The evolution of China’s regulation of agricultural biotechnology

Abstract

To ensure safe use of genetically modified organisms (GMOs), since 1993, China has made great efforts to establish and improve the safety regulatory system for GMOs. Here, we summarize and analyze the regulatory framework of agricultural GMOs, and the progress in regulatory approval of GM crops in China. In general, the development of GMO safety regulations underwent four stages: exploration (1993–2000), development (2001–2010), improvement (2011–2020) and current (2021-present) stage. The first formal regulation was promulgated in 1993, which provided a basis for further development of the regulations, during the exploration stage, when insect-resistant GM cotton, expressing genes from Bacillus thuringiensis (Bt), was approved for cultivation. During the development stage, the Chinese government issued a series of administrative measures, which covered almost all the fields relative to GMO safety when the basic regulatory system was established. Along with the controversy over GMO safety, the regulations have been further, and greatly improved, during improvement stage. From 2021, a few additional revisions have been made, and meanwhile, the new regulation on gene-edited crops was introduced with the development of biotechnology, forming a relative complete regulation and law system for China. The well-developed GMO regulations establishes a firm basis for safe use of GM crops in China. Currently, GM cotton and GM papaya have been widely grown on a large scale in China that have brought great economic and ecological benefits. In addition, 12 corn events, 3 soybean events, and 2 rice events have also obtained biosafety certification, but presently, these lines have yet to enter commercial production. However, several GM soybean and corn events have entered pilot industrialization, and can soon be expected to be commercially grown in China. In addition to planting, six GM crops, including soybean, corn, cotton, canola, papaya and sugar beet, with a total of 64 events, have been approved for import as processing material in China.

Introduction

Genetically modified (GM) crops have been widely grown and consumed, globally, for over two decades. GM crops can bring enormous agricultural, environmental, economic, and societal benefits to farmers and consumers and also help in addressing the challenges posed by population growth and climate change. In 2019, 29 countries planted some 190 million hectares in GM crops. Additionally, 42 non-planting countries (16 countries + 26 European Union countries) have approved the import of GM crops for food, feed, and processing (ISAAA 2019). However, not only benefits but also risks come with this new technology. Therefore, the regulation of biotechnology and the derived products are of great concern to international organizations, governments, and consumers. International organizations, such as the United Nations and governments of various countries, attach a high level of importance to the safety management of genetically modified organisms (GMOs), and for many countries this takes the form of legislation to implement appropriate biosecurity management (Hristova 2013). Effective biotechnology regulations, which follow scientific principles, will contribute to improving the efficacy of regulatory agencies, worldwide, through reduced duplication of work, and also bring benefits for regulators, consumers, industry and farmers (Mitre and Reis 2014; Qaim 2020).

At present, differences exist in the regulatory requirements of various governments for biotechnology-derived products. In many countries, the regulatory policy was conducted based on risk analysis, which required similar information. Nevertheless, these various policy orientations led to different management models, which are mainly divided into “product-based regulations” and “process-based regulations” (Nap et al. 2003). For example, the United States regulations are typically “product-based regulations”, and the “reliability science principle” is applied for risk analysis, which means that, if the risk cannot be proven scientifically, it shall not be restricted. In the alternative approach, as exemplified by the European Union, regulations are “process-based regulations”, and the precautionary principle is applied for risk analysis, which means that, as long as the risk cannot be denied, it shall be restricted (USDA 2022).

In China, much attention has been paid to the development and application of GM technology and its safety management, and great efforts have been made to establish and improve its regulatory system for GM products (Huang and Wang 2002; Li et al. 2014; Gao et al. 2018). With nearly 30 years of national oversight of this new technology, Chinese regulations of GM products go through four stages, from exploration to current stage. Presently, China has in place a complete set of laws and regulations covering the entire process of research, production, processing, import and labeling of GMOs and related products, which has, for example, guaranteed the safe and sustainable use of insect-resistant GM cotton. Recently, the Chinese Ministry of Agriculture and Rural Affairs issued two variety certification standards (Try out), including soybean and corn, which signifies another important step forward in the establishment and commercial production of GM crops (MARA 2022a).

In this article, we briefly introduce the regulatory framework of biotechnology crops and the associated biosafety regulations, and then discuss its 30 years of evolution in China since 1993. The latest developments are presented in this article as well, including new regulations for gene-edited crops and some pilot work on GM soybean and corn, both of which may soon be commercially planted in China.

