1. Wen Xiang Faculty of Law University of Copenhagen Denmark
Regulation of GMOs in China: Does it fit for genome editing techniques?
Wen Xiang
Faculty of Law
University of Copenhagen
Denmark

2. Outline Regulation of GMOs in China Safety Evaluation
Enhedens navn
Outline
Regulation of GMOs in China
Safety Evaluation
Approval procedure
Labelling regulation
Public awareness
Is regulation of GMOs applicable to genome editing techniques?
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3. Background
Considering the large population and limited farmlands, biotechnology could be helpful to solve China’s food security problem, but it may also raise concerns due to the lack of capacity for regulation of GMOs in China.
It is noted that China has shifted from a pro-GMO attitude to a more cautious approach since its adoption of Cartagena Protocol on Biosafety, and accompanied by the State Council Regulation on Safety of Agricultural GMOs (2001) and Ministry of Agriculture (MOA) Implementing Regulations on Biosafety of Agricultural GMOs (concerning safety evaluation, import as well as labelling, 2002)

4. Main Agricultural GMOs Regulations and Implementing Measures
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Main Agricultural GMOs Regulations and Implementing Measures
Regulation on the Safety Administration of Agricultural Genetically Modified Organisms (RSAAGMOs)
Measures on the Safety Evaluation Administration of Agricultural Genetically Modified Organisms (MSEAAGMOs)
Measures on Administration of the Import Safety of Agricultural Genetically Modified Organisms (MAISAGMOs)
Measures on Administration of Labelling of Agricultural Genetically Modified Organisms (MALAGMOs)
Issuing authority
State Council
Ministry of Agriculture (MOA, 2002a)
MOA, 2002b
MOA, 2002c
Date issued
May 23rd 2001
January 5th 2002
Date revised
January 8th 2011
July 1st 2004
Level of authority
Administrative Regulations
Departmental Rules
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5. Structure of China’s regulation of GMOs

6. Safety evaluation in China
The GMO Biosafety Committee is the risk assessor for GMOs. The committee members meet several times a year. It has standing committee, two special working groups specializing in plant GMOs and animal GMOs，each working group will be able to establish review groups on food safety aspect, environmental aspect, etc. if needed. The opinion will be submitted to the standing committee for approval. The Biosafety Committee members are appointed by the Joint-ministry meeting, many of them are from public authority affiliated research institutes, the rest members are university researchers

7. Enhedens navn
The guidelines regarding safety evaluation are contained in MSEAAGMOs. It provides specific principles on safety evaluation and application procedures in a step-by-step manner and on a case-by-case basis. In general, concept of substantial equivalence will apply for evaluation, which means that GMOs will be compared with their conventional counterparts for identification of the safety class. The GMO biosafety Committee can assign the safety evaluation to a set of designated research institutes either at the central level, or local level. There are more than 40 competent authorities are eligible for this, and the risk assessment pf GMOs is carried out on a case-by-case and step-by-step approach.
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8. Approval procedure of GMOs in China
In recent years, China's biotech approval process has gone “from being slow but predictable to even slower, unpredictable and nontransparent," said the American Chamber of Commerce in a policy report.
It is clear that MOA is taking a more cautious attitude towards the introduction of GM crop as staple crops. It is noted that a recent attempt to incorporate the socio-economic consideration into the safety assessment finally failed in the revision of Regulation of Safety Evaluation of Agricultural GMOs.

9. Approval procedure of GMOs in China
Ministry of Agriculture (MOA) is designated as the risk manager. The decision-making is made on the basis of result of the risk assessment taken by the GMO Biosafety Committee. If the opinion on the risk assessment is favourable, the Biosafety Certificate will be issued by the Ministry of Agriculture accordingly.
It is arguable that the GMO Biosafety Committee is the de facto risk manager since the MOA will be in line with its opinion.
Biosafety certificate is the first step for applicant to market their products, followed by application of seed certificate, and business license, etc.

