Safeguarding the Bioeconomy (2020) / Chapter Skim
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7 Economic and National Security Risks Pertaining to the Bioeconomy
7 Economic and National Security Risks Pertaining to the Bioeconomy
Pages 275-336
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scientific leadership in the global bioeconomy. Identified risks include -- insufficient funding for research and development, -- asymmetric research constraints, -- an inadequate workforce, and -- an ineffective or inefficient intellectual property and regulatory environment.
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• The growing bioeconomy's reliance on software, networking, and computer hardware tools makes it vulnerable to fundamental cyber security risks similar to those faced by other sectors. In particular, bioeconomy stakeholders are at high risk for cyber intrusions, cyber enabled data loss or manipulation, and intellectual property theft as the risks and potential adverse biological outcomes are not well understood by the community.
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or datasets, conferring a competitive advantage on the recipients of that illicitly gained information. It also addresses failure to protect from harms mediated by the bioeconomy that relate to its subversion or misuse, including such traditional biosecurity risks as the development of biological weapons agents, as well as means by which attackers could hijack entities within the bioeconomy to pose risks to people, agriculture, and the environment or to threaten U.S.
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To retain this world leadership position, the United States will need to sustain its investment in basic research and the development of supporting and enabling technologies. The committee identified the potential risks described below should U.S.
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Continued funding and support for research that could extend and improve these tools or result in a new enabling technology is paramount to maintaining scientific leadership; however, identifying what research to fund is a perennial challenge. Within the synthetic biology community, the Engineering Biology Research Consortium (EBRC)
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; the Synthetic Biology Open Language (http://sbolstandard.org and https://doi.org/10.1016/j. synbio.2018.04.002)
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; Graduate STEM Education for the 21st Century (NASEM, 2018b) ; Indicators for Monitoring Undergraduate STEM Education (NASEM, 2018c)
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Teams compete for medals (demonstrating technical excellence in synthetic biology) and prizes (for outstanding work in specific areas)
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Assistant Director Edward William Priestap testified before a Senate Judiciary Committee subcommittee in June 2018, "Any research institution hoping to be -- and to remain -- among the best in the world must attract and retain the best people in the world, wherever they are from" (DOJ, 2018b, p.
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bioeconomy by negatively affecting both those pursuing patent protection and those wishing to bring innovations in biotechnology to practice. Since recent Supreme Court decisions have narrowed what is considered patent eligible (discussed below)
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Supreme Court decisions have expounded upon the judicial exceptions to patent subject-matter eligibility, including Mayo Collaborative Services v. Prometheus Labs (566 U.S.
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Over a 5-year period after the Myriad decision was issued, 6,785 patent applications in Technology Center 1600 (the technology center that provides examination for patent applications in biotechnology and organic chemistry) received a Myriad-based rejection, 85 percent of which covered products other than naturally occurring DNA (Aboy et al., 2018)
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The Court did not disagree that "detecting cell-free fetal DNA in maternal plasma or serum that before was discarded as waste material is a positive and valuable contribution to science," but found that "even such valuable contributions can fall short of statutory patentable subject matter." These findings reveal an unusually high degree of legal uncertainty both in prosecuting patent applications and in upholding the validity of granted patents in biotechnology. And while it is possible to overcome rejections under 35 U.S.C.
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Ineffective or Inefficient Regulatory Environment Excessive or poorly designed regulations could impede innovation by constraining the choices available to innovators or imposing on them requirements that would tend to increase cost or uncertainty. On the other hand, to the extent that regulations are perceived as protecting public health, public safety, and the environment, they can strengthen public trust in a new technology, leading to wider public acceptance and serving as an innovation driver.
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These concerns include • the safety, environmental, or land-use implications of the use of genetic engineering in agriculture or of the production of crops for biofuels; • the consequences of the release or potential release of genetically engineered organisms into the environment; • lack of confidence in government regulatory bodies; • the price of biotechnology-derived medical therapies; • the distribution of economic benefits between producers and con sumers, or among producers of different sizes; • the distribution of economic benefits between those who generate economic value from genetic information and those who had sov ereignty over the specimens from which that genetic information was originally obtained; • the ethics and propriety of modifying human DNA; • the ethics and propriety of engineering other living organisms; 10See https://www.whitehouse.gov/presidential-actions/executive-order-modernizing regulatory-framework-agricultural-biotechnology-products.