Biosafety GMO regulatory framework in China

Multiple Chinese administrative departments are involved in the regulation of GMO safety, including the Ministry of Agriculture and Rural Affairs (MARA), the State Administration for Market Regulation (SAMR), and the General Administration of Customs (GAC) (Fig. 1). MARA is the primary institution responsible for the supervision and administration of agricultural GMOs safety, nationwide. SAMR is responsible for the GM labeling management of processed foods, but the formulation of regulations on GM labeling, and supervision of the labeling of GM animals, plants, microorganisms, and the derive products, is delegated to MARA. GAC is responsible for the inspection and quarantine management of inbound and outbound GM products, across the country, and the associated customs office is responsible for inspection, quarantine, and regulation of inbound and outbound GM products, within its jurisdiction, and implements a licensing system for in transit agricultural GM products.

Fig. 1.

Biosafety regulatory framework for GMOs in China. Inter-ministerial joint meeting system for the safety management of agricultural GMOs is responsible for research and coordination of major issues in the safety management of agricultural GMOs. Three administrative departments (MARA, SAMR and GAC) are involved. An office in MARA organizes staff related to safety management of agricultural GMOs, and two committees were established. GMO supervising and testing centers belonging to MARA also worked for the safety management purpose. The agricultural administrative departments of the local People’s governments, at or above the county level, are also important parts in this system

The Chinese State Council established an inter-ministerial joint meeting system for the safety management of agricultural GMOs. This meeting system is composed of the heads of relevant departments of agriculture, science and technology, environmental protection, health, foreign trade, inspection and quarantine, etc., who are responsible for research and coordination of major issues in the safety management of agricultural GMOs (State Council 2007). In addition, the agricultural administrative departments of the local People’s governments, at or above the county level, are responsible for the supervision and administration of the safety aspects of agricultural GMOs, and GM food, within their respective administrative regions.

To deal with the routine work and daily management of GMO safety, an office of Agricultural GMO Safety Management was established under the MARA, which oversees safety assessment of agriculture GMOs. The Agricultural GMO Safety Committee and the National Standardization Committee for Agricultural GMO Safety were formed and hosted by MARA, and are composed of experts in the fields of agriculture, environment, quality inspection and food safety, etc. The former is mainly responsible for safety assessment GMOs, whereas the latter is in charge of setting and revising the technical standards of research, testing, production, processing, trading, import and export and safety management of agricultural GMOs. The Development Center of Science and Technology (DCST), an affiliate of MARA, serves as the Secretariat of these two Committees. There are three divisions (GMOs Biosafety Assessment Division, GMOs Biosafety Inspection Division, GMOs Biosafety Supervision Division) in DCST with responsibility for agricultural GMO biosafety evaluation, testing and standard revisions, etc. In addition, to date, there are 42 GMO supervising and testing centers, nationwide, which are certified by MARA and SAMR for analyzing molecular characteristics and assessing environmental and food safety of GMOs (Fig. 1).

Biosafety regulations and adjustment

Rapid development and application of biotechnology brought global emphasis on its safety. Different countries have, over time, established their own laws or regulations related to biotechnology and the related products. The Chinese government has, for a long time, attached importance to the safety management of biotechnology crops, and has established a set of laws and regulations that fits its national conditions and are consistent with international practice. These laws and regulations have been revised over time, based on technology and theory developments, as well as new requirements, within the different stages. Generally, this process has advanced through four stages: exploration, development, improvement and current (Fig. 2).

Fig. 2.

Timeline for the evolution of agricultural biotechnology safety regulations in China. In general, the development of agricultural biotechnology safety regulations experienced four stages, with details in each stage being shown

Exploration stage: 1993–2000

The initiation of the GMO safety management within China occurred later than that in other developed countries. Here, on December 24, 1993, the State Science and Technology Commission (SSTC), under the Ministry of Science and Technology (MOST), issued the first formal regulation for the administration of GMO safety in China; “Measures for the Safety Management of Genetic Engineering”. The focus was on safety aspects, during the research and development (R&D) processes of biotechnology and stipulated that safety evaluation should be carried out during this research phase. This regulation also provided input on GMO safety evaluation, application and approval, safety control measures, and legal responsibilities (Xiao and Kerr 2022).

On July 10, 1996, the Ministry of Agriculture (MOA, the predecessor of the MARA) released the document, “Implementing Rules on the Safety Management of Agricultural Biological Genetic Engineering”, directed specifically to agriculture GMOs. In the following year, the government officially began to accept applications for the safety evaluation of agricultural GMOs and its products. Then the government authorized the commercial production of Bt cotton. Subsequently, on December 1, 2000, the China Seed Law was passed by the National People’s Congress, in which the safety administration of GM crops was included. This was the first occasion that the administration of biosafety for GM crops was included in the national law. This China Seed Law emphasized that the breeding, experimentation, examination, and extension work, for GM plants, must be conducted within a safety-evaluation framework, and that strict safety control measures are required. Marketing, import and export of GM seed are also supervised under this law.

