Summary

Public and active transportation are not equally accessible to all Americans. Due to a lack of sufficient infrastructure and reliable service for public transportation and active modes like biking, walking, and rolling, Americans must often depend on personal vehicles for travel to work, school, and other activities. During the past two years, Congress has allocated billions of dollars to equitable infrastructure, public transportation upgrades, and decreasing greenhouse gas pollution from transportation across the United States. The Department of Transportation (DOT) and its agencies should embrace innovation and partnerships to continue to increase active and public transportation across the country. The DOT should require grant applications for funding to discuss cross-agency collaborations, partner with the Department of Housing and Urban Development (HUD) to organize prize competitions, encourage public-private partnerships (P3s), and work with the Environmental Protection Agency (EPA) to grant money for transit programs through the Greenhouse Gas Reduction Fund. 

Challenge and Opportunity

Historically, U.S. investment in transportation has focused on expanding and developing highways for personal vehicle travel. As a result, 45% of Americans do not have access to reliable and safe public transportation, perpetuating the need for single-use vehicles for almost half of the country. The EPA reports that transportation accounts for 29% of total U.S. greenhouse gas emissions, with 58% of those emissions coming from light-duty cars. This large share of nationwide emissions from personal vehicles has short- and long-term climate impacts. 

Investments in green public and active transit should be a priority for the DOT in transitioning away from a personal-vehicle-dominated society and meeting the Biden Administration’s “goals of a 100% clean electrical grid by 2035 and net-zero carbon emissions by 2050.” Public and active transportation infrastructure includes bus systems, light rail, bus rapid transit, bike lanes, and safe sidewalks. Investments in public and active transportation should go towards a combination of electrifying existing public transportation, such as buses; improving and expanding public transit to be more reliable and accessible for more users; constructing bike lanes; developing community-owned bike share programs; and creating safe walking corridors. 

In addition to reducing carbon emissions, improved public transportation that disincentivizes personal vehicle use has a variety of co-benefits. Prioritizing public and active transportation could limit congestion on roads and lower pollution. Fewer vehicles on the road result in less tailpipe emissions, which “can trigger health problems such as aggravated asthma, reduced lung capacity, and increased susceptibility to respiratory illnesses, including pneumonia and bronchitis.” This is especially important for the millions of people who live near freeways and heavily congested roads. 

Congestion can also be financially costly for American households; the INRIZ Global Traffic Scorecard reports that traffic congestion cost the United States $81 billion in 2022. Those costs include vehicle maintenance, fuel cost, and “lost time,” all of which can be reduced with reliable and accessible public and active transportation. Additionally, the American Public Transportation Association reports that every $1 invested in public transportation generates $5 in economic returns, measured by savings in time traveled, reduction in traffic congestion, and business productivity. Thus, by investing in public transportation, communities can see improvements in air quality, economy, and health.

Public transportation is primarily managed at the local and state level; currently, over  6000 local and state transportation agencies provide and oversee public transportation in their regions. Public transportation is funded through federal, state, and local sources, and transit agencies receive funding from “passenger fares and other operating receipts.” The Federal Transit Administration (FTA) distributes funding for transit through grants and loans and accounts for 15% of total income for transit agencies, including 31% of capital investments in transit infrastructure. Local and state entities often lack sufficient resources to improve public transportation systems because of the uncertainty of ridership and funding streams.

Public-private partnerships can help alleviate some of these resource constraints because contracts can allow the private partner to operate public transportation systems. Regional and national collaboration across multiple agencies from the federal to the municipal level can also help alleviate resource barriers to public transit development. Local and state agencies do not have to work alone to improve public and active transportation systems. 

The following recommendations provide a pathway for transportation agencies at all levels of government to increase public and active transportation, resulting in social, economic, and environmental benefits for the communities they serve. 

Plan of Action

Recommendation 1. The FTA should require grant applicants for programs such as the Rebuilding American Infrastructure with Sustainability and Equity (RAISE) to define how they will work collaboratively with multiple federal agencies and conduct community engagement. 

Per the National Blueprint for Transportation Decarbonization, FTA staff should prioritize funding for grant applicants who successfully demonstrate partnerships and collaboration. This can be demonstrated, for example, with letters of support from community members and organizations for transit infrastructure projects. Collaboration can also be demonstrated by having applicants report clear goals, roles, and responsibilities for each agency involved in proposed projects. The FTA should: 

1. Develop a rubric for evaluating partnerships’ efficiency and alignment with national transit decarbonization goals. 
2. Create a tiered metrics system within the rubric that prioritizes grants for projects based on collaboration and reduction of greenhouse gas emissions in the transit sector.
3. Add a category to their Guidance Center on federal-state-local partnerships to provide insight on how they view successful collaboration. 

Recommendation 2. The DOT and HUD should collaborate on a prize competition to design active and/or public transportation projects to reduce traffic congestion. 

Housing and transportation costs are related and influence one another, which is why HUD is a natural partner. Funding can be sourced from the Highway Trust Fund, which the DOT has the authority to allocate up to “1% of the funds for research and development to carry out . . . prize competition program[s].”

This challenge should call on local agency partners to provide a design challenge or opportunity that impedes their ability to adopt transit-oriented infrastructure that could reduce traffic congestion. Three design challenges should be selected and publicly posted on the Challenge.gov website so that any individual or organization can participate. 

The goal of the prize competition is to identify challenges, collaborate, and share resources across agencies and communities to design transportation solutions. The competition would connect the DOT with local and regional planning and transportation agencies to solicit solutions from the public, whether from individuals, teams of individuals, or organizations. The DOT and HUD should work collaboratively to design the selection criteria for the challenge and select the winners. Each challenge winner would be provided with a financial prize of $250,000, and their idea would be housed on the DOT website as a case study that can be used for future planning decisions. The local agencies that provide the three design challenges would be welcome to implement the winning solutions.

Recommendation 3. Federal, state, and local government should increase opportunities for public-private partnerships (P3s). 

The financial investment required to develop active and public transportation infrastructure is a hurdle for many agencies. To address this issue, we make the following recommendations: 

• Currently, only 36 out of the 50 states have policies that allow the use of P3s. The remaining 14 states should pass legislation authorizing the use of P3s for public transportation projects so that they too can benefit from this financing model and access federal P3 funding opportunities. 
• In 2016, the DOT launched the Build America Bureau to assist with financing transportation projects. The Bureau administers the Transportation Infrastructure Finance and Innovation Act (TIFIA) program, which provides financial assistance through low-interest loans for infrastructure projects and leverages public-private partnerships to access additional private-sector funding. Currently, only about 30% of all loans through the TIFIA are used for public transit projects while 66% are used on tolls and highways. Local and regional agencies should use the TIFIA loan more to fund public and active transit projects.
• EPA should specify in its Greenhouse Gas Reduction Fund guidelines that public and active transit projects are eligible for investment from the fund and can leverage public and private partnerships. EPA is set to distribute $27 billion through the Fund for carbon pollution reduction: $20 billion will go towards nonprofit entities, such as green banks, that will leverage public and private investment to fund emissions reduction projects, with $8 billion allocated to projects in low-income and disadvantaged communities; $7 billion will go to state and local agencies and nonprofits in the form of grants or technical assistance to low-income and disadvantaged communities. EPA should encourage applicants to include public and active transportation projects, which can play a significant role in reducing carbon emissions and air pollution, in their portfolios. 

Conclusion

The road to decarbonizing the transportation sector requires public and active transportation. Federal agencies can allocate funding for public and active transit more effectively through the recommendations above. It’s time for the government to recognize public and active transportation as the key to equitable decarbonization of the transportation sector throughout the United States.

Summary 

The $350 billion space industry could grow to more than $1 trillion by 2040, spurring international interest in harnessing space resources. But this interest will bring with it a challenge: while existing international agreements like the Artemis Accords promote the peaceful and shared exploration of celestial bodies, they do little to address differences between existing scientific research activities and emerging opportunities like lunar mining, particularly for water ice at polar latitudes and in the perpetually shaded depths of certain craters. Lunar water ice will be a vital resource for outer space exploration and development efforts because it can be used to make hydrogen fuel cells, rocket fuel, and drinking water for astronauts. It will also be cheaper than transporting water from Earth’s surface into outer space, given the moon’s lower surface gravity and proximity to human space operations on its surface and beyond. The moon harbors other valuable long-term commodities like helium-3, the fuel needed for low-emissions nuclear fusion energy.

However, current multilateral agreements do not address whether nongovernmental operators can claim territory on celestial bodies for their use or own the resources they extract. Further, the space object registration process is currently used for satellites and other spacecraft while in orbit, but it does not include space objects intended for use on the surface of celestial bodies, such as mining equipment. These gaps leave few options for the United States or other Artemis Accords nations to resolve conflicts over territorial claims on a celestial body. In the worst-case scenario, this increasing competition for resources—especially with other major space powers like China and Russia—could escalate into military conflict. 

Adopting new treaties or amendments to the existing Outer Space Treaty (OST) for modern space use is a slow process that may fail to meet the urgency of emerging space resource issues. However, the United States has another diplomatic avenue for faster action: revision of the existing United Nations’ Guidelines for the Long-term Sustainability of Outer Space under the auspices of the U.N. Committee on the Peaceful Uses of Outer Space (COPUOS). Such a process avoids the decade-long deliberations of a formal treaty amendment. The United States should thus lead the development of multilateral protocols for extracting resources from celestial bodies by proposing two updates to either the COPUOS Guidelines, the OST, or both. First, there should be an updated registration process for all space objects, which should specify the anticipated location, timeline, and  type(s) of operation to establish usage rights on a particular part of a celestial body. Second, the United Nations should establish a dispute resolution process to allow for peaceful resolution of competing claims on celestial surfaces. These strategies will lay the necessary foundation for peacefully launching new mining operations in space.

Challenge and Opportunity 

Right now, outer space is akin to the Wild West, in that the opportunities for scientific innovation and economic expansion are numerous, yet there is little to no political or legal infrastructure to facilitate orderly cooperation between interested terrestrial factions. For example, any nation claiming mining rights to lunar territory is on shaky legal ground, at best: the Outer Space Treaty and the subsequent Guidelines for the Long-term Sustainability of Outer Space, promulgated by the U.N. Committee on the Peaceful Uses of Outer Space, do not provide legally sound or internationally recognized development rights, enforcement structures, or deconfliction mechanisms. If one claimant allegedly violates the territorial rights of another, what legal systems could either party use to press their case? Moreover, what mechanisms would avert potential escalation toward militarized conflict? Right now, the answer is none. 

This is an unfortunate obstacle to progress given the enormous economic potential of outer space development in the coming decades. To put the potential value in perspective, the emerging $350 billion space industry could grow to more than $1 trillion by 2040, motivating significant international interest. One potentially lucrative subset of operations is space mining, a sector valued at $1 billion today with a potential value of $3 billion by 2027. Once operational, space mining would be a valuable source of rare earth elements (e.g., neodymium, scandium, and others), 60% of which are currently produced in China. Rare earth elements are necessary for essential technologies such as electric vehicles, wind turbines, computers, and medical equipment. Additionally, in the event that nuclear fusion becomes commercially viable in the long-term future, space mining will be an essential industry for securing helium-3 (He-3), an abundant isotope found on the moon. Recent increases in fusion investment and a breakthrough in fusion research show the potential for fusion energy, but there is no guarantee of success. He-3 could serve as a critical fuel source for future nuclear fusion operations, an emerging form of energy production free of carbon emissions that could provide humanity with the means to address global climate and energy crises without losing energy abundance. The abundance of lunar He-3 could mean having access to secure clean energy for the foreseeable human future.

Furthermore, human exploration and development of outer space will require water, both in the form of drinking water for crewed missions and in the form of rocket propellant and fuel cell components for spacecraft. As it costs over $1 million to transport a single cubic meter of water from Earth’s surface into low Earth orbit, extracting water from the lunar surface for use in outer space operations could be substantially more economical due to the moon’s lower escape velocity—in fact, lunar water ice is estimated to be worth $10 million per cubic meter. 

The space mining sector and lunar development also offer promise far beyond Earth. Our moon is the perfect “first port of call” as humanity expands into outer space. It has lower surface gravity, polar ice deposits, and abundant raw materials such as aluminum, and its status as our closest celestial neighbor make it the ideal layover supply depot and launch point for spacecraft from Earth heading deeper into our solar system. Spacecraft could be launched from Earth with just enough fuel to escape Earth’s gravity, land and refuel on the moon, and launch far more efficiently from the moon’s weaker gravity elsewhere into the system. 

All in all, the vast untapped scientific and economic potential of our moon underscores the need for policy innovation to fill the gaps in existing international space law and allow the development of outer space within internationally recognized legal lines. The imperative for leading on these matters falls to the United States as a nation uniquely poised to lead the space mining industry. Not only is the United States one of the global leaders in space operations, but U.S. domestic law, including the Commercial Space Launch Competitiveness Act of 2015, provides the U.S. private sector some of the necessary authority to commercialize space operations like mining. However, the United States’ rapid innovation has also led the way to a growing space industry internationally, and the sector is now accessible to more foreign states than before. The internationalization of the space economy further highlights the gaps and failings of the existing space policy frameworks. 

Two main challenges must be addressed to ensure current governance structures are sufficient for securing the future of lunar mining. First is clarifying the rights of OST State Parties and affiliated nongovernmental operators to establish space objects on celestial bodies and to own the resources extracted. The OST, the primary governing tool in space (Figure 2), establishes that no State that signed the treaty may declare ownership over all or part of a celestial body like the moon. And despite the domestic authority bestowed by the 2015 Commercial Space Launch Competitiveness Act, the multilateral OST does not address whether nongovernmental operators can claim territory and own resources they extract from celestial bodies. Thus, the OST promotes the peaceful and shared exploration of space and scientific research but does little to address differences between research operations and new commercial opportunities like lunar mining. This leaves few options to resolve conflicts that may arise between competing private sector entities or States.

Even if domestic authorization of mining operations were sufficient, a second challenge has emerged: ensuring transparency and recordkeeping of different operations to maintain peaceful shared operations in space. Through the OST and the Registration Convention, States have agreed to inform the U.N. Secretary General of space activities and to maintain a record of registered space objects (including a unique identifier, the location and date of launch, and its orbital path). But this registration process covers space objects simply at a geospatial position in orbit, and there are gaps in the process for space objects intended for use on the surface of celestial bodies and whether a spacecraft that was designed for one purpose (i.e., landing) can be repurposed for another purpose (i.e., mining). This leaves little recourse for any group that seeks to peacefully pursue mining operations on the moon’s surface if another entity also seeks to use that land.

In spite of these gaps, the U.S. government has been able to move forward with scaling up moon-related space missions via NASA’s bipartisan Artemis Program and the corresponding Artemis Accords (Figure 1), a set of bilateral agreements with updated principles for space use. The Accords have 24 signatories who collectively seek to reap the benefits of emerging space opportunities like mining. In part, the Artemis Accords aim to remedy the policy gaps of previous multilateral agreements like the OST by explicitly supporting private sector efforts to secure valuable resources like He-3 and water ice.

But the Accords do not address the key underlying challenges that could stifle U.S. innovation and leadership in space mining. For instance, while the Accords reaffirm the need to register space objects and propose the creation of safety zones surrounding lunar mining operations, gaps still remain in describing exactly how to register operations on celestial objects. This can be seen in Section 7 of the Artemis Accords, which states that space objects need to be registered, but does not specify what would classify as a “space object” or if an object registered for one purpose can be repurposed for other operations. Further, the Accords leave little room to address broader international tensions stemming from increased resource competition in space mining. While competition can have positive outcomes such as spurring rapid innovation, unchecked competition could escalate into military conflict, despite provisions in the original OST to avoid this.

In particular, preemptive measures must be taken to alleviate potential tensions with other OST signatories in direct competition with the Accords. China and Russia are not party to the Accords and therefore do not need to abide by the agreement. In fact, these nations have declared opposition to the Accords and instead formed their own partnership to establish a competing International Lunar Research Station. As these programs develop concrete lunar applications, designating methods to determine who can conduct what type of operations on specific timelines and in specific locations will be a crucial form of anticipatory diplomacy.

Plan of Action 

The United States should propose that when any State registers a space object in advance of operations on a celestial body, it must specify the anticipated location of the operation; the timeline; and the type(s) of operation, described as “intent to” do one or more of the following: mine/extract resources for sale, conduct scientific research, or perform routine maintenance. This multilaterally developed process would clarify the means to register space objects for peaceful occupation of celestial object surfaces. 

Additionally, the United States should propose the implementation of a process for States to resolve disputes through either bilateral negotiation or arbitration through another mutually agreed-upon third party such as the International Court of Justice (ICJ) or the Permanent Court of Arbitration (PCA). Similar disputes related to maritime resource extraction under the United Nations Law of the Sea have been resolved peacefully using the aforementioned bilateral negotiations or third party arbitration. The new dispute resolution process would similarly allow for peaceful resolution of competing claims on celestial body surfaces and resources.

To guide the creation of a space object arbitration process, other such processes like the ICJ, PCA, and International Tribunal of the Law of the Sea can be used as models. The PCA has had success with halting unfair processes and setting up a dialogue between participating parties. It has helped smaller countries set up arbitration processes with bigger ones, such as Ecuador vs. the United States, in which the Republic of Ecuador instituted arbitral proceedings against the United States concerning the interpretation and application of an investment treaty between the two countries. In the short term, existing negotiation avenues will likely be sufficient to allow for dispute resolution. However, as the space industry continues to grow, it may eventually be necessary to establish an internationally recognized “Space Court” to arbitrate disputes. The International Tribunal for the Law of the Sea provides an example of the type of international body that could arbitrate space disputes.

These anticipatory diplomacy steps could be implemented in one of three ways: 

1. As a binding amendment to the OST: This would require the most time to implement, but this would also make it enforceable and binding, an obvious advantage. It would also provide an opportunity to bring all the important players to the table, specifically the parties who did not sign the Artemis Accords, and would help to start a discussion on the improvement of diplomatic relations for future space operations.
2. As a nonbinding update to COPUOS Guidelines: This would be faster to implement, but would not be enforceable or binding.
3. As an update to the COPUOS Guidelines followed by an amendment to the OST: This would allow for both quick action in the nearer term and a permanent and enforceable implementation longer-term. Implementing a revised COPOUS could be a precursor to build support for the nonbinding updates to COPUOS. If the model is successful, State Parties would be more likely to agree to a binding amendment to OST. However they are implemented, these two proposed anticipatory diplomacy steps would improve the ability of space faring nations to peacefully use resources on celestial bodies.

