key: cord-0912276-etk6ynef
authors: Cao, Cong
title: China’s evolving biosafety/biosecurity legislations
date: 2021-06-30
journal: J Law Biosci
DOI: 10.1093/jlb/lsab020
sha: a47012685369a7fe73d3737d234cd694ac5d8c79
doc_id: 912276
cord_uid: etk6ynef

This paper represents a systematic effort to describe and assess China’s evolving biosafety/biosecurity legislative and regulatory regime. It catalogs and analyzes laws, regulations, and measures, including the newly passed Biosafety/Biosecurity Law. Various reasons are underlying China’s recently accelerating legislative process for such a law, from international attention increasingly turning biosafety/biosecurity governance into a more regular fixture; the emergence of infectious diseases and even pandemics linked with zoonosis; advances in the global frontier of the life sciences and biotechnology and their integration with other technologies, which, while holding great promise for advancements in global health, raises biosafety/biosecurity concerns; to the strengthening of biosafety/biosecurity governance in many countries. Chinese leadership’s ‘holistic view of national security’ encompasses broad areas of concerns of national security with biosafety/biosecurity being an integral part. However, having progressed alongside its development of the life sciences and biotechnology, China’s current biosafety/biosecurity legislative and regulatory regime is far from rising to the challenges and even the newly enacted Biosafety/Biosecurity law still has room for improvement. The paper’s findings have significant policy implications for further enhancing China’s biosafety/biosecurity legislation and governance and making them better serve domestic interests while converging with international norms.

China is accelerating the construction of its biosafety/biosecurity legislative regime. Since China started to develop biotechnology in the 1980s, there have been calls for a law of biosafety, whose urgency is on the rise especially given the new attention to biosafety/biosecurity in the wake of the outbreak of a novel coronavirus disease, COVID-19, which has been ravaging globally since late 2019 and touching upon many of the issues implicated by such a statute. China's National People's Congress (NPC), the legislature, has finally moved forward on the legislation (Table 1) . 1 In 2018, the first session of the 13th NPC included making the law into one of the Class-Three legislative projects, or those legislations that are premature and need further research and deliberation. In 2019, the NPC Environmental Protection and Resources Conservation Committee was tasked with leading the drafting of the law. The Standing Committee of the 13th NPC reviewed and debated the first two drafts of the law at the 14th and 17th meetings, in October 2019 and April 2020, respectively; and the second draft also was reviewed and debated at the third session of the 13th NPC in May. Then, there was a period for public comment on the draft law in the months of May and June. The third draft of the law had a review during the 22nd meeting of the 13th NPC Standing Committee before being passed on October 17. The law took effect on April 15, 2021, thus finalizing the institutionalization of China's biosafety/biosecurity legislations and marking a major milestone for China's biosafety/biosecurity governance.

The Chinese term, 'shengwu anquan,' used in the name of the law, denotes the protection of humans, animals, plants, and the environment from hazards or potential risks under two circumstances. 2 The first, biosafety, is about such protection from the risks and hazards caused inadvertently by working with microorganisms and toxins and the second, biosecurity, refers to such protection from the hazards that may arise in connection with deliberate theft, misuse, or diversion of biotechnology. Therefore, 'shengwu anquan' in a narrow sense is about biosafety but broadly biosecurity; as such, biosafety and biosecurity are distinct but closely related. In particular, intended to prevent accidents, biosafety measures designed to reduce accidental biological risks can indirectly help to mitigate intentional biosecurity hazards associated with challenges that 'the same scientific research, products, or facilities which are meant for social good could also have an unintended result of threatening a population.' 3 Not paying The first draft of the law is submitted to the 14th meeting of the 13th NPC Standing Committee for review April 2020

The second draft of the law goes through a review at the 17th meeting of the 13th NPC Standing Committee May 2020

The draft law is reviewed and deliberated in the third session of the 13th NPC May 3 to June 13, 2020 Public views on the draft law are solicitated via the NPC website June 1, 2020

The legislation of the law is included in NPC's legislative work plan for 2020 September 2, 2020

The NPC Constitution and Law Committee convenes to review the draft law September 27, 2020

The NPC Legislative Affairs Commission convenes to solicit views from relevant parties on feasibility of main institutional norms in the draft law, as well as timing, social effects, and possible problems associated with the implementation of the law September 29, 2020

The NPC Constitution and Law Committee convenes to review the draft of the law October 17, 2020

