Toward the effective implementation of the Biosafety Protocol: a Chinese regulatory capacity-building perspective

Abstract

The capacity-building mechanism in the Biosafety Protocol aims to assist the parties, inter alia, in establishing and implementing national measures concerning genetically modified organisms (GMOs) that are aligned with the objectives of the Biosafety Protocol. Regulatory capacities of developing countries to address environmental risks caused by GMOs remain to be improved. The article takes China as an example to analyze how regulatory capacity-building activities organized under the Biosafety Protocol contributed to and will further influence China’s establishment and implementation of GMO laws and regulations. A four-stage analytical framework is established to examine the interaction between capacity-building activities and the development of China’s GMO regulation. China has gradually developed its GMO laws and regulations, with each stage having different regulatory needs and capacity-building efforts. External intervention and endogenous regulatory capacity-building activities mutually strengthened China’s implementation of the Biosafety Protocol. Endogenous regulatory capacity-building activities are increasing in enhancing China’s GMO regulation. The article concludes by proposing ways to enhance China’s regulatory capacities regarding GMOs against the backdrop of adopting the Kunming-Montreal Global Biodiversity Framework and China’s Biosecurity Law, involving making laws and regulations on GMOs consistent with the Biosecurity Law and reconsidering the regulatory modes on genome-editing techniques.

I. INTRODUCTION

According to the report released by the International Service for the Acquisition of Agri-biotech Applications (ISAAA) in 2019 that describes the global status of commercialization of genetically modified crops (GM crops), high biotech adoption rates in the top five biotech countries benefited 1.95 billion people globally.¹ Given environmental and human health risks that may be caused by genetically modified organisms (GMOs),² biosafety laws and regulations at the national and international levels have been developed. These laws and regulations, if designed and implemented appropriately, will facilitate the development and utilization of GMOs and bio-economy.³ GMO regulatory systems at the national level take different approaches.⁴ Typical regulatory approaches include the US’s product-based approach and the EU’s process-based approach, and more and more nations take mixed approaches. At the center of international biosafety law is the Cartagena Protocol on Biosafety to the Convention on Biological Diversity (the Biosafety Protocol).⁵ The assumption on which the Biosafety Protocol was based is that GMOs present extra threats to biodiversity than non-GMOs and thus a specialized international instrument is needed.⁶ Based on Articles 8(g) and 19(3) of the CBD, the Biosafety Protocol was adopted to regulate trade in GMOs,⁷ aiming to establish a transparent and scientific regulatory system to ensure the safe transfer, handling, and use of GMOs and to prevent adverse effects caused by GMOs on biodiversity, considering risks to human health that may be caused by GMOs. A precautionary and process-based approach is taken by the protocol to guide the risk assessment and management of GMOs.⁸

As observed by Decision CP-10/7 adopted by the Conference of the Parties serving as the meeting of the Parties to the Cartagena Protocol on Biosafety (COP-MOP) in 2022, which reviewed the progress and challenges concerning the implementation of the Biosafety Protocol, a large number of the parties to the Biosafety Protocol were not in full compliance with the protocol’s key obligations, and, for instance, only about half of the parties had fully introduced the necessary legal, administrative, and other measures to implement their obligations under the protocol. The literature also observed that many developing countries including China have not developed or implemented integrated and fit-for-purpose GMO regulatory systems, leading to poor implementation of the Biosafety Protocol.⁹ Indeed, this is not uncommon in international environmental law: the lack of effective implementation of multilateral environmental agreements (MEAs) has been identified by the UN Secretary-General as one of the significant gaps in international environmental law.¹⁰ Enhancing parties’ regulatory capacities is a way to facilitate the effective implementation of the Biosafety Protocol.¹¹ Article 22 of the Biosafety Protocol stipulates a capacity-building mechanism, providing a normative basis for capacity-building activities on GMO regulation. The capacity-building mechanism in this regard is further elaborated on by COP-MOP decisions.¹² The capacity-building goals and guidance for implementing the Biosafety Protocol have been updated since COP 15 by the Implementation Plan for the Cartagena Protocol on Biosafety (hereinafter, the Implementation Plan, Annex to Decision CP-10/3) and the Capacity-Building Action Plan for the Cartagena Protocol on Biosafety (hereinafter, the Capacity-Building Action Plan, Annex to Decision CP-10/4) to respond to challenges identified by Decision CP-10/7. The updated global biodiversity strategy, the Kunming-Montreal Global Biodiversity Framework (the GBF), gives further momentum for considering how to improve national regulatory capacities, as it requests countries to establish, strengthen capacity for, and implement biosafety measures in its Target 17.

This article will analyze how the capacity-building mechanism in the Biosafety Protocol, promoted and, after the adoption of the GBF, will promote national regulatory capacities, taking China as an example. As presented by the ISAAA report mentioned above, China ranks seventh among the countries that cultivate GM crops, with 3.2 million hectares in total in 2018, including cotton and papaya.¹³ China had started building its regulatory capacities regarding biosafety long before it ratified the Biosafety Protocol in 2005. For instance, China participated in the Pilot Biosafety Enabling Activity Project (GEF Project ID: 402) that was jointly organized by the United Nations Environment Programme (UNEP) and the Global Environment Facility (GEF) in the late 1990s. One achievement was the taking stock of regulatory capacities and the design of a national biosafety framework (NBF) for China.¹⁴ China has established a legal system on GMOs and gained a wealth of experience of building and developing its regulatory capacities toward implementing the Biosafety Protocol. However, as concluded by China’s fourth national report on its implementation of the Biosafety Protocol, China’s regulatory capacity-building on GMOs was still insufficient.¹⁵

Legal developments on GMOs, such as the adoption of the Biosecurity Law of China and the GBF, provide new elements that would affect the effectiveness of China’s national implementation of the Biosafety Protocol. The article is structured as follows to unfold China’s regulatory capacity-building process and find ways forward. Section II of the article will explain the definition, requirements and practices of capacity-building, especially regulatory capacity-building, under the Biosafety Protocol. Sections III and IV review the interaction between regulatory capacity-building activities and China’s GMO regulation. A four-stage analytical framework regarding GMO regulation in China will follow, including the exploration, development, implementation and enhancement stages. The final section concludes with the characteristics of the Chinese approach toward enhancing its regulatory capacities on GMOs, the roles that external intervention and endogenous capacity-building activities played during this process, and recommendations for improving China’s GMO regulation.

II. REGULATORY CAPACITY-BUILDING AS A TOOL TO ENHANCE NATIONAL IMPLEMENTATION OF THE BIOSAFETY PROTOCOL

International environmental law is experiencing a shift of focus from treaty-making to treaty interpretation and implementation.¹⁶ Examining the national implementation of an MEA is one of the ways to check whether an MEA is truly effective and operative.¹⁷ Capacity-building is one of the tools for achieving sustainable development and promoting effective implementation of MEAs,¹⁸ including the Biosafety Protocol.¹⁹ Capacity-building mechanisms contribute to the effective implementation of MEAs in the sense that they enhance national capabilities in controlling and managing environmental issues by promoting financial resources, access to and transfer of technology and know-how, capacity of personnel, and regulatory measures. Although most literature discussing the capacity-building mechanism as stipulated by Article 22 of the Biosafety Protocol focuses on international technical and scientific cooperation, especially transferring technologies from developed countries to developing countries, regulatory capacity-building is specifically stressed by the article because sufficient national regulatory capacities will enable decision-makers regarding GMOs to make science-based decisions and ensure full compliance with the Biosafety Protocol,²⁰ while insufficient regulatory capacities may detrimentally affect the adequate assessment of potential risks caused by GMOs and the implementation of the Biosafety Protocol and further hinder the enjoyment of benefits derived from GMOs.²¹

II.A. Defining Regulatory Capacity-building

‘Capacity-building’ is a buzzword being used in various sectors by different entities.²² The term is often used and defined by UN system organizations working on development, such as the UN Sustainable Development Group (UNSDG) and the United Nations Development Programme (UNDP),²³ as capacity-building activities have been conducted along with development assistance projects since the 1950s.²⁴ ‘Capacity-building’ in the CBD and its protocols is defined by reference to these definitions. The Long-term Strategic Framework for Capacity-building and Development (hereinafter, the Long-term Strategic Framework) adopted by Decision 15/8 under the CBD refers to UNSDG’s definition and defines ‘capacity’ as ‘the ability of people, organizations and societies as a whole to achieve the biodiversity-related goals and action targets’ and ‘capacity-building and development’²⁵ as ‘the process whereby people, organizations and society as a whole unleash, strengthen, create, adapt and maintain capacity over time to achieve positive biodiversity results’.²⁶ IUCN defines ‘capacity-building’ as ‘the process by which individuals and groups, including organisations, institutions and countries, plan, develop, enhance, review and reorganize their systems, resources and knowledge; all reflected in their abilities, individually and collectively, to perform functions, solve problems and achieve objectives’.²⁷ This definition follows that of the UNDP.²⁸

Capacity-building in the Long-term Strategic Framework is divided into three levels, ie, the enabling environment, organizational and individual levels.²⁹ As the Capacity-Building Action Plan is complementary to the Long-term Strategic Framework and follows the latter’s general principles, approaches, and strategies for enhancing capacity-building, capacity-building in the Biosafety Protocol can also be strengthened by analyzing these three levels.³⁰ The enabling environment emphasizes the overall ability to tackle collective challenges and includes ‘the broader system within which individuals and organizations function, including the policy, legal, regulatory, economic, and social support system level’.³¹ To this end, sound laws and policies, high levels of commitment, effective coordination, and a stable economic environment, for instance, are important factors of enabling environment.³² To facilitate the subsequent analysis, regulatory capacity-building will be defined in the article as part of the enabling environment, emphasizing the overall ability to tackle collective challenges and including the broader regulatory system within which individuals and organizations function. The regulatory system covers policies, laws and regulations, and institutional arrangements related to GMOs.

