STC Number - 395

China's proposed amendments to the implementation regulations on safety assessment of agricultural GMOs

Maintained by: China
Raised by: Paraguay; United States of America
Supported by:
First date raised: July 2015 G/SPS/R/79 paras. 3.16-3.18
Dates subsequently raised: October 2015 (G/SPS/R/81 paras. 3.42-3.44)
March 2016 (G/SPS/R/82 paras. 3.59-3.60)
June 2016 (G/SPS/R/83 paras. 4.47-4.48)
October 2016 (G/SPS/R/84 paras. 3.52-3.53 )
March 2017 (G/SPS/R/86 paras. 3.42-3.43)
March 2018 (G/SPS/R/90 paras. 3.18-3.19)
July 2018 (G/SPS/R/92/Rev.1 paras. 4.91-4.92)
November 2018 (G/SPS/R/93 paras. 3.50-3.51)
July 2019 (G/SPS/R/95 paras. 4.97-4.98)
Number of times subsequently raised: 9
Relevant documents: G/SPS/N/CHN/881
Products covered:
Primary subject keyword: Food safety
Keywords: Control, Inspection and Approval Procedures; Food safety; Genetically modified organisms (GMOs); Human health; Risk assessment; Transparency; Undue delays
Status: Not reported
Solution:
Date reported as resolved:

Extracts from SPS Committee meeting summary reports

In July 2015, Paraguay raised a concern about the inclusion of some socio-economic aspects in the Chinese risk assessment process for GMOs, contrary to Article 5 of SPS Agreement and to the guidance of the relevant international organizations recognized by the WTO. The amendments to the implementing regulations had been notified in G/SPS/N/CHN/881. Paraguay stated that the measures, which went beyond scientific principles, could lead to arbitrary or unjustified distinctions, and that the inclusion of these elements could undermine the production of safe food. Paraguay therefore requested China to reconsider the amendments to the regulations.

The United States shared Paraguay's concern, and stressed the importance of notification of such measures to allow trading partners to review proposed changes, provide and discuss comments, and see them being taken into account. The United States highlighted its concerns about the negative impact that policies related to regulatory approval procedures for biotech products could have on the ability of consumers and producers to reap the benefits of advances in technology through trade. The delays and lack of transparency in China's current biotech approval process meant that several products were pending at various stages in the process, despite the SPS Agreement's prohibition on undue delays in approval procedures and its obligation regarding standard processing periods and for a mechanism to resolve complaints. China was seeking to remove the specific timelines governing its regulatory review process, and was introducing new criteria referring to economic and social considerations. The United States had requested additional information from China in order to better understand the objectives behind the proposed changes. The United States also wished to ensure that the measures would comply with the SPS Agreement, and requested that China delay the implementation of the revisions to allow for a substantive dialogue with its trading partners. The United States further requested that China approve the currently pending events in a timely fashion and that the proposed changes to China's approval system not depart from the key tenets of timely, predictable science-based approvals required by the SPS Agreement.

China replied that the changes to its regulations aimed to enhance the management of safety evaluations for agricultural GMOs. The draft version of these management measures had been notified on 2 June and was open to comments until 1 August 2015. China indicated that it had not received comments from the United States and Paraguay, but would take any comments into consideration for further modification and improvement of the measures.

In October 2015, the United States again raised concerns with China's Proposed Amendments to the Implementation Regulations on Safety Assessment of Agricultural Genetically Modified Organisms, which amends the requirements for the safety assessment for genetically engineered products (notified as G/SPS/N/CHN/881). The United States appreciated the extensive and productive bilateral meetings held with Chinese authorities since the July 2015 Committee meeting. The United States also welcomed China's reaffirmation of the importance of implementing timely, transparent, predictable, and science-based approval processes that were based on international standards, as well as China's commitment to revise and improve its regulation based on comprehensive consultations with domestic and international stakeholders and to enhance its capabilities in safety administration and safety approval of agricultural biotechnology products. The United States noted again that there were 24 products pending at various stages in China's regulatory process, including seven poised for final adoption that had been pending as long as since 2010, and requested that China approve these products in a timely and expeditious fashion. The United States thanked China for its engagement and commitments to resolving this process.