The 22nd meeting of the 13th NPC Standing Committee passes the law after reviewing its third draft April 15, 2021 The law comes into force attention to biosafety/biosecurity would pose potentially catastrophic consequences to a country's political, social, and economic development, public health, and ecology and the environment. China's biosafety/biosecurity legislations need to be understood in such contexts. This paper represents a systematic effort to describe and assess the evolution of China's biosafety/biosecurity legislative regime. The next session outlines the background against which China has endeavored to beef up its biosafety/biosecurity leg-islations. This is followed by an analysis of China's biosafety/biosecurity legislative and regulatory regime up to the passage of the Biosafety/Biosecurity Law in 2020 so as to lay a foundation for examining the most recent development as well as the deficiencies that exist in China's biosafety/biosecurity legislations. China's biosafety regime for agricultural genetically modified organisms (GMOs) is used to illustrate its legislative practice. The paper then takes a preliminary reading of China's biosafety/biosecurity law passed by the NPC. It will conclude with a prospect of China's biosafety/biosecurity legislations and governance.

Developments at several fronts have prompted China to accelerate biosafety/biosecurity legislations. First, international attention has increasingly turned biosafety/biosecurity governance into a more regular fixture, as evidenced by the introduction of relevant international treaties. In 1988, the United Nations Environment Programme (UNEP) explored the need for a Convention on Biological Diversity (CBD), which became effective in late 1993, with biosafety as one of the important components. Afterward, the international negotiation on CBD's implementation, conducted under the UNEP, focused, among other issues, on potential threats of GMOs to biodiversity, the environment, and human health (1992) . 4 The Cartagena Protocol on Biosafety to implement the CBD was adopted in 2000 as a risk assessment and regulatory framework governing the cross-border movements of GMOs (2000) . 5 Meanwhile, in June 1992, the United Nations (UN) adopted Agenda 21 as a comprehensive plan of action to build a global partnership for sustainable development to improve human lives and protect the environment. The UN declared Millennium Development Goals (MDGs) in 2000 to encourage a global combined commitment for addressing challenges facing the 21st century and MDGs evolved into Sustainable Development Goals in 2012. 6 These developments need to be examined against a globally challenging background. For example, according to a UNEP report (2017), approximately 700,000 people worldwide die each year from drug-resistant bacterial infections; 7 in a global biodiversity assessment, the Intergovernmental Science-Policy Platform on Biodiversity and Ecosystem Services, under the United Nations Educational, Scientific and Cultural Organization, warned that one in eight species are in danger of extinction. 1972 and came into force in 1975, the rising threats of bioterrorism have made global governance necessary. 9 Second, past two decades have witnessed the emergence of infectious diseases and even pandemics linked with zoonosis, from severe acute respiratory syndrome (SARS), Middle East respiratory syndrome (MERS), H1N1 influenza, to now COVID-19. In retrospect, in 1951, the World Health Organization (WHO) introduced the International Health Regulations (IHRs), a binding international legal instrument addressing public health risks of international concern, which have been revised several times to respond to the changes of the most dangerous infectious diseases. Among others, the IHRs require that each member state report any disease outbreaks and certain public health events to the WHO. 10 Given that infectious diseases present risks that cannot be tackled by any one country, there has been increasing urgency about not only globally coordinated and efficient disease detection, assessment, reporting, and response systems in animal and human health but also globally explicit recognition of the existence of a health-security nexus. 11 Established in 2014, Global Health Security Agenda is now a network of 69 countries, which works together with international and nongovernment organizations and private companies to secure global health security. 12 Third, advances have been made at the global frontier of the life sciences and biotechnology, especially in bioinformatics, genomics, gene editing, systems biology, and synthetic biology. And the life sciences and biotechnology also have become increasingly integrated with nanotechnology, information technology, artificial intelligence, precision electronics, optoelectronic engineering, micromanufacturing, and delivery technologies. 13 As well as holding great promise for advancements in global health, the progress would have significant implications for biosafety/biosecurity governance. 14 For one thing, laboratory-acquired infection (LAI), or mismanagement in which microorganisms escape from laboratories, highlights the necessity to raise the awareness of biosafety. A particular line of research, 'gain of function,' is aimed at improving understanding of disease-causing pathogens and viruses, their interaction with human hosts, and/or their potential to cause pandemics by enhancing the pathogenicity or transmissibility of such agents, which has generated rampant worries about potential risks associated with the misuse and abuse of the information or products resulting from such research. 15 Fourth, many countries have strengthened their biosafety/biosecurity governance. Since 2010, the USA has issued a series of biosafety/biosecurity-related policies. In general, oversight of biological science activities in the USA is governed through three channels-legal statutes and regulations; guidelines and guidance set up by funding agencies; and voluntary policy implementation of unregulated science or entities. 16 In addition to high-level strategies-the Bioeconomy Blueprint (2012) and National Biodefense Strategy (2018)-under the Obama and Trump administrations, respectively, 17 18 A National Science Advisory Board for Biosecurity was established to advise the American government on the evaluation and oversight of proposed dual-use and gain-of-function research. 19 Similarly, in the UK, in 2018, the Department for Environment, Food and Rural Affairs, the Department of Health and Social Care, and the Home Office issued the country's first Biological Security Strategy to assess three broad categories of future biological threats-natural biological risks, accidental biological risks, and deliberate threats. The European Union also has had a series of multilateral agreements and legislations against the proliferation of biological weapons, as well as those on public health and environmental protection, safety and security measures in laboratories, dualuse technology and measures of secure transport of biohazard materials, and genetic engineering. 20 These international developments have given China reasons to take swift and necessary actions. 21 As a frontrunner in certain areas of the global life sciences and biotechnology research and development (R&D), China at the turn of the 21st century contributed to the International Human Genome Project alongside the USA, Germany, the UK, France, and Japan. China has been among the leading countries in the research and commercialization of GMOs. 22 However, China also is facing the challenges of balancing developing the life sciences and biotechnology and adhering to global research norms and bioethics. In the past few years, by taking advantage of gene-editing technologies, for example, Chinese scientists made the first-ever genetic modifications to human embryos in laboratory, which precipitated controversies. Reckless activities such as producing the first known gene-edited babies by editing the genomes of two embryos that were then implanted via in vitro fertilization into the mother's womb have been condemned by the scientific communities in China and beyond. 23 There has been increasing demand for greater biosafety/biosecurity oversight.