Could this be done through bilateral agreements? After all, the United States has shown diplomatic initiative by entering into agreements with countries such as France, Germany, and India with the aim of using space for peaceful purposes and cooperation, though they don’t explicitly mention mining. But a bilateral process does not offer good prospects for global solutions. For one, it would be very slow and time-consuming for the United States to enter into bilateral agreements with every major country with stakes in lunar mining. If space mining agreements were to occur on a similar timeline to bilateral trade agreements, each agreement could take from one to six years to take effect. A crucial obstacle is the Wolf Amendment, which prevents the United States from entering into bilateral agreements with China, one of the its major competitors in the space industry. This restriction makes it hard to negotiate bilaterally with an important stakeholder concerning space mining.

Further, reaching these agreements would require addressing aspects of the Accords that have made many major stakeholder countries hesitant to sign on. Thus, an easier path would be to operate diplomatically through the COPUOS, which already represents 95 major countries and oversees the existing multilateral space treaties and potential amendments to them. This approach would ensure that the United States still has some power over potential amendment language but would bring other major players into some sort of dialogue regarding the usage of space for commercial purposes. 

While the COPUOS guidelines are not explicitly binding, they do provide a pathway for verification and arbitration, as well as a foundation for the adoption of a binding amendment or a new space treaty moving forward. Treaty negotiations are a slow, lengthy process; the OST required several years of work before it took full effect in 1967. With many Artemis Program goals reliant upon successful launches and milestones achieved by 2025, treaty amendments are not the timeliest approach. Delays could also be caused by the fact that some parties to the OST may have reservations about adopting an amendment for private sector space use due to another space treaty, the Moon Agreement. This agreement, which the United States is not party to, asserts that “the Moon and its natural resources are the common heritage of mankind and that an international regime should be established to govern the exploitation of such resources when such exploitation is about to become feasible.” Thus, countries that have signed the Moon Agreement probably want the moon to operate like a global commons with all countries on Earth having access to the fruits of lunar mining or other resource extraction. Negotiations with these nations will require time to complete.

The U.S. State Department’s Office of Space Affairs, under the Bureau of Oceans and Environmental and Scientific Affairs (OES), is the lead office for space diplomacy, exploration, and commercialization and would be the ideal office to craft the required legislation for an OST amendment. Additionally, the Office of Treaty Affairs, which is often tasked with writing up the legal framework of treaties, could provide guidance on the legislation and help initiate the process within the U.S. State Department and the United Nations. Existing U.S. law like the Commercial Space Launch Competitiveness Act, and international treaties like OST and Registration Convention, provide authority for these proposals to be implemented in the short term. However, negotiation of updates to COPOUS Guidelines and amendments to the OST and other relevant space treaties over the next 5 to 10 years will be essential to their long term success.

Finally, the Federal Aviation Administration (FAA) at the Department of Transportation would be the logical federal agency to initially lead implementing the updated registration process for U.S.-affiliated space objects and for verifying the location and intended use of space objects from other nations. FAA implements the current U.S. process for space objects registration. In the long term it could be appropriate to transfer responsibility for space object registration to the rapidly growing Office of Space Commerce (OSC) at the Department of Commerce. Moving responsibilities for implementing space object registration and verification to the OSC would provide opportunities for the office to expand with the rapidly expanding space industry. This change would also allow the FAA to focus on its primary responsibilities for regulating the domestic aerospace industry. 

Conclusion

Douglas Adams may have put it best: “Space is big. You just won’t believe how vastly, hugely, mind-bogglingly big it is.” While Adams was describing the sheer size of space, this description applies just as well to the scale of outer space’s scientific and economic prospects. After all, any new economic theater that will grow into a multi-trillion dollar market in just a few decades is not to be taken lightly. But without a plan to avert and resolve potential conflicts with other outer space actors, the United States’ future efforts in this emerging theater will be hamstrung. Improved collaboration on space mining provides an opportunity to promote international cooperation and economic development, while military conflict in space poses high risks to the economic potential of the current and future space industry. Transparent and widely agreed-upon frameworks would allow for peaceful competition on scientific research and resource extraction on celestial objects.

Lunar mining has shown promise for providing access to water ice, rare earth metals, He-3, and other raw materials crucial for the further exploration of space. Providing a peaceful and secure source of these materials would build on the bipartisan Commercial Space Launch Competitiveness Act’s guidelines for space resource extraction and, in the long run, further enable the modernization and decarbonization of the U.S. electric grid for public benefit. 

In order to promote the peaceful exploration and development of space, we must update existing international law—either the COPUOS Guidelines, the OST, or both—to clarify the locations, timeline, and types of outer space operations conducted by state actors. We must also propose deconfliction mechanisms for OST parties to resolve disputes peacefully via bilateral negotiation or arbitration by a mutually acceptable third party like the ICJ or PCA. Just as the United States led the world into the “final frontier” in the 20th century, so too must we lead the next chapter in the 21st. If implemented successfully, the anticipatory space diplomacy we propose will allow for the shared peaceful use of celestial bodies for decades to come.

Acknowledgments

Dr. Sindhu Nathan provided valuable insights into the writing of this memo.

Summary

Federal, state, local, tribal, and territorial agencies collect and maintain a range of disaster resilience, vulnerability, and loss data. However, this valuable data lives on different platforms and in various formats across agency silos. Inconsistent data collection and lack of validation can result in gaps and inefficiencies and make it difficult to implement appropriate mitigation, preparedness, response, recovery, and adaptation measures for natural hazards, including wildfires, smoke, drought, extreme heat, flooding, and debris flow. Lack of complete data down to the granular level also makes it challenging to gauge the true cost of disasters.

The Biden-Harris Administration should launch an Open Disaster Data Initiative to mandate the development and implementation of national standards for disaster resilience, vulnerability, and loss data to enable federal, state, local, tribal, and territorial agencies to regularly collect, validate, share, and report on disaster data in consistent and interoperable formats.

Challenge and Opportunity

Disaster resilience, vulnerability, and loss data are used in many life-saving missions, including early detection and local response coordination, disaster risk assessments, local and state hazard mitigation plans, facilitating insurance and payouts, enabling rebuilding and recovery, and empowering diverse communities to adapt to climate impacts in inclusive, equitable, and just ways. 

While a plethora of tools are being developed to enable better analytics and visualizations of disaster and climate data, including wildfire data, the quality and completeness of the data itself remains problematic, including in the recently released National Risk Index. 

This is because there is a lack of agency mandates, funding, capacity, and infrastructure for data collection, validation, sharing, and reporting in consistent and interoperable formats. Currently, only a few federal agencies have the mandate and funds from Congress to collect disaster data relevant to their mission. Further, this data does not necessarily integrate state and local data for non-federally declared disasters. 

Due to this lack of national disaster and climate data standards, federal and state agencies, universities, nonprofits, and insurers currently maintain disaster-related data in silos, making it difficult to link in productive and efficient ways down to the granular level. 

Also, only a few local, state, and federal agencies regularly budget for or track spending on disaster resilience, vulnerability, and response activities. As a result, local agencies, nonprofits, and households, particularly in underserved communities, often lack access to critical lifesaving data. Further, disaster loss data is often private and proprietary, leading to inequality in data access and usability. This leaves already disadvantaged communities unprepared and with only a limited understanding of the financial burden of disaster costs carried by taxpayers. 

Since the 1990s, several bipartisan reviews, research, data, and policy documents, including the recent President’s Council of Advisors on Science and Technology (PCAST) report on modernizing wildland firefighting, have reiterated the need to develop national standards for the consistent collection and reporting of disaster vulnerability, damage, and loss data. Some efforts are under way to address the standardization and data gaps—such as the all-hazards dataset that created an open database by refining the Incident Command System data sets (ICS-209). 

However, significant work remains to integrate secondary and cascading disasters and monitor longitudinal climate impacts, especially on disadvantaged communities. For example, the National Interagency Fire Center consolidates major wildfire events but does not currently track secondary or cascading impacts, including smoke (see AirNow’s Fire and Smoke Map), nor does it monitor societal vulnerabilities and impacts such as on public health, displacement, poverty, and insurance. There are no standardized methods for accounting and tracking damaged or lost structures. For example, damage and loss data on structures, fatalities, community assets, and public infrastructure is not publicly available in a consolidated format. 

The Open Disaster Data Initiative will enable longitudinal monitoring of pre- and post-event data for multiple hazards, resulting in a better understanding of cascading climate impacts. Guided by the Open Government Initiative (2016), the Fifth National Action Plan (2022), and in the context of the Year of Open Science (2023), the Open Disaster Data Initiative will lead to greater accountability in how federal, state, and local governments prioritize funding, especially to underserved and marginalized communities. 

Finally, the Open Disaster Data Initiative will build on the Justice40 Initiative and be guided by the recommendations of the PCAST Report on Enhancing prediction and protecting communities. The Open Disaster Data Initiative should also reiterate the Government Accountability Office’s 2022 recommendation to Congress to designate a federal entity to develop and update climate information and to create a National Climate Information System. 

Precedents 

Recent disaster and wildfire research data platforms and standards provide some precedence and show how investing in data standards and interoperability can enable inclusive, equitable, and just disaster preparedness, response, and recovery outcomes.

The Open Disaster Data Initiative must build on lessons learned from past initiatives, including:

• the National Weather Service’s (NWS) Storm Events database, which collects meteorological data on when and where extreme events occur, along with occasional but unverified estimates of socioeconomic impacts.
• the Centers for Disease Control’s (CDC) COVID-19 Data Modernization Initiative, which attempts to  harmonize data collection and reporting across national, tribal, state, and local agencies. 
• the National Oceanic and Atmospheric Administration’s (NOAA) National Integrated Drought Information System (NIDIS), a multiagency partnership that coordinates drought monitoring, forecasting, planning, and information at national, tribal, state, and local levels but is impacted by inconsistent data reporting.
• the Federal Emergency Management Agency (FEMA)’s OpenFEMA initiative, which shares vast amounts of data on multiple aspects of disaster outcomes, including disaster assistance, hazard mitigation investments, the National Flood Insurance Program, and grants, but requires technical expertise to access and utilize the data effectively.
• FEMA’s National Risk Index, which maps the nation’s resilience, vulnerability, and disaster losses at county and census tract levels but shows shortcomings in capturing the risk of geophysical events such as earthquakes and tsunamis. In late 2022, Congress passed the Community Disaster Resilience Zones Act (P.L. 117-255), which codifies the National Risk Index. The goal is to support the census tracts with the highest risk rating with financial, technical, and other forms of assistance. 

There are also important lessons to learn from international efforts  such as the United Nations’ ongoing work on monitoring implementation of the Sendai Framework for Disaster Risk Reduction (2015–2030) by creating the next generation of disaster loss and damage databases, and the Open Geospatial Consortium’s Disaster Pilot 2023 and Climate Resilience Pilot, which seek to use standards to enable open and interoperable sharing of critical geospatial data across missions and scales. 

Plan of Action

President Biden should launch an Open Disaster Data Initiative by implementing the following four actions.

Recommendation 1. Issue an Executive Order to direct the development and adoption of national standards for disaster resilience, vulnerability, and loss data collection, validation, sharing, and reporting, by all relevant federal, state, local, tribal, and territorial agencies to create the enabling conditions for adoption by universities, non-profits, and the private sector. The scope of this Executive Order should include data on local disasters that do not call for a Presidential Disaster Declaration and federal assistance.

Recommendation 2. Direct the Office of Management and Budget (OMB) to issue an Open Disaster Data Initiative Directive for all relevant federal agencies to collaboratively implement the following actions:

• Direct the National Council on Science and Technology to appoint a subcommittee to work with the National Institute of Standards and Technology to develop national standards for disaster resilience, vulnerability, and loss data collection, sharing, and reporting, by all relevant federal, state, local, tribal, and territorial agencies, as well as by universities, nonprofits, and the private sector. 
• Direct all relevant federal agencies to adopt national standards for disaster resilience, vulnerability, and loss data collection; validation; sharing; and reporting to address ongoing issues concerning data quality, completeness, integration, interoperability, accessibility, and usability.

• Develop federal agency capacities to accurately collect, validate, and use disaster resilience, vulnerability, and loss data, especially as it relates to population estimates of mortality, morbidity, and displacements, including from extreme heat and wildfire smoke.
• Direct FEMA to coordinate and implement training for state, local, tribal, and territorial agencies on how to collect disaster resilience, vulnerability, and loss data in line with the proposed national standards. Further, building on the FEMA Data Strategy 2023-2027 and in line with OpenFEMA, FEMA should review its private and sensitive data sharing policy to ensure that disaster data is publicly available and useable. FEMA’s National Incident Management System will be well positioned to cut across hazard mission silos and offer wide-ranging operational support and training for disaster loss accounting to federal, state, local, tribal, and territorial agencies, as well as nonprofit stakeholders, in coordination with FEMA’s Emergency Management Institute.

Recommendation 3. Designate a lead coordinator for the Open Disaster Data Initiative within the Office of Science Technology and Policy (OSTP), such as the Tech Team, to work with the OMB on developing a road map for implementing the Open Disaster Data Initiative, including developing the appropriate capacities across all of government.

Recommendation 4. Direct FEMA to direct appropriate funding and capacities for coordination with the National Weather Service (NWS), the U.S. Department of Agriculture’s Risk Management Agency, and the National Centers for Environmental Information (NCEI) to maintain a federated, open, integrated, and interoperable disaster data system that can seamlessly roll up local data, including research, nonprofit, and private, including insurance data. 

In addition, Congress should take the following three actions to ensure success of the Open Disaster Data Initiative:

Recommendation 5. Request the Government Accountability Office to undertake a Disaster Data Systems and Infrastructure Review to:

• Inform the development of national standards and identify barriers for accurate disaster data collection, validation, accounting, and sharing between federal, state, local, tribal, and territorial agencies, as well as the philanthropic and private sector. 
• Review lessons learned from precedents (including NWS’s Storm Events database, CDC’s Data Modernization Initiative, NOAA’s NIDIS, and FEMA’s National Risk Index). 
• Form the basis for the OMB and the OSTP to designate an appropriate budget and capacity commitment and suggest a national framework/architecture for implementing an Open Disaster Data Initiative. 

Recommendation 6. Appropriate dedicated funding for the implementation of the Open Disaster Data Initiative to allow federal agencies, states, nonprofits, and the private sector to access regular trainings and develop the necessary infrastructure and capacities to adopt national disaster data standards and collect, validate, and share relevant data. This access to training should facilitate seamless roll-up of disaster vulnerability and loss data to the federal level, thereby enabling accurate monitoring and accounting of community resilience in inclusive and equitable ways.

Recommendation 7. Use the congressional tool of technical corrections to support and enhance the Initiative:

• Pass Technical Corrections and Improvements to the Community Disaster Resilience Zones Act to include provisions for the collection, sharing, and reporting of disaster resilience, vulnerability, and loss data by all relevant federal, state, local, tribal, and territorial agencies and academic, private, community-based, and nonprofit entities, in consistent and interoperable formats, and in line with the proposed national disaster data standards. Technical corrections language could point to the requirement to “review the underlying collection and aggregation methodologies as well as consider the scoping of additional data the agency (ies) may be collecting.” This language should also direct agencies to review dissemination procedures for propriety, availability, and access for public review. The scope of this technical correction should include local disasters that do not call for a Presidential Disaster Declaration and federal assistance. 
• Pass Technical Corrections and Improvements or suspension bill to the ​​Disaster Recovery Reform Act, section 1223 which mandates a study of information collection or section 1224, which requires publication of said data accessible to the public would complement the above by tasking FEMA to study, aggregate, and share information with the public in a way that is digestible and actionable. 

Conclusion

The Open Disaster Data Initiative can help augment whole-of-nation disaster resilience in at least three ways: 

1. Enable enhanced data sharing and information coordination among federal, state, local, tribal, and territorial agencies, as well as with universities, nonprofits, philanthropies, and the private sector.
2. Allow for longitudinal monitoring of compounding and cascading disaster impacts on community well-being and ecosystem health, including a better understanding of how disasters impact poverty rates, housing trends, local economic development, and displacement and migration trends, particularly among disadvantaged communities.
3. Inform the prioritization of policy and program investments for inclusive, equitable, and just disaster risk reduction outcomes, especially in socially and historically marginalized communities, including rural communities.

Summary  

The advancement and commercialization of bioprocesses in the United States is hindered by a lack of suitable and available pilot-scale and manufacturing-scale facilities. This challenge stems in part from our inability to repurpose facilities that are no longer needed due to a lack of standardization and inadequate original design. Historically, most biomanufacturing facilities have been built with a single product in mind and with a focus on delivering a facility as cheaply and quickly as possible. While this might be the best approach for individual private companies, it is not the best approach for the bioeconomy as a whole. The Biden-Harris Administration should establish a program to standardize the construction of biomanufacturing facilities across the United States that also permits facilities to be repurposed for different products in the future. 

Through government-incentivized standardization, better biomanufacturing facilities can be built that can be redeployed as needed to meet future market and governmental needs and ultimately solve our nation’s lack of biomanufacturing capacity. This program will help protect U.S. investment in the bioeconomy and accelerate the commercialization of biotechnology. Enforcement of existing construction standards and the establishment of new standards that are strictly adhered to through a series of incentivization programs will establish a world-leading biomanufacturing footprint that increases supply resilience for key products (vaccines, vitamins, nutritional ingredients, enzymes, renewable plastics), reduces reliance on foreign countries, and increases the number of domestic biomanufacturing jobs. Furthermore, improved availability of pilot-scale and manufacturing-scale facilities will accelerate growth in biotechnology across the United States.

This memo details a framework for developing and deploying the necessary standards to enable repurposing of biomanufacturing facilities in the future. A team of 10–12 experts led by the National Institute for Standards and Technology (NIST) should develop these standards. A government-sponsored incentivization program with an estimated cost of $50 million per year would then subsidize the building of new facilities and recognition of participating companies.

