UNEP-GEF PROJECT ON THE SUPPORT FOR THE IMPLEMENTATION OF THE NATIONAL BIOSAFETY FRAMEWORK OF CHINA

Transcription

1 UNEP-GEF PROJECT ON THE SUPPORT FOR THE IMPLEMENTATION OF THE NATIONAL BIOSAFETY FRAMEWORK OF CHINA QUARTERLY OPERATIONAL REPORT: 1 APRIL JUNE 2004 a. Results of the planned activities General 1. The third expert meeting of the UNEP/GEF Project on Implementation of the National Biosafety Framework of China The third expert meeting of the UNEP/GEF Project on Implementation of the National Biosafety Framework of China was held in Beijing on th April This meeting was intended mainly to promote the smooth implementation of the project, get to know the existing problems and identify the working plans for 2004 and Present at the meeting were 21 experts and representatives, who participate in the project, from the Biosafety Office of SEPA, the Ministry of Education, the Ministry of Agriculture, the Ministry of Health, the State Forestry Administration, Chinese Academy of Sciences, Foreign Economic Cooperation Office (FECO) and Nanjing Institute of Environmental Science (NIES) of SEPA. The meeting was organized by the Biosafety Office of SEPA and presided by Pro. Xue Dayuan, (Professor, NIES of SEPA). Mr. Zhu Guangqing, (Deputy Chief, Director, Biosafety Office of SEPA), and Mr. Zhang Yongchun, (Deputy Director-General of NIES, SEPA), delivered the opening speeches. Pro. Xu Haigen, (NIES, SEPA), then introduced the targets and major activities of the project and the main jobs which have been accomplished. The leaders of each task group introduced the progress made in the following areas; policy, regulation, risk assessment, monitoring, public information and public participation. Dr. Jianzhi Zhang ( Biosafety Office of SEPA) introduced the basic requirements of UNEP/GEF projects and informed the meeting that the Biosafety Office was actively communicating with UNEP and had made arrangement for a teleconference with the Task Manager of UNEP/GEF on 30 th April. The participants came up with the following opinions and suggestions: 1) To intensify the biosafety regulatory Regime of the country. It was essential to work out a comprehensive biosafety law that would comply with the Cartagena Protocol on Biosafety (CPB), through the process of analyzing the existing biosafety regulatory regime in China, and at the same time come up with an integrated and centrally coordinated biosafety management system. 2) To make further progress on the case study reports on risk assessment and risk management of living modified organisms, so that these would form the basis for the compilation of technical guidelines for risk assessment and risk management of living modified organisms. 3) It was suggested that coordination with related departments shall be intensified. More experts who are working on the six major transgenic plants (soybean, cotton, corn, rice, rape and poplar) in China will be invited to join the project. The index systems. 1