Despite its efforts to build up a biosafety regulatory regime to govern the research and commercialization of GMOs, while being criticized for not engaging an active and systematic participation of scholars from the humanities and social sciences and the public in general, China's introduction of a comprehensive law of biosafety has been long overdue. 24 In 2004, the mishandling of the SARS virus at the Chinese Centers for Disease Control and Prevention (CDC) resulted in two separate virus-escape incidents infecting eight persons. 25 Seven years later, in the Northeast Agricultural University, a damaging lab outbreak sickened 27 students who contracted brucellosis while dissecting goats in an anatomy course. 26 Such LAIs were more than wake-up calls, not only exposing the limitations of China's existing biosafety regulatory regime but also posing great challenges to China's biosafety governance. 27 For healthy development of biotechnology and maintenance of public confidence, China needs to improve its legislative and regulatory regime and address the lack of a law of biosafety that reconciles and coordinates relevant regulations and measures on laboratory biosafety, biotechnology management, biosafety related to GMOs, and others that China has put in place. In particular, there is the need to clarify responsibilities for those involved in the life sciences and biotechnology R&D on top of meeting similar biosafety/biosecurity challenges confronting many countries in the world.

Meanwhile, Xi Jinping, general secretary of the CCPCC and Chinese president, has advanced a 'holistic view of national security,' encompassing 11 broad areas of national security concerns-from political, homeland, military, economic, cultural, social, technological, information, ecological, resource, to nuclear. 28 In the 12th meeting of the Central Committee for Comprehensive Deepening Reform, held on February 14, 2020, Xi highlighted the need to incorporate biosafety/biosecurity into his 'holistic view' by systematically planning the construction of national biosafety/biosecurity risk prevention and control systems and comprehensively improving national biosafety/biosecurity governance capabilities. 29 Xi's remark implies his awareness of the seriousness of China's biosafety/biosecurity challenges on one hand and his realization of the need for relevant legislations in China on the other. Given the top-down and sometimes politics-driven nature of lawmaking in China, Xi's political commitment has set the tone for the recent acceleration on the Biosafety/Biosecurity Law.

Although China's biosafety/biosecurity legislative process started before Xi Jinping's recent remark, as noted, the global COVID-19 pandemic added a further sense of urgency. 30 Conspiracy theories concerning the origin of COVID-19 have abounded. But concerns about the safety of laboratories handling a highly contagious virus and the possibility of the virus jumping from wildlife to humans via bats are real and having a clear perspective of biosafety/biosecurity governance. 31

China has engaged in policy and regulatory learning through actively participating in international conventions and treaties pertaining to biosafety/biosecurity. China is a party to the major international agreements regulating biological weapons, having 32 Such experience has incentivized China to harmonize domestic laws, regulations, norms, and statutes with international ones and to make domestic legislations in line with both its own legislative procedures and its international responsibilities and obligations.

