agricultural innovation.

Additionally, Congress should appropriate funding for the Agriculture Advanced Research and Development Authority (AgARDA) at its full $50 million authorization. Similar to its counterparts in other agencies such as ARPA-E and DARPA, AgARDA would enable “moonshot” R&D projects that are high-reward but high-risk or have a long timeline—such as genetically engineered organisms with genetically complex traits. This can be especially valuable for promoting the development of sustainability-oriented crops traits: though they are a clear public good, they may be less profitable and/or marketable than crops with consumer-targeted traits such as sweetness or color, and as such profit-driven companies may be dissuaded from investing in their development. The USDA just published its implementation strategy for AgARDA. Congress must now fully fund AgARDA such that it can execute its strategy and fuel much-needed innovation in agricultural biotechnology. 

Conclusion

Current federal funding for genetically engineered organism R&D does not reflect their substantial impact in ensuring a sustainable, climate-smart future for American agriculture, with applications ranging from increasing resource-use efficiency in bioproduction to enhancing the resilience of food systems to environmental and manmade crises. Recent technology breakthroughs have opened many frontiers in engineering biology, but free market dynamics alone are not sufficient to guarantee that these breakthroughs are applied in the service of the public good in a timely manner. The USDA and Congress should therefore take advantage of upcoming opportunities to secure funding for genetic engineering research projects.

Appendix

Biological and Environmental Research Program Examples 

Research focus area added in CHIPS and Science ActExample of genetic engineering contribution
Bioenergy and biofuelOptimizing biomass composition of bioenergy crops
Non-food bioproductsLab-grown cotton; engineering plants and microbes to produce medicines
Carbon sequestrationImproving photosynthetic efficiency; enhancing carbon storage in plant roots
Plant and microbe interactionsEngineering microbes to counter plant pathogens; engineering microbes to make nutrients more accessible to plants
BioremediationEngineering plants and microbes to sequester and/or breakdown contaminants in soil and groundwater
Gene editing Engineering plants for increased nutrient content, disease-resistance, storage performance
New characterization toolsCreating molecular reporters of plant response to abiotic and biotic environmental dynamics 

Farm Bill Amendments 

Agriculture and Food Research Initiative

One of the Agriculture and Food Research Initiative (AFRI)’s focus areas is Sustainable Agricultural Systems, with topics including “advanced technology,” which supports “cutting-edge research to help farmers produce higher quantities of safer and better quality food, fiber, and fuel to meet the needs of a growing population.” Furthermore, AFRI’s Foundational and Applied Science Program supports grants in priority areas including plant health, bioenergy, natural resources, and environment. The 2023 Farm Bill could amend the Competitive, Special, and Facilities Research Grant Act (7 U.S.C. 3157) to highlight the potential of genetic engineering in the pursuit of AFRI’s goals. 

Example text: 

Subsection (b)(2) of the Competitive, Special, and Facilities Research Grant Act (7 U.S.C. 3157(b)(2)) is amended—

(1) in subparagraph (A)—

(A) in clause (ii), by striking the semicolon at the end and inserting “including genetic engineering methods to make modifications (deletions and/or insertions of DNA) to plant genomes for improved food quality, improved yield under diverse growth conditions, and improved conservation of resource inputs such as water, nitrogen, and carbon;”;

(B) in clause (vi), by striking the “and”;

(C) in clause (vii), by striking the period at the end and inserting “; and”; and

(D) by adding at the end the following: 

“(viii) plant-microbe interactions, including the identification and/or genetic engineering of microbes beneficial for plant health”

(2) in subparagraph (C), clause (iii), by inserting “production and” at the beginning;

(3) in subparagraph (D)– 

(A) in clause (vii), by striking “and”;

(B) in clause (vii), by striking the period at the end and inserting “; and”; and

(C) by adding at the end the following: 

“(ix) carbon sequestration”.

Agricultural Genome to Phenome Initiative

The goal of this initiative is to understand the function of plant genes, which is critical to crop genetic engineering for sustainability. The ability to efficiently insert and edit genes, as well as to precisely control gene expression (a core tenet of synthetic biology), would facilitate this goal.

Example text:

Section 1671(a) of the Food, Agriculture, Conservation, and Trade Act of 1990 (7 U.S.C. 5924(a)) is amended—

  1. In subparagraph (4), by inserting “and environmental” after “achieve advances in crops and animals that generate societal”; and
  2. In subparagraph (5), by inserting “genetic engineering, synthetic biology,” after “to combine fields such as genetics, genomics,”

Specialty Crop Research Initiative

Specialty crops can be a particularly fertile ground for research. There is a paucity of genetic engineering tools for specialty crops as compared to major crops (e.g. wheat, corn, etc.). At the same time, specialty crops such as fruit trees offer the opportunity to effect larger sustainability impacts: as perennials, they remain in the soil for many years, with particular implications for water conservation and carbon sequestration. Finally, economically important specialty crops such as oranges are under extreme disease threat, as identified by the Emergency Citrus Disease Research and Extension Program. Genetic engineering offers potential solutions that could be accelerated with funding. 

Example text:

Section 412(b) of the Agricultural Research, Extension, and Education Reform Act of 1998 (7 U.S.C. 7632(b)) is amended—

  1. In paragraph (1), by inserting “transgenics, gene editing, synthetic biology” after “research in plant breeding, genetics,” and—
    1. In subparagraph (B), by inserting “and enhanced carbon sequestration capacity” after “size-controlling rootstock systems”; and
    2. In subparagraph (C), by striking the semi-colon at the end and inserting “, including water-use efficiency;”
Frequently Asked Questions
What is the definition of a genetically engineered organism? What is the difference between genetically engineered, genetically modified, transgenic, gene-edited, and bioengineered?

Scientists usually use the term “genetic engineering” as a catch-all phrase for the myriad methods of changing an organism’s DNA outside of traditional breeding, but this is not necessarily reflected in usage by regulatory agencies. The USDA’s glossary, which is not regulatorily binding, defines “genetic engineering” as “​​manipulation of an organism’s genes by introducing, eliminating or rearranging specific genes using the methods of modern molecular biology, particularly those techniques referred to as recombinant DNA techniques.” Meanwhile, the USDA’s Animal and Plant Health Inspection Service (APHIS)’s 2020 SECURE rule defines “genetic engineering” as “techniques that use recombinant, synthesized, or amplified nucleic acids to modify or create a genome.” The USDA’s glossary defines “genetic modification” as “the production of heritable improvements in plants or animals for specific uses, via either genetic engineering or other more traditional methods”; however, the USDA National Organic Program has used “genetic engineering” and “genetic modification” interchangeably. 


“Transgenic” organisms can be considered a subset of genetically engineered organisms and result from the insertion of genetic material from another organism using recombinant DNA techniques. “Gene editing” or “genome editing” refers to biotechnology techniques like CRISPR that make changes in a specific location in an organism’s DNA. 


The term “bioengineered” does carry regulatory weight. The USDA-AMS’s National Bioengineered Food Disclosure Standard (NBFDS), published in 2018 and effective as of 2019, defines “bioengineered” as “contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques; and for which the modification could not otherwise be obtained through conventional breeding or found in nature.” Most gene-edited crops currently in development, such as those where the introduced gene is known to occur in the species naturally, are exempt from regulation under both the AMS’s NBFDS and APHIS’s SECURE acts.

What are some examples of genetic engineering methods?

Though “genetic engineering” has only entered the popular lexicon in the last several decades, humans have modified the genomes of plants for millennia, in many different ways. Through genetic changes introduced via traditional breeding, teosinte became maize 10,000 years ago in Mesoamerica, and hybrid rice was developed in 20th-century China. Irradiation has been used to generate random mutations in crops for decades, and the resulting varieties have never been subject to any special regulation.


In fact, transfer of genes between organisms occurs all the time in nature. Bacteria often transfer DNA to other bacteria, and some bacteria can insert genes into plants. Indeed, one of the most common “genetic engineering” approaches used today, Agrobacterium-mediated gene insertion, was inspired by that natural phenomenon. Other methods of DNA delivery including biolistics (“gene gun”) and viral vectors. Each method for gene transfer has many variations, and each method varies greatly in its mode of action and capabilities. This is key for the future of plant engineering: there is a spectrum—not a binary division—of methods, and evaluations of engineered plants should focus on the end product.

How are genetically engineered organisms regulated in the United States?

Genetically engineered organisms are chiefly regulated by USDA-APHIS, the EPA, and the FDA as established by the 1986 Coordinated Framework for the Regulation of Biotechnology. They oversee experimental testing, approval, and commercial release. The Framework’s regulatory approach is grounded in the judgment that the potential risks associated with genetically engineered organisms can be evaluated the same way as those associated with traditionally bred organisms. This is in line with its focus on “the characteristics of the product and the environment into which it is being introduced, not the process by which the product is created.”


USDA-APHIS regulates the distribution of regulated organisms that are products of biotechnology to ensure that they do not pose a plant pest risk. Developers can petition for individual organisms, including transgenics, to be deregulated via Regulatory Status Review.


The EPA regulates the distribution, sale, use, and testing of all pesticidal substances produced in plants and microbes, regardless of method of production or mode of action. Products must be registered before distribution. 


The FDA applies the same safety standards to foods derived from genetically engineered organisms as it does to all foods under the Federal Food, Drug, and Cosmetic Act. The agency provides a voluntary consultation process to help developers ensure that all safety and regulatory concerns, such as toxicity, allergenicity, and nutrient content, are resolved prior to marketing.

How do genetically engineered crops work?

Mechanisms of action vary depending on the specific trait. Here, we explain the science behind two types of transgenic crops that have been widespread in the U.S. market for decades. 


Bt crops: Three of the major crops grown in the United States have transgenic Bt varieties: cotton, corn, and soybean. Bt crops are genetically engineered such that their genome contains a gene from the bacteria Bacillus thuringiensis. This enables Bt crops to produce a protein, normally only produced by the Bt bacteria, that is toxic to a few specific plant pests but harmless for humans, other mammals, birds, and beneficial insects. In fact, the bacteria itself is approved for use as an organic insecticide. However, organic applications of Bt insecticides are limited in efficacy: since the bacteria must be topically applied to the crop, the protein it produces is ineffective against insects that have penetrated the plant or are attacking the roots; in addition, the bacteria can die or be washed away by rain. 


Engineering the crop itself to produce the insecticidal protein more reliably reduces crop loss due to pest damage, which also minimizes the need for other, often more broadly toxic systemic pesticides. Increased yield allows for more efficient use of existing agricultural land. In addition, decreased use of pesticides reduces the energy cost associated with their production and application while also preserving wildlife biodiversity. With regards to concerns surrounding insecticide resistance, the EPA requires farmers who employ Bt, both as a transgenic crop and as an organic spray, to also plant a refuge field of non-Bt crops, which prevents pests from developing resistance to the Bt protein.


The only substantive difference between Bt crops and non-Bt crops is that the former produces an insecticide already permitted by USDA organic regulations. 


Ringspot-resistant rainbow papaya: The transgenic rainbow papaya is another example of the benefits of genetic engineering in agriculture. Papaya plantations were ravaged by the papaya ringspot virus in the late 1900s, forcing many farmers to abandon their lands and careers. In response, scientists developed the rainbow papaya, which contains a gene from the virus itself that allows it to express a protein that counters viral infection. This transgenic papaya was determined to be equivalent in nutrition and all other aspects to the original papaya. The rainbow papaya, with its single gene insertion, is widely considered to have saved Hawaii’s papaya industry, which in 2013 accounted for nearly 25% of Hawaii’s food exports. Transgenic papaya now makes up about 80% of the Hawaiian papaya acreage. The remaining comprise non-GMO varieties, which would have gone locally extinct had it not been for transgenic papayas preventing the spread of the virus. The rainbow papaya’s success has clearly demonstrated that transgenic crops can preserve the genetic diversity of American crops and preserve yield without spraying synthetic pesticides, both of which are stated goals of the USDA Organic Program. However, the National Organic Program’s regulations currently forbid organic farmers from growing virus-resistant transgenic papaya.

How have recent biotechnology breakthroughs accelerated the development of new crops?

With the advent of CRISPR gene-editing technology, which allows scientists to make precise, targeted changes in an organism’s DNA, new genetically engineered crops are being developed at an unprecedented pace. These new varieties will encompass a wider variety of qualities than previously seen in the field of crop biotechnology. Many varieties are directly aimed at shoring up agricultural resilience in the face of climate change, with traits including tolerance to heat, cold, and drought. At the same time, the cost of sequencing an organism’s DNA continues to decrease. This makes it easier to confirm the insertion of multiple transgenes into a plant, as would be necessary to engineer crops to produce a natural herbicide. Such a crop, similar to Bt crops but targeting weeds instead of insects, would reduce reliance on synthetic herbicides while enabling no-till practices that promote soil health. Furthermore, cheap DNA sequencing facilitates access to information about the genomes of many wild relatives of modern crops. Scientists can then use genetic engineering to make wild relatives more productive or introduce wild traits like drought resilience into domesticated varieties. This would increase the genetic diversity of crops available to farmers and help avoid issues inherent to monocultures, most notably the uncontrollable spread of plant diseases. 


At present, most crops engineered with CRISPR technology do not contain genes from a different organism (i.e., not transgenic), and thus do not have to face the additional regulatory hurdles that transgenics like Bt crops did. However, crops developed via CRISPR are still excluded from organic farming.

What are examples of genetically engineered organisms currently on the market or in active development that address sustainability issues?

  • Improving sustainability and land conservation: potatoes that are slower to spoil, wheat with enhanced carbon sequestration capacity 

  • Increasing food quality and nutrition: vegetables with elevated micronutrient content 

  • Increasing and protecting agricultural yields: higher-yield fish, flood-tolerant rice

  • Protecting against plant and animal pests and diseases: blight-resistant chestnut, HLB-resistant citrus

  • Cultivating alternative food sources: bacteria for animal-free production of protein

Which agricultural stakeholders are engaged in genetic engineering R&D and will benefit from federal funding?

The pool of producers of genetically engineered crops is increasingly diverse. In fact, of the 37 new crops evaluated by APHIS’s Biotechnology Regulatory Service under the updated guidelines since 2021, only three were produced by large (>300 employees) for-profit corporations. Many were produced by startups and/or not-for-profit research institutions. USDA NIFA research grants predominantly fund land-grant universities; other awardees include private nonprofit organizations, private universities, and, in select cases (such as small business grants), private for-profit companies.

Why are GMOs so often vilified?

Historically, the concept of GMOs has been associated with giant multinational corporations, the so-called Big Ag. The most prevalent GMOs in the last several decades have indeed been produced by industry giants such as Dow, Bayer, and Monsanto. This association has fueled the negative public perception of GMOs in several ways, including: 



  • Some companies, such as Dow, were responsible for producing the notorious chemical Agent Orange, used to devastating effect in the Vietnam War. While this is an unfortunate shadow on the company, it is unrelated to the properties of genetically engineered crops.

  • Companies have been accused of financially disadvantaging farmers by upholding patents on GMO seeds, which prevents farmers from saving seeds from one year’s crop to plant the next season. Companies have indeed enforced seed patents (which generally last about 20 years), but it is important to note that (1) seed-saving has not been standard practice on many American farms for many decades, since the advent of (nonbioengineered) hybrid crops, from which saved seeds will produce an inferior crop, and (2) bioengineered seeds are not the only seeds that can be and are patented.

How to Replicate the Success of Operation Warp Speed

Operation Warp Speed (OWS) was a public-private partnership that produced COVID-19 vaccines in the unprecedented timeline of less than one year. This unique success among typical government research and development (R&D) programs is attributed to OWS’s strong public-private partnerships, effective coordination, and command leadership structure. Policy entrepreneurs, leaders of federal agencies, and issue advocates will benefit from understanding what policy interventions were used and how they can be replicated. Those looking to replicate this success should evaluate the stakeholder landscape and state of the fundamental science before designing a portfolio of policy mechanisms.

Challenge and Opportunity

Development of a vaccine to protect against COVID-19 began when China first shared the genetic sequence in January 2020. In May, the Trump Administration announced OWS to dramatically accelerate development and distribution. Through the concerted efforts of federal agencies and private entities, a vaccine was ready for the public in January 2021, beating the previous record for vaccine development by about three years. OWS released over 63 million doses within one year, and to date more than 613 million doses have been administered in the United States. By many accounts, OWS was the most effective government-led R&D effort in a generation.

Policy entrepreneurs, leaders of federal agencies, and issue advocates are interested in replicating similarly rapid R&D to solve problems such as climate change and domestic manufacturing. But not all challenges are suited for the OWS treatment. Replicating its success requires an understanding of the unique factors that made OWS possible, which are addressed in Recommendation 1. With this understanding, the mechanisms described in Recommendation 2 can be valuable interventions when used in a portfolio or individually.

Plan of Action

Recommendation 1. Assess whether (1) the majority of existing stakeholders agree on an urgent and specific goal and (2) the fundamental research is already established. 

Criteria 1. The majority of stakeholders—including relevant portions of the public, federal leaders, and private partners—agree on an urgent and specific goal.

The OWS approach is most appropriate for major national challenges that are self-evidently important and urgent. Experts in different aspects of the problem space, including agency leaders, should assess the problem to set ambitious and time-bound goals. For example, OWS was conceptualized in April and announced in May, and had the specific goal of distributing 300 million vaccine doses by January. 

Leaders should begin by assessing the stakeholder landscape, including relevant portions of the public, other federal leaders, and private partners. This assessment must include adoption forecasts that consider the political, regulatory, and behavioral contexts. Community engagement—at this stage and throughout the process—should inform goal-setting and program strategy. Achieving ambitious goals will require commitment from multiple federal agencies and the presidential administration. At this stage, understanding the private sector is helpful, but these stakeholders can be motivated further with mechanisms discussed later. Throughout the program, leaders must communicate the timeline and standards for success with expert communities and the public.

Example Challenge: Building Capability for Domestic Rare Earth Element Extraction and Processing
Rare earth elements (REEs) have unique properties that make them valuable across many sectors, including consumer electronics manufacturing, renewable and nonrenewable energy generation, and scientific research. The U.S. relies heavily on China for the extraction and processing of REEs, and the U.S. Geological Survey reports that 78% of our REEs were imported from China from 2017-2020. Disruption to this supply chain, particularly in the case of export controls enacted by China as foreign policy, would significantly disrupt the production of consumer electronics and energy generation equipment critical to the U.S. economy. Export controls on REEs would create an urgent national problem, making it suitable for an OWS-like effort to build capacity for domestic extraction and processing.

Criteria 2. Fundamental research is already established, and the goal requires R&D to advance for a specific use case at scale.

Efforts modeled after OWS should require fundamental research to advance or scale into a product. For example, two of the four vaccine platforms selected for development in OWS were mRNA and replication-defective live vector platforms, which had been extensively studied despite never being used in FDA-licensed vaccines. Research was advanced enough to give leaders confidence to bet on these platforms as candidates for a COVID-19 vaccine. To mitigate risk, two more-established platforms were also selected.

Technology readiness levels (TRLs) are maturity level assessments of technologies for government acquisition. This framework can be used to assess whether a candidate technology should be scaled with an OWS-like approach. A TRL of at least five means the technology was successfully demonstrated in a laboratory environment as part of an integrated or partially integrated system. In evaluating and selecting candidate technologies, risk is unavoidable, but decisions should be made based on existing science, data, and demonstrated capabilities.

Example Challenge: Scaling Desalination to Meet Changing Water Demand
Increases in efficiency and conservation efforts have largely kept the U.S.’s total water use flat since the 1980s, but drought and climate variability are challenging our water systems. Desalination, a well-understood process to turn seawater into freshwater, could help address our changing water supply. However, all current desalination technologies applied in the U.S. are energy intensive and may negatively impact coastal ecosystems. Advanced desalination technologies—such as membrane distillation, advanced pretreatment, and advanced membrane cleaning, all of which are at technology readiness levels of 5–6—would reduce the total carbon footprint of a desalination plant. An OWS for desalination could increase the footprint of efficient and low-carbon desalination plants by speeding up development and commercialization of advanced technologies.

Recommendation 2: Design a program with mechanisms most needed to achieve the goal: (1) establish a leadership team across federal agencies, (2) coordinate federal agencies and the private sector, (3) activate latent private-sector capacities for labor and manufacturing, (4) shape markets with demand-pull mechanisms, and (5) reduce risk with diversity and redundancy.

Design a program using a combination of the mechanisms below, informed by the stakeholder and technology assessment. The organization of R&D, manufacturing, and deployment should follow an agile methodology in which more risk than normal is accepted. The program framework should include criteria for success at the end of each sprint. During OWS, vaccine candidates were advanced to the next stage based on the preclinical or early-stage clinical trial data on efficacy; the potential to meet large-scale clinical trial benchmarks; and criteria for efficient manufacturing.

Mechanism 1: Establish a leadership team across federal agencies

Establish an integrated command structure co-led by a chief scientific or technical advisor and a chief operating officer, a small oversight board, and leadership from federal agencies. The team should commit to operate as a single cohesive unit despite individual affiliations. Since many agencies have limited experience in collaborating on program operations, a chief operating officer with private-sector experience can help coordinate and manage agency biases. Ideally, the team should have decision-making authority and report directly to the president. Leaders should thoughtfully delegate tasks, give appropriate credit for success, hold themselves and others accountable, and empower others to act.

The OWS team was led by personnel from the Department of Health and Human Services (HHS), the Department of Defense (DOD), and the vaccine industry. It included several HHS offices at different stages: the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA). This structure combined expertise in science and manufacturing with the power and resources of the DOD. The team assigned clear roles to agencies and offices to establish a chain of command.

Example Challenge: Managing Wildland Fire with Uncrewed Aerial Systems (UAS)
Wildland fire is a natural and normal ecological process, but the changing climate and our policy responses are causing more frequent, intense, and destructive fires. Reducing harm requires real-time monitoring of fires with better detection technology and modernized equipment such as UAS. Wildfire management is a complex policy and regulatory landscape with functions spanning multiple federal, state, and local entities. Several interagency coordination bodies exist, including the National Wildfire Coordinating Group, Wildland Fire Leadership Council, and the Wildland Fire Mitigation and Management Commission, but much of these efforts are consensus-based coordination models. The status quo and historical biases against agencies have created silos of effort and prevent technology from scaling to the level required. An OWS for wildland fire UAS would establish a public-private partnership led by experienced leaders from federal agencies, state and local agencies, and the private sector to advance this technology development. The team would motivate commitment to the challenge across government, academia, nonprofits, and the private sector to deliver technology that meets ambitious goals. Appropriate teams across agencies would be empowered to refocus their efforts during the duration of the challenge.

Mechanism 2: Coordinate federal agencies and the private sector

Coordinate agencies and the private sector on R&D, manufacturing, and distribution, and assign responsibilities based on core capabilities rather than political or financial considerations. Identify efficiency improvements by mapping processes across the program. This may include accelerating regulatory approval by facilitating communication between the private sector and regulators or by speeding up agency operations. Certain regulations may be suspended entirely if the risks are considered acceptable relative to the urgency of the goal. Coordinators should identify processes that can occur in parallel rather than sequentially. Leaders can work with industry so that operations occur under minimal conditions to ensure worker and product safety.

The OWS team worked with the FDA to compress traditional approval timelines by simultaneously running certain steps of the clinical trial process. This allowed manufacturers to begin industrial-scale vaccine production before full demonstration of efficacy and safety. The team continuously sent data to FDA while they completed regulatory procedures in active communication with vaccine companies. Direct lines of communication permitted parallel work streams that significantly reduced the normal vaccine approval timeline.