2 and the monitoring methods for environmental impact by GMOs will be established or developed. 4) It was suggested that SEPA will further coordinate with MOA on the construction of a Biosafety Clearing House (BCH) and SEPA will improve the management mechanism and operation of the BCH. Mr. Zhu Guangqing made a conclusion speech and came up with some recommendations. 2. The teleconference between SEPA and UNEP In order to strength the communication with UNEP, discuss the work plan, identify the priorities of the Project, know how to prepare the right progress report and financial report, a teleconference was held between SEPA and UNEP on April 30, At first, SEPA introduced the new national coordinators (Mr. Zhuang Guotai, Deputy Director-General, and Mr. Zhu Guangqing, Director) and the contact person (Dr. Zhang Jianzhi) for the project and their duties. SEPA understood the requirements of the progress report and financial report of UNEP/GEF projects in detail and suggested that the project should be implemented according to the project work plan. Given the enormous amount of work mentioned in the work plan, and considerable delay of the progress of the project behind the schedule that was required by the project document due to various reasons, UNEP suggested that the priorities should be identified, such as what should be done in 2004 and 2005, and the report of progress of the risk assessment research should be submitted. One of the priorities identified by SEPA is the assessment of biosafety legislation in China and preparation of a comprehensive national law for biosafety. SEPA is actively organizing some experts to investigate and research, and is preparing to draft the Biosafety Regulation of the People s Republic of China, based on the requirements of the Biosafety Protocol. SEPA will try to promulgate the Regulation before the end of the project, however SEPA also recognizes that it will take a lot of time to communicate and coordinate with the related ministries for approving the Regulation. SEPA requested UNEP to assemble a panel of independent international experts to provide a technical review of the existing biosafety regulatory system of China. SEPA sent UNEP the English version of the existing biosafety regulations on 10 May. SEPA agreed to revise the progress and financial reports according to the suggestions and comments given by UNEP, and would further discuss the adjustment on budget with UNEP. After the conference, UNEP drafted and sent the minutes of the discussion to the Biosafety Office, SEPA. In the minutes, the requirements of the progress report, financial report, budget adjustment of project, time of submission of the existing biosafety regulations in English version were clarified. On that day, the conference minutes were discussed and amended by the Biosafety Office, SEPA. The revised minutes were then sent to UNEP.. 2

3 3. The Clarification of the priorities of the work plan and readjustment of the budget In response to the requirements set forth in the teleconference minutes, SEPA submitted to UNEP an Additional statement on the work plan for the UNEP/GEF Project on Implementation of the National Biosafety Framework of China, and clarified the order of priority and schedule for all the activities, and put forth a readjusted budget. SEPA submitted and revised the progress report and financial report in the first quarter of 2004 and the readjusted budget of the project, according to the comments of UNEP. Attached documents - Annex 1: the Minutes of the third expert meeting of the UNEP/GEF Project on Implementation of the National Biosafety Framework of China Biosafety Policy The team headed by Prof. Xia Youfu, Research Centre for Technical Barriers to Trade, the University of International Business and Economics, has further amended the report on Strategies for Chinese government to comply with the Biosafety Protocol and WTO obligations. Experts including Pro. Xue Dayuan, Nanjing Institute of Environmental Science, SEPA, will further revise and improve these thematic reports and compile an overall report on biosafety policies. Regulatory regime SEPA organized the translation of the Regulations on Safety of Agricultural Genetically Modified Organisms, Implementation Regulations on Safety Assessment of Agricultural Genetically Modified Organisms, Implementation Regulations on the Safety of Import of Agricultural Genetically Modified Organisms, and Implementation Regulations on Labelling of Agricultural Genetically Modified Organisms and submitted the English versions of these documents to UNEP. Upon receiving these documents, UNEP contacted the independent international experts from the governments, international organizations, academic groups, NGOs and private institutions to make one independent panel, who would volunteer to assess the biosafety regulations in China. The experts are expected to give the feedback to SEPA after end July. According to the need of the country for biosafety management and the progress in biosafety legislation, SEPA plans to organize Chinese experts to draft a biosafety law. Dr. Xue Dayuan, Nanjing Institute of Environmental Science, SEPA, has set down a work plan for drafting the Biosafety Law. The plan outlines the tasks for drafting of the Biosafety Law, including: 1) conduct in-depth topical research and prepare a special analysis and verification report; 2) draft the text of the Biosafety Law (draft for review and approval); 3) draft a statement on legislation of the Biosafety Law ; 4) consult various experts to solicit comments and opinions. According to the work plan, organizational arrangement, working procedures and schedule for drafting the Biosafety Law are also specified. It is anticipated that by May and June 2005, amendment of the draft text of the Biosafety Law will be completed.. 3

