8

OVERALL CONCLUSIONS AND RECOMMENDATIONS

The integration of engineering practices and principles, as well as advances in computing and information sciences, has transformed the life sciences and biotechnology, opening up new avenues for discovery, innovation, job creation, and economic growth while also raising a number of security issues. It is in this context that this committee was asked to analyze the current U.S. bioeconomy, consider how to define and measure it, and identify risks and policy gaps that need to be addressed to safeguard its continued advancement.

In the preceding chapters, the committee has examined the definition of the bioeconomy and the landscape covered by that definition. The committee also has reviewed and evaluated metrics used to determine the value of the bioeconomy and the leadership position of the U.S. bioeconomy in the context of the global bioeconomy. The committee has explored the ecosystem of the U.S. bioeconomy and methods for horizon scanning and foresight. Lastly, the committee has identified associated economic and national security risks and policy gaps. This chapter provides the committee’s overall conclusions and recommendations, integrating at a higher level the various topics covered in the report, and offers a path for safeguarding the U.S. bioeconomy while sustaining innovation and growth.

DEFINING THE U.S. BIOECONOMY

The committee was asked to “outline the landscape of the U.S. bioeconomy,” which required an examination of past descriptions of the bioeconomy (international and U.S.-based studies). Drawing on its members’ own expertise, its information-gathering sessions, and its examination of past attempts to define the bioeconomy, the committee recognized immediately the breadth of activities and disciplines that are either rooted in or becoming integrated with the life sciences and biotechnology. Therefore, the committee drew the following conclusion:

Conclusion: The U.S. bioeconomy is a broad and diverse enterprise that spans many scientific disciplines and sectors and includes a wide and dynamic range of stakeholders.

In addition to exploring the landscape of disciplines and activities associated with the life sciences, the committee holistically examined the ecosystem that translates basic biological research into products and services. Basic life sciences research often begins with public investment in research and training of scientists working in academic and federal research settings or within the research and development (R&D) departments of corporations. In addition to these traditional stakeholders, many large research settings have spurred the development of local innovation ecosystems bringing in a wider range of stakeholders, such as citizen science laboratories, incubator spaces, start-up companies, small businesses, and partnerships with larger industrial companies. These innovation ecosystems have the potential to accelerate the translation of basic research or the realization of new concepts into practical applications for agriculture, human health, energy, and industrial manufacturing.

The generation, analysis, sharing, and application of large biological datasets have been associated with increased use of computational capacity and information sciences within the bioeconomy. These advances in informatics, together with the adoption of engineering principles in biological R&D and the current genome-editing revolution, are opening up new application areas for biotechnology and life sciences research. Collectively, these developments are expanding the reach of the bioeconomy into many varied sectors. A new definition is therefore needed to better capture the dynamism of the U.S. bioeconomy.

Recommendation 1: For purposes of demarcating the scope and reach of the U.S. bioeconomy and establishing a uniform framework for valuing the bioeconomy and its assets, the U.S. government should adopt the following definition of the U.S. bioeconomy:

The U.S. bioeconomy is economic activity that is driven by research and innovation in the life sciences and biotechnology, and that is enabled by technological advances in engineering and in computing and information sciences.

As discussed in more detail in Chapter 2, this definition recognizes the increasing contributions being made by other disciplines to advance biological research and encompasses the contributions made by biological discovery to sectors that in the past would not have been considered “biological.” In Chapter 2, several examples illustrate the scope and reach of the bioeconomy. Recognizing that a definition of the U.S. bioeconomy needs to be flexible enough to allow for the future incorporation of new developments, the above definition does not limit the scope of the bioeconomy to particular sectors, technologies, or processes.

Having a definition that captures the breadth and depth of this dynamic enterprise provides a starting point for a common understanding of the boundaries of the bioeconomy and its transdisciplinary nature. Having a standard and consistent definition could also enable the U.S. government to better assess the current state of the bioeconomy, develop strategies for supporting and safeguarding its continued growth, devise metrics and data collection efforts to track its growth and conduct economic assessments, and allow policy makers to keep abreast of advances that have the potential to pose new national or economic security challenges.

MEASURING THE U.S. BIOECONOMY

The committee was also tasked to outline approaches for assessing the value of the bioeconomy and to identify intangible assets that may not be well captured by those approaches. The committee reviewed and summarized previous attempts to value the U.S. bioeconomy and discussed some of the drawbacks of those approaches. However, existing studies of the bioeconomy do not capture the activities encapsulated by the definition of the bioeconomy put forth in this report. To assess the value of the bioeconomy, the committee used the above definition to identify the primary segments (components or domains) of the bioeconomy and the data that would be needed to assess the bioeconomy’s full value. Given the breadth and scope of the bioeconomy, identifying the data sources and components necessary to assess its value was an enormous effort, leading the committee to the following conclusion:

Conclusion: Measuring the bioeconomy is challenging since it has extended beyond the traditional biobased sectors of agriculture, biomedical science, and industrial biotechnology.