Paraguay shared this concern about the inclusion of socio-economic aspects in the Chinese risk assessment process for GMOs, contrary to Article 5 of SPS Agreement and to the guidance of the relevant international organizations. Paraguay stated that the measures, which went beyond scientific principles, could lead to arbitrary or unjustified distinctions, and that the inclusion of these elements could undermine the production of safe food. Paraguay therefore requested China to reconsider the amendments to the regulations.

China replied that the changes to its regulations aimed to enhance the management of safety evaluations for agricultural GMOs in response to the rapid development of biotechnology and social and environmental concerns. The draft version of these management measures had been notified on 2 June and had been open to comments until 1 August 2015. China received comments from Australia, Brazil, Canada and the United States. China thanked Members for their comments and was now in the process of reviewing and analysing them. Feedback to Members would be provided through the proper channels. China assured Members that, in line with the relevant requirements of the SPS Agreement, China's agricultural GMOs safety evaluation would be based on science, taking into account the relevant economic factors. China remained ready to continue bilateral discussions and consultations with interested Members on this issue.

In March 2016, the United States again raised concerns with China's Proposed Amendments to the Implementation Regulations on Safety Assessment of Agricultural GMOs, which amended the requirements for the safety assessment for genetically engineered products, notified as G/SPS/N/CHN/881. The United States stated that China approved only three of the 11 pending products that were poised for final approval. The pending products were subject to technical and administrative questions. The United States viewed this as an attempt to slow down new product approvals by posing procedural questions, imposing regulatory requirements not used by other countries, and by asking questions outside of the contours of scientific evidence. Following the consensus between the presidents of the two countries and commitments made at the bilateral dialogues in November 2015, the United States expected that China's biotech reviews would move forward with greater transparency, timeliness, predictability and would rely on science as the only criterion for evaluating the products of agriculture biotechnology. The United States reiterated that China had also committed to revise its regulations, based on comprehensive consultation with domestic and international stakeholders, and to enhance its capability of safety administration and approval of agricultural products. Hence, the United States hoped to see China's concrete actions to achieve greater predictability in the approval process and to ensure that science based decisions were taken when amending its regulatory process, as indicated in G/SPS/N/CHN/881. In this regard, the United States looked forward to China's publication and notification of its final revision to Decree 8 upon completion of domestic procedures. Finally the United States noted that there were 22 products pending at various stages in China' regulatory process, including the eight products mentioned earlier, poised for final adoption. The United States appreciated the Chinese engagement to preserve a harmonious trade relationship.

China explained that its proposed amendments to the Implementation Regulations of Safety Assessment of Agricultural GMOs were aimed at improving the management of GMOs, in response to the rapid development of biotechnology, and social and environmental concerns. China reported that it was reviewing and analysing all comments and would provide Members with feedback through proper channels, while maintaining transparency. Further, China stated that its GMO safety management had always been based on internationally-acknowledged risk analysis principles, including risk assessment, risk management and risk communication. China also indicated that economic and social factors would not affect the scientific conclusions of risk assessment. This process, in turn, would make the decision-making process more transparent, promote development and trade while complying with SPS rules. China hoped to continue the bilateral consultation mechanism and discuss GMO-related concerns thoroughly in order to facilitate trade in a mutually beneficial manner.

In June 2016, the United States again raised its concern with the approval delay for products of agricultural biotechnology in China, and sought an update from China on its revised regulation on safety assessment of agricultural GMOs. The United States expressed appreciation for the bilateral dialogue that had taken place between Chinese and US officials, and based on this engagement, looked forward to the implementation of concrete action by China to ensure greater transparency, timeliness, and predictability in its approval process of biotech products. The United States requested with some urgency that action be taken regarding the eight products that were poised for final adoption in March 2016.

China reminded the Committee that a comprehensive system of regulations and technical protocols, all of which could be found on the website of the Ministry of Agriculture, had been put in place in accordance with the importance it attached to the safety management of agricultural GMOs. China declared that this GMO safety management was based on science and law, and that the procedure was clear and transparent. China indicated that the Implementation Regulations on Safety Assessment of Agricultural Genetically Modified Organisms was still under revision, that comments from Members were welcome and would be given full consideration, and that further feedback would be given to Members through proper channels.

