Coordinating the U.S. Government Approach to the Bioeconomy
Summary
The bioeconomy touches nearly every function of the U.S. government. The products of the bioeconomy compete in an international marketplace and include medicines, foods, fuels, materials, and novel solutions to broad challenges including climate and sustainability. The infrastructure, tools, and capabilities that drive the bioeconomy must be safeguarded to maintain U.S. leadership and to protect against misuse. The vast scale of these issues requires a cross-governmental approach that draws on input and engagement with industry, academia, nongovernmental organizations, and other stakeholders across the bioeconomy.
To achieve a durable and strategic interagency approach to the bioeconomy, the Office of Science and Technology Policy (OSTP) should establish and Congress should fund a Bioeconomy Initiative Coordination Office (BICO) to coordinate strategic U.S. government investments in the bioeconomy; facilitate efficient oversight and commercialization of biotechnology products; safeguard biotechnology infrastructure, tools and capabilities; and serve as a focal point for government engagement with nongovernmental partners and experts.
Challenge and Opportunity
Executive Order 14081, “Establishing a National Biomanufacturing and Biotechnology Initiative,” was released in September 2022. Since then, OSTP has worked to coordinate this Initiative and has made significant progress with the March 2023 release of “Bold Goals for Biotechnology and Biomanufacturing,” which describes how government agencies will support and benefit from investments in the bioeconomy; an implementation plan is forthcoming. EO 14081 also initiated interagency efforts to better measure and track the bioeconomy, prepare the regulatory system for future biotechnology products, and establish a Biosafety and Biosecurity Innovation Initiative. Although these efforts are laudable, we need a more strategic, longer-term, and outward-facing approach to ensure that the United States remains the world leader in biomanufacturing and biotechnology development. Expert reports over several years, including those from the National Academies, support the formation of strategic coordinating body within the U.S. government that focuses on the bioeconomy and more strategic planning for its investments in these areas.
The CHIPS and Science Act of 2022 provides a critical opportunity for improved interagency coordination. Division B, Title IV calls for the formation of a National Engineering Biology Research and Development Initiative coordinated by an interagency committee, co-chaired by OSTP, and supported by an Initiative Coordination Office (ICO) with a director and full-time staff. This bill stipulates that this coordination office should:
- Serve as “the point of contact on Federal engineering biology activities for government organizations, academia, industry, professional societies, State governments, interested citizen groups, and others to exchange technical and programmatic information”;
- Oversee “interagency coordination of the Initiative”; and
- Promote “access to, and early application of, the technologies, innovations, and expertise derived from Initiative activities to agency missions and systems across the Federal Government, and to United States industry, including startup companies.”
A recent bipartisan letter from Congressman Jake Auchincloss of Massachusetts confirms Congress’s intent that the ICO described in the legislation incorporate the Initiative as described in Executive Order 14081.
An ICO focused on the bioeconomy would be analogous to other congressionally mandated National Coordination Offices that drive effective interagency coordination at OSTP, including those for the U.S. Global Change Research Program (USGCRP), the National Nanotechnology Initiative (NNI), and the Networking and Information Technology Research and Development (NITRD) Program. These offices have several features in common, including:
- Support for regular interagency strategic planning and assessment mechanisms, including budget cross-cuts of relevant U.S. government activities;
- A focus on topics related to horizon scanning, technology development, and responsible innovation; and
- Robust outreach and engagement with non-government stakeholders, including industry partners.
Now is the time for OSTP to establish and for Congress to fund a durable and well-staffed Bioeconomy Initiative Coordination Office (BICO) that leads ongoing, strategic, interagency coordination across the government to support the bioeconomy. The BICO should not replace current interagency committees and processes. Instead, it should coordinate bioeconomy-related efforts that reach across multiple domains, ensure a durable and long-term approach to the bioeconomy, and serve as a focal point and doorway for U.S. government engagement with industry, academia, and other stakeholders.