Example Challenge: Public Transportation and Interstate Rail
Much of the infrastructure across the United States needs expensive repairs, but the U.S. has some of the highest infrastructure construction costs for its GDP and longest construction times. A major contributor to costs and time is the approval process with extensive documentation, such as preparing an environmental impact study to comply with the National Environmental Policy Act. An OWS-like coordinating body could identify key pieces of national infrastructure eligible for support, particularly for near-end-of-lifespan infrastructure or major transportation arteries. Reducing regulatory burden for selected projects could be achieved by coordinating regulatory approval in close collaboration with the Department of Transportation, the Environmental Protection Agency, and state agencies. The program would need to identify and set a precedent for differentiating between expeditable regulations and key regulations, such as structural reviews, that could serve as bottlenecks.

Mechanism 3: Activate latent private-sector capacities for labor and manufacturing

Activate private-sector capabilities for production, supply chain management, deployment infrastructure, and workforce. Minimize physical infrastructure requirements, establish contracts with companies that have existing infrastructure, and fund construction to expand facilities where necessary. Coordinate with the Department of State to expedite visa approval for foreign talent and borrow personnel from other agencies to fill key roles temporarily. Train staff quickly with boot camps or accelerators. Efforts to build morale and ensure commitment are critical, as staff may need to work holidays or perform higher than normally expected. Map supply chains, identify critical components, and coordinate supply. Critical supply chain nodes should be managed by a technical expert in close partnership with suppliers. Use the Defense Production Act sparingly to require providers to prioritize contracts for procurement, import, and delivery of equipment and supplies. Map the distribution chain from the manufacturer to the endpoint, actively coordinate each step, and anticipate points of failure.

During OWS, the Army Corps of Engineers oversaw construction projects to expand vaccine manufacturing capacity. Expedited visa approval brought in key technicians and engineers for installing, testing, and certifying equipment. Sixteen DOD staff also served in temporary quality-control positions at manufacturing sites. The program established partnerships between manufacturers and the government to address supply chain challenges. Experts from BARDA worked with the private sector to create a list of critical supplies. With this supply chain mapping, the DOD placed prioritized ratings on 18 contracts using the Defense Production Act. OWS also coordinated with DOD and U.S. Customs to expedite supply import. OWS leveraged existing clinics at pharmacies across the country and shipped vaccines in packages that included all supplies needed for administration, including masks, syringes, bandages, and paper record cards.

Example Challenge: EV Charging Network
Electric vehicles (EVs) are becoming increasingly popular due to high gas prices and lower EV prices, stimulated by tax credits for both automakers and consumers in the Inflation Reduction Act. Replacing internal combustion engine vehicles with EVs is aligned with our current climate commitments and reduces overall carbon emissions, even when the vehicles are charged with energy from nonrenewable sources. Studies suggest that current public charging infrastructure has too few functional chargers to meet the demand of EVs currently on the road. Reliable and available public chargers are needed to increase public confidence in EVs as practical replacements for gas vehicles. Leveraging latent private-sector capacity could include expanding the operations of existing charger manufacturers, coordinating the deployment and installation of charging stations and requisite infrastructure, and building a skilled workforce to repair and maintain this new infrastructure. In February 2023 the Biden Administration announced actions to expand charger availability through partnerships with over 15 companies.

Mechanism 4: Shape markets with demand-pull mechanisms

Use contracts and demand-pull mechanisms to create demand and minimize risks for private partners. Other Transaction Authority can also be used to procure capabilities quickly by bypassing elements of the Federal Acquisition Regulation. The types of demand-pull mechanisms available to agencies are:

HHS used demand-pull mechanisms to develop the vaccine candidates during OWS. This included funding large-scale manufacturing and committing to purchase successful vaccines. HHS made up to $483 million in support available for Phase 1 trials of Moderna’s mRNA candidate vaccine. This agreement was increased by $472 million for late-stage clinical development and Phase 3 clinical trials. Several months later, HHS committed up to $1.5 billion for Moderna’s large-scale manufacturing and delivery efforts. Ultimately the U.S. government owned the resulting 100 million doses of vaccines and reserved the option to acquire more. Similar agreements were created with other manufacturers, leading to three vaccine candidates receiving FDA emergency use authorization.

Example Challenge: Space Debris
Low-earth orbit includes dead satellites and other debris that pose risks for existing and future space infrastructure. Increased interest in commercialization of low-earth orbit will exacerbate a debris count that is already considered unstable. Since national space policy generally requires some degree of engagement with commercial providers, the U.S. would need to include the industry in this effort. The cost of active space debris removal, satellite decommissioning and recycling, and other cleanup activities are largely unknown, which dissuades novel business ventures. Nevertheless, large debris objects that pose the greatest collision risks need to be prioritized for decommission. Demand-pull mechanisms could be used to create a market for sustained space debris mitigation, such as an advanced market commitment for the removal of large debris items. Commitments for removal could be paired with a study across the DOD and NASA to identify large, high-priority items for removal. Another mechanism that could be considered is fixed milestone payments, which NASA has used in past partnerships with commercial partners, most notably SpaceX, to develop commercial orbital transportation systems.

Mechanism 5: Reduce risk with diversity and redundancy

Engage multiple private partners on the same goal to enable competition and minimize the risk of overall program failure. Since resources are not infinite, the program should incorporate evidence-based decision-making with strict criteria and a rubric. A rubric and clear criteria also ensure fair competition and avoid creating a single national champion. 

During OWS, four vaccine platform technologies were considered for development: mRNA, replication-defective live-vector, recombinant-subunit-adjuvanted protein, and attenuated replicating live-vector. The first two had never been used in FDA-licensed vaccines but showed promise, while the second two were established in FDA-licensed vaccines. Following a risk assessment, six vaccine candidates using three of the four platforms were advanced. Redundancy was incorporated in two dimensions: three different vaccine platforms and two separate candidates. The manufacturing strategy also included redundancy, as several companies were awarded contracts to produce needles and syringes. Diversifying sources for common vaccination supplies reduced the overall risk of failure at each node in the supply chain.

Example Challenge: Alternative Battery Technology
Building infrastructure to capture energy from renewable sources requires long-term energy storage to manage the variability of renewable energy generation. Lithium-ion batteries, commonly used in consumer electronics and electric vehicles, are a potential candidate, since research and development has driven significant cost declines since the technology’s introduction in the 1990s. However, performance declines when storing energy over long periods, and the extraction of critical minerals is still relatively expensive and harmful to the environment. The limitations of lithium-ion batteries could be addressed by investing in several promising alternative battery technologies that use cheaper materials such as sodium, sulfur, and iron. This portfolio approach will enable competition and increase the chance that at least one option is successful.

Conclusion

Operation Warp Speed was a historic accomplishment on the level of the Manhattan Project and the Apollo program, but the unique approach is not appropriate for every challenge. The methods and mechanisms are best suited for challenges in which stakeholders agree on an urgent and specific goal, and the goal requires scaling a technology with established fundamental research. Nonetheless, the individual mechanisms of OWS can effectively address smaller challenges. Those looking to replicate the success of OWS should deeply evaluate the stakeholder and technology landscape to determine which mechanisms are required or feasible.

Acknowledgments

This memo was developed from notes on presentations, panel discussions, and breakout conversations at the Operation Warp Speed 2.0 Conference, hosted on November 17, 2022, by the Federation of American Scientists, 1Day Sooner, and the Institute for Progress to recount the success of OWS and consider future applications of the mechanisms. The attendees included leadership from the original OWS team, agency leaders, Congressional staffers, researchers, and vaccine industry leaders. Thank you to ​​Michael A. Fisher, FAS senior fellow, who contributed significantly to the development of this memo through January 2023. Thank you to the following FAS staff for additional contributions: Dan Correa, chief executive officer; Jamie Graybeal, director, Defense Budgeting Project (through September 2022); Sruthi Katakam, Scoville Peace Fellow; Vijay Iyer, program associate, science policy; Kai Etheridge, intern (through August 2022).

Frequently Asked Questions
When is the OWS approach not appropriate?

The OWS approach is unlikely to succeed for challenges that are too broad or too politically polarizing. For example, curing cancer: While a cure is incredibly urgent and the goal is unifying, too many variations of cancer exist and they include several unique research and development challenges. Climate change is another example: particular climate challenges may be too politically polarizing to motivate the commitment required.

Can the OWS mechanisms work for politicized topics?

No topic is immune to politicization, but some issues have existing political biases that will hinder application of the mechanisms. Challenges with bipartisan agreement and public support should be prioritized, but politicization can be managed with a comprehensive understanding of the stakeholder landscape.

Can the OWS mechanisms be used broadly to improve interagency coordination?

The pandemic created an emergency environment that likely motivated behavior change at agencies, but OWS demonstrated that better agency coordination is possible.

How do you define and include relevant stakeholders?

In addition to using processes like stakeholder mapping, the leadership team must include experts across the problem space that are deeply familiar with key stakeholder groups and existing power dynamics. The problem space includes impacted portions of the public; federal agencies and offices; the administration; state, local, Tribal, and territorial governments; and private partners. 


OWS socialized the vaccination effort through HHS’s Office of Intergovernmental and External Affairs, which established communication with hospitals, healthcare providers, nursing homes, community health centers, health insurance companies, and more. HHS also worked with state, local, Tribal, and territorial partners, as well as organizations representing minority populations, to address health disparities and ensure equity in vaccination efforts. Despite this, OWS leaders expressed that better communication with expert communities was needed, as the public was confused by contradictory statements from experts who were unaware of the program details.

How can future OWS-like efforts include better communication and collaboration with the public?

Future efforts should create channels for bottom-up communication from state, local, Tribal, and territorial governments to federal partners. Encouraging feedback through community engagement can help inform distribution strategies and ensure adoption of the solution. Formalized data-sharing protocols may also help gain buy-in and confidence from relevant expert communities.

Can the OWS mechanisms be used internationally?

Possibly, but it would require more coordination and alignment between the countries involved. This could include applying the mechanisms within existing international institutions to achieve existing goals. The mechanisms could apply with revisions, such as coordination among national delegations and nongovernmental organizations, activating nongovernmental capacity, and creating geopolitical incentives for adoption.

Who was on the Operation Warp Speed leadership team?

The team included HHS Secretary Alex Azar; Secretary of Defense Mark Esper; Dr. Moncef Slaoui, former head of vaccines at GlaxoSmithKline; and General Gustave F. Perna, former commanding general of U.S. Army Materiel Command. This core team combined scientific and technical expertise with military and logistical backgrounds. Dr. Slaoui’s familiarity with the pharmaceutical industry and the vaccine development process allowed OWS to develop realistic goals and benchmarks for its work. This connection was also critical in forging robust public-private partnerships with the vaccine companies.

Which demand-pull mechanisms are most effective?

It depends on the challenge. Determining which mechanism to use for a particular project requires a deep understanding of the particular R&D, manufacturing, supply chain landscapes to diagnose the market gaps. For example, if manufacturing process technologies are needed, prize competitions or challenge-based acquisitions may be most effective. If manufacturing volume must increase, volume guarantees or advance purchase agreements may be more appropriate. Advance market commitments or milestone payments can motivate industry to increase efficiency. OWS used a combination of volume guarantees and advance market commitments to fund the development of vaccine candidates and secure supply.

Creating Equitable Outcomes from Government Services through Radical Participation

Government policies, products, and services are created without the true and full design participation and expertise of the people who will use them–the public: citizens, refugees, and immigrants. As a result, the government often replicates private sector anti-patterns1, using or producing oppressive, disempowering, and colonial policies through products and services that embody bias, limit access, create real harm, and discriminate against underutilized communities2 on the basis of various identities violating the President’s Executive Order on Equity. Examples include life-altering police use of racially and sexually biased facial recognition products, racial discrimination in the delivery access of life-saving Medicaid services and SNAP benefits, and racist child welfare service systems.

The Biden-Harris Administration should issue an executive order to embed Radical Participatory Design (RPD) into the design and development of all government policies, products, and services, and to require all federally-funded research to use Radical Participatory Research (RPR). Using an RPD and RPR approach makes the Executive Order on Racial Equity, Executive Order on Transforming the Customer Experience, and the Executive Order on DEIA more likely to succeed. Using RPD and RPR as the implementation strategy is an opportunity to create equitable social outcomes by embodying equity on the policy, product and service design side (Executive Order on Racial Equity), to improve the public’s customer experience of the government (Executive Order on Transforming the Customer Experience, President’s Management Agenda Priority 2), and to lead to a new and more just, equitable, diverse, accessible, and inclusive (JEDAI) future of work for the federal government (Executive Order on DEIA).

Challenge and Opportunity

The technology industry is disproportionately white and male. Compared to private industry overall, whites, men, and Asians are overrepresented while Latinx people, Black people, and women are underrepresented. Only 26% of technology positions in the U.S. are held by women though they represent 57% of the US workforce. Even worse, women of color hold 4% of technology positions even though they are 16% of the population. Similarly, Black Americans are 14% of the population but hold 7% of tech jobs. Latinx Americans only hold 8% of tech jobs while comprising 19% of the population. This representation decreases even more as you look at leadership roles in technology. In FY2020, the federal government spent $392.1 billion contracting services, including services to build products. Latinx, African Americans, Native Americans, and women are underrepresented in the contractor community.

The lack of diversity in designers and developers of the policies, products, and services we use leads to harmful effects like algorithmic bias, automatic bathroom water and soap dispensers that do not recognize darker skin, and racial bias in facial recognition (mis)identification of Black and Brown people. 

With a greater expectation of equity from government services, the public experiences greater disappointment when government policies, services, and products are biased, discriminatory, or harmful. Examples include inequitable public school funding services, race and poverty bias in child welfare systems, and discriminatory algorithmic hiring systems used in government.

The federal government has tried to improve the experience of its products and services through methodologies like Human-centered Design (HCD). In HCD, the design process is centered on the community who will use the design, by first conducting research interviews or observations. Beyond the research interactions with community members, designers are supposed to carry empathy for the community all the way through the design, development, and launch process. Unfortunately, given the aforementioned negative outcomes of government products and services for various communities, empathy often is absent. What empathy may be generated does not persist long enough to influence or impact the design process. Ultimately, individual appeals to empathy are inadequate at generating systems level change. Scientific studies show that white people, who make up the majority of technologists and policy-makers, have a reduced capacity for empathy for people of other and similar backgrounds. As a result, the push for equity remains in government services, products, and policies, leading to President Biden’s Executive Order on Advancing Racial Equity and Support for Underserved Communities and, still, again, with the Executive Order on Further Advancing Racial Equity and Support for Underserved Communities.

The federal government lacks processes to embed empathy throughout the lifecycle of policy, product, and service design, reflecting the needs of community groups. Instead of trying to build empathy in designers who have no experiential knowledge, we can create empathetic processes and organizations by embedding lived experience on the team.

Radical Participatory Design (RPD) is an approach to design in which the community members, for whom one is designing, are full-fledged members on the research, design, and development team. In traditional participatory design, designers engage the community at certain times and otherwise work, plan, analyze, or prepare alone before and after those engagements. In RPD, the community members are always there because they are on the team; there are no meetings, phone calls, or planning without them.

RPD has a few important characteristics. First, the community members are always present and leading the process. Second, the community members outnumber the professional designers, researchers, or developers. Third, the community members own the artifacts, outcomes, and narratives around the outcomes of the design process. Fourth, community members are compensated equitably as they are doing the same work as professional designers. Fifth, RPD teams are composed of a qualitatively representative sample (including all the different categories and types of people) of the community.

Embedding RPD in the government connects the government to a larger movement toward participatory democracy. Examples include the Philadelphia Participatory Design Lab, the Participatory City Making Lab, the Center for Lived Experience, the Urban Institute’s participatory Resident Researchers, and Health and Human Service’s “Methods and Emerging Strategies to Engage People with Lived Experience.” Numerous case studies show the power of participatory design to reduce harm and improve design outcomes. RPD can maximize this by infusing equity as people with lived experience both choose, check, and direct the process.

As the adoption of RPD increases across the federal government, the prevalence and incidence of harm, bias, trauma, and discrimination in government products and services will decrease, aiding the implementation of the executive orders on Advancing Racial Equity and Support for Underserved Communities and Further Advancing Racial Equity and Support for Underserved Communities, and ensuring the OSTP AI Bill of Rights for AI products and services. Additionally, RPR aligns with OSTP’s actions to advance open and equitable research. Second, the reduction of harm, discrimination, and trauma improves the customer experience (CX) of government services aiding the implementation of the Executive Order on Transforming the Customer Experience, the President’s Management Agenda Priority 2, and the CAP goal on Customer Experience. An improved CX will increase community adoption, use, and engagement with potentially helpful and life-supporting government services that underutilized people need. RPD highlights the important connection between equity and CX and creates a way to link the two executive orders. You cannot claim excellent CX when the CX is inequitable and entire underutilized segments of the public have a harmful experience.

Third, instead of seeking the intersection of business needs and user needs like in the private sector, RPD will move the country closer to its democratic ideals by equitably aligning the needs of the people with the needs of the government of the people, by the people, and for the people. There are various examples where the government acts like a separate entity completely unaligned to the will of a majority of the public (gun control, abortion). Project by project, RPD helps align the needs of the people and the needs of the government of the people when representative democracy does not function properly.
Fourth, all community members, from all walks of life, brought into government to do participatory research and design will gain or refine skills they can then use to stay in government policy, product, and service design or to get a job outside of government. The workforce outcomes of RPD further diversify policy, product, and service designers and researchers both inside and outside the federal government, aligning with the Executive Order on DEIA in the Federal Workforce.

Plan of Action

The use of RPD and RPR in government is the future of participatory government and a step towards truly embodying a government of the people. RPD must work at the policy level as well, as policy directs the creation of services, products, and research. Equitable product and service design cannot overcome inequitable and discriminatory policy.  The following recommended actions are initial steps to embody participatory government in three areas: policy design, the design and development of products and services, and funded research. Because all three areas occur across the federal government, executive action from the White House will facilitate the adoption of RPD.

Policy Design

An executive order from the president should direct agencies to use RPD when designing agency policy. The order should establish a new Radical Participatory Policy Design Lab (RPPDL) for each agency with the following characteristics:

The executive order should also create a Chief Experience Officer (CXO) for the U.S. as a White House role. The Office of the CXO (OCXO) would coordinate CX work across the government in accordance with the Executive Order on Transforming the CX, the PMA Priority 2, the CX CAP goal, and the OMB Circular A-11 280. The executive order would focus the OCXO on the work of coordinating, approving, advising the RPD work across the federal government, including the following initiatives:

Due to the distributed nature of the work, the funding for the various RPPDLs and the OCXO should come from money the director of OMB has identified and added to the budget the President submits to Congress, according to Section 6 of the Executive Order on Advancing Racial Equity. Agencies should also utilize money appropriated by the Agency Equity Teams required by the Executive Order on Further Advancing Racial Equity.

Product and Service Design

The executive order should mandate that all research, design, and delivery of agency products and services for the public be done through RPR and RPD. RPD should be used both for in-house and contracted work through grants, contracts, or cooperative agreements.

On in-house projects, funding for the RPD team should come from the project budget. For grants, contracts, and cooperative agreements, funding for the RPD team should come from the acquisition budget. As a result, the labor costs will increase since there are more designers on the project. The non-labor component of the project budget will be less. A slightly lower non-labor project budget is worth the outcome of improved equity. Agency offices can compensate for this by requesting a slightly higher project budget for in-house or contracted design and development services. 

In support of the Executive Order on Transforming the CX, the PMA Priority 2, and the CX CAP goal,  OMB should amend the OMB Circular A-11 280 to direct High Impact Service Providers (HISPs) to utilize RPD in their service work.

OSTP should add RPD and RPD case studies as example practices in OSTP’s AI Bill of Rights. RPD should be listed as a practice that can affect and reinforce all five principles.

Funded Research

The executive order should also mandate that all government-funded, use-inspired research about communities or intended to be used by people or communities, should be done through RPR. In order to determine if a particular intended research project is use-inspired, the following questions should be asked by the government funding agency prior to soliciting researchers:

  1. For technology research, is the technology readiness level (TRL) 2 or higher?
  2. Is the research about people or communities?
  3. Is the research intended to be used by people or communities?
  4. Is the research intended to create, design, or guide something that will be used by people and communities?

If the answer to any of the questions is yes, the funding agency should require the funded researchers to use an RPR approach.

Funding for the RPR team comes from the research grant or funding. Researchers can use the RPR requirement to estimate how much funding should be requested in the proposal.
OSTP should add RPR and the executive order to their list of actions to advance open and equitable research. RPR should be listed as a key initiative of the year of Open Science.

Conclusion

In order to address inequity, the public’s lived experience should lead the design and development process of government products and services. Because many of those products and services are created to comply with government policy, we also need lived experience to guide the design of government policy. Embedding Radical Participatory Design in government-funded research as well as policy, products, and services reduces harm, creates equity, and improves the public customer experience. Additionally, RPD connects and embeds equity in CX, moves us toward our democratic ideals, and creatively addresses the future of work by diversifying our policy, product, and service design workforce.

Frequently Asked Questions
What is the difference between a product and a service in technology?

Because we do not physically hold digital products, the line between a software product and a software service is thin. Usually, a product is an offering or part of an offering that involves one interaction or touchpoint with a customer. In contrast, a service involves multiple touchpoints both online and offline, or multiple interactions both digital and non-digital.


For example, Google Calendar can be considered a digital product. A product designer for Google Calendar might work on designing its software interface, colors, options, and flows. However, a library is a service. As a library user, you might look for a book on the library website. If you can’t find it, you might call the library. The librarian might ask you to come in. You go in and work with the librarian to find the book. After realizing it is not there, the librarian might then use a software tool to request a new book purchase. Thus, the library service involved multiple touchpoints, both online and offline: a website, a phone line, an in-person service in the physical library, and an online book procurement tool.


Most of the federal government’s offerings are services. Examples like Medicare, Social Security, and veterans benefits involve digital products, in-person services in a physical building, paper forms, phone lines, email services, etc. A service designer designs the service and the mechanics behind the service in order to improve both the customer experience and the employee experience across all touchpoints, offline and online, across all interactions, digital and non-digital.

Why do you use the word “radical?” What is the difference between Participatory Design and RPD?

Participatory design (PD) has many interpretations. Sometimes PD simply means interviewing research participants. Because they are “participants,” by being interviewees, the work is participatory. Sometimes, PD  means a specific activity or method that is participatory. Sometimes practitioners use PD to mean a way of doing an activity. For example, we can do a design studio session with just designers, or we can invite some community members to take part for a 90-minute session. PD can also be used to indicate a methodology. A methodology is a collection of methods or activities; or a methodology is a philosophy or guiding philosophy or principles that help you choose a particular method or activity at a particular point in time or in a process.


In all the above ways of interpreting PD, there are times when the community is present and times when they are not. Moreover, the community members are never leading the process.


Radical comes from the Latin word “radix” meaning root. RPD means design in which the community participates “to the root,” fully, completely, from beginning to end. There are no times, planning, meetings, or phone calls where the community is not present because the community is the team.

What is the difference between RPD and peer review?

Peer review is similar to an Institutional Review Board (IRB). A participatory version of this could be called a Community Review Board (CRB). The difficulty is that a CRB can only reject a research plan; a CRB does not create the proposed research plans. Because a CRB does not ensure that great research plans are created and proposed, it can only reduce harm. It cannot create good. 