The preamble of the Biosafety Protocol requires that ‘limited capabilities of many countries, particularly developing countries, to cope with the nature and scale of known and potential risks associated with living modified organisms’ be considered. The Biosafety Protocol mentions ‘capacity-building’ in Articles 11(9), 22, 28(3) and 28(4). The central one is Article 22, which specifically addresses capacity-building.³³ Specifically, regulatory capacity-building is requested by Article 22(2) of the Biosafety Protocol, and it specifically includes ‘legal, institutional, and administrative regulatory capacity with respect to biosafety’.³⁴ The development of NBFs is a typical example of regulatory capacity-building, as taking legal, administrative and other measures that address biosafety risks caused by GMOs is explicitly requested by Article 2 of the Biosafety Protocol.³⁵ Other substantive aspects in the Biosafety Protocol that need regulatory capacity-building include procedures in relation to the movement of living modified organisms intended for direct use as food or feed (Article 11), risk assessment (Article 15), risk management (Article 16), information sharing and the Biosafety Clearing-House (BCH, Article 20), public awareness and participation (Article 23) and monitoring and reporting (Article 33).

II.B. Capacity-building Goals and Practices

The GBF expressly set requirements in its Target 20 on capacity-building regarding the implementation of the CBD and its protocols. The Long-term Strategic Framework supplements the GBF by elaborating on requirements for capacity-building. Several COP-MOP decisions have been taken to set capacity-building goals and to specify the principles, methods, and elements for taking capacity-building activities under the Biosafety Protocol.³⁶ During different periods, concrete capacity-building goals change, while key capacity-building elements have not changed too much, as they are derived from obligations as provided for by the Biosafety Protocol. The latest decision is Decision CP-10/4, adopted in 2022, to which the Capacity-Building Action Plan is annexed.

The Capacity-Building Action Plan was developed in alignment with and complementary to the Implementation Plan, the predecessor of which is the Strategic Plan for the Cartagena Protocol on Biosafety for the Period 2011–20 (Annex I to Decision BS-V/16). The Implementation Plan sets out the goals and measures for promoting the effective implementation of the Biosafety Protocol before 2030. It is an important complement to the GBF, especially Target 17 of the GBF. The Implementation Plan details ten goals regarding the implementation of the protocol and four goals regarding the enabling environment. The Capacity-building Action Plan defined capacity-building goals for the goals identified in the Implementation Plan, specifying key areas for capacity-building, examples of capacity-building activities, and indicators and outcomes. The first capacity-building goal, for instance, is parties having in place functional NBFs. This goal is the very fundamental element of regulatory capacity-building in the Biosafety Protocol. The other capacity-building goals include improving the availability and exchange of relevant information through the BCH, submission of national reports, risk assessment and management, prevention of illegal and unintentional transboundary movements of GMOs, and developing national laws and procedures on liability rules.

Since the negotiation and especially the entry into force of the Biosafety Protocol, many capacity-building activities have been initiated and implemented by countries or organizations such as the UNEP, GEF, UNDP, Food and Agriculture Organization, and the World Bank.³⁷ Many of them covered regulatory capacity-building activities.³⁸ Among these activities, UNEP/GEF projects are significant.³⁹ GEF has provided continuous support for capacity-building in the Biosafety Protocol. For instance, one of the three goals of GEF-8 spanning from 2022 to 2026 is to implement the Biosafety Protocol and the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress (the Supplementary Protocol)⁴⁰ effectively.⁴¹ To be specific, the GEF aims to support the implementation of NBFs, the updating and revision of existing NBFs to adapt to the regulation and safe use of new biotechnologies and synthetic biology, thematic projects addressing specific provisions of the Biosafety Protocol, and the ratification and implementation of the Supplementary Protocol.⁴²

Capacity-building projects initiated and implemented by UNEP/GEF include the Pilot Biosafety Enabling Activity Project (approved in 1998, GEF Project ID: 402), Project for the Development of NBFs (approved in 2001, GEF Project ID: 875), projects for the implementation of NBFs (for instance, the project for China was approved in 2002, GEF Project ID: 1369), Project for Building Capacity for Effective Participation in the BCH (approved in 2004, GEF Project ID: 2128), Project for Building Capacity for Effective Participation in the BCH II (approved in 2010, GEF Project ID: 3856), Project for Sustainable Capacity Building for Effective Participation in the BCH (approved in 2016, GEF Project ID: 5688), and Support to Preparation of the Fourth National Biosafety Reports to the Cartagena Protocol on Biosafety (approved in 2020, GEF Project ID: 10639). The result is a mixed success: many developing countries still do not have enough regulatory capacities to develop and implement laws and regulations on GMOs and ultimately to implement effectively the requirements of the Biosafety Protocol.⁴³ The capacity-building mechanism in the Biosafety Protocol is likely to exert more significant influence on countries that have not developed systematic NBFs and where concerns are less related to market access and international competitiveness but more related to lack of capacities to manage potential risks.⁴⁴

Two channels of capacity-building contribute to developing national regulatory capacities: external intervention and endogenous capacity-building activities. External intervention refers to assistance from external donors or implementing agencies, such as the GEF and the UNEP, in designing and implementing the laws and regulations related to GMOs. Endogenous capacity-building emphasizes recipients’ responsibilities in achieving development goals rather than relying on external donors. As for regulatory capacity-building in GMOs, some biosafety capacity-building activities are mainly driven by external donors or agencies, short-termed, narrowly focused, short of follow-ups, and not coordinated well to avoid duplication.⁴⁵ It is thus recommended that local ownership should be strengthened, biosafety capacity-building projects be managed coherently and sustainably, and global and regional cooperation as well as innovative methods be promoted.⁴⁶ Furthermore, endogenous capacity-building should be promoted by two approaches. On the one hand, when assisted by external intervention, national regulatory capacity-building activities should stress national circumstances and specific national regulatory needs rather than simply taking up suggestions generally applicable to all countries. On the other hand, even if external intervention is not made, more endogenous efforts should be made at the national law level to establish and implement appropriate national measures to address risks that GMOs may cause.

III. DEVELOPMENT OF REGULATORY CAPACITIES IN CHINA PRIOR TO 2020

China’s research and development (R&D) of GM crops started in the 1980s.⁴⁷ Since then, steadily increasing funding has been given to the R&D of GMOs.⁴⁸ Tracking the development of Chinese laws and regulations on the safety management of GMOs, several distinct stages can be distinguished by changing regulatory needs and key regulatory capacity-building activities. When analyzing the development of laws and regulations on biotechnology in China, Xiao and Kerr described four stages: Stage I (1978–85, building up regulatory environment for launching biotech R&D); Stage II (1986–92, initiating biotech R&D); Stage III (1993–2009, developing bio-administration system and preparing to promote commercializing GM crops); and Stage IV (2010 and afterwards, delays in commercialization of GM major crops).⁴⁹ Liang and others focused on the development of GMO laws and regulations after 1993, dividing it into four stages: the exploration stage (1993–2000), the development stage (2001–10), the improvement stage (2011–20), and the current stage (2021–present).⁵⁰ Based on these divisions, the article will divide the development of the laws and regulations on GMOs into four stages: the exploration stage (1993–99), the development stage (2000–10), the improvement stage (2011–20), and the enhancement stage (2021–present). Compared with Liang and others’ divisions, this division pays more attention to the biosafety aspects of laws and regulations on GMOs, the original start year of the development stage is revised from 1999 to 2000 to correspond with the adoption of the Biosafety Protocol, which is one of the core international instruments that stress biosafety issues, and the stage after 2021 is specifically named the enhancement stage as legal developments bring new challenges and opportunities. Furthermore, the development of regulatory capacities regarding GMOs in China can be seen from a broader background of how China participated in global biodiversity governance. As summarized by Qin, China played different roles at different stages in the implementation of the CBD, from a follower (1992–2000), a main participant (2000–12) to an active contributor (2012–present).⁵¹ The timeline of China’s participation in global biodiversity governance as described by Qin echoes the increasing endogenous capacity-building on GMO regulation. However, the period at each stage does not overlap completely. This section will analyze the first three stages to explain how current laws and regulations addressing GMO-related biosafety concerns were developed, emphasizing regulatory needs and capacity-building activities. The following section will analyze the opportunities and challenges regarding improving China’s regulatory capacities on GMOs after 2020.