Plan of Action
OSTP should establish the BICO within the next year. Its focus should be on (1) biomanufacturing, including infrastructure and capacity, pre-competitive industry issues (e.g., standards), and workforce; and (2) development and commercialization of biotechnology products, tools, and capabilities, with a particular focus on those developed for nontherapeutic uses. The interagency committee that drives the BICO should be established under the National Science and Technology Council, should be co-chaired by OSTP and the Department of Commerce, and should include as participants every agency listed in EO 14081, including:
- Department of Agriculture
- Department of Commerce
- Department of Defense
- Department of Energy
- Department of Health and Human Services
- Environmental Protection Agency
- National Economic Council
- National Science Foundation
- National Security Council
- Office of Management and Budget
- Office of Science and Technology Policy
Congress should provide an appropriation of at least $4 million per year to ensure funding for at least six full-time employees (director, lead for strategic planning and assessment, lead for regulation, lead for safeguarding, outreach coordinator, and administrator), plus office expenses, events, outreach, and other costs. Absent a specific appropriation from Congress, the BICO should follow the funding model of other congressionally mandated coordination offices, including the USGCRP and the NITRD Coordination Office: each participating agency would contribute a small percentage of its total expenditures on biomanufacturing and biotechnologies to support the BICO.
The office should be tasked with:
- Coordinating strategic planning for U.S. government investments in the bioeconomy;
- A “single door approach” for the biotechnology regulatory system that product developers can use to efficiently get actionable answers about their products’ regulatory pathways;
- An interagency process focused on safeguarding the bioeconomy by ensuring that infrastructure and supply chains are secure and reducing the risk that biotechnology tools and capabilities are accidentally or deliberately misused; and
- Extensive public outreach and engagement on these topics that includes academia, industry, nongovernmental organizations, and other bioeconomy stakeholders.
Strategic Planning
To maintain U.S. leadership in the bioeconomy, the federal government has made significant investments in biomanufacturing and biotechnology development over many years, and EO 14081 provided an important step toward a more strategic approach to these investments. However, we need a more robust and ongoing structure that incorporates opportunities for assessment of the rapidly changing bioeconomy and iteration of planning activities. The BICO should coordinate a strategic approach that includes:
- A strategic planning process with regular updates (e.g., every three years) to revisit goals, assess progress, and renew commitments;
- Budget cross-cuts, published annually, that track U.S. government investments in the bioeconomy; and
- A National Bioeconomy Assessment that incorporates advances in biotechnology products, tools, and capabilities; biomanufacturing infrastructure and workforce; and trends in public and private investment. Because the bioeconomy is rapidly changing, this assessment should incorporate a Living Evidence approach that identifies and incorporates relevant updates as they arise.
To generate an accurate National Bioeconomy Assessment and ensure that it captures updated, relevant information, the BICO should actively seek external stakeholder input and engagement that includes academia, industry, manufacturing institutes (such as BioMADE or NIIMBL), state and local governments, nongovernmental organizations, and others. In addition to informing federal investment in the bioeconomy, this ongoing assessment will be valuable for other activities within the BICO by providing insight into the types of novel products that regulators might expect to see and highlighting priority topics for outreach and engagement on safeguarding biotechnology tools and capabilities. If a Living Evidence approach is not feasible, then National Bioeconomy Assessments could be generated in a more traditional format, with publication of updated assessments at regular intervals (e.g., every three years, offset from the strategic planning publication cycle).
A “Single Door Approach” for the Biotechnology Regulatory System
For the bioeconomy to flourish, the biotechnology regulatory system must allow low-risk products to be developed and marketed quickly and efficiently. At the same time, regulatory oversight is essential to identify and limit risks to human health and the environment. The BICO should establish and support a “single door approach” for the biotechnology regulatory system to reduce ambiguities and uncertainties in the system and to better prepare the regulatory agencies for future products. (See FAQs for more information.)
