Getting an Imported GM Crop Approved in China

What are the procedures and trends for obtaining approval for imported genetically modified (GM) crops in China, and how do approval dates and length of approval in China compare with those in other countries? The answers are crucial for current food security in China and the future of crops derived by gene editing. What are the procedures and trends for obtaining approval for imported genetically modified (GM) crops in China, and how do approval dates and length of approval in China compare with those in other countries? The answers are crucial for current food security in China and the future of crops derived by gene editing. With only 6% of fresh water and 7% of arable land in the world, China must nurture nearly 20% of the world population [1Wong A.Y. Chan A.W. Genetically modified foods in China and the United States: a primer of regulation and intellectual property protection.Food Sci. Hum. Wellness. 2016; 5: 124-140Crossref Scopus (27) Google Scholar]. Imports of food commodities are an important component of China’s food security strategy. However, it is demanding to obtain approval for imported GM crops in China [2Huang J. et al.Genetically modified rice, yields, and pesticides: assessing farm-level productivity effects in China.Econ. Dev. Cult. Change. 2008; 56: 241-263Crossref Scopus (41) Google Scholar]. In this article we describe the approval process for GM crops in China, and compare the approval dates and length with those in the USA, Canada, and the EU. The length of the approval process and related differences have implications for food security in China, in particular because this may also affect the approval of food products derived from new plant breeding techniques [3Eriksson D. et al.A comparison of the EU regulatory approach to directed mutagenesis with that of other jurisdictions, consequences for international trade and potential steps forward.New Phytol. 2018; (Published online December 13, 2018. https://doi.org/10.1111/nph.15627)Crossref Scopus (68) Google Scholar]. The approval process for GM crops in China is complex and is almost exclusively overseen by the Ministry of Agriculture and Rural Affairs (MARA). The process starts with a biotech seed developer applying for a biosafety certificate. The application in China is not allowed until the variety has been approved in its country of origin for the same usei. The GM product is then examined for food safety, gene flow, nontarget organism effects, and other potential risk factors. A three-phase process then starts: field trials (equivalent to small contained trials in the USA), environmental release trials (known as farmer field trials in the USA), and preproduction trials [2Huang J. et al.Genetically modified rice, yields, and pesticides: assessing farm-level productivity effects in China.Econ. Dev. Cult. Change. 2008; 56: 241-263Crossref Scopus (41) Google Scholar]. In preproduction trials (on fields larger than 2 hectares and smaller than 66.7 hectares), farmers receive seeds, and scientists do not influence the cultivation [2Huang J. et al.Genetically modified rice, yields, and pesticides: assessing farm-level productivity effects in China.Econ. Dev. Cult. Change. 2008; 56: 241-263Crossref Scopus (41) Google Scholar]. Preproduction trials are only required when the developer applies for cultivation. Imported GM crops to be used as processing material do not need to go through this last phasei. In parallel with the three-phase process, research institutions or universities assigned by MARA conduct food safety tests. Foreign applicants for GM biosafety certificates need to document prior research and testing conducted in their country of origin. They also need to document that the exporting country or other countries have allowed commercialization of the GM product for the same intended use as that applied for in China. After MARA has issued the biosafety certificates, imported GM crops are allowed for commercialization as processing material. If they are used for cultivation in China, another three documents are needed: a seed variety certificate showing successful new crop variety registration, a production license for a new crop variety, and a marketing license for commercialization of a new crop variety (Box 1).Box 1The Three Main Governmental Departments and Committees Involved in the Approval ProcessMinistry of Agriculture and Rural Affairs (MARA)MARA is the primary department in charge of the approval process for domestic and imported GM crops. During the approval process, in addition to technical assessments and field trials, socioeconomic and political factors are also taken into consideration by MARA, but it is not clear to what extent. MARA makes a final decision on issuing biosafety certificates and registering seed varieties.National Agricultural GMO Biosafety Committee (NABC)Established by MARA, NABC nominates scientists from various disciplines as NABC members to perform technical assessments and evaluate applications for biosafety certificates. NABC gives recommendations to MARA on issuing biosafety certificates based on the results of analysis.National Crop Variety Registration Committee (CVRC)Established by MARA, CVRC nominates experts in research, production, marketing, and management to conduct field trials and