Equality means treating people the same. Equity means treating people differently to achieve equal outcomes. CRBs achieve equality only in approving power, by equally including community members in the approving process. CRBs fail to achieve equity in social outcomes of products and services because community members are missing in the research plan creation process, research plan implementation process, and the development process of policy, products, and services where inequity can enter. To achieve equal outcomes, equity, their lived experiential knowledge is needed throughout the entire process and especially in deciding what to propose to a CRB.


Still a CRB can be a preliminary step before RPR. Unfortunately, IRBs are only required for US government-funded research with human subjects. In practice, it is not interpreted to apply to the approval of design research for policy, products, and services, even when the research usually includes human subjects. The application of participatory CRBs to approve all research–including design research for policy, products, and services–can be an initial step or a pilot.

If anyone can do research, design, and development work, what is the point of hiring professional researchers, designers, or developers?

A good analogy is that of cooking. It is quite helpful for everyone to know how to cook. Most of us cook in some capacity. Yet, there are people who attend culinary school and become chefs or cooks. Has the fact that individual people can and do cook eliminated the need for chefs? No. Chefs and cooks are useful for various situations – eating at a restaurant, catering an event, the creation of cookbooks, lessons, etc.


The main idea is that the chefs have mainstream institutional knowledge learned from books and universities or cooking schools. But that is not the only type of knowledge. There is also lived, experiential knowledge as well as community, embodied, relational, energetic, intuitive, aesthetic, and spiritual knowledge. It is common to meet amazing chefs who have never been to a culinary school but simply learned to cook through lived experience of experimentation and having to cook everyday for X people. Some learned to cook through relational and community knowledge passed down in their culture through parents, mothers, and aunties. Sometimes, famous chefs will go and learn the knowledge of a particular culture from people who did not go to a learning school. The chefs will appropriate the knowledge and then create a cookbook to sell marketing a fusion cuisine, infused with the culture whose culinary knowledge they appropriated.


Similarly, everyone designs. It is not enough to be tech-savvy or an innovation and design expert. The most important knowledge to have is the lived experiential, community, relational, and embodied knowledge of the people for whom we are designing. When lived experience leads, the outcomes are amazing. Putting lived experience alongside professional designers can be powerful as well. Professional designers are still needed, as their knowledge can help improve the design process. Professionals just cannot lead, lead alone, or be the only knowledge base because inequity enters the system more easily.

Do RPR or RPD teams serve full-time or is it a part-time role?

To realize the ambitions of this policy proposal, full-time teams will be needed. The RPPDLs who are designing policy are full-time roles due to the amount and various levels of policy to design. For products and services, however, some RPD teams may be part-time. For example, improving an existing product or service may be one of many work projects a government team is conducting. So if they are only working on the project 50% of the time, they may only require a group of part-time community members. On the other hand, the work may require full-time work for RPD team members for the design and development of a greenfield or new product or service that does not exist. Full-time projects will need full-time community members. For part-time projects, community members can work on multiple projects to reach full-time capacity.

How do we compensate RPR or RPD team members outside of a grant, cooperative agreement, or contract?

Team members can receive non-monetary compensation like a gift card, wellness services, or child care. However, it is best practice to allow the community member to choose. Most will choose monetary compensation like grants, stipends, or cash payments.


Ultimately they should be paid at a level equal to that of the mainstream institutional experts (designers and developers) who are being paid to do the same work alongside the community members. Remember to compensate them for travel and child care when needed.

Why is the government the right sector to implement this? Why can’t this first be done in the private or nonprofit sector or even by government at the state or local level?

RPD is an opportunity for the government to lead the way. The private sector can make money without equitably serving everyone, so it has no incentive to do so. Nonprofits do not carry the level of influence the federal government carries. The federal government has more money to engage in this work than state or local governments. The federal government has a mandate to be equitable in its products and services and their delivery, and if this goes well, the government can make a law mandating organizations in the private and nonprofit sector to do the same work to transform. The government has a long history of using policy and services to discriminate against various underutilized groups. So the federal government should be the first one to use RPD to move towards equity. Ultimately the federal government has a huge influence on the lives of citizens, immigrant residents, and refugees, and the opportunity is great to move us toward equity.


Embedding RPD in government products and services should also be done at the state and local level. Each level will require different memos due to the different mechanics, budgets, dynamics, and policies. The hope is that RPD work at the federal government can help spark RPD work at various state, local, and county governments.

Is there a pilot or scaled-down version that could be implemented as a first step?

Possible first steps include:



  • Mandate that all use-inspired research, including design research for policy, products, and services, be reviewed by a Community Review Board (CRB) for approval.



  • If not approved, the research, design, and development cannot move forward.



  • Only mandate all government-funded, use-inspired research be conducted using RPR. Focusing on research funding alone shifts the payment of RPR community teams to the grant recipients, only.



  • Mandate all government-funded, use-inspired research use RPR and all contracted research, design, development, and delivery of government products and services uses RPD.



  • Focusing on research funding and contracted product and service work shifts the payment of RPR and RPD community team members to the grant recipients, vendors, and contract partners.



  • Choose a pilot agency, like NIH, to start.




  • Start with a high-profile set of projects such as the OMB life experience projects.
    Then, later we can advance to an entire pilot agency.



  • Focus on embedding equity measures in CX.


After equity is embedded in CX, start by choosing a pilot agency, benchmarking equity and CX, piloting RPD, and measuring the change attributable to RPD.
This allows time to build more evidence.

What participatory design case studies exist?

There are many existing case studies of participatory design.



Also there are also case studies of participatory design in the public sector.


How do you ensure that a product or service continues developing according to community desires after the RPD team is finished?

In modern product and service development, products and services never convert into an operations and maintenance phase alone. They are continually being researched, designed, and developed due to continuous changes in human expectations, migration patterns, technology, human preferences, globalization, etc. If community members were left out of research, design, and development work after a service or product launches, then the service or product would no longer be designed and developed using an RPD approach. As long as the service or product is active and in service, radical participation in the continuous research, design, and development is needed.

Protecting Civil Rights Organizations and Activists: A Policy Addressing the Government’s Use of Surveillance Tools

In the summer of 2020, some 15 to 26 million people across the country participated in protests against the tragic killings of Black people by law enforcement officers, making it the largest movement in US history. In response, local and state government officials and federal agencies deployed surveillance tools on protestors in an unprecedented way. The Department of Homeland Security used aerial surveillance on protesters across 15 cities, and several law enforcement agencies engaged in social media monitoring of activists. But there is still a lot the public does not know, such as what other surveillance tactics were used during the protests, where this data is being stored, and for what future purpose. 

Government agencies have for decades secretly used surveillance tactics on individual activists, such as during the 1950s when the FBI surveilled human rights activists and civil rights organizations. These tactics have had a detrimental effect on political movements, causing people to forgo protesting and activism out of fear of such surveillance. The First Amendment protects freedom of speech and the right to assemble, but allowing government entities to engage in underground surveillance tactics strips people of these rights. 

It also damages people’s Fourth Amendment rights. Instead of agencies relying on the court system to get warrants and subpoenas to view an individual’s online activity, today some agencies are entering into partnerships with private companies to obtain this information directly. This means government agencies no longer have to meet the bare minimum of having probable cause before digging into an individual’s private data.

This proposal offers a set of actions that federal agencies and Congress should implement to preserve the public’s constitutional rights. 

Challenges and Opportunities 

Government entities have been surveilling activists and civil rights organizations long before the 2020 protests. Between 1956 and 1971, the FBI engaged in surveillance tactics to disrupt, discredit, and destroy many civil rights organizations, such as the Black Panther Party, American Indian Movement, and the Communist Party. Some of these tactics included illegal wiretaps, infiltration, misinformation campaigns, and bugs. This program was known as COINTELPRO, and the FBI’s goal was to destroy organizations and activists who had political agendas that they viewed as radical and would challenge “the existing social order.” While the FBI didn’t completely achieve this goal, their efforts did have detrimental effects on activist communities, as members were imprisoned or killed for their activist work, and membership in organizations  like the Black Panther Party significantly declined and eventually dissolved in 1982. 

After COINTELPRO was revealed to the public, reforms were put in place to curtail the FBI’s surveillance tactics against civil rights organizations, but those reforms were soon rolled back after the September 11 attacks. Since 9/11, it has been revealed, mostly through FOIA requests, that the FBI has surveilled the Muslim community, Occupy Wall Street, Standing Rock protesters, murder of Freddie Gray protesters, Black Lives Matter protests, and more. Today, the FBI has more technological tools at their disposal that make mass surveillance and data collection on activist communities incredibly easy. 

In 2020, people across the country used social media sites like Facebook to increase engagement and turnout in local Black Lives Matters protests. The FBI’s Joint Terrorism Task Forces responded by visiting people’s homes and workplaces to question them about their organizing, causing people to feel alarmed and terrified. U.S. Customs and Border Protection (CBP) also got involved, deploying a drone over Minneapolis to provide live video to local law enforcement. The Acting Secretary of CBP also tweeted out that CBP was working with law enforcement agencies across the nation during the 2020 Black Lives Matter Protests. CBP involvement in civil rights protests is incredibly concerning given its ability to circumvent the Fourth Amendment and conduct warrantless searches due to the border search exception. (Federal regulations and federal law gives CBP the authority to conduct warrantless searches and seizures within 100 miles of the U.S. border, where approximately two-thirds of the U.S. population resides.)

The longer government agencies are allowed to surveil people who are simply organizing for progressive policies, the more people will be terrified to voice their opinion about the state of affairs in the United States. This has had detrimental effects on people’s First and Fourth Amendment rights and will continue to have even more effects as technology improves and government entities have access to advanced tools. Now is the time for government agencies and Congress to act to prevent further abuse of the public’s rights to protest and assemble. A country that uses tools to watch its residents will ultimately lead to a country with little to no civic engagement and the complete silencing of marginalized communities. 

While there is a lot of opportunity to address mass surveillance and protect people’s constitutional rights, government officials have refused to address government surveillance for decades, despite public protest. In the few instances where government officials put up roadblocks to stop surveillance tactics, those roadblocks were later removed or reformed so as to allow the previous surveillance to continue. The lack of political will of Congressmembers to address these issues has been a huge challenge for civil rights organizations and individuals fighting for change. 

Plan of Action 

Regulations need to be put in place to restrict federal agency use of surveillance tools on the public. 

Recommendation 1. Federal agencies must disclose technologies they are using to surveil individuals and organizations, as well as the frequency with which they use them. Agencies should to publish this information on their websites and produce a more comprehensive report for the Department of Justice (DOJ) to review. 

Every six months, Google releases the number of requests it receives from government agencies asking for user information. Google informs the public on the number of accounts that were affected by those requests and whether the request was a subpoena, search warrant, or other court order. The FBI also discloses the number of DNA samples it has collected from individuals in each U.S. state and territory and how many of those DNA samples aided in investigations.

Likewise, government agencies should be required to disclose the names of the technologies they are purchasing to surveil people in the United States as well as the number of times they use this technology within the year. Government entities should no longer be able to hide which technologies their departments are using to watch the public. People should be informed on the depth of the government’s use of these tools so they have a chance to voice their objections and concerns. 

Federal agencies also need to publish a more comprehensive report for the DOJ to review. This report will include what technologies were used and where, what category of organizations they were used against, racial demographics of the people who were surveilled, and possible threats to civil rights. The DOJ will use this information to run investigate whether agencies are violating the Fourth Amendment or First Amendment in using these technologies against the public. 

Agencies may object to releasing this information because of the possibility of it interfering with investigations. However, Google does not release the names of individuals who have had their user information requested, and neither should government agencies release user information. Because government agencies won’t be required to release specific information on individuals to the public, this will not affect their investigations. This disclosure request is aimed at knowing what tools government agencies are using and giving the DOJ the opportunity to investigate whether these tools violate constitutional rights. 

Recommendation 2. Attorney General Guidelines should be revised in collaboration with the White House Office of Science and Technology Policy (OSTP) and civil rights organizations that specialize in technology issues.

The FBI has used advanced technology to watch activists and protests with little to no government oversight or input from civil rights organizations. When conducting an investigation or assessment of an individual or organization, FBI agents follow the Attorney General Guidelines, which dictate how investigations should be conducted. Unfortunately, these guidelines do little to protect the public’s civil rights—and in fact contain a few provisions that are quite problematic: 

These provisions are problematic for a few reasons. FBI employees should not be able to conduct assessments on individuals without a factual basis. Giving employees the power to pick and choose who they want to assess provides an opportunity for inherent bias. Instead, all assessments and investigations should have some factual basis behind them and receive approval from a supervisor. Physical surveillance and internet searches, likewise, should not be conducted by FBI agents without probable cause. Allowing these kinds of practices opens the entire public to having their privacy invaded. 

These policies should be reviewed and revised to ensure that activists and organizations won’t be subject to surveillance due to internal bias. President Biden should issue an executive order directing OSTP to collaborate with the Office of the Attorney General on the guidelines. OSTP should have a task force dedicated to researching government surveillance and the impact on marginalized groups to guide them on this collaboration. 

External organizations that are focused on technology and civil rights should also be brought in to review the final guidelines and voice any concerns. Civil rights organizations are more in tune with the effect that government surveillance has on their communities and the best mechanisms that should be put in place to preserve privacy rights. 

Congress also should take steps to protect the public’s civil rights by passing the Fourth Amendment Is Not for Sale Act, revising the Stored Communications Act, and passing border exception legislation. 

Recommendation 3. Congress should close the loophole that allows government agencies to circumvent the Fourth Amendment and purchase data from private companies by passing the Fourth Amendment Is Not for Sale Act. 

In 2008, it was revealed that AT&T had entered into a voluntary partnership with the National Security Agency (NSA) from 2001 to 2008. AT&T built a room in its headquarters that was dedicated to providing the NSA with a massive quantity of internet traffic, including emails and web searches. 

Today, AT&T has eight facilities that intercept internet traffic across the world and provide it to the NSA, allowing them to view people’s emails, phone calls, and online conversations. And the NSA isn’t the only federal agency partnering with private companies to spy on Americans. It was revealed in 2020 that the FBI has an agreement with Dataminr, a company that monitors people’s social media accounts, and Venntel, Inc., a company that purchases bulk location data and maps the movements of millions of people in the United States. These agreements were signed and modified after BLM protests were held across the country. 

Allowing government agencies to enter into agreements with private companies to surveil people gives them the ability to bypass the Fourth Amendment and spy on individuals with no restriction. Federal agencies no longer need rely on the courts when seeking private communications and thoughts; they can now purchase sensitive information like a person’s location data and social media activity from a private company. Congress should end this practice and ban federal government agencies from purchasing people’s private data from third parties by passing the Fourth Amendment Is Not For Sale Act. If this bill passed, government agents could no longer purchase location data from a data broker to figure out who was in a certain area during a protest or partner with a company to obtain people’s social media postings without going through the legal process. 

Recommendation 4. Congress should amend the Stored Communications Act of 1986 (SCA) to compel electronic communication service companies to prove they are in compliance with the act. 

The SCA prohibits companies that provide an electronic communication service from “knowingly” sharing their stored user data with the government. While data brokers are more than likely excluded from this provision, companies that provide direct services to the public such as Facebook, Twitter, and Snapchat are not. Because of this law, direct service companies aren’t partnering with government agencies to sell user information, but they are selling user data to third parties like data brokers. 

There should be a responsibility placed on electronic communication service companies to ensure that the companies they sell user information to won’t sell data to government entities. Congress should amend the SCA to include a provision requiring companies to annually disclose who they sold user data to and whether they verified with the third party that the data will not be eventually sold to a government entity. Verification should require at minimum a conversation with the third party about the SCA provision and a signed agreement that the third party will not sell any user information to the government. The DOJ will be tasked with reviewing these disclosures for compliance. 

Recommendation 5. Congress should pass legislation revoking the border search exception. As stated earlier, this exception allows federal agents to conduct warrantless searches and seizures within 100 miles of the U.S. border. It also allows federal agents to search and seize digital devices at the border without having any level of suspicion that the traveler has committed a crime. CBP agents have pressured travelers to unlock their devices to look at the content, as well as downloaded the content of the devices and stored the data in a central database for up to 15 years. 

While other law enforcement agencies are forced to abide by the Fourth Amendment, federal agents have been able to bypass the Fourth Amendment and conduct warrantless searches and seizures without restriction. If federal agents are allowed to continue operating without the restrictions of the Fourth Amendment, it’s possible we will see more instances of local law enforcement agencies calling on CBP to conduct surveillance operations on the general public during protests. This is an unconscionable amount of power to give to agencies that can and has led to serious abuse of the public’s privacy rights. Congress must roll back this authority and require all law enforcement agencies—local, state, and federal—to have probable cause at a minimum before engaging in searches and seizures. 

Conclusion

For too long, government agencies have been able to surveil individuals and civil rights organizations with little to no oversight. With the advancement of technology, their surveillance capabilities have grown tremendously, leading to near 24/7 surveillance. Regulations must be put in place to restrict the use of surveillance technologies by federal agencies, and Congress must pass legislation to protect the public’s constitutional rights.

Frequently Asked Questions
What are Attorney General Guidelines?

The FBI operates under the jurisdiction of the DOJ and reports to the Attorney General. The Attorney General has been granted the authority under U.S. Codes and Executive Order 12333 to issue guidelines for the FBI to follow when they conduct domestic investigations. These are the Attorney General Guidelines.

What is the Fourth Amendment Is Not For Sale Act?

This bill was introduced by Senators Ron Wyden, Rand Paul, and 18 others in 2021 to protect the public from having government entities purchase their personal information, such as location data, from private companies rather than going through the court system. Instead, the government would be required to obtain a court order before they getting an individual’s personal information from a data broker. This is a huge step in protecting people’s private information and stopping mass government surveillance.

Modernizing Enforcement of the Civil Rights Act to Mitigate Algorithmic Harm in Determining Federal Benefits

The Department of Justice should modernize the enforcement of Title VI of the Civil Rights Act to guide effective corrective action for algorithmic systems that produce discriminatory outcomes with regard to federal benefits. To do so, the Department of Justice should clarify the definition of “algorithmic discrimination” in the context of federal benefits, establish systems to identify which federally funded public benefits offices use machine-learning algorithms, and secure the necessary human resources to properly address algorithmic discrimination. This crucial action would leverage a demonstrable, growing interest in regulating algorithms that has bloomed over the past year via policy actions in both the White House and Congress but has yet to concretely establish an appropriate enforcement mechanism for acting on instances of demonstrated algorithmic harm. 

Challenge and Opportunity

Algorithmic systems are inescapable in modern life. They have become core elements of everyday activities, like surfing the web, driving to work, and applying for a job. It is virtually impossible to go through life without encountering an algorithmic system multiple times per day.

As machine-learning technologies have become more pervasive, they have also become gatekeepers for crucial resources, like accessing credit, receiving healthcare, securing housing, and getting a mortgage. Both local and federal governments have embraced algorithmic decision-making to determine which constituents are able to access key services, often with little transparency, if any, for those who are subject to such decision-making.

When it comes to federal benefits, imperfections in these systems scale significantly. For example, the deployment of flawed algorithmic tools led to the wrongful termination of Medicaid for 19% of beneficiaries in Arkansas, the wrongful termination of Social Security income for thousands in New York, wrongful termination of $78 million worth of Medicaid and Supplemental Nutrition Assistance Program benefits in Indiana, and erroneous unemployment fraud charges for 40,000 people in Michigan. These errors are particularly harmful to low-income Americans for whom access to credit, housing, job opportunities, and healthcare are especially important.

Over the past year, momentum for regulating algorithmic systems has grown, resulting in several key policy actions. In February 2022, Senators Ron Wyden and Cory Booker and Representative Yvette Clarke introduced the Algorithmic Accountability Act. Endorsed by AI experts, this bill would have required deployers of algorithmic systems to conduct and publicly share impact assessments of their systems. In October 2022, the White House released its Blueprint for an AI Bill of Rights. Although not legally enforceable, this robust rights-based framework for algorithmic systems was developed with a broad coalition of support through an intensive, yearlong public consultation process with community members, private sector representatives, tech workers, and policymakers. Also in October 2022, the AI Training Act was passed into law. The legislation requires the development of a training curriculum covering core concepts in artificial intelligence for federal employees in a limited range of roles, primarily those involved in procurement. Finally, January 2023 saw the introduction of the NIST AI Risk Management Framework to guide how organizations and individuals design, develop, deploy, or use artificial intelligence to manage risk and promote responsible use.

Collectively, these actions demonstrate clear interest in preventing harm caused by algorithmic systems, but none of them provide clear enforcement mechanisms for federal agencies to pursue corrective action in the wake of demonstrated algorithmic harm.

However, Title VI of the Civil Rights Act offers a viable and legally enforceable mechanism to aid anti-discrimination efforts in the algorithmic age. At its core, Title VI bans the use of federal funding to support programs (including state and local governments, educational institutions, and private companies) that discriminate on the basis of race, color, or national origin. Modernizing the enforcement of Title VI, specifically in the context of federal benefits, offers a clear opportunity for developing and refining a modern enforcement approach to civil rights law that can respond appropriately and effectively to algorithmic discrimination. 

Plan of Action

Fundamentally, this plan of action seeks to:

Clarify the Framework for Algorithmic Bias in Federal Benefits

Recommendation 1. Fund the Department of Justice (DOJ) to develop a new working group focused specifically on civil rights concerns around artificial intelligence.

The DOJ has already requested funding for and justified the existence of this unit in its FY2023 Performance Budget. In that budget, the DOJ requested $4.45 million to support 24 staff. 

Clear precedents for this type of cross-sectional working group already exist within the Department of Justice (e.g., the Indian Working Group and LGBTQI+ Working Group). Both of these groups contain members of the 11 sections of the Civil Rights Division to ensure a comprehensive strategy for protecting the civil rights of Indigenous peoples and the LGBTQ+ community, respectively. The pervasiveness of algorithmic systems in modern life suggests a similarly broad scope is appropriate for this issue.

Recommendation 2. Direct the working group to develop a framework that defines algorithmic discrimination and appropriate corrective action specifically in the context of public benefits.

A clear framework or rubric for assessing when algorithmic discrimination has occurred is a prerequisite for appropriate corrective action. Despite having a specific technical definition, the term “algorithmic bias” can vary widely in its interpretation depending on the specific context in which an automated decision is being made. Even if algorithmic bias does exist, researchers and legal scholars have made the case that biased algorithms may be preferable to biased human decision-makers on the basis of consistency and the relative ease of behavior change. Consequently, the DOJ should develop a context-specific framework for determining when algorithmic bias leads to harmful discriminatory outcomes in federal benefits systems, starting with major federal systems like Social Security and Medicare/Medicaid. 

As an example, the Brookings Institution has produced a helpful report that illustrates what it means to define algorithmic bias in a specific context. Cross-walking this blueprint with existing Title VI procedures can yield guidelines for how the Department of Justice can notify relevant offices of algorithmic discrimination and steer corrective action.

Identify Federal Benefits Systems that Use Algorithmic Tools

Recommendation 3. Establish a federal register or database for offices that administer federally funded public benefits to document when they use machine-learning algorithms.

This system should specifically detail the developer of the algorithmic system and the office using said system. If possible, descriptions of relevant training data should be included as well, especially if these data are federal property. Consider working with the Office of Federal Contract Compliance Programs to secure this information from current and future government contractors within the federal benefits domain.

In terms of cost, previous budget requests for databases of this type have ranged from $2 million to $5 million.

Recommendation 4. Provide public access to the federal register.