An effective single door approach requires robust interagency coordination that includes OSTP and high-level decision makers from each of the primary regulatory agencies: Environmental Protection Agency (EPA), Food and Drug Administration (FDA), and U.S. Department of Agriculture (USDA). Future biotechnology products will include a wide range of applications in the environment, so governmental entities responsible for environmental protection should also be included in this interagency process, including U.S. Fish and Wildlife Service, the National Marine Fisheries Service, and the Council on Environmental Quality. These groups have rarely engaged on issues related to the use of genetically engineered organisms in the environment but should prepare for this type of decision-making. Representation in this interagency process should include lawyers from the Offices of the General Counsel of EPA, FDA, and USDA who can work together within a reasonable time frame (e.g., three months) to determine which agency should lead when novel products arise. To support this single door approach, the BICO should:
- Work with the regulatory agencies to establish a method or portal through which product developers can submit information and requests about their products;
- Facilitate interagency meetings and discussion, including with product developers, as needed;
- Track submissions and timelines, work to address bottlenecks to decision-making, and maintain accountability by publishing summaries of decision-making efficiency; and
- Conduct outreach to relevant product developers and industry groups, including a website, to raise awareness and provide information about the regulatory system.
When possible and as experience is gained, the BICO should work with the agencies to distill generalizable principles or summaries of decisions to provide guidance to product developers and the broader bioeconomy on how different types of products are likely to be regulated.
Safeguarding the Bioeconomy
As the bioeconomy grows, the United States must ensure that its investments are protected and that biotechnology tools and capabilities are not accidentally or intentionally misused. In addition to coordinating discussions among U.S. government agencies on these topics, a key role for the BICO will be to conduct outreach and engagement with the broader bioeconomy community. There are several areas where outreach, particularly to industry partners, will be critical to maintaining U.S. competitiveness and leadership in the bioeconomy. Many industry standards and practices are not well-established, and there are opportunities for the federal government to work with industry partners to protect U.S. assets and keep biomanufacturing and biotechnology development securely within the United States. The BICO, in collaboration with the National Security Council, should facilitate engagement on topics such as:
- Supplies and capabilities that create key bottlenecks for U.S. companies;
- Industry best practices for securing biomanufacturing infrastructure from cyberattacks;
- Industry best practices that enable secure sharing of materials and data between partnering companies or entities, including legal approaches (e.g., contracting and subcontracting arrangements) and technical solutions such as developing standards for APIs (application programming interfaces); and
- How to navigate venture capital interest and investment from other countries, including China, which is particularly difficult for smaller companies and start-ups.
Safeguarding the bioeconomy also requires a process to better understand the potential for accidental or deliberate misuse of biotechnology tools, services, and capabilities to cause harm, and to support development of resources and best practices to reduce these risks. The BICO should develop an engagement strategy that includes opportunities for public discussion of risks related to misuse and strategies to reduce those risks; a publicly accessible portal for experts outside the government to raise concerns or suggest topics for further scrutiny; and a protected venue in which companies can securely share more sensitive information about business products, interactions, or practices. The BICO will maximize the benefit of this forum by conducting outreach and raising awareness of these opportunities, particularly by targeting industry partners.
Currently, the U.S. government does not have a venue or forum for multi-stakeholder engagement on risks related to potential misuse of biotechnology tools and capabilities. As the bioeconomy grows, a wide range of tools and capabilities will be developed to make biology easier to engineer, including many enabled by artificial intelligence. Accidental or deliberate misuse of these rapidly expanding capabilities could pose risks that will be difficult to anticipate and mitigate. By establishing a process for ongoing and robust engagement to better understand and manage these risks, the BICO can help address these biosecurity needs.
Conclusion
By establishing the BICO as a focal point for coordination among the interagency community and outreach to the broader bioeconomy, OSTP can ensure a long-term and robust U.S. government commitment to biomanufacturing and biotechnology. This commitment includes a strategic approach to investments that can be tracked over time, improvements to the regulatory system that will enable safe and useful products to be more easily commercialized, and activities and engagement to better safeguard advances in the bioeconomy. With appropriate funding, the BICO will form the foundation for a true cross-governmental approach that will ensure U.S. leadership and competitiveness and will ultimately enable the bioeconomy to flourish.
