Fueling the Bioeconomy: Clean Energy Policies Driving Biotechnology Innovation

The transition to a clean energy future and diversified sources of energy requires a fundamental shift in how we produce and consume energy across all sectors of the U.S. economy. The transportation sector, a sector that heavily relies on fossil-based energy, stands out not only because it is the sector that releases the most carbon into the atmosphere, but also for its progress in adopting next-generation technologies when it comes to new technologies and fuel alternatives. 

Over the past several years, the federal government has made concerted efforts to support clean energy innovation in transportation, both for on-road and off-road. Particularly, in hard-to-electrify transportation sub-sectors, there has been added focus such as through the Sustainable Aviation Fuel (SAF) Grand Challenge. These efforts have enabled a wave of biotechnology-driven solutions to move from research labs to commercial markets, such as LanzaJets alcohol-to-jet technology in producing SAF. From renewable fuels to bio-based feedstocks, biotechnologies are enabling the replacement of fossil-derived energy sources and contributing to a more sustainable, secure, and diversified energy system. 

SAF in particular has gained traction, enabled in part by public investment and interagency coordination, like the SAF Grand Challenge Roadmap. This increased federal attention demonstrated how strategic federal action, paired with demand signals from government, targeted incentives, and industry buy-in, can create the conditions needed to accelerate biotechnology adoption.

To better understand the factors driving this progress, FAS conducted a landscape analysis at the federal and regional level of biotechnology innovation within the clean energy sector, complemented by interviews with key stakeholders. Several policy mechanisms, public-private partnerships, and investment strategies were identified that were enablers of advanced SAF adoption and production and similar technologies. By identifying the enabling conditions that supported biotechnology’s uptake and commercialization, we aim to inform future efforts on how to accelerate other sectors that utilize biotechnologies and overall, strengthen the U.S. bioeconomy.

Key Findings & Recommendations

An analysis of the federal clean energy landscape reveals several critical insights that are vital for advancing the development and deployment of biotechnologies. Federal and regional strategies are central to driving innovation and facilitating the transition of biotechnologies from research to commercialization. The following key findings and actionable recommendations address the challenges and opportunities in accelerating this transition.

Federal Level Key Findings & Recommendations

The federal government plays a pivotal role in guiding market signals and investment toward national priorities. In the clean energy sector, decarbonizing aviation has emerged as a strategic objective, with SAF serving as a critical lever. Federal initiatives such as the SAF Grand Challenge, the SAF Roadmap, and the SAF Metrics Dashboard have helped to elevate SAF within national climate priorities and enabled greater interagency coordination. These mechanisms not only track progress but also communicate federal commitment. Still, despite these efforts, current SAF production remains far below target levels, with capacity largely concentrated in HEFA, a pathway with constrained feedstock availability and limited scalability. 

This production gap reflects deeper structural challenges, many of which parallel broader issues across the clean-energy biotech interface. One of the main challenges is the fragmented, short-duration policy incentives currently in use. Tax credits like 40B and 45Z, while important, lack the longevity and clarity required to unlock large-scale, long-term private investment. The absence of binding fuel mandates further undermines market certainty. These policy gaps limit the ability of the clean energy sector to serve as a sustained demand signal for emerging biotechnologies and slow the transition from pilot to commercial scale. 

Importantly, these challenges point to a broader opportunity: SAF as a test case for how the clean energy sector can serve as a driver of biotechnology uptake. Promising biotechnologies, such as alcohol-to-jet and power-to-liquid, are currently stalled by high capital costs, uncertain regulatory pathways, and a lack of coordinated federal support. Addressing these bottlenecks through aligned incentives, technology-neutral mandates, and harmonized accounting frameworks could not only accelerate SAF deployment but also establish a broader policy blueprint for scaling biotechnology across other clean energy applications.

To alleviate some of the challenges identified, the federal government should:

Extend & Clarify Incentives

While tax incentives such as the 45Z Clean Fuel Production Credit offer a promising framework to accelerate low-carbon fuel deployment, current design and implementation challenges limit their impact, particularly for emerging bio-based and synthetic fuels. To fully unlock the climate and market potential of these incentives, Congress and relevant agencies should take the following steps:

Scale Biotech Commercialization Support

The clean energy transition depends in part on the successful commercialization of enabling biotechnologies, ranging from advanced biofuels to bio-based carbon capture, SAF and biomanufacturing platforms that reduce industrial emissions. Recent or proposed funding cuts to clean energy programs risk stalling this progress and undermining U.S. competitiveness in the bioeconomy. 

To accelerate biotechnology deployment and bridge the gap between lab-scale innovation and commercial-scale production, Congress should take the following actions:

Design and Promote Next-Gen Biofuel Policies

To accelerate the deployment of low-carbon fuels and enable innovation in next-generation bioenergy technologies, Congress and relevant agencies should take the following actions:

Regional Level Key Findings & Recommendations

Regional strengths continue to serve as foundational drivers of clean energy innovation, with localized assets shaping the pace and direction of technology development. Federal designations, such as the Economic Development Administration (EDA) Tech Hub program (Tech Hub), have proven catalytic. These initiatives enable regions to unlock state-level co-investment, attract private capital, and align workforce training programs with local industry needs. Early signs suggest that the Tech Hub framework is helping to seed innovation ecosystems where they are most needed, but long-term impact will depend on sustained funding support and continued regional coordination. 

Workforce readiness and enabling infrastructure remain critical differentiators. Regions with deep and committed involvement from major research universities, national labs, or advanced manufacturing clusters are better positioned to scale innovation from prototype to deployment. Real-world testbeds provide environments for stress-testing technologies and accelerating regulatory and market readiness, reinforcing the importance of place-based strategies in federal innovation planning. 

At the same time, private investment in clean energy and enabling biotechnologies remains crucial to developing and scaling innovative technologies. High capital costs, regulatory uncertainty, and limited early-stage demand signals continue to inhibit market entry, especially in geographies with less mature innovation ecosystems. Addressing these barriers through coordinated federal procurement, long-term incentives, and regional capacity-building will be essential to supporting growth in regions with strong assets to develop industry clusters that could yield clean energy benefits. 

To accomplish this, the federal government and regional governments should: 

Strengthen Regional Workforce Pipelines

A skilled and regionally distributed workforce is essential to realizing the full economic and technological potential of clean energy investments, particularly as they intersect with the bioeconomy. While federal funding is accelerating deployment through initiatives such as the IRA and DOE programs, workforce gaps, especially outside major innovation hubs, pose barriers to implementation. Addressing these gaps through targeted education, training, and talent retention efforts will be critical to ensuring that clean energy projects deliver durable, regionally inclusive economic growth. To this end:

Strengthen Regional Infrastructure and Foster Cross-Sector Collaboration

Robust regional infrastructure and cross-sector collaboration are essential to accelerating the deployment of clean energy technologies that leverage advancements in biotechnology and manufacturing. Strategic investments in shared facilities, modernized logistics, and coordinated innovation ecosystems will strengthen supply chain resilience and improve technology transfer across sectors. Facilitating access to R&D infrastructure, particularly for small and mid-sized enterprises, will ensure that innovation is not limited to large firms or major metropolitan areas. To support these outcomes: 

Attract and De-Risk Private Capital

Attracting and de-risking private capital is critical for scaling clean energy and biotechnology innovations. By offering targeted financial mechanisms and leveraging federal visibility, governments can reduce the financial uncertainties that often deter private investment. Effective strategies, such as state-backed loan guarantees and co-investment models, can help bridge funding gaps while strategic partnerships with philanthropic and venture capital entities can unlock additional resources for emerging technologies. To this end: 

Cross-Cutting Key Findings

The successful deployment of federal clean energy and biotechnology initiatives, such as the SAF Grand Challenge, relies heavily on the capacity of regional ecosystems and the private sector to absorb and implement national goals. Many regions, particularly those outside established innovation hubs, lack the infrastructure, resources, and technical expertise to effectively utilize federal funding. As a result, the impact of national policies is often limited, and the full potential of federal investments goes unrealized in certain areas.

Federal programs often take a one-size-fits-all approach, overlooking regional variability in feedstocks, industrial bases and cost structures. Programs like tax credits and life cycle analysis models can unintentionally disadvantage regions with different economic contexts, creating disparities in access to federal incentives. This lack of regional customization prevents certain areas from fully benefiting from national clean energy and biotech initiatives. 

The diffusion of innovation in clean energy and biotechnology remains concentrated in a few key regions, leaving others underutilized. Despite robust federal R&D investments, commercialization and scaling of innovations are primarily concentrated in regions with established infrastructure, hindering the broader geographic spread of these technologies. In addition, workforce development efforts across federal and regional programs are fragmented, creating misalignments in talent pipelines and further limiting the ability of local industries to leverage available resources effectively. The absence of a unified system for tracking key metrics, such as SAF production and emissions reductions, makes it difficult to coordinate efforts or assess progress consistently across regions. To address this, the federal and regional governments should:

Create a Federal–Regional Clean Energy Deployment Compact

A Federal-Regional Clean Energy Deployment Compact is critical for aligning federal clean energy initiatives with the unique capabilities and needs of regional ecosystems. By establishing formal mechanisms, such as intergovernmental councils and regional liaisons, federal programs can be more effectively tailored to local conditions. These mechanisms will ensure two-way communication between federal agencies and regional stakeholders, fostering a collaborative approach that adapts to evolving technological, economic, and environmental conditions. In addition, treating regional tech hubs and initiatives as testbeds for new policy tools, such as performance-based incentives or carbon standards, will allow for innovative solutions to be tested locally before scaling them nationally, ensuring that policies are effective and contextually relevant across diverse regions. To this end:

Build a National Innovation-to-Deployment Pipeline

Creating a seamless innovation-to-deployment pipeline is essential for scaling clean energy technologies and ensuring that regional ecosystems can fully participate in national clean energy transitions. By linking DOE national labs, Tech Hubs, and regional consortia into a coordinated network, the U.S. can support the full life cycle of innovation, from early-stage R&D to commercialization and deployment, across diverse geographies. Additionally, co-developing curricula and training programs between federal agencies, regional tech hubs, and industry partners will ensure that talent pipelines are closely aligned with the evolving needs of the clean energy sector, providing the skilled workforce necessary to implement and scale innovations effectively. To accomplish this the:

Develop a Shared Metrics and Monitoring Platform

A centralized dashboard for tracking key metrics related to clean energy and biotechnology initiatives is crucial for guiding investment and policy decisions. By integrating federal and regional data can provide a comprehensive, real-time view of progress across the country. This shared platform would enable better coordination among federal, state, and local agencies, ensuring that resources are allocated efficiently and that policy decisions are informed by accurate, up-to-date data. Moreover, a unified system would allow for more effective tracking of regional performance, enabling tailored solutions and based on localized needs and challenges. To this end:

The clean energy sector, and specifically SAF, highlights both the promise and the persistent challenges of scaling biotechnologies, reflecting broader issues, such as fragmented regulation, limited commercialization support, and misaligned incentives that hinder the deployment of advanced biotechnologies. Overcoming these systemic barriers requires coordinated, long-term policies including performance-based incentives, and procurement mechanisms that reduce investment risk and free up capital. SAF should be seen not as a standalone initiative but as a model for integrating biotechnology into industrial and energy strategy, supported by a robust innovation pipeline, expanded infrastructure, and shared metrics to guide progress. With sustained federal leadership and strategic alignment, the bioeconomy can become a key pillar of a low-carbon, resilient energy future.

Planning for the Unthinkable: The targeting strategies of nuclear-armed states

This report was produced with generous support from Norwegian People’s Aid.

READ THE FULL REPORT HERE

The quantitative and qualitative enhancements to global nuclear arsenals in the past decade—particularly China’s nuclear buildup, Russia’s nuclear saber-rattling, and NATO’s response—have recently reinvigorated debates about how nuclear-armed states intend to use their nuclear weapons, and against which targets, in what some describe as a new Cold War. 

Details about who, what, where, when, why, and how countries target with their nuclear weapons are some of states’ most closely held secrets. Targeting information rarely reaches the public, and discussions almost exclusively take place behind closed doors—either in the depths of military headquarters and command posts, or in the halls of defense contractors and think tanks. The general public is, to a significant extent, excluded from those discussions. This is largely because nuclear weapons create unique expectations and requirements about secrecy and privileged access that, at times, can seem borderline undemocratic. Revealing targeting information could open up a country’s nuclear policies and intentions to intense scrutiny by its adversaries, its allies, and—crucially—its citizens. 

This presents a significant democratic challenge for nuclear-armed countries and the international community. Despite the profound implications for national and international security, the intense secrecy means that most individuals—not only including the citizens of nuclear-armed countries and others that would bear the consequences of nuclear use, but also lawmakers in nuclear-armed and nuclear umbrella states that vote on nuclear weapons programs and policies—do not have much understanding of how countries make fateful decisions about what to target during wartime, and how. When lawmakers in nuclear-armed countries approve military spending bills that enhance or increase nuclear and conventional forces, they often do so with little knowledge of how those bills could have implications for nuclear targeting plans. And individuals across the globe do not know whether they live in places that are likely to be nuclear targets, or what the consequences of a nuclear war would be.

While it is reasonable for governments to keep the most sensitive aspects of nuclear policies secret, the rights of their citizens to have access to general knowledge about these issues is equally valid so they may know about the consequences to themselves and their country, and so that they can make informed assessments and decisions about their respective government’s nuclear policies. Under ideal conditions, individuals should reasonably be able to know whether their cities or nearby military bases are nuclear targets and whether their government’s policies make it more or less likely that nuclear weapons will be used.

As an organization that seeks to empower individuals, lawmakers, and journalists with factual information about critical topics that most affect them, the Federation of American Scientists—through this report—aims to help fill some of these significant knowledge gaps. This report illuminates what we know and do not know about each country’s nuclear targeting policies and practices, and considers how they are formulated, how they have changed in recent decades, whether allies play a role in influencing them, and why some countries are more open about their policies than others. The report does not claim to be comprehensive or complete, but rather should be considered as a primer to help inform the public, policymakers, and other stakeholders. This report may be updated as more information becomes available.

Given the secrecy associated with nuclear targeting information, it is important at the outset to acknowledge the limitations of using exclusively open sources to conduct analysis on this topic. Information in and about different nuclear-armed states varies significantly. For countries like the United States—where nuclear targeting policies have been publicly described and are regularly debated inside and outside of government among subject matter experts—official sources can be used to obtain a basic understanding of how nuclear targets are nominated, vetted, and ultimately selected, as well as how targeting fits into the military strategy. However, there is very little publicly available information about the nuclear strike plans themselves or the specific methodology and assumptions that underpin them. For less transparent countries like Russia and China—where targeting strategy and plans are rarely discussed in public—media sources, third-country intelligence estimates, and nuclear force structure analysis can be used, in conjunction with official statements or statements from retired officials, to make educated assumptions about targeting policies and strategies. 

It is important to note that a country’s relative level of transparency regarding its nuclear targeting policies does not necessarily echo its level of transparency regarding other aspects of its governance structure. Ironically, some of the most secretive and authoritarian nuclear-armed states are remarkably vocal about what they would target in a nuclear war. This is typically because those same countries use nuclear rhetoric as a means to communicate deterrence signals to their respective adversaries and to demonstrate to their own population that they are standing up to foreign threats. For example, while North Korea keeps many aspects of its nuclear program secret, it has occasionally stated precisely which high-profile targets in South Korea and across the Indo-Pacific region it would strike with nuclear weapons. In contrast, some other countries might consider that frequently issuing nuclear threats or openly discussing targeting policies could potentially undermine their strategic deterrent and even lower the threshold for nuclear use.

READ THE FULL REPORT HERE

The Two-Hundred Billion Dollar Boondoggle

Nearly one year after the Pentagon certified the Sentinel intercontinental ballistic missile program to continue after it incurred critical cost and schedule overruns, the new nuclear missile could once again be in trouble.1

An April 16th article from Defense Daily broke the news that the Air Force will have to dig new holes for the Sentinel silos.2 The service had been planning to refurbish the existing 450 Minuteman silos but recently discovered, as noted in a follow-up article from Breaking Defense, that the silos will “largely not be reusable after all.”3 Brig. Gen. William Rogers, the Air Force’s director of the ICBM Systems Directorate, cited asbestos, lead paint, and other issues with the existing silos that make refurbishment difficult.4 Air Force officials also stated that an ongoing study into missileer cancer rates played a role in the decision to build new silos.5 

This news comes shortly after reports that the Air Force is planning to extend the life of the currently deployed Minuteman III ICBMs until “at least” 2050—roughly 20 years beyond their intended service lives—due to delays in the Sentinel program.6 

For those who have been tracking the Sentinel development since the Air Force first conceptualized a new ICBM in the early 2010s, the reports of Minuteman life-extension likely made them pause and recall the common refrain from Sentinel proponents over the years that life-extending Minuteman III missiles would be too expensive or even impossible. “You cannot life-extend Minuteman III,” then-commander of US Strategic Command Adm. Charles Richard told reporters in 2021.7 In 2016, the Air Force told Congress that the Minuteman III was aging out, therefore the “GBSD solution” was necessary to ensure the future viability of the ICBM force (GBSD is short for Ground-Based Strategic Deterrent, the programmatic name for the ICBM before Sentinel was chosen in 2022). Air Force officials still maintain that a life-extension program for Minuteman is not possible. In their words, Minuteman will be “sustain[ed] to keep it viable until Sentinel is delivered.”8 Regardless of how the Air Force refers to the effort, it appears that Minuteman III will be made to operate well beyond its planned service life.