In October 2016, the United States again raised its concern with the approval delay for products of agricultural biotechnology in China, and sought an update from China on its revised regulation on safety assessment of agricultural GMOs. The United States expressed appreciation for the bilateral dialogue that had taken place between Chinese and US officials, including the US-China strategic and economic dialogue held in Beijing in June 2016, and looked forward to the implementation of concrete action by China to ensure greater transparency and timeliness, and to rely on science-based risk assessment as the only criterion for the evaluation biotech products. The United States noted that China had taken a number of steps forward, including the issuance in July 2016 of its final revision of the regulation and the first meeting of its reconstituted national biosafety committee. The United States indicated that some uncertainty remained with regards to how these steps would translate into shorter and more predictable timelines for biotech approval. The United States also noted with some urgency that some products were still poised for final adoption, and stressed the importance of ongoing communication with these products' applicants. The United States encouraged China to take action on these pending products in a timely manner.

China stated that it attached great importance to safety management of agricultural GMOs and its GMO safety management had always been based on internationally recognized risk analysis principles and scientific information. China recalled that it had notified its draft amendment to the implementation regulations on safety assessment of agricultural GMOs to the WTO in June 2015. The comments received during the 60-day comment period were taken into careful consideration in finalizing the regulation. After fulfilling the WTO transparency requirements fully, the final rules entered into force on 1 October 2016. This amendment aimed at making the GMO safety assessment procedure more streamlined, transparent and science-based. With regards to the delay of the assessment process, China informed the United States that three out of the 11 applications submitted by the United States had been approved. During the process, China always kept the procedure transparent and had provided the United States with the detailed reasons for the non-approval of the eight pending applications. China had asked the United States to continue to provide additional necessary information to allow completion of their approval procedures. China noted that after having received the supplementary information requested, its experts were currently conducting assessments. China invited the United States to make use of bilateral mechanisms in order to further discuss this issue.

In March 2017, the United States again raised its concern with the approval delay for products of agricultural biotechnology and the lack of transparency and predictability in China's agricultural biotechnology regulatory process. The United States expressed appreciation for the high level bilateral engagement on these issues with China, but regretted that after the revision of its regulation some uncertainty remained with regards to whether and how the revisions would translate into shorter and more predictable timelines for biotech approval. The United States also noted that some products were still poised for final adoption, and stressed the importance of ongoing communication with the products' applicants. The United States encouraged China to take action on those pending products in a timely manner. Finally, the United States appreciated China's engagement and commitment to support beneficial trade in the products of agricultural biotechnology.

China stated that it attached great importance to safety management of agricultural GMOs, and that its GMO safety management had always been based on internationally recognized risk analysis principles and scientific information. China recalled that it had notified to the WTO its draft amendment to the implementation regulations on safety assessment of agricultural GMOs, and had reflected WTO Members' comments in the final rule. China reported that the implementation regulations on safety assessment of agricultural GMOs had entered into force on 1 October 2016. That amendment would make the GMO safety assessment procedures more streamlined, transparent and science-based. With regards to the assessment process, China informed the United States that the reason why eight applications had not been approved was that they had failed to pass the assessment of China's Safety Committee for Agricultural GMOs - the detailed reasons had been notified to the applicants in writing. China had asked the United States to continue to provide additional necessary information to allow completion of their approval procedures, and that its experts were currently conducting assessments based on the supplementary information received. China invited the United States to make use of bilateral mechanisms to further discuss the issue.

In March 2018, the United States reiterated its concern regarding China's proposed amendment to the implementation regulations on safety assessment of agricultural GMOs. The United States expressed its disappointment with the lengthy delays in product approvals by China, noting that there were currently ten products poised for final adoption, some of which had been under review since 2011. The United States highlighted the obligation under the SPS Agreement for Members to provide timely information to applicants on the processing periods, the completeness of documentation, and also to explain any delays in the process. The United States further requested China to provide such information to applicants, and to approve these products without further delay.