Challenge and Opportunity 

Currently, the United States faces a shortage in both pilot-scale and manufacturing-scale biomanufacturing facilities that severely hinders product development and commercialization. This challenge is particularly large for the fermentation industry, where new facilities take years to build and require hundreds of millions of dollars in infrastructure investment. Many companies rely on costly foreign assets to advance their technology or delay their commercialization for years as they wait for access to one of the limited contract pilot or manufacturing facilities in the United States. 

Why do we have such a shortage of these facilities? It is because numerous facilities have been shut down due to changing market conditions, failed product launches, or bankruptcy. When the facilities were ultimately abandoned and dismantled for scrap, the opportunity to repurpose expensive infrastructure was lost along with them. 

Most U.S. biomanufacturing facilities are built to produce a specific product, making it difficult to repurpose them for alternative products. Due to strict financing and tight timelines for commercialization, companies often build the minimally viable facility, ultimately resulting in a facility with niche characteristics specific to their specific process and that has a low likelihood of being repurposed. When the facility is no longer needed for its original purpose—due to changes in market demand or financial challenges—it is very unlikely to be purchased by another organization. 

This challenge is not unique to the biomanufacturing industry. In fact, even in the highly established automotive industry, less than half of its manufacturing facilities are repurposed. The rate of repurposing biomanufacturing facilities is much lower, given the lower level of standardization. Furthermore, nearly 30% of currently running biomanufacturing facilities have some idle capacity that could be repurposed. This is disappointing considering that many of these biomanufacturing facilities have similar upstream operations involving a seed bioreactor (a small bioreactor to be used as inoculum for a larger vessel) to initiate fermentation followed by a production reactor and then harvest tanks. Downstream processing operations are less similar across facilities and typically represent far less than half the capital required to build a new facility.

The United States has been a hot spot for biotech investment, with many startups and many commercial successes. We also have a robust supply of corn dextrose (a critical input for most industrial fermentation), reasonable energy costs, and the engineering infrastructure to build world-class biomanufacturing facilities providing advantages over many foreign locations. Our existing biomanufacturing footprint is already substantial, with hundreds of biomanufacturing facilities across the country at a variety of scales, but the design of these facilities lacks the standardization needed to meet the current and future needs of our biomanufacturing industry. There have been some success stories of facilities being repurposed, such as the one used by Gevo for the production of bio-butanol in Minnesota or the Freedom Pines facility in Georgia repurposed by LanzaTech. 

However, there are numerous stories of facilities that were unable to be repurposed, such as the INEOS facility that was shuttered in India River, Florida. Repurposing these facilities is challenging for two primary reasons: 

1. A lack of forethought that the facility could be repurposed in the future (i.e., no space for additional equipment, equipment difficult to modify, materials of construction that do not have broad range of process compatibility). 
2. A lack of standardization in the detailed design (materials of construction, valve arrangements, pipe sloping, etc.) that prevents processes with higher aseptic requirements (lower contamination rates) from being implemented. 

In order to increase the rate at which our biomanufacturing facilities are repurposed, we need to establish the policies and programs to make all new biomanufacturing facilities sustainable, more reliable, and capable of meeting the future needs of the industry. These policies and associated standards will establish a minimum set of guidelines for construction materials, sterilizability, cleanability, unit operation isolation, mixing, aeration, and process material handling that will enable a broad range of compatibility across many bioprocesses. As a specific example, all fermentors, bioreactors, and harvest tanks should be constructed out of 316L grade stainless steel minimum to ensure that the vast majority of fermentation and cell culture broths could be housed in these vessels without material compatibility concerns. Unfortunately, many of the U.S. biomanufacturing facilities in operation today were constructed with 304 grade stainless steel, which is incompatible with high-salt or high-chloride content broths. Furthermore, all process equipment containing living microorganisms should be designed to aseptic standards, even if the current product is not required to be axenic (absent of foreign microorganisms). 

These standards should focus on upstream equipment (fermentors, media preparation tanks, sterilization systems), which are fairly universal across the food, pharma, and industrial biotech industries. While there are some opportunities to apply these standards to downstream process equipment, the downstream unit operations required to manufacture different biotech products vary significantly, making it more challenging to repurpose equipment. 

Fortunately, guiding principles covering most factors that need to be addressed have already been developed by experts in the American Society of Mechanical Engineers (ASME), Bioprocess Equipment (BPE), and the International Society for Pharmaceutical Engineering (ISPE). These standards cover the gamut of biomanufacturing specifications: piping, mixing, valves, construction materials, and, in some cases, the design of specific unit operations. Companies are often forced to decide between following best practices in facility design and making tight timelines and budgets. 

Following these standards increases capital costs of the associated equipment by 20% to 30%, and can extend construction timelines, preventing companies from adopting the standards even though it directly improves their top or bottom line by improving process reliability. Our biggest gap today is not ability to standardize but rather the incentivization to standardize. If the government provides incentives to adopt these standards, many companies will participate as it is widely recognized that these standards will result in facilities that are more reliable and more flexible for future products. 

The National Institute for Standards and Technology (NIST) should initiate a program focused on biomanufacturing standards. The proposed program could be housed or coordinated out of a new office at the NIST—for example, as described in the previously proposed “Bio for America Program Office (BAPO)”—which should collaborate closely with the Office of the Secretary of Commerce and the Under Secretary of Commerce for Standards and Technology, as well as additional government and nongovernmental stakeholders as appropriate. NIST is the appropriate choice because it harbors cross-disciplinary expertise in engineering, and the physical, information, chemical, and biological sciences; is a nonregulatory agency of the U.S. Department of Commerce, whose mission it is “to drive U.S. economic competitiveness, strengthen domestic industry, and spur the growth of quality jobs in all communities across the country”; and is a neutral convener for industry consortia, standards development organizations, federal labs, universities, public workshops, and interlaboratory comparability testing.

Plan of Action 

The Biden-Harris Administration should sponsor an initiative to incentivize the standardization that will enables the repurposing of biomanufacturing facilities, resulting in a more integrated and seamless bioeconomy. To do so, Congress should appropriate funds for a program focused on biomanufacturing standards at NIST. This program should:

• Develop a set of design and construction standards that enable facilities to be efficiently repurposed for different products in the future.
• Create, in collaboration with other government agencies, an incentivization program to encourage participation.
• Recognize participating companies with a certification.
• Track the program’s impact by measuring the rate of facility repurposing long-term.

First, the program will need to be funded by Congress and stood up within NIST. The award amounts will vary based on the facility size, but it is estimated that each participating company will receive $6 million on average, leading to a total program cost in the range of $30 million to $50 million per year. While the costs might seem high, the investment is at reduced risk by design, since facilities that adopt the program are better equipped to be repurposed should the original company abandon the facility. 

Next, design and building standards would be defined that ensure the highest chance of redeployment along with reliable operation. While relevant standards exist (i.e., ASME BPE Standards), they should be refined and elaborated by an expert panel established by NIST with the purpose of promoting repurposing. The adoption rate of the existing nonmandatory standards is low, particularly outside of the pharma industry. This new NIST program should establish a panel of experts, including industry and government representatives, to fully develop and publish these standards. A panel of 10–12 members could develop these standards in one year’s time. Thereafter, the panel could be assembled regularly to review and update these standards as needed. 

Once the standards are published, NIST should launch (and manage) a corresponding incentivization program to attract participation. The program should be designed such that an estimated 50% incremental cost savings would be achieved by adhering to these standards. In other words, the improved infrastructure established by following the standards would not be fully subsidized, but it would be subsidized at the rate of 50%. The NIST program could oversee applicants’ adherence to the new standards and provide awards as appropriate. NIST should also work with other federal government agencies that support development of biomanufacturing capacity (e.g., Department of Energy [DOE], Department of Defense [DoD], and Department of Agriculture [USDA]) to explore financial incentives and funding requirements to support adherence with the standards. 

In addition, the government should recognize facilities built to the new standards with a certification that could be used to strengthen business through customer confidence in supply reliability and overall performance. NIST will publish a list of certified facilities annually and will seek opportunities to recognize companies that broadly participate as a way to recognize their adoption of this program. Furthermore, this type of certification could become a prerequisite for receiving funding from other government organizations (i.e., DoE, DoD, USDA) for biomanufacturing-related funding programs.

Last, to measure the program’s success, NIST should track the rate of redeployment of participating facilities. The success rate of redeployment of facilities not participating in the program should also be tracked as a baseline. After 10 years, at least a twofold improvement in redeployment rate would be expected. If this does not occur, the program should be reevaluated and an investigation should be conducted to understand why the participating facilities were not redeployed. If needed, the existing biomanufacturing standards should be adjusted.

Conclusion 

Given the large gap in biomanufacturing assets needed to meet our future needs across the United States, it is of paramount importance for the federal government to act soon to standardize our biomanufacturing facilities. This standardization will enable repurposing and will build a stronger bioeconomy. By establishing a program that standardizes the design and construction of biomanufacturing facilities across the country, we can ensure that facilities are built to meet the industry’s long-term needs—securing the supply of critical products and reducing our reliance on foreign countries for biomanufacturing needs. In the long run, it will also spur biotech innovation, since startup companies will need to invest less in biomanufacturing due to the improved availability of manufacturing assets.

Summary

Entrepreneurship and innovation are crucial for sustained community development, as new ventures create new jobs and wealth. As entrepreneurs start and grow their companies, access to capital is a significant barrier. Communities nationwide have responded by initiating programs, policies, and practices to help entrepreneurs creatively leverage philanthropic dollars, government grants and loans, and private capital. But these individually promising solutions collectively amount to a national patchwork of support. Those who seek to scale promising ideas face a funding continuum that is filled with gaps, replete with high-transaction costs, and highly variable depending on each entrepreneur’s circumstances. 

To help entrepreneurs better and more reliably access capital no matter where in the country they are, the Small Business Administration (SBA) should work with the other Interagency Community Investment Committee (ICIC) agencies to expand the SBA’s secondary market capacity. The SBA’s secondary market allows lenders to sell the guaranteed portion of a loan backed by the SBA. This provides additional liquidity to lenders, which in turn expands the availability of commercial credit for small businesses. However, there is no large standardized secondary market for debt serviced by other federal agencies, so the benefits of a secondary market are limited to only a portion of federal lending programs that support entrepreneurship. Expanding SBA’s secondary market authority would increase access to large pools of private capital for a larger proportion of entrepreneurs and innovative small businesses. 

As a first step towards this goal, one or several agencies should enter into a pilot partnership with SBA to use SBA’s existing administrative authority and infrastructure to enable private lenders to sell other forms of federally securitized loans. Once proven, the secondary market could be expanded further and permanently established as a government-sponsored enterprise (GSE). This GSE would provide accessible capital for entrepreneurs and small businesses in much the same way that the GSEs Fannie Mae and Freddie Mac provide accessible capital, as mortgages, for prospective homeowners.

With the 118th Congress considering the reauthorization of SBA for the first time in 22 years, there is an opportunity to seize on this reauthorization to modernize the SBA. Piloting the SBA’s secondary market capacity is a crucial piece of modernization to increase access to capital for entrepreneurs. 

Challenge and Opportunity

Access to capital changes the economic trajectory of individuals and communities. Approved small business loan applicants, for instance, report average income increases of more than 10% five years after loan approval. Unfortunately, capital for budding entrepreneurs is scarce and inequitably allocated. Some 83% of budding entrepreneurs never access adequate capital to start or grow their business. Success rates are even lower for demographic minorities. And when entrepreneurs can’t access capital to start their business, the communities around them suffer, as evidenced by the fact that two out of every three new jobs over the past 25 years has been generated by small businesses. 

The vast majority of new businesses in the United States are funded by personal or family savings, business loans from banks or financial institutions, or personal credit cards. Venture capital is used by only 0.5% of entrepreneurs because most entrepreneurs’ businesses are not candidates for it. Public and mission-driven lending efforts are valiant but can’t come close to matching the scale of this untapped potential. Outside of the COVID-19 emergency response, the SBA annually appropriates $1–2 billion for lending programs. The Urban Institute found that between 2011 and 2017, Chicago alone received $4 billion of mission-driven lending that predominantly went toward communities of color and high-poverty communities. But during the same time period, Chicago also received over $67 billion of market investment—most of which flowed to white and affluent neighborhoods.

Communities across the country have sought to bridge this gap with innovative ideas to increase access to private capital, often by leveraging federal funding or federal programmatic infrastructure. For example: 

• The Entrepreneur Backed Asset Fund is a philanthropically funded initiative that creates a secondary market for microloans made through Community Development Financial Institutions (CDFIs). This idea came from an experienced microlender who was frustrated with the illiquidity of microloans and subsequent need to constantly engage in time-consuming philanthropic fundraising. 
• ESO Ventures is a nonprofit organization out of East Oakland, California, that combines competency-based curriculum and access to capital. As entrepreneurs grow their skills through the program, they receive access to increasing lines of credit to apply those new skills to their businesses. ESO Ventures has grown rapidly by using both federal recovery grants funneled through the state of California and access to private banks for credit lines. The organization’s goal is to create 3,000 more businesses and generate $3 billion in economic activity by 2030. 
• Network Kansas is an entrepreneurial support organization born out of the first version of the Treasury Department’s State Small Business Credit Initiative (SSBCI) program under the Obama Administration. The organization leverages a Kansas state tax credit to provide below-market debt to rural entrepreneurs in the most remote parts of Kansas. Since 2006, Network Kansas has deployed $500 million.

These example programs are successful, replicable, and already supported by some of the agencies in the ICIC. These programs use traditional, well-understood financial mechanisms to provide capital to entrepreneurs: credit lines, insurance, shared-equity agreements, tax credits, and low-interest debt. The biggest obstacle to scaling these types of programs is financial: they must first raise money to support their core financial mechanism(s) and their dependence on ad hoc fundraising almost inevitably yields uneven results.

There is a clear rationale for federal intervention to improve capital access for entrepreneurship-support programs. Successful investment in marginalized communities serves the public interest by generating positive externalities such as increases in jobs, wealth, and ownership. Government can grow these externalities manyfold by reducing risk for investors and reducing the cost of capital to entrepreneurs through the expansion of SBA’s secondary market authority and ultimate creation of a GSE to create permanence, increased accountability, and further flexibility of capital access. With SBA reauthorization on the legislative docket, this is a prime opportunity to address the core challenge of capital access for entrepreneurs. 

Plan of Action 

Federal government should create standardized, straightforward mechanisms for entrepreneurs and small businesses across the country to tap into vast pools of private capital at scale. A first step is launching an administrative pilot that extends the SBA’s current secondary market capacity to interested agencies in the ICIC. An initial pilot partner could be the Department of the Treasury in order to recapitalize its Community Development Financial Institutions (CDFI) Fund. If the pilot proves successful, the secondary market could be expanded further and permanently established as a government-sponsored enterprise.

Recommendation 1. Establish an administrative pilot.

The SBA’s secondary market can already serve small business debt and debt-like instruments for small businesses and community development. The SBA currently underwrites, guarantees, securitizes, and sells pools of 7(a) and 504 loans, unsecured SBA loans in Development Company Participation Certificates, and Small Business Investment Company Debentures. Much like Federal Housing Administration and Veterans Affairs home loans offer guaranteed debt to homeowners, there are programs that offer guaranteed debt for entrepreneurs. However, there is no large standardized secondary market for the debt that extends across agencies. 

An interagency memorandum of understanding between interested ICIC agencies could quickly open up the SBA’s secondary market infrastructure to other forms of small business debt. This would allow the ICIC to explore, with limited risk, the extent to which an expanded secondary market for federally securitized debt products enables entrepreneurs and small businesses to more easily access low-cost capital. Examples of other forms of small business lending provided by ICIC agencies include Department of Agriculture Rural Business Development Grants, Department of Housing and Urban Development Community Development Block Grants, and the Treasury Small Business Lending Fund, among others.

An ideal initial pilot partner target among ICIC agencies would be the Treasury, which could pilot a secondary market approach to recapitalizing its CDFI Fund. This fund allocates capital via debenture to CDFIs for them to make personal, mortgage, and commercial loans to low-income and underserved communities. The fund is recapitalized on an annual basis through the federal budget process. A partnership with SBA to create a secondary market for the CDFI Fund would effectively double the federal support available for CDFIs that leverage that fund.

It is important to note that while SBA can create pilot intergovernmental agreements to extend its secondary market infrastructure, broader or permanent extension of secondary market authority may require congressional approval.

Recommendation 2. Create a government-sponsored enterprise (GSE).

Upon successful completion of the administrative pilot, the ICIC should explore creating a GSE that decreases the cost of capital for entrepreneurs and small businesses and expands capital access for underserved communities. This separate entity would be a more independent body than an expanded secondary market created through SBA’s existing infrastructure. Benefits of creating a GSE include providing more flexibility and allowing the agency to function more independently and with greater authority while being subject to more rigorous reporting and oversight requirements to ensure accountability. 

After the 2008 housing-market crash and subsequent recession, the concept of a GSE was criticized and reforms were proposed. There is no doubt that GSEs made mistakes in the housing market, but they also helped standardize and grow the mortgage market that now serves 65% of American households. The federal government will need to implement thoughtful, innovative governance structures to realize the benefits that a GSE could offer entrepreneurs and small businesses while avoiding repeating the mistakes that the mortgage-focused GSEs Fannie Mae and Freddie Mac made. 

One potential ownership structure is the Perpetual Purpose Trust (PPT). PPTs work by separating the ownership right of governance from the ownership right of financial return and giving them to different parties. The best-known example of a PPT to date is likely the one established by Yvon Chouinard to take over his family’s ownership interest in Patagonia. In a PPT, trustees—organized in a Trust Steward Committee (TSC)—are bound by a fiduciary duty to maintain focus on the stated purpose of the trust. None of the interests within the TSC are entitled to financial return; rather, the rights to financial return are held in a separate entity (the Corporate Trustee) that does not possess governance rights. This structure, which is backed by a Trust Enforcer, ensures that the TSC cannot force the company to do something that is good for profits but bad for purpose. 

Emulating this basic structure for a capital-focused GSE could circumvent the moral hazard that plagued the mortgage-focused GSEs. The roles of TSC, Trust Enforcer, and Corporate Trustee in a federal context could be filled as follows:

• Trust Steward Committee: The TSC possesses a fiduciary for the PPT and typically makes strategic decisions to pursue the PPT’s purpose. For a capital-focused GSE, the TSC’s role would be limited to governance. The TSC would be populated by a mix of stakeholders, such as entrepreneurs, community developers, investors, and support organizations. 
• Trust Enforcer: The Trust Enforcer is an independent entity that rules on whether the TSC is sufficiently pursuing the PPT’s stated purpose. For a capital-focused GSE, this role could be filled by federal agency staff. The trust that holds the governance rights serves as the vehicle for the regulatory body to oversee the GSE. 
• Corporate Trustee: The entity that holds the financial interest of the GSE could be sold to investors, granted to employees, or given away to relevant nonprofit and other stakeholder groups. 