For some, like our team at the Federation of American Scientists’ Nuclear Information Project, Sentinel’s newest struggles came as no surprise at all. For years, it has been clear to observers that this program has suffered from chronic unaccountability, overconfidence, poor performance, and mismanagement. Project benchmarks were cherry-picked, viable alternatives were prematurely dismissed, competition was discouraged, and goalposts were continuously moved. Ultimately, it will be U.S. taxpayers who pay the increasingly rising costs, and other—more critical—priorities will suffer as Sentinel continuously sucks money away from other programs. 

It comes as no surprise that Sentinel was specifically named in the White House’s recent memo requiring all Major Defense Acquisition Programs more than 15% over-budget or behind schedule to be “reviewed for cancellation;” Sentinel is the poster-child for inefficiency, which the administration claims to be obsessed with eliminating.9 In order to prevent this type of mismanagement for future programs, we must first understand how Sentinel went so wrong. 

How We Got Here

The Federation of American Scientists has been intensively tracking the progress of the Sentinel program for years. Throughout the acquisition process, the Air Force clung to its fundamental and counterintuitive assumption that building an entirely new ICBM from scratch would be cheaper than life-extending the current system. We now know that this assumption was wildly incorrect, but how did it reach this point? 

Cherry-picked project benchmarks

When seeking to plug a capability gap, the Pentagon is required to consider a range of procurement options before proceeding with its acquisition. This process takes place over several years and culminates in an “Analysis of Alternatives”—a comparative evaluation of the operational effectiveness, suitability, risk, and life-cycle costs of the various options under consideration. This assessment can have tremendous implications for an acquisition program, as it documents the rationale for recommending a particular course of action. 

The Air Force’s Analysis of Alternatives for the program that would eventually become Sentinel was conducted between 2013 and 2014, and concluded that the costs of pursuing a Minuteman III life-extension would be nearly the same as those projected for Sentinel.10 Crucially, this cost comparison was pegged to a predetermined requirement to continue deploying the same number of missiles until the year 2075.11 

These benchmarks, despite having no apparent inalterable national security imperative, appear to have played a significant role in shaping perceptions of the two options. While it is now clear that Minuteman III could be—and likely will be—life-extended for several more decades, the Air Force does not have enough airframes to keep at least 400 of them in service through 2075 and maintain the testing campaign needed to ensure reliability. As a result, in order to push the ICBM force beyond 2075, the Air Force would need to life-extend Minuteman III and pursue a follow-on system after that point. 

This was reportedly reflected in the Air Force’s cost analysis, which explains why the cost of the Minuteman III life-extension option was estimated by the Air Force to be roughly the same as the cost of building an entirely new ICBM.12 The service was not simply comparing the costs of a life-extension and a brand-new system; it was instead comparing the costs of pursuing Sentinel immediately on the one hand, versus a Minuteman III life-extension and development of a follow-on system on the other hand. 

Of course, policymakers require benchmarks in order to make estimates: it would not be reasonable to analyze the feasibility of a particular system without considering how long and at what level that system needs to perform. However, in the case of the Sentinel, selecting those particular benchmarks at the beginning of the process essentially pre-baked the analysis before it even began in earnest. 

Let’s say a different evaluation benchmark had been selected—2050, for example, rather than 2075. 

In January 2025, Defense Daily reported that the Air Force would likely have to keep portions of the Minuteman III fleet in service until 2050 or later.13 This may require altering certain aspects of the Minuteman III’s deployment—such as reducing the number of deployed ICBMs or annual test launches in order to preserve airframes. While no final decisions have been made, the Air Force is clearly evaluating continued reliance on Minuteman III as a potential option, despite years of high-ranking military and political officials stating that doing so was impossible.14 

Benchmarking the cost analysis at 2050 rather than 2075 would have thus yielded wildly different results. In 2012, the Air Force admitted that it cost only $7 billion to modernize its Minuteman III ICBMs into “basically new missiles except for the shell.”15 While getting those same missiles past 2050 would certainly add additional cost and complexity—particularly to replace parts whose manufacturers no longer exist—it is unfathomable that the costs would come anywhere close to those of the Sentinel program, which was estimated by the Pentagon’s Director of Cost Assessment and Program Evaluation (CAPE) in 2020 (before the critical cost overrun) to have a total lifecycle cost of $264 billion in then-year dollars.

It is particularly troubling that very few public or independent government-sponsored analyses were conducted to look into the Sentinel program’s flawed assumptions, nor the realistic possibility of a Minuteman III life-extension. Countless congressional and non-governmental attempts to push for one were stymied at every turn. In 2019, for example, dozens of lobbyists from the Sentinel contract bidders successfully helped to eliminate a proposed amendment to the National Defense Authorization Act calling for an independent study on a Minuteman III life-extension program.16 

The most comprehensive public study on this issue was a 2022 report published by the Carnegie Endowment for International Peace under contract from the Pentagon; however, the study noted that “the iterative process through which we received information, the unclassified nature of our study, and the limited time available for investigating DOD conclusions left us unable to assess the DOD’s position regarding the technical and cost feasibility of an extended Minuteman III alternative to GBSD;” the authors ultimately concluded that a more detailed technical analysis was required in order to answer these questions.17 

While the findings of such a study will never be known, it is likely that they would have supported what was clear to government watchdogs at the time and has been validated in spades since then: the assumptions baked into this program were flawed from the start, and the system’s costs would be significantly larger than initially expected. Given that the Pentagon ultimately went in the opposite direction, taxpayers are now on the hook for both a de facto Minuteman III life-extension program as well as the substantial costs associated with acquiring Sentinel—with limited further possibilities for near-term cost mitigation. 

Failure to predict the true costs and needs of the program

In addition to the cherry-picked benchmarks that tipped the scales towards a brand-new ICBM, when comparing costs the Air Force made a key error in its assumptions: it assumed that the Sentinel would be able to reuse much of the original Minuteman launch infrastructure. 

Some level of infrastructure modernization for the Sentinel was always planned, including building entirely new launch control centers and additional infrastructure for the launch facilities.18 However, the original plans called for reusing existing copper command and control cabling and the refurbishment—not reconstruction—of 450 silos. Both assumptions have proven incorrect, and perhaps more than anything else, now represent the single greatest driver of Sentinel’s skyrocketing costs. 

While both the current cabling and launch facilities work fine for the existing Minuteman III and would presumably function similarly following a life-extension, they are apparently incompatible with Sentinel’s increasingly complex design. 

The Air Force must now dig up and replace 7,500 miles of cabling with the latest fiber optic cables. Much of these cables are buried underneath private property, meaning that local landowners must lease 100-foot-wide lines on their property to the Pentagon to be dug up for multi-year periods.19 

In addition, both the Air Force and Northrop Grumman have now recognized that it will take more than simple refurbishments to make the existing Minuteman III launch facilities compatible with Sentinel. Both the service and the contractor have stated that several of the assumptions regarding the conversion process that went into the 2020 baseline review have now proved to be incorrect.20 

As a result, the Air Force is apparently now planning to build entirely new launch facilities to house the Sentinel, most of which will require digging new holes in the ground.21 As one Northrop Grumman official explained, “When you multiply that by 450, if every silo is a little bit bigger or has an extra component, that actually drives a lot of cost because of the sheer number of them that are being updated.”22 It is unclear whether the costs will increase beyond the new estimate released with the Nunn-McCurdy decision, but the program is clearly trending in the wrong direction.

The Air Force had been publicly teasing the prospect of digging new holes for nearly a year. At the Triad Symposium in Washington, D.C., in September 2024, Maj. Gen. Colin Connor, director of ICBM Modernization at Barksdale Air Force Base, responded to an audience question about the new silos rumor by saying, “we’re looking at all of our options.” Despite the noncommittal answer, the decision to dig new silos seems to have already been made by the time of Connor’s statement. 

Firstly, it has since been revealed that the estimated costs of the new silos were included in the Nunn-McCurdy review process which concluded in July 2024. Additionally, although the decision was not made public until the April 16 Defense News article, Northrop Grumman may have inadvertently revealed the news much earlier. Included in the gallery of images of the Sentinel program on Northrop’s website is a digital mockup of a Sentinel launch facility. The first version of the image (see Figure A below) illustrates the Air Force’s original plan to refurbish the Minuteman III silos for Sentinel, with a key indicating the silo and silo lid as “Reclaimed MMIII Facilities.” A newer version of the image (see Figure B below) was uploaded to the gallery as early as February 2024 and shows the entire launch facility—including the silo and silo lid—as “New Sentinel Facilities.”

Figure A

Original rendering of Sentinel launch facility. (Source: Northrop Grumman)

Figure B

New rendering of Sentinel launch facility. (Source: Northrop Grumman)

Unwarranted overconfidence 

Despite the clear concerns outlined above, the Pentagon was remarkably confident in its and Northrop Grumman’s abilities to deliver the Sentinel on-time and on-budget. 

In September 2020, the Pentagon delivered its Milestone B summary report to Congress—a key decision point at which acquisition programs are authorized to enter the Engineering and Manufacturing Development phase, considered to be the official start of a program. The Milestone B report included an estimate of $95.8 billion in then-year dollars to acquire the Sentinel—a significant increase from previous estimates, but not yet the dire situation that we find ourselves in today (Figure C). 

Figure C

The above table from the Congressional Budget Office shows the cost growth for the Sentinel’s acquisition program between the Sentinel’s Milestone B assessment in 2020 and the post-Nunn-McCurdy review process in 2025. All costs are reflected in FY2020 dollars to allow for an accurate comparison between years.

We now know, however, based on recent statements from Pentagon and Air Force officials, that there were “some gaps in maturity” in the Milestone B report.23 Specifically, “in September of 2020, the knowledge of the ground-based segment of this program was insufficient in hindsight to have a high-quality cost estimate.” What this means is that at the most consequential stage of the program to-date, it was approved without a comprehensive understanding of the likely cost growth. 

Furthermore, the Air Force was heavily delayed in creating an integrated master schedule for the Sentinel program. An integrated master schedule includes the planned work, the resources necessary to accomplish that work, and the associated budget; from the government’s perspective, it is considered to be the keystone for program management.24 Although the Under Secretary of Defense for Acquisition and Sustainment testified to Congress that “By the time you’re six months after Milestone B, you should have an integrated master schedule,” the Air Force had not met this mark.25 If the Air Force did manage to create such a schedule, it became obsolete with the Nunn-McCurdy Act’s requirement to restructure the program and rescind its Milestone B approval.

During that same hearing, the Air Force’s Deputy Chief of Staff for Strategic Deterrence and Nuclear Integration also admitted that at that time, the service had been experiencing poor communication with Northrop Grumman, the primary contractor for the ICBM. 

Performance issues also appear to have had an impact on the program. In June 2024, the Air Force removed the colonel in charge of its Sentinel program—reportedly for a “failure to follow operational procedures”—and replaced him with a two-star general, with the rank change indicating a need for greater high-level attention.26 

Throughout this time, the Air Force remained overconfident in its abilities to deliver the program; in December 2020, the Assistant Secretary of the Air Force for Acquisition, Technology, and Logistics told reporters that the Air Force had “godlike insight into all things GBSD.”27 And in September 2022, the Air Force Major General responsible for Sentinel’s strategic planning and requirements said in a Breaking Defense interview that the program was “on cost, on schedule, and the acquisition program baseline is being met.”28 

Given everything we now know about the state of the Sentinel program, these statements were either clear obfuscations or just pure fantasy. 

Non-competitive disadvantages

When addressing concerns about the rising projected costs of the Sentinel program, Air Force leaders were confident that a competitive and healthy industrial base would be able to keep the overall price tag down. As Gen. Timothy Ray, then-Commander of Air Force Global Strike Command, told reporters in 2019, “our estimates are in the billions of savings over the lifespan of the weapon.”29 

These expected savings clearly never materialized, however, nor did the Pentagon help facilitate the conditions for them to be realized. In March 2018, the Air Force Nuclear Weapons Center submitted a document justifying its intention to restrict competition for the Sentinel contract to just two suppliers—Boeing and Northrop Grumman—stating that this limitation would still constrain costs because the two companies would be in competition with one another.30 

However, this specter of competition evaporated when Boeing withdrew from the competition following Northrop Grumman’s acquisition of Orbital ATK—one of two independent producers of large solid rocket motors left in the US market.31 As these motors are necessary to make ICBMs fly, the merger put Northrop Grumman in the driver’s seat: it could restrict access to those motors from Boeing, thus tanking its competitor’s chances at the Sentinel bid. 

Doing so would not have been allowed by the terms of the Federal Trade Commission, which permitted the merger in 2018 but subsequently investigated it in 2022 under the Biden administration, and also subsequently blocked a similar attempted merger between Lockheed Martin and Aerojet Rocketdyne that same year.32 However, the Pentagon, which had initially included non-exclusionary and pro-competition language in its requirements for an earlier phase of the Sentinel contract, removed that language from future phases.33 By refusing to wield its own power to preserve competition—initially a key driver for promoting Sentinel over a Minuteman III life-extension—the Air Force essentially left the state of the competition in Northrop Grumman’s hands. According to Boeing’s CEO, Northrop Grumman subsequently slow-walked the process of hammering out a competition arrangement with Boeing—apparently not leaving enough time for Boeing to negotiate a competitive price for solid rocket motors before the Sentinel deadline.34 

As a result, Boeing pulled out of the competition altogether, and the Air Force awarded the Sentinel engineering and manufacturing development contract to Northrop Grumman through an unprecedented single-source bidding process. As the Under Secretary of Defense for Acquisition and Sustainment admitted during 2024 testimony to Congress, what this amounted to was that “effectively there was not, at the end of the day, competition in this program.”35 

Reflecting on the Sentinel procurement process, House Armed Services Committee chairman Adam Smith—who has a sizable Boeing presence in his home state of Washington—suggested in October 2019 that the Air Force is “way too close to the contractors they are working with,” and implied that the service was biased towards Northrop Grumman.36 

Predictably, the evaporation of competition has coincided with skyrocketing Sentinel acquisition costs. In July 2024, the Air Force’s acquisition chief Andrew Hunter reportedly told reporters that the Air Force was considering reopening parts of the Sentinel contract to bids. “I think there are elements of the ground infrastructure where there may be opportunities for competition that we can add to the acquisition strategy for Sentinel,” Hunter said.37

The Nunn-McCurdy Saga

In January 2024, the Air Force notified Congress that the Sentinel program had incurred a critical breach of the Nunn-McCurdy Act, legislation designed to keep expensive programs in check.38 One week after notifying Congress of the breach, the Air Force fired the head of the Sentinel program, but said the move was “not directly related” to the Nunn-McCurdy breach.39

At the time of the notification, the Air Force stated that the program was 37% over budget and two years behind schedule. Six months later, after conducting the cost reassessment mandated by Nunn-McCurdy, the Pentagon announced that the Sentinel program would cost 81% more than projected and be delayed by several years.40 Nevertheless, the Secretary of Defense certified the program to continue. 

Per the requirements of the Nunn-McCurdy Act, the Under Secretary of Defense for Acquisition and Sustainment, who serves as the Milestone Decision Authority for the program, rescinded Sentinel’s Milestone B approval, which is needed for a program to enter the engineering and manufacturing development phase.41 The Air Force must restructure the program to address the root cause of the cost growth before receiving a new milestone approval, a process the service has said will take approximately 18 to 24 months.42 

Where Sentinel Stands Now

Work on the Sentinel program has continued while the Air Force carries out the restructuring effort, but the government can’t seem to decide whether things are going well or not.  

On February 10, the Air Force told Defense One that parts of the Sentinel program had been “suspended.”43 Due to “evolving” requirements related to Sentinel launch facilities, the Air Force instructed Northrop Grumman to halt “design, testing, and construction work related to the Command & Launch Segment.” There has been no indication of when the stop work order will be lifted. Nevertheless, during an April 10 Air Force town hall on Sentinel in Kimball, Nebraska, Wing Commander of F.E. Warren AFB Col. Johnny Galbert told attendees that Sentinel “is not on hold; it is moving forward.”44

Just under one month after the stop work order was made, the Air Force announced that the Sentinel program had achieved a “modernization milestone” with the successful static fire test of Sentinel’s stage-one solid rocket motor.45 The test marked the successful test firing of each stage of Sentinel’s rocket motor after the second and third stages were tested in 2024. 

On March 27, the same day Bloomberg reported that the Air Force was considering a life-extension program for Minuteman III missiles, President Trump’s nominee for Secretary of the Air Force (confirmed by the Senate on May 13), Troy Meinke, committed in his testimony to pushing Sentinel over the finish line, calling the program “foundational to strategic deterrence and defense of the homeland.”46 During the same hearing, Trump’s nominee for undersecretary of Defense for acquisition and sustainment, Michael P. Duffey, also shared his support for the Sentinel program, saying “nuclear modernization is the backbone of our strategic deterrent,” and endorsing Sentinel as “critical.” Yet, two weeks later, on April 9, President Trump signed an executive order to address defense acquisition programs that mandates, “any program more than 15% behind schedule or 15% over cost will be scrutinized for cancellation.”47 This places Sentinel well beyond the threshold for potential cancellation, and the White House fact sheet detailing the order explicitly called out Sentinel’s cost and schedule overruns.

The next day, the Air Force announced that another “key milestone” for the Sentinel program had been met with the stand-up of Detachment 11 at Malmstrom AFB, which will oversee implementation of the Sentinel program at the base.48 But of course, less than thirty days later, Sentinel took a major blow with the Air Force’s admittance that hundreds of new silos would have to be dug up and constructed for the new ICBM. 

