China’s New Biosecurity Law Gives Limited Insight into Government Priorities and Next Steps

Introduction

The new Biosecurity Law ([生物安全法], Shengwu anquan fa, hereafter “Law”) of the People’s Republic of China (PRC) went into effect on the country’s sixth National Security Education Day on April 15 (Xinhua, April 15). Adopted by the National People’s Congress (NPC) in October 2020, the Law is comprised of 10 chapters and 88 articles and stipulates the establishment of 11 basic systems for biosecurity risk prevention and control, including biosecurity risk monitoring and early warning, risk investigation and assessment, information sharing and information release (Xinhua, April 15). Just before its implementation, China’s top legislator Li Zhanshu (栗战书) called for the country to adopt a “holistic approach to national security and ensuring both development and security” upon implementing the Law (Xinhua, April 1).

Chinese Communist Party (CCP) General Secretary Xi Jinping first mentioned the “Holistic National Security Concept” (总体国 家安全观, zongti guojia anquan guan) as early as April 13, 2014 (China Law Insight, October 20, 2020). The concept encompasses not only biosecurity, but also the realms of “politics, territory, military, economy, culture, society, science and technology, information, ecology, natural resources and nuclear programs” (China Daily, April 16, 2014). Although the Biosecurity Law was not classified as a high priority project in the 13th National People’s Congress Standing Committee five-year legislative plan (2018-2023), its importance was elevated following international criticisms of a Chinese scientist who created the world’s first gene-edited babies in 2018, and its implementation was reportedly accelerated in the wake of the COVID-19 pandemic (NPC Observer, Oct. 15, 2019, m.21jingji.com, February 27, 2020). NPCSC Chairman Li Zhanshu, who chaired a July 2019 symposium on the Law, noted that the CCP “attaches great importance to biosecurity issues” and said that the law must “guide” human biotechnology “to the correct path” (National People’s Congress,, July 11, 2019). The NPC reviewed the first draft of the Biosecurity Law in October 2019. A second draft was released for public comment in April 2020 and the Law was finalized in October 2020 (Xinhua, April 14, Covington, December 9, 2020, China MFA, February 14, 2020).

Although the Law is sweeping in its scope, it is also light on details regarding implementation, enforcement mechanisms, and so forth, leaving room for follow on legislation. For example, the Law does not  clearly define laboratory safety procedures or implementation of containment principles that would be relevant to preventing the risk of accidental outbreaks, unlike comparable Western regulations such as the Laboratory Biorisk Management guidelines, a high-level strategy document issued by the U.S. government (Pandora Report, March 19; European Committee for Standardization, September 2011). The Law reflects the Chinese scientific community’s understanding of “biosecurity” (生物安保, shengwu anbao) as a subcategory of “biosafety” (生物安全, shengwu anquan), rather than an independent field of study, leading to these terms being used interchangeably. Western scientific norms typically distinguish these terms for better clarity. For example, according to a 2009 U.S. National Research Council report: “Biosafety is about protecting people from bad ‘bugs’; biosecurity is about protecting ‘bugs’ from bad people” (Pandora Report, March 19, National Research Council, 2009). Although the lack of distinction is unlikely to lead to significant changes in regulation, it does represent a slightly less-evolved academic framework for regulating biohazards in China.

It is likely that individual PRC ministries, including the National Health Commission, the State Council, the People’s Liberation Army, the People’s Armed Police Force and the Central Military Commission, could issue more detailed guidance on implementing and enforcing the Biosecurity Law (Pandora Report, March 19). The Law also calls for the establishment of a new enforcement entity, the national biosecurity coordination mechanism (国家生物安全工作协调机制, guojia shengwu anquan gongzuo xietiao jizhi), which could play a role in centralizing control over biosecurity issues (China Law Translate, October 18, 2020). Numerous other ministries could also have potential roles in implementing the new Law, including the Ministry of Ecology and Environment, the Ministry of Agriculture and Rural Affairs, the Ministry of Science and Technology, the Ministry of Commerce, the General Administration of Customs, and the State Administration for Market Regulation (China Law Insight, October 20, 2020).