Adequately assessing the economic contribution of the bioeconomy to the larger U.S. economy could go a long way toward raising awareness of the importance of the U.S. bioeconomy and the need to monitor and safeguard it. A full assessment of the inputs and outputs of the bioeconomy could also enable future analysis of how investment in basic research is tied to productivity in this area, thus enabling better tracking of the outcomes of public investments. This enhanced tracking could serve as an indicator of the health of the sector, allow for an assessment of the impact of policy changes on the economic potential of the bioeconomy (or its subsectors), and help identify areas of growth that are worth protecting from a security standpoint.

In Chapter 3, the committee discusses various conceptual frameworks that could be used to determine the value of the bioeconomy and the merits and limitations of each. Moving beyond the three primary segments of the U.S. bioeconomy (agriculture, bioindustrial, and biomedical), the committee needed to determine the subset of these primary segments for which economic activity data are captured. Thus, the committee identified six segments within the broad category of goods and services, which includes materials, business services, and consumer products. At this level, the following six segments are taken as an approximation of the bioeconomy, as best as can be determined from the available data, and recognizing that they incompletely capture the bioeconomy as the committee has defined it: genetically engineered crops/products; biobased industrial materials (which include the agricultural feedstocks used for fermentation and other downstream processes); biopharmaceuticals and biologics and other pharmaceuticals; biotechnology consumer products; biotechnology R&D business services, including laboratory testing and purchased equipment services; and the design of biological data-driven patient health care solutions. Furthermore, the bioeconomy draws on specialized equipment and services, and produces intangible assets that all need to be considered and accounted for to determine the full value of the bioeconomy.

Following this economic categorization and to find data on the value added for each user-driven segment, the committee identified the relevant North American Industry Classification System (NAICS) codes, found estimates for how much of the activity included within a particular segment is related to the bioeconomy, and tabulated a sum of the value of each segment based on the available data (as summarized in Box 8-1). From this analysis, the committee determined that the U.S. bioeconomy represented roughly 5.1 percent of the gross domestic product (GDP) in 2016, or $959.2 billion (see Chapter 3 for a fuller discussion of this process). However, given that innovation can lead to the replacement of traditional products with biobased or bioeconomy-relevant products, it is possible

that this figure is an underestimation. And over the course of its analysis, the committee determined that significant data gaps were created by current classification and reporting mechanisms, which is sure to have an impact on the outcome of future valuations of the U.S. bioeconomy.

Conclusion: Existing data collection mechanisms for measuring economic activity are insufficient to monitor the bioeconomy holistically. Improved data collection is needed to better (1) understand the scope and reach of the U.S. bioeconomy, (2) provide a comprehensive valuation of the U.S. bioeconomy, (3) support U.S. decision

making with regard to the bioeconomy, and (4) identify indicators of leadership and global connections.

Recommendation 2: The U.S. Department of Commerce and the U.S. National Science Board should expand and enhance data collection efforts relevant to the economic contribution of the U.S. bioeconomy as defined by this committee.

The committee developed a subset of recommendations that would be most likely to expand and enhance data collection efforts to facilitate future valuations of the bioeconomy.

Recommendation 2-1: The U.S. Department of Commerce and other relevant agencies and entities involved in the collection of U.S. economic data should expand their collection and analysis of bioeconomic data. The U.S. Department of Commerce should obtain input from partners in science agencies and from nongovernmental bioeconomy stakeholders to supplement and guide these efforts.

These expanded data collection efforts could provide a foundation of information that could be used to inform other activities within the U.S. Department of Commerce related to the bioeconomy. In Chapter 3, the committee mentions a number of other actions or activities that the U.S. Department of Commerce currently oversees that could benefit from an expanded collection and analysis of the activities of the bioeconomy and the permeation of products, processes, and services. The following two recommendations relate specifically to two of those activities.

Recommendation 2-2: The existing North American Industry Classification System (NAICS) and North American Product Classification System (NAPCS) codes should be revised to more accurately capture and track commercial activity and investments related to the biological sciences and track the growth of individual segments of the bioeconomy (e.g., biological production of chemicals and materials). In addition, the U.S. Department of Commerce’s Office of Technology Evaluation should undertake a study aimed at richer characterization of the permeation of biologically based products, processes, and services in the U.S. economy. Such a study would greatly inform revisions of the NAICS and NAPCS codes. Additionally, the U.S. Census Bureau should refine and regularly collect comprehensive statistics on bioeconomic activities.

Currently, there are some codes that are wholly included within this study’s definition of the bioeconomy, such as Research and Development in Biotechnology (NAICS 541714) and Biomass Electric Power Generation (NAICS 221117). However, other components, such as soy ink production, are currently lost in the broader categories that would appear not to be part of the bioeconomy, such as Printing Ink Manufacturing (NAICS 325910). Additionally, some components of the U.S. bioeconomy, such as synthetic biology, are worth tracking because of the apparent growth and sense of expansion within the scientific community, but are not currently captured in any single code or set of codes to enable an accurate economic assessment. Given the importance of this classification system for tracking the economic data associated with various activities, one can imagine the usefulness of codes that would specifically track developments in synthetic biology, such as Synthetic Biology R&D Services, Consumer Biotech, Synthetic Biology Devices, and Biotechnology Automation.