China introduced legislations on biosafety/biosecurity much later than developed countries. In fact, many of the country's biosafety/biosecurity-related laws and regulations were promulgated in the 1980s to promote the development of biotechnology. 33 Since the 1990s China has stepped up regulatory efforts to promote biosafety if not biosecurity. And the government has made a new wave of legislative efforts in the past or so decade (Table 2 ). 34 The current laws, regulations, and measures cover a wide range of biosafety/ biosecurity issues. To start with, there are the Food Safety Law, Grassland Law, Wildlife Protection Law, Environmental Protection Law, and related implementation regulations and measures. As concerns about biosafety/biosecurity, especially those about the prevention and control of infectious diseases in the aftermath of SARS, gained urgency, China has greatly improved its capabilities of responding to emerging infectious diseases and safeguarding biosafety/biosecurity by amending such laws as the Border Health and Quarantine Law and the Law on the Prevention and Control of Infectious Diseases, Emergency Response Law, among others. Given that the SARS outbreak showed greatest risks of viruses jumping from animals to human, China amended the Wildlife Protection Law, the Law on Quarantine of Entry and Exit of Animals and Plants, and the Law on Animal Epidemic Prevention.

The SARS outbreak also has stimulated China's enthusiasm to build more high-level biosafety laboratories that enable its scientists to carefully handle dangerous pathogens and effectively prevent and control severe and emerging infectious diseases. Currently, China has 48 biosafety level (BSL)-3 laboratories and its first BSL-4 lab, located at the Institute of Virology, Chinese Academy of Sciences, in Wuhan, began operations in 2015. 35 And the 2016 High-Level Biosafety Laboratory System Construction Plan stipulates that by 2025 China should have had a national system of higher BSL laboratories, including five to seven BSL-4 laboratories, reasonably distributed and operated. 36 Therefore, China, like other countries, has introduced and implemented relevant regulations on the safety and security of these laboratories through enhancing personnel training, conducting scientific research, and assessing possible risks. 37 One of the most significant legislations is the Regulations on the Management of Biosafety of Pathogenic Microorganism Laboratories, issued by the State Council, China's cabinet, in 2004 and amended in 2018. Consequently, LAI accidents did not happen during China's responses to the Ebola epidemic in West Africa 38 and during the COVID-19 epidemic; nor is there scientific evidence to support conspiracy theories that the coronavirus escaped from the BSL-4 lab in Wuhan. 39 Entering 2020, China's NPC has planned to enact and amend 17 laws and regulations, some of which are related to health security. 40 As there was possible association between the COVID-19 outbreak and one of China's many wildlife food markets, in January 2020, the State Administration for Market Regulation (SAMR), the Ministry of Agriculture and Rural Affairs (MOARA), and the National Forestry and Grassland Administration announced to ban all trading of wild animals at markets and restaurants and on e-commerce platforms. A month later, the NPC Standing Committee passed the Decision on Comprehensively Prohibition of Illegal Trade of Wild Animals, aimed at eradicating the abuse of wild animals and effectively guaranteeing people's lives and health, restricting wildlife trade, and banning the consumption of bushmeat and market sales of farmed wild animals. Also under amendment are the Wildlife Protection Law, the Law on Animal Epidemic Prevention, the Border Health and Quarantine Law, the Emergency Response Law, the Law on the Entry and Exit Animal and Plant Quarantine, as well as the Law on the Prevention and Control of Infectious Diseases. The most important is no doubt to enact the Biosafety/Biosecurity Law.

Altogether, the existing laws, regulations, and measures (see Table 2 ), along with those in the legislative pipeline, form a comprehensive legal biosafety/biosecurity legislative and regulatory regime. However, such a regime is far from rising to the mounting challenges. First, China needs a specific piece of legislation pertaining to biosafety/biosecurity whose enactment is said to be not easy. 41 The missing of such an overarching and critical piece of legislation has handicapped China's efforts to develop biotechnology and the life sciences. The existing laws and regulations also are not applicable to emerging biosecurity issues such as dealing with the risks arising from the dual-use technologies and gain-of-function research and appropriately managing human genetic resources and bioresources, among others.