The Law’s ten chapters broadly fall into three categories covering preventive measures, containment recommendations, and enforcement mechanisms. Chapters 1-3 and 7 highlight prevention, Chapters 4-6 examine containment—mostly in laboratory environments—and Chapters 8-9 focus on enforcement (China Law Translate, October 18, 2020, NPC, October 17, 2020). As already mentioned, Xi’s public criticism of systemic weaknesses and loopholes exposed by the COVID-19 pandemic in early 2020 underscores the necessity to rapidly implement the Law (Xinhua, February 15, 2020).

Prevention (Chapters 1-3, 7, 10)

The first three chapters of the Law lay out expectations for governmental organs to establish various systems and draft standards and regulations on biosecurity, but do not specify exactly what those should be. Details on enforcement and legal obligation are similarly sparse. The text does legally defines biosafety at the national level for the first time, referring to the need for “the nation effectively preventing and responding to the threat of dangerous biological factors and related factors, biotechnology developing steadily and healthily, people’s lives and health and ecosystems being in a state of relatively no danger and threats, and the biological field having the capacity to preserve national security and sustainable development” (NPC, October 17, 2020).

The Law also expands the legal scope of biosecurity enforcement to apply to infectious disease control; biotechnology research, development, and applications; microbiology laboratories; and human genetic resources and biological resources, among others, and establishes a clearer framework for the targeted prevention and control of biosafety risks (Legal Daily, April 16). Four principles and eight applications for the prevention and control of biosecurity risks map onto the CCP principle of “four beams and eight pillars,” (四梁八柱, siliang bazhu), which Premier Li Keqiang first used in 2015 to describe the foundations of China’s economy (People’s Daily, April 15; Legal Daily, April 16; China News, September 10, 2015), and has subsequently been adopted as a methodology for a variety of governance and reform measures. Essentially, the concept highlights the CCP’s aim to achieve interlocking strength through engaging multiple government organs, rather than assigning all responsibility to just one organ.

This first section of the Law also calls for the establishment of a biosecurity risk monitoring and early warning system; a biological security risk investigation and assessment system; systems for sharing information on biological security; and a system for responding to major overseas biosecurity incidents (China Law Translate, October 18, 2020). Notably, although the details on the early warning implementation are light, the information sharing mechanisms specified by the Law could be integrated with China’s national credit system, according to Article 26 (China Law Translate, October 18, 2020). Although the development of an actual national credit system for individuals is still in the early phases, one could foresee a future in which an individual’s social credit score could be impacted by whether they are reported to have violated the biosecurity law by, for instance, importing invasive species.

The warning systems would necessarily connect to the prevention and control of major emerging infectious diseases, animal and plant epidemics, biotechnology research, development and application safety, pathogenic microorganism laboratory biosafety, human genetic resources and biological resource safety, prevention of bioterrorism and biological weapons threats, and biological safety, according to Sun Youhai (孙佑海), Dean of the Tianjin University Law School and deputy director of the Tianjin University Biosafety Strategy Center. Sun wrote an interpretation of the Law, first published by the Yunnan Provincial Department of Ecological Environment, which highlighted, in particular, the security threat posed by invasive species, more than 660 of which have been discovered in China. Seventy-one have caused or present potential threats to the natural ecosystem and have been included in the “List of Invasive Alien Species in China” (The Paper, November 29, 2020).