The NAICS and NAPCS codes are updated every 5 years through a process that involves soliciting and reviewing proposals from the public.¹ In addition to this normal process, the committee suggests that a detailed study focused on examining the pervasiveness of bioeconomy products, processes, and services could be instrumental in informing future revisions. The U.S. Department of Commerce’s Office of Technology Evaluation analyzes “critical technologies and industrial capabilities of key defense-related sectors,”² using, among other techniques, industry-specific surveys to which recipients are required by law to respond.³ The committee believes that the bioeconomy is sufficiently important to national defense to warrant the use of this capability and that the outcome should be used to inform future revisions of the NAICS and NAPCS codes.

Recommendation 2-3: The Bureau of Economic Analysis of the U.S. Department of Commerce should lead the development of bioeconomy satellite accounts linked to central national accounts. These satellite accounts should include databases of biological information

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¹ For more information, see https://www.census.gov/eos/www/naics/reference_files_tools/NAICS_Update_Process_Fact_Sheet.pdf.

² See the “Industrial Base Assessment” page on the website of the U.S. Department of Commerce, Bureau of Industry and Security at https://www.bis.doc.gov/index.php/other-areas/office-of-technology-evaluation-ote/industrial-base-assessments.

³ The U.S. Department of Commerce’s Office of Technology Evaluation exercises authorities delegated by the President to the Secretary of Commerce under the Defense Production Act to obtain information that may be “necessary or appropriate” to enforce or administer that Act. For more information see, 50 U.S.C. § 4555(a), Section 705(a) of the Defense Production Act of 1950 (P.L. 81-774), as amended; Executive Order 13603.

as assets and over time be expanded to include environmental and health benefits attributable to the bioeconomy.

As described in Chapter 3, a satellite account is a system of economic data that portrays expenditures, production, and income generated by a specified set of activities. The creation and use of a bioeconomy satellite account could provide a flexible tracking mechanism that would be customizable and flexible across sectors. The committee sees great potential in such a tool for enabling better tracking of the growth and dynamism of the U.S. bioeconomy, particularly given that it could be used to explore new data collection and reporting methods and develop new accounting procedures that, once accepted, could become part of standard national income accounting procedures.

Recommendation 2-4: The U.S. National Science Board should direct the U.S. National Science Foundation to undertake new data collection efforts and analyses of innovation in the bioeconomy for the Science and Engineering Indicators report so as to better characterize and capture the depth and breadth of the bioeconomy, with an emphasis on identifying indicators that provide insight into U.S. leadership and competitiveness.

The Science and Engineering Indicators (S&E) report served as a valuable tool in the committee’s analysis of the bioeconomy and its effort to understand leadership metrics. As noted in Chapter 4, however, the committee encountered many data gaps during its assessment, particularly around new trends and fields within the life sciences. Much of this has to do with the categorization and classification of particular activities. For example, it is not always clear whether such fields as biomedical engineering are classified within “engineering” or within “life sciences.” These limitations are not different in concept from the limitations encountered when the committee was considering the NAICS codes. While the committee understands that changing the nature of the metrics and classification system can make historical comparisons very difficult, an effort is needed to enable capturing the dynamism of newly emerging fields. As many research disciplines continue to change and converge with other disciplines, it will be important for the S&E report to adjust its own data collections to capture these changes so it can continue to serve as a useful tool for tracking and understanding the state of the bioeconomy (and beyond).

SAFEGUARDING THE U.S. BIOECONOMY

Establishing a Coordinating Body

During the course of this study, the committee consistently heard that an “all of government” or “all of society” effort is needed to address some of the challenges facing the U.S. bioeconomy, particularly with respect to potential national or economic security concerns. While the committee recognizes that all of the stakeholders within the bioeconomy have a role to play, leadership and strategic direction are needed. Given the breadth of the bioeconomy across the many sectors discussed throughout this report, it is not surprising that life sciences research is distributed across many agencies and departments of the U.S. government (as explored in Chapter 5). This disaggregated distribution poses a significant challenge for large-scale coordination, particularly when there is no clear candidate agency to take leadership. Each agency and department has its defined mission space and associated scientific domain; therefore, no government agency has the mandate to monitor and assess the U.S. bioeconomy holistically, let alone determine a strategy for promoting and protecting it.

Conclusion: Given the lack of an obvious lead government agency for the bioeconomy, the committee concluded that a mechanism through which the science, economic, and security agencies could bridge the gaps in communication and coordination is needed.