The Government Accountability Office’s (GAO) latest Weapon Systems Annual Assessment from June 11 reports that Sentinel’s costs “could swell further” as the Air Force “continues to evaluate its options and develop a new schedule as part of restructuring efforts.” The assessment also notes that the Sentinel program alone accounted for over $36 billion of the $49.3 billion increase from 2024 to 2025 in GAO’s combined total estimate of major defense acquisition program costs, and noted that the first flight test now would not take place until March 2028.49 In a sweeping criticism of the program, the GAO report notes that the continued immaturity of the program’s critical technologies more than 4 years into its development phase “calls into question the level of work required to mature these technologies and the validity of the cost estimate used to certify the program.”50

450 Money Pits

We probably will never know how much money could have been saved if the Air Force had elected from the beginning to life-extend the existing ICBMs rather than build an entirely new system from scratch. The opportunity to have a proactive, independent cost comparison and corresponding public debate was eliminated through intense rounds of Pentagon and industry lobbying. But we certainly now know that the Air Force’s assertion—that the Sentinel would be cheaper and easier than a life-extension—was wrong, and that the suppression of an independent review contributed to these rising costs. 

The Sentinel saga, with its seemingly unending series of setbacks and continued uncertainties, begs a crucial question: what incentives exist for the Air Force to get it right? That the program, along with numerous other nuclear modernization programs, was green-lighted to continue despite ever-increasing cost and schedule delays exposes a major flaw in U.S. nuclear weapons acquisition programs – they are too big to fail. The government, evidently, will always write a bigger check, will always move the goalposts, because the alternative is either failing to maintain the U.S. strategic deterrent or admitting that U.S. nuclear strategy and force structure is not as immutable and unquestionable as the public has been made to believe. In such a system of blank checks and industry lobbying, what incentivizes the Pentagon to ensure programs are as cost efficient as possible? The only mechanism for oversight and accountability is Congress. Congress must increase oversight of nuclear modernization programs like Sentinel to ensure a limit is placed on how much taxpayer money can be spent on failing programs in the name of national security.

De-Risking the Clean Energy Transition: Opportunities and Principles for Subnational Actors

Executive Summary

The clean energy transition is not just about technology — it is about trust, timing, and transaction models. As federal uncertainty grows and climate goals face political headwinds, a new coalition of subnational actors is rising to stabilize markets, accelerate permitting, and finance a more inclusive green economy. This white paper, developed by the Federation of American Scientists (FAS) in collaboration with Climate Group and the Center for Public Enterprise (CPE), outlines a bold vision: one in which state and local governments – working hand-in-hand with mission-aligned investors and other stakeholders – lead a new wave of public-private clean energy deployment.

Drawing on insights from the closed-door session “De-Risking the Clean Energy Transition” and subsequent permitting discussions at the 2025 U.S. Leaders Forum, this paper offers strategic principles and practical pathways to scale subnational climate finance, break down permitting barriers, and protect high-potential projects from political volatility. This paper presents both a roadmap and an invitation for continued collaboration. FAS and its partners will facilitate further development and implementation of approaches and ideas described herein, with the goals of (1) directing bridge funding towards valuable and investable, yet at-risk, clean energy projects, and (2) building and demonstrating the capacity of subnational actors to drive continued growth of an equitable clean economy in the United States.

We invite government agencies, green banks and other financial institutions, philanthropic entities, project developers, and others to formally express interest in learning more and joining this work. To do so, contact Zoe Brouns (zbrouns@fas.org).

The Moment: Opportunity Meets Urgency

We are in the complex middle of a global energy transition. Clean energy and technology are growing around the world, and geopolitical competition to consolidate advantage in these sectors is intensifying. The United States has the potential to lead, but that leadership is being tested by erratic federal environmental policies and economic signals. Meanwhile, efforts to chart a lasting domestic clean energy path that resonates with the full American public have fallen short. Demand is rising — fueled by AI, electrification, and industrial onshoring – yet opposition to clean energy buildout is growing, permitting systems are gridlocked, and legacy regulatory frameworks are failing to keep up. This moment calls for new leadership rooted in local and regional capacity and needs. Subnational governments, green and infrastructure banks, and other funders have a critical opportunity to stabilize clean energy investment and sustain progress amid federal uncertainty. Thanks to underlying market trends favoring clean energy and clean technology, and to concerted efforts over the past several years to spur U.S. growth in these sectors, there is now a pipeline of clean projects across the country that are shovel-ready, relatively de-risked and developed, and investable (Box 1). Subnational actors can work together to identify these projects, and to mobilize capital and policy to sustain them in the near term.

Box 1. Streamlining administrative procedure to unleash clean energy in New York.

The New York Power Authority used a simple, quick Request for Information (RFI) to identify readily investible clean energy projects in New York, and was then able to financially back many of the identified projects thanks to its strong bond rating and ability to access capital. As Paul Williams, CEO of the Center for Public Enterprise, noted, this powerful approach allowed the Authority to “essentially [pull] a 3.5-gigawatt pipeline out of thin air in less than a year.”

States, cities, and financial institutions are already beginning to provide the support and sustained leadership that federal agencies can no longer guarantee. They’re developing bond-backed financing, joint procurement schemes, rapid permitting pilot zones, and revolving loan funds — not just to fill gaps, but to reimagine what clean energy governance looks like in an era of fragmentation. One compelling example is the Connecticut Green Bank, which has successfully blended public and private capital to deploy over $2 billion in clean energy investments since its founding. Through programs like its Commercial Property Assessed Clean Energy (C-PACE) financing and Solar for All initiative, the bank has reduced emissions, created jobs, and delivered energy savings to underserved communities.

Indeed, this kind of mission-oriented strategy – one that harnesses finance and policy towards societally beneficial outcomes, and that entrepreneurially blends public and private capacities – is in the best American tradition. Key infrastructure and permitting decisions are made at the state and local levels, after all. And state and local governments have always been central to creating and shaping markets and underwriting innovation that ultimately powers new economic engines. The upshot is clear and striking: subnational climate finance isn’t just a workaround. It may be the most politically durable and economically inclusive way to future-proof the clean energy transition.

The Role of Subnational Finance in the Clean Energy Transition

Recent years saw heavy reliance on technocratic federal rules to spur a clean energy transition. But a new political climate has forced a reevaluation of where and how federal regulation works best. While some level of regulation is important for creating certainty, demand, and market and investment structures, it is undeniable that the efficacy and durability of traditional environmental regulatory approaches has waned. There is an acute need to articulate and test new strategies for actually delivering clean energy progress (and a renewed economic paradigm for the country) in an ever-more complex society and dynamic energy landscape.

Affirmatively wedding finance with larger public goals will be a key component of this more expansive, holistic approach. Finance is a powerful tool for policymakers and others working in the public interest to shape the forward course of the green economy in a fair and effective way. In the near term, opportunities for subnational investments are ripe because the now partially paused boom in potential firms and projects generated by recent U.S. industrial policy has generated a rich set of already underwritten, due-diligenced projects for re-investment. In the longer term, the success of redesigned regulatory schema will almost certainly depend on creating profitable firms that can carry forward the energy transition. Public entities can assume an entrepreneurial role in ensuring these new economic entities, to the degree they benefit from public support, advance the public interest. Indeed, financial strategies that connect economic growth to shared prosperity will be important guardrails for an “abundance” approach to environmental policy – an approach that holds significant promise to accelerate necessary societal shifts, but also presents risk that those shifts further enrich and empower concentrated economic interests.

To be sure, subnational actors generally cannot fund at the scale of the federal government. However, they can mobilize existing revenue and debt resources, including via state green and infrastructure banks, bonding tools, and direct investment financing strategies, to seed capital for key projects and to provide a basis for larger capital stacks for key endeavors. They are also particularly well suited to provide “pre-development” support to help projects move through start-up phases and reach construction and development. Subnational entities can engage sectorally and in coalition to scale up financing, to draw in private actors, and to support projects along the whole supply and value chain (including, for instance, multi-state transmission and grid projects, multi-state freight and transportation network improvements, and multi-state industrial hubs for key technologies).

A wide range of financing strategies for clean energy projects already exist. For instance:

Strategies like these empower states and other subnational actors to de-risk and drive the clean energy transition. The expanding green banking industry in the United States, and similar institutions globally, further augment subnational capacity. What is needed is rapid scaling and ready capitalization.

There is presently tremendous need and opportunity to deploy flexible financing strategies across projects that are shovel-ready or in progress but may need bridge funding or other investments in the wake of federal cuts. The critical path involves quickly identifying valuable, vetted projects in need of support, followed by targeted provision of financing that leverages the superior capital access of public institutions.

Projects could be identified through simple, quick Requests for Information (RFIs) like the one recently used to great effect by the New York Power Authority to build a multi-gigawatt clean energy pipeline (see Box 1, above). This model, which requires no new legislation, could be adopted by other public entities with bonding authority. Projects could also be identified through existing databases, e.g., of projects funded by, or proposed for funding under, the Inflation Reduction Act (IRA) or Infrastructure Investment and Jobs Act (IIJA). 

There is even the possibility of establishing a matchmaking platform that connects projects in need of financing with entities prepared to supply it. Projects could be grouped sectorally (e.g., freight or power sector projects) or by potential to address cross-cutting issues (e.g., cutting pollution burdens or managing increasing power grid load and its potential to electrify new economic areas). As economic mobilization around clean energy gains steam and familiarity with flexible financing strategies grows, such strategies can be extended to new projects in ways that are tailored to community interests, capacity, and needs.

Principles for Effective, Equitable Investment

The path outlined above is open now but will substantially narrow in the coming months without concerted, coordinated action. The following principles can help subnational actors capitalize on the moment effectively and equitably. It is worth emphasizing that equitable investment is not only a moral imperative – it is a strategic necessity for maintaining political legitimacy, ensuring community buy-in, and delivering long-term economic resilience across regions.

Funders must clearly state goals and be proactive in pursuing them – starting now to address near-term instability. Rather than waiting for projects to come to them, subnational governments, financial institutions, and other funders should use their platforms and convening power to lay out a “mission” for their investments – with goals like electrifying the industrial sector, modernizing freight terminals and ports, and accelerating transmission infrastructure with storage for renewables. Funders should then use tools like simple RFIs to actively seek out potential participants in that mission.

Public equity is a key part of the capital stack, and targeted investments are needed now. With significant federal climate investments under litigation and Congressional debates on the Inflation Reduction Act ongoing, other participants in the domestic funding ecosystem must step up. Though not all federal capital can (or should) be replaced, targeted near-term investments coupled with multi-year policy and funding roadmaps by these actors can help stabilize projects that might not otherwise proceed and provide reassurance on the long-term direction of travel.

Information is a surprisingly powerful tool. Deep, shared, information architectures and clarity on policy goals are key for institutional investors and patient capital. Shared information on costs, barriers, and rates of return would substantially help facilitate the clean energy transition – and could be gathered and released by current investors in compiled form. Sharing transparent goals, needs, and financial targets will be especially critical in the coming months. Simple RFIs targeted at businesses and developers can also function as dual-purpose information-gathering and outreach tools for these investors. By asking basic questions through these RFIs (which need not be more than a page!), investors can build the knowledge base for shaping their clean technology and energy plans while simultaneously drawing more potential participants into their investment networks.

States should invest to grow long-term businesses. The clean energy transition can only be self-sustaining if it is profitable and generates firms that can stand on their own. Designing state incentive and investment projects for long-term business growth, and aligning complementary policy, is critical – including by designing incentive programs to partner well with other financing tools, and to produce long-term affordability and deployment gains, especially for entities which may otherwise lack capital access. State strategies, like the one New Mexico recently published, that outline energy-transition and economic plans and timelines are crucial to build certainty and align action across the investment and development ecosystem. Metrics for green programs should assess prospects for long-term business sustainability as well as tons of emissions reduced.

States can finance the clean energy transition while securing long-term returns and other benefits. Many clean technology projects may have higher upfront costs balanced by long-term savings. Debt equity, provided through revolving loan funds, can play a large role in accelerating deployment of these technologies by buying down entry costs and paying back the public investor over time. Moreover, the superior bond ratings of state institutions substantially reduce borrowing costs; sharing these benefits is an important role for public finance. State financial institutions can explore taking equity stakes in some projects they fund that provide substantial public benefits (e.g., mega-charging stations, large-scale battery storage, etc.) and securing a rate of return over time in exchange for buying down upfront risk. Diversified subnational institutions can use cash flows from higher-return portions of their portfolios to de-risk lower-return or higher-risk projects that are ultimately in the public interest. Finally, states with operating carbon market programs can consider expanding their funding abilities by bonding against some portion of carbon market revenues, converting immediate returns to long-term collateral for the green economy.

Financing policy can be usefully combined with procurement policy. As electrification reaches individual communities and smaller businesses, many face capital-access problems. Subnational actors should consider packaging similar businesses together to provide financing for multiple projects at once, and can also consider complementary public procurement policies to pull forward market demand for projects and products (Box 2).

Explore contract mechanisms to protect public benefits. Distributive equity is as important as large-scale investment to ensure a durable economic transition. The Biden-Harris Administration substantially conditioned some investments on the existence of binding community benefit plans to ensure that project benefits were broadly shared and possible harms to communities mitigated. Subnational investors could develop parallel contractual agreements. There may also be potential to use contracts to enable revenue sharing between private and public institutions, partially addressing any impacts of changes to the IRA’s current elective pay and transferability provisions by shifting realized income to the public entities that currently use those programs from the private entities that realize revenue from projects.

Box 2. Combining financing and procurement policy to electrify bus systems.

Joint procurements, whereby two or more purchasers enter into a single contract with a vendor, can bring down prices of emerging clean technologies by increasing purchase volume, and can streamline technology acquisition by sharing contracting workload across partners. Joint procurement and other innovative procurement policies have been used successfully to drive deployment of zero-emission buses in Europe and, more recently, the United States. Procurement strategies can be coupled with public financing. For instance, the Federal Transit Agency’s Low or No Emission Grant Program for clean buses preferences applications that utilize joint procurement, thereby helping public grant dollars go further.

The rising importance of the electrical grid across sectors creates new financial product opportunities. As the economy decarbonizes, more previously independent sectors are being linked to the electric grid, with load increasing (AI developments exacerbate this trend). That means that project developers in the green economy can offer a broader set of services, such as providing battery storage for renewables at vehicle charging points, distributed generation of power to supply new demand, and potential access to utility rate-making. Financial institutions should closely track rate-making and grid policy and explore avenues to accelerate beneficial electrification. There is a surprising but potent opportunity to market and finance clean energy and grid upgrades as a national security imperative, in response to the growing threat of foreign cyberattacks that are exploiting “seams” in fragile legacy energy systems.

Global markets can provide ballast against domestic volatility. The United States has an innovative financial services sector. Even though federal institutions may retreat from clean energy finance globally over the next few years, there remains a substantial opportunity for U.S. companies to provide financing and investment to projects globally, generate trade credit, and to bring some of those revenues back into the U.S. economy.

Financial products and strategies for adaptation and resilience must not be overlooked. Growing climate-linked disasters, and associated adaptation costs, impose substantial revenue burdens on state and local governments as well as on insurers and businesses. Competition for funds between adaptation and mitigation (not to mention other government services) may increase with proposed federal cuts. Financial institutions that design products that reduce risk and strengthen resilience (e.g., by helping relocate or strengthen vulnerable buildings and infrastructure) can help reduce these revenue competitions and provide long-term benefits by tapping into the $1.4 trillion market for adaptation and resilience solutions. Improved cost-benefit estimates and valuation frameworks for these interacting systems are critical priorities.

Conclusion: A Defining Window for Subnational Leadership

Leaders from across the country agree: clean energy and clean technology are investable, profitable, and vital to community prosperity. And there is a compelling lane for innovative subnational finance as not just a stopgap or replacement for federal action, but as a central area of policy in its own right.

The federal regulatory state is, increasingly, just a component of a larger economic transition that subnational actors can help drive, and shape for public benefit. Designing financial strategies for the United States to deftly navigate that transition can buffer against regulatory uncertainty and create a conducive environment for improved regulatory designs going forward. Immediate responses to stabilize climate finance, moreover, can build a foundation for a more engaged, and innovative, coalition of subnational financial actors working jointly for the public good.

Active state and private planning is the key to moving down these paths, with governments setting a clear direction of travel and marshaling their convening powers, capital access, and complementary policy tools to rapidly stabilize key projects and de-risk future capital choices.

There is much to do and no time to lose as governments and investors across the country seek to maintain clean technology progress. The Federation of American Scientists (FAS) and its partners will facilitate further development and implementation of approaches and ideas described above, with the goals of (1) directing bridge funding towards valuable and investable, yet at-risk, clean energy projects, and (2) building and demonstrating the capacity of subnational actors to drive continued growth of an equitable clean economy in the United States.

We invite government agencies, green banks and other financial institutions, philanthropic entities, project developers, and others to formally express interest in learning more and joining this work. To do so, contact Zoe Brouns (zbrouns@fas.org).

Acknowledgements 

Thank you to the many partners who contributed to this report, including: Dr. Jedidah Isler and Zoë Brouns at the Federation of American Scientists, Sydney Snow at Climate Group, Yakov Feigin, Chirag Lala, and Advait Arun at the Center for Public Enterprise, and Jayni Hein at Covington and Burling LLP.