Implementation: Chapters 4-6

Sections of the Law regarding containment (Chapters 4-6) primarily address laboratory work in virology labs, biotechnology and microorganism laboratories, and labs dealing with human genetic resources and biological resources, but also touch on issues concerning invasive species, microbial resistance and biological weapons. The legislation could be seen as an indirect response to concerns over Chinese laboratory safety protocols, which have been subject to international scrutiny amid outstanding questions over the origins of the coronavirus outbreak. But the actual text is not especially prescriptive. It calls for “high-level laboratories engaging in laboratory activities with highly pathogenic, or suspected highly pathogenic, microbes” to be “approved by the department of health or rural affairs of a provincial-level people’s governments, and [to] report on the experimental activities to the approving department.” It also calls for experiments involving new microbes to obtain approvals, take measures to prevent experimental animals from escaping, and provide for responsible waste management (China Law Translate, October 18, 2020; NPC, October 17, 2020). Perhaps of most note to foreign observers are the restrictions in Articles 56-58 on collecting Chinese citizens’ “genetic resources” and “biological resources,” which may relate to China’s documented attempts to build a national DNA database (South China Morning Post, September 22, 2016). Some in the West have also criticized China’s collection of genetic data beyond its borders (Nature, July 7, 2020, U.S. National Counterintelligence and Security Center, February 2021). In contrast to a long-standing international consensus on the importance of open genomic data sharing to benefit scientific research and innovation, Chinese regulations have underscored the national security risks of cross-border data transfers as early as 2016 (Human Genetics, August 17, 2018).

Chapters 8 and 9 focus on enforcement of the prevention and containment provisions. Article 70 of Chapter 8 says that “The state is to strengthen reserves of biosecurity risk prevention and control supplies for major emergent infectious diseases and plant and animal diseases” (China Law Translate, October 18, 2020). In addition to domestic risks, this admonition connects to Article 24, which reads that when “major biosecurity incidents occur overseas, [the custom] is to lawfully employ emergency biosecurity prevention” by controlling flows of people and goods into the country (China Law Translate, October 18, 2020).

One non-COVID-19 related example of containment could include the ongoing swine flu epidemic in China that has decimated China’s pork production, with some estimates suggesting that as much as half of Chinese pig herds died from the flu in 2020 (Reuters, January 16, 2020). In the first quarter of 2021, industry sources and analysts reported that at least 20 percent of the breeding herd in northern China was lost, exceeding expected losses and raising fears about the potential for further impact in the south (Reuters, April 1). Full rehabilitation to pre-swine flu levels is more likely by the second-half of 2022 (Caixin, Feb. 24). Although the new Law has limited ability to affect the epidemic response ex post facto (centralized reporting mechanisms may be one exception), its most significant ramifications could include increased scrutiny of future pork imports and other staple foods.

The penultimate chapter concludes by outlining the fines and sanctions that may be levied by the on those who violate the law. Enforcement bodies vary by sanction, and the text of the Law does not indicate any kind of centralized oversight. Those violating biotechnology research regulations can be fined up to 10 million RMB (a little over $1.5 million), those setting loose unauthorized animals up to 1 million RMB ($154,340), those violating human genetic material regulations up to 10 million RMB ($1.54 million), and those importing foreign species without permission up to 250,000 RMB ($38,585) (China Law Translate, October 18, 2020).

Conclusion

While recent challenges including genetic research and testing controversies, the COVID-19 pandemic, and last year’s swine flu epidemic all clearly had an impact on fast-tracking China’s new Biosecurity Law, it is not clear whether the Law’s general provisions would have prevented any of the major issues that it was crafted to address. Many have noted that China’s public health warning system, which was dramatically revamped following the SARS epidemic in 2002-2003, failed to work as expected in the early days of the coronavirus pandemic (AJPH, June 10, 2020; Science, May 18). Because the new Biosecurity Law is so vague, it is also uncertain how it will affect ongoing biosecurity challenges facing the Chinese state, including measures to block frozen food imports that are feared to transmit the infectious SARS-CoV-2 (South China Morning Post, November 14, 2020).[1]

Although China’s existing patchwork of laws may have contributed to the lagging response to its biosecurity challenge, it remains to be seen what kind of teeth this new law will have. In its current form, it looks more like a strategy document or list of priorities. Perhaps by the next National Security Education Day in 2022 the picture will appear clearer.

The author thanks Jamie Horsley and Tim Jia for their research assistance, edits, and feedback on this piece.

James Haynes is an independent research consultant for the New Yorker and an alumnus of Princeton University. He is also the founder and editor of the China Biotech Bulletin, an email newsletter of Chinese biotechnology policy news. His work has appeared in The Houston Chronicle, The Hill, and The Diplomat, among others.

Notes

[1] Note that the theory about the transmissibility of coronavirus via frozen food packaging is not widely accepted outside of China.