Second, despite their overwhelming number, relevant legislations, including the Constitution, Criminal Law, National Security Law, Anti-Terrorism Law, and other laws and regulations, tend to be 'general and non-specific in most cases' to biosafety and biosecurity. 42 For example, although it stipulates the prevention and control of infectious diseases, biological invasions, and bioterrorism and the prevention and control and bioresource conservation, the Criminal Law may not be able to deter and investigate wrongdoing and pursue related responsible parties accordingly. 43 The proliferation of laws and regulations has made it difficult to maintain a delicate balance between their specificity and excessive generality. In fact, such problems have persisted, caused in large part by China's 'relatively closed nature, limited capacity and inexperience characteristic of the drafting process, and the paucity of institutional means to identify and remedy such problems in the drafting process.' 44 China as a latecomer and follower in various legislations also may have exacerbated the problems.

Third, laws, regulations, and measures are always reactive rather than proactive, with the biosafety/biosecurity legislations no exception. 45 Laws and regulations are not sophisticated and delicate and contain principles but not necessary and detailed provisions so as to cause problems in implementation. Consequently, the Chinese lawmakers have to amend them frequently. And last, laws and regulations do not appear to be mounting sufficiently coordinated efforts in formulation and especially in implementation. 46 China's development of a GMO biosafety regulatory regime illustrates many of the problems identified here. 47 In 1993, the State Science and Technology Commission, the predecessor of the Ministry of Science and Technology (MOST), followed international experiences to come up with regulations to support the development of biotechnology. Such regulations mostly dealt with biosafety issues relating to scientific research, from risk assessment, biosafety application and approval processes, control principles, and legal responsibilities. Then, the Ministry of Agriculture (MOA), the predecessor of the MOARA, got involved with formulating procedures for research, field tests, and commercialization of GM crops. Symbolically, these two government agencies initiated a process of the establishment of China's biosafety regulatory regime. But it is until 2001 that the State Council stepped in with high-level legislations. At one time China was expected to enact a biosafety law in October 2003, 48 which, in fact, had not been materialized until 2018 when the NPC Standing Committee formally put the lawmaking on its legislative agenda.

The operation of China's GMO biosafety regulatory regime involved many government agencies. At the highest level was the Joint Ministerial Conference ( JMC), a mechanism within the State Council responsible for overall policymaking, administration, and coordination pertaining to GMO biosafety. Convened by the minister of agriculture and rural affairs once a year, the JMC consisted of ministers or vice ministers from several government agencies within the State Council-the National Development and Reform Commission, the National Health Commission (NHC), the ministries of science and technology, education, finance, commerce, and ecology and environment (MOEE), the SAMR, and the National Medical Products Administration.

Then the MOARA led the biosafety regulation by functionally carrying out nationwide oversight and inspection of biosafety involving agricultural GMOs through an Office of Agricultural Genetic Engineering Biosafety Administration that handles dayto-day operations and routine matters and a National Biosafety Committee on Agricultural Genetically Modified Organisms that oversees research and commercialization activities in agricultural GMOs. The NHC was in charge of safety management of GM foods by assembling experts on food safety, nutrition, and toxicology at the Chinese CDC to review and assess GM crops and foods whereas the SAMR had the mandate of safety management of food production and marketing, including labeling of GM foods, and the was General Administration for Quality Supervision, Inspection and Quarantine responsible for safety issues related to imports and exports of GM foods. Finally, given its representation of China in the international negotiation on the CBD and the Cartagena Protocol on Biosafety, the MOEE was also actively and aggressively involved in the risk assessment of GMOs and indeed was in charge of drafting the now-defunct GMO-oriented biosafety law. Such a description seems to suggest that China's GMO biosafety regulatory regime mostly operated at ministerial levels. The MOA minister, who coordinated the JMC, was just an average minister among many equals so that he did not possess enough administrative power. Each ministry would bring its own interests into the JMC that would run into difficulties formulating and implementing regulations and measures and whose mechanism would fall apart if efforts at participating ministries were not properly coordinated. Inevitably, there existed legislative gaps, conflicts, and inconsistencies, as well as ineffective law enforcement. 49 It is against such a backdrop that China felt it necessary to formulate a comprehensive law that makes systematic institutional arrangements, construction, and innovations for the protection of its biosafety/biosecurity.