10. Enhedens navn
Case of Bt rice
Bt rice proves to be the most controversial case in the approval process. In December two Bt rice (Huahui 1 and Bt Shanyou 63) were issued safety certificates and the term of validity of the certificates are five years. However, Bt rice varieties were de facto suspended in the pipeline for commercialization. The safety certificates were only renewed at the very last moment in December 2014 for another term of five years.
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11. Enhedens navn
Case of Bt rice
Two points are argued to explain the undue delay of the MOA to move step forward. Firstly, China is world’s largest producer of rice, meanwhile rice is one of the major staple foods for China. The public concern to the safety of Bt rice plays an important role. Secondly, illegal cultivation of unauthorized Bt rice were found in several provinces and placed in the market in recent years even before the Safety Certificate issued. Moreover, some trade partners, such as the EU and Japan, have been consistently reported that a number of unauthorized GMO ingredients were found in importing products from China.
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12. Enhedens navn
Labelling Regulation
The objectives of labelling regulations in China include five GMOs, i.e. soybean, corn seeds, rape seeds, cotton seeds and tomato seeds, and the products made directly from the above GMOs. The lack of any threshold in the Labelling Regulation results in de facto zero tolerance for labelling of GM products. It is then very difficult to deal with the contingent mixture with GMOs because of accidental factors and unavoidable technical factors. In the EU, the threshold is 0.9%, 3% in South Korea and 5% in Japan. Therefore, a national consistent threshold needs to be introduced into the Chinese labelling system for effective implementation, and to lower the cost of compliance for operators of GMOs as well.
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13. Enhedens navn
Secondly, within defining objectives, the labelling regulation only applies to agricultural GMOs and products made directly from the GMOs. There is no explanation of the term ‘directly from the GMOs’ in the relevant documents. Furthermore, the list of GM products that need to be labelled under the Labelling Regulation has not been updated since As the indirectly processed or deep-processed products are likely to contain GMO ingredients, the undefined norm will definitely cause confusion in implementation of GMO regulation. Then the legitimacy of labelling system would be undermined accordingly. This concern will be explained in the Nestlé labelling case.
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14. Enhedens navn
Nestlé Labelling Case
In December 2003, Miss. Zhu bought a Nestlé sweet (Qiao Banban) for her son, and found out from the internet that the product may contain GMO ingredients. She sued Nestle Company at the Shanghai No.2 Intermediate Court because the product was not expressly labelled with GM information, and violated her right to know as a consumer. The key point of this case was whether or not the product fell within the compulsory category. It should be noted that the deciding factor strongly relied on the detecting technical standard and method. The Court called the GM Food Laboratory of Shanghai Agricultural Academy to investigate the questioned product. The Laboratory first detected the GM ingredients with PCR (Polymerase Chain Reaction) methods, but then this was overruled by its second investigation with another national detection method, and ruled that no GMOs were found in the sample product.
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15. Enhedens navn
Nestlé Labelling Case
Miss. Zhu lost both the case and the appeal, but she raised a very interesting debate regarding producers’ labelling liability. According to the Consumer Protection Law, business operators should disclose the information regarding the products or services, and should not conduct false and misleading publicity. In this case, the court held two points to support the Nestlé company: The Nestlé products may not be covered by the compulsory list; No GM ingredients were found in the second investigation conducted by an authorized authority. Therefore, Nestlé did not have an obligatory legal responsibility to disclose the requested information, and did not bear any liability.
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16. Public Awareness of GMOs
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Public Awareness of GMOs
Several surveys have already been conducted by researchers to illustrate public awareness of GMOs in China. (Peng and Huang 2015, Zhang, et al., 2014). Peng and Huang carried out a research in 2015 on the basis of the data collected from 2002 to One of the major findings is that 45% of consumers believe that GMOs are with adverse effects to human health in 2012, compared to 13% in Similarly 36% consumers believe that GMOs are having adverse effects to environment, compared to 11% in It is important to note that almost 50% of consumers choose the option “I don’t know” during the survey both in 2002 and 2012.
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17. Public Awareness of GMOs
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Public Awareness of GMOs
Another survey (Zhang et al., 2014) illustrates that over 50% consumers hold negative opinion of GM food, and 40% of them are against GM rice, compared to 23% of those who are in favor of it. In addition, it indicates that over 75% people would like to know more about GM food, the number is even higher (80.5%) when they are told about the information of GMOs by scientists. The surveys conducted by the MOA research projects and natural science projects in 2009 and 2010, also found that over 60% of interviewees believe that risk communication is a necessity to enhance consumers’ confidence on GMOs.
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18. Lawsuits related to disclosure of information
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Lawsuits related to disclosure of information
There are several lawsuits in recent years fueled the debate regarding information disclosure of agricultural GMOs in China. The case Huang v. MOA failed to challenge the MOA in 2013, but it raised an issue regarding the scope of information be made publicly available. More importantly, competent authorities are starting to be aware of this necessity of communication. MOA stated in its response to the inquiry of Ms. Cai et al. in 2015 that it established an information disclosure platform at its official website. At the first time, the MOA detailed procedures and required documents for request for information with respect to agricultural GMOs. It concluded that it finalized 27 replies and 12 replies in 2014 and 2015 respectively among some 100 inquiries.