Development stage: 2001–2010

As the previous regulations and guidelines were not very detailed, and to better administrate the biosafety of agricultural GMOs, in 2001, the State Council released a document, “Regulations on the Administration of Safety of Agricultural GMOs” to replace the 1993 regulation issued by the MOST (State Council 2001). This regulation provided more legal importance, and in scope, it included not only animals, microorganisms, and plants, produced by biotechnology, but also the products related to these GMOs. This regulation provides comprehensive details covering laboratory research, biosafety assessment, production, processing, marketing, and import and export activities relative to agricultural GMOs.

To better execute the State Council regulation, in January 2002 the MOA announced a series of implementing regulations, including “Administrative Measures on the Safety Assessment of Agricultural GMOs”, “Administrative Measures on the Safety of Imported Agricultural GMOs”, “Administrative Measures on the Labeling of Agricultural GMOs”, and, in 2006, “Administrative Measures on Authorization of Processing Agricultural GMOs” (Sun et al. 2019). These decrees covered almost all aspects related to agricultural GMO safety, including laboratory research, biosafety evaluation, biosafety administration for imports, labeling and processing, and import and export of GMOs and the related products. In May 2004, SAMR issued the “Administrative Measures on Supervision of Inspection and Quarantine of Entry-Exit Genetically Modified Commodities”. The development and implementation of these “regulations” and the five supported administrative measures underlies the formation of the legal and regulatory GMO framework in China.

In addition, since 2005, the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, which sets out the first comprehensive regulatory system for ensuring the safe transfer, handling and use of GMOs, in international trade, has been in effect in China. From then on, China maintained a rapid development of agricultural GMOs. There were 100–150 new agricultural varieties approved for production over the period of the “11th Five-Year Plan” (Xiao and Kerr 2022).

On June 1, 2009, the National People’s Congress released the China Food Safety Law, in which GM food safety was included, and it was the first national law addressing GM food safety in China. Soon thereafter, on August 17, 2009, the MOA issued production safety certificates for two Bt rice lines (Huahui-1 and Xianyou-63) and a phytase corn (BVLA430101), with an aim to prepare the commercialization of them as GM crops. However, no GM rice or corn has been planted to date.

Improvement stage: 2011–2020

From the early 2000s to 2015, incidents related to GMOs had attracted public attention, and the GMO debate became very intense and had negative impacts on GMOs, especially from 2014 to 2015 (Li et al. 2019). Worse still, there were some illegal events, related to GMOs production, plantation, and export, reported around 2011–2014 (Sun et al. 2019). The safety situation for agricultural GMOs was facing substantial difficulties and was extremely challenging.

In January 2011, for the first time, the State Council revised the “Regulations on the Administration of Safety of Agricultural GMOs”. The health administrative departments were replaced by the relevant departments responsible for the supervision and management of GM food safety, at, or above, the county level of the People’s governments. The MOA also announced the revising of “Administrative Measures on the Safety Assessment of Agricultural GMOs”, in 2004, 2016 and 2017, to strengthen the control of GM crops.

The State Council revised, for the second time on October 7, 2017, the “Regulations on the Administration of Safety of Agricultural GMOs”. The core changes within this revision were mainly focused on the following two aspects: (1) The technical testing institutions that issue testing reports were changed from self-selected to being entrusted and appointed by The State Council, regardless of the domestic GMO safety certificate application, or the foreign import application; (2) The function of the National Entry-exit Inspection and Quarantine Authority, within the administration of examination and approval, was weakened, and the agricultural administrative departments of the State Council became the primary office responsible for the administration of examination and approval of GMOs. This modification further standardized the approval process for GM crops, further improved the GMOs safety approval system in China, and paved the way for the future commercialization of GMOs.

On November 30, 2017, the MOA revised the “Administrative Measures on the Safety Assessment of Agricultural GMOs”, “Administrative Measures on the Safety of Imported Agricultural GMOs” and “Administrative Measures on the Labeling of Agricultural GMOs”. The main purpose for the revision of the Evaluation Measures was to clarify the management responsibility of the organization engaged in R&D, guarantee the safety, reduce the burden of the organizations engaged in R&D, and encourage innovation. SAMR revised the “Administrative Measures on Supervision of Inspection and Quarantine of Entry-Exit Genetically Modified Commodities” in March 2018, and the GAC revised it twice more in April and November 2018.