The law has been formulated to serve both domestic and international purposes. Domestically, it delineates strategic objectives of fitting biosafety/biosecurity into Xi Jinping's 'holistic view of national security' and promoting the harmony between human and nature, or ecological civilization, one of Xi's favorable terms. It also converges with international norms in biosafety/biosecurity, thus facilitating China's implementation of relevant international treaties and international exchanges and cooperation.

In particular, the Biosafety/Biosecurity Law defines biosafety/biosecurity as 'a country's capacities of effectively preventing and responding to the dangerous threats of biological agents and related factors so as to maintain stable and healthy development of biotechnology, to affirm a status of less danger and threats to the lives and health of people and ecosystem, and to ensure national security and sustainable development.' Apparently, such a definition is not completely consistent with the definition of biosafety or the definition of biosecurity discussed at the onset of the paper. Or, the law uses 'shengwu anquan' in the name but covers both 'shengwu anquan' and 'shengwu anbao' in terms of content. The law also focuses on protecting the safety and security of China's bioresources, promoting and safeguarding the development of biotechnology, and preventing and prohibiting the use of biological agents or biotechnology for the purpose of harming national security. To fulfill these objectives, it has 88 articles in 10 chapters stipulating regulations in five broad categories:

• Preventing and controlling major emerging infectious diseases and animal and plant epidemics; • Managing research, development, and application of biotechnology; • Ensuring biosafety in laboratories; • Ensuring the security of human genetic resources and bioresources; and • Preventing bioterrorism attacks and defending against the threat of biological weapons. 50

The law stipulates that its comprehensive implementation need to emphasize the principles of risk prevention and prudent development through establishing national systems, covering 11 biosafety/biosecurity-related aspects from monitoring and early warning; risk investigation and assessment; information sharing; information disclosure; catalogs and lists; standards; reviews; emergency responses; investigation and source tracing for incidents; entry approval; to responses to major overseas incidents. Although confining its geographical scope to China's sovereign jurisdiction, the law has implications beyond the Chinese territory. For example, the law stipulates that approval be needed for foreign investment in the establishment of pathogenic microbial laboratories and for acquisition and utilization of indigenous bioresources; it also prohibits foreign organizations, individuals, and their China-based entities from harvesting and preserving human genetic resources in China.

One of the notable and innovative features of the law is its attention devoted to the strengthening of the nation's biosafety/biosecurity capacities. Indeed, the implementation of biosafety/biosecurity measures relevant to biological research and products, the management of bioresources and human genetic resources, dual-use biotechnology and its control, animal and plant quarantine, entry-exit inspection and quarantine, emergency incident response, and ethical management require the possession of capabilities in preventing, protecting, and mitigating the risks that may endanger China's biosafety/biosecurity. Doing so needs not only financial resources but also policy support for biosafety/biosecurity governance through increasing funding, infrastructure construction, talent training, encouraging and supporting indigenous research and innovation, and the development of technologies and industry.

Nevertheless, there is still room for improvement for the law. First, while having a fairly comprehensive and systematic coverage, the law itself is short of detailed provisions, a long existing problem. And stipulations are vague on the relationship between the new law and related special legislations such as the prevention and control of infectious diseases; live animals and plants; biodiversity and ecological protection; food safety; animal and plant inspection and quarantine, among others. 51 Are they complementary or supplementary? The relationship between biosafety/biosecurity measures and the protection of live products, for example, involves regulating the introduction of alien species. Regarding the research and commercialization of biotechnology, presumably the law overwrites those existing regulations and measures; but the law says little of how. Different norms can be adopted to resolve these issues. For 50 The law claims to be applicable to preventing the invasion of alien species and protecting biodiversity and dealing with microbial drug resistance but does not have separate chapters on them. 51 Chang Jiwen, Accelerate the Establishment of a National Biosafety/Biosecurity Legal and Regulatory System (in Chinese), Study Times, Feb. 17, 2020, at 1. example, if there are provisions in the existing laws, the Biosafety/Biosecurity Law needs to consider making the entire legislative regime more cohesive; in areas that the current laws have no provisions, obviously the Biosafety/Biosecurity Law takes over. There is similar need to deal with the relationship between the law and State Council regulations and ministerial measures as well. Second, given the involvement of quite a number of ministries under the State Council-NHC, MOARA, MOST, the Ministry of Foreign Affairs, and military apparatuses-in the implementation, the law campaigns for a coordination mechanism, one that is similar to China's biosafety administration of GMOs but at a higher level, involving more bureaucracies. Such a mechanism would be responsible for analyzing and judging the national biosafety/biosecurity situation, organizing, coordinating, supervising, and promoting national biosafety/biosecurity-related work. But the questions lie in what lessons China has learned from its previous practice of the GMO biosafety regulatory mechanism and especially how effective and efficient such an institutional arrangement had been in addressing various issues arising from GMO research and commercialization. As the coverage of the Biosafety/ Biosecurity Law is much wider and the national security emphasized, China may have to consider instead having a permanent government body that functions as an intergovernment coordinator and resolves disputes between government agencies. In the case of food safety, in 2010, following the passage of the Food Safety Law, the State Council established a high-level regulatory body, the National Food Safety Commission, headed by the first vice-premier, as an overarching, supraministry food safety watchdog to centralize and consolidate the management of food safety and a coordinator of various related regulatory functions. 52 In terms of coordination, China's NHC, MOST, Ministry of Industry and Information Technology, SAMR, and NMPA jointly issued the General Requirements for the Biosafety of Vaccine Production Facilities as a temporary emergency standard to promote the production of vaccines for COVID- 19. 53 Apparently, at least equally important, biosafety/biosecurity involves multiple and vast bureaucracies, policy coordination and implementation are tremendously challenging so that innovation is necessary to simplify chains of command and reduce bureaucratic stovepiping.