Recommendation 3: The Executive Office of the President should establish a government-wide strategic coordinating body tasked with safeguarding and realizing the potential of the U.S. bioeconomy. To be successful, this coordinating body should be presided over by senior White House leadership, with representation from science, economic, regulatory, and security agencies. It should be responsible for relevant foresight activities and informed by input from a diverse range of relevant external stakeholders.

Having a coordinating body would overcome the concern that no single agency has the responsibility to monitor the bioeconomy holistically. Given the increase in specialized knowledge and the disciplinary convergence in the bioeconomy, it will be difficult for individual agencies, despite their ability to support their individual mission space, to identify policies, funding priorities, and areas of opportunity that would collectively strengthen the U.S. bioeconomy. Therefore, a U.S. government coordinating body informed by nongovernmental bioeconomy stakeholders is needed to create and implement a national strategy that will sustain and grow the bioeconomy. In addition, the inclusion of a specialized security

component could enable the development of policies that would strike the right balance between protecting the U.S. bioeconomy and mitigating the potential for negative impacts. It will be crucial for these discussions to involve not only scientific and security agencies but also economic agencies tasked with tracking indicators of the bioeconomy’s growth and health.

Without stipulating how the U.S. government could organize such a coordinating body, the committee notes that precedents exist. Cross-governmental coordination can be accomplished through an interagency working group chartered independently or under one of the White House policy-making offices (e.g., the Office of Science and Technology Policy, the National Security Council, the National Science and Technology Council, the National Economic Council). Alternatively, the coordinating body could be established through a congressional mandate, as was the National Nanotechnology Initiative, a mechanism by which the U.S. government coordinates the R&D activities of 20 departments and agencies involved in nanotechnology.⁴

Over the course of its information-gathering sessions, the committee learned during its third such session in May 2019 that some coordinating activity was being actively discussed and in the early planning stages within the Executive Office of the President (EOP). In September 2019, the EOP released a request for information to gather stakeholder input,⁵ which was followed by the White House Summit on America’s Bioeconomy in October 2019 (EOP, 2019). However, these events did not describe or elaborate the structure, strategy, or membership of the agencies involved in this effort.

Furthermore, the committee identified the importance of engaging with nongovernmental stakeholders to inform this process. Examples of potential engagement strategies include the establishment of formal federal advisory committees, regular public convening activities, targeted outreach to different scientific communities and societies, and the use of public–private partnership agreements. Enabling the participation of industrial and academic leaders will facilitate the development of a strategy and supporting policies that address the needs of the bioeconomy.

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⁴ Originally proposed by the Clinton administration in 2000, the National Nanotechnology Initiative (NNI) was formally created in 2003 with passage of the 21st Century Nanotechnology Research and Development Act, P.L. 108-153. The Nanoscale Science, Engineering, and Technology Subcommittee of the National Science and Technology Council’s Committee on Technology coordinates the NNI’s planning, budgeting, program implementation, and review. Technical and administrative support and public outreach are provided by the National Nanotechnology Coordination Office. See “About the NNI” at www.nano.gov/about-nni.

⁵ See https://www.federalregister.gov/documents/2019/09/10/2019-19470/request-forinformation-on-the-bioeconomy.

Sustaining and Growing the U.S. Bioeconomy

In addition to recommending a coordinating body across the federal government and with nongovernmental stakeholders, the committee developed a subset of more specific recommendations designed to help sustain and grow the U.S. bioeconomy.

Recommendation 3-1: The coordinating body should develop, adopt, and then regularly update a living strategy with goals for sustaining and growing the U.S. bioeconomy. This strategy should be informed by an ongoing, formal horizon-scanning process within each of the relevant science agencies, as well as by input from industry, nongovernmental organizations, and academia. Additionally, through this strategy, the coordinating body should identify and raise awareness of means through which the U.S. government can advance the bioeconomy, including such existing means as government procurement of biobased products.

Setting a unified strategy for the bioeconomy informed by relevant governmental and nongovernmental bioeconomy stakeholders will enable meaningful coordination and alignment of individual agency efforts toward pursuing a common goal: sustaining, growing, and safeguarding the U.S. bioeconomy. Elements of such a strategy could include the support of innovative, multidisciplinary, and convergent research to drive biological discovery; maintenance of a robust talent base that is well prepared to join the bioeconomy workforce; prioritization of the development and maintenance of a modern, secure, and connected research infrastructure that best serves the needs of all bioeconomy stakeholders; and mechanisms for safeguarding the bioeconomy and its assets.

While creating a U.S. bioeconomy strategy would provide a powerful policy tool for relevant federal agencies, the committee emphasizes the importance of continually tracking developments in the bioeconomy and proactively incorporating these developments into the strategic and policy apparatus. Therefore, the committee stresses the importance of establishing an ongoing horizon-scanning and foresight process that will identify emerging developments in science and technology that could raise new issues or require new policy. A U.S. bioeconomy strategy linked to a horizon-scanning process would allow for an anticipatory approach that would permit the identification of new issues or the prioritization of those issues likely to have the greatest scientific, economic, and policy impact. Currently, policy makers cannot keep up with the rapid pace of developments in science and technology, and thus policy tends to be reactionary, and sometimes significantly delayed. As discussed in Chapter

7, policy and regulatory uncertainty also has the potential to dampen innovation.