Making the federal register public would provide baseline transparency regarding the federal funding of algorithmic systems. This would facilitate external investigative efforts to identify possible instances of algorithmic discrimination in public benefits, which would complement internal efforts by directing limited federal staff bandwidth towards cases that have already been identified. The public-facing portion of this registry should be structured to respecting appropriate privacy and trade secrecy restrictions

Recommendation 5. Link the public-facing register to a public-facing form for submitting claims of algorithmic discrimination in the context of federal benefits.

This step would help channel public feedback regarding claims of algorithmic discrimination with a sufficiently high threshold to minimize frivolous claims. A well-designed system will ask for evidence and data to justify any claim of algorithmic discrimination, allowing federal employees to prioritize which claims to pursue.

Equip Agencies with Necessary Resources for Addressing Algorithmic Discrimination

Recommendation 6. Authorize funding for technical hires in enforcement arms of federal regulatory agencies, including but not limited to the Department of Justice.

Effective enforcement of anti-discrimination statutes today requires technical fluency in machine-learning techniques. In addition to the DOJ’s Civil Rights Division (see Recommendation 1), consider directing funds to hire or train technical experts within the enforcement arms of other federal agencies with explicit anti-discrimination enforcement authority, including the Federal Trade Commission, Federal Communications Commission, and Department of Education.

Recommendation 7. Pass the Stopping Unlawful Negative Machine Impacts through National Evaluation Act.

This act was introduced with bipartisan support in the Senate at the very end of the 2021–2022 legislative session by Senator Rob Portman. The short bill seeks to clarify that civil rights legislation applies to artificial intelligence systems and decisions made by these systems will be liable to claims of discrimination under said legislation, including the Civil Rights Act, the Americans with Disabilities Act, and the Age Discrimination Act of 1975, among others. Passing the bill is a simple but effective way to indicate to federal regulatory agencies (and those they regulate) that artificial intelligence systems must comply with civil rights law and affirms the federal government’s authority to ensure they do so.

Conclusion

On his first day in office, President Biden signed an executive order to address the entrenched denial of equal opportunities for underserved communities in the United States. Ensuring that federal benefits are not systematically denied via algorithmic discrimination to low-income Americans and Americans of color is crucial to successfully meeting the goals of that order and the rising chorus of voices who want meaningful regulation for algorithmic systems. The authority for such regulation in the context of federal benefits already exists. To ensure that authority can be effectively enforced in the modern age, the federal government needs to clearly define algorithmic discrimination in the context of federal benefits, identify where federal funding is supporting algorithmic determination of federal benefits, and recruit the necessary talent to verify instances of algorithmic discrimination.

Frequently Asked Questions
What is an algorithm? How is it different from machine learning or artificial intelligence?

An algorithm is a structured set of steps for doing something. In the context of this memo, an algorithm usually means computer code that is written to do something in a structured, repeatable way, such as determining if someone is eligible for Medicare, identifying someone’s face using a facial recognition tool, or matching someone’s demographic profile to a certain kind of advertisement.


Machine-learning techniques are a specific set of algorithms that train a computer to do different tasks by taking in a massive amount of data and looking for patterns. Artificial intelligence generally refers to technical systems that have been trained to perform tasks with minimal human oversight. Machine learning and artificial intelligence are similar and often used as interchangeable terms.

How can we determine if an algorithm is biased?

We can identify algorithmic bias by comparing the expected outputs of an algorithm to the actual outputs for an algorithm. For example, if we find that an algorithm uses race as a decisive factor in determining whether someone is eligible for federal benefits that should be race-neutral, that would be an example of algorithmic bias. In practice, these assessments often take the form of statistical tests that are run over multiple outputs of the same algorithmic system.

Is algorithmic bias inherently bad?

Although many algorithms are biased, not all biases are equally harmful. This is due to the highly contextual nature in which an algorithm is used. For example, a false positive in a criminal-sentencing algorithm arguably causes more harm than a false positive in a federal benefits determination. Algorithmic bias is not inherently a bad thing and, in some cases, can actually advance equity and inclusion efforts depending on the specific contexts (consider a hiring algorithm for higher-level management that weights non-male gender or non-white race more heavily for selection).

Using a Digital Justice Framework To Improve Disaster Preparation and Response

Social justice, environmental justice, and climate justice are all digital justice. Digital injustice arises from the fact that 21 million Americans are not connected to the internet, and seven percent of Americans do not use it, even if they have access to it. This lack of connectivity can lead to the loss of life, disrupted communities, and frayed social cohesion during natural disasters, as people are unable to access life-saving information and preventive tools found online.

Digital injustice primarily affects poor rural communities and African American, Indigenous, and other communities of color. These communities are also overexposed to climate risk, economic fragility, and negative public health outcomes. Digital access is a pathway out of this overexposure. It is a crucial aspect of the digital justice conversation, alongside racial equity and climate resilience. 

Addressing this issue requires a long-term commitment to reimagining frameworks, but we can start by helping communities and policymakers understand the problem. Congress and the Biden-Harris Administration should embrace and support the creation of a Digital Justice Policy Framework that includes:

Challenges and Opportunities 

The internet has become a crucial tool in preparing for and recovering from ecological emergencies, building wealth, and promoting community connections. However, the digital divide has created barriers to accessing these resources for millions of people, particularly low-income individuals and people of color. The lack of access to the internet and technology during emergencies deepens existing vulnerabilities and creates preventable losses of life, displacement, and disrupted lives.

The map above shows the intersection between flood or sea level risk and lack of access to the internet. Credit: ArcGIS Online, Living Atlas, Monica Sanders. Click through for full interactive map.

Digital divestment, disasters, and poverty overlap in dangerous ways that reveal “inequities and deepen existing vulnerability… In the United States, roughly 21% of children live in poverty and without consistent access to food. Cascading onto poverty and vulnerability to large-scale events like pandemics and other disasters is the lack of access to the Internet and the education and opportunity that comes with it.”

A recent report about digital divestment in rural communities shows that access to internet infrastructure, devices, and information is critical to economic development. Yet rural communities are more likely to have no device in the home—26.4% versus 20% of the broader United States. Access to broadband is even lower, as most rural counties have just one or no provider. Geography often challenges access to public services. 

To tackle this issue, we must reimagine the use of data to ensure that all communities have access to information that reduces vulnerability and strengthens resilience. One pathway to reimagining data in a meaningful way is laid out in a National Academies of Science consensus study report, “Communities need information that they can effectively use in making decisions and investments that reduce the vulnerability and strengthen the resilience of their residents, economy, and environment. Assembling and using that information requires three things. First, data, while often abundantly available to communities, can be challenging for local communities and users to navigate, access, understand, and evaluate relative to local needs and questions. Second, climate data needs to be vetted and translated into information that is useful at a local level. Finally, information that communities receive from other sources needs to reflect the challenges and opportunities of those communities to not just be useful but also used.” Once communities are effectively connected and skilled up, they can use the information to make effective decisions.

The Government Accountability Office (GAO) looked into the intersection of information and justice, releasing a study on the fragmented and overlapping broadband plan and funding. It recommended a national strategy to help scale these efforts across communities and focus agency efforts on communities in need that includes recommendations for education, workforce training, and evidence-based policymaking.

Communities can be empowered to take a data-driven journey from lack of access to resources to using innovative concepts like regenerative finance to build resiliency. With the right help, divested communities can co-create sustainable solutions and work toward digital justice. The federal government should leverage initiatives like the Justice 40 initiative, aimed at undoing past injustices and divestment, to create opportunities for communities to gain access to the tools they need and understand how to use them.

Plan of Action

Executive branch agencies and Congress should initiate a series of actions to establish a digital justice framework. The first step is to provide education and training for divested communities as a pathway to participate in digital and green economies. 

  1. Funding from recent legislation and agency earmarks should be leveraged to initiate education and training targeted at addressing historical inequities in the localization, quality, and information provided by digital infrastructure:
    • The Infrastructure Investment and Jobs Act (IIJA) allocates $65 billion to expand the availability of broadband Internet access. The bulk of that funding is dedicated to access and infrastructure. Under the National Telecommunications and Information Administration’s (NTIA) Broadband Equity, Access, and Deployment (BEAD) Program, there is both funding and broad program language that allows for upskilling and training. Community leaders and organizations need support to advocate for funding at the state and local levels.  
  2. The Environmental Protection Agency’s (EPA)1 environmental education fund, which traditionally has $2 million to $3.5 million in grant support to communities, is being shaped right now. Its offerings and parameters can be leveraged and extended without significant structural change. The fund’s parameters should include elements of the framework, including digital justice concepts like climate, digital, and other kinds of literacy programs in the notices of funding opportunities. This would enable community organizations that are already doing outreach and education to include more offerings in their portfolios. 

To further advance a digital justice framework, agencies receiving funding from IIJA and other recent legislative actions should look to embed education initiatives within technical assistance requests for proposals and funding announcements. Communities often lack access to and support in how to identify and use public resources and information related to digital and climate change challenges. One way to overcome this challenge is to include education initiatives as key components of technical assistance programs. In its role of ensuring the execution of budget proposals and legislation, the Office of Budget and Management (OMB) can issue guidance or memoranda to agencies directing them to include education elements in notices of funding, requests for proposals, and other public resources related to IIJA, IRA and Justice 40. 

One example can be found in the Building Resilient Infrastructure and Communities (BRIC) program. In addition to helping communities navigate the federal funding landscape, OMB could require that new rounds of the program include climate or resilience education and digital literacy. The BRIC program can also increase its technical assistance offerings from 20% of applicants to 40%, for example. This would empower recipients to navigate the fuller landscape of using science to develop solutions and then successfully navigate the funding process. 

Another program that is being designed at the time of this writing is the Environmental and Climate Justice Grant Program, which contains $3 billion in funding from the IRA. There is a unique opportunity to draft requests for information, collaboration, or proposals to include ideas for education and access programs to democratize critical information by teaching communities how to access and use it.

An accompanying public education campaign can make these ideas sustainable. Agencies should engage with the Ad Council on a public education campaign about digital justice or digital citizenship, social mobility, and climate resilience. As an example, in 2022 FEMA funded a preparation initiative directed at Black Americans and disasters with the Ad Council that discussed protecting people and property from disasters across multiple topics and media. The campaign was successful because the information was accessible and demonstrated its value. 

Climate literacy and digital citizenship training are as necessary for those designing programs as they are for communities. The federal agencies that disburse this funding should be tasked with creating programs to offer climate literacy and digital citizenship training for their workforce. Program leaders and policy staff should also be briefed and trained in understanding and detecting data collection, aggregation, and use biases. Federal program officers can be stymied by the lack of baseline standards for federal workforce training and curricula development. For example, FEMA has a goal to create a “climate literate” workforce and to “embed equity” into all of its work—yet there is no evidence-based definition nor standard upon which to build training that will yield consistent outcomes. Similar challenges surface in discussions about digital literacy and understanding how to leverage data for results.2 Within the EPA, the challenge is helping the workforce understand how to manage the data it generates, use it to inform programs, and provide it to communities in meaningful ways. Those charged with delivering justice-driven programs must be provided with the necessary education and tools to do so. 

FEMA, like the EPA and other agencies, will need help from Congress. Congress should do more to support scientific research and development for the purpose of upskilling the federal workforce. Where necessary, Congress must allocate funding, or adjust current funding mechanisms, to provide necessary resources. There is $369 billion for “Energy Security and Climate Change” in the Inflation Reduction Act of 2022 that broadly covers the aforementioned ideas. Adjusting language to reference programs that address education and access to information would make it clear that agencies can use some of that funding. In the House, this could take the form of a suspension bill or addition as technical correction language in a report. In the Senate, these additions could be added as amendments during “vote-o-rama.”

For legislative changes involving the workforce or communities, it is possible to justify language changes by looking at the legal intent of complementary initiatives in the Biden-Harris Administration. In addition to IIJA provisions, policy writers can use parts of the Inflation Reduction Act and the Justice 40 initiative, as well as the climate change and environmental justice executive orders, to justify changes that will provide agencies with direction and resources. Because this project is at the intersection of climate and digital justice, the jurisdictional alignments would mainly be with the United States Department of Commerce, the National Telecommunications and Information Administration, the United States Department of Agriculture, EPA and FEMA.

Recommendations for federal agencies:

Recommendations for Congress:

Conclusion

Digital justice is about a deeper understanding of the generational challenges we must confront in the next few years: the digital divide, climate risk, racial injustice, and rural poverty. Each of these connects back to our increasingly digital world and efforts to make sure all communities can access its benefits. A new policy framework for digital justice should be our ultimate goal. However, there are present opportunities to leverage existing programs and policy concepts to create tangible outcomes for communities now. Those include digital and climate literacy training, public education, and better education of government program leaders as well as providing communities and organizations with more transparent access to capital and information.

Frequently Asked Questions
What is digital divestment?

Digital divestment refers to the intentional  exclusion of certain communities and groups from the social, intellectual, and economic benefits of the internet, as well as technologies that leverage the internet.

What is climate resilience?

Climate resilience is about successfully coping with and managing the impacts of climate change while preventing those impacts from growing worse. This does not mean only thinking about severe weather. It also includes economic shocks and public health emergencies that come with climate change. During the COVID-19 pandemic, women disproportionately passed away and in one Maryland city, survivors’ social mobility decreased by 1%. However, the introduction of community WIFI began to change these outcomes.

What does digital justice have to do with climate change?

Communities (municipalities, states) that are left out of access to internet infrastructure not only miss out on educational, economic, and social mobility opportunities; they also miss out on critical information about severe weather and climate change. Scientists and researchers depend on an internet connection to conduct research to target solutions. No high-quality internet means no access to information about cascading risk.

How does this impact rural areas?

While the IIJA broadband infrastructure funding is a once-in-a-generation effort, the reality is that in many rural areas broadband is either not cost-effective nor a feasible solution due to geography or other contexts.

How can technology policy help create solutions?

By opening funding to different kinds of internet infrastructures (community Wi-Fi, satellite, fixed access), communities can increase their risk awareness and make their own solutions.

Why should the federal government take action on this issue vs. a state or local government or the private sector?

The federal government is already creating executive orders and legislation in this space. What is needed is a more cohesive plan. In some cases that may entail partnering with the private sector or finding creative ways to partner with communities.

What is the first step?

The first step is briefings and socializing this policy work because looking at equity, tech, and climate change from this perspective is still new and unfamiliar to many.

Enabling Faster Funding Timelines in the National Institutes of Health

Summary

The National Institutes of Health (NIH) funds some of the world’s most innovative biomedical research, but rising administrative burden and extended wait times—even in crisis—have shown that its funding system is in desperate need of modernization. Examples of promising alternative models exist: in the last two years, private “fast science funding” initiatives such as Fast Grants and Impetus Grants have delivered breakthroughs in responding to the coronavirus pandemic and aging research on days to one-month timelines, significantly faster than the yearly NIH funding cycles. In response to the COVID-19 pandemic the NIH implemented a temporary fast funding program called RADx, indicating a willingness to adopt such practices during acute crises. Research on other critical health challenges like aging, the opioid epidemic, and pandemic preparedness deserves similar urgency. We therefore believe it is critical that the NIH formalize and expand its institutional capacity for rapid funding of high-potential research.

Using the learnings of these fast funding programs, this memo proposes actions that the NIH could take to accelerate research outcomes and reduce administrative burden. Specifically, the NIH director should consider pursuing one of the following approaches to integrate faster funding mechanisms into its extramural research programs: 

Future efforts by the NIH and other federal policymakers to respond to crises like the COVID-19 pandemic would also benefit from a clearer understanding of the impact of the decision-making process and actions taken by the NIH during the earliest weeks of the pandemic. To that end, we also recommend that Congress initiate a report from the Government Accountability Office to illuminate the outcomes and learnings of fast governmental programs during COVID-19, such as RADx.

Challenge and Opportunity

The urgency of the COVID-19 pandemic created adaptations not only in how we structure our daily lives but in how we develop therapeutics and fund science. Starting in 2020, the public saw a rapid emergence of nongovernmental programs like Fast Grants, Impetus Grants, and Reproductive Grants to fund both big clinical trials and proof-of-concept scientific studies within timelines that were previously thought to be impossible. Within the government, the NIH launched RADx, a program for the rapid development of coronavirus diagnostics with significantly accelerated approval timelines. Though the sudden onset of the pandemic was unique, we believe that an array of other biomedical crises deserve the same sense of urgency and innovation. It is therefore vital that the new NIH director permanently integrate fast funding programs like RADx into the NIH in order to better respond to these crises and accelerate research progress for the future. 

To demonstrate why, we must remember that the coronavirus is far from being an outlier—in the last 20 years, humanity has gone through several major pandemics, notably swine flu, SARS CoV-1, and Ebola. Based on the long-observed history of infectious diseases, the risk of pandemics with an impact similar to that of COVID-19 is about two percent in any year. An extension of naturally occurring pandemics is the ongoing epidemic of opioid use and addiction. The rapidly changing landscape of opioid use—with overdose rates growing rapidly and synthetic opioid formulations becoming more common—makes slow, incremental grantmaking ill-suited for the task. The counterfactual impact of providing some awards via faster funding mechanisms in these cases is self-evident: having tests, trials, and interventions earlier saves lives and saves money, without sacrificing additional resources.

Beyond acute crises, there are strong longer-term public health motivations for achieving faster funding of science. In about 10 years, the United States will have more seniors (people aged 65+) than children. This will place substantial stress on the U.S. healthcare system, especially given that two-thirds of seniors suffer from more than one chronic disease. New disease treatments may help, but it often takes years to translate the results of basic research into approved drugs. The idiosyncrasies of drug discovery and clinical trials make them difficult to accelerate at scale, but we can reliably accelerate drug timelines on the front end by reducing the time researchers spend in writing and reviewing grants—potentially easing the long-term stress on U.S. healthcare.

The existing science funding system developed over time with the best intentions, but for a variety of reasons—partly because the supply of federal dollars has not kept up with demand—administrative requirements have become a major challenge for many researchers. According to surveys, working scientists now spend 44% of their research time on administrative activities and compliance, with roughly half of that time spent on pre-award activities. Over 60% of scientists say administrative burden compromises research productivity, and many fear it discourages students from pursuing science careers. In addition, the wait for funding can be extensive: one of the major NIH grants, R01, takes more than three months to write and around 8–20 months to receive (see FAQ). Even proof-of-concept ideas face onerous review processes and take at least a year to fund. This can bottleneck potentially transformative ideas, as with Katalin Kariko famously struggling to get funding for her breakthrough mRNA vaccine work when it was at its early stages. These issues have been of interest for science policymakers for more than two decades, but with little to show for it. 

Though several nongovernmental organizations have attempted to address this need, the model of private citizens continuously fundraising to enable fast science is neither sustainable nor substantial enough compared to the impact of the NIH. We believe that a coordinated governmental effort is needed to revitalize American research productivity and ensure a prompt response to national—and international—health challenges like naturally occurring pandemics and imminent demographic pressure from age-related diseases. The new NIH director has an opportunity to take bold action by making faster funding programs a priority under their leadership and a keystone of their legacy. 

The government’s own track record with such programs gives grounds for optimism. In addition to the aforementioned RADx program at NIH, the National Science Foundation (NSF) runs the Early-Concept Grants for Exploratory Research (EAGER) and Rapid Response Research (RAPID) programs, which can have response times in a matter of weeks. Going back further in history, during World War II, the National Defense Research Committee maintained a one-week review process.
Faster grant review processes can be either integrated into existing grant programs or rolled out by institutes in temporary grant initiatives responding to pressing needs, as the RADx program was. For example, when faced with data falsification around the beta amyloid hypothesis, the National Institute of Aging (NIA) could leverage fast grant review infrastructure to quickly fund replication studies for key papers, without waiting for the next funding cycle. In case of threats to human health due to toxins, the National Institute of Environmental Health Sciences (NIEHS) could rapidly fund studies on risk assessment and prevention, giving public evidence-based recommendations with no delay. Finally, empowering the National Institute of Allergy and Infectious Diseases (NIAID) to quickly fund science would prepare us for many yet-to-come pandemics.

Plan of Action

The NIH is a decentralized organization, with institutes and centers (ICs) that each have their own mission and focus areas. While the NIH Office of the Director sets general policies and guidelines for research grants, individual ICs have the authority to create their own grant programs and define their goals and scope. The Center for Scientific Review (CSR) is responsible for the peer review process used to review grants across the NIH and recently published new guidelines to simplify the review criteria. Given this organizational structure, we propose that the NIH Office of the Director, particularly the Office of Extramural Research, assess opportunities for both NIH-wide and institute-specific fast funding mechanisms and direct the CSR, institutes, and centers to produce proposed plans for fast funding mechanisms within one year. The Director’s Office should consider the following approaches. 

Approach 1. Develop an expedited peer review process for the existing R21 grant mechanism to bring it more in line with the NIH’s own goals of funding high-reward, rapid-turnaround research. 

The R21 program is designed to support high-risk, high-reward, rapid-turnaround, proof-of-concept research. However, it has been historically less popular among applicants compared to the NIH’s traditional research mechanism, the R01. This is in part due to the fact that its application and review process is known to be only slightly less burdensome than the R01, despite providing less than half of the financial and temporal support. Therefore, reforming the application and peer review process for the R21 program to make it a fast grant–style award would both bring it more in line with its own goals and potentially make it more attractive to applicants. 

All ICs follow identical yearly cycles for major grant programs like the R21, and the CSR centrally manages the peer review process for these grant applications. Thus, changes to the R21 grant review process must be spearheaded by the NIH director and coordinated in a centralized manner with all parties involved in the review process: the CSR, program directors and managers at the ICs, and the advisory councils at the ICs. 

The track record of federal and private fast funding initiatives demonstrates that faster funding timelines can be feasible and successful (see FAQ). Among the key learnings and observations of public efforts that the NIH could implement are:

Pending the success of these changes, the NIH should consider applying similar changes to other major research grant programs.

Approach 2. Direct NIH institutes and centers to independently develop and deploy programs with faster funding timelines using Other Transaction Authority (OTA).

Compared to reforming an existing mechanism, the creation of institute-specific fast funding programs would allow for context-specific implementation and cross-institute comparison. This could be accomplished using OTA—the same authority used by the NIH to implement COVID-19 response programs. Since 2020, all ICs at the NIH have had this authority and may implement programs using OTA with approval from the director of NIH, though many have yet to make use of it.

As discussed previously, the NIA, NIDA, and NIAID would be prime candidates for the roll-out of faster funding. In particular, these new programs could focus on responding to time-sensitive research needs within each institute or center’s area of focus—such as health crises or replication of linchpin findings—that would provide large public benefits. To maintain this focus, these programs could restrict investigator-initiated applications and only issue funding opportunity announcements for areas of pressing need. 

To enable faster peer review of applications, ICs should establish (a) new study section(s) within their Scientific Review Branch dedicated to rapid review, similar to how the RADx program had its own dedicated review committees. Reviewers who join these study sections would commit to short meetings on a monthly or bimonthly basis rather than meeting three times a year for one to two days as traditional study sections do. Additionally, as recommended above, these new programs should have a three-page limit on applications to reduce the administrative burden on both applicants and reviewers. 

In this framework, we propose that the ICs be encouraged to direct at least one percent of their budget to establish new research programs with faster funding processes. We believe that even one percent of the annual budget is sufficient to launch initial fast grant programs funded through National Institutes. For example, the National Institute of Aging had an operating budget of $4 billion in the 2022 fiscal year. One percent of this budget would constitute $40 million for faster funding initiatives, which would be on the order of initial budgets of Impetus and Fast Grants ($25 million and $50 million accordingly). 