Third, the liability and punishment for violation are not always clearly defined in China's legislations. Likewise, the Biosafety/Biosecurity Law does not explicitly address administrative, criminal, and civil responsibilities for violation of its different provisions, although it specifies monetary penalties for such violation. But there is a need to establish an institutional mechanism that is able to remediate and compensate for accidental and intentional damages to public health and safety, the ecological environment, and biodiversity.

Fourth, the law needs to make provisions available on the supervision of research carried out using modern biotechnology such as embryo transfer, genetic modification, and gene editing to prevent scandals such as gene-edited babies from happening. Sometimes the relationship between the development of biotechnology, especially the dual-use ones, and biosafety/biosecurity is irreconcilable while lawmaking is often lagging, how to prioritize one over the other is challenging. As the risk incurred in embryo transfer and gene editing differs from that of laboratory leaks with the former also invoking bioethics concerns, calls for different legislations are also warrant.

Finally, provisions about GMOs are conspicuously missing in the Biosafety/Biosecurity Law, although GMOs are an area with significant biosafety and biosecurity concerns. One possible explanation is the inclusion of GMOs would make the law cumbersome and controversial. However, would having two sets of legislations dealing with virtually similar biosafety/biosecurity issues make the implementation of both legislations more complicated and problematic?

V. CONCLUSION AND DISCUSSIONS Some 40 years ago, a biosafety regulatory regime started to take shape in China to stimulate the development of genetic engineering and especially agricultural GMOs. But China's biosafety/biosecurity legislations have evolved to achieve a thoughtful balance between developing biotechnology and the life sciences, protecting human health and the environment, and aligning its domestic laws and regulations with international norms and standards. The promulgation of the Biosafety/Biosecurity Law was much delayed until 2018 when the Chinese government and legislature finally put it on their agenda. The enactment of the law shows Chinese government's strong commitment to refining its biosafety/biosecurity governance. This is a positive development insofar as the law fills gaps where the existing statutes may have been too general.

The law clearly delineates maintaining biosafety/biosecurity and harmonious coexistence of human and nature as its overall requirement and elevates biosafety/biosecurity to the level of national security. Indeed, biosafety/biosecurity is entwined with concerns about a country's national security in a rapidly changing world and the Chinese leader Xi Jinping has called for the inclusion of biosafety/biosecurity into his 'holistic view of national security.' The law covers a wide range of biosafety/biosecurity issues, setting up main tasks such as the safeguarding of health and lives of people and ecosystem, the protection of genetic resources and bioresources, the promotion of the healthy development of biotechnology, and the prevention of biological threats. The timing of the legislation also coincided with the rise of global epidemics of infectious diseases, microbial resistance, biological invasion and loss of biodiversity, loss and piracy of genetic resources, laboratory safety, misuse of biotechnology, threats of biological weapons, and bioterrorism. As a whole, China's Biosafety/Biosecurity Law not only meets but also overlaps with or exceeds the legislative objectives of its existing ecological and environmental protection laws. In fact, such a Chinese legislative approach also leads the world. Going forward, China, as many countries in the world, is facing the risks and threats from both outside and inside of the country such as rising global population, looming climate change, rapid technological change, and economic transformation. China also needs to cooperate with other countries in dealing with biosafety/biosecurity challenges.