Conclusion 

The ICIC agencies support and create many creative solutions that blend private and public dollars to increase entrepreneurship and community development. Yet the federal government stops short of providing the most important benefit: standardization and scale. The ICIC agencies should therefore create an entity that unlocks standardization and scale for the programs they help create, with the overall goals of:

• Unifying small-business and community-development underwriting
• Broadening private-actor participation in small business loan origination by creating the risk standards that allow for greater liquidity
• Opening the capital markets to lower the cost of capital for entrepreneurs

A first step towards accomplishing these goals is to establish an administrative pilot, by which interested ICIC agencies would use the SBA’s existing authority and infrastructure to create a secondary market for their securitized debt instruments. 

If the pilot proves successful, the next step is to expand the secondary market and establish it for the long term through a GSE modeled on those that have effectively supported the mortgage industry—but with a creative structure that proactively addresses GSE weaknesses unveiled by the 2008 housing-market crash. The result is a stable, permanent institution that enables all communities to realize the benefits of robust entrepreneurship by ensuring that budding entrepreneurs and small-business owners across the country can easily tap into the capital they need to get started. 

Summary

65,000 miles of pipeline: that’s the distance that may be necessary to achieve economy-wide net-zero emissions by 2050, according to a Princeton University study. The United States is on the verge of constructing a vast network of pipelines to transport hydrogen and carbon dioxide, incentivized by the Infrastructure Investment and Jobs Act and the Inflation Reduction Act. Yet the lifecycle emissions generated by a typical steel pipeline is 27.35 kg carbon dioxide eq per ft¹. Which means 65,000 miles would result in nearly 9.4 million megatons of carbon dioxide eq (equal to over 2 million passenger cars annually) produced just from steel pipeline infrastructure alone.

Pipelines made from composite materials offer one pathway to lowering emissions. Composite pipe is composed of multiple layers of different materials—typically a thermoplastic polymer as the primary structural layer with reinforcing materials such as fibers or particulate fillers to increase strength and stiffness. Some types have lifecycle emissions that are nearly one-third less than typical steel pipeline. Depending on the application, composite pipelines can be safer and less expensive. However, the process under Pipeline and Hazardous Materials and Safety Administration (PHMSA) to issue permits for composite pipe takes longer than steel, and for hydrogen and supercritical carbon dioxide, the industry lacks regulatory standards altogether. Reauthorization of the Protecting Our Infrastructure of Pipelines and Enhancing Safety (PIPES) Act offers an excellent opportunity to review the policies concerning new, less emissive pipeline technologies.

Challenge and Opportunity

Challenge

The United States is on the verge of a clean energy construction boom, expanding far beyond wind and solar energy to include infrastructure that utilizes hydrogen and carbon capture. The pump has been primed with $21 billion for demonstration projects or “hubs” in the Infrastructure Investment and Jobs Act and reinforced with another $7 billion for demonstration projects and at least $369 billion in tax credits in the Inflation Reduction Act. Congress recognized that pipelines are a critical component and provided $2.1 billion in loans and grants under the Carbon Dioxide Transportation Infrastructure Finance and Innovation Act (CIFIA).

The United States is crisscrossed by pipelines. Approximately 3.3 million miles of predominately steel pipelines convey trillions of cubic feet of natural gas and hundreds of billions of tons of liquid petroleum products each year. A far fewer 5,000 miles are used to transport carbon dioxide and only 1,600 miles are dedicated to hydrogen. Research suggests the existing pipeline network is nowhere near what is needed. According to Net Zero America, approximately 65,000 miles of pipeline will be needed to transport captured carbon dioxide to achieve economy-wide net zero emissions in the United States by 2050. The study also identifies a need for several thousand miles of pipelines to transport hydrogen within each region.

Making pipes out of steel is a carbon-intensive process, and steel manufacturing in general accounts for seven to nine percent of global greenhouse gas emissions. There are ongoing efforts to lower emissions generated from steel (i.e., “green steel”) by being more energy efficient, capturing and storing emitted carbon dioxide, recycling scrap steel combined with renewable energy, and using low-emissions hydrogen. However, cost is a significant challenge with many of these mitigation strategies. The estimated cost of transitioning global steel assets to net-zero compatible technologies by 2050 is $200 billion, in addition to a baseline average of $31 billion annually to simply meet growing demand.

Opportunity

Given the vast network of pipelines required to achieve a net-zero future, expanding use of composite pipe provides a significant opportunity for the United States to lower carbon emissions. Composite materials are highly resistant to corrosion, weigh less and are more flexible, and have improved flow capacity. This means that pipelines made from composite materials have a longer service life and require less maintenance than steel pipelines. Composite pipe can be four times faster to install, require one-third the labor to install, and have significantly lower operating costs.² The use of composite pipe is expected to continue to grow as technological advancements make these materials more reliable and cost-effective. 

Use of composite pipe is also expanding as industry seeks to improve its sustainability. We performed a lifecycle analysis on thermoplastic pipe, which is made by a process called extrusion that involves melting a thermoplastic material, such as high-density polyethylene or polyvinyl chloride, and then forcing it through a die to create a continuous tube. The tube can then be cut to the desired length and fittings can be attached to the ends to create a complete pipeline. We found that the lifecycle emissions from thermoplastic pipe were 6.83 kg carbon dioxide eq/ft and approximately 75% lower than an equivalent length of steel pipe, which has lifecycle emissions of 27.35 kg carbon dioxide eq/ft. 

These estimates do not include potential differences in leaks. Specifically, composite pipe has a continuous structure that allows for the production of longer pipe sections, resulting in fewer joints and welds. In contrast, metallic pipes are often manufactured in shorter sections due to limitations in the manufacturing process. This means that more joints and welds are required to connect the sections together, which can increase the risk of leaks or other issues. Further, approximately half of the steel pipelines in the United States are over 50 years old, increasing the potential for leaks and maintenance cost.³ Another advantage of composite pipe is that it can be pulled through steel pipelines, thereby repurposing aging steel pipelines to transport different materials while also reducing the need for new rights of way and associated permits. 

Despite the advantages of using composite materials, the standards have not yet been developed to allow for safe permitting to transport supercritical carbon dioxide⁴ and hydrogen. At the federal level, pipeline safety is administered by the Department of Transportation’s Pipeline and Hazardous Materials Administration (PHMSA).⁵ To ensure safe transportation of energy and other hazardous materials, PHMSA establishes national policy, sets and enforces standards, educates, and conducts research to prevent incidents. There are regulatory standards to transport supercritical carbon dioxide in steel pipe.⁶ However, there are no standards for composite pipe to transport either hydrogen or carbon dioxide in either a supercritical liquid, gas, or subcritical liquid state.

Repurposing existing infrastructure is critical because the siting of pipelines, regardless of type, is often challenging. Whereas natural gas pipelines and some oil pipelines can invoke eminent domain provisions under federal law such as the Natural Gas Act or Interstate Commerce Act, no such federal authorities exist for hydrogen and carbon dioxide pipelines. In some states, specific statutes address eminent domain for carbon dioxide pipelines. These laws typically establish the procedures for initiating eminent domain proceedings, determining the amount of compensation to be paid to property owners, and resolving disputes related to eminent domain. However, current efforts are under way in states such as Iowa to restrict use of state authorities to grant eminent domain to pending carbon dioxide pipelines. The challenges with eminent domain underscore the opportunity provided by technologies that allow for the repurposing of existing pipeline to transport carbon dioxide and hydrogen.

Plan of Action

How can we build a vast network of carbon dioxide and hydrogen pipelines while also using lower emissive materials? 

Recommendation 1. Develop safety standards to transport hydrogen and supercritical carbon dioxide using composite pipe. 

PHMSA, industry, and interested stakeholders should work together to develop safety standards to transport hydrogen and supercritical carbon dioxide using composite pipe. Without standards, there is no pathway to permit use of composite pipe. This collaboration could occur within the context of PHMSA’s recent announcement to update its standards for transporting carbon dioxide, which is being done in response to an incident in 2020 in Sartartia, MS.

Ideally, the permits could be issued using PHMSA’s normal process rather than as special permits (e.g., 49 CFR § 195.8). It takes several years to develop standards, so it is critical to launch the standard-setting process so that composite pipe can be used in Department of Energy-funded hydrogen hubs and carbon capture demonstration projects.

Europe is ahead of the United States in this regard, as the classification company DNV is currently undertaking a joint industry project to review the cost and risk of using thermoplastic pipe to transport hydrogen. This work will inform regulators in the European Union, who are currently revising standards for hydrogen infrastructure. The European Clean Hydrogen Alliance recently adopted a “Roadmap on Hydrogen Standardization” that expressly recommends setting standards for non-metallic pipes. To the extent practicable, it would benefit export markets for U.S. products if the standards were similar.  

Recommendation 2. Streamline the permitting process to retrofit steel pipelines. 

Congress should streamline the retrofitting of steel pipes by enacting a legislative categorical exclusion under the National Environmental Policy Act (NEPA). NEPA requires federal agencies to evaluate actions that may have a significant effect on the environment. Categorical exclusions (CEs) are categories of actions that have been determined to have no significant environmental impact and therefore do not require an environmental assessment (EA) or an environmental impact statement (EIS) before they can proceed. CEs can be processed within a few days, thereby expediting the review of eligible actions.

The CE process allows federal agencies to avoid the time and expense of preparing an EA or EIS for actions that are unlikely to have significant environmental effects. CEs are often established through agency rulemaking but can also be created by Congress as a “legislative CE.” Examples include minor construction activities, routine maintenance and repair activities, land transfers, and research and data collection. However, even if an action falls within a CE category, the agency must still conduct a review to ensure that there are no extraordinary circumstances that would warrant further analysis.

Given the urgency to deploy clean technology infrastructure, Congress should authorize federal agencies to apply a categorical exclusion where steel pipe is retrofitted using composite pipe. In such situations, the project is using an existing pipeline right-of-way, and there should be few, if any, additional environmental impacts. Should there be any extraordinary circumstances, such as substantial changes in the risk of environmental effects, federal agencies would be able to evaluate the project under an EA or EIS. A CE does not obviate the review of safety standards and other applicable, substantive laws, but simply right-sizes the procedural analysis under NEPA.

Recommendation 3. Explore opportunities to improve the policy framework for composite pipe during reauthorization of the PIPES Act. 

Both of the aforementioned ideas should be considered as Congress initiates its reauthorization of the Protecting Our Infrastructure of Pipelines and Enhancing Safety (PIPES) Act of 2020. Among other improvements to pipeline safety, the PIPES Act reauthorized PHMSA through FY2023. As Congress begins work on its next reauthorization bill for PHMSA, it is the perfect time to review the state of the industry, including the potential for composite pipe to accelerate the energy transition.

Recommendation 4. Consider the embedded emissions of construction materials when funding demonstration projects. 

The Office of Clean Energy Demonstrations should consider the embedded emissions of construction materials when evaluating projects for funding. Applicants that have a plan to consider embedded emissions of construction materials could receive additional weight in the selection process. 

Recommendation 5. Support research and development of composite materials. 

Composite materials offer advantages in many other applications, not just pipelines. The Office of Energy Efficiency and Renewable Energy (EERE) should support research to further enhance the properties of composite pipe while improving lifecycle emissions. In addition to ongoing efforts to lower the emissions intensity of steel and concrete, EERE should support innovation in alternative, composite materials for pipelines and other applications.

Conclusion

Recent legislation will spark construction of the next generation in clean energy infrastructure, and the funding also creates an opportunity to deploy construction materials with lower lifecycle emissions of greenhouse gases. This is important, because constructing vast networks of pipelines using high-emissive processes undercuts the goals of the legislation. However, the regulatory code remains an impediment by failing to provide a pathway for using composite materials. PHMSA and industry should commence discussions to create the requisite safety standards, and Congress should work with both industry and regulators to streamline the NEPA process when retrofitting steel pipelines. As America commences construction of hydrogen and carbon capture, utilization, and storage networks, reauthorization of the PIPES Act provides an excellent opportunity to significantly lower the emissions.

Summary

Efforts to monitor and combat online harassment have fallen short due to a lack of cooperation and information-sharing across stakeholders, disproportionately hurting women, people of color, and LGBTQ+ individuals. We propose that the White House Task Force to Address Online Harassment and Abuse convene government actors, civil society organizations, and industry representatives to create an Anti-Online Harassment (AOH) Hub to improve and standardize responses to online harassment and to provide evidence-based recommendations to the Task Force. This Hub will include a data-collection mechanism for research and analysis while also connecting survivors with social media companies, law enforcement, legal support, and other necessary resources. This approach will open pathways for survivors to better access the support and recourse they need and also create standardized record-keeping mechanisms that can provide evidence for and enable long-term policy change. 

Challenge and Opportunity 

The online world is rife with hate and harassment, disproportionately hurting women, people of color, and LGBTQ+ individuals. A research study by Pew indicated that 47% of women were harassed online for their gender compared to 18% of men, while 54% of Black or Hispanic internet users faced race-based harassment online compared to 17% of White users. Seven in 10 LGBTQ+ adults have experienced online harassment, and 51% faced even more severe forms of abuse. Meanwhile, existing measures to combat online harassment continue to fall short, leaving victims with limited means for recourse or protection. 

Numerous factors contribute to these shortcomings. Social media companies are opaque, and when survivors turn to platforms for assistance, they are often met with automated responses and few means to appeal or even contact a human representative who could provide more personalized assistance. Many survivors of harassment face threats that escalate from online to real life, leading them to seek help from law enforcement. While most states have laws against cyberbullying, law enforcement agencies are often ill-trained and ill-equipped to navigate the complex web of laws involved and the available processes through which they could provide assistance. And while there are nongovernmental organizations and companies that develop tools and provide services for survivors of online harassment, the onus continues to lie primarily on the survivor to reach out and navigate what is often both an overwhelming and a traumatic landscape of needs. Although resources exist, finding the correct organizations and reaching out can be difficult and time-consuming. Most often, the burden remains on the victims to manage and monitor their own online presence and safety.

On a larger, systemic scale, the lack of available data to quantitatively analyze the scope and extent of online harassment hinders the ability of researchers and interested stakeholders to develop effective, long-term solutions and to hold social media companies accountable. Lack of large-scale, cross-sector and cross-platform data further hinders efforts to map out the exact scale of the issue, as well as provide evidence-based arguments for changes in policy. As the landscape of online abuse is ever changing and evolving, up-to-date information about the lexicons and phrases that are used in attacks also change.

Forming the AOH Hub will improve the collection and monitoring of online harassment while preserving victims’ privacy; this data can also be used to develop future interventions and regulations. In addition, the Hub will streamline the process of receiving aid for those targeted by online harassment.

Plan of Action

Aim of proposal

The White House Task Force to Address Online Harassment and Abuse should form an Anti-Online Harassment Hub to monitor and combat online harassment. This Hub will center around a database that collects and indexes incidents of online harassment and abuse from technology companies’ self-reporting, through connections civil society groups have with survivors of harassment, and from reporting conducted by the general public and by targets of online abuse. Civil society actors that have conducted past work in providing resources and monitoring harassment incidents, ranging from academics to researchers to nonprofits, will run the AOH Hub in consortium as a steering committee. There are two aims for the creation of this hub. 

First, the AOH Hub can promote collaboration within and across sectors, forging bonds among government, the technology sector, civil society, and the general public. This collaboration enables the centralization of connections and resources and brings together diverse resources and expertise to address a multifaceted problem. 

Second, the Hub will include a data collection mechanism that can be used to create a record for policy and other structural reform. At present, the lack of data limits the ability of external actors to evaluate whether social media companies have worked adequately to combat harmful behavior on their platforms. An external data collection mechanism enables further accountability and can build the record for Congress and the Federal Trade Commission to take action where social media companies fall short. The allocated federal funding will be used to (1) facilitate the initial convening of experts across government departments and nonprofit organizations; (2) provide support for the engineering structure required to launch the Hub and database; (3) support the steering committee of civil society actors that will maintain this service; and (4) create training units for law enforcement officials on supporting survivors of online harassment. 

Recommendation 1. Create a committee for governmental departments.

Survivors of online harassment struggle to find recourse, failed by legal technicalities in patchworks of laws across states and untrained law enforcement. The root of the problem is an outdated understanding of the implications and scale of online harassment and a lack of coordination across branches of government on who should handle online harassment and how to properly address such occurrences. A crucial first step is to examine and address these existing gaps. The Task Force should form a long-term committee of members across governmental departments whose work pertains to online harassment. This would include one person from each of the following organizations, nominated by senior staff:

• Department of Homeland Security
• Department of Justice
• Federal Bureau of Investigation
• Department of Health and Human Services
• Office on Violence Against Women
• Federal Trade Commission

This committee will be responsible for outlining fallibilities in the existing system and detailing the kind of information needed to fill those gaps. Then, the committee will outline a framework clearly establishing the recourse options available to harassment victims and the kinds of data collection required to prove a case of harassment. The framework should be completed within the first 6 months after the committee has been convened. After that, the committee will convene twice a year to determine how well the framework is working and, in the long term, implement reforms and updates to current laws and processes to increase the success rates of victims seeking assistance from governmental agencies. 

Recommendation 2: Establish a committee for civil society organizations.

The Task Force shall also convene civil society organizations to help form the AOH Hub steering committee and gather a centralized set of resources. Victims will be able to access a centralized hotline and information page, and Hub personnel will then triage reports and direct victims to resources most helpful for their particular situation. This should reduce the burden on those who are targets of harassment campaigns to find the appropriate organizations that can help address their issues by matching incidents to appropriate resources. 