NIH ICs should develop success criteria in advance of launching new fast funding programs. If the success criteria are met, they should gradually increase the budget and expand the scope of the program by allowing for investigator-initiated applications, making it a real alternative to R01 grants. A precedent for this type of grant program growth is the Maximizing Investigators’ Research Award (MIRA) (R35) grant program within the National Institute of General Medical Sciences (NIGMS), which set the goal of funding 60% of all R01 equivalent grants through MIRA by 2025. In the spirit of fast grants, we recommend setting a deadline on how long each institute can take to establish a fast grants program to ensure that the process does not extend for too many years.

Additional recommendation. Congress should initiate a Government Accountability Office report to illuminate the outcomes and learnings of governmental fast funding programs during COVID-19, such as RADx.

While a number of published papers cite RADx funding, the program’s overall impact and efficiency haven’t yet been assessed. We believe that the agency’s response during the pandemic isn’t yet well-understood but likely played an important role. Illuminating the learnings of these interventions would greatly benefit future emergency fast funding programs.

Conclusion

The NIH should become a reliable agent for quickly mobilizing funding to address emergencies and accelerating solutions for longer-term pressing issues. As present, no funding mechanisms within NIH or its branch institutes enable them to react to such matters rapidly. However, both public and governmental initiatives show that fast funding programs are not only possible but can also be extremely successful. Given this, we propose the creation of permanent fast grants programs within the NIH and its institutes based on learnings from past initiatives.

The changes proposed here are part of a larger effort from the scientific community to modernize and accelerate research funding across the U.S. government. In the current climate of rapidly advancing technology and increasing global challenges, it is more important than ever for U.S. agencies to stay at the forefront of science and innovation. A fast funding mechanism would enable the NIH to be more agile and responsive to the needs of the scientific community and would greatly benefit the public through the advancement of human health and safety.

Frequently Asked Questions
What actions, besides RADx, did the NIH take in response to the COVID-19 pandemic?

The NIH released a number of Notices of Special Interest to allow emergency revision to existing grants (e.g., PA-20-135 and PA-18-591) and a quicker path for commercialization of life-saving COVID technologies (NOT-EB-20-008). Unfortunately, repurposing existing grants reportedly took several months, significantly delaying impactful research.

What does the current review process look like?

The current scientific review process in NIH involves  multiple stakeholders. There are two stages of review at NIH, with the first stage being conducted by a Scientific Review Group that consists primarily of nonfederal scientists. Typically, Center for Scientific Review committees meet three times a year for one or two days. This way, the initial review starts only four months after the proposal submission. Special Emphasis Panel meetings that are not recurring take even longer due to panel recruitment and scheduling. The Institute and Center National Advisory Councils or Boards are responsible for the second stage of review, which usually happens after revision and appeals, taking the total timeline to approximately a year.

Is there evidence for the NIH’s current approach to scientific review?

Because of the difficulty of empirically studying drivers of scientific impact, there has been little research evaluating peer review’s effects on scientific quality. A Cochrane systematic review from 2007 found no studies directly assessing review’s effects on scientific quality, and a recent Rand review of the literature in 2018 found a similar lack of empirical evidence. A few more recent studies have found modest associations between NIH peer review scores and research impact, suggesting that peer review may indeed successfully identify innovative projects. However, such a relationship still falls short of demonstrating that the current model of grant review reliably leads to better funding outcomes than alternative models. Additionally, some studies have demonstrated that the current model leads to variable and conservative assessments. Taken together, we think that experimentation with models of peer review that are less burdensome for applicants and reviewers is warranted.

One concern with faster reviews is a lower science quality. How do you ensure high-quality science while keeping fast response times and short proposals?

Intuitively, it seems that having longer grant applications and longer review processes ensures that both researchers and reviewers expend great effort to address pitfalls and failure modes before research starts. However, systematic reviews of the literature have found that reducing the length and complexity of applications has minimal effects on funding decisions, suggesting that the quality of resulting science is unlikely to be affected. 


Historical examples have also suggested that the quality of an endeavor is largely uncorrelated from its planning times. It took Moderna 45 days from COVID-19 genome publication to submit the mRNA-1273 vaccine to the NIH for use in its Phase 1 clinical study. Such examples exist within government too: during World War II, National Defense Research Committee set a record by reviewing and authorizing grants within one week, which led to DUKW, Project Pigeon, Proximity fuze, and Radar.


Recent fast grant initiatives have produced high-quality outcomes. With its short applications and next-day response times, Fast Grants enabled:



  • detection of new concerning COVID-19 variants before other sources of funding became available.

  • work that showed saliva-based COVID-19 tests can work just as well as those using nasopharyngeal swabs.

  • drug-repurposing clinical trials, one of which identified a generic drug reducing hospitalization from COVID-19 by ~40%. 

  • Research into “Long COVID,” which is now being followed up with a clinical trial on the ability of COVID-19 vaccines to improve symptoms.


Impetus Grants focused on projects with longer timelines but led to a number of important preprints in less than a year from the moment person applied:



With the heavy toll that resource-intensive approaches to peer review take on the speed and innovative potential of science—and the early signs that fast grants lead to important and high-quality work—we feel that the evidentiary burden should be placed on current onerous methods rather than the proposed streamlined approaches. Without strong reason to believe that the status quo produces vastly improved science, we feel there is no reason to add years of grant writing and wait times to the process.

Why focus on the NIH, as opposed to other science funding agencies?

The adoption of faster funding mechanisms would indeed be valuable across a range of federal funding agencies. Here, we focus on the NIH because its budget for extramural research (over $30 billion per year) represents the single largest source of science funding in the United States. Additionally, the NIH’s umbrella of health and medical science includes many domains that would be well-served by faster research timelines for proof-of-concept studies—including pandemics, aging, opioid addiction, mental health, cancer, etc.

Project BOoST: A Biomanufacturing Test Facility Network for Bioprocess Optimization, Scaling, and Training

Summary

The U.S. bioeconomy commands millions of liters of bioproduction capacity, but only a tiny fraction of this capacity supports process optimization. Companies of all sizes face great pressures that limit their ability to commit resources to these important efforts. Consequently, the biomanufacturing industry is often forced to juggle sensitive, brittle production processes that don’t scale easily and are prone to disruption. As some recent failures of prominent companies demonstrate, this increases risk for the entire bioeconomy, and especially for the development of new companies and products.

To remedy this, the Department of Commerce should first allocate $80 million to seed a bioproduction R&D facility network that provides process optimization capability to the greater bioeconomy, followed by a $30 million process optimization challenge wherein participating facilities compete at workflow optimization, scaling, and transfer. Part one of the proposal requires rapid development, with the initial R&D facility network of four sites starting bioprocessing operations within 12 months of award. In addition to training workers for the greater bioeconomy, the facility network’s services would be available on a contract basis to any company at any stage of maturity. This work could include optimization for yield, scaling, process resilience, and/or technology transfer—all critical needs across the sector. After federal government startup funding, the network would transition toward financial independence, increasingly running on revenue from process optimization work, workforce training, and state/local support.

Part two of the plan lays out a biomanufacturing “Grand Challenge” in which participating network facilities compete to optimize a standardized biomanufacturing process. Prioritizing process resilience, security, and transferability in addition to yield, this effort would help set a new industry standard for what process optimization really means in addition to demonstrating what can be accomplished by the network facilities. With this demonstration of value, demand for facility services in other geographic locations would increase, spurring the growth of the facility network across the country.

By the end of the program, the U.S. biomanufacturing sector would see a number of benefits, including easier process innovation, a larger and better trained workforce, shortened product time to market, and reduced production risks.

Challenge & Opportunity

Biological products are, by definition, made by means of complex biological processes carried out by sensitive—some might even say fickle—microorganisms and cell lines. Determining the right steps and conditions to induce a microbe into producing a given product at a worthwhile yield is an arduous task. And once produced, the product needs to be extensively processed to make it pure, stable, and safe enough for shipping and use. Working out this entire production workflow takes a great deal of time, energy, and expertise, and the complexity of production workflows increases alongside the complexity of biological products. Many products fail at this point in development, keeping beneficial products out of the hands of end users and cutting off constructive contributions—revenue, jobs—to the larger bioeconomy. 

Once a bioproduction process is worked out at an R&D level, it must be scaled up to a much larger commercial level—another major point of failure for academic and commercial programs. Scaling up requires different equipment with its own controls and idiosyncrasies, each generating additional, sometimes unpredictable, complexities that must be corrected for or managed. The biomanufacturing industry has been asking for help with process scaling for years, and recent national initiatives, such as the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) and the BioIndustrial Manufacturing and Design Ecosystem (BioMADE), have sought to address this strategic need.

Each step on this road to the end market represents a chance for failure, and the risks are so high that the road is littered with failed companies that had a promising product that just couldn’t be made reliably or a brittle production process that blew up when performed at scale. The overarching competitive commercial environment doesn’t help, as new companies must rush from concept to production, often cutting corners along the way. Meanwhile, mature biomanufacturing companies often nurse small profit margins and must aggressively guard existing revenue streams, leaving little or no spare capacity to innovate and improve processes. All of these factors result in production workflows that are hastily constructed, poorly optimized, prone to scaling difficulties, and vulnerable to failure at multiple points. When—not if—process failures occur, the entire economy suffers, often in catastrophic ways. In the last several years alone, such failures have been witnessed at Emergent Biosciences, Dr Reddy’s, and Abbott, with any number of downstream effects. Society, too, misses out when more sustainable, environmentally friendly production methods are overlooked in favor of older, less efficient but more familiar ones. 

There is an urgent need for a national network of biomanufacturing facilities dedicated to process optimization and scaling—critical efforts that are too often overlooked or hastily glossed over, to the subsequent detriment of the entire bioeconomy. Available to any company at any stage of maturity, this facility network would operate on a contract basis to optimize biological production processes for stability, resilience, and technology transfer. The facilities would also assist with yield optimization, in addition to incorporating the specialized equipment designed to aid in scale-up risk analysis. Once established with government funding, the facility network would stand on its own, running on contract fees for process optimization and scale-up efforts. As demand for services grows, the facility network model could spread out geographically to support other markets.

This a highly opportune time for such a program. The COVID-19 pandemic has highlighted the essential importance of biomanufacturing capabilities—extending to the geopolitical level—as well as the fragility of many supply chains and processes. In response, the CHIPS and Science Act and Executive Order on Advancing Biotechnology and Biomanufacturing, among others, have provided directives to shore up U.S. biomanufacturing capacity and resilience. Project BOoST seeks to meet those directives all while building a workforce to support broader participation in a strong national bioeconomy.

Plan of Action

Project BOoST encompasses a $110 million ask spread out over four years and two overlapping phases: a first phase that quickly stands up a four-facility network to perform biomanufacturing process optimization, and a second phase that establishes a biomanufacturing “Grand Challenge” wherein facilities compete in the optimization of a standardized bioproduction process. 

Phase I: Establishing the facility network

The Department of Commerce should allocate $80 million over three years to establish the initial facility network at four sites in different regions of the country. The program would be structured as a competitive contract, with a preference for contract bidders who:

Possible funding pathways include one of the bio-related Manufacturing Innovation Institutes (MIIs), such as NIIMBL, BioMADE, or BioFabUSA. At a minimum, partnerships would be established with these MIIs to disseminate helpful information gained from the facility network. The National Institute of Standards and Technology (NIST) could also be helpful in establishing data standards for technology transfer. The Bioeconomy Information Sharing and Analysis Center (BIO-ISAC) would be another important partner organization, helping to inform the facilities’ efforts to increase both cyber resilience of workflows and industry information sharing.

Funds would be earmarked for initial startup expenditures, including lease/purchase of appropriate buildings, equipment purchases, and initial salaries/benefits of operating personnel, trainers, and program support. Funding milestones would be configured to encourage rapid movement, including:

Since no actual product made in these facilities would be directed toward regulated use (e.g., food, medical), there would likely be reduced need to build and operate the facilities at full Current Good Manufacturing Practice (CGMP) specification, allowing for significant time and cost savings. Of course, the ultimate intent is for optimized and scaled production processes to migrate back to regulated use where relevant, but process optimization need not be done in the same environment. Regardless, the facilities would be instrumented so as to facilitate bidirectional technology transfer. With detailed telemetry of processes and data traffic collected in a standardized manner from the network’s sites, organizations would have a much easier time bringing optimized, scaled processes from these facilities out to commercial production. This would result in faster parameter optimization, improved scale-up, increased workflow resilience, better product assurance, and streamlined tech transfer—all of which are major impediments and risks to growth of the U.S. bioeconomy.

Process optimization and scaling work would be accomplished on a contract basis with industry clients, with robust intellectual property protections in place to guard trade secrets. At the same time, anonymized information and techniques gathered from optimization and scaling efforts would be automatically shared with other sites in the network, enabling more globalized learning and more rapid method development. These lessons learned would also be organized and published to the relevant industry organizations, allowing these efforts to lift all ships across the bioeconomy. In this way, even a facility that failed to achieve sufficient economic self-sustainability would still make significant contributions to the industry knowledge base.

Focused on execution speed, each facility would be a public-private consortium, bringing together regional companies, universities, state and local governments, and others to create a locus of education, technology development, and job creation. In addition to hewing to provisions within the CHIPS and Science Act, this facility network would also match the “biomanufacturing infrastructure hubs” recommendation from the President’s Council of Advisors on Science and Technology.

Using the Regional Technology and Innovation Hubs model laid out in the CHIPS and Science Act, the facilities would be located near to, but not within, leading biotechnology centers, with an eye to benefiting small and rural communities where possible. All the aforementioned stakeholders would have a say in site location, with location criteria including: 

Although some MIIs have innovation acceleration and/or improving production availability within their charters, to date no production capacity has been built specifically to address the critical issues of process optimization and scaling. Project BOoST would complement the ongoing work of the bio-focused MIIs. And since the aforementioned risks to the bioeconomy represent a strategic threat today, this execution plan is intentionally designed to move rapidly. Locating network facilities outside of costly metropolitan areas and not needing full cGMP certification means that an individual facility could be spun up in months as opposed to years and at much lower cost. These facilities would quickly be able to offer their benefits to industry, local economies, and workers looking to train into a growing job sector.

Phase II: Scale-up challenge

Approximately 30 months from program start, facilities that meet the aforementioned funding milestones and demonstrate continuous movement toward financial self-sustainability (as measured by a shift from federal to state, local, and industry support) would be eligible to participate in an additional $30 million, 18-month scale-up challenge, wherein they would receive a reference production workflow so they could compete at workflow optimization, scaling, and transfer.

In contrast to previous Grand Challenges, which typically have a unifying theme (e.g., cancer, clean energy) but relatively open goals and means, Project BOoST would be hyperfocused to ensure a high degree of applicability and benefit to the biomanufacturing industry. The starting reference production workflow would be provided at lab scale, with specifications of materials, processing steps, and instrument settings. From this starting point, participating facilities would be asked to characterize and optimize the starting workflow to produce maximal yield across a broad range of conditions; scale the workflow to a 1,000L batch level, again maximizing yield; and transfer the workflows at both scales to a competing facility both for verification purposes and for proof of transferability.

In addition, all competing workflows would be subject to red-teaming by an independent group of biomanufacturing and cybersecurity experts. This examination would serve as an important assessment of workflow resilience in the setting of equipment failure, supply chain issues, cyberattack, and other scenarios.

The winning facilities—represented by their workflows—would be determined by a combination of factors:

The end result would be the practical demonstration and independent verification of the successful optimization, scale-up, and transfer of a production process—a major opportunity for learning and knowledge sharing across the entire industry.

Conclusion

Scientific innovation and advanced automation in biomanufacturing represent a potent double-edged sword. While they have allowed for incredible advances in biomanufacturing capability and capacity—to the benefit of all—they have also created complexities and dependencies that together constitute a strategic risk to the bioeconomy. This risk is a significant threat, with process failures already creating national headlines out of company collapses and congressional investigations. We propose to act now to create a biomanufacturing facility network dedicated to making production workflows more robust, resilient, and scalable, with a plan strongly biased toward rapid execution. Bringing together commercial entities, educational institutions, and multiple levels of government, Project BOoST will quickly create jobs, provide workforce development opportunities, and strengthen the bioeconomy as a whole.

Frequently Asked Questions
What differentiates Project BOoST from other facilities and networks proposed by MIIs, current Centers for Innovation in Advanced Development and Manufacturing (CIADMs), and the Department of Defense (DoD) authorization to support bioindustrial R&D included in the National Defense Authorization Act?






































Project BOoST MIIs CIADMs DoD/NDAA
Time frame to start of facility operations Estimated 12 months from funding Unknown—as of yet no new ground broken   Already operational, although only one surviving Unknown—plan to meet goals of act due 6/2023
Geographic location Targeting small and rural communities Unknown Mix: urban and less urban Unknown
Scope Process optimization, resilience, and scaling, including scale-up risk assessment DOD MII: TRL acceleration in nonmedical products


DOC MII: accelerate biopharmaceutical innovation 

 Maintenance of critical product stockpiles, reserve production capacity Research into new methods, capacity building, scaling 
Financial model Initial government funding with transition to self-sufficiency Government funding plus partner contributions Persistent government funding Unknown
Will this effort address supply chain threats?

Yes. Supply chain resilience will be a constant evaluation criterion through the program. A more resilient workflow in this context might include onshoring and/or dual sourcing of critical reagent supplies, establishing on-site reserves of single-point-of-failure equipment, maintaining backups of important digital resources (e.g., software, firmware, ladder logic), and explicitly rehearsing failure recovery procedures.

What kind of workforce training opportunities would be available at these facilities?

While the specifics will be left up to the contract bidders, we recommend training programs ranging from short, focused trainings for people already in the biomanufacturing industry to longer certificate programs that can give a trainee the basic suite of skills needed to function in a skilled biomanufacturing role.

Why can’t industry address these issues on its own?

They would if they could. On a fundamental level, due to the nature of the U.S. economic system, the biomanufacturing industry is focused on competition, and there’s a lot of it. Industry organizations, whether large or small, must be primarily concerned with some combination of generating new products and producing those products. They are unable to devote resources toward more strategic efforts like resilience, data standards, and process assurance simply because energy and dollars spent there means less to put toward new product development or increasing production capacity. (Contrast this to a country like China, where the government can more easily direct industry efforts in a certain direction.) Revolutionary change and progress in U.S. biomanufacturing requires the public sector to step up to solve some of these holistic, longer-term challenges.

Advancing the U.S. Bioindustrial Production Sector

Summary

The bioindustrial production of chemicals and other goods is a critical sector of the U.S. bioeconomy. However, the sector faces challenges such as drawn-out research and development timelines, low profit margins, the requirements to produce and sell product in vast quantities over long periods of time, and barriers to accessing scale-up capacity. Companies can find it challenging to rapidly exchange helpful knowledge, attract early-stage investors, access pilot-scale infrastructure to generate evidence that forecasts cost-effective production at scale, and obtain the financing to build or access domestic commercial-scale bioproduction, biomanufacturing, and downstream bioprocessing infrastructure and facilities.

The federal government has already recognized the need to take action to sustain and extend U.S. leadership in biotech and biomanufacturing. The recent Executive Order on advancing the U.S. bioeconomy and relevant provisions in the CHIPS and Science Law and the Inflation Reduction Law have put forward high aspirations, as well some funding, that could help stimulate the biotech and biomanufacturing ecosystem.

The U.S. government should create a Bio for America Program Office (BAPO) at the National Institute for Standards and Technology (NIST) to house a suite of initiatives that would lead to the creation of more well-paying U.S.-based biomanufacturing jobs, spur economic growth and development in areas of the country that haven’t historically benefited from biotech or biomanufacturing, and ensure more resilient U.S. supply chains, the more sustainable production of chemicals and other goods, and enhanced U.S. competitiveness.

Challenge and Opportunity

The bioeconomy—the part of the economy driven by the life sciences and biotech, and enabled by engineering, computing, and information science—has the potential to revolutionize human health, climate and energy, food security and sustainability, and supply chain stability, as well as support economic growth and well-paying jobs across the country. Indeed, the sector has already produced many breakthroughs, such as mRNA vaccines that help counter the devastating impacts of COVID-19 and genetically engineered microbes that provide nutrients to crops without the pollution associated with traditional fertilizers. Valued at over $950 billion, the U.S. bioeconomy accounts for more than five percent of the U.S. gross domestic product—more than the contribution from the construction industry and on par with the information sector.

However, without sufficient federal support and coordination, the U.S. risks ceding economic, national security, and societal benefits provided by a strong bioeconomy to competitors that are implementing cohesive strategies to advance their bioeconomies. For example, China aims to dominate the 21st-century bioeconomy and has prioritized the growth of its bioeconomy in its five-year plans. From 2016 to July 2021, the market value of publicly listed biopharmaceutical innovators from China increased approximately 127-fold across several major stock exchanges, to more than $380 billion, with biotechnology companies accounting for more than 47 percent of that valuation.

Bioindustrial manufacturing (nonpharmaceutical) is a critical segment of the bioeconomy but faces low profit margins combined with the need to produce and sell product in vast quantities over long timelines. It is challenging for companies to translate research and development into commercially viable efforts and attract investors to finance access to or construction of domestic bioproduction, biomanufacturing, and downstream bioprocessing infrastructure and facilities such as fermentation tanks and bioreactors. Furthermore, many biotech and synthetic biology companies face difficulty acquiring capital for scale-up, whether that requires building custom demonstration- or commercial-scale infrastructure, contracting with fee-for-service bioproduction organizations to outsource manufacturing in external facilities, or retooling existing equipment.

All this has the potential to lead to yet more instances of “designed in America, made elsewhere”: microbes that are engineered by U.S. companies to fabricate chemicals or other products could end up being used to produce at commercial scale abroad, which is not a recipe for economic growth and improving quality of life for residents of the U.S. Domestic manufacturers should be executing bioindustrial production so that more well-paying jobs are accessible in the U.S., with the added benefits of contributing to a more stable supply chain, which bolsters U.S. national and economic security.

The federal government has recognized the need for U.S. leadership in biotech and biomanufacturing: the recent Executive Order on advancing the U.S. bioeconomy and relevant provisions in the CHIPS and Science Law and the Inflation Reduction Act (IRA)  provide high-level aspirations and some actual dollars to bolster the biotech and biomanufacturing ecosystem. Indeed, some funds appropriated in the IRA could be used to meet biomanufacturing goals set in the CHIPS and Science Law and EO.

To reach its full potential, bioindustrial manufacturing requires additional support at various levels and may need as much as hundreds of billions of dollars in capital. There is an opportunity for the U.S. government to be intentional about accelerating the growth of the bioindustrial manufacturing sector, and reaping the economic, national security, and societal benefits that would come with it.

Public-private partnerships aimed at providing resources and capital for experimental development at early-stage companies, as well as bioindustrial production scale-up and commercialization projects that are techno-economically sound, would be a strong signal that the federal government is serious about leveraging bioindusty to meet human health, climate and energy, food security and sustainability, and supply chain stability needs, as well as support economic growth and well-paying jobs. Many of the investments by the U.S. taxpayers would be matched and multiplied by investments from nongovernment sources, amplifying the impact, and generating high return on investment for Americans in the form of well-paying jobs, breakthrough products, and more stable supply chains. Furthermore, the investment would show that the U.S. is committed to leveraging advanced manufacturing to raise quality of life for Americans and retain leadership in biotech and biomanufacturing.