By enacting the Biosafety/Biosecurity Law, China is making an urgent strategic choice to enhance the nation's biosafety/biosecurity governance capabilities. However, having a law is one thing, having the law fully implemented and enforced is quite another. Efforts need to be escalated in several areas. The implementation of the law involves the cooperation, coordination, and communication between various government ministries. More importantly, the legislature and government need to sort out its relationship with the existing laws, regulations, and measures and streamline them while avoiding redundancy caused by excessive legislations. Accordingly, the NPC Standing Committee has taken steps to amend the Criminal Law and the Law on Animal Epidemic Prevention in 2021. The State Council and relevant ministries need authorization to formulate administrative regulations and implementation measures. Increasing public awareness of the danger of unsafety and insecurity also is necessary.

Maintaining biosafety/biosecurity is a societal endeavor. As a multidisciplinary concept, biosafety/biosecurity focuses on keeping various stakeholders-lawmakers, scientists, and the public, among others-secure from the malicious exploration and exploitation of biological knowledge, technologies, and products. 54 Therefore, China still has a long way to go to fulfill its ultimate objective of having a biosafety/biosecurity law that prevents, protects, and mitigates the risks and hazards to people, society, and the environment.

Global Health and Security: Threats and Opportunities

Surveillance and Response in An Era of Globalization

Implementing the Global Health Security Agenda: Lessons from Global Health and Security Programs, 13 Health Secur

Accelerating Action in Global Health Security: Global Biosecurity Dialogue as a Model for Advancing the Global Health Security Agenda, 17 Health Secur

Deutscher Ethikrat, supra note 3 in chapter 2

The Convergence of Advances in Biology and Emerging Technologies

Governing the Risks of the Convergence of Giology and Emerging Technologies

The Ethics of Biosafety Considerations in Gain-of-Function Research Resulting in the Creation of Potential Pandemic Pathogens, 41

Gain-of-Function Research: Ethical Analysis, 22

Prudently Conduct the Engineering and Synthesis of the SARS-CoV-2 Virus

Roadmap for Biosecurity and Biodefense Policy in the United States

From Biodefence to Biosecurity: The Obama Administration's Strategy for Countering Biological Threats

The Challenge of Framing for Efforts to Mitigate the Risks of 'Dual Use' Research in the Life Sciences

Proposed Framework for the Oversight of Dual Use Life Sciences Research: Strategies for Minimizing the Potential Misuse of Research Information

State-of-the-Art in Biosafety and Biosecurity in European Countries

How Global Debates Transformed China's Agricultural Biotechnology Policies

Human Genome Editing: Science, Ethics and Governance

Human Germline Genome Editing in the He Jiankui Affair

Infectious Diseases: Mounting Lab Accidents Raise SARS Fears

Managing Biosecurity Threats in China

Collection of Laws, Regulations, and Standards of the People's Republic of China on Biosafety and Biosecurity (in Chinese)

A Compilation of Laws and Regulations of the People's Republic of China on Biosafety and Biosecurity

Laws and Regulations for Biosafety in China: Status and Prospect

History of and Suggestions for China's Biosafety Legislation, 1

Biosafety/Biosecurity Legislation in China: Reflection and Improvement (in Chinese)

Inside China's Pathogen Lab

Biosafety: Build a 'Great Wall' (in Chinese), Science Times

Studies on Developing a Safe-Management Standard System for Chinese Biosafety Laboratories, 1

Current Status and Future Challenges of High-Level Biosafety Laboratories in China, 1

Promoting Biosecurity by Professionalizing Biosecurity

supra note 30; Van Beusekom, supra note 30

National People's Congress, Legislation and Law Amendment Work Plan of the 13th National People's Congress Standing Committee on Strengthening the Rule of Law in Public Health

A Global Biosafety Strategy Research Framework with Specific Implications for China, 1

supra note 33; Zhang and Ma, supra note 33

I am grateful for comments on an earlier draft of the paper by Richard P. Suttmeier, Bing Lu, Guoyu Wang, Ying Wang and an anonymous reviewer. Research assistance provided by Judy Zhang is much appreciated.

The research on which the paper is based is supported by grants from the National Natural Science Foundation of China (71774091) and China National Office for Philosophy and Social Sciences (20&ZD074). The views expressed herein are those of the author and not necessarily those of the funders.

The author has no financial, personal, academic, or other conflicts of interest in the subject matter discussed in this manuscript.