To create the AOH Hub, members of the Task Force can map out civil society stakeholders in the space and solicit applications to achieve comprehensive and equitable representation across sectors. Relevant organizations include organizations/actors working on (but not limited to):

• Combating domestic violence and intimate partner violence
• Addressing technology-facilitated gender based violence (TF-GBV)
• Developing online tools for survivors of harassment to protect themselves
• Conducting policy work to improve policies on harassment
• Providing mental health support for survivors of harassment
• Servicing pro bono or other forms of legal assistance for survivors of harassment
• Connecting tech company representatives with survivors of harassment
• Researching methods to address online harassment and abuse

The Task Force will convene an initial meeting, during which core members will be selected to create an advisory board, act as a liaison across members, and conduct hiring for the personnel needed to redirect victims to needed services. Other secondary members will take part in collaboratively mapping out and sharing available resources, in order to understand where efforts overlap and complement each other. These resources will be consolidated, reviewed, and published as a public database of resources within a year of the group’s formation. 

For secondary members, their primary obligation will be to connect with victims who have been recommended to their services. Core members, meanwhile, will meet quarterly to evaluate gaps in services and assistance provided and examine what more needs to be done to continue growing the robustness of services and aid provided. 

Recommendation 3: Convene committee for industry.

After its formation, the AOH steering committee will be responsible for conducting outreach with industry partners to identify a designated team from each company best equipped to address issues pertaining to online abuse. After the first year of formation, the industry committee will provide operational reporting on existing measures within each company to address online harassment and examine gaps in existing approaches. Committee dialogue should also aim to create standardized responses to harassment incidents across industry actors and understandings of how to best uphold community guidelines and terms of service. This reporting will also create a framework for standardized best practices for data collection, in terms of the information collected on flagged cases of online harassment.

On a day-to-day basis, industry teams will be available resources for the hub, and cases can be redirected to these teams to provide person-to-person support for handling cases of harassment that require a personalized level of assistance and scale. This committee will aim to increase transparency regarding the reporting process and improve equity in responses to online harassment.

Recommendation 4: Gather committees to provide long-term recommendations for policy change.

On a yearly basis, representatives across the three committees will convene and share insights on existing measures and takeaways. These recommendations will be given to the Task Force and other relevant stakeholders, as well as be accessible by the general public. Three years after the formation of these committees, the groups will publish a report centralizing feedback and takeaway from all committees, and provide recommendations of improvement for moving forward. 

Recommendation 5: Create a data-collection mechanism and standard reporting procedures.

The database will be run and maintained by the steering committee with support from the U.S. Digital Service, with funding from the Task Force for its initial development. The data collection mechanism will be informed by the frameworks provided by the committees that compose the Hub to create a trauma-informed and victim-centered framework surrounding the collection, protection, and use of the contained data. The database will be periodically reviewed by the steering committee to ensure that the nature and scope of data collection is necessary and respects the privacy of those whose data it contains. Stakeholders can use this data to analyze and provide evidence of the scale and cross-cutting nature of online harassment and abuse. The database would be populated using a standardized reporting form containing (1) details of the incident; (2) basic demographic data of the victim; (3) platform/means through which the incident occurred; (4) whether it is part of a larger organized campaign; (5) current status of the incident (e.g., whether a message was taken down, an account was suspended, the report is still ongoing); (6) categorization within existing proposed taxonomies indicating the type of abuse. This standardization of data collection would allow advocates to build cases regarding structured campaigns of abuse with well-documented evidence, and the database will archive and collect data across incidents to ensure accountability even if the originals are lost or removed.

The reporting form will be available online through the AOH Hub. Anyone with evidence of online harassment will be able to contribute to the database, including but not limited to victims of abuse, bystanders, researchers, civil society organizations, and platforms. To protect the privacy and safety of targets of harassment, this data will not be publicly available. Access will be limited to: (1) members of the Hub and its committees; (2) affiliates of the aforementioned members; (3) researchers and other stakeholders, after submitting an application stating reasons to access the data, plans for data use, and plans for maintaining data privacy and security. Published reports using data from this database will be nonidentifiable, such as with statistics being published in aggregate, and not be able to be linked back to individuals without express consent.

This database is intended to provide data to inform the committees in and partners of the Hub of the existing landscape of technology-facilitated abuse and violence. The large-scale, cross-domain, and cross-platform nature of the data collected will allow for better understanding and analysis of trends that may not be clear when analyzing specific incidents, and provide evidence regarding disproportionate harms to particular communities (such as women, people of color, LGBTQ+ individuals). Resources permitting, the Hub could also survey those who have been impacted by online abuse and harassment to better understand the needs of victims and survivors. This data aims to provide evidence for and help inform the recommendations made from the committees to the Task Force for policy change and further interventions.

Recommendation 6: Improve law enforcement support.

Law enforcement is often ill-equipped to handle issues of technology-facilitated abuse and violence. To address this, Congress should allocate funding for the Hub to create training materials for law enforcement nationwide. The developed materials will be added to training manuals and modules nationwide, to ensure that 911 operators and officers are aware of how to handle cases of online harassment and how state and federal law can apply to a range of scenarios. As part of the training, operators will also be notified to add records of 911 calls regarding online harassment to the Hub database, with the survivor’s consent. 

Conclusion

As technology-facilitated violence and abuse proliferates, we call for funding to create a steering committee in which experts and stakeholders from civil society, academia, industry, and government can collaborate on monitoring and regulating online harassment across sectors and incidents. The resulting Anti-Online Harassment Hub would maintain a data-collection mechanism accessible to researchers to better understand online harassment as well as provide accountability for social media platforms to address the issue. Finally, the Hub would provide accessible resources for targets of harassment in a fashion that would reduce the burden on these individuals. Implementing these measures would create a safer online space where survivors are able to easily access the support they need and establish a basis for evidence-based, longer-term policy change.

Summary 

A number of biomanufactured products require amino acids and growth factors as inputs, but these small molecules and proteins can be very expensive, driving up the costs of biomanufacturing, slowing the expansion of the U.S. bioeconomy, and limiting the use of novel biomedical and synthetically produced agricultural products. Manufacturing costs can be substantially limiting: officials from the National Institutes of Health and the Bill & Melinda Gates Foundation point to the manufacturing costs of antibody drugs as a major bottleneck in developing and distributing treatments for a variety of extant and emerging infectious diseases. To help bring down the costs of these biomanufacturing inputs, the Biden-Harris Administration should allocate federal funding for a Grand Challenge to research and develop reduced-cost manufacturing processes and demonstrate the scalability of these solutions. 

Amino acids are essential but costly inputs for large-scale bioproduction. To reduce these costs, federal funding should be used to incentivize the development of scalable production methods resulting in production costs that are half of current costs. Specifically, the U.S. Department of Agriculture (USDA) and ARPA-H should jointly commit to an initial funding amount of $15 million for 10 research projects in the first year, with a total of $75. million over five years, in Grand Challenge funding for researchers or companies who can develop a scalable process for producing food-grade or pharmaceutical-grade amino acids or growth factors at a fraction of current costs. ARPA-H should also make funding available for test-bed facilities that researchers can use to demonstrate the scalability of their cost-saving production methods. 

Scaling up the use of animal cell culture for biosynthetic production will only be economically effective if the costs of amino acids and growth factors are reduced. Reducing the cost of bioproduction of medical and pharmaceutical products like vaccines and antimicrobial peptides, or of animal tissue products like meat or cartilage, would improve the availability and affordability of these products, make innovation and new product development easier and more cost effective, and increase our ability to economically manufacture bioproducts in the United States, reducing our dependence on foreign supply chains. 

For a better understanding of the use of amino acids and growth factors in the production of biologics and animal cell-based products, and to accurately forecast supply and demand to ensure a reliable and available supply chain for medical products, the Department of Defense (DoD) and USDA should jointly commission an economic analysis of synthetic manufacturing pathway costs for common bioproducts and include assessments of comparative costs of production for major international competitors. 

Challenge and Opportunity

Amino acids are necessary inputs when synthesizing protein and peptide products, including pharmaceutical and healthcare products (e.g., antibodies, insulin) and agricultural products (e.g., synthetic plant and animal proteins for food, collagen, gelatin, insecticidal proteins), but they are very expensive. Amino acids as inputs to cell culture cost approximately $3 to $50 per kg, and growth factors cost $50,000 per gram, meaning that their costs can be half or more of the total production cost. 

Biomanufacturing depends on the availability of reagents, small molecules, and bioproducts that are used as raw inputs to the manufacturing process. The production of synthetic bioproducts is limited by the cost and availability of certain reagents, including amino acids and small signaling proteins like hormones and growth factors. These production inputs are used in cell culture to increase yields and production efficiency in the biosynthesis of products such as monoclonal antibodies, synthetic meat, clotting factors, and interferon (proteins that inhibit tumor growth and support immune system function). While some bioproducts can be produced synthetically in plant cells or bacterial cells, some products benefit from production steps in animal cells. One example is glycosylation, a protein-modification process that helps proteins fold into stable structures, which is a much simpler process in animal cells than in bacteria or in cell-free systems. The viruses used in vaccine development are also usually grown in animal cells, though some recombinant vaccines can be made in yeast or insect cells. There are benefits and drawbacks to the use of plant, fungi, bacteria, insect, or animal cells in recombinant bioproduction; animal cells are generally more versatile because they mimic human processes closely and require less engineering than non-animal cells. All cells, whether they are animal, plant or bacteria, require amino acids and various growth factors to survive and function efficiently. While in the future growth factors may no longer be required, amino acids will always be required. Amino acids are the most costly necessary additive on a price per kilogram basis; the most costly of the supporting additives are growth factors. 

Growth factors are proteins or steroids that act as signaling molecules that regulate cells’ internal processes, while amino acids are building blocks of proteins that are necessary both for cell function and for producing new proteins within a cell. Cells require supplementation with both growth factors and amino acids because most cells are not capable of producing their own growth factors. Biosynthetic production in animal cells frequently uses growth factors (e.g., TGF, IGF) to increase yield and increase production speed, signaling cells to work faster and make more of a particular compound.

Pharmaceuticals

Although pharmaceutical products are expensive, relatively small demand volumes prevent market forces from exerting sufficient cost pressure to spur innovation in their production. The biosynthetic production of pharmaceuticals involves engineering cells to produce large quantities of a molecule, such as a protein or peptide, which can then be isolated, purified, and used in medicine. Peptide therapeutics is a $39 billion global market that includes peptides sold as end products and others used as inputs to the synthesis of other biological compounds. Protein and peptide product precursors, including amino acids and growth factors, represent a substantial cost of production, which is a barrier to low-cost, high-volume biomanufacturing.

For example, the production of antimicrobial peptides, used as therapeutics against antibiotic-resistant bacteria and viruses, is strongly constrained by the cost of chemical inputs. One input alone, guanidine, accounts for more than 25% of the approximately $41,000 per gram production cost of antimicrobial peptides. Reducing the cost of these inputs will have substantial downstream effects on the economics of production. Antimicrobial peptides are currently very expensive to produce, limiting their development as alternatives to antibiotics, despite a growing need for new antibiotics. The U.S. National Action Plan for Combating Antibiotic-Resistant Bacteria (CARB) outlines a coordinated strategy to accelerate the development of new antibiotics and slow the spread of antibiotic resistance. Reducing the cost to produce antimicrobial peptides would support these goals. 

The high costs of synthetic production limit the growth of the market for synthetic products. This creates a local equilibrium that is suboptimal for the development of the synthetic biology industry and creates barriers to market entry for synthetic products that could, at scale, address environmental and bioavailability concerns associated with natural sources. The federal government has already indicated an interest in supporting the development of a robust and innovative U.S.-based biomanufacturing center, with the passage of the CHIPS and Science Act and Executive Order 14081 on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy. Reducing the costs of basic inputs to the biomanufacturing process of a range of products addresses this desire to make U.S. biomanufacturing more sustainable. There are other examples of federal investment to reduce the cost of manufacturing inputs, from USDA support for new methods of producing fertilizer, to Food and Drug Administration investment to improve pharmaceutical manufacturing and establish manufacturing R&D centers at universities, to USDA National Institute of Food and Agriculture (NIFA) support for the development of bioplastics and bio-based construction materials. Federal R&D support increases subsequent private research funding and increases the number of new products that recipients develop, a positive measure of innovation. 

The effort to reduce biomanufacturing costs is larger than any one company; therefore, it requires a coordinated effort across industry, academia, and government to develop and implement the best solution. The ability to cost-effectively manufacture precursors will directly and indirectly advance all aspects of biomanufacturing. Academia and industry are poised and ready to improve the efficiency and cost of bioproduction but require federal government coordination and support to achieve this essential milestone and to support the development of the newly emerging industry of large-scale synthetic bioproducts.  

Synthetic meat

Developing cost-effective protein and peptide synthesis would remove a substantial barrier to the expansion of synthetic medical and agricultural products, which would address current supply bottlenecks (e.g., blood proteins, antibody drugs) and mounting environmental and political challenges to natural sourcing (e.g., beef, soy protein). Over the past decade, breakthroughs in the manufacturing capability to synthetically produce biological products, like biofuels or the antimalarial drug artemisinin, have failed to reach cost-competitiveness with naturally sourced competitors, despite environmental and supply-chain-related benefits of a synthetic version. The Department of Energy (DoE) and others continue to invest in biofuel and bioproduct development, and additional research innovation may soon bring these products to a cost-competitive threshold. For bioproducts that depend on amino acids and growth factors as inputs, that threshold may be very close. Proof of concept research on growth factor and amino acid production, as well as techno-economic assessments of synthetic meat products, point to precursor amino acids and proteins as being substantial barriers to cost competitiveness of bioproduction—but close to being overcome through technological development. Potential innovators lack support to invest in the development of potentially globally beneficial technologies with uncertain returns.

Reducing the costs of these inputs for the peptide drug and pharmaceutical market could also bring down the costs of synthetic meat, thereby increasing a substantial additional market for low-cost amino acids and growth factors while alleviating the environmental burdens of a growing demand for meat. Israel has demonstrated that there is strong demand for such products and has substantially invested in its synthetic meat sector, which in turn has augmented its overall bioeconomy. 

Bringing the cost of synthetic meat from current estimates of $250 per kg to the high end of wholesale meat prices at $10 per kg is infeasible without reducing the cost of growth factors and amino acids as production inputs but would also reduce the water and land usage of meat production by 70% to 95%. Synthetic meat would also alleviate many of the ethical and environmental objections to animal agriculture, reduce food waste, and increase the amount of plant products available for human consumption (currently 77% of agricultural land is used for livestock, meat, and dairy production, and 45% of the world’s crop calories are eaten by livestock).

Bioeconomy initiatives and opportunity

Maintaining U.S. competitiveness and leadership in biomanufacturing and the bioeconomy is a priority for the Biden-Harris Administration, which has led to a national bioeconomy strategy that aims to coordinate federal investment in R&D for biomanufacturing, improve and expand domestic biomanufacturing capacity, and expand market opportunities for biobased products. Reducing the cost and expanding the supply of amino acids and growth factors supports these three objectives by making bioproducts derived from animal cells cheaper and more efficient to produce. 

Several directives within President Biden’s National Biotechnology and Biomanufacturing Initiative could apply to the goal of producing cost-effective amino acids and growth factors, but a particular stipulation for the Department of Health and Human Services stands out. The 2022 Executive Order 14081 on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy includes a directive for the Department of Health and Human Services (HHS) to invest $40 million to “expand the role of biomanufacturing for active pharmaceutical ingredients (APIs), antibiotics, and the key starting materials needed to produce essential medications and respond to pandemics.” Protein and peptide product precursors are key starting materials for medical and pharmaceutical products, justifying HHS support for this research challenge. 

Congress has also signaled its intent to advance U.S. biotech and biomanufacturing. The CHIPS and Science Act authorizes funding for projects that could scale up the U.S. bioeconomy. Title IV of the Act, on bioeconomy research and development, authorizes financial support for research, test beds for scaling up technologies, and tools to accelerate research. This support could take the form of grants, multi-agency collaborative funding, and Small Business Innovation Research (SBIR) or Small Business Technology Transfer Program (SBTTP) funding. 

Biomanufacturing is important for national security and stability, yet much research and development are needed to realize that potential. The abovementioned funding opportunities should be leveraged to support foundational, cross-cutting capabilities to achieve affordable, accessible biomanufactured products, such as the production of essential precursor molecules. 

Plan of Action

To provide the catalyst for innovation that will drive down the price of components, federal funding should be made available to organizations developing cost-effective biosynthetic production pathways. Initial funding would be most helpful in the form of research grants as part of a Grand Challenge competition. University researchers have made some proof-of-concept progress in developing cost-effective methods of amino acid synthesis, but the investment required to demonstrate that these methods succeed at scale is currently not provided by the market. The main market for synthetic biomanufacturing inputs like amino acids is pharmaceutical products, which can pass on high production costs to the consumer and are not sufficiently incentivized to drive down the costs of inputs. 

Recommendation 1. Provide Grand Challenge funding for reduced-cost scalable production methods for amino acids and growth factors.

The USDA (through the USDA-NIFA Agriculture and Food Research Initiative [AFRI] or through AgARDA if it is funded) and ARPA-H should jointly commit to $15 million for 10 projects in the first year, with a total of $75 million over five years, in Grand Challenge¹ funding for researchers or companies who can develop a scalable process for producing food-grade or pharmaceutical-grade amino acids or growth factors at a fraction of current costs (e.g., $100,000 per kg for growth factors, and $1.50 per kg for amino acids), with escalating prizes for greater cost reductions. Applicants can also demonstrate the development of scalably produced bioengineered growth factors that demonstrate increased efficacy and efficiency. Grand Challenges offer funding to incentivize productive competition among researchers to achieve specific goals; they may also offer prizes for achieving interim steps toward a larger goal.

ARPA-H and USDA are well-positioned to spur innovation in cost-effective precursor production. Decreasing the costs of producing amino acids and growth factors would enable the transformative development of biologics and animal-cell-based products like synthetic meat, which aligns well with ARPA-H’s goal of supporting the development of breakthrough medical and biological products and technologies. ARPA-H aims to use its $6.5 billion in funding from the FY22 federal budget to invest in three-to-five-year projects that will support breakthrough technologies that are not yet economically compelling or sufficiently feasible for companies to invest internally in their development. An example technology cited by the ARPA-H concept paper is “new manufacturing processes to create patient-specific T-cells to search and destroy malignant cells, decreasing costs from $100,000s to $1000s to make these therapies widely available.” Analogously, new manufacturing processes for animal cell culture inputs will make biosynthetic products more cost-effective and widely available, but the potential market is still speculative, making investment risky.