Plan of Action

This plan focuses on four initiatives that address specific challenge points:

The proposed initiatives could all be housed in a new office at NIST called the Bio for America Program Office (BAPO), which would collaborate closely with the Office of the Secretary of Commerce and the Under Secretary of Commerce for Standards and Technology, as well as additional government and nongovernmental stakeholders as appropriate. NIST would be an effective home for the BAPO given that it harbors cross-disciplinary expertise in engineering and the physical, information, chemical, and biological sciences; is a nonregulatory agency of the U.S. Department of Commerce, whose mission it is “to drive U.S. economic competitiveness, strengthen domestic industry, and spur the growth of quality jobs in all communities across the country”; and serves as a neutral convener for industry consortia, standards development organizations, federal labs, universities, public workshops, and interlaboratory comparability testing.

Bioindustrial Production Precompetitive Consortium

NIST should establish a Consortium, coordinated out of BAPO, to address the measurements, tools, and standards needed to advance both research and commercial bioindustrial products. The Consortium would convene industry, academia, and government to identify and address measurement, tool, and standards needs; enable members to work with NIST to develop those solutions and standards; leverage NIST expertise; and collaborate with related programs at other federal agencies. The Consortium could rapidly develop relationships with organizations such as the Bioindustrial Manufacturing and Design Ecosystem (BioMADE, a Manufacturing Innovation Institute that is part of the Manufacturing USA network), the Engineering Biology Research Consortium (EBRC), SynBioBeta, the Alternative Fuels & Chemicals Coalition (AFCC), the Synthetic Biology Coalition, the Joint BioEnergy Institute, and the Advanced Biofuels and Bioproducts Process Development Unit at Lawrence Berkeley National Laboratory, and the National Renewable Energy Laboratory’s pilot-scale Integrated Biorefinery Research Facility. It would also be useful to communicate with efforts in the biopharmaceutical space such as the Biomedical Advanced Research and Development Authority (BARDA) and the National Institute for Innovation in Manufacturing Biopharmaceuticals.

The benefits to members would include access to a neutral forum for addressing precompetitive needs; participation in the development of experimental benchmarks, guidelines, and terminology; access to tools developed by the consortium ahead of public release; and institutional representation on the consortium steering committee. Members would contribute an annual fee of, for example, $20,000 or in-kind support of equivalent value, as well as sign a Cooperative Research and Development Agreement.

Congress should initially appropriate $20 million over five years to support the Consortium’s activities, and the Consortium could launch by putting forward a Notice of Consortium establishment and letter of interest form.

U.S. Bioindustrial Production Investment Portfolio

Early-stage companies are the engine for U.S. job creation, regional economic development, and technological innovation. A more consistent, yet scrupulous, source of funding for nascent companies in the bioindustrial production space would be catalytic. Using the BARDA Ventures-Global Health Investment Corporation (GHIC) Global Health Security Portfolio public-private partnership as a model, the U.S. government, coordinating both existing and new appropriations via BAPO Ventures, should seed a nonprofit partnership manager to launch a U.S. Bioindustrial Production Investment Portfolio. The portfolio would crowd-in additional capital and invest in early-stage, domestic bioindustrial production companies that share sound metrics and credible techno-economic analyses that they are on the path to product commercialization and profitability.

The portfolio’s nonprofit partnership manager should be empowered to crowd-in capital using return augmentation and risk mitigation incentives as they see fit. Measures that a venture fund could take to incentivize coinvestment could include but are not limited to:

Launching a U.S. Bioindustrial Production Investment Portfolio requires the following four steps.

1. Both existing and newly appropriated federal funds should be used to seed investments in the U.S. Bioindustrial Production Investment Portfolio.

Existing appropriations: Appropriations have already been made to some federal agencies through the IRA and other vehicles that could be used to seed the portfolio. BAPO Ventures should coordinate with the interagency, and agencies with available funds could contribute to directly seeding the portfolio. Some examples of existing funds to coordinate include:

New appropriations: Congress should appropriate $500 million in new funding for BAPO Ventures over five years to support BAPO Ventures personnel and operations and augment the portfolio. These funds would be critical since they could be applied for all-purpose venture capital investments in early-stage bioindustrial production companies. Congress should also grant BAPO Ventures, as well as other agencies or programs, any authority needed to transfer funds to the portfolio for these purposes.

2. Identify the nonprofit partnership manager.

BAPO Ventures should solicit proposals for an existing nonprofit partner to manage the U.S. Bioindustrial Production Investment Portfolio. Selection should be based on demonstrated track record of experience with and successful venture investments in bioindustrial manufacturing or a closely related space. Potential nonprofit partners include Breakthrough Energy Catalyst or America’s Frontier Fund. GHIC should also be consulted. 

3. Transfer funds from the appropriate U.S. government programs to funds within the portfolio and support the nonprofit partnership manager in crowding-in additional capital.

The nonprofit partnership manager will recruit capital from nonfederal government sources into the portfolio’s different funds with the aim of matching and/or exceeding the dedicated public funds to generate a multiplier effect and access even more capital. Capital from investors willing to take on risk equatable to venture capital would be the most viable targets.

4. The nonprofit partnership manager will use the portfolio’s funds to invest in U.S. early-stage bioindustrial production companies on the basis of sound techno-economic analyses and robust metrics.

The nonprofit partnership manager would invest in bioindustrial production companies that commit to hiring and manufacturing domestically and making products useful to Americans and the country, on the basis of robust techno-economic analyses of the companies’ commercial potential, and generate returns on investments. BAPO Ventures, as well as NIST writ large, would be accessible for technical assistance, if necessary. The nonprofit partnership manager would structure investments with co-funding from additional nonfederal government investors. As this public-private partnership generates investment returns, proceeds from the BAPO Ventures funding will be returned to the portfolio and its funds for reinvestment and sustainment of BAPO Ventures. If this evergreen fund begins to compete with, rather than incentivize, private market funding, or otherwise begins to be unproductive, the fund should be tapered off and/or sunset.

Bioindustrial Production Scale-up Infrastructure Group

It is critical for early-stage bioindustrial production companies to gather evidence that their production processes have the potential to be commercially viable at scale—or not. To learn this, companies need access to pilot- and intermediate-scale bioindustrial production infrastructure like fermenters and bioreactors, as well as modern downstream bioprocessing equipment. The BAPO should house a Bioindustrial Production Scale-up Infrastructure Group (BPSIG). which, as an initial step, would work with both the interagency and nonfederal government partners to conduct a comprehensive analysis of the U.S. bioindustrial production pilot- and intermediate-scale infrastructure landscape with the aim of informing a precision strategy for most effectively leveraging federal resources.

The BPSIG would aim to complete the landscape analysis in three months, seeking to understand deficiencies in capacities such as the different volumes of fermenters and bioreactors that are accessible (and the costs associated with their use) and modular downstream bioprocessing equipment accessibility. They should also identify existing facilities that have accessible capacity, such as corporations’ sites where capacity might be rented, toll facilities, or facilities that could be retooled or rehabilitated to provide the necessary pilot-scale capacity. BPSIG should engage with organizations such as Capacitor, the Bioprocess to Product Network, Royal DSM, DuPont, Cargill, BioMADE, Battelle, MITRE, and the Advanced Biofuels and Bioproducts Process Development Unit at Lawrence Berkeley National Laboratory when performing this evaluation.

If the assessment concludes that retooling existing sites or building new pilot- or intermediate-scale infrastructure is necessary, and that government support would be catalytic, some funds would already be available via existing appropriations, and new appropriations might also be necessary. Appropriations have already been made to some federal agencies through the IRA and other vehicles that could be coordinated by the BPSIG. BPSIG should coordinate with the interagency, and agencies with available funds could contribute directly to building the network. Existing funds to leverage include:

Additionally, Congress may need to make appropriations directly to BPSIG, which BPSIG could then allocate to other federal financing programs for retooling or building any additional pilot- or intermediate-scale bioindustrial production infrastructure projects outside the scope of existing pools of already-appropriated funds.

Bioindustrial Production Loan Program Office

To ensure techno-economically sound bioindustrial production companies can secure financing for demonstration- or commercial-scale infrastructure and equipment needs, Congress should enable an initiative within BAPO called the Bioindustrial Production Loan Programs Office (BPLPO) that replicates and improves the DOE LPO model. The BPLPO would be tailored to the bioindustrial production segment, without agencies’ science or technology mission area constraints (for instance, energy), offering flexible debt instruments and supporting large-scale projects. For example, assistance in the form of loan guarantees would help underwrite debt associated with launching bioproduction plants.

Coordination with DOE LPO, DOE Office of Clean Energy Demonstrations, the U.S. Small Business Association, the relevant U.S. Department of Agriculture loan programs, and other government agencies and offices would be key to avoid duplicating efforts and to incorporate lessons learned and best practices from existing efforts. Congress should appropriate an initial $5 billion for the BPLPO, authorizing the program for an initial 10 years.

Conclusion

Launching a suite of public-private partnerships to advance domestic bioproduction would create more well-paying biomanufacturing jobs in the U.S., expand economic opportunity across the country by spreading the biotech and biomanufacturing footprint into nontraditional areas, produce more high-quality chemicals and goods in the U.S., and help meet national and economic security needs, such as strengthened supply chains and more sustainable production methods.

Frequently Asked Questions
Is there precedent for a federal agency–nonprofit venture capital organization public-private partnership in biotech or biomanufacturing?

BARDA, situated within the Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response, launched BARDA Ventures in June 2021 to “accelerate development and commercialization of technologies and medical products needed to respond to or prevent public health emergencies, such as pandemics, and other health security threats.” BARDA has provided the nonprofit organization GHIC tens of millions of dollars. GHIC launched and manages a global health security fund with matching capital from other investors. This partnership allows direct linkage with the investment community and establishes sustained and long-term efforts to identify, nurture, and commercialize technologies that aid the U.S. in responding effectively to future health security threats.

Could the BARDA-GHIC model be applied to other sectors in addition to bioindustrial manufacturing?

Yes. The BARDA-GHIC model can be considered when there is underinvestment from the capital markets in a particular early-stage commercial area.

Why the focus on coordinating existing funds from DoD and DOE?

Some funds have already been appropriated to DoD and DOE that could be used to advance U.S. bioindustrial production. DoD and DOE are both stakeholders in bioindustrial manufacturing whose missions would benefit from virtually any domestic bioindustrial manufacturing efforts.

What are some other opportunities for capital for bioindustrial production?

Capital from strategic investors, venture investors with long-term outlooks, and private equity, with growth equity of particular interest, could be targeted. Examples of strategic investors that could be pursued include IndianOil Corp, Petronas, Brookfield, or BASF. Venture investors with longer-term outlook funds like Breakthrough Energy Catalyst would also be candidates to pursue to recruit capital.


The scale-up and commercialization of some bioindustrial production capabilities can be capital intensive; however, standing-up bioproduction facilities can cost two to 2,000 times less than chemical facilities, and operating expenses for a bioproduction facility are relatively low, making return on capital more attractive to capital markets. It’s likely that investments’ returns should be expected to be long-term in nature. Investments now could help some bioindustrial production operations reach profitability by the mid- to late 2020s, with positive returns on investments likely. In addition to acquiring equity in bioindustrial production companies, some investors may contribute to commercializing the bioindustrial production of those operations’ chemicals or other goods in their regions of influence, etc.

What’s a potential starting point for the equitable and strategic placement of pilot- and intermediate-scale bioindustrial production facilities?

Potential regional targets include Suffolk, Massachusetts, and Albany, New York, in the Northeast; Warren, Ohio, Johnson, Kansas, and Porter, Indiana, in the Midwest; Denton, Texas, Wake, North Carolina, and Canadian, Oklahoma, in the South; and Yavapai, Arizona, and Honolulu, Hawaii, in the West.

Accelerating Bioindustry Through Research, Innovation, and Translation

Summary

America’s bioeconomy is entering a once-in-a-generation moment. Research and development (R&D) breakthroughs have brought us to a scientific tipping point; at the same time, health and security threats are inspiring a new level of strategic coordination. Although we now have a strong base of fundamental science, we lack the equally powerful industrial foundation needed to put the “economy” in bioeconomy. Bioindustry, encompassing less flashy products (chemicals, plastics, fuels) and bio-enabling tools and capabilities, often fails to capture the attention and investment needed to connect research with use cases, commercialize, and scale. But without solutions and capabilities that span multiple applications and sectoral silos, our bioeconomy will stall at the lab door.

Rapid progress in strengthening American bioindustry is possible, but it demands a coordinated and concerted effort that taps the federal government’s unique combination of scale and highly effective lab-to-market incentive mechanisms. Streamlined funding of open and cross-disciplinary research, prize and challenge mechanisms, and market shaping through innovative procurement have all proven highly effective in the face of market failures and applied technology gaps like those seen in our bioindustry.

To refine, tailor, and manage its unique lab-to-market toolkit in this space, the federal government should establish a single coordinating entity to accelerate bioindustry in close partnership with stakeholder agencies. The Bioindustrial Research, Innovation, and Translation Engine (BRITE), housed within National Institute of Standards and Technology (NIST), would do this by:

Challenge and Opportunity

After steadily gaining mindshare and momentum among policymakers, our bioeconomy has reached a once-in-a-generation moment. This has been amplified by the urgency of biothreats revealed during the COVID-19 pandemic, as well as the role that biotechnology and biopharmaceutical innovation played in the global response. While efforts to realize a comprehensive U.S. bioeconomy vision date back to 2012, the Biden Administration’s September 2022 Executive Order provides a clear and compelling new articulation of that vision and can serve as a platform for realizing it. Moreover, recent legislative actions, including the CHIPS and Science Law, Inflation Reduction Law, and various appropriations (see FAQ), have enabled a range of federal bioeconomy initiatives and investments.

The greatest barrier to meeting our bioeconomic moment is not one of fundamental science; it is the underdevelopment of America’s bioindustry. Bioindustry encompasses both the manufacturing of biochemicals, bioplastics, and biofuels as well as the tools, kits, and services that drive and enable the wider bioeconomy. There are very real technical, capability, and incentive barriers to bioindustrial progress, including:

Given these barriers, bioindustry is particularly susceptible to two “valleys of death”—one between a scientific breakthrough and a usable product and another between a market-ready product and deployment. In these valleys, typical innovation funders are disincentivized from high-risk / high-reward investment and struggle to achieve any sort of investment coherence or cohesion. A Congressional Research Service report notes that the very definition of bioeconomy varies widely across sectors and countries. Capital tends to isolate around one thematic area (e.g., climate, advanced materials, agriculture, health) rather than fueling systems-based, cross-cutting investments that grow the overall pie. This creates a high risk of duplicated effort and repetition of missteps. A Schmidt Futures task force report estimates that without a vibrant bioindustry, the U.S. risks losing out on at least $260 billion of annual economic opportunity that will otherwise go overseas. We will also face new economic and national security threats if we fail to establish resilient domestic bioeconomic supply chains and a robust competitive landscape.

The federal government stands alone in its ability to rapidly close the gaps that hold bioindustry back. Federal agencies are uniquely incentivized to bridge the valleys of death by tapping agencies’ unique portfolios of lab-to-market, demand-pull mechanisms. These include:

The barriers to bioindustrial progress—complex technical gaps, incentive and market failures, and misalignment of innovation culture—are daunting. Encouragingly, they are just the sort of barriers that these federal lab-to-market and demand-pull mechanisms were designed to overcome.

What are the broader benefits of accelerating our bioindustry?

Building a more robust industrial foundation for our bioeconomy benefits the entire nation but has particular potential to close economic gaps in regions historically left behind. A range of different production infrastructure, from dormant plants to breweries, can be retrofit more efficiently, especially in places outside traditional biotechnology hubs. Broadening the range of bioindustrial tools and processes, and moving to scale manufacturing, will create new job opportunities beyond advanced researchers in labs. There are also many advantages to locating biomanufacturing infrastructure in proximity to rural areas rich in feedstocks. The intersection of place-based innovation and bioindustry has already been brought to life through efforts like the U.S. Department of Agriculture Bioproduct Pilot Program and will no doubt accelerate through the NSF Regional Innovation Engines opportunity, which will align use-inspired research, translation, and workforce development in new self-sustaining innovation hubs across the country.

Plan of Action

Business as usual will not realize the full potential of—or avoid the many pitfalls awaiting—our national bioeconomy strategy. The pace and scale of bioindustrial progress require us to tap into all of the capabilities and resources noted above. In general, we need more coordinated action across the public and private sectors, including streamlined R&D partnerships to close gaps in health vs. industrial applications; competitions and challenges that translate breakthroughs to real-world use; market-shaping activities to achieve scale; and strategic coordination of sustainable funding to maximize investment leverage.

A new, whole-of-government entity should be established to marshal federal tools, best practices, and investments toward shared priorities that are critical to American bioindustrial leadership. The Bioindustrial Research, Innovation, and Translation Engine (BRITE) will encompass open innovation programs, market-shaping activities, and stakeholder engagement. BRITE can be housed within a new NIST Bio for America Program Office and convene relevant program owners from core agencies with bioeconomy mandates: National Science Foundation (NSF), Department of Energy (DOE), Department of Defense (DOD), Department of Agriculture (USDA), and Department of Health and Human Services (HHS).

Streamlined R&D partnerships

BRITE can take advantage of the growing body of ideas and insights coming from academic and commercial communities through open and accessible calls for projects. This could be achieved through an EZ-BAA vehicle, modeled after BARDA DRIVe’s open call for projects that address a broad set of health security problems. The BRITE EZ-BAA would offer up to $500,000 for research and commercialization projects addressing a set of announced areas of interest (AOIs). Early engagement with BRITE through this program would improve the efficiency and win rate of technology development—and incentivize success-enabling design principles, such as designing for future biomanufacturing scale versus pure scientific outcomes. Initial AOIs could focus on scientific and technical rate limiters for growth in nonhealth bio, including development of novel high-performance biomaterials with features optimized for specific industrial use cases, or tailored to replace carbon-based inputs, as well as foundry-style projects that scale known, high-potential platforms—like spider silk protein or mycelium—with a wide array of potential use cases.

Innovation competitions and challenges

Engaging the broader scientific community through a research BAA will deliver novel and surprising ideas but will not itself advance actionable ideas to solve concrete problems. To complement a research BAA, BRITE can launch, cosponsor, or administer prize competitions and grand challenges. Open innovation programs accelerate solution development for even the most complex and stubborn bioindustrial development challenges. They are most successful when a clear ‘Goldilocks’ problem can be defined—narrow enough to be addressable by the market, but broad enough that solutions are not presupposed or prescribed. BRITE team members would work with sponsoring agencies to identify “prizeable” issues and optimize problem statements for the prize mechanism. Initial prizes or challenge series could address such diverse problems as:

Once refined, problem statements can then be designed into single- or multistage competitions. Prize design parameters can be fine-tuned to the nature of the problem and the communities that have the potential to solve them. Using strategic design to balance the fidelity of solutions sought, scale and type of incentives on offer, and timeline for development or refinement maximizes the impact of prizes. One-off or series of single phase competitions can be used to quickly prime the pump and identify potential solutions and solvers. Multistage competitions that down-select to a high-potential cohort provide the added benefit of offering targeted technical assistance over and above prize funds. This form of support is often more valuable to solvers than money—and for bioindustrial challenges could include unique resources such as support for producing demonstration projects, access to third-party validation, and engagement with federal and external experts in science, standards, or regulations.

Market shaping

The quick and meaningful wins achieved through an EZ-BAA and open innovation programs need to be sustained by a robust bioindustrial marketplace. BRITE and partner agencies could draw upon nontraditional procurement mechanisms to amplify the ideas and products that emerge from research and innovation. Other Transaction Authorities could be developed to rapidly engage production capacity from a consortium of biomaterial demonstration and scale-up providers. Advance market commitments to fund procurement of biomaterials or production capacity can position agencies as tentpole customers for applied bioindustrial solutions. These could be executed through strategic national stockpiles, chemical reserves, or other critical product procurements.

Beyond procurement, BRITE can be a driving force across agencies to lower barriers to market entry development. Housed within NIST, BRITE would have a unique ability to directly translate research and innovation outcomes to inform new or revised biomanufacturing and bioindustrial standards. BRITE could also serve as a neutral party that supports alignment of incentives and development of interoperable platforms and standards, facilitating longer-term innovation while preserving private companies’ ability to succeed. Through relationships with various bioindustry regulators (Food and Drug Administration, Environmental Protection Agency, USDA), BRITE could facilitate clearer delineation and harmonization of regulatory responsibilities. This engagement could also better incorporate the current voice of science and technology in defining and refining bioindustry rules, experimental sandboxes, and optimization for different subsectors.

Finally, BRITE can shape the market from the grassroots, engaging a wider set of scientific and general communities in the growing bioindustry. As research and innovation activities ramp up, BRITE can convene prize winners to share insights and spur serendipitous collaborations. BRITE can also steer effective scientific communication on bioindustry, engage stakeholders more directly in the innovation process, and feed community insights back into future programs and priorities. BRITE can follow the example of accelerators like HHS’s LymeX, which actively engages clinical and scientific roundtables to inform prizes and strategy.

Case example: How BRITE activities coordinate for greater impact

The federal lab-to-market tools BRITE would foster are powerful in their own right. Applied in a coordinated fashion, they can rapidly bring transformative bioindustrial solutions to bear against intractable problems.

Consider how all facets of BRITE might contribute to a pressing, multifaceted problem like lead exposure:

Sustainable funding

Based on analogous programs, including DOE American Made Challenges, an initial appropriation or discretionary allocation of $100–200 million is needed to catalyze BRITE’s standup and early wins. This could be assembled by pooling agency funds authorized for bioeconomy activities and/or unspent from recent appropriations (see Table A in FAQ). Private-sector partners or existing public-private partnerships (PPPs) could also support initial funding, though a new PPP likely could not be executed in the required timeframe. In the longer term, BRITE funding can be supported by one or more fit-to-purpose PPPs and should be enshrined in annual appropriations, following the example of KidneyX. Consistent funding is important to show commitment to bioindustrial innovation, enable more multiyear programs or recurring prize series, and provide resilience in the event of budget conflict. A minimum $15 million annual appropriation to sustain BRITE innovation activities could easily be input into one or a combination of bills (Agriculture, Commerce/Justice/State, and Energy and Water).

Conclusion

We are fortunate as a country to have a strong bench of talent working hard to push what is possible in our bioeconomy. They deserve tools and capabilities2 that enable them to work smart, delivering a far greater return on the dollars we invest in our bio-driven future. It is not sustainable for the federal government to be the only customer driving bioindustrial progress. But as a catalytic force that bridges valleys of death and solves chicken-and-egg dilemmas, strategic government action to nurture bioindustry out of the lab and into markets will take us farther, faster. By fully utilizing the world-class mechanisms smart policymakers of the past have provided us, we can de-risk bioeconomic investments while yielding maximum benefit for our economy, security, and society.

Frequently Asked Questions
What authorities and funding sources would agencies use to work with or through BRITE?

Multiple departments and agencies have been charged with advancing U.S. bioindustry. While the latest and most fit-to-purpose authorities were established under Title IV of the CHIPS and Science Law (42 U.S.C. §19135), agencies can draw upon multiple authorities to support and incentivize bioindustrial research, innovation, and translation. The following table is far from exhaustive, but it highlights several such authorities, as well as existing funding agencies could leverage to act on them.