Reawakening a Nuclear Legacy: The Potential Return of the US Nuclear Mission to RAF Lakenheath

In the spring of 2022, researchers at the Federation of American Scientists began reading newly released U.S. Defense Department budget documents to look for updates concerning the Pentagon’s priorities for the next fiscal year. As the researchers poured over hundreds of pages, two words suddenly captured their attention: the Biden administration’s Fiscal Year (FY) 2023 budget request had added “the UK” to a list of countries receiving upgrades to their “special weapons” storage sites under a 13-year NATO investment program. The term “special weapons” is often used by the U.S. government when referring to nuclear weapons. However, the United States has not deployed nuclear weapons in the United Kingdom for nearly two decades. Those two words sparked dozens of questions, years of continued research, and a new local movement of protests against the return of a potential nuclear mission to RAF Lakenheath.

This new report provides an account of the nuclear history of RAF Lakenheath and the role it played in the US nuclear mission until nuclear weapons were withdrawn in 2008. The report then explains the mounting evidence from three years of collection of documentation and observations that show the United States Air Force is re-establishing its nuclear mission on UK soil for the first time in nearly two decades.

As of February 2025, there are no known public indications that nuclear weapons have been deployed to RAF Lakenheath – we assess that the return of the nuclear mission is intended primarily as a backup rather than to deploy weapons now. However, if this were to happen, it would break with decades of policy and planning and reverse the southern focus of the European nuclear deployment that emerged after the end of the Cold War. Even without weapons present, the addition of a large nuclear air base in northern Europe is a significant new development that would have been inconceivable just a decade-and-a-half ago.

Read the full report here

The authors would like to thank Matt Korda and Kate Kohn for their invaluable contributions to this report, as well as the Joseph Rowntree Charitable Trust for their support.

Solutions for an Efficient and Effective Federal Permitting Workforce

The United States faces urgent challenges related to aging infrastructure, vulnerable energy systems, and economic competitiveness. Improving American competitiveness, security, and prosperity depends on private and public stakeholders’ ability to responsibly site, build, and deploy critical energy and infrastructure. Unfortunately, these projects face one common bottleneck: permitting. 

Permits and authorizations are required for the use of land and other resources under a series of laws, such as the National Environmental Policy Act (NEPA), the Endangered Species Act (ESA), and National Historic Preservation Act of 1966. However, recent court rulings and the Trump Administration’s executive actions have brought uncertainty and promise major disruption to the status quo. The Executive Order (EO) on Unleashing American Energy mandates guidance to agencies on permitting processes be expedited and simplified within 30 days, requires agencies prioritize efficiency and certainty over any other objectives, and revokes the Council of Environmental Quality’s (CEQ) authority to issue binding NEPA regulations. While these changes aim to advance the speed, efficiency, and certainty of permitting, the impact will ultimately depend on implementation by the permitting workforce.

Unfortunately, the permitting workforce is unprepared to swiftly implement changes following shifts in environmental policy and regulations. Teams responsible for permitting have historically been understaffed, overworked, and unable to complete their project backlogs, while demands for permits have increased significantly in recent years. Building workforce capacity is critical for efficient and effective federal permitting. 

Project Overview

Our team at the Federation of American Scientists (FAS) has spent 18 months studying and working to build government capacity for permitting talent. The Inflation Reduction Act (IRA) provided resources to expand the federal permitting workforce, and we partnered with the Permitting Council, which serves as a central body to improve the transparency, predictability, and accountability of the federal environmental review and authorization process, to gain a cross-agency understanding of the hiring challenges experienced in permitting agencies and prioritize key challenges to address. Through two co-hosted webinars for hiring managers, HR specialists, HR leaders, and program leaders within permitting agencies, we shared tactical solutions to improve the hiring process.

We complemented this understanding with voices from agencies (i.e., hiring managers, HR specialists, HR teams, and leaders) by conducting interviews to identify new issues, best practices, and successful strategies for building talent capacity. With this understanding, we developed long-term solutions to build a sustainable, federal permitting workforce for the future. While many of our recommendations are focused on permitting talent specifically, our work naturally uncovered challenges within the broader federal talent ecosystem. As such, we’ve included recommendations to advance federal talent systems and improve federal hiring.

Problem

Building permitting talent capacity across the federal government is not an easy endeavor. There are many stakeholders involved across different agencies with varying levels of influence who need to play a role: the Permitting Council staff, the Permitting Council members-represented by Deputy Secretaries (Deputy Secretaries) of permitting agencies, the Chief Environmental Review and Permitting Officers (CERPOs) in each agency, the Office of Personnel and Management (OPM), the Chief Human Capital Officer (CHCO) in each permitting agency, agency HR teams, agency permitting teams, hiring managers, and HR specialists. Permitting teams and roles are widely dispersed across agencies, regions, states, and programs. The role each agency plays in permitting varies based on their mission and responsibilities, and there are many silos within the broader ecosystem. Few have a holistic view of permitting activities and the permitting workforce across the federal government.

With this complex network of actors, one challenge that arises is a lack of standardization and consistency in both roles and teams across agencies. If agencies are looking to fill specialized roles unique to one permitting need, it means that there will be less opportunity for collaboration and for building efficiencies across the ecosystem. The federal hiring process is challenging, and there are many known bottlenecks that cause delays. If agencies don’t leverage opportunities to work together, these bottlenecks will multiply, impacting staff who need to hire and especially permitting and/or HR teams who are understaffed, which is not uncommon. Additionally, building applicant pools to have access to highly qualified candidates is time consuming and not scalable without more consistency.

Tracking workforce metrics and hiring progress is critical to informing these talent decisions. Yet, the tools available today are insufficient for understanding and identifying gaps in the federal permitting workforce. The uncertainty of long-term, sustainable funding for permitting talent only adds more complexity into these talent decisions. While there are many challenges, we have identified solutions that stakeholders within this ecosystem can take to build the permitting workforce for the future.

There are six key recommendations for addressing permitting workforce capacity outlined in the table below. Each is described in detail with corresponding actions in the Solutions section that follows. Our recommendations are for the Permitting Council staff, Deputy Secretaries, CERPOs, OPM, CHCOs, OMB, and Congress.

High-level Recommendations

Enhance the Permitting Council’s Authority to Improve Processes and Workforce CollaborationCongress needs to give the Permitting Council staff greater authority to standardize permitting practices, direct better permitting outcomes, and serve as a central authority for mandating permitting performance.
Build Efficient Permitting Teams and Standardize RolesThe Permitting Council staff, Deputy Secretaries, CERPOs, OMB, and the CHCO Council should improve the performance and consistency of permitting processes by establishing standards in permitting team roles and configurations to support cross-agency collaboration and drive continuous improvements.
Improve Workforce Strategy, Planning, and Decisions through Quality Workforce MetricsOPM, OMB, the CHCO Council, and Permitting Council staff need to accurately gather and report on hiring metrics for talent surges and workforce metrics by domain.
Invest in Professional Development and Early Career PathwaysThe Permitting Council staff, Deputy Secretaries, and CERPOs should create more development opportunities and early career pathways for civil servants.
Improve and Invest in Pooled Hiring for Common PositionsOPM, CHCOs, OMB, Permitting Council staff, Deputy Secretaries, and CERPOs should improve and make joint announcements, shared position descriptions, assessments, and certificates of eligibles for common positions a standard practice.
Improve Human Resources Support for Hiring ManagersThe CHCO Council, OPM, CERPOs, and the Permitting Council staff need to test new HR resourcing models to implement hiring best practices and offer additional support to hiring managers.

Solutions

The six solutions described below include an explanation of the problem and key actions our signal stakeholders (Permitting Council staff, Deputy Secretaries, CERPOs, OPM, CHCOs, OMB, and Congress) can take to build permitting workforce capacity. The table in the appendix specifies the stakeholders responsible for each recommendation.

Enhance the Permitting Council’s Authority to Improve Permitting Processes and Workforce Collaboration 

Permitting process, performance, and talent management cut across agencies and their bureaus—but their work is often disaggregated by agency and sub-agency, leading to inefficient and unnecessarily discrete practices. While the Permitting Council plays a critical coordinating role, it lacks the authority and accountability to direct and guide better permitting outcomes and staffing. There is no central authority for influencing and mandating permitting performance. Agency-level CERPOs vary widely in their authority, whereas the Permitting Council is uniquely positioned for this role. Choosing to overlook this entity will lead to another interagency workaround. Congress needs to give the Permitting Council staff greater authority to improve permitting processes and workforce collaboration. 

  1. Enhance Permitting Council Authority for Improved Performance: Enhance provisions in FAST-41 and IRA by passing legislation that empowers the Permitting Council staff to create and enforce consistent performance criteria for permitting outcomes, permitting process metrics, permitting talent acquisition, talent management, and permitting teams KPIs.
  2. Enhance Permitting Council Authority for Interagency Coordination: Empower the Permitting Council staff to manage interagency coordination and collaboration for defining permitting best practices, establishing frameworks for permitting, and reinforcing those frameworks across agencies. Clarify the roles and responsibilities between Permitting Council staff, Deputy Secretaries, CERPOs, and the Council on Environmental Quality (CEQ).
  3. Assign Responsibility for Tracking Changes and Providing Guidance for Permitting Practices: Assign the Permitting Council staff in coordination with OMB responsibility for tracking changes and providing guidance on permitting practices in response to recent and ongoing court rulings that change how permitting outcomes are determined (e.g., Loper Bright/Chevron Deference, CEQ policies, etc.).
  4. Provide Permitting Council staff with Consistent Funding: Either renew components of IRA and/or IIJA funding that enables the Council to invest in agency technologies, hiring, and workforce development, or provide consistent appropriations for this.
  5. Enhance CERPO Authority and Position CERPOs for Agency-Wide and Cross-Agency Permitting Actions: Expand CERPO authority beyond the FAST-41 Act to include all permitting work within their agency. Through legislation, policy, and agency-level reporting relationships (e.g., CERPO roles assigned to the Secretary’s office), provide CERPOs with clear authority and accountability for permitting performance. 

Build Efficient Permitting Teams and Standardize Roles

In our research, we interviewed one program manager who restructured their team to drive efficiency and support continuous improvement. However, this is not common. Rather, there is a lack of standardization in roles engaged in permitting teams within and across agencies, which hinders collaboration and prevents efficiencies. This is likely driven by the different roles played by agencies in permitting processes. These variances are in opposition to shared certifications and standardized job descriptions, complicate workforce planning, hinder staff training and development, and impact report consistency. The Permitting Council staff, Deputy Secretaries, CERPOs, OMB, and the CHCO Council should improve the performance and consistency of permitting processes by establishing standards in permitting team roles and configurations to support cross-agency collaboration and drive continuous improvements.

  1. Characterize Types of Permitting Processes: Permitting Council staff should work with Deputy Secretaries, CERPOs, and Permitting Program Team leaders to categorize types of permitting processes based on project “footprint”, complexity, regulatory reach (i.e., regulations activated), populations affected and other criteria. Identify the range of team configurations in use for the categories of processes.  
  2. Map Agency Permitting Roles: Permitting Council staff should map and clarify the roles played by each agency in permitting processes (e.g., sponsoring agency, contributing agency) to provide a foundation for understanding the types of teams employed to execute permitting processes.
  3. Research and Analyze Agency Permitting Staffing: Permitting Council staff should collaborate with OMB to conduct or refine a data call on permitting staffing. Analyze the data to compare the roles and team structures that exist between and across agencies. Conduct focus groups with cross agency teams to identify consistent talent needs, team functions, and opportunities for standardization.
  4. Develop Permitting Team Case Studies: Permitting Council staff should conduct research to develop a series of case studies that highlight efficient and high performing permitting team structures and processes.
  5. Develop Permitting Team Models: In collaboration with Deputy Secretaries and CERPOs, Permitting Council staff should develop team models for different agency roles (i.e., sponsor, lead agency, coordinating agency) that focus on driving efficiencies through process improvements and technology, and develop guidelines for forming new permitting teams.
  6. Create Permitting Job Personas: In collaboration with Deputy Secretaries and CERPOs, Permitting Council staff should develop personas to showcase the roles needed on each type of permitting team and roles, recognizing that some variance will always remain, and the type of hiring authority that should be used to acquire those roles (e.g., IPA for highly specialized needs). This should also include new roles focused on process improvements; technology and data acquisition, use, and development; and product management for efficiency, improved customer experience, and effectiveness.
  7. Define Standardized Permitting Roles and Job Analyses: With the support of Deputy Secretaries and CERPOs, Permitting Council staff should identify roles that can be standardized across agencies based on the personas, and collaborate with permitting agencies to develop standard job descriptions and job analyses.
  8. Develop Permitting Practice Guide: In collaboration with Deputy Secretaries and CERPOs, Permitting Council staff should develop a primer on federal permitting practices that explains how to efficiently and effectively complete permitting activities.
  9. Place Organizational Strategy Fellows: Permitting Council staff should hire at least one fellow to their staff to lead this effort and coordinate/liaise between permitting teams at different agencies.
  10. Mandate Permitting Hiring Forecasts: Permitting Council staff should collaborate with the CHCO Council to mandate permitting hiring forecasts annually with quarterly updates.
  11. Revise Permitting Funding Requirements: Permitting Council staff should include requirements for the adoption of new team models and roles in the resources and coordination provided to permitting agencies to drive process efficiencies.

Improve Workforce Strategy, Planning, and Decisions through Quality Workforce Metrics

Agency permitting leaders and those working across agencies do not have the information to make informed workforce decisions on hiring, deployment, or workload sharing. Attempts to access accurate permitting workforce data highlighted inefficient methods for collecting, tracking, and reporting on workforce metrics across agencies. This results in a lack of transparency into the permitting workforce, data quality issues, and an opaque hiring progress. With these unknowns, it becomes difficult to prioritize agency needs and support. Permitting provided a purview into this challenge, but it is not unique to the permitting domain. OPM, OMB, the CHCO Council, and Permitting Council staff need to accurately gather and report on hiring metrics for talent surges and workforce metrics by domain.

  1. Establish Permitting Workforce Data Standards: OPM should create minimum data standards for hiring and expand existing data standards to include permitting roles in employee records, starting with the Request for Personnel Action that initiates hiring (SF52). Permitting Council staff should be consulted in defining standards for the permitting workforce.
  2. Mandate Agency Data Sharing: OPM and OMB should require agencies share personnel action data; this should be done automatically through APIs or a weekly data pull between existing HR systems. To enable this sharing, agencies must centralize and standardize their personnel action data from their components.
  3. Create Workforce Dashboards: OPM should create domain-specific workforce dashboards based on most recent agency data and make it accessible to the relevant agencies. This should be done for the permitting workforce.
  4. Mandate Permitting Hiring Forecasts: The CHCO Council should mandate permitting hiring forecasts annually with quarterly updates. This data should feed into existing agency talent management/acquisition systems to track workforce needs and support adaptive decision making.

Invest in Professional Development and Early Career Pathways

There are few early career pathways and development opportunities for personnel who engage in permitting activities. This limits agencies’ workforce capacity and extends learning curves for new staff. This results in limited applicant pools for hiring, understaffed permitting teams, and limited access to expertise. More recently, many of the roles permitting teams hired for were higher level GS positions. With a greater focus on early career pathways and development, future openings could be filled with more internal personnel. In our research, one hiring manager shared how they established an apprenticeship program for early career staff, which has led 12 interns to continue into permanent federal service positions. The Permitting Council staff, Deputy Secretaries, and CERPOs should create more development opportunities and early career pathways for civil servants.

  1. Invest in Training to Upskill and Reskill Staff: The Permitting Council staff should continue investing in training and development programs (i.e., Permitting University) to upskill and reskill federal employees in critical permitting skills and knowledge. Leveraging the knowledge gained through creating standard permitting team roles and collaborating with permitting leaders, the Permitting Council staff should define critical knowledge and skills needed for permitting and offer additional training to support existing staff in building their expertise and new employees in shortening their learning curve.
  2. Allocate Permitting Staff Across Offices and Regions: CERPOs and Deputy Secretaries should implement a flexible staffing model to reallocate staff to projects in different offices and regions to build their experience and skill set in key areas, where permitting work is anticipated to grow. This can also help alleviate capacity constraints on projects or in specific locations.
  3. Invest in Flexible Hiring Opportunities: CERPOs and Deputy Secretaries should invest in a range of flexible hiring options, including 10-year STEM term appointments and other temporary positions, to provide staffing flexibility depending on budget and program needs. Additionally, OPM needs to redefine STEM to include technology positions that do not require a degree (e.g., Environmental Protection Specialists).
  4. Establish a Permitting Apprenticeship: The Permitting Council staff should establish a 1-year apprenticeship program for early career professionals to gain on-the-job experience and learn about permitting activities. The apprenticeship should focus on common roles shared across agencies and place talent into agency positions. A rotational component could benefit participants in experiencing different types of work.

Improve and Invest in Pooled Hiring for Common Positions

Outdated and inaccurate job descriptions slow down and delay the hiring process. Further delays are often caused by the use of non-skills-based assessments, often self-assessments, which reduce the quality of the certificate list, or the list of eligible candidates given to the hiring manager. HR leaders confront barriers in the authority they have to share job announcements, position descriptions (PDs), classification determinations, and certificate lists of eligible candidates (Certs). Coupled with the above ideas on creating consistency in permitting teams and roles and better workforce data, OPM, CHCOs, OMB, Permitting Council staff, Deputy Secretaries, and CERPOs should improve and make joint announcements, shared position descriptions, assessments, and certificates of eligibles for common positions a standard practice.