III.A. Exploration Stage (1993–99)

1. Regulatory needs

In the 1990s, the central government of China adopted several national policy documents and allocated research funding to support the R&D of GMOs.⁵² GM tobacco was approved for cultivation in 1992 in China.⁵³ However, no systematic legal rules were there to ensure biosafety.⁵⁴ This was partially due to China’s promotional strategy on GMOs which was an important component of the national scientific and technological strategies to make China an innovation-oriented nation and a global leader in modern biotechnology.⁵⁵ Meanwhile, international biosafety rules emerged: Article 8(g) of the CBD requires its parties to establish or maintain measures to regulate, manage, or control the risks associated with the use and release of GMOs which are likely to have adverse environmental effects on biodiversity, taking into account the risks to human health; and Article 19(4) of the CBD requires the parties to exchange information on the use, safety regulations and adverse effects of GMOs in international trade. Article 19(3) of the CBD further mandates its parties to, if appropriate, negotiate a protocol on biosafety. Besides, Agenda 21 in Chapter 16 addresses the environmentally sound application of biotechnology.⁵⁶ The UNEP adopted technical guidelines in 1995, guiding evaluating biosafety levels and identifying measures to manage biosafety risks.⁵⁷ China became a party to the CBD on Dec. 29, 1993, agreed with Agenda 21, and followed the UNEP technical guidelines. As a result, before China ratified the Biosafety Protocol in 2005, China already had domestic and international pressures to take legal measures to ensure the safe use of GMOs.

2. Key regulatory capacity-building activities

Two ministerial measures were adopted to regulate GMOs in the 1990s.⁵⁸ The first one was the Administrative Measures on the Safety of Genetic Engineering,⁵⁹ as promulgated by the State Science and Technology Commission of China (SSTC, renamed the Ministry of Science and Technology of China, MOST, in 1998) in 1993. Its aims included promoting the R&D of biotechnology, strengthening the safety management of genetic engineering techniques, preventing environmental pollution, and maintaining the balance of ecosystems. Risk assessment and management procedures were stipulated: genetic engineering activities should be controlled based on their levels of risk.⁶⁰ On the basis of their threats to human health and the environment, genetic engineering activities should be categorized as safety level I to IV. Genetic engineering activities designated as safety level I posed no threat, while those at safety level IV had the highest threat to human health and the environment.

The second one was the Administrative Measures on the Safety of Agricultural Genetic Engineering,⁶¹ which was adopted by the Ministry of Agriculture (MOA, renamed the Ministry of Rural and Agriculture, MARA, in 2018) in 1996 to implement the Administrative Measures on the Safety of Genetic Engineering. It specifically focused on the agricultural aspects of genetic engineering, as some varieties of GM crops were being researched and were waiting for commercialization before 1996. It provided for procedures for risk assessments and approvals of research, field-testing, environmental release, and commercialization of agricultural GMOs.⁶² These measures laid the foundations for further detailed rules and institutional arrangements after 2000. Based on the Administrative Measures on the Safety of Agricultural Genetic Engineering, China permitted several GM crops to be released and cultivated.⁶³ GM cotton has been cultivated since 1997.⁶⁴

Regarding institutional arrangements, ministerial departments such as the MOA (now MARA) and the National Environmental Protection Agency (NEPA, now MEE)⁶⁵ had done work on biosafety. The Administrative Measures on the Safety of Agricultural Genetic Engineering established the Biosafety Management Office for Agricultural GMOs (hereinafter, the Biosafety Management Office) and the Biosafety Committee for Agricultural GMOs (hereinafter, the Biosafety Committee).⁶⁶ Both were operated by the MOA, showing that biosafety management was strengthened.⁶⁷ Meanwhile, the NEPA contributed to biosafety management by proposing technical guidelines and standards for risk assessment and management about the transportation, storage and release of GMOs.⁶⁸

To implement the CBD and the UNEP technical guidelines and to get parties prepared to implement the to-be-adopted Biosafety Protocol, a Pilot Biosafety Enabling Activity Project was organized by the UNEP/GEF at the end of the 1990s. It selected 18 countries, including China, to assist them in developing NBFs.⁶⁹ This project aimed to increase the regulatory capacities of developing countries regarding GMOs and to promote communication among nations for this purpose.⁷⁰ Common components of NBFs include a government policy on biosafety, a regulatory regime for biosafety, a system to handle notifications or requests, follow-up measures such as enforcement and monitoring for environmental effects, and approaches for public information and public participation.⁷¹

China formulated its NBF under the support and stimulation of the Pilot Biosafety Enabling Activity Project, leading to the publication of a report entitled National Biosafety Framework of China in 1998 by the SEPA (now the MEE).⁷² In the report, the framework of policy and legislation on biosafety management, technical norms for risk assessment and risk management of GMOs and their products, and requirements for national capacity building on biosafety management are suggested and explained.⁷³ The design of the legal framework on GMOs was based on an assessment of the Administrative Measures on the Safety of Genetic Engineering and the Administrative Measures on the Safety of Agricultural Genetic Engineering, with the conclusions that GMO-related rules were not systematic and there were gaps in capacity-building and safety management of risks caused by GMOs to biodiversity and the environment.⁷⁴ For instance, detailed legal rules had been established for agricultural GMOs rather than for other types of GMOs than agricultural GMOs, and the emphasis of GMO regulation was on the R&D of GMOs instead of ensuring biosafety. Thus, systematic GMO-related rules should be contained in a biosafety law that was adopted by the Standing Committee of the National People’s Congress (NPC) and a biosafety regulation that was adopted by the State Council, including risk assessment, permits, prior informed consent for transboundary movements of GMOs, public involvement rules, and liability rules and covering a whole cycle of the development and use of GMOs.⁷⁵ Ministerial departments should then adopt more detailed rules regarding agricultural GMOs, pharmaceutical GMOs, and GM food.⁷⁶ According to the first national report submitted by China to the CBD Secretariat in 1998, a regulation on biosafety was being drafted.⁷⁷ A national coordinating group on biosafety was recommended to be established by the report, and it was later established by the NEPA.⁷⁸

3. Progress and challenges

Implementing the CBD provided an opportunity and incentives for China to uptake international guidance into domestic law. China Biodiversity Conservation Action Plan was published in 1994 to guide China’s implementation of the CBD.⁷⁹ According to the first national report submitted by China to the CBD Secretariat in 1998, biosafety management was one of the priority areas in implementing the CBD. China set guidance regarding the strengthening of capacity-building for biosafety management. With the guidance of international capacity-building projects, such as the Pilot Biosafety Enabling Activity Project, China drafted and reported its NBF, which set forth a systematic and comprehensive framework of laws and regulations to be adopted later, proposing a nationwide law and regulation to control biosafety issues caused by GMOs generally.⁸⁰ In addition to the NBF that was formulated thanks to the international capacity-building activities, bilateral cooperation also promoted the GMO regulation in China.⁸¹ For instance, China and Canada jointly implemented the project of Capacity Building on Regulation and Technical Guidelines for Biosafety Management in China.⁸² The second report submitted by China to the CBD Secretariat in 2001 further summarized laws and regulations on GMOs adopted by China until 2000 and planned the following steps to enhance GMO regulation in China.⁸³ The next key step was to enact such laws and regulations that address GMO-related biosafety issues. However, as discussed below in Section IV, such a nationwide law was not enacted until 2020.

When designing a legal framework that controls risks caused by GMOs, China had to decide which regulatory approach to take.⁸⁴ The EU and the US had already adopted biosafety-related laws and regulations in the 1990s to control risks caused by GMOs. By contrast, many developing countries’ development of GMO regulation was catalyzed by the negotiation and implementation of the Biosafety Protocol and the associated international capacity-building activities.⁸⁵ Indeed, the EU and the US’s regulatory approaches showed various impacts on developing countries. For instance, many developing countries had adopted stringent measures similar to the EU due to the desire to export their agricultural products to the EU member states.⁸⁶ China referenced international and developed countries’ experiences, especially risk assessment and management measures in the US, when the MOA drafted the Administrative Measures on the Safety of Agricultural Genetic Engineering.⁸⁷ According to the Coordinated Framework for Regulation of Biotechnology adopted in 1986 (updated in 1992 and 2017), the US established a product-based approach that was based on scientifically sound risk assessment, aiming at balancing ensuring public safety and reducing overly stringent regulatory measures that could hinder technological development.⁸⁸ China also emphasized the promotion of agricultural biotechnology, taking into account of ensuring biosafety. Thus, China referenced the approach taken by the US, and a more enabling legal framework regarding GMOs was set in China.