4 System to handle request Mr. Wang Xuejun, from the Office of Biosafety Management on Agricultural Genetically Modified Organism, MOA, wrote a report on the Procedures for application, safety evaluation and approval of living modified organisms in China (Annex 2). which presents a brief introduction on the institutions in charge of the application, safety evaluation and approval of agricultural genetically modified organisms(gmo). It introduced the procedures of safety evaluation of living modified organisms intended for research, testing and production, including the procedures of reporting system for lab research of Safety Grade III and IV and restricted field-testing of all safety grades of agricultural genetically modified organisms. Procedures for examination and approval system for enlarged field-testing, productive testing and safety certificates were included in the report. Procedures for safety management of import of agricultural genetically modified organisms, including the procedures for safety management of agricultural genetically modified organisms imported for use in research, testing and production as well as for use as raw materials in processing were also described. The report also described details on procedures for examination and certification of agricultural genetically modified organism labels. These procedures for application, safety evaluation and ratification all have clearly identified roles and responsibilities of specific agencies involved, including requirements such as administrative institutions, application forms, major indices for safety evaluation and ratification, and deadlines for response and decision making. Dr. Wan Fanghao and Ms Guo Jianying, (Institute of Biological Control, Chinese Academy of Agricultural Sciences), Dr. Liu Biao and Professor Wang Changyong, (Nanjing Institute of Environmental Sciences, SEPA), Prof. Zhang Guoan, (College of Plant Sciences and Technology, Huazhong Agricultural University), Dr. Zhang Zhen, (Institute of Forest Eco-environment and Protection, Chinese Academy of Forestry Sciences), Dr. Xu Haibin, (Institute of Nutrition and Food Safety, Chinese Center for Disease Control and Prevention) and other experts who are charged with compiling the technical guideline for risk assessment and risk management of genetically modified organisms, attended the third expert meeting of the project. At this meeting, a preliminary scheme was put forth for the amendment and finalization of case study reports. Case study reports of the technical guideline for risk assessment and risk management include: Transgenic fish (Liu Shaojun, College of Life Sciences, Hunan Normal University) Transgenic pest-resistant Bt cotton (Guo Jianying) Herbicide-tolerant soybean (Wang Changyong) Transgenic Bt rice (Zhang Guoan) Transgenic Bt polar (Zhang Zhen) Transgenic nifa Pseudomonas stutzeri (Lu Wei, Institute of Biotechnology Research, Chinese Academy of Agricultural Sciences) Transgenic Bt fluorescent pseudomonas (Chen Zhongyi, who went to the United States in May 2004 and will work there for two years. As no suitable substitute can be found in China to continue his work, the case study has to stop.) Food safety (Xu Haibin). 4

5 On May 23, 2004, Dr. Xu Haigen, Mr. Liu Biao visited the Institute of Biological Control, Chinese Academy of Agricultural Sciences, to talk about how to compile the technical guideline for risk assessment and risk management of genetically modified organisms with Dr. Wan Fanghao, Prof. Zhang Guoan and Ms. Guo Jianying. After the discussion, a reference model and a schedule for further amendment and finalization of the case study reports were specified, with the following arrangements: (1) Mr. Liu Biao is to distribute the scheme for amendment of the case study reports via to the experts concerned, who will then follow the scheme (Annex 3 & 4) to modify and perfect their own case study reports, respectively. (2) As the case study reports are the foundation for compilation of the technical guideline for risk assessment and risk management of genetically modified organisms, the experts are expected to finish the tasks within the period from June to September 2004, though the workload of amending the reports is rather heavy. It is tentatively decided that the experts will have to get together at the end of September 2004 to discuss and finalize the manuscripts. Presently, the work of amending and finalizing the case study reports is under way as scheduled and is expected to be successfully accomplished by the end of September Attached documents - Annex 2: Procedures for application, safety evaluation and approval of living modified organisms in China - Annex 3: Scheme for Amendment of Case Study Reports for the Technical Guideline of Risk Assessment and Risk Management of Transgenic Organisms - Annex 4: Guide for compilation of technical guideline for risk assessment and risk management of various environmental problems Monitoring and Enforcement 1 Risk assessment and environmental monitoring of transgenic cotton On April 10 th and June 10 th 2004, two lots of soil samples were collected from the Cotton Research Institute of the Chinese Academy of Agricultural Sciences (Anyang, Henan), and each lot had 45 soil samples gathered from 5 cotton fields, one having been cultivated with conventional cotton for 7 years in a row and the other four with insect-resistant transgenic cotton for 1, 2, 4 and 7 years, respectively. Each field, 3 Mu in area, had 3 sampling points and from each point, 3 samples were collected. Data of the soil microbes in the samples were obtained after analysis of the samples by the BIOLOG GN and flat band methods, which are used mainly to find changes in soil microbes through comparison. According to the work plan, the Cotton Research Institute grew bivalent insect-resistant cotton and conventional cotton (CK) in April 2004 and will gather pollen from these cotton crops in early July. 2 Risk assessment and environmental monitoring of transgenic soybean (1) As wild soybean could not germinate uniformly in the field, a makeshift greenhouse was erected in the field on April 2 nd 2004, to ensure uniform germination.. 5