  1. Provide CHCOs the Delegated Authority to Share Announcements, PDs, Assessments, and Certs: OPM and OMB should lower the barriers for agencies to share key hiring elements and jointly act on common permitting positions by delegating the authority for CHCOs to work together within and across their agencies, including with the Permitting Council staff.
  2. Revise Shared Certificate Policies: OPM and OMB should revise shared certificate policies to allow agencies to share certificates regardless of locations designated in the original announcement and the type of hire (temporary or permanent). They should require skills-based assessments in all pooled hiring. Additionally, OPM should streamline and clarify the process for sharing certificates across agencies. Agencies need to understand and agree to the process for selecting candidates off the certificate list.
  3. Create a Government-wide Platform for Permitting Hiring Collaboration: OPM should create a platform to gather and disseminate permitting job announcements, PDs, classification determinations, job/competency evaluations, and cert. lists to support the development of consistent permitting teams and roles.
  4. Pilot Sharing of Announcements, PDs, Assessments, and Certs for Common Permitting Positions: OPM and the CHCO Council should collaborate with the Permitting Council staff to select most common and consistent permitting team roles (e.g., Environmental Protection Specialist) to pilot sharing within and across agencies.
  5. Track Permitting Hiring and Workforce Performance through Data Sharing and Dashboards: Permitting Council staff, Deputy Secretaries, and CERPOs should leverage the metrics (see Improve Workforce Decisions Through Quality Workforce Metrics) and data actions above to track progress and make adjustments for sharing permitting hiring actions.
  6. Incorporate Shared Certificates into Performance: OPM and the CHCO Council should incorporate the use of shared certificates into the performance evaluations of HR teams within agencies.

Improve Human Resources Support for Hiring Managers

Hiring managers lack sufficient support in navigating the hiring and recruiting process due to capacity constraints. This causes delays in the hiring process, restricts the agency’s recruiting capabilities, limits the size of the applicant pools, produces low quality candidate assessments, and leads to offer declinations. The CHCO Council, OPM, CERPOs, and the Permitting Council staff need to test new HR resourcing models to implement hiring best practices and offer additional support to hiring managers.

  1. Develop HR Best Practice Case Studies: OPM should conduct research to develop a series of case studies that highlight HR best practices for recruitment, performance management, hiring, and training to share with CHCOs and provide guidance for implementation.
  2. Document Surge Hiring Capabilities: In collaboration, the Permitting Council staff and CERPOs should document successful surge hiring structures (e.g., strike teams), including how they are formed, how they operate, what funding is required, and where they sit within an organization, and plan to replicate them for future surge hiring.
  3. Create Hiring Manager Community of Practice: In collaboration, the Permitting Council staff and Permitting Agency HR Teams with support from the CHCO Council should convene a permitting hiring manager community of practice  to share best practices, lessons learned, and opportunities for collaboration across agencies. Participants should include those who engage in hiring, specifically permitting hiring managers, HR specialists, and HR leaders.
  4. Develop Permitting Talent Training for HR: OPM should collaborate with CERPOs to create a centralized training for HR professionals to learn how to hire permitting staff. This training could be embedded in the Federal HR Institute.
  5. Contract HR Support for Permitting: The Permitting Council staff should create an omnibus contract for HR support across permitting agencies and coordinate with OPM to ensure the resources are allocated based on capacity needs.
  6. Establish HR Strike Teams: OPM should create a strike team of HR personnel that can be detailed to agencies to support surge hiring and provide supplemental support to hiring managers.
  7. Place a Permitting Council HR Fellow: The Permitting Council should place an HR professional fellow on their staff to assist permitting agencies in shared certifications and build out talent pipelines for the key roles needed in permitting teams.
  8. Establish Talent Centers of Excellence: The CHCO Council should mandate the formation of a Talent Center of Excellence in each agency, which is responsible for providing training, support, and tools to hiring managers across the agency. This could include training on hiring, hiring authorities, and hiring incentives; recruitment network development; career fair support; and the development of a system to track potential candidates.

Next Steps

These recommendations aim to address talent challenges within the federal permitting ecosystem. As you can see, these issues cannot be addressed by one stakeholder, or even one agency, rather it requires effort from stakeholders across government. Collaboration between these stakeholder groups will be key to realizing sustainable permitting workforce capacity.

Technology and NEPA: A Roadmap for Innovation

Improving American competitiveness, security, and prosperity depends on private and public stakeholders’ ability to responsibly site, build, and deploy proposed critical energy, infrastructure, and environmental restoration projects. Some of these projects must undergo some level of National Environmental Policy Act (NEPA) review, a process that requires federal agencies to consider the environmental impacts of their decisions. 

Technology and data play an important role in and ultimately dictate how agencies, project developers, practitioners and the public engage with NEPA processes. Unfortunately, the status quo of permitting technology falls far short of what is possible in light of existing technology. Through a workstream focused on technology and NEPA, the Federation of American Scientists (FAS) and the Environmental Policy Innovation Center (EPIC) have described how technology is currently used in permitting processes, highlighted pockets of innovation, and made recommendations for improvement. 

Key findings, described in more detail below, include: 

Introduction

The Federation of American Scientists (FAS) is a nonprofit, nonpartisan organization that works to embed science, technology, innovation, and experience into government and public discourse. The Environmental Policy Innovation Center (EPIC) is a nonprofit, nonpartisan organization focused on building policies that deliver spectacular improvement in the speed of environmental progress. 

FAS and EPIC have partnered to evaluate how agencies use technology in permitting processes required by NEPA. We’ve highlighted pockets of innovation, talked to stakeholders working to streamline NEPA processes, and made evidence-based recommendations for improved technology practices in government. This work has substantiated our hypothesis that technology has untapped potential to improve the efficiency and utility of NEPA processes and data. 

Here, we share challenges that surfaced through our work and actionable solutions that stakeholders can take to achieve a more effective permitting process.

Background

NEPA was designed in the 1970s to address widespread industrial contamination and habitat loss. Today, it often creates obstacles to achieving the very problems it was designed to address. This is in part because of an emphasis on adhering to an expanding list of requirements that adds to administrative burdens and encourages risk aversion. 

Digital systems and tools play an important role at every stage of the permitting process and ultimately dictate how federal employees, permit applicants, and constituents engage with NEPA processes and related requirements. From project siting and design to permit application steps and post-permit activities, agencies use digital tools for an array of tasks throughout the permitting “life-cycle”—including for things like permit data collection and application development; analysis, surveys, and impact assessments; and public comment processes and post-permit monitoring. 

Unfortunately, the current technology landscape of NEPA comprises fragmented and outdated data, sub-par tools, and insufficient accessibility.  Agencies, project developers, practitioners and the public alike should have easy access to information about proposed projects, similar previous projects, public input, and up-to-date environmental and programmatic data to design better projects. 

Our work has largely been focused on center-of-government agencies and actions agencies can take that have benefits across government. 

Key actors include: 

Below, we outline key challenges identified through our work and propose actionable solutions to achieve a more efficient, effective, and transparent NEPA process.

Challenges and Solutions

Product management practices are not being applied broadly to the development of technology tools used in NEPA processes. 

Applying product management practices and frameworks has potential to drastically improve the return on investment in permitting technology and process reform.  Product managers help shepherd the concept for what a project is trying to achieve and get it to the finish line, while project managers ensure that activities are completed on time and on budget.  In a recent blog post, Jennifer Pahlka (Senior Fellow at the Federation of American Scientists and the Niskanen Center) contrasts the project and product funding models in government. Product models, executed by a team with product management skills, facilitate iterative development of software and other tools that are responsive to the needs of users. 

Throughout our work, the importance of product management as a tool for improving permitting technology has become abundantly clear; however there is substantial work to be done to institutionalize product management practices in policy, technology, procurement, and programmatic settings.

Solutions: 

Siloed, fragmented data and systems cost money and time for governments and industry

As one partner said, “NEPA is where environmental data goes to die.” Data is needed to inform both risk analysis and decisions; data can and should be reused for these purposes. However, data used and generated through the NEPA process is often siloed and can’t be meaningfully used across agencies or across similar projects. Consequently, applicants and federal employees spend time and money collecting environmental data that is not meaningfully reused in subsequent decisions.   

Solutions: 

Technology tools used in NEPA processes fall far short of their potential

The status quo of permitting technology falls far short of what is possible in light of existing technology. Permitting tools we identified in our inventory range widely in intended use cases and maturity levels. Opportunities exist to reduce feature fragmentation across these tools and improve the reliability of their content. Additionally, many software tools are built and used by a single agency, instead of being efficiently shared across agencies. Consequently, technology is not realizing its potential to improve environmental decision-making and mitigation through the NEPA process. 

Solutions: 

Existing NEPA technology tools are difficult for agencies, applicants, and constituents to use 

Agencies generally do not conduct sufficient user research in the development of permitting technology. This can be because agencies do not have the resources to hire product management expertise or train staff in product management approaches. Consequently, agencies may only engage users at the very end (if at all), or not think expansively about the range of users in the development of technology for NEPA applications. Advocacy groups and permit applicants aren’t well considered as tools are being developed. As a consequence, permitting forms and other tools are insufficiently customized for their sectors and audiences.

Solutions: 

Poor understanding of the costs and benefits of NEPA processes

Costs and benefits of the federal permitting sector have to date been poorly quantified, which makes it difficult to decide where to invest in technology, process reform, talent, or a combination. Applying technology solutions in the wrong place or at the wrong time could make processes more complicated and expensive, not less. For instance, automating a process that simply should not exist would be a waste of resources. At the same time, eliminating processes that provide critical certainty and consistency for developers while delivering substantial environmental benefits would work against goals of achieving greater efficiency and effectiveness.

A more reliable, comprehensive accounting of NEPA costs and benefits will help us design solutions that cost less for taxpayers, better account for public input, and enable rapid yet responsible deployment of energy infrastructure and other critical projects. 

Solutions: 

Conclusion

Policymakers, agencies, and permitting stakeholders should recognize the important role that systems and digital tools play in every stage of the permitting process and take steps to ensure that these technologies meet user needs. Developing data standards and a data fabric should be a high priority to support agency innovation and collaboration, while case management systems and a cohesive NEPA database are essential for supporting policy decisions and ensuring that data generated through NEPA is reusable. Leveraging technology in the right place at the right time can support permitting innovation that improves American competitiveness, security, and prosperity.

ARPA-I National Listening Tour Report

The United States is in the midst of a once in a generation effort to rebuild its transportation and mobility systems. Through the Infrastructure Investment and Jobs Act (IIJA) of 2021, hundreds of billions of dollars of new investments are flowing into American highway, rail, transit, aviation, port, pipeline, and active transportation projects.

This transportation infrastructure will be tested by new and emerging threats ranging from increased risk of flooding and heatwaves to supply chain disruptions and cyberattacks. Citizens are also rightly demanding more from the transportation sector—enhanced safety, faster project delivery, lower costs, increased sustainability, efficiency, resiliency, and a more equitable system for all users.

Meeting this moment will require bold investments in new and emerging transportation technologies—new materials, construction techniques, operations systems, planning tools, advanced sensing, computation, and beyond. Authorized in the IIJA, the Advanced Research Projects Agency – Infrastructure (ARPA-I), a new agency within the U.S. Department of Transportation (DOT), is poised to catalyze the transportation innovation ecosystem and accelerate and commercialize essential technologies that solve persistent infrastructure problems.

To inform its research agenda, ARPA-I embarked on a National Listening Tour from September 2023 through June 2024 to gather insights from a wide range of stakeholders from across the transportation ecosystem. With convenings held in the Pacific Northwest, Southeast, Midwest, and Mid-Atlantic, the tour provided several opportunities for ARPA-I to engage with 280 leading transportation experts. The goal was to ensure that ARPA-I heard both the priorities and capabilities of a broad range of transportation and infrastructure stakeholders from across the ecosystem. Of the 280 participants, 99 (35%) were from academia; 58 (21%) were from private corporations; 42 (15%) were from policy and nonprofit organizations; 38 (14%) were from federal, state, and local transportation agencies; 37 (13%) were from startups; and 6 (2%) were financial investors. The ideas shared by these participants will help shape ARPA-I’s future research agenda and will provide a framework for the Agency’s ambitions that will be achieved in part with the participation of and input from this broad ecosystem of stakeholders.

Purpose and Organization of this Report

This report summarizes the insights collected over the course of the ARPA-I National Listening Tour in 2023 and 2024 and the inaugural ARPA-I expert community convening in Washington, DC in December 2022. Insights were gathered from 280 participants in the form of written worksheets and transcribed notes from discussions during the Workshops. The insights summarized in sections 4-7 of this report are intended to inform potential areas for future innovative advanced research and development (R&D) programs to be funded and managed by ARPA–I.

This report is organized into the following sections:

  1. Laying the Groundwork for ARPA-I
  2. ARPA-I National Listening Tour Overview
  3. Promising Ideas for Future ARPA-I R&D Programs
  4. Challenges Facing U.S. Transportation Infrastructure
  5. Opportunities to Solve U.S. Transportation Infrastructure Challenges
  6. Predictions for U.S. Transportation Infrastructure in 10-20 Years
  7. Conclusion
  8. Acknowledgements

Laying the Groundwork for ARPA-I

In November 2021, Congress passed the Infrastructure Investment and Jobs Act (IIJA), allocating $550 billion in new funding for various programs within the U.S. Department of Transportation (DOT), including the establishment of the Advanced Research Projects Agency-Infrastructure (ARPA-I). Modeled after highly successful agencies like the Defense Advanced Research Projects Agency (DARPA) and the Advanced Research Projects Agency-Energy (ARPA-E), ARPA-I aims to address significant transportation infrastructure challenges through innovative technology solutions.

ARPA-I’s mission involves funding high-risk, high-reward next-generation innovative technologies with the potential to revolutionize U.S. transportation infrastructure. The agency aims to develop innovative solutions that reduce long-term infrastructure costs, minimize environmental impacts, enhance the safe and efficient movement of goods and people, and improve infrastructure resilience against physical and cyber threats.

To achieve its goals, ARPA-I will support projects that advance early-stage novel research with practical applications, translate conceptual technologies to prototype and testing stages, develop advanced manufacturing processes, and accelerate technological advancements in areas where industry may not invest due to technical and financial uncertainties.

ARPA-I continues a legacy of ARPAs that have delivered breakthrough innovations in a number of sectors. DARPA, established in 1958 in response to the Soviet Sputnik launch, has led to significant technological advances, including the internet, GPS, and mRNA vaccines. Inspired by DARPA’s success, the government created similar agencies for other critical sectors, including the Intelligence Advanced Research Projects Activity (IARPA), ARPA-E, and the Advanced Research Projects Agency-Health (ARPA-H). ARPA-I will adopt many of the core cultural traits and rigorous ideation processes honed by prior ARPAs to seek similar breakthroughs for the transportation infrastructure sector.

To lay the groundwork for ARPA-I’s future, the White House Office of Science and Technology Policy (OSTP) and DOT hosted an inaugural ARPA-I Summit in June 2023 during which a series of announcements were made on future ARPA-I activities. These announcements included:

Building upon the initiatives announced in June 2023, DOT has since undertaken additional efforts related to key transportation infrastructure areas. In January 2024, DOT announced the winners of the first phase of the U.S. DOT Intersection Safety Challenge, a call for opportunities “to transform roadway intersection safety by incentivizing new and emerging technologies that identify and address unsafe conditions involving vehicles, and vulnerable road users at intersections.” In February 2024, DOT announced an RFI about opportunities and challenges of artificial intelligence (AI) in transportation, along with the $15 million Complete Streets AI Initiative–a new opportunity for American small businesses to leverage advancements in AI to improve transportation. 

Since its authorization, ARPA-I has made steady progress to gather insights from across our country’s transportation infrastructure experts and is prepared for future ARPA-I projects that will be both appropriately ambitious and focused on our largest transportation problems.

ARPA-I National Listening Tour Overview

The ARPA-I National Listening Tour was the continuation and expansion of an inaugural ARPA-I expert community convening held at DOT headquarters in Washington, DC in December 2022 titled Transportation, Mobility, and the Future of Infrastructure. The National Listening Tour stops included:

The purpose of the ARPA-I National Listening Tour was to convene leading researchers, entrepreneurs, companies, and other transportation innovators and initiate a dialogue to ensure that ARPA-I reflects the priorities and capabilities of transportation and infrastructure R&D stakeholders across the ecosystem. 

Each Workshop followed a consistent format of plenary presentations from DOT leadership highlighting the opportunity and imperative of this community’s involvement, along with providing background on the unique cultural and structural components that set ARPA agencies up to seed breakthrough innovations, how ARPAs ideate advanced research program designs, and crucial roles that partners outside of government can participate in ARPA-I programs. 

Beyond the plenary presentations, the bulk of each Workshop consisted of breakout activities and discussions that focused on some combination of ideal future visions for what U.S. transportation infrastructure could look like in 10-20 years, the biggest problems facing U.S. transportation infrastructure, and novel technological breakthroughs and opportunities that have the potential to solve those fundamental problems.

In total, 280 transportation infrastructure experts participated in the four Workshops and the inaugural convening in Washington, DC. These experts included representatives from academia; corporations; policy and nonprofit organizations; federal, state, and local departments of transportation; venture capital (VC) and other investment firms; and startups.

Promising Ideas for Future ARPA-I R&D Programs

While the DOT continues to engage in strategy development and seek expert inputs to help shape ARPA-I’s initial set of research priorities once fully resourced, several promising ideas were uncovered during the ARPA-I National Listening Tour. Those ideas are described below in no particular order, along with the potential impact they could have on U.S. transportation infrastructure systems at scale. These ideas are not meant to serve as a current representation of priorities or research agendas of ARPA-I, but instead as a showcase of the creative and transformative solutions that the U.S. transportation infrastructure expert community is capable of envisioning.