Best practices for conducting a robust horizon-scanning process are enumerated in Chapter 6. In short, the committee suggests that each bioeconomy-relevant science agency establish a horizon-scanning process focused on identifying new issues, topics, and technology developments in its specific domain. As concluded in Chapter 6, there are four key considerations for establishing a horizon-scanning process: approach, scope, process, and timeframe (see Box 8-2). These agencies would report out to the larger government-wide coordinating body called for in Recommendation 3 every 2 years, thereby enabling a comprehensive scan across the full scope of the bioeconomy. Having these activities start within each of the relevant science agencies would ensure that there would be subject-matter experts involved in conducting the scan; however, unless an effort were undertaken to bring in nontechnical experts, these activities could be limited (as described in Chapter 6). The ultimate goal of these actions would be to (1) identify new technologies, markets, and data sources that could provide insights into the bioeconomy (from a policy, security, or economic assessment perspective); (2) identify specific and timely opportunities for the bioeconomy; and (3) identify disruptive events or other

threats. Lastly, given that establishment of the coordinating body the committee is recommending calls for the inclusion of the economic agencies, it is the committee’s intention that the horizon-scanning activities described here would be linked to efforts to improve the data sources and economic metrics discussed in Recommendation 2 and explored more thoroughly in Chapters 3 and 4.

The last component of Recommendation 3-1 calls on the federal government to take stock of the actions that can be taken now to help grow and sustain the U.S. bioeconomy. Chief among those actions could be to use the power of federal procurement to drive the bioeconomy through the strategic procurement of biobased goods. As an example, strategic biobased procurement by government and industry procurement offices of the U.S. Department of Agriculture’s BioPreferred Program would catalyze the creation of new markets and jobs. This program is designed to increase the development, use, and purchase of biobased products that are derived from agricultural, marine, and forestry materials. Although the Farm Bill mandates that federal agencies and contractors purchase biobased products when doing so does not impose cost or performance penalties, no regular report is available through which to understand the progress or scale of biobased procurement. Updating the reporting mechanisms involved in the federal procurement of biobased products, setting procurement targets, and increasing funding for the program to enable increased awareness and standardized reporting—such as a real-time public-facing dashboard to report federal progress in biobased procurement—would go a long way toward stimulating the bioeconomy and supporting jobs in rural areas where many source materials are concentrated. Encouraging private-sector retailers to feature BioPreferred products among their offerings would advance these goals even further.

Addressing the Economic and National Security Risks Pertaining to the Bioeconomy

This committee was tasked to “outline potential economic and national security risks and identify policy gaps pertaining to the collection, aggregation, analysis, and sharing of data and other outputs of the bioeconomy,” as well as to examine whether particular features of the bioeconomy would require different protection mechanisms. In Chapter 7, the committee presents some identified risks and their potential implications. Where possible, the committee also discusses the relevant policy tools that could be used to address the identified risks. It should be noted that the committee performed this analysis solely on the basis of publicly available information.

The committee identified (1) risks that would harm the bioeconomy’s continued growth or hamper the innovative ecosystem within which it currently operates, (2) risks from the theft of or asymmetries in access to intellectual property or key bioeconomy information that would confer a competitive advantage on another party at the expense of the U.S. bioeconomy, and (3) risks from misuse or hijacking of bioeconomy outputs or entities. To address these risks, the committee focused its recommendations on talent, foreign investment in U.S. research, and cybersecurity approaches.

Conclusion: Protecting the U.S. bioeconomy while preserving the open, collaborative environment required to sustain the bioeconomy will require a carefully considered balance.

The U.S. bioeconomy has historically benefited from participation in an open, global, and collaborative scientific environment that relies on the academic integrity of individuals and their willingness to adhere to research norms and values (IAP, 2016; NAS et al., 2009; NASEM, 2018). However, there has been increasing concern among some federal officials that the openness of the U.S. scientific enterprise puts its integrity and competitiveness at risk. Safeguarding the U.S. bioeconomy while protecting innovation and growth could be facilitated by developing a more thorough understanding of the mechanisms by which the open conduct of and participation in fundamental scientific research drive proprietary innovation by entrepreneurs, both within the United States and among economic competitors, and conversely, of how restrictions on openness may affect the scientific research environment. The tension between these two goals will require that policy makers strive for a balance that maximizes the benefits of scientific openness while protecting U.S. economic and security interests from countries that would exploit this nation’s openness unfairly.

Funding and Sustaining the Bioeconomy Research Enterprise

Conclusion: The U.S. bioeconomy relies on a robust and well-funded research enterprise that seeds innovation and supports a technically skilled and diverse workforce.