Current stage: 2021—present

In recent years, China has made great progress in development of GMOs, and several new GM varieties, with independent intellectual property rights and application prospects, have been developed. To promote the industrial application of GM varieties, develop the modern seed industry, and ensure food security, four regulations of the “Administrative Measures on the Safety Assessment of Agricultural GMOs”, “Measures for the Examination and Approval of Main Crop Varieties”, “Measures for the Administration of Production and Operation Licensing of Crop Seeds”, and “Nomenclature of Agricultural Plant Varieties” were revised and improved, which further paves the way for the development of agricultural biotechnology and the commercialization of its products (MARA 2022b). After the amendments to these for four regulations, the requirements for safety assessment, at different stage of GM plant varieties, examination and approval, production and operation licensing of GM crop seeds, and nomenclature of GM crop varieties, became more scientific, definite, and feasible (MARA 2022c). With the enforcement of these revised regulations, in parallel, the regulation of the “Production and Operation License of GM Cotton Seeds” released by the MARA on September 18, 2016, and revised on April 25, 2019, were abolished.

Most important, gene editing has been applied in agricultural, and MARA formulated the “Guideline for the Safety Evaluation of Gene-edited Plants for Agricultural Use (Trial)”, which indicated the application, as well as management of biotechnology in China has entered a new era.

New regulations for gene-edited crops

As an emerging biotechnology, gene editing provides a powerful genetic manipulation tool for biotech breeding. Its great application prospect has become a global consensus. In the field of agriculture, gene editing technology has been successfully applied in variety design and breeding of crops, such as high-yield rice, disease-resistant wheat, storage-stable potato, and healthy soybeans with high oleic acid, as well as with animals, such as hornless dairy cows, fast-growing salmon, and lean hogs (Ran et al. 2013; Char et al. 2020). The rapid development of this technology has brought forward new requirements for the scientific and technological management system and the policy system.

Establishing and improving a biotech regulatory policy system, which is compatible with the development of gene editing technology, is not only a key factor to promote innovation in this area, but also the only way to realize the modernization of the technology governance system and capacity. Currently, many major agricultural products producing and consuming countries, such as the United States, Japan, Brazil, Australia, etc., have established or are establishing their regulatory system for the management of products created by gene editing biotechnology. It is widely considered that gene-edited crops, which do not introduce foreign components, are not fundamentally different from crops developed by traditional genetic-based crossbreeding. Therefore, it is necessary to avoid restricting the development and application of this new technology due to excessive regulation. At present, the approval process of gene-edited agricultural products in quite a few countries, such as the USA, is greatly simplified compared with the management of traditional GM crops.

In China, plant gene editing technology has developed rapidly in recent years. It has shown great potential for agricultural application. To accelerate the development and application of this new biotechnology, the first regulation on gene-edited products, “Guideline for the Safety Evaluation of Gene-edited Plants for Agricultural Use (Trial)”, was formulated by MARA in January 2022. The release of this guideline incorporates the revolutionary technology of gene editing into effective management (Fig. 3). However, the current regulations may be imperfect, and an improvement of the regulations for gene-edited products will be needed in the coming days. Specifically, the standards or specific requirements for evaluating the molecule characteristics, genetic stability, environmental safety, and food safety, of gene-edited products need to be more fully described.

Fig. 3.

Evaluation system for gene-edited crops. Gene-edited crops with foreign genes were treated as equivalent to transgenic plants. Gene-edited crops without foreign genes were classed into four categories, based on the potential risk to environmental and food safety. Some categories require additional field testing or information data processing

To regulate gene-edited products, it is necessary to build the construction of a molecular identification and detection technology standard system. With the continuous emergence of gene-edited plants, we face enormous challenges in how to detect them quickly and accurately, which is at the basis for regulation of this new technology. At present, among the mainstream gene editing product safety management policies, ensuring that there are no foreign components is an important prerequisite for the large-scale commercial production and market access of gene-edited products in various countries.

Different from traditional GM technology, gene editing technology directly performs targeted mutation on its own genome, which cannot be effectively distinguished from natural mutation or physicochemical mutagenesis. How to accurately record the sequence changes at the target site(s), to protect the legitimate rights and interests of gene editing and breeding enterprises, requires standardized detection technology and evaluation indicators. Existing studies have shown that the high-throughput sequencing technologies, developed in recent years, can comprehensively detect gene-edited plants, from the whole genome level, to ensure that gene-edited plants are not contaminated by foreign components, and therefore may be suitable for detection of gene-edited products. Therefore, formulating detailed rules and technical standards for the molecular detection of gene-edited products, based on high-throughput sequencing technology, is of paramount importance. In addition, some relevant regulations should be necessarily adjusted for better regulating gene-edited plants. Although the “Guideline for the Safety Evaluation of Gene-edited Plants for Agricultural Use (Trial)” has been released, the developers of gene-edited plants are still unclear as to how to evaluate such new products, and the “Regulations on the Administration of Safety of Agricultural GMOs” is still being followed in risk assessment of gene-edited plants. More detailed regulations, measures or rules for biosafety assessment, production, processing, marketing, and import and export activities, relative to gene-edited products needs to be urgently formulated.