AI-enabled efficiency throughout the infrastructure lifecycle

One of the most pervasive challenges in U.S. transportation infrastructure is the inefficiency of current project planning, design, and construction processes. Traditional methods often involve lengthy timelines, costly overruns, and frequent delays due to a lack of coordination and integration between stakeholders, planners, and contractors. These inefficiencies contribute to significant cost burdens on public funds and delay the delivery of much-needed transportation maintenance and improvements.

To address this challenge, one concept raised during the Workshops was that of a fully integrated, AI-enhanced project planning, design, scheduling, and construction schema. This idea leverages advancements in AI and “digital twin” technologies to streamline the entire lifecycle of transportation infrastructure projects—from conception to completion. By incorporating digital twins at all scales (geographic, structural, and temporal), the solution provides a powerful opportunity.

Implementing this AI-enhanced system would significantly accelerate the delivery of transportation infrastructure projects across the U.S., reducing both project completion times and overall costs. By enabling predictive analysis and continuous optimization, it would also lead to better resource allocation, reducing material waste and minimizing environmental impact. The result would be more efficient, resilient infrastructure systems that can adapt to future demands more effectively.

Priming physical road infrastructure for a digital future 

The rigidity of traditional road infrastructure design remains a key issue contributing to inefficient traffic management, safety concerns, and costly, timely physical infrastructure adaptations. Physical road infrastructure like bike lanes, vehicle lanes, and curbs are static and not reflective of the fluid nature of transportation needs, particularly in urban environments. A suite of technologies such as AI, drones, automated systems, and sensor-equipped barriers could be used to create smart lanes and barriers that adjust according to live traffic data, weather conditions, or sudden hazards, by rerouting traffic or narrowing lanes to optimize for current conditions.

If the U.S. could develop systems like this that have been piloted in other countries (e.g., Spain), the impact on transportation infrastructure would be transformative. City planners would have the ability to program infrastructure dynamically, creating safer, more adaptive environments for cyclists and other road users. The result would be fewer accidents, better traffic management, and more efficient use of space, with the additional benefit of reducing emissions by promoting cycling over car travel. The flexible nature of this infrastructure could also support emerging technologies such as connected vehicles and autonomous driving systems and allow the U.S. to design more sustainable, future-proof cities that prioritize adaptability, safety, and user-centric design.

Automated maintenance and on-site manufacturing

ARPA-I National Listening Tour Workshop participants repeatedly raised concerns around transportation construction and repair challenges, including labor shortages, inconsistent funding, slow project timelines, inefficiencies in traditional construction methods, and high carbon emissions to these methods.

Technologies including AI, robotics, and large-scale additive manufacturing, were noted for their potential to solve these challenges when applied at scale. AI-powered systems can monitor roads and bridges in real-time, predicting failures and enabling proactive repairs. Once detected, autonomous drones and robots can perform immediate repairs, reducing downtime and keeping workers safe by eliminating the need for human intervention in unsafe environments. Simultaneously, on-site manufacturing, using 3D printing and generative design, can produce infrastructure components directly at construction sites, reducing the need for long-distance transportation and reducing carbon emissions.

These solutions, especially if applied in tandem with one another, have the potential to make infrastructure maintenance autonomous, continuous, safer, and more cost-effective. On-site manufacturing would speed up construction projects and minimize logistical challenges while reducing the substantial impact the transportation sector currently has on carbon emissions.

New and emerging alternative PNT technologies

Positioning, Navigation, and Timing (PNT) services are essential to the nation’s critical infrastructure, enabling the safe, secure, and efficient operation of transportation systems for federal, state, commercial, and private entities across the U.S., including tribal lands and territories. These services provide crucial data that supports air and maritime supply chains, freight logistics, efficient roadway operations, crash prevention, and shared road use among vehicles and pedestrians. PNT services also ensure the safety and efficiency of aviation operations. For decades, the Global Positioning System (GPS) has been the backbone of PNT, continually evolving to improve accuracy, integrity, and security while expanding its applications.

However, despite the emergence of technologies like inertial navigation systems and Light Detection and Ranging (LiDAR) to improve the reliability of PNT data, these tools still have limitations. GPS, for example, relies on satellites, making it vulnerable to space weather disturbances and adversarial actions. Additionally, GPS systems can be compromised by threats such as jamming and spoofing.

Quantum sensors offer a promising solution, providing navigation capabilities in areas where GPS signals are weak or unavailable. These sensors use the principles of quantum mechanics to measure physical properties like time, acceleration, and magnetic fields with unprecedented accuracy. Quantum clocks, for instance, provide exceptional timekeeping precision, critical for synchronizing networks and systems. Quantum inertial sensors deliver highly accurate position and velocity measurements, making them invaluable during extended periods where GPS is unavailable. Meanwhile, quantum gravimeters and quantum magnetometers, which are passive systems, can operate under all weather conditions, at any time, and in featureless terrains such as oceans. These sensors enable gravitational anomaly-aided navigation (GravNav) and magnetic anomaly-aided navigation (MagNav). They collectively offer pathways to make our PNT systems more precise, more reliable and resilient.

Repurposing transportation rights-of-way for infrastructure of the future

Another critical challenge raised throughout the Workshops was that of meeting the growing demand for electric vehicles (EVs) and the integration of modern, sustainable technologies at scale. The current network, designed for traditional internal combustion engines, lacks the infrastructure to support widespread EV adoption and smart technologies like connected and autonomous vehicles. 

One solution posed during Workshops (and as part of the White House’s Net-Zero Game Changers Initiative) is to repurpose existing transportation rights-of-way (ROWs) along highways and railroads for dual use, enabling the development of EV charging infrastructure and clean energy transmission without the need for costly land acquisition or major structural changes. With 48,000 miles of interstate highways and 140,000 miles of freight railroads, the U.S. has a vast network of ROWs that can be leveraged for new infrastructure. These ROWs can host charging stations, and in some cases, technologies like inductive charging embedded within roadways, allowing vehicles to recharge as they drive. This would make long-distance EV travel more feasible, eliminating range anxiety and encouraging broader adoption of electric vehicles. 

Technological innovations like high-voltage underground cables and modular interconnection power electronics would help ensure grid stability while integrating energy and transportation infrastructure. These tools would allow the grid to balance the energy demands of electric vehicles in real time, creating a smarter, more resilient transportation network.

Challenges Facing U.S. Transportation Infrastructure

A portion of each Workshop breakout discussion focused on identifying the fundamental problems and challenges facing U.S. transportation infrastructure. Throughout these discussions, 353 individual responses were gathered. Themes that emerged consisted of problems related to safety, aging infrastructure and maintenance, data access and other data issues, environmental sustainability and resilience, financial constraints, operational inefficiencies related to existing structures and processes, equity and accessibility, technology adoption and scaling, energy and electrification, and community and planning challenges. Each of these broad themes that arose is broken down in further detail below.

Categories of Transportation Infrastructure Challenges 

Safety (66 mentions): Safety remains a paramount issue with transportation-related fatalities once again topping 40,000 in the U.S. during 2023. Factors raised by participants as contributing to safety risks include impaired driving, driver distractions, excessive speeds, and inadequate infrastructure accommodations for vulnerable road users like pedestrians and cyclists. Unsafe street and intersection designs were also a critical concern, described as “the majority of intersections outside of urban centers are not designed to accommodate pedestrians safely.” The rise in the size and weight of vehicles, along with the general car-centric nature of much of U.S. transportation infrastructure, were frequently noted as an impediment to pedestrian safety. Multiple participants noted that current infrastructure prioritizes vehicle speed and efficiency over driver, pedestrian, and cyclist safety.

Aging Infrastructure (56 mentions): Aging physical infrastructure continues to be a top concern for many experts. Challenges participants pointed to included failing bridges, deteriorating road conditions, and corrosion of materials, resulting in considerable maintenance backlogs. Participants also frequently pointed to outdated designs that do not accommodate modern transportation needs and struggle to adapt to contemporary demands, including electrification needs and the ability to withstand climate-related events.

Data Inadequacies (42 mentions): Many participants made reference to a significant lack of real-time and comprehensive data for the transportation planning the U.S. needs. For instance, data on pedestrian and bike activities to analyze crash risks effectively is often historic, segmented, inaccurate, and inaccessible. Data collection on vehicle collisions takes up to a year, delaying critical safety decisions. Digital infrastructure gaps were a frequent concern, noting “many areas lack the necessary digital infrastructure for modern transportation systems.” The need for better people-oriented data was also emphasized, referring specifically to data on pedestrian and cyclist movements to improve safety. 

Environmental Sustainability and Resilience (37 mentions): The transportation sector is the largest contributor (28%) to U.S. greenhouse gas emissions. Accordingly, participants called out these emissions rates, the environmental impact of larger vehicles, the carbon intensive materials and processes currently used in infrastructure construction, and the need for influencing travel behavior towards low carbon trips. Alongside sustainability concerns, infrastructure resilience was another common challenge raised.

Financial Constraints (34 mentions): According to participants, high costs associated with constructing, repairing, and maintaining transportation infrastructure limit the scope and speed of improvements. Public agencies face difficulties in efficient procurement and funding allocation, exacerbated by a backlog in maintenance and capital improvements. There were also mentions of profit-driven interests in car infrastructure, limited revenue from fares, and the need for funding catalysts and public-private collaborations.

Operational Inefficiencies (34 mentions): Operational inefficiencies were a recurring theme among discussions, specifically fragmented management with comments like “the lack of coordination between agencies results in redundant efforts.” Inefficiencies in resource utilization were highlighted along with a lack of coordination across transportation modes.

Equity and Accessibility (25 mentions): Disparities in access to transportation infrastructure affect low-income and rural communities, as well as vulnerable populations. Car-centric infrastructure impacts and social inequities are major concerns. There are also challenges related to accessibility for people with disabilities, rural area connectivity, and access to reliable wireless connectivity for digital infrastructure advancements.

Technological Integration (21 mentions): Slow adoption of new technologies and integration with legacy systems are major hurdles, with participants asserting that there is resistance to adopting new technologies in the transportation sector. Challenges with autonomous vehicle integration, maritime and port digital integration, and procurement of new technologies are significant. There is also a need for improved cybersecurity alongside digital infrastructure buildout. 

Energy and Electrification (20 mentions): Grid limitations in rural areas and the need for improved electric vehicle (EV) charging infrastructure were common among discussions around our largest transportation infrastructure challenges. Specifically, there pointing to a mismatch between the transportation sector and the electric grid, as the current grid is not designed to handle the demands of electric transportation. 

Community and Planning Issues (18 mentions): Slow community engagement processes and the need for adaptable project designs were frequently cited issues. Encouraging transit ridership and the need for inclusive transportation planning are also mentioned.

Opportunities to Solve U.S. Transportation Infrastructure Challenges

Building upon ARPA-I National Listening Tour breakout discussion on U.S. transportation infrastructure’s biggest challenges, Workshop participants shifted their attention to solving these problems. In order to do so, they brainstormed and discussed current and coming opportunities upon which we must capitalize in order to solve our most pressing challenges highlighted in the section above. 

Throughout these discussions, 415 individual responses were gathered. Participant insights included policy suggestions, stakeholder engagement strategies, and infrastructure improvements, but the primary focus of these discussions–given ARPA-I’s scope–was on technological opportunities (accounting for 334 of the 415 responses). Key themes raised include the integration of cutting-edge technologies such as artificial intelligence (AI) and machine learning (ML) AI, sensor technology, internet of things (IoT), digital twins, and edge computing to enhance data collection, processing, and real-time decision-making. Participants also emphasized the need for interoperable systems, standardization of data, and the creation of national repositories to streamline information sharing and improve infrastructure planning.

Technology Opportunities

Given ARPA-I’s focus on technology solutions, the primary opportunity types identified throughout National Listening Tour Workshops were cross-cutting technologies, described in detail below.

Sensors and Sensor-related Technologies (71 mentions): Sensors were the most frequently cited technology opportunity to address transportation infrastructure problems including real-time detection of hazards, infrastructure wear and tear, and the need for accurate, continuous data collection. Examples of specific sensor technologies or applications included:

AI and Machine Learning (AI/ML) (50 mentions): AI and ML were mentioned throughout the National Listening Tour Workshops as necessary pieces to solve complex problems related to traffic management, predictive maintenance, and autonomous vehicle operations. AI and ML can improve the accuracy of predictions, optimize system performance, and automate decision-making processes. Examples of specific types and applications include:

Data Standardization and Management (32 mentions): One opportunity that may not have one specific technology tool to point to, but is inherently a technological opportunity, is data standardization and management. This would tackle the issue of fragmented data systems, ensuring consistency and interoperability across various modes, networks, and stakeholders. This would facilitate better decision-making and more efficient infrastructure management. Examples of specific standardizations and management tools include:

Autonomous Vehicles (AVs) (28 mentions): Participants pointed to advancement and widespread rollout of AV technology as perhaps the biggest transformation to come in U.S. transportation systems. Achieving this maturation and scale could address the problem of human error in driving, which is a leading cause of crashes. AVs could optimize traffic flow and reduce congestion, making transportation systems both safer and more efficient. Examples of AV applications and associated technologies include:

Internet of Things (IoT) (27 mentions): IoT technology can help solve the problem of disconnected systems by enabling communication between various elements of the transportation network. Participants assert it as a way to achieve real-time monitoring, improve safety, and increase efficiency. Examples of IoT applications include:

Digital Twins (23 mentions): Digital twins have the potential to address inefficient planning and maintenance by providing accurate virtual representations of physical infrastructure. This would allow for better simulation, monitoring, and optimization, leading to more informed decision-making. Examples of applications from Workshop participants include:

Edge Computing (19 mentions): According to many participants, edge computing could completely fix the issue of latency in data processing, which is critical for applications requiring immediate responses, such as AVs and real-time traffic management systems. Examples of edge computing applications include:

Electric Vehicles (EVs) (19 mentions): Participants pointed to the readily apparent opportunity that EVs represent if the technology, costs, and infrastructure can be achieved at scale. To get to scale, it was widely acknowledged that we need more efficient EV charging experience, with infrastructure that allows for rapid charging along service areas. Another challenge for EV adoption is the need to build a widespread, reliable charging network that can meet the demands of all users, including long-haul trucks.

Modeling-related Technologies(17 mentions): Modeling technologies are essential for predicting infrastructure performance, traffic patterns, and the impact of various interventions. Examples of modeling-related technologies raised by participants were:

5G/6G Communication (15 mentions): Advanced communication technologies like 5G and 6G were mentioned as crucial for enabling real-time data exchange between vehicles, infrastructure, and central systems. An example is the deployment of 6G to support point-to-point communications in vehicle-to-everything (V2X) systems. Examples  of applications include:

Carbon Capture Technologies (10 mentions): Carbon capture technologies are critical for reducing greenhouse gas emissions across the transportation sector. Example mentioned by participants include: 

Drones and Related Technologies (10 mentions): Workshop discussions around drones noted that they offer innovative solutions for infrastructure monitoring, logistics, and transportation management. 

Low Carbon-related Innovations (9 mentions): Similar to carbon capture technologies, low carbon-related innovations will be important in reducing carbon emissions. Example of technologies raised during breakout discussions include:

Quantum Computing (4 mentions): Quantum computing was raised a few times throughout discussions as a means for quantum material sensor development and also quantum sensing for unprecedented precision in infrastructure monitoring.

Non-technology Opportunities

Policy suggestions: Policy-related opportunities focused on creating a supportive regulatory framework, aligning financial investments with long-term infrastructure goals, and ensuring that policies are inclusive and equitable. These policies were intended to address challenges in planning, funding, and implementing large-scale infrastructure projects. Specifically, participants discussed opportunities to craft policies to ensure that transportation investments prioritize underserved communities, addressing the problem of unequal access to transportation resources. 

Stakeholder engagement strategies: Participants emphasized the opportunity presented by involving diverse groups, particularly those traditionally underserved or impacted by infrastructure projects to raise the voices of all community members so that infrastructure development is responsive to their needs. 

Physical infrastructure improvements: Non-technology-specific infrastructure improvements highlighted throughout the Workshops included enhancing the physical aspects of transportation systems, such as road design and public transit accessibility. 

For instance, increasing the use of roundabouts can help solve the problem of high accident rates at traditional intersections. Additionally, developing complete streets infrastructure that supports all users, including pedestrians and cyclists, addresses the problem of limited accessibility and safety on roads designed primarily for vehicles.

Financial and economic strategies: Opportunities raised  centered on creating sustainable funding mechanisms for transportation infrastructure projects. These strategies address the challenges of securing adequate, long-term financing for both new projects and the maintenance of existing infrastructure. Ideas included alternative funding mechanisms such as value capture or tolling.

Predictions for U.S. Transportation Infrastructure in 10-20 Years

One of the key criteria for any good ARPA project is that it is appropriately ambitious. To set that level of ambition, ARPA-I National Listening Tour participants were asked to make a prediction for U.S. transportation infrastructure 10-20 years from now, taking an ambitious perspective and focusing on what could be. Throughout these discussions, 291 individual predictions were gathered. Despite the wide ranging and sometimes narrowly focused predictions, continuous themes emerged to help reveal a shared vision for what participants want to see in the transportation systems of tomorrow. 