AgARDA was meant to complement AFRI, in its model for soliciting research proposals, and being able to jointly support projects like a Grand Challenge to scale up amino acids and growth factors provides reason to fund AgARDA at its authorized level. Because producing cell-based meat at cost parity to animal meat would be an agricultural achievement, lowering the cost of necessary inputs to cell-based meat production could fall under the scope of AgARDA. 

Recommendation 2. Reward Grand Challenge winners who demonstrate scalability and provide BioPreferred program purchasing preference. 

Researchers developing novel low-cost and high-efficiency production methodology for amino acids and growth factors will also need access to facilities and manufacturing test beds to ensure that their solutions can scale up to industrial levels of production. To support this, ARPA-H should make funding available to Grand Challenge winners to demonstrate scaling their solutions to hundreds of kilograms per year. This is aligned with the test-bed development mandated by the CHIPS and Science Act. This funding should include $15 million to establish five test-bed facilities (a similar facility at the University of Delaware was funded at $3 million) and an additional $3 million to provide vouchers of between $10,000 and $300,000 for use at test-bed facilities. (These amounts are similar to the vouchers  provided by the California Department of Energy for its clean energy test-bed program.) 

To support the establishment of a market for the novel production processes, USDA should add to its BioPreferred program a requirement that federal procurement give preference to winners of the Grand Challenge when purchasing amino acids or growth factors for the production of biologics and animal cell-derived products. The BioPreferred program requires that federal purchases favor bio-based products (e.g., biodegradable cutlery rather than plastic cutlery) where the bio-based product meets the requirements for the purchaser’s use of that product. This type of purchasing commitment would be especially valuable for Grand Challenge winners who identify novel production methods—such as molecular “farming” in plants or cell-free protein synthesis—whose startup costs make it difficult to bootstrap incremental growth in production. Requiring that federal purchasing give preference to Grand Challenge winners ensures a certain volume of demand for new suppliers to establish themselves without increasing costs for purchasers. 

Stakeholder support for this Grand Challenge would include research universities; the alternative protein, peptide products, and synthetic protein industries; nonprofits supporting reduced peptide drug prices (such as the American Diabetes Association or the Boulder Peptide Foundation) and a reduction in animal agriculture (such as New Harvest or the Good Food Institute); and U.S. biomanufacturing supporters, including DoE and DoD. Companies and researchers working on novel methods for scalable amino acid and growth factor production will also support additional funding for technology-agnostic solutions (solutions that focus on characteristics of the end product rather than the method—such as precision fermentation, plant engineering, or cell-free synthesis—used to obtain the product). 

As another incentive, ARPA-H should solicit additional philanthropic and private funding for Grand Challenge winners, which could take the form of additional prize money or advance purchase commitment for a specified volume of amino acids or growth factors at a given threshold price, providing further incentive for bringing costs below the level specified by the Challenge. 

Recommendation 3. To project future demand, DoD should commission an economic analysis of synthetic manufacturing pathway costs for common bioproducts, and include assessments of comparative costs in major international competitors (e.g., China, the European Union, the United Kingdom, Singapore, South Korea, Japan). 

This analysis could be funded in part via BioMADE’s project calls for technology and innovation research. BioMADE received $87 million in DoD funding in 2020 for a seven-year period, plus an additional $450 million announced in 2023. Cost sharing for this project could come from the NSF Directorate for Technology, Innovation, and Partnerships or from the DoE’s Office of Science’s Biological and Environmental Research Program, which has supported techno-economic analyses of similar technologies, such as biofuels. 

EO 14081 also includes DoD as a major contributor to building the bioeconomy. The DoD’s Tri-Service Biotechnology for a Resilient Supply Chain program will invest $270 million over five years to speed the application of research to product manufacturing. Decreasing the costs of amino acids and growth factors as inputs to manufacturing biologics could be part of this new program, depending on the forthcoming details of its implementation. Advancing cost-effective biomanufacturing will transform defense capabilities needed to maintain U.S. competitiveness, secure critical supply chains, and enhance resiliency of our troops and defense needs, including medicines, alternative foods, fuels, commodity and specialty chemicals, sensors, materials, and more. China recently declared a focus on synthetic animal protein production in its January 2022 Five Year Plan for Agriculture. Our trade relationship with China, which includes many agricultural products, may shift if China is able to successfully produce these products synthetically.

Conclusion

To support the development of an expansive and nimble biomanufacturing economy within the United States, federal agencies should ensure that the necessary inputs for creating biomanufactured products are as abundant and cost-effective as possible. Just as the cost to produce an almond is greatly dependent on the cost of water, the cost to manufacture a biological product in a cell-based manufacturing system depends on the cost of the inputs used to feed that system. Biomanufactured products that require amino acids and growth factors as inputs range from the medically necessary, like clotting factors and monoclonal antibodies, to the potentially monumental and industry-changing, like cell-based meat and dairy products. Federal actions to increase the feasibility and cost-effectiveness of manufacturing these products in the United States will beneficially affect the bioeconomy and biotechnology industry, the pharmaceutical and biomedical industries, and potentially the food and agriculture industries as well.

Summary

The COVID-19 pandemic severely impaired State Department (DOS) processing capacity by interrupting operations at U.S. consulates and foreign posts, slashing revenue for consular services through the resultant collapse in collected fees, and straining preexisting staffing challenges. To respond to diminished capacity, the State Department used its authority to waive in-person interviews to efficiently process visas with the resources it had available, while protecting national security. Even after COVID-19 ends as an official public health emergency, its effects on visa processing capacity will  linger. In 2022, 48 percent of nonimmigrant visas were issued with an interview waiver, which was a vital component in rejuvenating the global talent mobility. Current visa interview waiver policies should remain  in place until U.S. visa processing fully rebounds and should become a permanent  feature of the State Department’s ongoing efforts to develop country-by-country consular policies that mitigate risk and avoid backlogs. 

Expanded use of interview waivers because of diminished processing capacity

Congress authorized interview waivers to allow the State Department to focus its scarce resources on potential threats. The State Department originally had complete discretion about who must make a “personal appearance” and who may be waived under the Immigration and Nationality Act of 1952.¹ Before the September 11th attacks, personal appearance waivers were relatively common,² but post-9/11 policy guidance, initially codified in regulation in 2003, restricted the use of waivers to certain circumstances.³ Congress codified these restrictions in the Intelligence Reform and Terrorism Prevention Act of 2004, which added an in-person interview requirement for all applicants between 14 and 79 except under particular circumstances.⁴ Namely, DOS can offer waivers for the in-person interview requirement to applicants renewing visas (who have already had interviews) and for designated low-risk applicants.⁵ 

The 2004 State Department waiver authorities that Congress left to the State Department contain three components. First, individual consular officers may waive in-person interviews in certain cases when the applicant “presents no national security concerns requiring an interview.” Second, the Secretary of State may waive interviews when it is in the national interest. Third, the Deputy Assistant Secretary for Visa Services has the authority to waive interviews when it is “necessary as a result of unusual or emergent circumstances.”⁶ 

In the wake of COVID-19, the State Department has strategically used these waivers to address growing backlogs. After a temporary suspension of visa processing at the beginning of the pandemic, DOS resumed limited visa processing in July 2020. However, limited capacity led to significant backlogs and wait times. A number of factors have contributed to lengthy backlogs: 

1. Interrupted operations at consulates and embassies: Many consular offices shut down temporarily or scaled back their services during peak pandemic times due to lockdown measures and health risks. This led to delays in application processes that spiraled into massive backlogs when normal functionality resumed.
2. Diminished revenue: As a fee-based agency, consular services lost the revenue associated with normal operations. Cuts to staff and resources left the agency with higher caseloads per officer. 
3. Limited resources before pandemic: Even before COVID-19, US consulates and embassies had inadequate resources to efficiently handle significant processing demands. This problem was exacerbated by pandemic-related disruptions.
4. Increased application volumes: Global travel resumed as vaccines became widely available. Families reuniting after extended time apart was a primary contributor to rising visa application volumes.  

The Department of State’s current policies focus on low-risk applicants, namely individuals who: have previously traveled to the United States; have biometrics on file for full screening and vetting; and either are the beneficiary of an approved petition from DHS confirming their eligibility for a visa classification or have already received a Certificate of Eligibility for a visa classification by an institution designated by DOS. 

On March 26, 2020, Secretary of State Pompeo announced that the DOS would expand the availability of waivers to certain H-2 applicants, marking the first expansion of visa waivers in response to reduced processing capacity.  In August 2020, Pompeo announced that applicants seeking a visa in the same category they previously held would be allowed to get an interview waiver if their visa expired in the last 24 months. Before this, the expiration period for an interview waiver was only 12 months. In December 2020, just two days before this policy was set to expire, DOS extended it through the end of March 2021. In March, the expiration period was doubled again, from 24 months to 48 months and the policy extended through December 31, 2021. In September of 2021, DOS also approved waivers through the remainder of 2021 for applicants of F, M, and academic J visas from Visa Waiver Program countries who were previously issued a visa.

In December 2021, DOS extended its then-existing policies (with some minor modifications) through December 2022. It also expanded its interview waiver policies by making first-time applicants for H-1, H-3, H-4, L, O, P, and Q visas — all classifications requiring petition adjudication by DHS — eligible for waivers if they are nationals of countries participating in the Visa Waiver Program and are a previous traveler to the United States through the Electronic System for Travel Authorization (ESTA). Applicants for H-1, H-3, H-4, L, O, P, and Q visas are also eligible for waivers if they have previously been issued any type of visa (meaning their  biometric data was on file with DOS), have never been refused a visa (unless the refusal was overcome or waived), and provided they have no apparent or potential ineligibility. Applicants who have been issued a valid Certificate of Eligibility for classification as an F-1 student or an exchange visitor on an academic J-1 program may also be issued a visa without an interview.  Moreover, the interview waiver policy that individuals renewing a visa in the same category as a visa that expired in the preceding 48 months may be eligible for issuance without an interview was announced as a standing policy of the State Department, and added to the department’s Foreign Affairs Manual for consular officers.  In December 2022, DOS announced another extension of these policies, which are set to expire at the end of 2023. 

In April 2023, President Biden signed a resolution ending the state of national emergency initiated by the pandemic. The public health emergency expires on May 11, 2023. 

As policymakers consider the future of interview waivers beyond the official COVID emergency, they should note that new waiver policies were a response to a profound reduction in processing capacity rather than as a direct public health measure. Even with an expanded use of waivers, backlogs are still significant. The average wait time is estimated to be about 100 days—well above pre-pandemic waits.  Even though the public health emergency has ended, we must retain current policies on interview waivers as long as processing delays persist. 

Interview Waivers Have Been Highly Effective

Interview waivers have positively contributed to effective visa processing. Recent data show a decline in global wait times for various applicant types, including students, exchange visitors, temporary workers requiring DHS petition approval, and B-1/B-2 visitors.⁷ Moreover, interview waivers have had a minimal impact on overstay rates. 

It should be noted that waivers are not granted at the expense of national security or public safety. Robust screening and vetting protocols persist even when interviews are waived. Preserving the waiver mechanism can help strike a balance between robust screening and vetting measures and the  procedural workflows that are vital for efficiently managing backlog cases.  Waived applicants typically consist of low-risk profiles or those who have previously been granted visas after comprehensive background checks, who are then subjected to the same screening and vetting checks and reviews as interviewed applicants based on their biometrics already on file.  The ability of State’s consular posts to receive visa applications without an interview, but not mandating that posts do so for all available categories,allows consular officials to take into account country-specific conditions.  

As the State Department recently noted: “These interview waiver authorities have reduced visa appointment wait times at many embassies and consulates by freeing up in-person interview appointments for other applicants who require an interview. Nearly half of the almost seven million nonimmigrant visas the Department issued in Fiscal Year 2022 were adjudicated without an in-person interview. We are successfully lowering visa wait times worldwide, following closures during the pandemic, and making every effort to further reduce those wait times as quickly as possible, including for first-time tourist visa applicants. Embassies and consulates may still require an in-person interview on a case-by-case basis and dependent upon local conditions.”⁸

Given that about half of all nonimmigrant visas were issued last year without an interview, discontinuing interview waivers following the end of the public health emergency will create undue strain on an already understaffed  consular workforce and hamper global mobility just as academic, industrial, and government travel is returning to pre-pandemic levels. The workload that previously took care of almost half of successful visa applications will instead increase pressure on a system that is poorly equipped to service the growing post-pandemic demand.

Interview waivers do not jeopardize security

As the State Department explained in 2015, “interview waiver options do not represent a reduced scrutiny of applicants; rather, they are intended to enhance the security of the visa process by allowing State to focus more of its resources on potential threats.” 

First, expanded use of interview waivers as a result of the pandemic only applies to low-risk applicants. The waivers are subject to important guardrails to safeguard security. They are not available to any applicant who: has previously been denied a visa; is listed in the Consular Lookout and Support System (CLASS); requires a Security Advisory Opinion or State Department clearance; is applying from a country they are not a national or resident of; or who is applying from a country designated a state sponsor of terrorism. Furthermore, they cannot be a member of any group that poses a security threat, has historically had an above average rate of visa denials, or poses a substantial risk of visa fraud. 

Second, applicants eligible for interview waivers remain subject to the background checks and all screening and vetting required for all nonimmigrants, including name checks and biometric screening. 

Third, the waivers are discretionary. Consular officers always have the option to interview an  applicant if they doubt their credibility or have any other questions about their eligibility following standard screening procedures.

Interview waivers maximize the security afforded by DOS for a given level of processing capacity by allowing the department to deploy its resources where they are most needed.

Recommendations

Current interview waivers should be extended until at least 80% of non-immigrant visa applicants in categories requiring USCIS petition approval or sponsor-issued Certificates of Eligibility can schedule an interview within three weeks. Existing waivers should not be lifted unless this benchmark for visa processing can be maintained. In 2012, the president established this benchmark as a target for DOS with regard to business and tourist visas. By 2015, the Department successfully brought wait times down with the help of numerous policy changes, including the use of interview waivers. This benchmark provides a reasonable criterion to define unusual or emergent circumstances related to visa processing justifying waivers. 

Consular management controls should include required annual reporting by consular posts to the State Department’s Bureau of Consular Affairs on the use of interview waivers.  Consular posts typically conduct a handful of validation studies each year for Visa Services leadership in Consular Affairs.  Each consular post should be tasked with reporting: whether the post utilized interview waiver authorities, and the reasoning for when the authorities were employed or not, what efficiencies or hurdles were encountered; and how the targeted use of interview waivers at the individual post can mitigate risks by allowing consular officials to focus attention on country-specific conditions.

Congress should authorize expanded interview waivers beyond the emergent circumstances of reduced processing capacity and task DOS with piloting other policies that would institutionalize efficient visa processing. Waivers are justified under current authority by the unusual circumstance of reduced processing capacity but may be helpful even when processing capacity has rebounded. Congress can and should make clear that it intends the national interest authorities left to the Secretary of State be utilized for the purpose of keeping processing times down. Congress can also help DOS pilot remote interviews for those  lowest risk applicants that remain ineligible for interview waivers or in countries where interview waivers are not an appropriate response for country conditions. Combining interview waivers with remote interviewing authority would allow the State Department to better choose how to deploy its resources while also maintaining thorough screening and vetting through biometrics.  Institutionalizing more certain and predictable timing on visa applications would help ensure the U.S. is attractive to international talent that is key to keeping the country competitive.

Conclusion

Despite reported improvements in pandemic conditions, visa backlogs continue to pose significant challenges at U.S. diplomatic missions around the world. The State Department should be allowed to broadly and flexibly use consular resources to collect and review screening and vetting results and complete all processing requirements without scheduling interviews. This will allow the Department to offer more timely options for qualified individuals seeking entry into the country. Maintaining interview waivers after the official expiration of the COVID-19 health crisis allows experts to focus on essential cases requiring more in-depth scrutiny, thus bolstering the security of our immigration system.

Lifting COVID-related restrictions does not automatically imply that all embassies or consulates will be able to immediately manage pre-pandemic levels of visa applications. Adjusting staffing resources and infrastructure could take time, especially when considering additional constraints from dealing with limited operational capacities. In these cases, visa interview waivers can help alleviate undue stress on embassy operations while providing flexibility to consular officers.

Summary

To increase protections for fair work, the U.S. Department of Labor (DOL) should create an Office of the Ombudsman for Fair Work. Gig workers are a category of non-employee contract workers who engage in on-demand work, often through online platforms. They have had historic vulnerabilities in the U.S. economy. A large portion of gig workers are people of color, and the nature of their temporary and largely unregulated work can leave them vulnerable to economic instability and workplace abuse. Currently, there is no federal mechanism to protect gig workers, and state-level initiatives have not offered thorough enough policy redress. Establishing an Office of the Ombudsman would provide the Department of Labor with a central entity to investigate worker complaints against gig employers, collect data and evidence about the current gig economy, and provide education to gig workers about their rights. There is strong precedent for this policy solution, since bureaus across the federal government have successfully implemented ombudsmen that are independent and support vulnerable constituents. To ensure its legal and long-lasting status, the Secretary of Labor should establish this Office in an act of internal agency reorganization.

Challenge and Opportunity

The proportion of the U.S. workforce engaging in gig work has risen steadily in the past few decades, from 10.1% in 2005 to 15.8% in 2015 to roughly 20% in 2018. Since the COVID-19 pandemic began, this trend has only accelerated, and a record number of Americans have now joined the gig economy and rely on its income. In a 2021 Pew Research study, over 16% of Americans reported having made money through online platform work alone, such as on apps like Uber and Doordash, which is merely a subset of gig work jobs. Gig workers in particular are more likely to be Black or Latino compared to the overall workforce.

Though millions of Americans rely on gig work, it does not provide critical employee benefits, such as minimum wage guarantees, parental leave, healthcare, overtime, unemployment insurance, or recourse for injuries incurred during work. According to an NPR survey, in 2018 more than half of contract workers received zero benefits through work. Further, the National Labor Relations Act, which protects employees’ rights to unionize and collectively bargain without retaliation, does not protect gig workers. This lack of benefits, rights, and voice leaves millions of workers more vulnerable than full-time employees to predatory employers, financial instability, and health crises, particularly during emergencies—such as the COVID-19 pandemic. 