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. Moreover, quantitative assessments may not even address underlying ethical or social concerns or value conflicts that may be crucial to public acceptance and could potentially be addressed through various engagement BOX 7-2 Misinformation About Vaccines in the United States Increasingly, public opinion is shaped by social media and the blogosphere, as well as traditional information sources.
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As the goods and services offered by the bioeconomy become more widely integrated into the society and the economy at large, adversaries may cause harm through interruption or corruption of bioeconomy operations. Dangerous biological outcomes may be generated through such means as the covert adulteration of biological outputs.
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firms are forced to release critical bioeconomy datasets to foreign firms as the price of doing business abroad or following a firm's acquisition by foreign entities. Asymmetric Access to National Sources of Genetic Information The U.S.
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. China does not permit foreign researchers to conduct research involving human genetic resources (genetic materials in human samples or genetic information)
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has initiated discussions on the relevance of "digital sequence information" to the Convention's goals.11 This move reflects the changing nature of mechanisms for distributing knowledge or information about a biological entity, which traditionally has relied on the exchange of physical specimens but now may be accomplished by generating and distributing various digital representations of those specimens. The most widely discussed digital representation is an organism's genetic sequence.
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provide a brief overview of the implications of this access to the growing field of synthetic biology. They conclude that policies regarding DSI "could have a significant influence on synthetic biology research and development internationally.
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Use of Bioeconomy Datasets to the Detriment of Individual Privacy or National Security Two risks associated with bioeconomy datasets involve harm to either individual privacy or national security: exploitation of genetic vulnerabilities and genetic targeting of populations. Exploitation of Genetic Vulnerabilities Whole human genomic data, such as those collected by such companies as 23andMe and Ancestry.com, are building the broader informational dataset about genes, inheritance, and subpopulations.
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. These potential harms become national security concerns when they provide adversaries with a means to elicit personal information about, or even mechanisms to influence, key national decision makers or security personnel, such as members of the military or police forces.
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The promise of precision medicine in tailoring medical treatments to individuals or groups on the basis of genetic characteristics and the ability of genetic testing services to categorize people into "haplogroups" that share common ancestors in their patrilineal or matrilineal lines make clear that groups of people who share some common genetic characteristics are increasingly being identified. Whether those groupings correlate with criteria an attacker might seek to target (racial, ethnic, social, political, national, or ideological)
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. In response to this lack of privacy with respect to law enforcement, GEDmatch adopted a new privacy policy in May 2019 requiring its users to opt in to use of their genetic information by law enforcement (Aldhous, 2019)
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Congress took action to mitigate this problem in 2008 by passing the Genetic Information Nondiscrimination Act (GINA) , which prohibits discrimination by employers and health insurers based on genetic information, but it fails to cover many other critical areas in which discrimination is possible, such as life insurance or health care plans from employers with fewer than 15 employees.
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. As genetic information becomes more reliable and reveals more information about individuals, it can open opportunities for new avenues of genetic discrimination.
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A recent report from the White House estimates that malicious cyber activity imposes costs on the U.S. economy (through the theft of IP and personally identifiable information, denial-of-service attacks, data and equipment destruction, and ransomware attacks)
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Department of Justice Unseals Indictment Against Iranians in 2018 Relation to SamSam Ransomware Attacks November 27, Atrium Discloses Unauthorized Database Access 2018 November 16, Episcopal Health Services Notifies Individuals of Data Breach 2018 October 25, 2018 Bankers Life Announces Data Breach September 11, Health Management Concepts Discloses Ransomware Attack 2018 continued
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Suffers NotPetya Ransomware Attack May 12, 2017 Britain's National Health Service Attacked by WannaCry Ransomware January 15, 2017 Indiana Cancer Nonprofit Announces Cyber Attack October 13, 2016 Peachtree Orthopedics Suffers Data Breach August 25, 2016 MedSec Cybersecurity Researchers Report Vulnerabilities in Pacemakers March 29, 2016 Security Researchers Identify Vulnerabilities in Medical Dispensing Systems March 23, 2016 Verizon Details Cyber Attack Against Water Treatment Plant February 11, Hollywood Presbyterian Medical Center Hit with Ransomware 2016 Attack July 17, 2015 UCLA Health System Discloses Data Breach February 5, 2015 Anthem Discloses Breach of Customer Data NOTES: Dates reflect when the incidents were first reported. GE = General Electric; SEC = Securities and Exchange Commission; UCLA = University of California, Los Angeles.