Participants frequently emphasized the importance of widespread adoption and integration of advanced technologies such as autonomous vehicles, AI-driven traffic management, and real-time data communication to create a connected and efficient transportation network. Sustainability also emerged as a central theme, with many predicting a shift toward carbon-neutral transportation systems powered by renewable energy sources. Ideas included dynamic wireless charging for electric vehicles, infrastructure embedded with carbon sequestration capabilities, and the widespread adoption of alternative fuels like hydrogen. The focus on sustainability also extended to construction practices, with participants envisioning the use of self-healing and recyclable materials to build resilient infrastructure that can adapt to climate challenges.

Equity and accessibility were also frequently mentioned, with a strong emphasis on creating a transportation system that serves everyone, regardless of location or socioeconomic status. Visions included universal Americans with Disabilities Act (ADA) compliance, free public transportation, and the development of equity-based planning tools to ensure that investments benefit all communities. The overarching ambition is to build a transportation network that is not only technologically advanced and environmentally sustainable but also inclusive and equitable, providing reliable access to mobility for all.

Categories of Predictions for U.S. Transportation Infrastructure in 10-20 years

Automation and Autonomy (36 mentions): Participants imagined a future dominated by autonomous systems, including self-driving cars, autonomous shuttles, and urban air mobility. These systems would be interconnected, allowing for seamless operation and enhanced efficiency. Ideas included autonomous vehicle fleets, virtual “rails” for guiding autonomous vehicles, and the deployment of autonomous drones for transport. The overarching vision was a transportation ecosystem where human error is minimized, and transportation becomes more efficient and safer.

Connectivity (31 mentions): Connectivity was seen as the backbone of transportation infrastructure in the future, with participants envisioning a fully interconnected system where vehicles, infrastructure, and personal devices communicate seamlessly. Advanced technologies such as quantum sensing, AI-driven traffic management, and universal communication standards were proposed to create a hyperconnected network. This would enable real-time traffic management, reduce congestion, and optimize the flow of goods and people.

Sustainability and Environmental Impact (29 mentions): Participants proposed a wide range of ideas aimed at reducing the environmental impact of transportation in the future. These included self-healing materials that extend infrastructure life and reduced emissions associated with frequent maintenance and construction, carbon sequestration integrated into construction materials, and the development of energy-generating infrastructure such as smart trails to generate energy for electric bikes. Participants also discussed the potential of dynamic wireless charging for electric vehicles and the large-scale adoption of alternative fuels, ensuring that the transportation system is not only sustainable but actively contributes to environmental restoration.

Safety (28 mentions): Safety innovations were a frequent theme, with participants proposing strategies to achieve a near-zero fatality transportation system. Ideas included expanding Vision Zero strategies, integrating AI for real-time risk detection, and deploying automated enforcement systems to prevent unsafe driving behaviors. The reimagining of urban spaces to prioritize pedestrian and cyclist safety was also highlighted, with infrastructure designed to protect the most vulnerable road users.

Climate Resilience (25 mentions): Participants emphasized the importance of building infrastructure that can withstand and adapt to the impacts of climate change. Ideas included the use of self-healing and self-sensing materials, modular designs for easier repairs and upgrades, and infrastructure that is resilient to extreme weather events. The vision was for transportation infrastructure that is not only durable but also adaptable to future climate challenges, contributing to overall climate resilience.

Equity and Accessibility (24 mentions): Ensuring equity and accessibility was a priority for participants when thinking about the future, with ideas like universal ADA compliance, free public transportation, and the development of equity-based asset management tools. The goal was to create a transportation system that serves all communities, including those that are traditionally underserved, such as rural areas and marginalized populations. 

Public Transit (22 mentions): Public transit was envisioned as a fully integrated, multimodal system that is easy to use and highly efficient. Participants proposed the elimination of car-centric roadways in urban areas, replacing them with dedicated lanes for public transit, cycling, and walking. High-speed rail development, particularly in key regions, and the expansion of micro-mobility options were also highlighted as ways to enhance last-mile connectivity and reduce reliance on personal vehicles.

Innovation and Technology Adoption (18 mentions): Participants predicted a future where technologies like AI, quantum computing, and digital twins have been adopted at scale to optimize infrastructure performance and maintenance. These technologies at scale would allow for real-time monitoring, predictive maintenance, and dynamic system adjustments, and contribute to transportation systems being more efficient, resilient, and future-proofed.

Data-driven Planning (17 mentions): Participants envisioned the use of AI for real-time data analysis, along with the establishment of national data standards to ensure seamless integration across different modes, organizations, and stakeholders. 

Policies and Partnerships (13 mentions): Despite not being the focus of ARPA-I policy and governance were mentioned as enablers for many of the ambitious future visions. Participants proposed establishing public-private partnerships to fund and manage infrastructure projects and allow for more flexible and innovative financing models. They also envisioned equity-based asset management tools and policies, increased cross-jurisdictional collaboration, and policies to set national guidelines for climate adaptation in infrastructure design and construction. 

Multimodal Mobility (11 mentions): The collective vision for mobility included creating a seamless multimodal transportation system that allows users to easily switch between different modes such as bikes, trains, and buses. Participants hope for the development of unified payment systems to enhance the user experience and reduce reliance on personal vehicles. 

Energy (10 mentions): Energy integration predictions centered on using renewable energy sources, bidirectional EV charging for grid stability, and dynamic load management systems. Overall, participants want a future where transportation systems are tightly integrated with energy networks, ensuring reliability while reducing the carbon footprint of the transportation sector.

Urban Planning (10 mentions): Urban planning-related visions included the removal of highways in cities, replacing them with green spaces, light rail, and pedestrian-friendly streets. Participants also predicted the development of high-speed rail corridors connecting major cities, reducing the need for air travel and long car journeys, and integrating land use with transportation planning for more sustainable urban growth.

Materials and Construction (10 mentions): Participants want to see increased use of self-healing and self-sensing materials to extend infrastructure lifespans by centuries. Modular construction techniques and adopting low-carbon materials were also noted as ways to reduce construction times, costs, and environmental impact.

Community and Health Impacts (7 mentions): Transportation infrastructure was envisioned by some as a tool for improving community health and well-being in the future. Ideas included designing infrastructure that supports physical and mental health, reducing the “pink tax” on transportation for women and families, and creating transportation systems that enhance social cohesion and community safety.

Conclusion

As ARPA-I continues its mission to revolutionize transportation infrastructure, it is essential to sustain and expand the support of the transportation expert community and stakeholders across the country. ARPA-I’s success will depend on the collective effort of researchers, innovators, policymakers, and industry leaders who recognize the agency’s potential to drive breakthrough solutions. To truly tackle our biggest transportation infrastructure challenges, we must deepen our commitment to collaboration, align resources strategically, and remain focused on innovative, high-impact outcomes. The expert community should continue to engage with DOT and ARPA-I, push the boundaries of what is possible in their own work, and seek to build the support necessary to turn ARPA-I’s ambitions into reality.

For a full list of organizers, facilitators, and participant organizations, please see the full PDF-version of the report here.

Improving Public Awareness and Understanding of Advisory Committees

From January 2024 to July 2024, the Federation of American Scientists interviewed 30 current and former Advisory Committee (AdComm) members. Based on these discussions, we were able to source potential policy recommendations that may assist with enhancing the FDA’s ability to obtain valuable advice for evidence-based decision-making. The results of these discussions are presented in case study format detailing the recurring themes that emerged and policy recommendations for improvement.

The FDA holds one of the most important roles as a federal agency which is to ensure public safety when approving vaccines, medical devices, and medicines. The approval of these products usually require extensive trials with data that supports their safety and efficacy. Considering that most of these decisions are complex and multifaceted, the FDA enlists the support of Advisory Committees to assist with their decision-making process. The primary role of FDA Advisory Committee members is to provide the FDA with informed advice and recommendations on issues spanning science, regulatory policy, and the evaluation of products under the FDA’s jurisdiction. Although AdComm members serve the FDA in an advisory capacity, their recommendations are non-binding. Therefore, they do not have the final say in the regulatory approval process. 

However, over the years, it has been made evident that the public is unaware of the role of Advisory Committees and ways in which they can engage with the FDA. In this case study, FAS hopes to share the current problem and actionable recommendations to combat public misconceptions regarding FDA AdComm roles and provide guidance on increasing FDA engagement with the public and other relevant stakeholders throughout the regulatory process.

Public Awareness Problems

While AdComm members are experts in their respective fields and volunteer their time to provide advice to the FDA, there are multiple factors that must be considered before making official decisions. The recommendations provided during Advisory Committee meetings are just one aspect that is considered for regulatory decision-making and do not guarantee an official approval or denial of a product by the FDA. During AdComm meetings, the FDA allows the general public to make public comments to the Agency and the AdComm regarding the topic that is being addressed. Despite this, members of the general public have expressed that, on many occasions, they are unaware AdComm meetings are occurring. This, in effect, deprives them of the opportunity to communicate directly with the FDA and the AdComm. Additionally, they feel the FDA fails to engage them in an adequate manner, thereby limiting opportunities for participatory engagement. It has also been noted that most members of the general public are unaware FDA Advisory Committees exist; and, for those who are aware, they are unclear about the capacity of their role within the regulatory process. 

For these reasons, the FDA must take measures to enhance public understanding in an effort to combat misinformation, educate, and raise awareness on the existence of Committees and their purpose.  

Communicating AdComms to the Public

Improving Public Awareness of Advisory Committees and their Role

Improving public awareness on the existence of FDA Advisory Committees and their purpose would assist the FDA with improving public trust and debunking myths and misinformation related to the approval of medical products. Advisory committees operate as an independent party and their recommendations assist with guiding regulatory decision-making. However, their recommendations are non-binding, and FDA leadership must consider additional factors before granting approvals or denials of medical products. 

To increase public awareness on Advisory Committees, it should be made clear that AdComm recommendations are not conclusive, as the FDA considers multiple factors in its official decisions. The FDA can leverage social media platforms to increase awareness and understanding of AdComms through the use of disseminating information via the use of ads and active social media engagement. A survey conducted by Pew Research Center states that eight in ten Americans believe social media platforms are an effective way to bring awareness. In addition, disclaimers should be included on all public facing materials referencing AdComms to indicate their purpose. Clearly communicating this to the public will dispel myths that AdComms make the final call on the approvals of medical products. 

Improving Communication about Advisory Committee Meetings

Encouraging public participation for Advisory Committee meetings will help foster a collaborative and engaged general public who can contribute valuable life experience to the regulatory process. FAS has identified ways in which the FDA can better communicate with the public to inform them of Advisory Committee meetings. First, the FDA can develop a webpage that allows people to receive notifications of upcoming AdComm meetings. The FDA can also establish relationships with state and local public health agencies, as well as advocacy organizations to spread awareness. Through these relationships, the various agencies and organizations can use their networks to disseminate widespread information on AdComm meetings. Public health agencies and advocacy organizations can gauge the best ways in which these communities would like the FDA to engage with them. This understanding of the communities they serve makes them an ideal partner for fostering continuous engagement.  

Policy Recommendations

In an effort to improve public awareness and understanding of AdComms, the potential policy recommendations are as follows: 

Conclusion

Advisory Committees are essential to the FDA regulatory decision-making process. It’s imperative that their role is understood by them and the general public to best move the needle forward. While the FDA currently allows the public to provide public comment at Committee meetings, that alone cannot be considered engaging the community. The FDA must create new opportunities for interpersonal communication which will create an environment of mutual trust and understanding between both parties.

The Role of Patient Advocacy in the AdComm Process

From January 2024 to July 2024, the Federation of American Scientists interviewed 30 current and former Advisory Committee (AdComm) members. Based on these discussions, we were able to source potential policy recommendations that may assist with enhancing the FDA’s ability to obtain valuable advice for evidence-based decision-making. The results of these discussions are presented in case study format detailing the recurring themes that emerged and policy recommendations for improvement.

The regulation of medical products is the responsibility of the Food and Drug Administration (FDA). To ensure effective decision-making regarding these products, the FDA recognizes the importance of patient advocacy and the perspectives of patients. In 1988, the FDA initiated the patient engagement process through the Office of Aids Coordination, and within five years, the first patient representative was appointed to an FDA Advisory Committee. Since then, the FDA has significantly enhanced its methods of engaging patients, caregivers, and patient advocates. This includes the establishment of various offices, programs, collaboratives, listening sessions, public guidance, and more.

The Evolution of Patient Engagement at the FDA

The FDA employs several avenues to engage patients in the regulatory process. Some avenues include the Patient Engagement Advisory Committee (PEAC), public comment, the Patient Focused Drug Development Initiative (PFDD), the Patient Listening Session Program, Patient Engagement Collaborative (PEC), and the Patient Representative Program (PRP). This list does not cover all the ways in which the FDA engages patients and advocates but provides an overview of the key operations involved in patient engagement efforts. 

The Patient Engagement Advisory Committee is the only Committee that is completely composed of caregivers, patients, and patient representatives from various organizations, as a way to ensure that the lived experiences of these populations and their opinions are included in the deliberations and regulatory decision-making of medical products. Public comment is a requirement by law for federal agencies, allowing the public to provide feedback on proposed actions or new rules and regulations. Public comment is also sought during Advisory Committee meetings to gather information and perspectives from the public. PFDD meetings provide a platform for the FDA to obtain insights from patients on specific diseases and their treatments. To identify the issues most important to patients, the FDA has a series of guidance documents that are used specifically for PFDD meetings. 

The Patient Listening Session Program facilitates informal meetings between patients, their representatives, and FDA staff. These sessions cover a range of topics, including treatment preferences, quality of life, unmet medical needs, and the impact of diseases and their symptoms. The PEC offers a forum for patients, caregivers, and advocates to discuss patient engagement operations. Lastly, the PRP allows patients, caregivers, and advocates who serve as special government employees the opportunity to provide advice to the FDA’s Commissioner or a designated representative on matters related to medical devices and their regulation.

Although there are various avenues for patient engagement and advocacy participation in the medical product regulation process, there are also ways in which these avenues can be expanded or improved.   

Patient Advocacy Problems

For many years, patients and their caregivers have not seen significant or sustainable treatments that have been developed to treat many illnesses and diseases. Some treatments have proven to be ineffective yet still made it to market approval. On the other hand, there are treatments that met safety and efficacy standards but were not approved. There are also those treatments that are simply not affordable to the populations that need them most. In many of these scenarios, the patient representative voice was lost as they did not have the option to express their concerns or perspectives on certain treatments with decision makers. This further confirms that the role of patient advocacy and allowing space for the patient representative voice is crucial to the regulation process of medical products. 

At the moment, the patient voice is not always heard because there are some FDA Advisory Committees that do not have a patient representative.

While the role of patient advocacy is crucial, it is important to note there should be boundaries in which patient perspective is considered for decision-making. Although patients and their advocates seek treatments that better address their needs, this desire can sometimes obscure their judgment concerning long-term treatment effectiveness. Frequently, patients and their supporters present powerful arguments to Advisory Committees and the FDA for approval of particular medical products which can lead to expedited medical product approval in the absence of supportive evidence. 

The endorsement of eteplirsen, which was intended for the treatment of Duchenne muscular dystrophy (DMD), illustrates this point. Despite a 7 to 3 vote by the FDA’s Advisory Committee against approval due to insufficient evidence of its benefits, opposition from the FDA’s Center for Drug Evaluation and Research’s former leader resulted in the drug’s authorization. This sparked substantial internal and public criticism and led Dr. Ellis Unger from the FDA’s Office of Drug Evaluation to challenge the approval decision. Dr. Unger emphasized that “patient-focused drug development is about listening to patient perspectives about what matters to them; it is not about basing drug approvals on anecdotal testimony that is not corroborated by data.”

This approval was perceived by many as having been heavily influenced by patient advocacy and raised concerns about potential long-term implications for patient health. It also signaled a need to further examine both patient education and the appropriate limits of patient involvement in the regulatory process. This could have been mitigated had there been a list of criteria in place to be followed for public comment. 

Incorporating Patient Perspectives

The Food and Drug Administration (FDA) is committed to understanding the balance of benefits and risks acceptable to patients as they relate to medical products. The FDA defines the role of patient representatives that serve on Advisory Committees as “Special Government Employees” who provide direct input to agency staff and share valuable insight on their experiences with various diseases, conditions, and devices while gaining access to confidential information. These representatives are selected by the FDA to serve on Advisory Committees using a specific set of criteria including, but not limited to: 

This criteria ensures the FDA will understand the patient perspective as it relates to various medical products and ensures those selected to serve on Advisory Committees are knowledgeable about the areas in which they are aiming to provide guidance. Currently, there are some FDA Advisory Committees that do not have a patient representative. Further, the patient representatives serving on committees do not always have voting privileges. The absence of consistent voting privileges for some patient representatives on Advisory Committees and not having a standing patient representative on all committees hinders these individuals from providing an official stance on behalf of the community they represent. Additionally, public comment plays a significant role at Advisory Committee meetings by permitting individuals—including patients, caregivers, and advocacy organizations—to highlight concerns and propose solutions that may not have been previously considered by decision-makers. This process also helps the committee and agency gauge patient acceptance or opposition related to medical products, thereby enhancing their ability to make decisions that more accurately reflect public needs. 

When Sarepta was seeking approval of eteplirsen for the treatment of DMD, a patient advocacy organization brought hundreds of patients, caregivers, and other advocates to the Advisory Committee convening so they could make a public comment to the Committee and the agency. Shortly after, the drug received a swift approval. Although it presented much controversy within the agency and the public, it showed how influential patient advocacy can be. Personal lived experiences, compelling stories of debilitating illnesses, and experiences with current treatment have the ability to impact regulatory decision-making. 