Chapters 3, 4, and 5 explore the foundational role played by public investments in science and engineering research in driving America’s research enterprise, investments that have built the university research and education system that continually produces more doctoral graduates than does any other country. These investments directly benefit the

U.S. bioeconomy given that growing fields, such as synthetic biology, will require a consistent influx of new minds to continue to drive innovation and discovery. Through partnerships between industry and high schools, community colleges, and universities, innovation ecosystems are creating opportunities for training and developing a talent pool to power the bioeconomy. These partnerships are expanding the potential workforce beyond Ph.D.-level researchers. However, as other countries scale up investments in their own life sciences research enterprises and begin to increase their scientific output, concerns arise about the ability of the United States to maintain its leadership. Currently, the United States remains among the world’s leaders in public investment in the biological sciences, but erosion in support for government investment is a concern. Therefore, the committee makes the following recommendation:

Recommendation 4: To maintain U.S. competitiveness and leadership within the global bioeconomy, the U.S. government should prioritize investment in basic biological science, engineering, and computing and information sciences. In addition, talent development, at all levels, to support these research areas should be a high priority for future public investment.

Lack of coordinated funding across the science and engineering disciplines in support of a U.S. bioeconomy strategy has the potential to weaken the ecosystem that has enabled the translation of research and knowledge into innovative goods and services. The committee’s analysis of past and current investments suggests that the rate of federal investment has become stagnant. Securing future U.S. leadership in the bioeconomy will likely require returning to investment levels characteristic of the 1990s and early 2000s. The present stagnation in federal investment is in contrast with the increasing investments of other countries. The number of countries that are creating and implementing their own bioeconomy strategies, often with considerable funding and resources to support these initiatives, is challenging continued U.S. leadership.

Insufficient federal funding for U.S. universities and bioeconomy training programs has the potential to diminish the ability to produce and retain a skilled technical workforce. Increased federal support for science, technology, engineering, and mathematics (STEM) education and partnerships between community colleges and industry aimed at growing a technically skilled workforce could create employment opportunities in U.S. regions whose traditional employment opportunities may have changed. As articulated in Chapter 5, for example, the development of biotechnology capabilities in rural areas holds promise, and investments in training

programs and facilities in these areas could open up new opportunities for those communities while growing the bioeconomy.

In addition to the importance of training a domestic bioeconomy workforce, the United States has historically benefited from the ability to attract students and scientists from around the world to its universities. International students constitute a significant fraction of the enrollments at U.S. colleges and universities, particularly in STEM disciplines at the graduate level, and foreign-born employees form a substantial component of the U.S. STEM workforce. These researchers have contributed immensely to the vibrant research enterprise that the United States currently enjoys. As explored in Chapter 7, however, a number of domestic and international factors could potentially complicate the nation’s ability to attract and retain international scientists and engineers. As other countries increasingly prioritize their bioeconomies and create appealing locations for companies to establish their operations, opportunities for students and researchers to remain in their home countries will increase. Domestically, changes in visa policy and investigations into researchers with ties to foreign governments, talent programs, and funding also have the potential to discourage talented researchers from around the world from coming to the United States or even collaborating with U.S.-based scientists. For this reason, the committee makes the following recommendation:

Recommendation 4-1: The U.S. government should continue to support policies that attract and retain scientists from around the world who can contribute to the U.S. bioeconomy, recognizing that open academic engagement has been strongly beneficial to the U.S. scientific and technological enterprise, even as it inherently offers potential benefits to other countries as well. Policies intended to mitigate any economic and security risks posed by foreign researchers in U.S. research institutions should be formulated by U.S. security, science, and mission agencies working closely together, and through ongoing engagement with a group of recognized scientific leaders. Having this group able to be fully briefed on the threat environment will greatly facilitate these discussions, since access to classified, proprietary, or other nonpublic information may be needed.

Such discussions, if necessary, can be accomplished through a number of existing mechanisms in which scientific and industry leaders can provide advice on a classified basis. Examples include the National Science Advisory Board for Biosecurity or other federal advisory committee, or tasking of such groups as the JASONs or the President’s Council of Advisors on Science and Technology to conduct an initial focused study

on the subject.⁶ These discussions and/or studies could serve a number of purposes. They would permit scientific experts and federal officials to have a full and frank discussion of the rationale for proposed security policies. Policy makers would receive input on the direct and indirect consequences of potential security policies from those with first-hand experience conducting and/or administering state-of-the-art scientific research or technological entrepreneurship. Furthermore, members of the broader scientific community who were not in a position to participate in these discussions could have some confidence that colleagues with a deep understanding of how the scientific enterprise works were being consulted. Both scientists and policy makers should thereby have some assurance that experts from both communities were able to evaluate the evidence underlying proposed security policies and to have an informed discussion of the potential consequences of those policies.

Securing Value Chains and Examining Foreign Investments

Conclusion: Securing value chains vital to the U.S. bioeconomy will be necessary for its continued growth.