By the end of the 1990s, China had established its NBF which fit its national circumstances and regulatory needs while also being consistent with international law requirements (Table 1).⁸⁹ China became one of the earliest developing countries to develop and implement biosafety laws by adopting rules that address the biosafety management of GMOs, especially agricultural GMOs, although China’s GMO regulation at this stage was in its infant stages. External interventions, such as the Pilot Biosafety Enabling Activity Project, contributed to building and developing China’s legal system on GMOs. At this stage, endogenous capacity-building activities regarding biosafety regulation started but were limited. For both administrative measures, the objective of biosafety management was secondary to the main aim of promoting the R&D of GMOs.⁹⁰ This was partially attributed to the SSTC’s mission to promote the R&D of technologies.⁹¹ As the SSTC and the MOA separately formulated and implemented the administrative measures from the perspective of their own missions, the comprehensive evaluation of safety considerations on GMOs was underrated, necessitating a nationwide law or regulation.⁹² Moreover, biosafety management rules were general and abstract.⁹³ The requirements to commercialize GM crops over this period were much simpler compared with current legal procedures.⁹⁴

Table 1.

China’s key regulatory capacity-building activities at the exploration stage

	Adopting legislation	Establishing regulatory institutions	Participating in the Pilot Biosafety Enabling Activity Project
Main actors	SSTC MOA	MOA NEPA	SEPA
Objectives	To adopt systematic legal rules to ensure biosafety	To guide and supervise safety assessment and management of GMOs	To get prepared for implementing the Biosafety Protocol
Outcomes	The Administrative Measures on the Safety of Genetic Engineering The Administrative Measures on the Safety of Agricultural Genetic Engineering	The Biosafety Management Office The Biosafety Committee Technical guidelines and standards for risk assessment and management	National Biosafety Framework of China A draft regulation on biosafety A national coordinating group on biosafety
The nature	Endogenous activities	Endogenous activities	External intervention

III.B. Development Stage (2000–10)

1. Regulatory needs

At this stage, China’s central government supported the R&D of GM crops through leaders’ statements, No.1 documents, five-year plans, strategic plans, and research funding.⁹⁵ As a result, more and more applications were filed for the commercialization of GMOs in China, and a legal system that covered detailed authorization procedures was demanded.⁹⁶ Such authorization procedures should continue balancing two objectives: industrial development of GMOs and safe use of GMOs. Asynchronous approval of GMOs, meaning that some GMOs that already held permits in foreign countries were not issued with permits to be commercialized in China,⁹⁷ further highlighted the necessity to have clear and detailed authorization procedures to review the commercialization of GMOs. The US, for instance, expressed its concerns over this issue, alleging that China could only join the WTO after such procedures had been adopted.⁹⁸ China therefore had to consider the impact of its GMO regulation on international trade of GMOs.

At the international law level, the Biosafety Protocol which China ratified in 2005 provided an incentive and guidance to promote and improve GMO laws and regulations in China.⁹⁹ The Biosafety Protocol stipulates a precautionary approach and risk assessment procedures. After negotiating and implementing the Biosafety Protocol, China gradually incorporated biosafety regulation into its domestic agenda.¹⁰⁰ However, how to implement the protocol effectively needed to be answered.

2. Key regulatory capacity-building activities in China

The Intergovernmental Committee on the Cartagena Protocol (ICCP) adopted the Action Plan for Building Capacities for the Effective Implementation of the Cartagena Protocol on Biosafety in 2001, which had been revised and updated by the COP-MOP several times since 2004.¹⁰¹ Regulatory capacity building was one of the capacity-building elements in these action plans, several multilateral and bilateral capacity-building projects were initiated and implemented accordingly at this stage. China got support for implementing its NBF from 2001 to 2005 by participating in the UNEP/GEF project on the Implementation of NBFs.¹⁰² The overall aim was to help China establish a workable and transparent NBF consistent with its international obligations. This project addressed issues identified in China’s NBF as published in 1998, including formulating laws and regulations, establishing proper measures for the safe use of GMOs, enhancing capacities to do risk assessment and risk management by formulating technical guidelines and standards, developing monitoring methods for environmental release of GMOs, establishing BCH mechanisms, and organizing a series of workshops and training courses. Expected outcomes included a draft law on biosafety and a draft regulation.

Since 2000, a set of legal rules on agricultural GMOs had been adopted by the State Council and its ministries, and the key ministry was the MOA (Table 2).¹⁰³ The central piece of legislation is the Regulation on the Administration of the Safety of Agricultural GMOs (hereinafter, the Regulation on Agricultural GMOs)¹⁰⁴ as enacted by the State Council in 2001. Following the Biosafety Protocol’s precautionary approach and affected by the EU’s regulatory approach, the Regulation on Agricultural GMOs took a stringent and precautionary approach.¹⁰⁵ Compared with previous laws and regulations, the Regulation on Agricultural GMOs expanded stages of GMO-related field testing from two to three (field testing, environmental release, and productive field testing), and a system of issuing biosafety certificates for producing and processing agricultural GMOs was established.¹⁰⁶ Two authorization procedures regulated the development and commercialization of agricultural GMOs, depending on their intended use – for production (cultivation or raising), or for processing as raw materials. The authorization procedure followed a multi-staged, step-by-step approach, meaning that the activities within a stage could only be initiated after the completion of the previous stage.¹⁰⁷ After obtaining biosafety certificates and before commercialization, GMO developers must apply for the validation or registration of GM varieties and must be licensed for production and business operations, such as marketing and selling of GM seeds.¹⁰⁸ The MOA approved more GM crops than it did before 2000.¹⁰⁹ GM crops such as GM papaya and GM cotton were issued with biosafety certificates and then cultivated.¹¹⁰ GM rice and GM maize were issued with biosafety certificates in 2009, but the following permits needed to be obtained before they could finally be commercialized and cultivated.¹¹¹ In addition, up to 2011, GM crops that could be imported to China for processing included GM soybeans, GM maize, GM cotton, GM canola, et al.¹¹²

Table 2.

China’s key regulatory capacity-building activities at the development stage

	Adopting legislation	Strengthening capacities of GMO-related authorities	Participating in the UNEP/GEF project on the implementation of NBFs
Main actors	The NPC The State Council MOA	The State Council The Inter-Ministerial Joint Conference MOA SEPA	SEPA
Objectives	To make detailed authorization procedures	To achieve a balance between promoting the R&D of GM crops and ensuring biosafety	To improve China’s laws and regulations on GMOs To implement the Biosafety Protocol effectively
Outcomes	The Regulation on Agricultural GMOs Five administrative measures The Seed Law The Agricultural Law The Food Safety Law	The Biosafety Committee upgraded to a national-level committee The National Biosafety Administration Office Guidelines and technical standards	The Regulation on Agricultural GMOs A draft GMO biosafety law National reports on the implementation of the CBD and the Biosafety Protocol
The nature	Endogenous activities	Endogenous activities	External intervention

Five administrative measures were adopted by relevant ministries under the State Council from 2002 to 2006 to make the regulation more practical and to alleviate exporters’ concerns over the uncertainties in the implementation of the regulation.¹¹³ These administrative measures cover safety assessment, labeling, safe import, inspection and quarantine, and processing of agricultural GMOs. The Administrative Measures on Safety Assessment of Agricultural GMOs repealed the Administrative Measures on the Safety of Agricultural Genetic Engineering as adopted in 1996 and contained detailed risk assessment and management rules regarding agricultural GMOs.¹¹⁴ The Administrative Measures on Safe Import were especially important for China implementing the Biosafety Protocol, as it provided for measures that address risks that transboundary movements of agricultural GMOs may cause. Several guidelines and technical standards were also adopted at this stage.¹¹⁵ For instance, in 2010, the MOA issued the guideline for GM plants’ safety assessment, which was later revised in 2017 and 2022, respectively. These guidelines specified permits to be applied for and documents to be submitted during different stages of the R&D of GMOs.

