Safeguarding

THE BIOECONOMY



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With its value nearing $1 trillion, the U.S. bioeconomy holds promise for an improved quality of life, with benefits ranging from health care solutions to environmental stewardship. The integration of engineering principles and advances in computing and information sciences has transformed the life sciences and biotechnology. The economic activity related to the life sciences research enterprise is referred to conceptually as the bioeconomy. A concerted effort is needed to safeguard the potential of the bioeconomy and minimize associated risks.



What is the Landscape of the U.S. Bioeconomy?

The definition of the U.S. bioeconomy is intended to be flexible enough to anticipate the inclusion of new advancements and applications within the life sciences and all of biotechnology. As technology continues to develop, there will be a need for continual reassessment of whether new and emerging fields and existing fields belong in the bioeconomy.

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Valuing the Bioeconomy

The framework for determining the value of the bioeconomy is described by the four steps below.


1
Set boundaries of definition of the bioeconomy to identify primary segments of interest (see Chapter 2).
2
Identify subsets of the primary segments to be included, including relevant bioeconomy-specific equipment investments (e.g., sequencing machines) and services (e.g., biotechnology patent and legal services), and intangible assets produced and/or curated for use by the sector (e.g., genomic databases).
3
Identify the relevant production data that map to the delineated bioeconomy segments.

  • provides a mapping based on the North American Industry Classification System (NAICS) codes currently used by the U.S. Census Bureau to collect detailed data on the value of production.

    • Certain bioeconomy activities are inherently narrower than existing NAICS codes, and measuring the relevant activities requires developing estimates based on auxiliary sources (or new NAICS codes), or building new aggregates from establishment-level survey or administrative microdata
    • For each bio-based production activity, determine the portion that is currently versus potentially (under existing technology) bio-based (e.g., determine what percentage of plastics are made through a bio-based process).
  • Obtain estimates for value-added for each relevant bioeconomy activity based on the same methods and data used in national accounts (“gross domestic product (GDP) by industry”).
  • Determine appropriate inter-industry linkages and sources of supply (i.e., domestic versus foreign) and estimate relevant input-output “multipliers” based on these linkages.
4
Sum of value added estimates is the direct impact of bioeconomy production on the U.S. economy; the additional value added implied by input-output multipliers is an estimate of the total contribution of the bioeconomy to the U.S. economy.
Table 3-3 Summary of Illustrative Bioeconomy Valuation Experiment
 

Value added in 2016 (billions of dollars)
 

Major sector Current Potential
 

Direct contribution:  

 

1.

Private industry

343.7

512.8

2.

Public/nonprofits

58.7

58.7

3.

Total

402.5

571.6

4.

Percent of GDP

2.2

3.1

    Including indirect and induced effects:    
5.

Private industry

859.3

1282.1

6.

Public/nonprofits

99.9

99.9

7.

Total

959.2

1,381.9

8.

Percent of GDP

5.1

7.4

Source: Table 3-2 for bioeconomy valuation. BEA for U.S. GDP in 2016, which was $18,715 billion.

Key Considerations in Horizon Scanning and Foresight for the Bioeconomy

APPROACH


The goal would be to design a horizon-scanning activity that is capable of feeding information into both scenario planning and issue identification processes.

SCOPE


There are two levels at which the scope of the bioeconomy should be considered:
  1. Defining the bioeconomy—Given that the bioeconomy is broad and is increasingly penetrating new technical fields and economic sectors, a broad horizon-scanning effort will be needed to continuously monitor its scope.
  2. Tracking specific lines of development or policy issues—A detailed consultation process (such as the Delphi method) could be used to drill down into specific topics or to address specific questions.

PROCESS


In the near term, horizon-scanning activities are likely to be human-driven; however, tools for automated data gathering are advancing and could be used to feed into a meta-review.

TIMEFRAME


Combining horizon-scanning and foresight approaches will enable the identification of both near-term developments (foresight) and longer-term developments (horizon scanning).