Regulatory approval of GM crops

Since the first commercial approval of Bt cotton in 1997, there have been a total of 5 crops approved for commercial planting in China, whereas only insect-resistant Bt cotton and virus-resistant papaya have been widely cultivated so far. In 2019, China planted a total of 245,000 ha of GM crops, with 12,125 ha of virus-resistant papaya. In addition, various published articles report that a few varieties of GM tomato, GM petunia, and GM sweet pepper have been also approved for commercial production, but no definitive data confirms their cultivation in China (Li et al. 2014). These GM crops were therefore not included in Table 1 of this article. In 2009, two GM Bt rice lines and one GM phytase corn line were granted biosafety certificates, but they have not yet been commercially cultivated in China, due to the great public concern regarding potential effects on human health and the environment (Li et al. 2020). In recent years, China has accelerated the commercialization of GM crops. For example, since 2019, an additional 11 GM corn and 3 soybean events that express either insect-resistant trait or herbicide-tolerant trait, or both, obtained biosafety certificates (Table 1). What is worth noting is that a few events have just entered the process of pilot industrialization. Thus, it can be expected that China will soon usher in the era of commercial cultivation of GM corn and soybean.

Table 1.

Genetically modified plant events approved for commercial planting in China (Oct. 3, 2022)

No	Crop	Event/variety name	Applicant	Exogenous gene	Commercial trait	Year of first approval	Year of expiration
1	Cottona	GK12	Biotechnology Research Institute, Chinese Academy of Agricultural Sciences	cry1A	(Singular) insect resistance	1997-07-01	2020-04-15
2		Jinmian 26	Biotechnology Research Institute, Chinese Academy of Agricultural Sciences	cry1A	(Singular) insect resistance	1997-07-01	2019-04-10
3		NC33B	Monsanto	cry1A	(Singular) insect resistance	1998-04-01	2015-05-07
4		SGK-321	Biotechnology Research Institute, Chinese Academy of Agricultural Sciences	cry1A, CpTI	(Stacked) herbicide tolerance	1997-07-01	2015-03-01
7		DR409	Institute of Microbiology, Chinese Academy of Sciences/Cotton Research Institute, Shanxi Academy of Agricultural Sciences	cry1A, API	(Stacked) herbicide tolerance	2003-12-20	2015-03-01
8	Papaya	Huanong No. 1	Huazhong Agricultural University	prsv_rep	(Singular) disease resistance	2006-07-20	2025-12-29
9		YK-1601	Chinese Academy of Tropical Agricultural Sciences	PRSV-YK CP	(Singular) disease resistance	2018-12-20	2023-12-20
10	Cornb	BVLA430101	Biotechnology Research Institute, Chinese Academy of Agricultural Sciences	phyA2	(Singular) modified product quality	2009-08-17	2019-12-11
11		DBN9936	Dabeinong	cry1Ab, epsps	(Stacked) herbicide tolerance + insect resistance	2019-12-02	2025-12-28
12		Ruifeng125	Rfgene	cry1Ab-cry2Aj, g10evo-epsps	(Stacked) herbicide tolerance + insect resistance	2019-12-02	2026-02-09
13		DBN9858	Dabeinong	epsps, pat	(Stacked) herbicide tolerance	2020-06-11	2025-12-28
14		DBN9501	Dabeinong	vip3Aa19, pat	(Stacked) herbicide tolerance + insect resistance	2020-12-29	2025-12-28
15		ND207	China National Tree Seed Group/China Agriculture University	mcry1Ab, mcry2Ab	(Stacked) insect resistance	2021-12-17	2026-12-16
16		Zheda Ruifeng 8	Rfgene	cry1Ab, cry2Ab	(Stacked) insect resistance	2021-12-17	2026-12-16
17		DBN3601T	Dabeinong	cry1Ab, epsps, vip3Aa19, pat	(Stacked) herbicide tolerance + insect resistance	2021-12-17	2026-12-16
18		nCX-1	Rfgene	CdP450, cp4epsps	(Stacked) herbicide tolerance	2022-04-22	2027-04-21
19		Bt11 x GA21	China National Seed Group	cry1Ab, pat, mepsps	(Stacked) herbicide tolerance + insect resistance	2022-04-22	2027-04-21
20		Bt11 x MIR162 x GA21	China National Seed Group	cry1Ab, pat, vip3Aa20, mepsps	(Stacked) herbicide tolerance + insect resistance	2022-04-22	2027-04-21
21		GA21	China National Seed Group	mepsps	(Singular) herbicide tolerance	2022-04-22	2027-04-21
22	Soybeanb	SHZD3201	Shanghai Jiao Tong University	g10evo-epsps	(Singular) herbicide tolerance	2019-12-02	2024-12-02
23		Zhonghuang6106	Institute of Crop Sciences, Chinese Academy of Agricultural Sciences	g2-epsps, gat	(Stacked) herbicide tolerance	2020-06-11	2026-02-09
24		DBN9004	Dabeinong	epsps, pat	(Stacked) herbicide tolerance	2020-12-29	2025-12-28
25	Riceb	Huahui-1	Huazhong Agricultural University	cry1Ab-Ac	(Singular) insect resistance	2009-08-17	2026-02-09
26		BT Shanyou 63	Huazhong Agricultural University	cry1Ab-Ac	(Singular) insect resistance	2009-08-17	2026-02-09