Additionally, in 2022, inflation reached a decades-long high, and though the price of necessities has spiked, wages have not increased correspondingly. Extreme inflation hurts lower-income workers without savings the most and is especially dangerous to gig workers, some of whom make less than the federal minimum hourly wage and whose income and work are subject to constant flux.

State-level measures have as yet failed to create protections for all gig workers. In 2020, California passed AB5, legally reclassifying many gig workers as employees instead of independent contractors and thus entitling them to more benefits and protections. But further bills and Proposition 22 reverted several groups of gig workers, including online platform gig workers like Uber and Doordash drivers, to being independent contractors. Ongoing litigation related to Proposition 22 leaves the future status of online platform gig workers in California unclear. In 2022, Washington State passed ESHB 2076 guaranteeing online platform workers—but not all gig workers—the benefits of full-time employees. 

This sparse patchwork of state-level measures, which only supports subgroups of gig workers, could trigger a “race to the bottom” in which employers of gig workers relocate to less strict states. Additionally, inconsistencies between state laws make it harder for gig workers to understand their rights and gain redress for grievances, harder for businesses to determine with certainty their duties and liabilities, and harder for states to enforce penalties when an employer is headquartered in one state and the gig worker lives in another. The status quo is also difficult for businesses that strive to be better employers because it creates downward pressure on the entire landscape of labor market competition. Ultimately, only federal policy action can fully address these inconsistencies and broadly increase protections and benefits for all gig workers. 

The federal ombudsman’s office outlined in this proposal can serve as a resource for gig workers to understand the scope of their current rights, provide a voice to amplify their grievances and harms, and collect data and evidence to inform policy proposals. It is the first step toward a sustainable and comprehensive national solution that expands the rights of gig workers.

Specifically, clarifying what rights, benefits, and means of recourse gig workers do and do not have would help gig workers better plan for healthcare and other emergent needs. It would also allow better tracking of trends in the labor market and systemic detection of employee misclassification. Hearing gig workers’ complaints in a centralized office can help the Department of Labor more expeditiously address gig workers’ concerns in situations where they legally do have recourse and can otherwise help the Department of Labor better understand the needs of and harms experienced by all workers. Collecting broad-ranging data on gig workers in particular could help inform federal policy change on their rights and protections. Currently, most datasets are survey based and often leave out people who were not working a gig job at the time the survey was conducted but typically otherwise do. More broadly, because of its informal and dynamic nature, the gig economy is difficult to accurately count and characterize, and an entity that is specifically charged with coordinating and understanding this growing sector of the market is key.

Lastly, employees who are not gig workers are sometimes misclassified as such and thus lose out on benefits and protections they are legally entitled to. Having a centralized ombudsman office dedicated to gig work could expedite support of gig workers seeking to correct their classification status, which the Wage and Hour Division already generally deals with, as well as help the Department of Labor and other agencies collect data to clarify the scope of the problem.

Plan of Action

The Department of Labor should establish an Office of the Ombudsman for Fair Work. This office should be independent of Department of Labor agencies and officials, and it should report directly to the Secretary of Labor. The Office would operate on a federal level with authority over states.

The Secretary of Labor should establish the Office in an act of internal agency reorganization. By establishing the Office such that its powers do not contradict the Department of Labor’s statutory limitations, the Secretary can ensure the Office’s status as legal and long-lasting, due to the discretionary power of the Department to interpret its statutes.

The role of the Office of the Ombudsman for Fair Work would be threefold: to serve as a centralized point of contact for hearing complaints from gig workers; to act as a central resource and conduct outreach to gig workers about their rights and protections; and to collect data such as demographic, wage, and benefit trends on the labor practices of the gig economy. Together, these responsibilities ensure that this Office consolidates and augments the actions of the Department of Labor as they pertain to workers in the gig economy, regardless of their classification status.

The functions of the ombudsman should be as follows:

1. Establish a clear and centralized mechanism for hearing, collating, and investigating complaints from workers in the gig economy, such as through a helpline or mobile app.
2. Establish and administer an independent, neutral, and confidential process to receive, investigate, resolve, and provide redress for cases in which employers misrepresent to individuals that they are engaged as independent contractors when they’re actually engaged as employees.
3. Commence court proceedings to enforce fair work practices and entitlements, as they pertain to workers in the gig economy, in conjunction with other offices in the DOL.
4. Represent employees or contractors who are or may become a party to proceedings in court over unfair contracting practices, including but not limited to misclassification as independent contractors. The office would refer matters to interagency partners within the Department of Labor and across other organizations engaged in these proceedings, augmenting existing work where possible.
5. Provide education, assistance, and advice to employees, employers, and organizations, including best practice guides to workplace relations or workplace practices and information about rights and protections for workers in the gig economy.
6. Conduct outreach in multiple languages to gig economy workers informing them of their rights and protections and of the Office’s role to hear and address their complaints and entitlements.
7. Serve as the central data collection and publication office for all gig-work-related data. The Office will publish a yearly report detailing demographic, wage, and benefit trends faced by gig workers. Data could be collected through outreach to gig workers or their employers, or through a new data-sharing agreement with the Internal Revenue Service (IRS). This data report would also summarize anonymized trends based on the complaints collected (as per function 1), including aggregate statistics on wage theft, reports of harassment or discrimination, and misclassification. These trends would also be broken down by demographic group to proactively identify salient inequities. The office may also provide separate data on platform workers, which may be easier to collect and collate, since platform workers are a particular subject of focus in current state legislation and litigation.

Establishing an Office of the Ombudsman for Fair Work within the Department of Labor will require costs of compensation for the ombudsman and staff, other operational costs, and litigation expenses. To reflect the need for a reaction to the rapid ongoing changes in gig economy platforms, a small portion of the Office’s budget should be set aside to support the appointment of a chief innovation officer, aimed at examining how technology can strengthen its operations. Some examples of tasks for this role include investigating and strengthening complaint sorting infrastructure, utilizing artificial intelligence to evaluate contracts for misclassification, and streamlining request for proposal processes.

Due to the continued growth of the gig economy, and the precarious status of gig workers in the onset of an economic recession, this Office should be established in the nearest possible window. Establishing, appointing, and initiating this office will require up to a year of time, and will require budgeting within the DOL.

There are many precedents of ombudsmen in federal office, including the Office of the Ombudsman for the Energy Employees Occupational Illness Compensation Program within the Department of Labor. Additionally, the IRS established the Office of the Taxpayer Advocate, and the Department of Homeland Security has both a Citizenship and Immigration Services Ombudsman and an Immigration Detention Ombudsman. These offices have helped educate constituents about their rights, resolved issues that an individual might have with that federal agency, and served as independent oversight bodies. The Australian Government has a Fair Work Ombudsman that provides resources to differentiate between an independent contractor and employee and investigates employers who may be engaging in sham contracting or other illegal practices. Following these examples, the Office of the Ombudsman for Fair Work should work within the Department of Labor to educate, assist, and provide redress for workers engaged in the gig economy.

Conclusion

How to protect gig workers is a long-standing open question for labor policy and is likely to require more attention as post-pandemic conditions affect labor trends. The federal government needs a solution to the issues of vulnerability and instability experienced by gig workers, and this solution needs to operate independently of legislation that may take longer to gain consensus on. Establishing an office of an ombudsman is the first step to increase federal oversight for gig work. The ombudsman will use data, reporting, and individual worker cases to build a clearer picture for how to create redress for laborers that have been harmed by gig work, which will provide greater visibility into the status and concerns of gig workers. It will additionally serve as a single point of entry for gig workers and businesses to learn about their rights and for gig workers to lodge complaints. If made a reality, this office will be an influential first step in changing the entire policy ecosystem regarding gig work. 

Summary

Maternal mortality is a crisis in the United States. Yet more than 60% of maternal deaths are preventable—with the right evidence-based interventions. Data is a powerful tool for uncovering best care practices. While healthcare data, including maternal health data, has been generated at a massive scale by the widespread adoption and use of Electronic Health Records (EHR), much of this data remains unstandardized and unanalyzed. Further, while many federal datasets related to maternal health are openly available through initiatives set forth in the Open Government National Action Plan, there is no central coordinating body charged with analyzing this breadth of data. Advancing data harmonization, research, and analysis are foundational elements of the Biden Administration’s Blueprint for Addressing the Maternal Health Crisis. As a data-driven technology, artificial intelligence (AI) has great potential to support maternal health research efforts. Examples of promising applications of AI include using electronic health data to predict whether expectant mothers are at risk of difficulty during delivery. However, further research is needed to understand how to effectively implement this technology in a way that promotes transparency, safety, and equity. The Biden-Harris Administration should establish an AI Center of Excellence to bring together data sources and then analyze, diagnose, and address maternal health disparities, all while demonstrating trustworthy and responsible AI principles.  

Challenge and Opportunity

Maternal deaths currently average around 700 per year, and severe maternal morbidity-related conditions impact upward of 60,000 women annually. Stark maternal health disparities persist in the United States, and pregnancy outcomes are subject to substantial racial/ethnic disparities, including maternal morbidity and mortality. According to the Centers for Disease Control and Prevention (CDC), “Black women are three times more likely to die from a pregnancy-related cause than White women.” Research is ongoing to specifically identify the root causes, which include socioeconomic factors such as insurance status, access to healthcare services, and risks associated with social determinants of health. For example, maternity care deserts exist in counties throughout the country where maternal health services are substantially limited or not available, impacting an estimated 2.2 million women of child-bearing age.

Many federal, public, and private datasets exist to understand the conditions that impact pregnant people, the quality of the care they receive, and ultimate care outcomes. For example, the CDC collects abundant data on maternal health, including the Pregnancy Mortality Surveillance System (PMSS) and the National Vital Statistics System (NVSS). Many of these datasets, however, have yet to be analyzed at scale or linked to other federal or privately held data sources in a comprehensive way. More broadly, an estimated 30% of the data generated globally is produced by the healthcare industry. AI is uniquely designed for data management, including cataloging, classification, and data integration. AI will play a pivotal role in the federal government’s ability to process an unprecedented volume of data to generate evidence-based recommendations to improve maternal health outcomes. 

Applications of AI have rapidly proliferated throughout the healthcare sector due to their potential to reduce healthcare expenditures and improve patient outcomes (Figure 1). Several applications of this technology exist across the maternal health continuum and are shown in the figure below. For example, evidence suggests that AI can help clinicians identify more than 70% of at-risk moms during the first trimester by analyzing patient data and identifying patterns associated with poor health outcomes. Based on its findings, AI can provide recommendations for which patients will most likely be at-risk for pregnancy challenges before they occur. Research has also demonstrated the use of AI in fetal health monitoring. 

Figure 1: Areas Where Artificial Intelligence and Machine Learning Is Used for Women’s Reproductive Health

Source: Davidson and Boland (2021). 

Yet for all of AI’s potential, there is a significant dearth of consumer and medical provider understanding of how these algorithms work. Policy analysts argue that “algorithmic discrimination” and feedback loops in algorithms—which may exacerbate algorithmic bias—are potential risks of using AI in healthcare outside of the confines of an ethical framework. In response, certain federal entities such as the Department of Defense, the Office of the Director of National Intelligence, the National Institute for Standards and Technology, and the U.S. Department of Health and Human Services have published and adopted guidelines for implementing data privacy practices and building public trust of AI. Further, past Day One authors have proposed the establishment of testbeds for government-procured AI models to provide services to U.S. citizens. This is critical for enhancing the safety and reliability of AI systems while reducing the risk of perpetuating existing structural inequities. 

It is vital to demonstrate safe, trustworthy uses of AI and measure the efficacy of these best practices through applications of AI to real-world societal challenges. For example, potential use cases of AI for maternal health include a social determinants of health [SDoH] extractor, which combines AI with clinical notes to more effectively identify SDoH information and analyze its potential role in health inequities. A center dedicated to ethically developing AI for maternal health would allow for the development of evidence-based guidelines for broader AI implementation across healthcare systems throughout the country. Lessons learned from this effort will contribute to the knowledge base around ethical AI and enable development of AI solutions for health disparities more broadly. 

Plan of Action

To meet the calls for advancing data collection, standardization, transparency, research, and analysis to address the maternal health crisis, the Biden-Harris Administration should establish an AI Center of Excellence for maternal health. The AI Center of Excellence for Maternal Health will bring together data sources, then analyze, diagnose, and address maternal health disparities, all while demonstrating trustworthy and responsible AI principles. The Center should be created within the Department of Health and Human Services (HHS) and work closely with relevant offices throughout HHS and beyond, including the HHS Office of the Chief Artificial Intelligence Officer (OCAIO), the National Institutes of Health (NIH) IMPROVE initiative, the CDC, the Veterans Health Administration (VHA), and the National Institute for Standards and Technology (NIST). The Center should offer competitive salaries to recruit the best and brightest talent in AI, human-centered design, biostatistics, and human-computer interaction.

The first priority should be to work with all agencies tasked by the White House Blueprint for Addressing the Maternal Health Crisis to collect and evaluate data. This includes privately held EHR data that is made available through the Qualified Health Information Network (QHIN) and federal data from the CDC, Centers for Medicare and Medicaid (CMS), Office of Personnel Management (OPM), Healthcare Resources and Services Agency (HRSA), NIH, United States Department of Agriculture (USDA), Housing and Urban Development (HUD), the Veterans Health Administration, and Environmental Protection Agency (EPA), all of which contain datasets relevant to maternal health at different stages of the reproductive health journey from Figure 1. The Center should serve as a data clearing and cleaning shop, preparing these datasets using best practices for data management, preparation, and labeling.

The second priority should be to evaluate existing datasets to establish high-priority, high-impact applications of AI-enabled research for improving clinical care guidelines and tools for maternal healthcare providers. These AI demonstrations should be aligned with the White House’s Action Plan and be focused on implementing best practices for AI development, such as the AI Risk Management Framework developed by NIST. The following examples demonstrate how AI might help address maternal health disparities, based on priority areas informed by clinicians in the field:   

1. AI implementation should be explored for analysis of electronic health records from the VHA and QHIN to predict patients who have a higher risk of pregnancy and/or delivery complications. 
2. Drawing on the robust data collection and patient surveillance capabilities of the VHA and HRSA, AI should be explored for the deployment of digital tools to help monitor patients during pregnancy to ensure adequate and consistent use of prenatal care.  
3. Using VHA data and QHIN data, AI should be explored in supporting patient monitoring in instances of patient referrals and/or transfers to hospitals that are appropriately equipped to serve high-risk patients, following guidelines provided by the American College of Obstetricians and Gynecologists.
4. Data on housing from HUD, rural development from the USDA, environmental health from the EPA, and social determinants of health research from the CDC should be connected to risk factors for maternal mortality in the academic literature to create an AI-powered risk algorithm.
5. Understand the power of payment models operated by CMS and OPM for novel strategies to enhance maternal health outcomes and reduce maternal deaths.

The final priority should be direct translation of the findings from AI to federal policymaking around reducing maternal health disparities as well as ethical development of AI tools. Research findings for both aspects of this interdisciplinary initiative should be framed using Living Evidence models that help ensure that research-derived evidence and guidance remain current.

The Center should be able to meet the following objectives within the first year after creation to further the case for future federal funding and creation of more AI Centers of Excellence for healthcare:

1. Conduct a study on the use cases uncovered for AI to help address maternal health disparities explored through the various demonstration projects.
2. Publish a report of study findings, which should be submitted to Congress with recommendations to help inform funding priorities for subsequent research activities.
3. Make study findings available to the public to help build public trust in AI.

Successful piloting of the Center could be made possible by passage of an equivalent bill to S.893 in the current Congress. This is a critical first step in supporting this work. In March 2021, the S.893—Tech to Save Moms Act was introduced in the Senate to fund research conducted by National Academies of Sciences, Engineering, and Medicine to understand the role of AI in maternal care delivery and its impact on bias in maternal health. Passage of an equivalent bill into law would enable the National Academies of Sciences, Engineering, and Medicine to conduct research in parallel with HHS to generate more findings and to broaden potential impact.

Conclusion

The United States has the highest rate of maternal health disparities among all developed countries. Yet more than 60% of pregnancy-related deaths are preventable, highlighting a critical opportunity to uncover the factors impeding more equitable health outcomes for the nation as a whole. Legislative support for research to understand AI’s role in addressing maternal health disparities will affirm the nation’s commitment to ensuring that we are prepared to thrive in a 21^st century influenced and shaped by next-generation technologies such as artificial intelligence.

Summary

Despite the World Health Organization’s (WHO) designation of medical oxygen as an essential medicine in 2017, oxygen is still not consistently available in all care settings. Shortages in medical oxygen, which is essential for surgery, pneumonia, trauma, and other hypoxia conditions in vulnerable populations, existed prior to the COVID-19 pandemic and persist today. By one estimate, pre-pandemic, only 20% of patients in low- and middle-income countries (LMICs) who needed medical oxygen received it. The pandemic tremendously increased the need for oxygen, further compounding access issues as oxygen became an indispensable treatment. During the peak of the pandemic, dozens of countries faced severe oxygen shortages due to patient surges impacting an already fragile infrastructure. 

The core driver of this challenge is not a lack of funding and international attention but rather a lack of infrastructure to buy oxygen, not just equipment. Despite organizations such as Unitaid, Bill & Melinda Gates Foundation, Clinton Health Access Initiative, UNICEF, WHO and U.S. Agency for International Development (USAID) prioritizing funding and provisions of medical oxygen, many countries still face critical shortages. Even fewer LMICs, such as Brazil, are truly oxygen self-sufficient. A broken and inequitable global oxygen delivery infrastructure inadvertently excludes low-income and rural area representation during the design phase. Furthermore, the current delivery infrastructure is composed of many individual funders and private and public stakeholders who do not work in a coordinated fashion because there is no global governing body to establish global policy, standards, and oversight; identify waste and redundancy; and ensure paths to self-sufficiency. As a result, LMICs are at the mercy of other nations and entities who may withhold oxygen during a crisis or fail to adequately distribute supply. It is time for aid organizations and governments to become more efficient and effective at solving this systemic problem by establishing global governance and investing in and enabling LMICs to become self-sufficient by establishing national infrastructure for oxygen generation, distribution, and delivery.