Table A. Example authorities and appropriations to support bioindustry



































Agency Bioindustry-relevant authorities Select bioindustry-related funding
(active or FY23 appropriations)
Department of Commerce

  • Title IV: NIST standards, facilities, and capabilities to advance engineering biology and biomanufacturing

  • Manufacturing USA (15 U.S.C. §278s)

  • NIST Working Capital Fund (15 U.S.C. §278b)

  • NIST: $33M for bioeconomy enablement and emerging technology standards 

  • EDA: $200M through ongoing Build Back Better Regional Challenge activities
Department of Energy

  • Title IV: Engineering biology research, development, demonstration, and commercial application and translation

  • Multiple research and Manufacturing USA programs (e.g., Agile BioFoundry, ABPDU)

  • Incentives, including loans, for innovative technology development
    (42 U.S.C. §16513)

  • $470M for Advanced Research Projects Agency—Energy (ARPA-E) 

  • $66M for Title XVII Innovative Technology Loan Guarantee Program
Department of Agriculture

  • Title IV: Engineering biology R&D through Agricultural Research Service, National Institute of Food and Agriculture, and Office of the Chief Scientist

  • BioPreferred Program (7 U.S.C. §8102)

  • Bioproduct Pilot Program (P.L. 117-58, Title V, Section 70501)

  • Regional Bioeconomy Development Grants (42 U.S.C. §16254; expired 2015, but could be renewed)

  • National Forest System: $20M to incentivize increased use of biomass from NFS lands
National Science Foundation

  • Title IV: Engineering biology and biomanufacturing research, plus support for research infrastructure

  • Regional innovation initiatives, likely including bioeconomy and bioindustry, run through new Directorate for Technology, Innovation, and Partnerships (TIP)

  • TIP likely to be funded from a portion of $7.8B Research & Related Activities appropriation
Department of Defense

  • Title IV: R&D in engineering biology and associated data and information sciences

  • BioMADE (Manufacturing USA institute)

  • $270 million from the Department of Defense (DOD) over five years for the TriService Biotechnology for a Resilient Supply Chain program;

  • $1 billion from DOD over five years to catalyze the establishment of a domestic biomanufacturing industrial base
Who would staff BRITE? What are the ideal characteristics of a program manager?

While initial stand-up of BRITE may require detail assignments from partner agencies, BRITE should have its own dedicated, permanent staff. Beyond strategic and operational leadership, program managers (PMs) would be needed to own particular topics or problem areas. The ideal PM profile would differ by function; for example, research PMs would have an applied research background and experience leading high-risk, high-reward activities in a government or industry capacity. Prize PMs would have experience with large-scale grant and prize authorities—as well as experience educating different agencies and functions (legal, political, communications) on the ins and outs of prize authorities. This expertise could also be accessed through support contracts or working with cross-agency centers of excellence in open innovation, such as NASA’s Center of Excellence for Collaborative Innovation.

Why should BRITE be housed within NIST? Why couldn’t these activities be carried out under an entity like ARPA-E, ARPA-H, or BARDA?

BRITE draws on analogous entities and initiatives from different agencies. Indeed, by leaning on various precedents, BRITE will be easier for agency stakeholders (particularly general counsels) to understand and will be able to enact faster than relying on a brand-new legislative mandate. That said, BRITE’s mission to accelerate bioindustry in underaddressed spaces is inherently cross-disciplinary. The outcomes spearheaded by BRITE will benefit multiple agencies’ bioeconomy-related objectives; but outside of Commerce, any other agency would naturally prioritize its particular sector and set of use cases, even if it failed to lift all bioindustrial boats. Furthermore, housing BRITE within a NIST bioeconomy program office or entity could inform more rapid and effective development of bioeconomy standards, frameworks, and systems interoperability. An inspiring analog is NIST’s Public Safety Communications Research Division.

How is it possible for agencies to sponsor prize competitions through BRITE without new legislation or authorization?

Any federal agency is authorized to run a prize competition under the America COMPETES Act, (see footnote 2) and federal prize activity has increased dramatically over the last decade. In addition to COMPETES, there are various agency-specific prize authorities (e.g., NSF, DOE, DOD, NASA, HHS). While agency-specific authorities sometimes have a narrow topic focus, they can add flexibility beyond COMPETES provisions (for example, DOD and NASA competitions can award monetary prizes to non-U.S. entrants, which is not possible under COMPETES). Multiagency collaboration on prizes is common—over a quarter of agency prizes were conducted with at least one other federal partner. In addition, many agencies receive expert support in prize administration from partner entities like GSA’s Challenge.gov and NASA’s Center of Excellence for Collaborative Innovation.

How will BRITE advance the field if only winners benefit from prize competitions? Are there ways to reward or support non-winners with good ideas?

Prizes confer many benefits beyond the direct cash payment and in-kind support awarded to top teams. The experience of entering a competition alone is often a helpful forcing function for teams to crystallize ideas and present them in a more compelling way. But prizes can also include design elements that advance the wider field beyond the winners. In multistage prizes, non-winning teams can partner with or even provide technical assistance and expertise to the teams that advance. Honorable mention or other award categories can also provide a lift. For example, the VA’s recent Mission Daybreak challenge issued small “Promise Awards” to teams that were not named finalists but showed potential, which provides them a boost in securing future funding and support. Finally, some or all of the technical assistance provided to winners (in the form of webinars, documents, templates, etc.) can be disseminated to the general public as an open resource.

Tilling the Federal SOIL for Transformative R&D: The Solution Oriented Innovation Liaison

Summary 

The federal government is increasingly embracing Advanced Research Projects Agencies (ARPAs) and other transformative research and engagement enterprises (TREEs) to connect innovators and create the breakthroughs needed to solve complex problems. Our innovation ecosystem needs more of these TREEs, especially for societal challenges that have not historically benefited from solution-oriented research and development. And because the challenges we face are so interwoven, we want them to work and grow together in a solution-oriented mode. 

The National Science Foundation (NSF)’s new Directorate for Technology, Innovation and Partnerships should establish a new Office of the Solution-Oriented Innovation Liaison (SOIL) to help TREEs share knowledge about complementary initiatives, establish a community of practice among breakthrough innovators, and seed a culture for exploring new models of research and development within the federal government. The SOIL would have two primary goals: (1) provide data, information, and knowledge-sharing services across existing TREEs; and (2) explore opportunities to pilot R&D models of the future and embed breakthrough innovation models in underleveraged agencies.

Challenge and Opportunity

Climate change. Food security. Social justice. There is no shortage of complex challenges before us—all intersecting, all demanding civil action, and all waiting for us to share knowledge. Such challenges remain intractable because they are broader than the particular mental models that any one individual or organization holds. To develop solutions, we need science that is more connected to social needs and to other ways of knowing. Our problem is not a deficit of scientific capital. It is a deficit of connection.

Connectivity is what defines a growing number of approaches to the public administration of science and technology, alternatively labeled as transformative innovation, mission-oriented innovation, or solutions R&D. Connectivity is what makes DARPA, IARPA, and ARPA-E work, and it is why new ARPAs are being created for health and proposed for infrastructure, labor, and education. Connectivity is also a common element among an explosion of emerging R&D models, including Focused Research Organizations (FROs) and Distributed Autonomous Organizations (DAOs). And connectivity is the purpose of NSF’s new Directorate for Technology, Innovation and Partnerships (TIP), which includes “fostering innovation ecosystems” in its mission. New transformative research and engagement enterprises (TREEs) could be especially valuable in research domains at the margins, where “the benefits of innovation do not simply trickle down.

The history of ARPAs and other TREEs shows that solutions R&D is successfully conducted by entities that combine both research and engagement. If grown carefully, such organisms bear fruit. So why just plant one here or there when we could grow an entire forest? The metaphor is apt. To grow an innovation ecosystem, we must intentionally sow the seeds of TREEs, nurture their growth, and cultivate symbiotic relationships—all while giving each the space to thrive.

Plan of Action

NSF’s TIP directorate should create a new Office of Solution-Oriented Innovation (SOIL) to foster a thriving community of TREEs. SOIL would have two primary goals: (1) nurture more TREEs of more varieties in more mission spaces; and (2) facilitate more symbiosis among TREEs of increasing number and variety. 

Goal 1: More TREEs of more varieties in more mission spaces

SOIL would shepherd the creation of TREEs wherever they are needed, whether in a federal department, a state or local agency, or in the private, nonprofit, or academic sectors. Key to this is codifying the lessons of successful TREEs and translating them to new contexts. Not all such knowledge is codifiable; much is tacit. As such, SOIL would draw upon a cadre of research-management specialists who have a deep familiarity with different organizational forms (e.g., ARPAs, FROs, DAOs) and could work with the leaders of departments, businesses, universities, consortia, etc. to determine which form best suits the need of the entity in question and provide technical assistance in establishment.

An essential part of this work would be helping institutions create mission-appropriate governance models and cultures. Administering TREEs is neither easy nor typical. Indeed, the very fact that they are managed differently from normal R&D programs makes them special. Former DARPA Director Arati Prabhakar has emphasized the importance of such tailored structures to the success of TREEs. To this end, SOIL would also create a Community of Cultivators comprising former TREE leaders, principal investigators (PIs), and staff. Members of this community would provide those seeking to establish new TREEs with guidance during the scoping, launch, and management phases.

SOIL would also provide opportunities for staff at different TREEs to connect with each other and with collective resources. It could, for example, host dedicated liaison officers at agencies (as DARPA has with its service lines) to coordinate access to SOIL resources and other TREEs and support the documentation of lessons learned for broader use. SOIL could also organize periodic TREE conventions for affiliates to discuss strategic directions and possibly set cross-cutting goals. Similar to the SBIR office at the Small Business Administration, SOIL would also report annually to Congress on the state of the TREE system, as well as make policy recommendations.

Goal 2: More symbiosis among TREEs of increasing number and variety

Success for SOIL would be a community of TREEs that is more than the sum of its parts. It is already clear how the defense and intelligence missions of DARPA and IARPA intersect. There are also energy programs at DARPA that might benefit from deeper engagement with programs at ARPA-E. In the future, transportation-infrastructure programs at ARPA-E could work alongside similar programs at an ARPA for infrastructure. Fostering stronger connections between entities with overlapping missions would minimize redundant efforts and yield shared platform technologies that enable sector-specific advances.

Indeed, symbiotic relationships could spawn untold possibilities. What if researchers across different TREEs could build knowledge together? Exchange findings, data, algorithms, and ideas? Co-create shared models of complex phenomena and put competing models to the test against evidence? Collaborate across projects, and with stakeholders, to develop and apply digital technologies as well as practices to govern their use? A common digital infrastructure and virtual research commons would enable faster, more reliable production (and reproduction) of research across domains. This is the logic underlying the Center for Open Science and the National Secure Data Service.

To this end, SOIL should build a digital Mycelial Network (MyNet), a common virtual space that would harness the cognitive diversity across TREEs for more robust knowledge and tools. MyNet would offer a set of digital services and resources that could be accessed by TREE managers, staff, and PIs. Its most basic function could be to depict the ecosystem of challenges and solutions, search for partners, and deconflict programs. Once partnerships are made, higher-level functions would include secure data sharing, co-creation of solutions, and semantic interconnection. MyNet could replace the current multitude of ad hoc, sector-specific systems for sharing research resources, giving more researchers access to more knowledge about complex systems and fewer obstacles from paywalls. And the larger the network, the bigger the network effects. If the MyNet infrastructure proves successful for TREEs, it could ultimately be expanded more broadly to all research institutions—just as ARPAnet expanded into the public internet. 

For users, MyNet would have three layers:

These functions would collectively require:

How might MyNet be applied? Consider three hypothetical programs, all focused on microplastics: a medical program that maps how microplastics are metabolized and impact health; a food-security program that maps how microplastics flow through food webs and supply chains; and a social justice program that maps which communities produce and consume microplastics. In the data layer, researchers at the three programs could combine data on health records, supply logistics, food inspections, municipal records, and demographics. In the information layer, they might collaborate on coding and evaluating quantitative models. Finally, in the knowledge layer, they could work together to validate claims regarding who is impacted, how much, and by what means.

Initial Steps

First, Congress should authorize and appropriate the NSF TIP Directorate with $500 million over four years for a new Office of the Solution-Oriented Innovation Liaison. Congress should view SOIL as an opportunity to create a shared service among emergent, transformative federal R&D efforts that will empower—rather than bureaucratically stifle—the science and technological advances we need most. This mission fits squarely under the NSF TIP Directorate’s mandate to “mobilize the collective power of the nation” by serving as “a crosscutting platform that collaboratively integrates with NSF’s existing directorates and fosters partnerships—with government, industry, nonprofits, civil society and communities of practice—to leverage, energize and rapidly bring to society use-inspired research and innovation.” 

Once appropriated and authorized to begin intentionally growing a network of TREEs, NSF’s TIP Directorate should focus on a four-year plan for SOIL. TIP should begin by choosing an appropriate leader for SOIL, such as a former director or directorate manager of an ARPA (or other TREE). SOIL would be tasked with first engaging the management of existing ARPAs in the federal government, such as those at the Departments of Defense and Energy, to form an advisory board. The advisory board would in turn guide the creation of experience-informed operating procedures for SOIL to use to establish and aid new TREEs. These might include discussions geared toward arriving at best practices and mechanisms to operate rapid solutions-focused R&D programs for the following functions:

Beyond these structural aspects, the board must also incorporate important cultural aspects of TREES into best practices. In my own research into the managerial heuristics that guide TREEs, I found that managers must be encouraged to “drive change” (critique the status quo, dream big, take action), “be better” (embrace difference, attract excellence, stand out from the crowd), “herd nerds” (focus the creative talent of scientists and engineers), “gather support” (forge relationships with research conductors and potential adversaries), “try and err” (take diverse approaches, expect to fail, learn from failure), and “make it matter” (direct activities to realize outcomes for society, not for science).

The board would also recommend a governance structure and implementation strategy for MyNet. In its first year, SOIL could also start to grow the Community of Cultivators, potentially starting with members of the advisory board. The board chair, in partnership with the White House Office of Science and Technology Policy, would also convene an initial series of interagency working groups (IWGs) focused on establishing a community of practice around TREEs, including but not limited to representatives from the following R&D agencies, offices, and programs: 

In years two and three, SOIL would focus on growing three to five new TREEs at organizations that have not had solutions-oriented innovation programs before but need them. 

SOIL would also start to build a pilot version of MyNet as a resource for these new TREEs, with a goal of including existing ARPAs and other TREEs as quickly as possible. In establishing MyNet, SOIL should focus on implementing the most appropriate system of data governance by first understanding the nature of the collaborative activities intended. Digital research collaborations can apply and mix a range of different governance patterns, with different amounts of availability and freedoms with respect to digital resources. MyNet should be flexible enough to meet a range of needs for openness and security. To this end, SOIL should coordinate with the recently created National Secure Data Service and apply lessons forward in creating an accessible, secure, and ethical information-sharing environment. 

Year four and beyond would be characterized by scaling up. Building on the lessons learned in the prior two years of pilot programs, SOIL would coordinate with new and legacy TREEs to refresh operating procedures and governance structures. It would then work with an even broader set of organizations to increase the number of TREEs beyond the three to five pilots and continue to build out MyNet as well as the Community of Cultivators. Periodic evaluations of SOIL’s programmatic success would shape its evolution after this point. These should be framed in terms of its capacity to create and support programs that yield meaningful technological and socioeconomic outcomes, not just produce traditional research metrics. As such, in its creation of new TREEs, SOIL should apply a major lesson of the National Academies’ evaluation of ARPA-E: explicitly align the (necessarily) robust performance management systems at the project level with strategy and evaluation systems at the program, portfolio, and agency levels. The long-term viability of SOIL and TREEs will depend on their ability to demonstrate value to the public.

Frequently Asked Questions
What is the transformative research model? What makes it different from a typical R&D model?

The transformative research model typically works like this:



  • Engage with stakeholders to understand their needs and set audacious goals for addressing them.

  • Establish lean projects run by teams of diverse experts assembled just long enough to succeed or fail in one approach.

  • Continuously evaluate projects, build on what works, kill what doesn’t, and repeat as necessary.


In a nutshell, transformative research enterprises exist solely to solve a particular problem, rather than to grow a program or amass a stock of scientific capital.


To get more specific, Bonvillian and Van Atta (2011) identify the unique factors that contribute to the innovative nature of ARPAs. On the personnel front, ARPA program managers are talented managers, experienced in business, and appointed for limited terms. They are “translators,” as opposed to subject-matter experts, who actively engage with allies, rivals, and others. They have great power to choose projects, hire, fire, and contract. On the structure front, projects are driven by specific challenges or visions—co-developed with stakeholders—designed around plausible implementation pathways. Projects are executed extramurally, and managed as portfolios, with clear metrics to asses risk and reward. Success for ARPAs means developing products and services that achieve broad uptake and cost-efficacy, so finding first adopters and creating markets is part of the work.

What kinds of TREEs could SOIL help to create?

Some examples come from other Day One proposals. SOIL could work with the Department of Labor to establish a Labor ARPA. It could work with the Department of Education on an Education ARPA. We could imagine a Justice Department ARPA with a program for criminal justice reform, one at Housing and Urban Development aimed at solving homelessness, or one at the State Department for innovations in diplomacy. And there are myriad opportunities beyond the federal government.

What kind of authority over TREEs should SOIL have? Since TREEs are designed to be nimble and independent, wouldn’t SOIL oversight inhibit their operations with an extra layer of bureaucracy?

TREEs thrive on their independence and flexibility, so SOIL’s functions must be designed to impose minimal interference. Other than ensuring that the TREEs it supports are effectively administered as transformative, mission-oriented organizations, SOIL would be very hands-off. SOIL would help establish TREEs and set them up so they do not operate as typical R&D units. SOIL would give TREE projects and staff the means to connect cross-organizationally with other projects and staff in areas of mutual interest (e.g., via MyNet, the Community of Cultivators, and periodic convenings). And, like the SBIR office at the Small Business Administration, SOIL would report annually to Congress on its operations and progress toward goals.

What is the estimated cost of SOIL and its component initiatives? How would it be funded?

An excellent model for SOIL is the Small Business Innovative Research (SBIR) system. SBIR is funded by redirecting a small percentage of the budgets of agencies that spend $100 million or more on extramural R&D. Given that SOIL is intended to be relevant to all federal mission spaces, we recommend that SOIL be funded by a small fraction (between 0.1 and 1.0%) of the budgets of all agencies with $1 billion or more in total discretionary spending. This would yield about $15 billion to support SOIL in growing and connecting new TREEs in a vastly widened set of mission spaces. 


The risk is the opportunity cost of this budget reallocation to each funding agency. It is worth noting, though, that changes of 0.1–1.0% are less than the amount that the average agency sees as annual perturbations in its budget. Moreover, redirecting these funds may well be worth the opportunity cost, especially as an investment in solving the compounding problems that federal agencies face. By redirecting this small fraction of funds, we can keep agency operations 99–99.9% as effective while simultaneously creating a robust, interconnected, solutions-oriented R&D system.

Empower the Geothermal Earthshot: Solve the Climate Crisis with Earth’s Energy

Summary

As a result of human activity, greenhouse gas emissions are increasing so rapidly that climate disaster is imminent. To avoid catastrophe, all economic sectors––industry, agriculture, transport, buildings, and electricity––require immediate energy and climate policy solutions. Only with a resilient and renewable, bipartisan, clean, and reliable partner can America fully decarbonize its economy and avert the devastating effects of climate change. As America’s clean energy transformation proceeds, there is one energy technology up for the task across all these sectors––geothermal. 

Geothermal is the energy source naturally produced by the Earth. It is a proven technology with decades of utilization across the United States, including New York, Idaho, North Dakota, California, Arkansas, New Mexico, and everywhere in between.

Government agencies and academic institutions have already identified more than enough untapped Earth-powered energy in the United States alone to meet the nation’s energy needs while also achieving its emissions goals. In fact, the total amount of heat energy in the Earth’s crust is many times greater than the energy available globally from all fossil fuels. 

Despite these benefits, geothermal represented just 0.4% of total U.S. utility-scale electricity generation in 2021 and only 1% of the residential and commercial building heating and cooling market. What is holding geothermal back is a lack of policy attention at both the federal and state levels. Geothermal has been drastically underfunded and continues to be left out of energy, climate, and appropriations legislation. By acting as the primary facilitator and coordinator for geothermal technology policy and deployment, the U.S. government can significantly accelerate the clean energy transformation. 

Our Empowering the Geothermal Earthshot proposal is a multibillion dollar interagency effort to facilitate the energy revolution America needs to finally solve the climate crisis and complete its clean energy transformation. This top-down support would allow the geothermal industry to fully utilize the power of the free market, commercialize innovation into mass production, and scale technologies.

Challenge and Opportunity

Geothermal energy––clean renewable energy derived from the unlimited heat in the Earth––is a proven technology that can contribute to achieving aggressive climate goals but only if it gets much-needed policy support. Geothermal urgently requires the same legislative and executive attention, policy momentum, and funding that all other energy technologies receive. The Biden Administration as well as Republicans and Democrats in Congress need to lift up the profile of geothermal on par with other energy technologies if we are to reach net-zero by 2050 and eventually 24/7 carbon-free energy.

On day one of his administration, President Biden charged his National Climate Task Force to utilize all available government resources to develop a new target for reductions in greenhouse gas (GHG) emissions. As a result, in April 2021 the Biden Administration announced an aggressive new GHG target: a 50% reduction from 2005 levels by 2030. To meet this challenge, the administration outlined four high-priority goals:

Pie chart showing Total Greenhouse Gas Emissions by Economic Sector in the U.S. in 2020. Transportation is responsible for 27%; Electricity, 25%; Industry, 24%; Commercial; Residential, 13%; Agriculture, 11%.
Figure 1.

Pie chart showing Total Greenhouse Gas Emissions by Economic Sector in the U.S. in 2020. Transportation is responsible for 27%; Electricity, 25%; Industry, 24%; Commercial; Residential, 13%; Agriculture, 11%.

  1. Invest in clean technology infrastructure.
  2. Fuel an economic recovery that creates jobs.
  3. Protect our air and water and advance environmental justice.
  4. Do this all in America.

Geothermal energy’s primary benefits make it an ideal energy candidate in America’s fight against climate change. First, geothermal electricity offers clean firm, reliable, and stable baseload power. As such, it easily complements wind and solar energy, which can fluctuate and produce only intermittent power. Not only does geothermal energy offer more resilient and renewable energy, but––unlike nuclear and biomass energy and battery storage––it does so with no harmful waste by-products. Geothermal energy does not depend on extractive activities (i.e., mining) that have a history of adversely impacting the environment and Indigenous communities. The underlying energy source––the literal heat beneath our feet––is local, is 100% American, and has demonstrated gigawatt-scale operation since the 1980s, unlike every other prospective clean energy technology. Geothermal energy offers a technology that we can export as a service provider and manufacturer to the rest of the world to reduce global GHG emissions, increase U.S. energy independence, and improve the country’s economy and national defense. 

Additionally, climate change continues to change outside air temperatures and weather patterns impacting building energy consumptions (e.g., heating and cooling), which are expected to increase. Geothermal heating and cooling meets these demands by providing reliable and distributed electricity generation, winter heating, and summer cooling. Geothermal heating and cooling offer solutions to other economic sectors that produce harmful carbon and methane emissions. 

Getting to net-zero by 2050––and eventually to 24/7 carbon-free energy––is a community problem, a public sector problem that affects America’s public health, economic survival, and national security. We can get here if geothermal is provided the same opportunities that the government has afforded all other energy technologies.

Geothermal Energy: The Forgotten Energy Technology

Today, geothermal power production is at the same developmental stage that oil production was 100 years ago. Geothermal power production has been proven at gigawatt scale, but in a limited range of locations where conventional hydrothermal systems are easily accessible. Petroleum drilling in the United States began in 1859 and expanded first in places where oil was visible, easily identifiable, and quickly accessible. In the 150 years since, continuous market support from governments and societies has allowed the fossil fuel economy not just to continue but to expand through technology innovation. Fossil fuel technologies have matured to the point where engineers regularly drill seven to eight miles underground, drill in deep ocean water, and utilize efficient recovery technologies such as steam-assisted gravity drainage.