^aAll cotton lines are not events, but varieties, since the GM crops were approved by variety but not event at the early stage

^bObtained “safety certificate”, but not commercialized for production

In addition to GM events approved for cultivation, so far since 2004 there have been 64 GM crop events approved for import as processing material in China. These events cover the 4 major commercialized GM crops, including corn, cotton, soybean and canola, with a total of 62 events, one event of GM papaya and one of GM sugar beet (Table 2).

Table 2.

Genetically modified crop events approved for import as processing materials (Oct. 3, 2022)

No	Crop	Event name	Applicant	Exogenous gene	Commercial trait	First approval date in China
1	Soybean	HB4	Verdeca	Hahb-4	(Singular) abiotic stress tolerance	2022-04-22
2		DBN9004	Dabeinong	Epsps, pat	(Stacked) herbicide tolerance	2020-06-11
3		MON87751	Monsanto	cry1A.105, cry2Ab2	(Singular) insect resistance	2020-06-11
4		DAS81419	Dow AgroSciences	cry1Fv3, cry1Ac (synpro)	(Stacked) insect resistance	2019-12-02
5		DAS-44406–6	Dow AgroSciences	2mepsps, aad-12, pat	(Stacked) herbicide tolerance	2018-12-20
6		SYHT0H2	Syngenta	avhppd-03, pat	(Stacked) herbicide tolerance	2018-12-20
7		MON87705	Monsanto	FAD2-1A/FATB1A, cp4 epsps	(Stacked) herbicide tolerance + modified product quality	2017-06-12
8		FG72	Bayer	2mepsps, hppdPf W336	(Stacked) herbicide tolerance	2016-12-31
9		MON87769	Monsanto	Pj.D6D, Nc.Fad3	(Stacked) modified product quality	2015-12-31
10		MON87708	Monsanto	dmo	(Stacked) herbicide tolerance	2015-12-31
11		A5547-127	Bayer	pat	(Singular) herbicide tolerance	2014-12-11
12		305,423 × GTS40-3–2	Pioneer	gm-fad2-1, cp4 epsps	(Stacked) herbicide tolerance + modified product quality	2014-12-11
13		CV127	BASF	csr1-2	(Singular) herbicide tolerance	2013-06-06
14		MON87701	Monsanto	cry1Ac	(Singular) insect resistance	2013-06-06
15		MON87701 × MON89788	Monsanto	cry1Ac, cp4 epsps	(Stacked) herbicide tolerance + insect resistance	2013-06-06
16		DP305423	Pioneer	gm-fad2-1	(Singular) modified product quality	2011-11-03
17		DP356043	DuPont	GAT, GM-HRA	(Stacked) herbicide tolerance	2010-12-30
18		MON89788	Monsanto	cp4 epsps	(Singular) herbicide tolerance	2008-08-28
19		A2704-12	Bayer	pat	(Singular) herbicide tolerance	2007-12-20
20		GTS 40–3-2	Monsanto	cp4 epsps	(Singular) herbicide tolerance	2004-02-20
21	Cotton	281–24-236	Corteva	cry1F	(Singular) insect resistance	2021-12-17
22		3006–210-23	Corteva	cry1Ac	(Singular) insect resistance	2021-12-17
23		COT102	Syngenta	vip3Aa19	(Singular) insect resistance	2015-12-31
24		GHB119	Bayer	cry2Ae, bar	(Stacked) herbicide tolerance + insect resistance	2014-04-10
25		T304-40	Bayer	cry1Ab, bar	(Stacked) herbicide tolerance + insect resistance	2014-04-10
26		GHB614	Bayer	2mepsps	(Singular) herbicide tolerance	2010-12-30
27		MON88913	Monsanto	cp4 epsps	(Singular) herbicide tolerance	2007-12-20
28		BollgardII(MON15985)	Monsanto	cry1Ac, cry2Ab	(Stacked) insect resistance	2006-07-20