China emphasized the importance it placed on managing the safety of agricultural GMOs, highlighting that they were conducted on the basis of scientific assessment principles, consistent with international practice. In addition, its procedures were transparent and standardized, and no delays had been experienced in the examination and approval process. China also reminded the Committee that the measure had been notified in 2015, following which submitted comments, including those of the United States, had been reviewed and taken into consideration in the amended administrative measure issued in 2016. China provided an overview of its revised administrative measure, highlighting that the measure had not reduced the frequency of decisions taken; instead statistics had shown that imports of agriculture GMOs had rapidly increased, indicating the smooth trade of GMOs.

In July 2018, the United States reiterated its concern regarding China's biotech approval system and its consistency with WTO SPS obligations. The United States expressed its disappointment with the lengthy delays and extensive data requirements for product approvals by China, noting that there were currently ten products poised for final adoption, some of which had been under review since 2011. The United States highlighted Members' obligation under the SPS Agreement to provide precise and timely information to applicants on the processing periods, information requirements, and also to explain any delays in the process. The United States indicated that in March 2018 it had requested China to provide this information to applicants. China had held a meeting of its National Biosafety Committee to review applications, and the results of the meeting were expected within 270 days. The United States requested China to provide precise and complete information to applicants on the results of that meeting, highlighting that any lack of communication of these results would have a damaging impact on agriculture for the United States, but also on all China's trading partners. The United States further expressed its concern regarding the new data requirements imposed by China in March 2018 for some products that were pending final approval. The United States urged China to refrain from revising regulations that resulted in increased timelines, decreased transparency and predictability. The United States also requested China to inform all applicants of any new data requirements, to notify these to the WTO, as well as to publish these requirements. The United States looked forward to continuing discussions with China on this important issue.

China explained that the measure had been amended on the basis of scientific assessment principles. China indicated that it had notified to the WTO and trading partners a proposed amendment, taking into account other countries' practices and Members comments. China indicated its willingness to continue bilateral discussions with the United States.

In November 2018, the United States reiterated its concern over undue delays and the lack of predictability, transparency, and scientific basis for products approvals by China, highlighting the long-standing, robust and mutually beneficial trade of biotechnology products between their countries. The United States indicated that in March and July 2018 ten products remained poised for final adoption, most of which had been under review for five or more years. The United States asked China to provide precise and complete information to applicants on the processing periods, information requirements, as well as to explain any delays in the process. The United States noted that no meeting of China's National Biosafety Committee (NBC) had been held thus far in 2018, whereas its domestic legislation on biotech approvals required that the NBC met at least twice a year. Finally, the United States urged China to take into account its SPS commitments in any revision of its biotech regulation.

China explained that the measure had been amended in 2016 on the basis of scientific assessment principles, and the approval procedures were open and transparent. China had notified to the WTO and trading partners a proposed amendment, taking into account other countries' practices and Members' comments. Finally, China remained open for further bilateral discussions with the United States on this matter.

In July 2019, the United States reiterated its concerns about the delays and the lack of predictability, transparency, and scientific justification in China's pre-market approval procedures for the products of biotechnology. It was especially concerned with China's new requirements that applicants had to submit materials for tests to be conducted in China, instead of accepting packages from tests conducted outside of China. These new in-country data and testing requirements did not differentiate – in terms of exposure or risk – between imported products used for food, feed and processing or domestic products for cultivation. The requirements also decreased regulatory transparency and predictability and had not been notified to the SPS Committee. The United States requested China to publish precise and complete information on processing periods and information requirements, to publish in advance schedules for meetings of its National Biosafety Committee and to respond to applicants in a timely manner to explain any delays in processing a request. They also requested that China notify all changes to its SPS measures to the SPS Committee, allow comments from its trading partners, and to take such comments into account in finalizing changes to its measures.

China replied that its approval of biotechnology products was transparent and science-based. China attached great importance to the safe management of GMOs. China's National Agricultural Genetically Modified Organisms Safety Committee (NAGMOS) was responsible for the safety evaluation of GMOs in China. Applicants were notified when their products were not approved, and they could always resubmit their applications for review with additional required data and materials.