Economic and National Security Risks Pertaining to the Bioeconomy


Failure to Promote the Bioeconomy
Failure to Protect the Bioeconomy or to Protect from Harms Mediated by the Bioeconomy
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To retain a world-leading bioeconomy, the United States will need to sustain its investment in basic research and the development of supporting and enabling technologies. Support for research fosters the United States’ ability to learn, achieve breakthrough scientific results, and apply research to new applications. Investments that help develop enabling tools, technologies, and standards have the potential to maintain the U.S. bioeconomy competitive in a global bioeconomy.

Constraints placed on U.S. bioeconomy research laboratories but not on academic competitors overseas can create a competitive disadvantage. Constraints on research such as limiting or preventing U.S. researchers from conducing certain types of research or limiting access to particular materials or samples could potentially provide incentives for productive researchers to leave the United States for countries with less stringent regulatory environments.

Growth of the U.S. bioeconomy may be hindered if the quantity or quality of workers with the appropriate skills is insufficient to meet demand. A skilled workforce supplies U.S. bioeconomy firms with the best talent, but it also can provide an incentive for foreign bioeconomy firms to establish research and production facilities in the United States.

Longstanding concerns on the ability of the U.S. K-12 education system to prepare students to study STEM subjects at the university and postgraduate level may also hinder the quality of workers. Opportunities to improve the workforce include improving outreach to minority-serving institutions, devising new mechanisms for undergraduate students to participate in research, and taking part in such programs as the International Genetically Engineered Machine (iGEM) competition. Foreign students constitute a significant fraction of the enrollments at U.S. colleges and universities, particularly in STEM disciplines, and foreign-born employees form a substantial component of the U.S. STEM workforce. Both domestic and international factors may complicate the ability of the United States to continue to attract scientists and engineers to the United States.

Uncertainty over what is considered patentable could have a destabilizing effect on the U.S. bioeconomy by negatively affecting both those pursuing patent protection and those wishing to bring to practice innovations to biotechnology. Narrowed patent eligibility has caused companies to experience difficulty in obtaining and defending patents on biological innovations. Patent eligibility is an important consideration for venture capitalists and private equity investors—the greater uncertainty over patent eligibility makes it less likely that firms will invest in biotechnology companies.

Uncertainty in the regulatory environment encourages developers to imitate products instead of pursuing innovative products that may have unknown paths with long regulatory delays. Innovators may also be reluctant to invest too much research and development funding in areas that might be precluded by later regulatory changes.

Full development of the U.S. bioeconomy will be impaired if its products and services fail to win public trust and acceptance or face opposition. Public trust concerns are numerous and can include such topics as the price of products, the consequence of the release of genetically engineered organisms into the environment, and ethical concerns.

Recommendations


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.

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.

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.

Recommendation 2-2: To better understand the U.S. bioeconomy, the U.S. Department of Commerce’s Office of Technology Evaluation should conduct a study aimed at richer characterization of the permeation of biologically based products, processes, and services in the U.S. economy. Based on the data thus collected, 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). Additionally, the U.S. Census Bureau should refine and regularly collect comprehensive statistics on bioeconomic activities.

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

Recommendation 2-4: The National Science Board should direct the 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.

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.

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 bio-based products.

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.

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 greatly benefited the U.S. scientific and technological enterprise while inherently offering 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. Interacting with scientists who can be fully briefed on the threat environment will greatly facilitate these discussions, since access to classified, proprietary, or other nonpublic information may be needed.

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 (CFIUS) in assessing the national security implications of foreign transactions involving the U.S. bioeconomy.

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.

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.

Recommendation 8:
Bioeconomy stakeholders should pursue membership in one or more relevant information sharing and analysis centers (ISACs) or information sharing and analysis organizations (ISAOs), 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 cyber threats. Those convened should consider whether an active repository is needed to host and maintain key bioeconomy-related open-source software, algorithm components, and datasets.

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.