29		LLCotton25	Bayer	bar	(Singular) herbicide tolerance	2006-12-20
30		MON531	Monsanto	cry1Ac	(Singular) insect resistance	2004-02-20
31		MON1445	Monsanto	cp4 epsps	(Singular) herbicide tolerance	2004-02-20
32	Maize	MON87411	Bayer	cry3Bb1, cp4 epsps (aroA:CP4), dvsnf7	(Stacked) herbicide tolerance + insect resistance	2020-12-29
33		MZIR098	Syngenta	ecry3.1Ab, mcry3A, pat	(Stacked) herbicide tolerance + insect resistance	2020-12-29
34		4114	Pioneer	cry1F, cry34Ab1, cry35Ab1, pat	(Stacked) herbicide tolerance + insect resistance	2018-12-20
35		DAS40278	Dow AgroSciences	aad-1	(Singular) herbicide tolerance	2017-06-12
36		MON87427	Monsanto	cp4 epsps	(Singular) herbicide tolerance	2017-07-16
37		5307	Syngenta	ecry3.1Ab	(Singular) insect resistance	2017-07-16
38		MIR162	Syngenta	vip3Aa20	(Singular) insect resistance	2014-12-11
39		3272	Syngenta	amy797E	(Singular) modified product quality	2013-05-21
40		MON87460	Monsanto	cspB	(Singular) abiotic stress tolerance	2013-05-21
41		Bt11 × GA21	Syngenta	cry1Ab, mepsps	(Stacked) herbicide tolerance + insect resistance	2011-11-03
42		MON89034	Monsanto	cry1A.105, cry2Ab2	(Stacked) insect resistance	2010-12-30
43		MIR604	Syngenta	mcry3A	(Singular) insect resistance	2008-08-28
44		MON88017	Monsanto	cry3Bb1, cp4 epsps	(Stacked) herbicide tolerance + insect resistance	2007-12-20
45		59,122	Pioneer/Dow AgroSciences	cry34Ab1, cry35Ab1	(Stacked) herbicide tolerance + insect resistance	2006-12-20
46		NK603	Monsanto	cp4 epsps	(Singular) herbicide tolerance	2005-07-08
47		TC1507	Pioneer/Dow AgroSciences	cry1F	(Stacked) herbicide tolerance + insect resistance	2004-04-06
48		MON810	Monsanto	cry1Ab	(Singular) insect resistance	2004-02-20
49		MON863	Monsanto	cry3Bb1	(Singular) insect resistance	2004-06-25
50		GA21	Syngenta	mepsps	(Singular) herbicide tolerance	2004-02-20
51		Bt176	Syngenta	cry1Ab	(Stacked) herbicide tolerance + insect resistance	2004-04-06
52		Bt11	Syngenta	cry1Ab	(Stacked) herbicide tolerance + insect resistance	2004-04-06
53		T25	Bayer	pat	(Singular) herbicide tolerance	2004-04-06
54	Canola	MON88302	Monsanto	cp4 epsps	(Singular) herbicide tolerance	2018-12-20
55		RF3	BASF	bar, barstar	(Stacked) herbicide tolerance + pollination control system	2018-12-20
56		MS1 x RF1 (PGS1)	Bayer	barnase, barstar, bar	(Stacked) Herbicide tolerance + pollination control system	2004-04-06
57		MS1 x RF2 (PGS2)	Bayer	barnase, barstar, bar	(Stacked) Herbicide tolerance + pollination control system	2004-04-06
58		MS8 x RF3	Bayer	barnase, barstar, bar	(Stacked) Herbicide tolerance + pollination control system	2004-04-06
59		T45	Bayer	pat	(Singular) herbicide tolerance	2004-04-06
60		Topas19/2	Bayer	pat	(Singular) herbicide tolerance	2004-04-06
61		Oxy-235	Bayer	oxy	(Singular) herbicide tolerance	2004-04-06
62		GT73	Monsanto	cp4 epsps, goxv247	(Singular) herbicide tolerance	2004-04-06
63	Papaya	55–1	University of Hawaii	PRSV CP	(Singular) disease resistance	2019-12-02
64	Sugar beet	H7-1	Monsanto	cp4 epsps	(Singular) herbicide tolerance	2009-04-20