We propose transforming current interventions by centering the concept known as Oxygen as a Utility (OaaU), which fundamentally reimagines a country’s infrastructure for medical oxygen as a public utility supported by private investment and stable prices to create a functionable, equitable market for a necessary public health good. With the White House Covid Response Team shuttering in the coming months, USAID’s Bureau for Global Health has a unique opportunity to take a global leadership role in spearheading the development of an accessible, affordable oxygen marketplace. USAID should convene a global public-private partnership and governing coalition called the Universal Oxygen Coalition (UOC), pilot the OaaU model in at least two target LMICs (Tanzania and Uttar Pradesh, India), and launch a Medical Oxygen Grand Challenge to enable necessary technological and infrastructure innovation.

Challenge and Opportunity

There is no medical substitute for oxygen, which is used to treat a wide range of acute respiratory distress syndromes, such as pneumonia and pneumothorax in newborns, and noncommunicable diseases, such as asthma, heart failure, and COVID-19. Pneumonia alone is the world’s biggest infectious killer of adults and children, claiming the lives of 2.5 million people, including 740,180 children, in 2019. The COVID-19 pandemic compounded the demand for oxygen, and exposed the lack thereof, with increased death tolls in countries around the world as a result.

For every COVID-19 patient who needs oxygen, there are at least five other patients who also need it, including the 7.2 million children with pneumonia who enter LMIC hospitals each year. [Ehsanur et al, 2021]. Where it is available, there are often improperly balanced oxygen distribution networks, such as high-density areas being overstocked while rural areas or tertiary care settings go underserved. Only 10% of hospitals in LMICs have access to pulse oximetry and oxygen therapy, and those better-resourced hospitals tend to be in larger cities closer to existing oxygen delivery providers.

This widespread lack of access to medical oxygen in LMICs threatens health outcomes and well-being, particularly for rural and low-income populations. The primary obstacle to equitable oxygen access is lack of the necessary digital infrastructure in-country. Digital infrastructure provides insights that enable health system managers and policymakers to effectively establish policy, manage the supply of oxygen to meet needs, and coordinate work across a complex supply chain composed of various independent providers. Until replicable and affordable digital infrastructure is established, LMICs will not have the necessary resources to manage a national oxygen delivery system, forecast demand, plan for adequate oxygen production and procurement, safeguard fair distribution, and ensure sustainable consumption.

Oxygen can be delivered in a number of forms—via concentrators, cylinders, plants, or liquid—and the global marketplace encompasses many manufacturers and distributors selling in multiple nations. Most oxygen providers are for-profit organizations, which are not commercially incentivized to collaborate to achieve equal oxygen access, despite good intentions. Many of these same manufacturers also sell medical devices to regulate or deliver oxygen to patients, yet maintaining the equipment across a distributed network remains a challenge. These devices are complex and costly, and there are often few trained experts in-country to repair broken devices. Instead of recycling or repairing devices, healthcare providers are often forced to discard broken equipment and purchase new ones, contributing to greater landfill waste and compounding health concerns for those who live nearby.

Common contributing causes for fragmented oxygen delivery systems in LMICs include:

1. No national digital infrastructure to connect, track, and monitor medical oxygen supply and utilization, like an electrical utility to forecast demand and ensure reliable service delivery.
2. No centralized way to monitor manufacturers, distributors, and the various delivery providers to ensure coordination and compliance with local policy.
3. In many cases, no established local policy for oxygen and healthcare regulation or no means to enforce local policy.
4. Lack of purchasing options for healthcare providers, who are often forced to buy whichever oxygen devices are available versus the type of source oxygen that best fits their needs (i.e., concentrator or liquid) due to cumbersome tender systems and lack of coordination across markets.
5. Lack of trained experts to maintain and repair devices, including limited national standardized certification programs, resulting in the premature disposal of costly medical devices contributing to waste issues. Further, lack of maintenance fuels the vicious cycle of LMICs requiring more regular funding to buy oxygen devices, which can increase reliance on third parties to sustain oxygen needs rather than domestic demand and marketplaces.

Medical oxygen investment is a unique opportunity to achieve global health outcomes and localization policy objectives. USAID invested $50 million to expand medical oxygen access through its global COVID-19 response for LMIC partners, but this investment only scratches the surface of what is needed to deliver self-sustainment. In response to oxygen shortages during the peaks of the pandemic, the WHO, UNICEF, the World Bank, and other donors shipped hundreds of thousands of oxygen concentrators to help LMICs deal with the rise in oxygen needs. This influx of resources addressed the interim need but did not solve the persisting healthcare system and underlying oxygen infrastructure problems. In 2021, the World Bank made emergency loans available to LMICs to help them shore up production and infrastructure capabilities, but not enough countries applied for these loans, as the barriers to solve these infrastructure issues are complex, difficult to identify without proper data and digital infrastructure to identify supply chain gaps, and hard to solve with a single cash loan.

Despite heavy attention to the issue of oxygen access in LMICs, current spending does not go far enough to set up sustainable oxygen systems in LMICs. Major access and equity gaps still persist. In short, providing funding alone without a cohesive, integrated industrial strategy cannot solve the root problem of medical oxygen inequality. 

USAID recently announced an expanded commitment in Africa and Asia to expand medical oxygen access, including market-shaping activities and partnerships. Since the pandemic began, USAID has directed $112 million in funding for medical oxygen to 50 countries and is the largest donor to The Global Fund, which has provided the largest international sums of money (more than $600 million) to increase medical oxygen access in over 80 countries. In response to the pandemic’s impacts on LMICs, the ACT-Accelerator (ACT-A) Oxygen Emergency Taskforce, co-chaired by Unitaid and the Wellcome Trust, has provided $700 million worth of oxygen supplies to over 75 countries and catalyzed large oxygen suppliers and NGO leaders to support LMICs and national healthcare ministries. This task force has brought together industry, philanthropy, NGO, and academic leaders. While USAID is not a direct partner, The Global Fund is a primary donor to the task force.

Without a sea change in policy, however, LMICs will continue to lack the support required to fully diagnosis national oxygen supply delivery system bottlenecks and barriers, establish national regulation policies, deploy digital infrastructures, change procurement approaches, enable necessary governance changes, and train in-country experts to ensure a sustained, equitable oxygen supply chain. To help LMICs become self-sufficient, we need to shift away from offering a piecemeal approach (donating money and oxygen supplies) to a holistic approach that includes access to a group of experts , funding for oxygen digital infrastructure systems, aid to develop national policy and governance mechanisms, and support for establishing specialty training and certification programs so that LMICs can self-manage their own medical oxygen supply chain. Such a development policy initiative relies on the Oxygen as a Utility framework, which focuses on creating a functional, equitable market for medical oxygen as a necessary public good. When achieved successfully, OaaU facilitates one fair rate for end-to-end distribution within a country, like other public utilities such as water and electricity.

A fully realized OaaU model within a national economy would integrate and streamline most aspects of oxygen delivery, from production to distribution of both the oxygen and the devices that dispense it, to training of staff on when to administer oxygen, how to use equipment, and equipment maintenance. This proposed new model coordinates industry partners, funders, and country leaders to focus on end-to-end medical oxygen delivery as an affordable, accessible utility rather than an in-kind development good. OaaU centers predictability, affordability, and efficiency for each stakeholder involved in creating sustainable LMIC medical oxygen supply chains. At its core, OaaU is about increasing both access and reliability by providing all types of oxygen at negotiated, market-wide, affordable, and predictable prices through industry partners and local players. This new business model would be sustainable by charging subscription and pay-per-use fees to serve the investment by private sector providers, each negotiated by Ministries of Health to empower them to manage their own country’s oxygen needs. This new model will incorporate each stakeholder in an LMIC’s healthcare system and facilitate an open, market-based negotiation to achieve affordable, self-sufficient medical oxygen supply chains.

Initial investment is needed to create a permanent oxygen infrastructure in each LMIC to digitally transform the tender system from an equipment and service or in-kind aid model to buying oxygen as a utility model. An industry business model transformation of this scale will require multistakeholder effort to include in-country coordination. The current oxygen delivery infrastructure is composed of many individual funders and private and public stakeholders who do not work in a coordinated fashion. At this critical juncture for medical oxygen provision, USAID’s convening power, donor support, and expertise should be leveraged to better direct this spending to create innovative opportunities. The Universal Oxygen Coalition would establish global policy, standards, and oversight; identify waste and redundancy; and ensure viable paths to oxygen self-sufficiency in LMICs. The UOC will act similarly to electric cooperatives, which aggregate supplies to meet electricity demand, ensuring every patient has access to oxygen, on demand, at the point of care, no matter where in the world they live.

Plan of Action

To steward and catalyze OaaU, USAID should leverage its global platform to convene funders, suppliers, manufacturers, distributors, health systems, financial partners, philanthropy, and NGOs and launch a call to action to mobilize resources and bring attention to medical oxygen inequality. USAID’s Bureau for Global Health, along with the its Private Sector Engagement Points of Contact, and the State Department’s Office of Global Partnerships should spearhead the UOC coalition. Using USAID’s Private Sector Engagement Strategy and EDGE fund as a model, USAID can serve as a connector, catalyzer, and lead implementer in reforming the global medical oxygen marketplace. The Bureau for Global Health should organize the initial summit, calls to action, and burgeoning UOC coalition because of its expertise and connections in the field. We anticipate that the UOC would require staff time and resources, which could be funded by a combination of private and philanthropic funding from UOC members in addition to some USAID resources.

To achieve the UOC vision, multiple sources of funding could be leveraged in addition to Congressional appropriation. In 2022, State Department and USAID funding for global health programs, through the Global Health Programs (GHP) account, which represents the bulk of global health assistance, totaled $9.8 billion, an increase of $634 million above the FY21 enacted level. In combination with USAID’s leading investments in The Global Fund, USAID could deploy existing authorities and funding from Development Innovation Ventures’ (DIV) and leverage Grand Challenge models like Saving Lives at Birth to create innovation incentive awards already authorized by Congress, or the newly announced EDGE Fund focused on flexible public-private sector partnerships to direct resources toward achieving equitable oxygen access for all. These transformative investments would also serve established USAID policy priorities like localization. UOC would work with USAID and the Every Breath Counts Initiative to reimagine this persistent problem by bringing essential players—health systems, oxygen suppliers, manufacturers and/or distributors, and financial partners—into a unified holistic approach to ensure reliable oxygen provision and sustainable infrastructure support. 

Recommendation 1.  USAID’s Bureau for Global Health should convene the Universal Oxygen Coalition Summit to issue an OaaU co-financing call to action and establish a global governing body. 

The Bureau for Global Health should organize the summit, convene the UOC coalition, and issue calls to action to fund country pilots of OaaU. The UOC coalition should bring together LMIC governments; local, regional, and global private-sector medical oxygen providers; local service and maintenance companies; equipment manufacturers and distributors; health systems; private and development finance; philanthropy organizations; the global health NGO community; Ministries of Health; and in-country faith-based organizations.

Once fully established, the UOC would invite industry coalition members to join to ensure equal and fair representation across the medical oxygen delivery care continuum. Potential industry members include Air Liquide, Linde, Philips, CHART, Praxair, Gulf Cryo, Air Products, International Futures, AFROX, SAROS, and GCE. Public and multilateral institutions should include the World Bank, World Health Organization, UNICEF, USAID country missions and leaders from the Bureau for Global Health, and selected country Ministries of Health. Funders such as Rockefeller Foundation, Unitaid, Bill & Melinda Gates Foundation, Clinton Health Access Initiative, and Wellcome Trust, as well as leading social enterprises and experts in the oxygen field such as Hewatele and PATH, should also be included.

UOC members would engage and interact with USAID through its Private Sector Engagement Points of Contact, which are within each regional and technical bureau. USAID should designate at least two points of contact from a regional and technical bureau, respectively, to lead engagement with UOC members and country-level partners. While dedicated funds to support the UOC and its management would be required in the long term either from Congress or private finance, USAID may be able to deploy staff from existing budgets to support the initial stand-up process of the coalition.

Progress and commitments already exist to launch the UOC, with Rockefeller Philanthropy Advisors planning to bring fiscal sponsorship as well as strategy and planning for the formation of the global coalition to the UOC with PATH providing additional strategic and technical functions for partners. The purpose of the UOC through its fiscal sponsor is to act as the global governing body by establishing global policy, standards, oversight controls, funding coordination, identifying waste & redundancy, setting priorities, acting as advisor and intermediary when needed to ensure LMIC paths to self-sufficiency are available. UOC would oversee and manage country selection, raising funding, and coordination with local Ministries of Health, funders, and private sector providers.

Other responsibilities of the UOC may include: 

• Issue feasibility studies to assess technology gaps in target countries. This research would inform future challenges, contracts, prioritization, design, and focus.
• Advise LMICs on identifying barriers and knowing best next steps. 
• Establish an official framework of best practices for OaaU that includes core metrics of success and replicable models. 

The first UOC Summit will issue a call to action to make new, significant commitments from development banks, philanthropies, and aid agencies to co-finance OaaU pilot programs, build buy-in within target LMICs, and engage in market-shaping activities and infrastructure investments in the medical oxygen supply chain. The Summit could occur on the sidelines of the Global COVID-19 Summit or the United Nations General Assembly. Summit activities and outcomes should include:

• Announce the launch and secure financial commitments from public and private funds for piloting OaaU in at least one national context.
• Identify and prioritize criteria for selecting pilot locations (regions or nations) for OaaU and select the initial country(s) for holistic oxygen self-sufficiency investment.
• Create the UOC Board representing manufacturers, global health experts, LMIC leaders, funders, multilateral institutions, and health providers who are empowered to identify geographic areas most in need of oxygen investment, issue market-specific grants and open innovation competitions, and leverage pooled public and private funds.
• Research, prioritize, and select at least two models of OaaU within a national marketplace to focus attention of all stakeholders on fixing the oxygen marketplace.

Recommendation 2. The UOC should establish country prioritization based on need and readiness and direct raised funds toward pilot programs.

USAID should co-finance an OaaU pilot model through investments in domestic supply chain streamlining and leverage matched funds from development bank, private, and philanthropic dollars. This fund should be used to invest in the development of a holistic oxygen ecosystem starting in Tanzania and in Uttar Pradesh, India, so that these regions are prepared to deliver reliable oxygen supply, catalyzing broad demand, business activity, and economic development.

The objective is to deliver a replicable global reference model for streamlining the supply chain and logistics, eventually leading to equitable oxygen catering to the healthcare needs that can be rolled out in other LMICs and improve lives for the deprived. The above sites are prioritized based on their readiness and need as determined by the 2020 PATH Market Research Study supported by the Bill and Melinda Gates Foundation. We estimate that $495 million for the pilots in both nations would provide oxygen for 270 million people, which equates to less than $2 per person. The UOC should:

• Invest in local providers: This will generate economic development and high-paying jobs in-country and throughout the supply chain. 
• Spur localized innovation and digital transformation: Foster locally driven innovation by in-country and regional systems integrators, especially in digital transformation of oxygen generation, distribution, and delivery. Solutions should include new digital tools for aggregation of supply and demand and real-time command and control to radically improve access to medical oxygen on demand.
• Create an in-country deployment coalition for each pilot country: Because oxygen marketplaces are unique to each context, having a market-based deployment coalition in each country that involves private, public, and social sector partners is critical to coordinating the deployment of resources and maintaining implementation efforts. The deployment coalition could be operated out of or supervised by a USAID Country Mission.
• Provide pilot model funding to enable Ministries of Health and the deployment coalition to streamline and fix supply chains.
• Issue calls to action for interested parties and stakeholders to submit plans to address both the immediate medical oxygen needs in the country of choice and the long-term infrastructure barriers. These plans could help inform strategy for deploying resources and making oxygen infrastructure investments.

This effort will result in a sustainable oxygen grid in LMICs to produce revenue via subscription and pay-per-use model, reducing the need for aid organization or donor procurement investment on an annual basis. To create the conditions for OaaU, the UOC will need to make a one-time investment to create infrastructure that can provide the volume of oxygen a country needs to become oxygen self-sufficient. This investment should be backed by the World Bank via volume usage guarantees similar to volume usage guarantees for electricity per country. The result will shift the paradigm from buying equipment to buying oxygen.

Recommendation 3. The UOC and partner agencies should launch the Oxygen Access Grand Challenge to invest in innovations to reduce costs, improve maintenance, and enhance supply chain competition in target countries.

We envision the creation of a replicable solution for a self-sustaining infrastructure that can then serve as a global reference model for how best to streamline the oxygen supply chain through improved infrastructure, digital transformation, and logistics coordination. Open innovation would be well-suited to priming this potential market for digital and infrastructure tools that do not yet exist. UOC should aim to catalyze a more inclusive, dynamic, and sustainable oxygen ecosystem of public- and private-sector stakeholders.

The Grand Challenge platform could leverage philanthropic and private sector resources and investment. However, we also recommend that USAID deploy some capital ($20 million over four years) for the prize purse focused on outcomes-based technologies that could be deployed in LMICs and new ideas from a diverse global pool of applicants. We recommend the Challenge focus on the creation of digital public goods that will be the digital “command and control” backbone of a OaaU in-country. This would allow a country’s government and healthcare system to know their own status of oxygen supply per a country grid and which clinic used how much oxygen in real time and bill accordingly. Such tools do not yet exist at affordable, accessible levels in LMICs. However, USAID and its UOC partners should scope and validate the challenge’s core criteria and problems, as they may differ depending on the target countries selected.

Activities to support the Challenge should include:

• Assessing technology and cost gaps in target partner countries in healthcare infrastructure, with a particular focus on supply chains and oxygen provision. This research would inform the Challenge design and focus.
• Creating partnerships with LMICs to implement promising innovations in pilots and secure advanced market commitments from healthcare ministries, the private sector, and multilateral or private financing to ensure viable pathways to scale for solutions.
• Establishing an official framework of best practices for OaaU that includes core metrics of success and replicable models that interested healthcare ministries could use to develop a system in their own nations.

Conclusion

USAID can play a catalytic role in spearheading the creation and sustainment of medical oxygen through a public utility model. Investing in new digital tools for aggregation of supply and demand and real-time command and control to radically improve access to medical oxygen on demand in LMICs can unlock better health outcomes and improve health system performance. By piloting the OaaU model, USAID can prove the sustainability and scalability of a solution that can be a global reference model for streamlining medical oxygen supply chain and logistics. USAID and its partners can begin to create sustained change and truly equitable oxygen access. Through enhancing existing public-private partnerships, USAID can also cement a resilient medical oxygen system better prepared for the next pandemic and better equipped to deliver improved health outcomes.

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