Furthermore, at this stage, several pieces of NPC-level legislation emphasized the safety management of GMOs. The Seed Law, as adopted in 2000, especially mentioned GM seeds in its Articles 14, 35, and 50, which mandated safety assessment and safety management measures, labeling of GM seeds, and rules regarding import of GM seeds.¹¹⁶ In 2002, when the Agricultural Law was revised, Article 64 required that research, experiment, production, processing, operation and other application of agricultural GMOs should comply with safety and control measures strictly. Detailed rules had been stipulated by the Regulation on Agricultural GMOs. Lastly, in 2009, the Food Safety Law was enacted to address GM food safety issues explicitly.¹¹⁷ Article 101 stated that GM food safety should be regulated under this law.¹¹⁸

During this period, regulatory capacities of GMO-related authorities also developed. Different from the previous stage, where the MOST held a central role in regulating GMOs, multiple ministerial departments were responsible for regulating GMOs after 2000.¹¹⁹ All relevant departments were coordinated by the Inter-Ministerial Joint Conference for Administration of the Safety of Agricultural GMOs (hereinafter, the Inter-Ministerial Joint Conference) as organized by the State Council.¹²⁰ The MOA (now MARA) was the central coordinating department. It still administered the Biosafety Management Office and Biosafety Committee. The Biosafety Management Office was responsible for supervising and managing the safety of agricultural GMOs. The Biosafety Committee provided scientific advice. The Biosafety Committee, as established by the Administrative Measures on the Safety of Agricultural Genetic Engineering in 1996, was a ministerial-level committee, while the Regulation on Agricultural GMOs lifted this committee to be a national-level committee.¹²¹ The first to the third Biosafety Committees were established in 2002, 2005, and 2009, respectively. The General Administration of Quality Supervision, Inspection and Quarantine (now the General Administration of Customs) was responsible for the inspection and quarantine management of GM products entering and exiting the territory. The National Biosafety Administration Office located in the Department of Nature and Ecology Conservation of the MEP (upgraded from SEPA in 2008, now the MEE) coordinated environmental management in relation to biotechnology. It was established in 2001 to ensure the implementation of the NBF in China.¹²² The MEE’s Department of International Cooperation worked as the focal point of the Biosafety Protocol in China and was responsible for international cooperation and exchanges in the field of biosafety. Meanwhile, the MEE was responsible for drafting and submitting national reports regarding the implementation of the CBD and the Biosafety Protocol to the CBD Secretariat. In addition, local authorities were involved in GMO regulation.¹²³

3. Progress and challenges

Since the enactment of the Regulation on Agricultural GMOs, the legal framework on agricultural GMOs has been basically and gradually established (Table 2).¹²⁴ Biosafety aspects were emphasized by specifying measures to control each stage of the development and commercialization of GMOs: from research, field testing, environmental release, labeling, and processing, to import and export.¹²⁵ China’s national reports on the CBD and the Biosafety Protocol submitted before 2010 concluded that China had acquired regulatory capacities to some extent to do a risk assessment and to enforce the requirements for identification and documentation of GMOs, but further regulatory capacity-building efforts were needed to fully meet the regulatory needs at both the national and international levels.¹²⁶

Several reasons explained China’s ratification of the Biosafety Protocol and its transition from the promotional and permissive approaches to the precautionary approach regarding the authorization of GMOs after 2000. First, although China’s agricultural biotechnologists strived for leading the global R&D of GMOs globally, they began to treat GM crops cautiously and adversely. Global debates were fierce as to whether GM crops were safe and thus could be commercialized, leading to divergent opinions.¹²⁷ Against this backdrop, it seemed rational for China to take a precautionary approach to avoid the rush to commercialize GM crops when debates on the safety of GMOs continued.¹²⁸ Second, China was under pressure to defend against imports of GM soybeans from the US to avoid over dependent on the US’s exportation while facilitating exports of GM crops to the EU.¹²⁹ Therefore, China was inclined to keeping abreast with the EU approach to regulating GMOs, the key characteristics of which included stringent measures on contained use, deliberate release, and labeling of GMOs. Granting biosafety certificates for GM rice after extended tests and detailed risk assessments was an example that China strengthened GMO regulation.¹³⁰

The willingness to implement the Biosafety Protocol and the external intervention helped to improve China’s legal framework on GMOs at this stage.¹³¹ However, from the perspective of transforming the requirements of the Biosafety Protocol to Chinese laws and regulations, endogenous regulatory capacity-building activities played a more important role than external intervention. On the one hand, although the NBF was formulated and its implementation was strengthened with the assistance of UNEP/GEF projects, the projects did not lead to the expected results of adopting a biosafety law and enabling the SEPA to be a focal department for the safety management of GMOs. An NPC-level law was proposed to overcome deficits of the Regulation on Agricultural GMOs: the regulation specifically addressed risks caused by agricultural GMOs rather than all types of GMOs, and it was adopted by the State Council rather than by the NPC, the highest legislator in China.¹³² In the hierarchy of Chinese legal system, laws adopted by the NPC or its standing committee hold a higher position than regulations adopted by the State Council. Legislators had, to some extent, responded to these recommendations by proposing a draft GMO biosafety law.¹³³ The SEPA made three attempts to propose a GMO biosafety law in 1999, 2005, and 2009.¹³⁴ However, a GMO biosafety law had not been adopted even before the Biosecurity Law¹³⁵ was adopted in 2020. The complexity of GMO issues, public opposition, shortage of experience, and immature legislative techniques were the main hindrances to making a GMO biosafety law before 2020.¹³⁶ As a result, local ownership was fully respected when developing China’s regulatory framework on GMOs. One reason is that at this stage, China had to address concerns such as market access and international competitiveness on which the Biosafety Protocol is not likely to exert significant influence.¹³⁷ On the other hand, national regulatory needs and national circumstances were respected when China formulating and implementing concrete measures to control risks that may be caused by GMOs. Although the EU’s precautionary approach affected the establishment of GMO regulations in China, China did not follow the EU’s approach completely. China took a regulatory approach that fell between those of the EU and the US.¹³⁸ For instance, China had the requirement of mandatory labeling GMOs based on the Administrative Measures on the Labelling of Agricultural GMOs.¹³⁹ Different from the EU’s labeling measures, labeling in China was not attached with a threshold and, moreover, it applied not only to approved imported GMOs and products containing such imports, but also to food products containing no trace of GMOs but using GMOs in the production.¹⁴⁰

Endogenous capacity-building was also made through enhancing the coordination among departments involved in GMO regulation and specifically underscoring the roles of the SEPA (now the MEE) in decision-making regarding GMOs. Institutional incoordination emerged in the 1990s but became salient after 2000.¹⁴¹ Before the late 1990s, scientists dominated decision-making on GMOs. Afterwards, the SEPA and Greenpeace got involved, asserting that they would represent the voices of the public and stressing ecological concerns related to GMOs. International NGOs, typically Greenpeace, raised the public’s awareness of and even disclosed misleading information regarding risks that may be caused by GMOs in China by activities such as releasing reports that described the negative effects of GM crops.¹⁴² At this stage, higher public concerns about the safety of GMOs expressed by the SEPA led to the loss of dominant roles of scientific communities in decision-making regarding GMOs, compelling legislators to reconsider how to balance various interests during decision-making on GMOs.¹⁴³ Meanwhile, the SEPA was the responsible agency for participating in capacity-building projects on the development and implementation of NBFs and indeed, as mentioned above, took measures to complete the legislative tasks proposed by the NBF report published in 1998.¹⁴⁴ The positive thing was that it incentivized China to take more precautious measures on GMOs.¹⁴⁵ Nonetheless, from an institutional perspective, the MOA dominated the decision-making on GMOs with the coordination of the Inter-Ministerial Joint Conference.¹⁴⁶ Furthermore, the MOA had its own deficits in managing and controlling risks caused by GMOs. For instance, when issuing biosafety certificates for GM rice in 2009, a public participation procedure was not practiced, and such decisions were not announced in a transparent way.¹⁴⁷

III.C. Implementation Stage (2011–20)

1. Regulatory needs

Extensive reports on illegal cultivation of GM crops happened from 2011 to 2014.¹⁴⁸ Illegal cultivation and other concerns such as food safety led to the low public acceptance of GMOs at this stage.¹⁴⁹ The public showed little impact on GMO regulation in China before 2008 because scientists dominated the decision-making process.¹⁵⁰ By contrast, after 2010, more dependent and influential opinions of the public were expressed in discussions on GMOs.¹⁵¹ A tension between experts and the public in decision-making regarding GMOs was thus observed.¹⁵² The central government of China became cautious over the approval for commercialization of GM crops while it still encouraged the R&D of GM crops.¹⁵³ As a result, some crops such as GM rice and GM maize were issued with biosafety certificates but further permits for the production and processing of GMOs had not yet been issued.¹⁵⁴ In other words, there was a delay in the commercialization of these GM crops.¹⁵⁵ Heilongjiang Province even revised its Food Safety Regulation in 2016 to ban the cultivation of GM crops totally, though such revision was repealed later.¹⁵⁶ Delayed commercialization of GM crops was also found in other developing countries. Key reasons that explained such delayed commercialization include burdensome authorization procedures and the absence of liability rules that address damage caused by a release of GM crops.¹⁵⁷ These were also challenges faced by China.¹⁵⁸ Against this backdrop, China needed to find ways to alleviate public opposition against the commercialization of GM crops by encouraging public participation and clear the hindrance on the commercialization of GM crops by streamlining authorization procedures.¹⁵⁹

Since 2006, several incidences of the mixture of GM crops with non-GM crops have caused border rejection from the EU, as reported by the Rapid Alert System for Food and Feed.¹⁶⁰ The existence of illegal cultivation and border rejection of GM crops showed that there were deficits in post-authorization monitoring measures.¹⁶¹ Thus, post-authorization monitoring of GM crops should also be strengthened. Meanwhile, liability rules were needed to address the harms caused by the illegal cultivation of GM crops. The Supplementary Protocol was adopted in 2010 to further elaborate on liability rules as contained in Article 27 of the Biosafety Protocol. The Although China has not yet become a party to the protocol, the adoption of this protocol highlighted the necessity for formulating specialized liability rules for damage caused by GMOs, pushing China to consider making such liability rules.