Pilot work for GM soybean and corn

With a population of 1.4 billion people, including 800 million farmers, China is an agricultural country with a large population. However, due to the limited land resources, extreme weather, and frequent agricultural disasters, it has become increasingly difficult to meet the demand for an increase in crop yield solely by traditional crop breeding technologies. Thus, biotech breeding is a critical and inevitable choice. Under the background of the central government’s proposal of “respect science, strictly regulate and orderly promote the industrial application of biotech breeding”, to improve the efficacy of agricultural production, and solve current problems such as the fall armyworms and weeds in agricultural production, in 2021, MARA launched the pilot industrialization for herbicide-tolerant GM soybean and insect-resistant and herbicide-tolerant GM corn, which has obtained production and application safety certificates. According to results of this pilot work, GM soybean and corn have excellent insect resistance and herbicide tolerance, and have significant yield gains and ecological benefits. By statistics, planting of the GM soybean could reduce weeding cost by 50% and increase the yield by 12%; the efficacy of GM corn for controlling fall armyworms could reach 95%, with yield increases of 6.7–10.7%, and the pest control costs also being greatly reduced (China Business Network 2021).

The pilot process followed the rule of “unified seed supply, unified acquisition and unified technical specifications” and carried out regular inspections to avoid potential illegal spread. It showed that the planting of GM soybean and corn had no negative effects on insects and soil animal communities. The planting of GM corn reduced the use of pesticides and benefitted the ecological environment. Meanwhile, GM corn is less moldy due to low pest damage than conventional corn, and then the low mycotoxin within the corn also resulted in a good quality. In addition, GM herbicide-tolerant soybean and corn will benefit through reducing labor and applying the same herbicide in intercropping systems. These results indicate that application of GM soybean and corn could benefit agriculture and farmers (China Business Network 2021).

Pilot work on GM crops is both an exploratory enterprise and a technology test. It is also an important complementation for the safety systems (China Discipline Inspection and Supervision 2021; Economic Daily 2022). On the other hand, pilot GMO industrialization is not only a technology test, but also a social test, which must be supported by the public. Although the safety of GM technology and products can be maintained by scientific and technical principles, but this is not well known for public, scientific popularization, and thus, publicity is of prime importance and urgently needed. It is necessary to overcome the prejudice against GMOs. Pilot industrialization for GM soybean and corn contributes to establishing a good science popularization environment, and positively impacting public opinion, creating a good social foundation for the development and industrialization of biotech breeding technologies in China (China Business Network 2021).

Prospects

Modern agricultural biotechnology breeding includes the use of GM, gene editing, genome-wide selection, synthetic biology, and other technologies to carry out efficient, precise and targeted genetic improvement and variety breeding of animals and plants (Journal of the Chinese People’s Political Consultative Conference 2022). Promoting the industrialization of biotech breeding is an inevitable choice to promote the high-quality development of the modern seed industry and ensure national food security and the effective supply of important agricultural products. The potential risks related to the use of GMOs have been an important subject of concern and debate and have become one of the major issues faced by governments. Therefore, establishment of a well-developed regulatory system for risk assessment and management of GMOs is a prerequisite for safe and sustainable use of GM products. Over the past 30 years, the Chinese government has introduced a comprehensive set of laws, regulations, specifications, management systems for agricultural GMOs safety that are in line with the Chinese reality and international practices (Kou et al. 2015). This system ensures national crop security, food security, and sufficient supply of agricultural products, and also plays a positive role for public opinion and confidence for GMO crop production.

Although the Chinese regulatory system of agricultural biotechnology has been well established, there are some points to which we may need to pay more attention. First, the regulatory systems should achieve appropriate balance of rigor and efficiency (Matten et al. 2008). Going beyond the limit is as bad as falling short. The safety system should be able to promote the progress of scientific research and commercialization. Considering this situation, China may streamline the regulatory process of agricultural biotechnology to promote the development of research and related industries, of course, safely. Second, biotechnology, international situations and public attitudes are constantly changing; therefore, the future updates of regulations for GMO crops will always be necessary. For example, the regulations for gene-edited crops were involved in this system due to the development of biotechnology. Third, the well execution of regulations is of great importance. A good strategy is necessary and good execution is critical! The responsibilities and rights should be clear and implemented. Each member in this system must fulfill their own responsibilities, with appropriate consequences for any illegal act associated with GM crops.

Funding

This project was financially supported by the National Special Biological Breeding Program of the People’s Republic of China.

Data availability

Data sharing not applicable to this article as no datasets were generated or analyzed during the current study.

Declarations

Conflict of interest

On behalf of all authors, the corresponding author states that there is no conflict of interest. Author Kongming Wu was not involved in the journal’s review of this manuscript.