evaluate applications for seed variety registration. CVRC gives recommendations to MARA on seed variety registration based on the results of analysis. Ministry of Agriculture and Rural Affairs (MARA) MARA is the primary department in charge of the approval process for domestic and imported GM crops. During the approval process, in addition to technical assessments and field trials, socioeconomic and political factors are also taken into consideration by MARA, but it is not clear to what extent. MARA makes a final decision on issuing biosafety certificates and registering seed varieties. National Agricultural GMO Biosafety Committee (NABC) Established by MARA, NABC nominates scientists from various disciplines as NABC members to perform technical assessments and evaluate applications for biosafety certificates. NABC gives recommendations to MARA on issuing biosafety certificates based on the results of analysis. National Crop Variety Registration Committee (CVRC) Established by MARA, CVRC nominates experts in research, production, marketing, and management to conduct field trials and evaluate applications for seed variety registration. CVRC gives recommendations to MARA on seed variety registration based on the results of analysis. Genetically modified organisms (GMOs) have been approved for import since 2002. We have analyzed the approval length of all GM crops submitted successfully for import as processing material between 2002 and 2017, as reported by MARA (50 varieties). We excluded domestic GM crops because the data are not publicly available. We measured the approval length as the number of months between the filing of the application and the issuance of the biosafety certificate. For the 50 imported GM varieties which have passed the approval process in China, the average approval length was 34 months, with a maximum of 71 months for MIR162 maize and a minimum of 18 months for MIR604 maize (Table S1 in the supplemental information online). Figure 1A shows that the approval length has increased considerably since 2010. We suggest two important causes, similar to the reasons suggested in [4Smart R.D. et al.Trends in approval times for genetically engineered crops in the United States and the European Union.J. Agric. Econ. 2017; 68: 182-198Crossref Scopus (54) Google Scholar] for the increase in approval length in the USA. First, there have been increasing public concerns since MARA issued biosafety certificates for Bt rice in 2009 [5Qu Y. et al.Survey analysis of the cognition of GMO risk and safety among Chinese public.J. China Agric. Univ. 2011; 16: 1-10Google Scholar]. Second, the Minister of Agriculture, who had a background in plant breeding and was supportive of GMO crops, was replaced by a less supportive minister with a background in law in December 2009. After 2010, it took on average of 15–16 months longer to approve an imported GM crop in China. For the 50 imported GM varieties, we find that the approval length varies according to different trait types, number of traits, companies, and crop type (Table S1). In addition, the approval length of maize is considerably longer (by 10–11 months) than for cotton (Table S2). The reason might be that China is largely self-sufficient in maize production and has a sizable stock of the commodity. Biotech seed developers are allowed to apply for the biosafety certificate in China only when a GM crop variety has been approved in the country of origin for the same use (see above). Of the 50 imported GM crop varieties approved, 46 were previously approved in the USA, and 47 in Canada. This policy results in approval asynchronicity and creates an invisible delay with significant trade impacts [6Faria R.N. Wieck C. Empirical evidence on the trade impact of asynchronous regulatory approval of new GMO events.Food Policy. 2015; 53: 22-32Crossref Scopus (20) Google Scholar]. Figure 1B shows that in China the same GM variety is approved on average 1544 days (4.2 years) after it has been approved in the USA, and 1783 days (4.9 years) after approval in Canada. A comparison of 32 crops that have been approved in both China and the EU indicates that the same GM crop is approved on average 1 year earlier in China. Although the previous comparisons indicate that China was not the first mover in the area of GM technology (at least relative to the USA and Canada), once the approval process starts it is shorter in China than elsewhere. We compared 19 GM crop varieties which have been approved in China, the USA, and the EU (relevant data for Canada are not available). We find that the average approval length is 2.9 years in China, 4.8 years in the EU, and 5.9 years in the USA. These results suggest that, once the approval process for imported GM products starts, it tends to be the shortest in China. Direct comparison with the USA is not possible because a large proportion of the required information is generated in the country of first submission, the USA. The shorter length for approval in comparison to the USA indicates that China benefits from the safety assessments conducted in the USA. The situation is different for comparisons with the EU, where the approval process for import can be considered to be more time-consuming than in China. A major underlying cause is the fact that the EU has a so called ‘risk management’ phase which is highly politicized [7Smart R.D. et al.EU member states’ voting for authorizing genetically engineered crops: a regulatory gridlock.Ger. J. Agric. Econ. 2015; 64: 244-262Google Scholar] and which contributes substantially to approval length [4Smart R.D. et al.Trends in approval times for genetically engineered crops in the United States and the European Union.J. Agric. Econ. 2017; 68: 182-198Crossref Scopus (54) Google Scholar]. Slow approval processes can hamper the commercialization of new GM crops. The largest potential constraint to commercialization is regulatory delay [8Kalaitzandonakes N. et al.Compliance costs for regulatory approval of new biotech crops.Nat. Biotechnol. 