The committee recognizes that the U.S. bioeconomy needs to be able to sustain itself through securing of the value chains that fuel it. The continued development of biological routes to the production of previously non-biobased products will disrupt existing value chains as the bioeconomy continues to permeate into new sectors. The nation would face potential risks should critical parts of bioeconomy value chains be disrupted, such as through supply shortages, interruptions in transport, or reliance on single sources. The latter is particularly important if the single source is based overseas and thus subject to foreign export regimes, changes in political relationships, or other factors beyond U.S. control. Key components of bioeconomy value chains, key capabilities and sources of supply that are intrinsic to the U.S. bioeconomy and warrant being maintained entirely domestically, and mechanisms by which these capabilities and sources can be secured remain to be identified.

Conclusion: Bioeconomy subject-matter expertise is needed for examining transactions involving foreign investors.

As pointed out in Chapter 5, the transitional space where research is too applied for university-level development and yet still too risky

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⁶ The National Science Foundation has already announced a study by the JASONs to inform potential policy changes related to such concerns.

to justify industry investment in commercial application represents an opportunity for venture capital to help start-up companies thrive. However, the source of venture capital funding for these early- to mid-stage developers may require more scrutiny, particularly given the increasing trend toward foreign investment in U.S. bioeconomy companies and startups. In Chapter 7, the committee cites a few examples in which investments by nondomestic parties, either private capital- or state-backed, in U.S. bioeconomy businesses—both large, highly successful companies and smaller companies and start-ups—were undertaken with the goal of acquiring intellectual property.

The Committee on Foreign Investment in the United States⁷ (CFIUS) is responsible for reviewing potential foreign investments in and purchases of U.S. companies. In August 2018, the Foreign Investment Risk Review Modernization Act was signed into law, expanding CFIUS’s purview. Given the specialized nature of the bioeconomy, the committee determined that CFIUS will likely require subject-matter expertise to adequately assess the implications of particular investments in U.S. bioeconomy entities.

Recommendation 5: The U.S. government should convene representatives from its science and economic agencies who can access relevant classified information to provide security agencies with subject-matter expertise so as to (1) identify aspects of bioeconomy global value chains that are vital to U.S. interests and to which access must be ensured, and (2) assist the Committee on Foreign Investment in the United States in assessing the national security implications of foreign transactions involving the U.S. bioeconomy.

Prioritizing Cybersecurity and Information Sharing

Conclusion: The digitization of biology and biotechnology automation are key drivers that enable the bioeconomy. Inadequate cybersecurity practices and protections expose the bioeconomy to significant new risks.

Life sciences research is driven by the collection and analysis of large amounts of data that are often generated through the use of automated and network-connected instruments. The ability to process such data is increasingly enabled by high-throughput laboratory technologies, computational processing power, and information exchange and storage capacity.

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⁷ See https://home.treasury.gov/policy-issues/international/the-committee-on-foreigninvestment-in-the-united-states-cfius.

Related trends—such as the use of machine learning to identify patterns, the integration of information across diverse life sciences datasets, and the easy storage and sharing of data—increasingly underpin innovation in pharmaceutical and agricultural product development, personalized medicine, disease surveillance, improved design of genetic circuits and biosynthetic pathways in synthetic biology, large-scale ecosystem studies, biomanufacturing, and many other areas.

Recommendation 6: All bioeconomy stakeholders should adopt best practices for securing information systems (including those storing information, intellectual property, private-proprietary information, and public and private databases) from digital intrusion, exfiltration, or manipulation.

While large companies tend to be aware of traditional cyber concerns and have information technology infrastructures that provide protection, smaller companies and academic institutions may not always be aware that they, too, are targets for cyber intrusions. Therefore, the committee recommends that all stakeholders (companies of all sizes, academic institutions, government agencies, and others) adopt best practices to create an organizational culture that promotes and values cybersecurity. Adoption of these best practices could be accomplished in a number of different ways, such as with training for all researchers within the bioeconomy to increase awareness of cybersecurity threats and vulnerabilities; adoption of the National Institute of Standards and Technology’s Cybersecurity Framework (which can be adapted for a wide range of organization sizes and types); and for some organizations, the appointment of chief information security officers.

Recommendation 7: To protect the value and utility of databases of biological information, U.S. science funding agencies should invest in the modernization, curation, and integrity of such databases.

Biological datasets increasingly underpin many of the advances driving the U.S. bioeconomy. Researchers receiving federal funding are often mandated to share their data and make them publicly available, thereby growing these vital databases rapidly. As explored in Chapter 5, however, the potential for redundancy, inaccuracy, and even conflicting entries poses a significant problem that is growing with the continued deluge of data. Attempts to merge, curate, and validate databases and redundant entries have demonstrated the considerable effort required; however, the potential net benefit for research would be immense. While the committee recognizes that the science-funding agencies are facing ever smaller

budgets, the investments (in time and resources) made to acquire data create a sufficiently compelling reason to increase investment in maintaining databases. It is difficult to imagine all the potential downstream applications of life sciences data; therefore, rather than require repetitive efforts to recreate datasets, the committee recommends increasing investment in databases. While some may consider the trade-off too great between funding new research and funding the modernization, curation, and integrity of databases, the committee believes this view is myopic. This report articulates the importance of large databases of biological information for fueling innovation and driving the bioeconomy, given that they are a source of novel discoveries while also enabling the improvement of machine learning and other computational tools. In Recommendation 4, the committee articulates the importance of increasing funding in the life sciences and related disciplines, and this recommendation further underscores the need for additional funding that is more focused on this important component of the bioeconomy.