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19. Enhedens navn
Some considerations
Firstly, both the government and scientists should improve public awareness and participation in the decision-making process regarding Bt rice commercialization. Secondly, it is necessary for the government and related sectors to disclose decisions and safety information about Bt rice to the general public, in order to build communication platforms and improve the transparency of the decision-making process. The communication platforms need to be formalised, such as public hearing, case discussion, public forum, community discussion, etc. Bt rice, as a staple food, has significant influence on the public’s livelihood. Facing the uncertainties, a democratic decision-making mechanism which requires broad public participation helps to strike a higher degree of legitimacy of the final decision.
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20. Enhedens navn
Thirdly, scientists play an important role in shaping the public’s awareness regarding Bt rice. They undertake the social responsibilities of disseminating scientific information, fairly evaluating the risk and benefits of GM crops, and helping the public to become aware of the uncertainties of such varieties, etc. For a better communication platform, the gap between scientists and the general public needs to be bridged.
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21. Genome editing techniques: to be or not be GMOs
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Genome editing techniques: to be or not be GMOs
Two general legal approaches to regulating and defining GMOs:
Process-based approach:
GMOs are defined as arising from the use of certain specific methods.
Product-based approach:
GMOs are defined as having a new combination of genetic material that could not have occurred naturally.
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22. Breeding techniques and their products in the European Union (EU)
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Breeding techniques and their products in the European Union (EU)
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23. Breeding techniques and their products in the European Union (EU)
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Breeding techniques and their products in the European Union (EU)
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24. Directive 2001/18/EC on deliberate release of GMOs
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Directive 2001/18/EC on deliberate release of GMOs
Article 2 Definitions: (2) "genetically modified organism (GMO)" means an organism, with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination; Within the terms of this definition: (a) genetic modification occurs at least through the use of the techniques listed in Annex I A, part 1; (b) the techniques listed in Annex I A, part 2, are not considered to result in genetic modification;
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25. Directive 2001/18/EC on deliberate release of GMOs
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Directive 2001/18/EC on deliberate release of GMOs
Article 3 Exemptions 1. This Directive shall not apply to organisms obtained through the techniques of genetic modification listed in Annex I B. 2. This Directive shall not apply to the carriage of genetically modified organisms by rail, road, inland waterway, sea or air. ANNEX I B Techniques referred to in Article 3: Techniques/methods of genetic modification yielding organisms to be excluded from the Directive, on the condition that: they do not involve the use of recombinant nucleic acid molecules or genetically modified organisms other than those produced by one or more of the techniques/methods listed below are: (1) mutagenesis, (2) cell fusion (including protoplast fusion) of plant cells of organisms which can exchange genetic material through traditional breeding methods.
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26. Enhedens navn
Precision breeding results in point mutations, but does not create any new combinations of genetic material, and similar mutations occur naturally in conventional breeding. Such mutations are targeted in precision breeding, whereas they occur at random in conventional breeding and are often accompanied by other unknown mutations. Precision-breeding techniques do not insert recombinant nucleic acids into the genome and so would seem to be excluded from the class of processes that result in GMOs referred to in Article 3(1).
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27. Enhedens navn
However, the case is not clear cut. First, this article was written before precision-breeding techniques emerged. Second, in precision breeding, the enzyme (nuclease) that induces the formation of mutations is guided to its target site by recombinant nucleic acids (directly or indirectly) and, therefore, the process arguably involves the use of recombinant nucleic acid molecules. By contrast, according to a product-based approach, precision breeding should clearly be included among the techniques exempted in Article 3(1) of Directive 2001/18/EC.
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28. Enhedens navn
Regulation on the Safety Administration of Agricultural Genetically Modified Organisms (China)
Article 3: Agricultural genetically modified organism, as referred to in these Regulations, means animals, plants, microorganisms and their products whose genomic structures have been modified by genetic engineering technologies for the use in agricultural production or processing, which mainly include:
genetically modified animals, plants (including plant seeds, breeding livestock and poultry, aquatic fry and seeds) and microorganisms;
products of genetically modified animals, plants and microorganisms;
products directly processed from genetically modified agricultural products;
seeds, breeding livestock and poultry, aquatic fry and seeds, pesticides, veterinary drugs, fertilizers, additives and other products containing ingredients of genetically modified animals, plants and microorganisms or their products.
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29. Thank you!
References:
1. Risk Regulation of Agricultural GMOs in China: Challenges and Prospects. In Genetically Modified Organisms in Developing Countries.(eds) / Xiang, Wen. Cambridge University Press, 2017.
2. Accelerating the domestication of new crops: feasibility and approaches. / Østerberg, JT, Xiang, W, Olsen, LI, et al,: Trends in Plant Science, Vol. 22, No. 5, 2017, p
3. Feasibility of new breeding techniques for organic farming. / Andersen, MM, Landes, X, Xiang, W, et al., 2015: Trends in Plant Science, Vol. 20, No. 7, 2015, p
This project is supported by University of Copenhagen 2016 Excellence Programme “Plants for a Changing World”