2007; 25: 509-511Crossref PubMed Scopus (128) Google Scholar, 9Purnhagen K. Wesseler J. Maximum vs. minimum harmonization: what to expect from the institutional and legal battles in the EU on gene editing technologies?.Pest Manag. Sci. 2019; (Published online February 3, 2019. https://doi.org/10.1002/ps.5367)Crossref PubMed Scopus (15) Google Scholar]. China, in common with many other countries in the world, experiences this delay, most particularly since 2010 when biosafety certificates for GM rice were issued by MARA. Because increasing national food security and improving agricultural productivity are major agricultural policy goals, the Chinese government has started to take action again in policy support since 2016. The 13th Five-Year Plan for Science and Technology Innovation aims to push forward the commercialization of new domestic GM crops by 2020ii. In the same year, MARA revealed a roadmap for commercializing GM crops, starting with cash crops ‘not for food use’ (e.g., cotton), followed by crops used as input for feed and industrial use (e.g., maize), and finally by staple food crops (such as rice)iii. Although each year more than 10 million tons of GM soybean oil have been sold with compulsory GM labeling in China since the early 2000s [10Huang J. et al.Impacts of and attitudes toward GM technology in China: challenges, policy and research implications.China Agric. Econ. Rev. 2017; 9: 334-339Crossref Scopus (10) Google Scholar], most Chinese agribusiness managers still oppose GM food adoption because they expect lower profits [11Deng H. et al.Attitudes toward GM foods, biotechnology R&D investment and lobby activities among agribusiness firms in the food, feed, chemical and seed industries in China.China Agric. Econ. Rev. 2017; 9: 385-396Crossref Scopus (16) Google Scholar]. In July 2018, MARA released a report on how to increase public knowledge of GMOs to push forward their commercialization. The strategy includes closer cooperation between local governments and mainstream mediaiv. The consequences of the policy strategy on promoting commercialization and increasing public knowledge for the approval process are not yet known. A direct positive impact on approval length at first sight might not exist because the same main governmental agencies are involved in the approval process. At second sight, the overall policy climate towards GMOs might be positively affected, with an overall positive effect on the approval process [4Smart R.D. et al.Trends in approval times for genetically engineered crops in the United States and the European Union.J. Agric. Econ. 2017; 68: 182-198Crossref Scopus (54) Google Scholar, 12Wesseler J. Zilberman D. Golden rice – no progress to be seen. Do we still need it?.Environ. Dev. Econ. 2017; 22: 107-109Crossref Scopus (5) Google Scholar]. The potential change in the trend will be of great interest for those working with genome-editing technologies in plant breeding to give them a better idea about what to expect [13Purnhagen K. et al.EU court casts new plant breeding techniques into regulatory limbo.Nat. Biotechnol. 2018; 36: 799-800Crossref PubMed Scopus (34) Google Scholar, 14Pray C. et al.Prospects for cultivation of genetically engineered food crops in China.Global Food Secur. 2018; 16: 133-137Crossref Scopus (16) Google Scholar]. Expectations are that genome-editing may be accepted by the public more easily [15Gao W. et al.Risk analysis for genome editing-derived food safety in China.Food Control. 2018; 84: 128-137Crossref Scopus (24) Google Scholar]. Possibilities for accelerating the approval process include immediate approval for the import and processing of GMOs that have received approval in the country of origin. Although the issue is controversial, this can substantially reduce trade disruptions caused by asynchronous approval, and increase the comparative advantage of food production in China. iwww.moa.gov.cn/ztzl/zjyqwgz/zcfg/201007/t20100717_1601304.htm iiwww.gov.cn/zhengce/content/2016-08/08/content_5098072.htm iiihttp://politics.people.com.cn/n/2014/1206/c1001-26158566.html ivwww.moa.gov.cn/govpublic/KJJYS/201807/t20180713_6154028.htm vwww.moa.gov.cn/ztzl/zjyqwgz/spxx/201307/t20130702_3509313.htm viwww.aphis.usda.gov/aphis/ourfocus/biotechnology/permits-notifications-petitions/petitions/petition-status viiwww.canada.ca/en/health-canada/services/food-nutrition/genetically-modified-foods-other-novel-foods/approved-products.html The following are Supplementary data to this article: Download .docx (.06 MB) Help with docx files Download .docx (.03 MB) Help with docx files

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