The role of patient advocacy continues to be important in the Advisory Committee process and FDA regulatory decision-making process because it is crucial to assisting with decisions that affect the American public. Patient advocacy can be presented in the form of patient representatives that serve on Advisory Committees, those who make public comments during Advisory Committee convenings, and various outreach programs by advocacy organizations. The role of advocacy gives patients and caregivers support, promotes and protects their rights, and allows broader visibility for the issues that are most important to them. All of these avenues for patient perspective are important to understand how treatments perform, the current needs of the patient population, and how to tailor care for these populations by truly understanding their condition, diagnosis, and current management. Therefore, their voice is critical to truly understanding how various medical products will benefit their population, how they will access and afford these products, and how they will fill an unmet medical need.

Policy Recommendations

In an effort to better leverage Advisory Committee membership, the potential policy recommendations are as follows: 

Conclusion

The landscape of disease burden and associated symptoms is ever-evolving. To ensure the FDA is best prepared for this changing landscape, patient advocacy and amplifying the patient voice should be considered vital to the development and regulation of medical products. Involving those who are the most impacted by these products is essential. The FDA can further promote the patient perspective and advance patient-centered health through incorporating patient representatives on all Committees that are reviewing medical products, making patient engagement an ongoing process, hosting town halls for patients to allow a broader audience the opportunity to voice opinions, and having dedicated staff to sort through public comments from patients.

FDA Staff and Leadership Disagreements and the Role of the AdComm in the Regulatory Process

From January 2024 to July 2024, the Federation of American Scientists interviewed 30 current and former Advisory Committee (AdComm) members. Based on these discussions, we were able to source potential policy recommendations that may assist with enhancing the FDA’s ability to obtain valuable advice for evidence-based decision-making. The results of these discussions are presented in case study format detailing the recurring themes that emerged and policy recommendations for improvement.

The FDA relies on its scientific staff and Advisory Committees to provide conclusions from trial and study data, which aid in the process of regulating and approving medical products. However, there are instances when disagreements arise between the agency’s scientists, statisticians, Advisory Committees, and leadership on the accelerated or full approval of medical products. The resolution of these disagreements present a growing concern about FDA leadership overruling the expert opinions of scientific staff and proceeding with official approvals, thus undermining staff expertise, decreasing agency morale, and potentially diminishing public trust.

When Disagreements Between FDA and AdComms Arise 

The Federal Advisory Committee Act governs the FDA’s Advisory Committees and establishes a process in which the FDA can seek expert advice on various issues related to science, regulatory policy, and the evaluation of products under the FDA’s jurisdiction. When the FDA has differing opinions on safety and efficacy requirements of medical products, certain products may be referred to an Advisory Committee for further data review by an impartial entity. To aid in this matter, the FDA has developed guidance detailing the process for assembling Advisory Committees. Since the resources required for convening these committees are significant, the FDA ensures there is substantial uncertainty or disagreement regarding the data. Advisory Committees will discuss the evidence and provide feedback with the goal of producing the most optimal evidence-based resolution. This part of the regulatory process is crucial to the agency’s regulatory decision-making as it involves unbiased parties and leads to transparency, upholding public safety, and maintaining public trust. However, there are times that FDA leadership disagrees with the votes of their Committees and proceeds with controversial approvals. One example of this scenario was approval of the drug Aduhelm. Aduhelm, which was marketed as a treatment for Alzheimer’s, received an overwhelmingly negative vote from the Advisory Committee to move forward with its approval for market distribution. Ten of eleven Committee members stated the data did not support adequate efficacy for approval. Nonetheless, the FDA granted accelerated approval, sparking resignations from a third of their Committee and outrage amongst the public. This disregard for expert opinion was viewed as the FDA exhibiting an approval bias, a perspective the public currently maintains of the FDA. 

In 2023, various organizations and coalitions, such as Doctors for America, Jacob’s Institute of Women’s Health, National Center for Health Research, TMJ Association and more publicly expressed concerns regarding the FDA’s leadership and their approach to drug approvals through a letter addressed to the FDA’s Chief Scientist, Dr. Namandje N. Bumpus. They highlighted FDA leadership had ignored claims by scientific staff that safety and efficacy standards were not being met for the drug Elevidys. Manufactured by Sarepta Therapeutics, Elevidys was granted accelerated approval by FDA leadership. Dr. Bumpus responded to this letter defending the FDA’s approval of Elevidys by referring to the agency’s comprehensive review of the data and consideration of the potential risks of the approved treatment, nature of the disease and its impact on patients, and the limited amount of therapies available. However, the response did little to quell public scrutiny of the controversial approval. Critics were apt to point out that the FDA had a record of approving products in this manner. Years prior, the FDA had approved the drug Eteplirsen for the treatment of duchenne muscular dystrophy (DMD), despite the objections of their scientific staff which disclosed a lack of evidence for the efficacy of this treatment. Criticism was also directed at FDA leadership suggesting the approval of some medical products were potentially due to favoritism toward companies seeking approval.

Resolving Internal FDA Disagreements

While it is acknowledged that the FDA must consider technological and political implications alongside scientific evidence in decision-making, it is essential to address the concerns of these organizations and coalitions. As part of an ongoing project to reform the FDA’s Advisory Committee system and assist the FDA with getting the advice needed to make the best evidence-based decisions, FAS engaged in discussions with current and former Advisory Committee members to seek their input on resolving disagreements between FDA staff and leadership. These conversations highlighted the breach of trust between the FDA, its staff, and the public.

Quotes from Experts

“FDA leadership needs to make is clear what data was used and why they’re moving forward when there is opposition”

“Disagreements should be addressed by a non-biased source because it affects the public safety.”

“There will be times where there are disagreements between staff and leadership. However, there’s a critical need for transparency within the FDA about why decisions are made. These are not decisions about evidence only. Ever.”

“Disagreements should be a matter of public scrutiny. There should be transparency that doesn’t jeopardize confidentiality.”

The FDA’s Commissioner has acknowledged the lack of trust within the institution and expressed a commitment to address the issue. There are many reasons for the lack of trust. However, one reason stems from the FDA’s approval of medical products despite clear opposition from its scientists and sometimes Advisory Committee members.

This raises the question of how the FDA intends to address these internal disagreements, which have the potential to impact the health and safety of the American public. Currently, the FDA has implemented a program called Scientific Dispute Resolution (SDR) to handle such conflicts. This document was initially developed in 2009 and recently updated in 2021 with the purpose of outlining the process for communication regarding internal scientific disputes within FDA Centers. It defines scientific disputes as disagreements that arise from the interpretation of science and the resulting decisions. This definition clearly distinguishes the circumstances in which the guidance should be utilized to resolve discrepancies between FDA scientists, statisticians, and their respective Center leadership. The guidance offers valuable examples of best practices for resolving formal and informal scientific disputes within the agency. Some of those best practices include, but are not limited to: 

However, it should be noted these best practice recommendations are not obligatory and their adoption is left to the discretion of the individual Centers. Furthermore, the document provides a process by which any of the internal parties involved can appeal the resolution of their dispute if they find it unsatisfactory through the Office of Research  Integrity at Health & Human Services (HHS).

Policy Recommendations

To increase morale and improve the approach and resolution of internal disagreements within the agency, the policy recommendations are as follows:

  1. Ensure that all FDA staff and leadership are fully cognizant of the existence and details of the Scientific Dispute Resolution at FDA guidance and the process for submitting disputes for review.
  2. Incorporate the Scientific Dispute Resolution at FDA guidance into FDA regulations
    1. Note: To incorporate this guidance into FDA regulations, the FDA will propose the regulation for OMB review. OMB will review and open the regulation up for public comment through the Federal Register. Responses to comments will be developed, and a final draft submitted to OMB for review. If approved, the final regulation will be published in the Code of Federal Regulations (Congressional Research Service, 2013). The involvement of Congress will not be necessary.
  3. Amend the Scientific Dispute Resolution at FDA guidance to dictate the mandatory execution of best practices within the dispute resolution process.
    1. This guidance should identify additional non-biased parties (that may not be government-affiliated) to provide impartial guidance on complex scientific matters affecting public safety. 
  4. Develop guidance that clearly explains a transparent process to communicate effectively with AdComm members regarding decision making when parties have opposing viewpoints
    1. Implementing a transparent process to communicate with AdComm members regarding differences between the agency and the AdComm will assist in improving morale between both parties, but also encourage continued support of the AdComm.
    2. This recommendation is also supported by a survey conducted by 3D Communications with 400+ AdComm members where 94% of members concurred that the FDA should develop a process to communicate their reasoning for decisions in opposition to Committee recommendations (3D Communications, 2024).

Conclusion

While FDA leadership ultimately holds the authority to grant approvals, it is crucial that the perspectives of all experts are duly considered. This includes the valuable input from the agency’s scientists, statisticians, and advisory committees. To regain public trust and restore integrity, it is imperative to first rebuild trust internally among the dedicated public servants within the FDA. Adoption of the aforementioned recommendations would start the trust-rebuilding process and lead to increased safety and precaution measures when approving drugs and medical devices.

Leveraging AdComm Membership

From January 2024 to July 2024, the Federation of American Scientists interviewed 30 current and former Advisory Committee (AdComm) members. Based on these discussions, we were able to source potential policy recommendations that may assist with enhancing the FDA’s ability to obtain valuable advice for evidence-based decision-making. The results of these discussions are presented in case study format detailing the recurring themes that emerged and policy recommendations for improvement.

The FDA relies on its scientific staff and Advisory Committees to provide conclusions from trial and study data, which aid in the process of regulating and approving medical products. Discussions have been centered around how to appropriately leverage the membership of Advisory Committee experts to assist with areas of difficulty surrounding the safety and efficacy of medical products. Nonetheless, the methods by which these systems currently generate the evidence the Government needs can be improved. This case study focuses on five key areas we believe can assist in fully utilizing the capacity in which AdComms serve and improve overall engagement with AdComms membership.

AdComm Membership Problems

Advisory Committees serve as the core for expert engagement in the Food and Drug Administration’s (FDA) decision-making processes and are composed of medical professionals, industry representatives, patient advocates, and scientific experts. Their primary role is to provide the FDA with informed advice and recommendations on issues spanning science, regulatory policy, and the evaluation of products under the FDA’s jurisdiction.

The intricacies of being an effective AdComm member, however, have been somewhat overlooked. Conversations with current and ex-members have highlighted areas for enhancement that would strengthen the function of AdComms and enrich the advice provided. Feedback indicated a lack of transparency in the FDA’s recruitment methods for committee positions, insufficient orientation or training for new members, limited understanding of regulatory procedures among members, and an onerous conflict of interest protocol that served as a deterrent for some members who were asked to return or renew their membership. 

Pathways to Improving AdComms Membership

Committee Composition

The composition of Advisory Committees vary depending on the charter that has been set in place. In some cases, committee composition has been set by law. However, where there is flexibility in determining the composition of a committee, consideration should be given to all categories of expertise that should be included and diversity of voices that are selected to participate in these meetings. Committee composition should reflect the diversity of the world and populations of whom their recommendations could potentially affect. For this reason, discussions with current and former Advisory Committee members indicated the need for three additional areas of expertise that should be included on all Committees. Insights discovered that all Committees should include a patient representative who has the knowledge from lived experience and understanding of how treatments affect day-to-day life. This recommendation was further corroborated by a 3D Communications survey conducted with 400+ FDA AdComm members where results indicated that 48% agreed there should be a patient and consumer representative on all Committees. Members also stated that pharmacists should be included because drugs and devices eventually pass through their hands to give to patients. Pharmacologists should serve on the Committee due to their clinical application knowledge of drugs and devices. Finally, a roster of temporary members should be created for varying categories to use when additional expertise is needed on a Committee because of a conflict of interest or when a certain skillset or knowledge base is lacking on the current Committee. 

Role of the Advisory Committee Chair

The FDA describes the purpose of an Advisory Committee chair as one who will “preside at committee meetings and ensure that all rules of order and conduct are maintained during each session”. The chair also has the responsibility of ensuring all recommendations and advice from AdComm members are clear and evidence-based. Moreover, the role of the chair should be used to enhance the overall committee experience as well as be of service to the FDA. Despite these requirements, there’s an underutilization of the chair’s role in terms of communication and stakeholder coordination, as evidenced by the chair not being listed as a primary point of contact for the Advisory Committee and a lack of coordination amongst stakeholders.

Chairpersons are usually selected due to their critical domain knowledge, understanding of best practices, ability to identify risks and keep members engaged, and expansive relationships within their industry. Maximizing the chairperson’s role requires discussion on how to utilize their valuable domain knowledge and professional networks. Chairs possess extensive networks that could support the identification of permanent or temporary expert participants for AdComms, aiding the FDA’s mission to recruit top talent for guidance. This would ensure the FDA’s continued success in recruiting the brightest minds in the industry to assist with providing advice. Additionally, chairs should have oversight in identifying relevant issues or products for their respective committees to appraise, which can provide another layer for the FDA to keep abreast of critical public concerns via appropriate committee evaluation. 

Training

Training is a significant part of many Federal Government service positions. However, besides ethics and conflict of interest trainings, there is no set training program in place for most new Advisory Committee members. Considering Advisory Committee members come from different professional backgrounds with varying levels of expertise, the FDA should develop an onboarding training program to assist with acclimating all new AdComm members into their roles. Many former and current AdComm members mentioned that no formal training was provided as part of the onboarding process. Some members who were new to the FDA AdComm process or who were not physicians or scientists stated they had no knowledge of statistical analyses, clinical trial design, or how the FDA views the role of the AdComm in the regulatory process. 

A foundational training, covering these aspects, would greatly benefit those members such as consumer and patient representatives who may lack this shared base of expertise. An investment in such an onboarding experience would promote stronger rapport among members and guarantee their preparedness in analyzing scientific and technical submissions.

Quotes from the Committee
“There should be basic training for all laypeople on the committee. This would help to prepare them for fulfilling their duties.”
“There should be an orientation that explains the relationship between the advisory committee and the FDA, and how the FDA thinks about this process.”

Learning about the FDA Regulatory Process

The Food & Drug Administration (FDA) was established with the purpose of regulating drugs and medical devices to ensure their safety and effectiveness for all citizens in the United States. Many Advisory Committee members join these committees without basic knowledge of the FDA’s regulatory process. During FAS’ discussions with current and former AdComm members, approximately 71% of members stated that basic knowledge of the regulatory process and how the FDA makes their decisions was unknown to them.

Providing AdComm members with an introductory course on the FDA’s regulatory process could enhance their comprehension, potentially allowing them to make more effective contributions and informed clinical decisions (based on their occupation). Although the FDA provides some online resources about its processes, like FAQs and guidelines, an expansion of this material should be considered for inclusion in AdComm orientation activities.  

Conflict of Interest (COI) Process

18 U.S.C. 208(a) prohibits Advisory Committee members who are designated as special government employees (SGE) from serving on federal advisory committees or any other Federal Government form of service that will have a “direct or predictable effect” on their financial interests. Similarly, the FDA describes a conflict of interest as an occurrence “when an individual selected to serve on an advisory committee has financial interests that may be impacted by the individual’s work on the advisory committee”. The auditing process for conflicts of interest is designed to confirm that the members of the advisory committee maintain impartiality and ensure the integrity of public health safety. Prior to any committee gathering, the FDA mandates that each participant, classified as either an AdComm member or SGE, complete an FDA 3410 form that reveals all financial connections that could be seen as potential COIs.

However, the process of what happens after the 3410 form has been completed is ambiguous. In 2007, the FDA submitted draft guidance to the federal register for comment entitled, Guidance for the Public, FDA Advisory Committee Members, and FDA Staff on Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees in an effort to determine if there is an inappropriate COI that should exclude members from participating in a committee meeting. Moreover, the official guidance is not easily accessible. Another draft guidance was developed with a detailed listing of considerations to be given when examining conflict of interests can be found in the FDA’s draft guidance on Procedures for Evaluating Appearance Issues and Granting Authorizations for Participation in FDA Advisory Committees.

Discussions with current and former AdComm members about the COI auditing process sparked varying views regarding whether flexibility should be exercised for COIs. 82% of members concurred that while they recognize the necessity for such a system, it tends to be overly demanding due to repetitive paperwork, especially when their circumstances remain unchanged. The strenuous nature of this routine has even deterred some from continuing their membership each year and remains a key aspect as to why members choose to end their service.

Despite having a COI process in place, there are loopholes that allow members with conflicts of interest to remain as voting members for specific AdComm meetings. A certain incident involved an Advisory Committee where 10 members who had financial ties to the sponsor were allowed to participate in an AdComm meeting. These individuals ultimately took part in endorsing the TriClip G4 System by Abbott and unanimously agreed that its benefits outweighed the potential risks. To further complicate matters, this information was not disclosed to the public at the time of approval.

While the COI process has resulted in members being rightfully disqualified from meetings due to actual or apparent conflicts, there is room to refine how these conflicts are identified and the standards employed to judge permissible COIs.

Policy Recommendations

In an effort to better leverage Advisory Committee membership, the potential policy recommendations are as follows:

Committee Composition

Role of the Chair

Training and Regulatory Process

COI Auditing Process

Conclusion

Advisory Committees are pivotal to maintaining trust with the public. It is essential for public safety to ensure that the most qualified experts are selected to serve on these Committees and that they have the tools to provide the FDA with informed and evidence-based recommendations. In an effort to increase public health safety, the FDA should enhance the AdComm structure by expanding the chair’s role, creating training programs for all new Advisory Committee members, and revising the conflict of interest procedures.