Because OSTP is part of the Executive Office of the President, there is a risk that establishing the BICO at OSTP will make it vulnerable to changes in funding or priorities, particularly during presidential transitions. However, there are several reasons for the BICO to be at OSTP. A critical factor is that the CHIPS and Science Act names OSTP as co-chair for the interagency engineering biology initiative that is described in the Act. Executive Order 14081 also names OSTP as a key point of coordination for U.S. government activities on the bioeconomy. Some aspects of the bioeconomy, particularly the regulation of biotechnology, have been coordinated by OSTP for decades. Furthermore, OSTP plays a key role in multiple science- and technology-rich initiatives that are supported by Coordination Offices, including the USGCRP, NITRD, and NNI.
If it is not feasible for OSTP to establish the BICO, coordination could be established by lead agencies that are committed to supporting the bioeconomy. A model for this type of coordination is the Wildland Fire Leadership Council, which is established by a Memorandum of Understanding among the Secretary of the Interior, Secretary of Agriculture, Secretary of Defense, and Secretary of Homeland Security. However, to capture the full scope of coordination that is needed for the bioeconomy, this approach may require negotiation of multiple MOUs among different sets of government agencies.
Currently, the U.S. government regulates biotechnology products based on the Coordinated Framework for the Regulation of Biotechnology, established in 1986 and most recently updated in 2017. Under this system, agencies regulate biotechnology products based on their product-based authorities (e.g., drugs are regulated by FDA; pesticides are regulated by EPA). However, there are gaps, ambiguities, and uncertainties in the regulatory system that will be compounded by the accelerating pace of biotechnology development, expanding range of applications, and potential novelty of new products. Often, developers of novel products struggle to determine which agency (FDA, EPA, or USDA) has primary responsibility for regulation of their product and can receive conflicting information from the agencies over the course of months or years. Several reports, including from the National Academies and from PCAST, have called for improved interagency coordination and a single door approach to the regulatory system that would enable product developers to contact a single entity within the U.S. government and receive an actionable answer about their product’s regulatory path. Importantly, this approach will not require changes to the underlying statutes that define regulatory authorities or to the regulations that define how these authorities are applied. Instead, it calls for efficient decision-making among the agencies to decide which agency will take the lead for novel products as they arise.
To use the single door approach, product developers would submit basic information about their products for the regulatory agencies to consider. At its simplest, this portal could be a submission system similar to that used by the federal government when requesting information from the public through regulations.gov (though product developer submissions would not be released publicly). A more secure system could be modeled on the Case Management System used for companies to share documents with the Committee on Foreign Investment in the U.S.
A more robust interagency process could also drive efforts to better harmonize regulatory approaches across agencies. For example, in 2017 the National Academies recommended ways the agencies could streamline oversight of familiar and low-risk products while focusing resources on products that are novel or require more complex risk assessments. The BICO should facilitate coordination on these topics, including progress agencies have made since 2017, lessons learned, and opportunities for improvements. The BICO should also conduct horizon scanning activities (e.g., as part of its National Bioeconomy Assessment or in public meetings focused on specific product types) so that regulators can best anticipate novel products and prepare for future decision-making. Expert groups, including PCAST, have also identified a need for training of regulators and opportunities for engagement between regulators and the broader bioeconomy; the BICO will be well-positioned to coordinate these activities.
DNA synthesis is one type of biotechnology for which the risks of misuse are well described, frameworks for reducing risk are already being developed and applied (including the 2010 HHS Screening Framework Guidance and efforts toward international harmonization), and best practices among responsible companies are established. An interagency process to update the Screening Framework Guidance is nearing completion; this process would have benefited from additional opportunities for engagement between the U.S. government and the DNA synthesis industry. The BICO should provide a forum for this type of engagement in support of future policy development.
For the U.S. bioeconomy to prosper and boom, the U.S. needs to land on a single, working definition of the bioeconomy while considering the role of sustainability in order to be competitive at the global scale.
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