Recommendation 8: Bioeconomy stakeholders should pursue membership in one or more relevant Information Sharing and Analysis Centers or Information Sharing and Analysis Organizations, or consider creating a new sector-based information sharing organization for members of the bioeconomy. The Cybersecurity and Infrastructure Security Agency within the U.S. Department of Homeland Security should convene bioeconomy stakeholders to build awareness about relevant models for sharing information on cyberthreats. Those convened should consider whether an active repository is needed to host and maintain key bioeconomy-related open-source software, algorithm components, and datasets.

The bioeconomy relies on the use of open-source software, which means the software and its source code are openly available to anyone. However, the software industry has learned that simply making code open-source does little or nothing to guarantee its quality, robustness, and security. Within the bioeconomy, several major open-source programs are used by a significant number of companies, universities, and national laboratories. In addition, many researchers develop highly individualized, bespoke software for use in a particular research effort or application that they then make available to others. In some cases, open-source software is available only for download, and any subsequent modification would be done by individual researchers to meet their specific needs. In other cases, however, source code used within the bioeconomy can be readily modified by anyone who wishes to do so. This introduces the potential for misuse, for example, if a malicious actor were to purposefully introduce a

vulnerability into source code that enabled unauthorized access by third parties. These concerns could potentially be mitigated by establishing a more formal repository of open-source software for the bioeconomy, a formal regime for controlling changes to source code, a testing regimen for any changes to the code, and restrictions on who can make changes. Programs and incentives could be established to improve relevant software. Bioeconomy stakeholders would need to determine what type of entity is most appropriate to manage such a regime. Although no entity currently performs this role for this sector, an information-sharing and analysis group, or perhaps a special-purpose consortium, could potentially serve as such an entity.

Participation in an information-sharing group could additionally enable bioeconomy stakeholders to share experiences in detecting, mitigating, and preventing cyber intrusions, as has been done in many infrastructure sectors. Cyberthreat actors may pursue campaigns against one company or against an entire sector. When an entire sector is targeted, information-sharing activities across the sector could be effective in mitigating the impact of such a campaign by enabling rapid communication and sharing of patches or strategies to counter an attack.

OPPORTUNITIES FOR INTERNATIONAL ENGAGEMENT

Finally, the committee recognizes that the U.S. bioeconomy exists in the broader context of a global bioeconomy. Science is an increasingly global enterprise, and as discussed throughout this report, there is immense value to be gained from participating in a scientific enterprise that enables and embraces the free flow of ideas and discussion, the wide dissemination of published results, and collaboration across disciplines and borders. The benefits of such a system are available to all participants. Moreover, future challenges will be global in nature and require a coordinated, global response. This will entail partnering with others who are actively growing and investing in their own bioeconomies, especially those who are likewise committed to open science, open economic development, and responsible research and innovation. It is essential that the United States continue its role in international collaborations and play an active role in the global bioeconomy.

Of course, one must recognize that not everything can and should be shared and that some actors within the system seek to take advantage of the current state of openness. It is for these reasons that policies, guidelines, and reporting mechanisms related to responsible science and ethical conduct have been devised to prevent abuses of the system. Chapter 7 explores concerns about uneven trade practices, the lack of reciprocity with respect to sample- and data-sharing practices, and even regulatory

regimes that make it more difficult for companies to bring their products to nondomestic markets. These practices, and others like them, have the potential to hinder the progress of research, the spread of innovative methods and ideas, and realization of the social and economic benefits of new products. These practices could also undermine the trust among collaborations and potentially lead to overreactive policies and decisions that could hinder the U.S. bioeconomy (these ideas and potential consequences are discussed more thoroughly in Chapter 7). Therefore, with a view toward striking a balance between security and engagement, the committee makes the following recommendation:

Recommendation 9: Through such entities as the World Trade Organization and the Organisation for Economic Co-operation and Development, as well as through other bilateral and multilateral engagements, the U.S. government should work with other countries that are part of the global bioeconomy to foster communication and collaboration. The goals of such international cooperation would be to (1) drive economic growth, (2) reinforce governance mechanisms within a framework that respects international law and national sovereignty and security, and (3) create a level playing field.

U.S. agencies tasked with international engagement and agreements could play a central role in facilitating discussions among countries to increase the benefits of an open research enterprise for all and incentivizing all to adhere to the agreed-upon norms.

REFERENCES