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may include full genetic sequences of humans and other organisms. Arguably, the features described above are thus materially different when understood in the context of the bioeconomy -- because the genetic information literally defines us as humans and enables manipulation at the level of life's component parts.
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in unwanted or dangerous biological outcomes. Some of these security vulnerabilities have been described previously (Peccoud et al., 2018)
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A variety of operations are performed on these databases, increasingly including use of machine learning and other artificial intelligence techniques that can, for example, associate a protein's amino acid sequence with its three-dimensional structure or identify pathways for and optimize the production of biosynthesized materials, or -- particularly in association with other sources of data such as medical records -- "identify the relations between genetic characteristics and the response to specific treatments" or identify new drugs "by training a classifier on a dataset where functioning and nonfunctioning drugs have been
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. Sharing of "narratives" by researchers speeds the analysis of data by new users, and new tools are generated using a software development kit that helps ensure compatibility in workflows.
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Information sharing Stakeholders in the bioeconomy sector may find it useful to develop and sustain cooperative structures that enable sharing of cyberthreat information. Many infrastructure sectors have developed capabilities to share information on cyberthreats among sector members.
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. 20Presidential Policy Directive 21, "Critical Infrastructure Security and Resilience" (White House Office of the Press Secretary, 2013)
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Although it would be possible for bioeconomy stakeholders to form an ISAO, start-up costs are entailed in building such a structure. Improved software engineering With respect to software development and software quality generally, more attention to standard software engineering techniques -- unit tests, regression test suites, code reviews, and the like -- will pay off in more reliable and more secure code.
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Because of the risks posed by disclosing information in patents (see Box 7-3) , many biotechnology companies decide to protect their IP assets as trade secrets instead.
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Of particular concern to some U.S. government officials are foreign talent recruitment programs, such as China's Thousand Talents Program, through which foreign countries offer salaries, research facilities, and titles to induce expatriate scientists and other overseas experts to bring their knowledge and experience to China.
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Because the public disclosure requirements are vastly different, and because patents and trade secrets are mutually exclusive for a given innovation, the choice between patent protection and trade secrecy must be carefully considered. The quid pro quo of the patent system is that companies must disclose information about an invention to obtain a patent.
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Unlike patent protection, for which disclosure of the preferred host strain is required, trade secret protection enables a company to withhold access to its preferred host strain as a means of maintaining a competitive advantage. It is worth noting, however, that although the number of trade secret indictments brought by the U.S.
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officials encompass several related issues that can be considered aspects of research misconduct, or the violation of academic norms or commitments: violations of the terms and conditions of federal grants that require disclosure of foreign financial conflicts and affiliations, unauthorized dissemination of proposals that have been circulated for confidential peer review, and theft of nonpublished research information (such as information obtained from the peer review of research manuscripts or through informal discussions) .25 Disclosure of foreign financial conflicts is important, as described by the head of NIH's extramural research program, Michael Lauer, to prevent duplicative funding for the same research.
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So while they all have the obligation to protect unpublished or confidential information and to respect IP, the idea that foreign researchers who come to American universities will not leave with any knowledge and technology is not well reasoned. Moreover, foreign researchers are often members of U.S.funded scientific teams and contribute their intellectual capital to their projects' success.
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warned against. Policies regarding foreign talent recruitment programs are challenged to find the appropriate balance.
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, a state-directed economic program provides government subsidies for Chinese companies and mobilizes state-backed financial institutions to fund the acquisition of foreign biotech companies, with the goal of acquiring IP, and artificially distorts the market to establish Chinese companies as world leaders. An example is the $43 billion acquisition of Syngenta by the China National Chemical Corp.
