Government & Politics

Regulating Synthetic Biology Practices

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Synthetic biology, the use of genetic engineering to rewrite the DNA of living organisms to fulfill new scientific purposes, is emerging as a priority for civilian and military researchers in the U.S. and elsewhere. One reason for this surge in attention is the advances in genetic engineering technologies and falling costs of DNA sequencing that make this research more accessible. Global crises like climate change and the COVID-19 pandemic have also highlighted how synthetic biology can help solve social problems. However, there are currently no internationally-recognized best practices for safe and effective synthetic biology research. The absence of such a crucial framework could enable authoritarian states like China to shape global norms and practices and empower state actors to use genetic data for ideological purposes. 

The U.S. synthetic biology regime evolved largely without government oversight, with the private sector and academia determining self-governing, industry-specific best practices. Federal regulations that do exist are dispersed and narrowly-focused, with at least five different agencies enforcing policies on specific technologies and applications. The scientific freedom afforded by minimal government involvement is often heralded as a competitive advantage in American innovation. But President Joe Biden’s recent executive order calling for a whole-of-government approach to biotechnology and biomanufacturing will reverse that historic laxness. We should expect to see streamlined regulation on DNA synthesis, as well as broader policies governing genetic research.

In contrast to the U.S., synthetic biology in China has long been under the purview of the government, with central planning offices dictating the distribution of research funding. Support for the biotechnology industry – a broader category that includes genetic synthesis – has been named an economic priority in China’s Five-Year Plans since 2006. These national plans prompted government investment in civilian synthetic biology projects for food and water management, manufacturing competitiveness, and elder care – a total investment that may be as high as 100 billion USD. State construction of cutting-edge synthetic biology research centers and supporting infrastructure, including gene banks and stem cell banks, have further contributed to this vision for the “Technology Revolution and the Future of China.”

The principal concern biotechnology experts and U.S. intelligence officials have expressed about China’s growing synthetic biology capabilities is bioterrorism. This may be a valid threat in the long-run, especially given calls from Chinese defense research officials for synthetic biology to become the “strategic commanding heights” of China’s national defense. For now, however, China appears to be prioritizing “quick and cheap” ways to expand its biotechnology capabilities, pursuing intellectual property theft from abroad over developing scientific talent domestically. Precision bioterrorism targeting the U.S. is likely not a short- or medium-term risk.

What we should focus on as the more immediate threat is China’s use of synthetic biology practices to control its citizens, as well as promoting such tactics to other authoritarian governments. As part of a campaign to build a Chinese gene bank, the government mined biomedical data on the 600 million citizens enrolled in the national healthcare system without seeking their consent. The state has also explicitly tied genetic data to the Chinese Communist Party’s ideological campaigns. For example, government entities have used forced DNA collection from Uighurs and other marginalized groups to support claims that these populations are fundamentally different from ethnic Chinese. Such intrusive practices are also affecting people beyond China’s borders. Chinese groups have been accused of phishing DNA information through fraudulent medical test kits or genealogy packages, and of hacking U.S. biotechnology and vaccine development firms.

One consequence of the U.S. moving so late on synthetic biology regulation is that multilateral conversations have already taken place without an American presence. The U.S. has held limited talks with NATO and OECD allies around synthetic biology and biotechnology, but has hesitated to get involved in broader global discussions. China, by contrast, is an active participant in the UN Convention on Biology Diversity (CBD), which prescribes management of environmental and human health risks associated with biological research generally. (The U.S. is the only country in the world that is not a party to CBD.) China hosted the annual CBD meeting in 2020, where synthetic biology was a stand-alone agenda item for the first time. While synthetic biology regulations were not included in the subsequent adopted protocols, the inclusion of the topic at a multilateral forum was an indication of increased global attention. We should expect to see China building on this opportunity at future CBD meetings to promote the legitimacy of its authoritarian synthetic biology practices.

If American leaders hope to limit the promotion of global synthetic biology regimes that favor authoritarian governments, they must first catch up to China in terms of domestic regulation. The language of Biden’s executive order promises streamlined regulations for a “risk-based, predictable, efficient, and transparent system” for safe use of biotechnology, “principles of security, privacy, and responsible conduct of research,” and “biological risk management as a cornerstone” of research and development. But it is unclear how those commitments will be implemented in practice. Steps towards synthetic biology practices “consistent with United States principles and values” may include policies asserting personal ownership over genetic data and regulations restricting government access to sensitive biomedical data. Such policies would set an unambiguous precedent against authoritarian actors co-opting genetic information.

Important as it is, however, U.S. domestic policymaking alone will be insufficient. The U.S. should also take steps to promote adoption of similar policies internationally, and not just to other states regarded as part of the ‘Western world.’ Partnerships with India, South Korea, Brazil, and other democratic regional powers could highlight the contrast between U.S. and Chinese regimes and curb global authoritarian creep in synthetic biology regulations.



About the Author: 

Kathryn Urban is a current graduate student in the School of International Service’s Global Governance, Politics, and Security program. Her research interests include Arctic securitization and the strategic logic of drone warfare.