Geothermal carries the same potential to drive new technologies of energy production and enable huge increases in energy recovery and output. However, unlike the petroleum industry, geothermal energy has never received comparable and effective policy support from the federal and state governments to drive this needed technology development, innovation, and deployment. As a result, the geothermal industry has been left behind in the United States. 

Pie chart of Federal Energy Subsidies between 1950 and 2010, showing a plurality of subsidies going to oil, while only a small sliver to geothermal.
Figure 2.

Pie chart of Federal Energy Subsidies between 1950 and 2010, showing a plurality of subsidies going to oil, while only a small sliver to geothermal.

Ironically, the fact that geothermal technologies have a long and successful track record has kept them out of the “new technology” focus that has been central to clean energy transition policy discussions.

Other technologies (e.g., hydro, solar, hydrocarbons, nuclear, biofuels, and wind) receive tens of billions of dollars each year to develop a path to continued, preferred, and widespread use, which generates commercialization, scalability, and profit. However, similar investment strategies have not been dedicated to geothermal energy infrastructure development. 

The United States needs critical capital investments to reach the vast amount of untapped Earth energy scientists have identified, expand the range of places where geothermal resources are possible, and lower the cost of geothermal drilling and production. Public investment will promote technologies such as heating and cooling systems that use individualized geothermal heat pumps (GHP) or district thermal systems. Significant public investment is needed in electricity generation technologies such as closed-loop, deep super hot rock, and enhanced systems (EGS). And of course, public and private investments are needed to help manufacturing and agricultural processes switch from fossil fuels to geothermal.

Investing in Our Future: Empowering the Geothermal Earthshot

Thankfully, investing in America’s energy infrastructure is a priority of our current presidential administration. As indicated in the April 2021 White House Fact Sheet and supported by Executive Order 14057 and the Department of Energy (DOE) Enhanced Geothermal Earthshot announced in September 2022, the Biden Administration realizes the need to marshal federal resources in a coordinated effort.

However, to fully realize and build upon the administration’s clean energy objectives, this proposal urges a holistic approach to empower geothermal deployment. The Enhanced Geothermal Earthshot falls short of the effort required to empower geothermal and scale a solution to draw down the climate crisis because it focuses on a single geothermal technology and involves just one federal agency. Instead, a whole-of-geothermal approach that harnesses the power of the entire federal government is necessary to create ambitious, positive, and widespread changes in America’s energy landscape and subvert the current fossil fuel status quo. The following action plan will usher in the geothermal era and ensure the United States meets its climate objectives and completes the clean energy transformation.

Plan of Action

The Biden Administration must set the targets and the agenda, propose policy and tax support, negotiate for appropriations, and issue regulatory support that allows commercialization and deployment of every possible Earth-powered technology solution. These steps will set up the market conditions for the private sector to commercialize and scale these proven technologies and new innovations. 

Creating policies and programs to support geothermal applications and technologies will accelerate the clean energy transformation and end our dependence on hydrocarbons. The U.S. government can usher in a new age of clean, renewable, and local energy through a combination of innovation, programs, and institutionalization. These are outlined in the recommendations detailed below.

Recommendation 1. Empower a Holistic Geothermal Earthshot

The Biden Administration should build upon and broaden the Enhanced Geothermal Earthshot to reduce the cost of EGS by 90% to $45 per megawatt hour by 2035. The administration should set a target for geothermal heat pumps and district thermal systems to reach 35% of U.S. energy consumption by 2035 and electricity generation to reach 10% of energy consumption by 2035. These objectives are in response to the administration’s carbon reduction goals for 2030 and 2050. To begin this initiative, President Biden––joined by the Secretaries of Energy, the Interior, Commerce, Defense, and Agriculture, as well as special climate and environment envoys and advisors and the Environmental Protection Agency (EPA) administrator, among others—should formally usher in a reimagined and holistic Geothermal Earthshot that leverages a whole-of-government approach.

Recommendation 2. Institutionalize and Coordinate Earth Energy Support

Create the Office of Earth Energy (OEE) at DOE through the president’s annual budget proposal. The OEE’s mission will be to coalesce federal and state governments, familiarize the public, and support all types of Earth-powered energy technologies. 

Existing DOE offices such as ONE and OFECM offer a proven template from which to model OEE. Geothermal’s potential to address the climate crisis and become a significant part of the cooling/heating and electricity mix in the United States requires significant growth of support within the federal government. The organizational structure of the federal government is imperative to spearhead geothermal development. Raising the awareness and profile of geothermal within the government requires higher-level offices and more senior-level personnel supporting, evaluating, and studying the industry. The three DAS subject-matter designations represent the three overarching applications of geothermal technologies.

Interagency coordination should be led by a Senior Director for Earth-Powered Energy within the National Security Council (NSC). Programs and initiatives involve executive agencies and offices, including DOE, Department of Defense (DOD), Department of Agriculture, Department of Commerce, Department of the Interior (DOI), Office of Science and Technology Policy, Office of Management and Budget, NSC, Domestic Policy Council, Department of State, and EPA, among others.

Recommendation 3. Accelerate Geothermal Innovation

The following innovation accelerator concepts can help unlock technical hurdles and unleash private sector thinking to expand the reach of geothermal energy applications. The needed primary research fits into three broad categories: streamlining existing geothermal energy development and reducing risk, technology innovations to support massively scaling the potential range and total energy available from the Earth, and technical refinements to optimize every Earth energy application.

For example, work is needed to reduce technical risk and predictability in siting geothermal wells to make drilling a geothermal well as predictable and repeatable as it is for oil and gas wells today. Reduced risk and greater predictability is critical to private sector investment support. 

Commercial and residential heat pumps and district heating systems need R&D support to improve deployability in urban settings and to maximize both heating and cooling efficiency.

Enhanced geothermal systems—those that expand traditional hydrothermal power generation to less permeable locations—have received modest public sector support for several decades but need greater and more focused application of technologies that were developed for oil and gas during the fracing expansion.

Achieving massive scalability for geothermal power means developing technologies that can operate well beyond traditional hydrothermal system locations. Closed-loop and other advanced geothermal technologies promise access to energy anywhere there is heat, but all are currently at the earliest stages of their technology lifecycles and operating without major public sector research support 

All of these use cases would benefit from a concerted, government-funded research effort, shared access to innovation and best practices, and a clear path to commercialization.

(A) Propose in the president’s annual budget a geothermal bureau, program, or focus area within the Advanced Research Projects Agency-Energy (ARPA-E) dedicated to promoting all types of geothermal innovations, from low- to high-temperature cooling/heating and electricity applications. ARPA-E “advances high-potential, high-impact energy technologies that are too early for private-sector investment.” Use this program to support research into new or expanded ways to use Earth energy that are too early or speculative for private sector investment and bring them to the point of commercialization.

(B) Create a new venture capital entity to accelerate commercialization of geothermal innovations by aggressively investing in geothermal-related technologies. Model it on the existing In-Q-Tel organization that has been very successful in driving national security technology development. This would be a new venture capital funding entity focused on commercializing Earth power technology innovation from U.S. government-funded research and development initiatives (e.g., the ARPA-E projects described above) and on exploring technology solutions to problems that remain unsolved across government, industry, and society yet are critically important for dealing with climate change. 

(C) Create a public-private Geothermal Center of Excellence (GeoExcel) at a DOE national lab. A sustained and robust public-private research program is essential for innovation, and many agencies leverage private sector investment through publicly funded centers of excellence. Currently, geothermal research is conducted haphazardly and incoherently across U.S. government agencies and DOE national labs such as Idaho National Lab, Sandia National Labs, Lawrence Berkeley Lab, U.S. Geological Survey, National Renewable Energy Lab, Brookhaven National Lab, Argonne National Lab, National Energy Technology Lab, and many more. To augment research within its national lab apparatus, DOE should establish GeoExcel to develop the technology necessary to produce low-cost geothermal power, cooling/heating, and mineral recovery such as lithium, manganese, gold, and silica. GeoExcel would also conduct education outreach and workforce development. GeoExcel would be a multibillion-dollar public-private partnership competitively awarded with multiyear funding. It would interact closely with one or two DOE national labs as well as federal, state, regional, and municipal government agencies, research universities, community college, nonprofits, and the private sector.

Recommendation 4. Create Earth Energy-Specific Programs and Policies

The following programs, funding, and regulatory suggestions should be proposed in the president’s budget and funded or authorized through congressional appropriations or moving authorization legislation. Some recommendations can be achieved through updating rules and regulations.

Programmatic: DOE Demonstration Projects

The Infrastructure Investment and Jobs Act (IIJA) appropriated $20 billion for demonstration projects, including those for hydrogen, direct air capture, and large-scale carbon capture. This funding provides vital capital to incentivize, commercialize, and scale public-private partnerships using the benefits of the free market to build major infrastructure projects that will expand clean energy and advance the energy transformation. The IIJA did not direct any funding specifically for geothermal technologies; yet geothermal provides the critical clean firm and renewable baseload energy that complements intermittent technologies, can be coupled to produce green hydrogen, and empowers direct air capture infrastructure. As part of its criteria for selecting applications for demonstration project funding, Congress should clarify and/or DOE should expressly include and announce that geothermal technology will receive significant demonstration appropriations funded through the IIJA.

Funding: Risk Mitigation and Management

Commercial investment in new technology hinges on risk assessment. Removing risk from new geothermal ventures will facilitate faster commercial-scale deployment and, in turn, lower risk as more projects are completed. Propose a $2 billion risk mitigation fund within the DOE’s OEE specific for district cooling/heating and electricity drilling and exploration projects. This geothermal risk mitigation fund would provide loans to cover a portion (i.e., 60%) of the drilling cost that can be converted into grants if development of the geothermal field is unsuccessful. To minimize losses, a premium can be charged to ensure a positive return based on risk and set limits on total wells covered and monetary claims to limit losses. 

This risk mitigation and management structure has been successfully implemented for geothermal projects in Kenya, Iceland, and Costa Rica, countries in the top five of geothermal energy production per capita. To further reduce risk, the OEE should only consider projects that have already completed some exploratory drilling. Before administering commercial debt financing, the OEE should also require these projects to receive concessional risk mitigation support prior to advancing with additional drilling, district cooling/heating system construction, or power plant construction.

Funding: Rural Development

Propose a $450 million Department of Agriculture Rural Development grant program to transition agricultural and industrial cool/heat applications from burning fossil fuels to Earth energy generation. This funding can be used to decarbonize over two million cooling and heating systems used in the agricultural sector in rural America. Agricultural activities such as food processing, pulp and paper manufacturing, vegetable dehydration, dairy processing, aquaculture, greenhouses, processing sugar, and much more can transition to the clean energy economy.

Funding: Community Development

Propose a $750 million grant program to be implemented by the Department of Commerce Economic Development Administration. Grants will be made for high- and low-temperature geothermal developers to partner with municipalities, electric or energy cooperatives, community choice aggregators, and public utilities servicing America’s communities to develop geothermal resources. This funding level could generate between 375 and 500 megawatts of electricity to power between 280,000 and 375,000 households or over 3,500 megawatts of cooling/heating energy and decarbonize two to three million households and commercial businesses around the country. It is important that the clean energy transition equitably and justly empower rural American communities along with urban and suburban communities.

Funding: Tribal Development

Fund a $275 million grant program through the proposed OEE at DOE or the Bureau of Indian Affairs (BIA) at DOI to support tribal nations to develop geothermal resources on their lands, such as electricity generation, industrial and agricultural decarbonization, residential and commercial GHPs or district cooling/heating installations, and recreation. This funding could be used to generate up to 183 megawatts of electricity or 1,375 megawatts of thermal energy for use on tribal lands. Native Americans used geothermal resources for thousands of years before European settlement. Today, tribal lands are the backbone of mineral exploitation, agriculture, industry, and power production in America. These OEE or BIA funds will facilitate the clean energy transition on tribal lands using geothermal resources.

Funding: Military Construction

Propose a $2.6 billion program for distributed geothermal power and cooling/heating projects on military installations across the United States and abroad. The Air Force recently selected two military installations to deploy geothermal energy. In an increasingly contested clean energy economy, we should build secure and resilient military infrastructure using local Earth energy technologies directly on military installations. DOD can use the funding to generate a combination of up to 1,733 megawatts of electricity or 13,000 megawatts of thermal energy to offset its massive carbon footprint from 500 fixed installations, which includes 300,000 buildings. This investment will help all service branches and DOD reach the Biden Administration’s renewable energy generation goals. This funding begins the vital transformation to secure the energy infrastructure of military installations through energy independence and protect our national security interests at home and abroad. Energy and mineral security are paramount for our national security. 

Funding: Smithsonian Institution

Geothermal energy is a story of the forgotten energy technology. Propose $25 million for the Smithsonian Institution to memorialize and narrate the history and future of geothermal energy in the United States. Museums familiarize and educate policymakers and the public about the past, present, and future of America. Permanent exhibitions in museums along the National Mall in Washington, DC, will help promote the potential of geothermal resources to policymakers as is already done with other energy technologies featured by the Smithsonian Institution.

Funding: Workforce Development and Community Colleges

The future of the clean energy transformation rests in the education of Americans and a smooth workforce transition of oil and gas professionals into the clean energy economy. Community colleges play a vital role in this transition. Allocate $300 million for the Department of Education to award grants to technical and vocational programs to develop and build geothermal-specific skill sets and needs into curriculums. These geothermal programs will build upon and expand existing programs such as drill rig crew member training programs like that at Houston Community College in Texas or cooling/heating apprenticeship programs like those at Mercer Community College in New Jersey or Foothills College in California. The objective of these grants is to amplify the capabilities of geothermal technologies and deepen the knowledge of professionals who install, sell, market, or manufacture products that could transition to geothermal technologies and away from burning fossil fuels.

Funding: Convert Abandoned Oil and Gas Wells

Expand the authorities of the Leaking Underground Storage Tank (LUST) Trust Fund within the EPA to include the conversion of existing and abandoned oil and gas fields into geothermal wells. The LUST Trust Fund is financed by a 0.1 cent tax on each gallon of motor fuel sold nationwide. Oil and gas wells can be retrofitted or reworked to provide geothermal cooling/heating for low-to-no-carbon direct use opportunities or generate power. Due to the years of development at these sites, the reservoir is well understood, thereby lowering risks and cost of exploration. Alternatively, this program could be a direct grant program funded through the proposed OEE within DOE or through EPA.

Regulatory: Geothermal Permitting Application Processing

Applications to conduct geophysical exploration are currently reviewed by the district office within the Bureau of Land Management (BLM) at DOI that has geographic jurisdiction over the specific geothermal project. Yet many district offices are unfamiliar with the technical aspects of geothermal development, causing significant delays in the review process. Fund $15 million for a national office with a dedicated geothermal team to develop training materials and standard operating procedures and to provide technical support to district offices to ensure timely review of geothermal power and cooling/heating projects on federal lands. Programs that cross-train staff will also improve the ability to coordinate between different agencies and offices.

Regulatory: Categorical Exclusions for Geothermal Projects

Several activities involved in geothermal resource development have no significant environmental effects yet lack an existing categorical exclusion under the National Environmental Policy Act. BLM’s regulations include only one categorical exclusion for geophysical exploration when no temporary or new road construction is required (43 CFR 4 3250); however, it does not cover resource confirmation activities. As a consequence, federal agencies take several months to approve what could be done in a matter of days via a categorical exclusion. Congress has recognized the need to improve the permitting process for geothermal production and introduced several bills to authorize categorical exclusions (i.e., S. 2949, S. 2824, and H.R. 5350).

Tax Support: Cooling and Heating

Propose a 40% tax incentive for residential and commercial building installation of geothermal heat pumps and extend the lifespan of these incentives through 2050, the date set to reach net zero emissions economy-wide. Additionally, the Biden Administration should publicly clarify or amend Presidential Determination No. 2022-18 of Section 303 of the Defense Production Act to include geothermal heat pumps.

Tax Support: Power

Geothermal electricity generation has traditionally been capital-intensive, and investment decisions depend in part on the predictability of tax incentives. This trend is best illustrated by the 1978 passage of the Public Utility Regulatory Policies Act (PURPA). This legislation’s tax consequences created more favorable conditions and a more robust market for renewable-energy suppliers. As a result, PURPA allowed the United States to rapidly increase its geothermal capacity throughout the 1980s.

Rapid deployment and growth after the passage of PURPA illustrates the impact of public policy on geothermal innovation and investment. However, renewable energy tax incentives provided in the Inflation Reduction Act of 2022 had intermittent energy and battery storage in mind when drafted. These tax incentives do not adequately support geothermal power development due to sunset clauses. The president’s budget as well as congressional appropriators and authorizers should extend the availability of the 30% Investment Tax Credit (ITC) and 2.6 cents per kWh for the Production Tax Credit (PTC) using a market approach akin to that proposed in the bipartisan Energy Sector Innovation Credit (ESIC) Act authored by Senators Whitehouse (D-RI), Crapo (R-ID), Barrasso (R-WY), Bennet (D-CO), and Hickenlooper (D-CO) as well as Representatives Reed (R-NY) and Panetta (D-CA). 

Chart showing eletricity generation capacity from geothermal development in the U.S. from 1970 to 2020. In that time, geothermal generation capacity has grown from 0 megawatts to nearly 4,000 megawatts.
Figure 3.

Chart showing eletricity generation capacity from geothermal development in the U.S. from 1970 to 2020. In that time, geothermal generation capacity has grown from 0 megawatts to nearly 4,000 megawatts.

The ITC and PTC are written with intermittent energy technologies in mind. Geothermal requires a tax incentive structure that does not sunset after two or 10 years but rather automatically scales down credits as geothermal technologies’ market penetration ramps up. The ESIC scale down should begin when geothermal reaches 10% market penetration instead of 2%. This empowers the free market to play a major role in commercialization and scaling geothermal technologies and provides much-needed predictability and planning for the geothermal industry. It also ensures taxpayer dollars do not subsidize market-mature technologies as they currently do for all other energy technologies such as hydrocarbon, solar, wind, and nuclear projects.

Conclusion 

We can find geothermal energy just below our feet, literally everywhere. It provides 24/7 carbon-free power, cooling, and heating that is safe, resilient, local, and American. A public-private partnership that leverages public-sector investment with private-sector know-how can make geothermal technology a viable replacement for hydrocarbons and a powerful solution to reducing greenhouse gas emissions. We must empower and broaden the Enhanced Geothermal Earthshot through the programs and recommendations listed in this plan of action. In doing so, a reimagined and holistic Geothermal Earthshot can leverage the position and influence of the federal government through a whole-of-government approach, allowing the free market to seize on this momentum to scale and commercialize geothermal energy solutions. This will expand the rapidly emerging technologies that make widespread Earth-energy harnessing possible. As the need for firm, scalable, renewable, stable baseload energy only becomes more urgent, these geothermal innovations make the possibility of continuous, reliable, global clean energy a reality.

Frequently Asked Questions
Many clean energy options require critical minerals that are difficult to obtain or come with security concerns. Does geothermal energy carry this same drawback?

No. Unlike some other clean energy technologies that require vital minerals extracted or refined in authoritarian countries including Russia and China, Earth energy technologies and innovations reduce the clean energy economy’s reliance on these foreign-extracted minerals. Resilience from domestic geothermal energy secures our supply chains, conserves from destruction vital forests and habitats from Brazil to the Democratic Republic of the Congo, and generates high-paid and sought-after union jobs here in the United States.

In the switch to geothermal energy, how do we ensure that the American workforce isn’t left behind?

The clean energy transformation brings with it a workforce transition. Geothermal technologies offer displaced fossil fuel workers employment opportunities that respect their professional experiences, maintain their community heritage, and preserve their place-based sense of self. Mechanical engineers, drill rig apprentices, drill supervisors, geophysicists, and project managers from the oil, gas, and coal industries all possess skills and training transferable to geothermal jobs—typically, six-figure salaried jobs. 


Workers are tired of hearing “trust us” refrains from politicians, the private sector, and government agencies that claim a new job will be found for them. These jobs need to be ready before an individual’s job disappears and not rely on potential tourism or the prospect of relocation to another community.

Do rural communities stand to benefit from geothermal energy production?

Geothermal provides solutions to the oil and gas workforce as it transitions to a clean energy economy and protects the integrity and honor of rural American communities once prominent in the fossil fuel economy such as Eddington in Maine, Page in Arizona, Colstrip in Montana, River Rouge in Michigan, St. James in Louisiana, and Winfield in West Virginia. All of these communities have had environmental and public health issues due to hydrocarbons or are experiencing major loss of employment due to closing hydrocarbon-burning power plants.


Rural America is poised to win big in the ongoing clean energy transformation once policymakers harness the vast geothermal potential everywhere under our feet.

Why is addressing residential and commercial cooling needs such a concern, and how can geothermal energy help?

Recent heat waves around the world, with record temperatures that threaten food production and even human survival, highlight an important fact: with global warming comes an increasing need for sustainable cooling strategies. 


 


Traditional air-conditioning removes dangerous heat from buildings and provides life-saving shelter and comfort. Unfortunately, air-conditioning systems worsen two other problems.


 


First, heat is not so much removed or eliminated as it is moved from one location to another. When a building interior is cooled, that thermal energy is transferred to the exterior surroundings. In dense urban areas, this effect increases local temperatures, exacerbating the heat wave in places that are already heat islands as a result of urbanization. 


 


Second, air-conditioning requires significant electricity, placing additional stress on electric grids and generation systems that are already struggling to decrease fossil fuel dependence and cope with the electrification needed to reduce greenhouse gas emissions. 


 


Thankfully, this increased demand can be partially offset by daytime solar generation. But nighttime cooling has become a necessity in many places. Geothermal technology has a major role to play here too. Geothermal (i.e., ground source) heat pumps are far more efficient than their air-source counterparts, especially at high and low temperatures. 



A ground-source cooling system can reduce building interior temperatures without heating the surrounding air space. But the capital costs for these systems are high. Public-sector support is needed via tax credits and the Defense Production Act to incentivize adoption now plus simultaneous investments in technology to streamline implementation and decrease cost over time.

What can geothermal energy provide that solar and wind energy cannot?

Intermittent energy technologies have proven they can scale and compete with fossil fuels. But wind and solar, along with battery storage, only get us part of the way through the clean energy transformation. These technologies have made enormous strides in cost-effectively replacing fossil fuels for power generation, but their intermittent nature means they cannot get us “the last mile” to total electrification. They also cannot provide scalable and distributed cooling/heating benefits to decarbonize the built environment or agriculture processes that produce harmful emissions by burning fossil fuels.

How much power and heat can geothermal produce?

A report published by a consortium of scientists and led by the Massachusetts Institute of Technology estimate conventional geothermal could provide 100,000 megawatts of electricity in the United States––enough energy to power 16 million U.S. households––while the Department of Energy estimates geothermal heating and cooling could reach 28 million U.S. households through the use of geothermal heat pumps. These are conservative estimates using proven technologies. Innovative technologies will exponentially grow these estimates with the right and much needed policy support.

What are the agriculture, industry, and manufacturing applications of geothermal?

Because geothermal energy is a reliable, carbon-free, and renewable source of power, it has wide-ranging applications that meet America’s key agricultural, manufacturing, and commercial needs, including aquaculture farming; dairy production; processing pulp and paper; mineral recovery for use in battery, wind turbine, and solar panel manufacturing; vegetable processing and drying; and zero-carbon electricity generation, to name a few. Find out more uses of geothermal on page 22 in the DOE’s GeoVision report.