2. Key regulatory capacity-building activities

Although there were setbacks and delays in GMO commercialization due to public opposition, the determination to promote R&D of GM crops had not changed.¹⁶² China integrated biosafety into its biodiversity strategy by adopting the China National Biodiversity Conservation Strategy and Action Plan (2011–30) (NBSAP (2011–30)):¹⁶³ the seventh of the ten priorities of the NBSAP (2011–2030) included the strengthening of biosafety management of GMOs.¹⁶⁴ To be specific, technical systems and platforms for biosafety assessment, inspection and monitoring of GMOs were proposed to be established and completed. In addition, participating in international negotiations about biosafety rules, especially liability rules, was also required. More specifically, regulatory capacities were improved through three approaches.

First, China streamlined authorization procedures to lower the costs of commercialization of GM crops. To this end, the Regulation on Agricultural GMOs was revised in 2011 and 2017, and the five Administrative Measures were revised at least once after 2011, respectively. The Administrative Measures on the Safety Assessment, for instance, was revised in 2016, 2017, and 2022. By revising the Administrative Measures on the Safety Assessment in 2016, the requirement regarding the provincial approval of field-testing and biosafety certification for GMOs was deleted, guidelines such as the guideline for safety assessment of GM plants were explicitly referred to, and specifications of application documents were provided. In 2017, Article 16 and Article 33 of the Regulation on Agricultural GMOs and Article 24 of the Administrative Measures on the Safety Assessment were revised to request the MOA designate capable detection institutions to do detection before risk assessment. Some technical guidelines and standards were released to guide further how to assess and manage risks associated with agricultural GMOs. The MOA issued more than 200 standards and specifications in 7 categories, including component testing of agricultural GM products, environmental safety testing, food safety testing, testing laboratory requirements, biosafety assessment, and biosafety monitoring.¹⁶⁵ For instance, the 2010 guideline for safety assessment of GM plants was revised in 2017 and 2022. In addition, the MEP adopted guidelines on the ecological risk assessment for insect-resistant transgenic plants in 2011.

At this stage, institutional arrangements were further streamlined. After the institutional reform in 2018, multiple ministerial departments were responsible for regulating GMOs. The key was the MARA, the General Administration of Customs, and the State Administration for Market Regulation (SAMR).¹⁶⁶ They were still coordinated by the Inter-Ministerial Joint Conference. A working rule was revised in 2013 for the Biosafety Committee.¹⁶⁷ According to Article 1 of the working rule, the MARA would determine members of the Biosafety Committee after consulting with other ministries within the Inter-Ministerial Joint Conference, the term of the committee members was five years, and the Biosafety Committee should make scientific sound and impartial decisions. The fourth and fifth Biosafety Committees were selected in 2013 and 2016, respectively.

Second, post-authorization monitoring of GMOs was enhanced by legal revisions at this stage.¹⁶⁸ When the Environmental Protection Law (EPL) was revised in 2014, Article 30(2) of it specifically required that measures be taken to prevent biodiversity degradation that the development and application of biotechnology may cause.¹⁶⁹ The Seed Law was revised in 2015 to increase measures and penalties for the illegal cultivation of GM crops.¹⁷⁰ Monitoring of field-testing of GMOs was strengthened because changes in testing sites should be reported to the Biosafety Office.¹⁷¹ The Food Safety Law was revised in 2015, and more detailed rules regarding the labeling of GM food were specified in Articles 69, 125, and 151. As for enforcement of laws and regulations on GMOs, the MOA issued several notifications on the strengthening of safety control for GMOs from 2009 to 2021.¹⁷² Border control departments enhanced their inspection of GMOs, with several unauthorized GMOs detected.¹⁷³

Third, China participated in capacity-building activities regarding institutional capacity-building, mainstreaming biosafety, risk assessment and management, public awareness, participation, and education in biosafety, information exchange and data management, including participating in the BCH, detection of GMOs, and measures to address unintentional and/or illegal transboundary movements of GMOs.¹⁷⁴ Public involvement, namely the public awareness, education, and participation concerning the safe transfer, handling, and use of GMOs as requested by Article 23 of the Biosafety Protocol, was specifically stressed. China participated in the UNEP-GEF Project for Sustainable Capacity Building for Effective Participation in the BCH (BCH-III).¹⁷⁵ The BCH is a part of the clearing-house mechanism under Article 18(3) of the CBD. It helps to facilitate the exchange of scientific, technical, environmental, and legal information on, and experience with GMOs and assist parties to implement the Biosafety Protocol.¹⁷⁶ More than 25 biosafety-related events happened in China during the fourth reporting period on the implementation of the Biosafety Protocol from 2015 to 2019. China had organized several workshops, training courses, or lectures on BCH or public involvement in biosafety management at the international, regional, or national levels. Moreover, the government began to emphasize scientific popularizing to enhance public acceptance of GMOs. For instance, in its No. 1 central document, the central government’s first policy statement released at the start of each year, for 2015, scientific popularizing regarding GMOs was first stated.¹⁷⁷ A special website was launched in 2013 by the MOA to publicize GMO-related information.¹⁷⁸ On this website, information on the biosafety certificates for domestically developed GM crops starting from 2002 and information on the biosafety certificates for imported GM crops starting from 2004 were available.

3. Progress and challenges

At this stage, the external intervention and endogenous capacity-building activities focused on improving the already-existing legal measures, with national laws and regulations to implement the Biosafety Protocol being basically in place and biosafety management capacities being further enhanced.¹⁷⁹ Detailed laws, regulations, guidelines, and technical standards regarding safety assessments of GMOs were gradually adopted or revised to respond to streamline authorization procedures of GMOs.¹⁸⁰ Principal measures applicable to GMOs included risk assessment, risk management, public involvement, labeling, and liability rules. However, challenges for China to implement the CBD and the Biosafety Protocol still existed.¹⁸¹ To be specific, more coordinated institutions, systematic prevention of risks, public involvement, labeling, and enforcement should be strengthened.¹⁸² Consequently, further regulatory capacity-building activities were needed according to the fourth national report on the implementation of the Biosafety Protocol.¹⁸³

At this stage, the enactment of a biosafety law was laid aside. Instead, more efforts were made to streamline the relevant measures to balance the promotion of research on GMOs and commercialization of GMOs and to enhance public involvement in GMO regulation (Table 3). Thus, the focus of the external intervention was shifted from sketching out and implementing the NBF to more concrete and urgent measures, including authorization measures, public involvement measures, and post-authorization monitoring of GM crops. UNEP-GEF Project on BCH helped enhance public involvement in China’s GMO regulation, as China could share and exchange information on GMOs, especially information that explained the safety and risks that may be caused by GMOs in a scientific and convincing way. This would increase public confidence on the research and commercialization of GM crops in China. Nonetheless, the major driving force for regulatory capacity-building was endogenous activities, which included the adoption and revision of laws, regulations, guidelines, and technical standards. For instance, the progress in public involvement in domestic environmental law promoted public involvement in GMO regulation. There were no expressly stipulated public involvement requirements in GMO-related laws and regulations. After 2014, the EPL, in its Article 5 and chapter 5 (Articles 53–58), stipulated the principle of public involvement in environmental issues and concrete requirements regarding this principle. These provisions also applied to GMO regulation, facilitating the public’s participation in decision-making on GMOs.¹⁸⁴ However, there were deficits.¹⁸⁵ Theoretically speaking, governance rather than regulation was preferred as a form of government intervention as the former involved more engagement and coordination among different stakeholders.¹⁸⁶ China needed to continue participating international capacity-building to get more experiences from other parties in effectively implementing public involvement requirements of the protocol.¹⁸⁷

Table 3.

China’s key regulatory capacity-building activities at the implementation stage

	Enacting or revising legislation	Participating in the UNEP/GEF project on BCH
Main actors	The State Council MOA	MEP MOA
Objectives	To streamline authorization procedures To address delayed commercialization of GM crops To enhance post-authorization monitoring	To alleviate public opposition against the commercialization of GM crops
Outcomes	The Regulation on Agricultural GMOs revised Five administrative measures revised Technical guidelines and standards released or revised Article 30(2) of the EPL adopted The Seed Law and the Food Safety Law revised to regulate illegal cultivation and GMO labeling	More than 25 biosafety-related events held Scientific popularizing emphasized A special website to release GMO-related information launched
The nature	Endogenous activities	External intervention

IV. POST-2020 ENHANCEMENT STAGE: OPPORTUNITIES AND CHALLENGES

After 2020, China entered an enhancement stage of GMO regulation: regulatory capacities built and developed need to be further bolstered by responding to legal and technological developments. China needs to respond to at least the following three challenges.