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," https://www.treasury.gov/resource-center/international/ foreign-investment/Documents/Section-721-Amend.pdf; and "Summary of the Foreign Investment Risk Review Modernization Act of 2018," https://www.treasury.gov/resourcecenter/international/Documents/Summary-of-FIRRMA.pdf. 28See https://www.treasury.gov/resource-center/international/Documents/Summary-of FIRRMA.pdf.
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approval processes of several European Union states were illegal. In 2013, the European Union General Court ruled that the European Union must process a long-pending authorization to import a genetically modified corn (Law Library of Congress, 2014)
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. According to the USTR report, the Chinese government forces the transfer of foreign companies' technologies and IP to Chinese companies though opaque administrative licensing and approval processes, noting that "Chinese officials may use oral communication and administrative guidance to pressure foreign firms to transfer technology." Such policies clearly disadvantage U.S.
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The operation of any bioeconomy facility that is dependent on input materials available only overseas is subject to interruption if the supply chains for those inputs are interrupted, whether by decisions of foreign powers to withhold shipment or by failures of international transportation networks.30 Moreover, dependence on imports exposes the United States to potential sources of counterfeit or adulterated products if the regime ensuring product integrity in the supplier country is inadequate.31 Protecting against such interruptions requires developing multiple secure sources of supply for critical inputs, stockpiling the inputs, or engineering around these dependencies. 29Presidential Policy Directive 21, "Critical Infrastructure Security and Resilience" (White House Office of the Press Secretary, 2013)
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Another possibility is the creation of novel bioweapons that do not currently exist on any security control lists and would be difficult to prevent, detect, and treat. A 2018 study by the National Academies highlights the most concerning capabilities stemming from synthetic biology that could harm humans (NASEM, 2018a)
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Certain U.S. export controls serve as one means of countering some biosecurity concerns.
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Department of Commerce to establish export controls on emerging and foundational technologies that are "essential to the national security of the United States." This process is intended to take into account the status of development of these technologies in foreign countries, the effect such controls might have on their development in the United States, and the potential effectiveness of the controls in curbing the proliferation of these technologies.35 On November 19, 2018, the U.S. Department of Commerce issued an Advance Notice of Proposed Rulemaking (ANPRM)
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ECONOMIC AND NATIONAL SECURITY RISKS 327 and economic growth," pointing out that the biotechnology industry is an inherently global ecosystem and utilizes global clinical research partnerships.38 The U.S. Department of Commerce received 247 responses to its request for comment and as of this writing had not responded to them.
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bioeconomy. Spe cifically, more information is needed regarding the extent to which patent eligibility requirements impact the ability of start-up com panies and larger, well-established companies to secure patent pro tection in the United States, and whether these companies are more or less inclined toward or successful in securing patent protection internationally.
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Patent and Trademark Office. https://www.uspto.gov/sites/default/files/documents/memo berkheimer-20180419.PDF (accessed October 19, 2019)
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Ag Policy Blog, July 11. https://www.dtnpf.com/agriculture/web/ag/blogs/ag-policy-blog/ blog-post/2019/07/11/aquabounty-salmon-longer-swimming-2 (accessed October 19, 2019)
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Senate, at a hearing "Student Visa Integrity: Protecting Edu cational Opportunity and National Security," June 6. https://www.judiciary.senate.gov/ imo/media/doc/06-06-18%20Priestap%20Testimony.pdf (accessed October 16, 2019)
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2019. Genentech trade secrets theft highlights risk for biotechs.
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Science News, June 5. https://www.sciencenews.org/blog/science-public/privacy-and-consumer-genetic testing-dont-always-mix (accessed October 16, 2019)
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https://www.nsf.gov/statistics/indicators (accessed October 16, 2019)
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Science News, October 12. https://www.sciencenews.org/article/genealogy-databases-could reveal-identity-most-americans (accessed October 16, 2019)
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Wired, February 1. https://www.wired.com/2016/02/schools-kicked-boy-based-dna (accessed October 16, 2019)
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