IV.A. Enhancing the Effective Implementation of the Biosafety Protocol against the New Legal Developments

The adoption of the GBF, the Implementation Plan, and the Capacity-Building Action Plan for the Biosafety Protocol in 2022 brought updated international goals and guidance on national implementation of the Biosafety Protocol. Detailed requirements in this regard should be incorporated and followed by parties to the protocol. The GBF and the Implementation Plan during the post-2020 era stress substantive requirements on GMO-related biosafety management in the Biosafety Protocol. Target 17 of the GBF requires explicitly parties to the CBD to establish, strengthen capacity for, and implement in all countries biosafety measures as set out in Article 8(g) of the CBD and measures for the handling of biotechnology and distribution of its benefits as set out in Article 19 of the CBD. The number of countries that have taken action to implement biosafety measures is the monitoring indicator for this target as explained in COP decision 16/31.¹⁸⁸

The Implementation Plan specifies ten implementation areas and four elements of the enabling environment. The ten implementation areas cover functional NBFs, BCH, timely national reports, effective compliance mechanisms, risk assessment and management, illegal and unintentional transboundary movements, handling, transport, packaging, and identification of GMOs, detection and identification of GMOs, socio-economic considerations, and the implementation of the Supplementary Protocol. Four elements of enabling environment include capacity-building activities, resource mobilization, public awareness, education, and participation, and cooperation and coordination on biosafety issues at the national, regional and international levels. Although no new requirements are imposed by these international guidance documents over the implementation of the CBD and the Biosafety Protocol, the incorporation of these targets into these documents shows that biosafety management is still an important aspect and continued national efforts should be made. Furthermore, the Capacity-Building Action Plan specifies capacity-building requirements to implement the Biosafety Protocol. It complements the Implementation Plan by elaborating on the goals, objectives, indicators, and outcomes of capacity-building. For each goal, key areas for capacity-building, examples of capacity-building activities, indicators and outcomes are provided in the Capacity-building Action Plan. These decisions, on the one hand, elaborate on implementation requirements regarding the Biosafety Protocol, and on the other hand, provide an opportunity for parties to reflect on their current NBFs and find out ways to do biosafety management effectively.

China responded to the GBF and the relevant decisions by updating its NBSAP in January 2024. The current version is NBSAP (2023–30), which contributes to mainstreaming biosafety concerns into national plans and other sectors. As emphasized by the fourth national report on the implementation of the Biosafety Protocol, China has made progress regarding mainstreaming biosafety: biosafety concerns have been integrated into the five-year plans since 2000 and into NBSAP since 2010. The fourteenth five-year plan also has specific requirements on biosafety regulation and promotion of commercialization of biological breeding. According to the NBSAP (2023–30), the ecological impact of the environmental release of GMOs to farmlands and ecosystems is one source of pressure on biodiversity in China. Thus, systematic risk prevention and control measures are still needed for GMOs and biotechnology. This requirement is contained in priority area 12 (biosafety management). Two tasks are mentioned. First, monitoring the impact of GMOs’ environmental release on biodiversity, genetic resources, and ecosystems should be enhanced. Second, focusing on new biotechnology products such as genome-edited organisms and synthetic biological products, China will develop rules regarding the identification, assessment, and monitoring of risks that these products may cause. The aim is to compose a whole life-cycle biosafety management system for these products.

China has incentives to participate in regulatory capacity-building further because it has the ambition to be a leader in global environmental protection governance and global biodiversity governance. China has gradually become a donor rather than a recipient in South–South cooperation regarding biodiversity under the CBD.¹⁸⁹ China’s participation in capacity-building projects funded by international donor agencies is one of the ways to internationalize China’s biosafety policy.¹⁹⁰ However, from the perspective of capacity-building mechanisms, to maximize China’s role as an active contributor to the implementation of the CBD, even to the effective implementation of the Biosafety Protocol, further efforts are still needed. First, the synergetic implementation of the CBD and the Biosafety Protocol by China is important. Suggestions to enhance capacity-building under the CBD can also give insights into the effective implementation of the Biosafety Protocol in China as for each of the suggestions, GMO-related biosafety issues should also be addressed.¹⁹¹ Second, promoting more international cooperation regarding GMO regulation is needed. The capacity-building mechanism itself is a form of international cooperation. The Biosecurity Law intends to facilitate China’s compliance with international treaties that address biosecurity issues, which include the CBD and the Biosafety Protocol, contributing to global biosecurity governance.¹⁹² International cooperation has been deemed to be one of the ways to promote the overall biosecurity capacities and China’s capacity to participate in the global biosecurity governance of China.¹⁹³ Furthermore, the Biosecurity Law specifically promotes capacity-building regarding biosecurity in China in chapter eight (Article 66 to Article 71). One aspect is to enhance biosecurity governance capacities.¹⁹⁴ GMO regulation capacity-building is one of the aims. Third, as will be discussed below, China needs to restructure its GMO legal system and address new legal challenges caused by new technologies.

IV.B. Improving GMO Regulation after the Biosecurity Law

At the national law level, the enactment of the Biosecurity Law in 2020 (revised in 2024) requires reconsiderations on the positioning of the GMO regulation into a broader biosecurity legal system; the Civil Code of China (the Civil Code)¹⁹⁵ was adopted in 2020 and contains tort liability rules that can be used to claim damage that is caused by GMOs, although it does not specifically refer to such damage.¹⁹⁶ A relevant legal development is the drafting of the environmental code.

The enactment of the Biosecurity Law is a step forward for improving GMO regulation in China, as GMO biosafety has been integrated into a broader national security legal system which covers eight types of biosecurity risks.¹⁹⁷ The Biosecurity Law has dual functions of providing the normative basis for addressing domestic biosecurity risks and converging with and facilitating China’s implementation of international norms in biosafety or biosecurity.¹⁹⁸ Detailed rules regarding each type of biosecurity risks can be formulated on the basis of the general rules stipulated by the Biosecurity Law. As for the regulation of GMO biosafety, some authors suggested adopting an NPC-level GMO biosafety law¹⁹⁹ or a regulation adopted by the State Council.²⁰⁰ Adopting a GMO biosafety law or regulation is consistent with the recommendations of the NBF report as released by the SEPA in 1998. Nonetheless, the Legislative Plan of the Fourteenth Standing Committee of the NPC, covering 2023 to 2028, does not mention GMO biosafety law. The provisions of the Biosecurity Law are general and abstract. Thus, a more practical way to improve GMO laws and regulations in the short term is to revise the Regulation on Agricultural GMOs, making laws and regulations on agricultural GMOs consistent with the Biosecurity Law.²⁰¹

On the one hand, a series of legal principles, legal measures, and institutional settings stipulated by the Biosecurity Law can apply to the biosafety management regarding GMOs, reiterating or supplementing current measures stipulated by the Regulation on Agricultural GMOs. The Biosecurity Law incorporates the precautionary principle, a fundamental principle of the Biosafety Protocol. Consequently, decision-making on agricultural GMOs should follow this principle. However, it should be noted that the principle has already been deemed as a key principle in regulating GMOs before 2020 by interpreting the provisions of the Regulation on Agricultural GMOs.²⁰² Similarly, public involvement is not explicitly mentioned by the Regulation on Agricultural GMOs but is stipulated by the Biosecurity Law.²⁰³

Furthermore, the whole process and life-cycle system established by the Biosecurity Law also apply to GMO regulation, including monitoring and early warning system (Article 14), risk investigation and assessment system (Article 15), information sharing and release system (Articles 16–17), category and list system (Article 18), standards system (Article 19), review system (Article 20), and emergency response measures (Article 21). Lastly, the Biosecurity Law enables the establishment of a national security institution and a national coordination mechanism for biosecurity.²⁰⁴ A central leading group on national security is responsible for significant decision-making, drafting and implementing biosecurity strategies and policies, planning and coordinating significant biosecurity matters and work, and establishing the Coordination Mechanism for National Biosecurity. The Coordination Mechanism is established to recognize and analyze biosecurity risks and coordinate and supervise national biosecurity-related work. The Coordination Mechanism is supported by the national biosecurity committee and sectoral biosecurity committees, such as the Biosafety Committee as administered by the MARA. The latest Biosafety Committee was selected and established in 2021.

On the other hand, the Regulation on Agricultural GMOs and the associated administrative measures have been revised to overcome the other challenges identified in Section III of the article, including the delayed commercialization and the lack of systematic liability rules. First, the Administrative Measures on the Safety Assessment, the Measures for the Validation of Main Crop Varieties, the Administrative Measures on the License for the Production and Business Operations of Agricultural Seeds, and the Nomenclature of Agricultural Plant Varieties were revised in January 2022 according to Order No. 2 of the MARA to facilitate the commercialization of GMOs. The MEE adopted Guidelines on the ecological risk assessment of GM plants for environmental release (on trial) in 2023. These documents provide for principles and steps of risk assessments. Principles include sound science, precautionary, case-by-case, and comparative principles.²⁰⁵ Five steps include risk recognition, assessment, identification, management, and monitoring.²⁰⁶

Second, liability and redress rules are necessary ex-post measures in GMO regulation as they have the function of ensuring compliance with legislation, repairing damage, and deterring effects.²⁰⁷ As Article 52 of the Regulation on Agricultural GMOs and Article 82 of the Biosecurity Law stipulate, damage caused by GMOs shall be addressed under the Civil Code.²⁰⁸ Articles 1229 and 1234 are legal bases for environmental tort liability and the ecological damage compensation system, addressing damage to persons and property and environmental damage, respectively. Ecological damage that is caused by activities that are in breach of any national laws and regulations shall be restored and compensated at the request of the authorities stipulated by the State or the organizations stipulated by the law.²⁰⁹ As such, if transboundary movements or the domestic release of GMOs into the environment causes damage to ecosystems, and if such activities do not comply with the Regulation on Agricultural GMOs, individuals and entities responsible for these activities will be required to restore the ecosystems and compensate for any damage caused. However, the Civil Code does not explicitly mention damage caused by GMOs. It fails to consider the particularities of damage caused by GMOs.²¹⁰ It would facilitate the redress of damage caused by GMOs if more specialized liability and redress rules were designed. Furthermore, the Supplementary Protocol provides for GMO-specific liability rules in international law. Regulatory capacities regarding liability rules should be strengthened in developing countries, including China, since the Supplementary Protocol has been adopted.²¹¹ Capacity-building requirements regarding the ratification and implementation of the Supplementary Protocol are contained in the Capacity-Building Action Plan. China needs to approve the Supplementary Protocol first and then fully use the relevant capacity-building initiatives to improve its liability rules. Domestically speaking, China already had administrative, civil, and criminal liability rules before 2020. However, more specific and effective liability rules are needed.²¹² China should ratify the supplementary protocol and incorporate international commitments into domestic law by specifying elements of liability for the damage caused by GMOs and the procedures to claim the liability.

IV.C. Regulating Genome-Editing Crops and Synthetic Biology

New techniques pose new challenges and thus demand updating GMO laws and regulations. Since 2015, there have been discussions on how to regulate genome-editing products.²¹³ COP and COP-MOP meetings have initiated discussions on how the risks posed by organisms developed through CRISPR/Cas9 or other new techniques should be assessed and managed. Decision 16/21, as adopted by the COP 16 in October 2024, emphasizes the urgent need for capacity-building and development, access to and transfer of technology and knowledge-sharing for synthetic biology, in particular for developing country parties, to achieve the goals and targets of the GBF, and establishes a new ad hoc technical expert group on synthetic biology. At the national law level, two types of regulatory approaches are taken: process-based and product-based.²¹⁴

In China, the bioethics issues surrounding genome editing were a concern when Jiankui He carried out illegal tests.²¹⁵ The Civil Code and the Biosecurity Law were adopted to respond to this issue. The enactment of the Biosecurity Law ensures that gene-editing regarding animals and plants is regulated to prevent potential risks. However, it is not clear whether organisms that are developed via new techniques such as CRISPR/Cas9 are covered by either the Biosafety Protocol or the Regulation on Agricultural GMOs.²¹⁶ Priority area 12 (biosafety management) of the latest NBSAP of China requires that more research and studies be done for identifying and managing risks caused by new techniques such as genome editing and synthetic biology. Some literature has concluded that genome editing falls into the scope of the Regulation on Agricultural GMOs but more lax regulation should be designed for it, as it is safer than GMOs and may be easily accepted by the public.²¹⁷ Lessons in regulating GMOs can give some experiences: regulatory modes from precautionary, and prudent, to promotional should be used for regulating new techniques such as nanotechnology.²¹⁸ Discussing how to regulate genome-editing techniques is still a matter of balance between scientific and technological developments and oversights on biosafety issues.

Currently, rules on risk assessment and management of genome editing are separately stipulated in China.²¹⁹ The MARA issued the Guideline for the Safety Evaluation of Gene-edited Plants for Agricultural Use (Trial) in January 2022. According to the principles of classification management and case-by-case analysis, the Guideline clarified the application procedures and information requirements for genome-edited plants. Detailed Rules on Assessment and Review of Gene-edited Plants for Agricultural Use (Trial), released by the MARA in April 2023, further clarified the classification standards and the elements to be assessed. Such elements include molecular characteristics, environmental safety, and food safety. Based on the Guideline, genome-editing techniques should be regulated under the Regulation on Agricultural GMOs and Guidance for Safety Assessment of GM plants, released by the MOA in 2017 and updated in 2022 to elaborate on the Regulation on Agricultural GMOs. In essence, China takes a precautionary and process-based approach regarding the risk assessment and management of genome-editing techniques.

China needs to participate in the study, negotiation, and formulation of international rules as required by Article 6 of the Biosecurity Law; on the other hand, China needs to follow the latest scientific evidence on the risks that may be caused by genome-editing techniques to the environment and human health and adjust regulatory approaches accordingly. For instance, the Court of Justice of the EU held that organisms obtained by techniques like genome editing, which have not conventionally been used in several applications and do not have a long safety record, come within the scope of Directive 2001/18 are regulated under that directive.²²⁰ Thus, a process-based approach is taken by the EU. Nonetheless, the European Commission conducted a study on genome-editing regulation and concluded that a permissive and product-based approach fits better for the EU. The European Commission consequently submitted a proposal for a regulation on plants obtained by specific new genomic techniques (2023/0226(COD)) in July 2023 to relax the regulation on genome editing in the EU.²²¹

V. CONCLUSION

GMO regulation in China developed gradually from barely having any legal documents to a systematic legal and regulatory system with a series of legal principles and legal measures. Legal developments at the international and national level provide an opportunity to examine GMO regulation in China. This article explored the development of laws and regulations on GMOs in China from the perspective of regulatory capacity-building. The regulatory needs and contribution of international capacity-building differ at the four stages of regulatory capacity-building.

Before 2020 and during the first three stages, China had gradually developed its GMO laws and regulations, with each stage having different regulatory needs and capacity-building efforts. At the exploration stage, China’s key task was to adopt risk assessment and management measures to control risks caused by GMOs. China consequently adopted the Administrative Measures on the Safety of Genetic Engineering in 1993 and the Administrative Measures on the Safety of Agricultural Genetic Engineering in 1996. With the assistance of the UNEP/GEF Pilot Biosafety Enabling Activity Project, the NBF was released by the SEPA (now the MEE) to lay the guidance for China to implement the Biosafety Protocol, which recommended that China adopt GMO biosafety laws and regulations and detailed risk assessment and management measures. At the development stage, China ratified the Biosafety Protocol, and more applications for the commercialization of GM crops pushed the Chinese government to adopt the Regulation on Agricultural GMOs in 2001 to expressly stipulate how developers of GM crops could get permits for research, field-testing, environmental release, productive field-testing and biosafety certificates to put GM crops on the market. Agricultural biotechnologists’ inherent concern on potential risks of GMOs and international trade pressure led China to shift from promotional and permissive approaches to the precautionary approach. The UNEP/GEF capacity-building project on the implementation of NBFs helped China enhance its overall regulatory capacities. Although a basic legal framework on GMO biosafety was established, with the Regulation on Agricultural GMOs being the central one, a biosafety law as proposed by the NBF report were not enacted. The implementation of the NBF showed that when building and developing regulatory capacities with the assistance of international capacity-building projects, China fully considered its national circumstances. At the implementation stage, China faced challenges to streamlining authorization procedures, enhancing public involvement, and strengthening post-authorization measures, as illegal cultivation was reported and decreased public acceptance of GM crops affected the government’s decisions on the commercialization of GM crops. Revisions on the Regulation on Agricultural GMOs and the associated administrative measures, as well as international capacity-building activities, alleviated China’s pressure to ensure the safe use of GMOs. The external intervention regarding Chinese regulatory capacity-building was mainly on concrete measures such as public involvement measures.

External intervention and endogenous capacity-building activities contributed to developing China’s regulatory capacities on GMOs, with the latter playing more and more roles. Emphasizing the endogenous aspect is consistent with the notion that local ownership and national circumstances be stressed in the national implementation of the GBF, the CBD, and the Biosafety Protocol. The process of developing GMO laws and regulations with the assistance of international capacity-building projects under the Biosafety Protocol may provide implications for other developing countries. A country without a systematic NBF can follow the guidance of external assistance such as the UNEP/GEF projects to establish a fundamental legal system first and then specifically respond to local regulatory demands to make it a functioning NBF.

China is at the enhancement stage, during which opportunities and challenges coexist. Until now, some goals and tasks, as defined in the NBF report, have not yet been achieved. An NPC-level law, the Biosecurity Law, was adopted in 2020. However, it is not specifically about GMOs’ biosafety management. During the post-2020 era, China should continue improving its regulatory capacities regarding GMOs, as the current GMO laws and regulations still have deficits. One possible solution is to incorporate the new legal measures into GMO regulation and revise the Regulation on Agricultural GMOs. Meanwhile, China should fully use bilateral and multilateral capacity-building activities to enhance its GMO regulation.

FUNDING

This work was supported by Tianjin Philosophy and Social Science Annual Planning Project (TJFX21-012).