6 (2) According to the deigning of the testing (including sites, area and cultivation pattern in the field, etc.), both wild soybeans and herbicide-tolerant transgenic soybeans were sown through dibbling in the fields on May 26 th 29 th, Currently the transgenic soybeans are in florescence whereas only a few of the wild soybean plants blossomed. In order that the transgenic soybeans and the wild soybean are synchronised in their florescent period, transgenic soybeans were sown again in the plots. Now the seedlings of the soybean are 15 cm high. (3) After sowing, major field management practices including weeding three times with hoe, filling the gap with seedlings and transplanting were carried out. (4) In the greenhouse, some transgenic soybeans and wild soybeans are grown in pots and sprayed in separate lots with glyphosate at different concentrations so as to determine the lethal dose for the wild soybeans in the field. (5) On May 27 th, 2004, seeds of the wild soybeans suspected to have been the result of pollination by pollen from transgenic soybeans were sown into the field and sprayed with the herbicide Glyphosate on July 2 nd and for the second time on July 10 th. It was found that some wild soybean plants have died. (6) To determine reaction conditions for detection of PCR in glyphosate-tolerant transgenic soybeans, amplification experiments on the endogenous gene (Lectin) and exogenous gene (CP4 EPSPS) in soybeans began on May 25 th., using the pot-cultured transgenic and wild soybeans which were grown indoors. Thus the PCR reaction conditions for amplification of these genes had been determined. Attached documents - Annex 5 Progress in risk assessment and environment monitoring of transgenic cotton and soybean in the second quarter of 2004 Public information and participation SEPA is in the process of negotiating with MOA on construction of the national agricultural biosafety clearing house. Ms. Li Wei and Ms. Lu Yan, from the Information Center, SEPA, maintain and update the website of the national biosafety clearing house regularly (at least once or twice a week). They also developed a remote system for the submission of news in the website. b. Constraints and suggested solutions Up to now, the Chinese government has not yet approved the Protocol. The management of biosafety affairs has some overlaps with different ministries. During the implementation of the UNEP/GEF Biosafety Framework Project of China, communication and coordination among relevant departments would be further enhanced. c. Planned activities for the next quarter General One meeting of the National Coordination Committee for CBD Implementation in China will be held in SEPA in September The achievements of the Project will be communicated and discussed at the meeting.. 6

7 The Biosafety Office, SEPA will further communicate and coordinate with other related departments. Biosafety policy The existing thematic policy research report will be modified, and an overall report of the policy research will be prepared. Regulatory regime Around the end July 2004, the independent international panel will give their comments and opinions on the existing biosafety regulations of China to SEPA. These documents will be translated into Chinese, and then the Chinese copies will be submitted to the high-level officials of SEPA. SEPA will also organize some Chinese experts to discuss these documents. Specific research, survey and expert consultation related to biosafety law would be carried out. System to handle requests Efforts will continue to amend the case study reports for compiling the technical guideline for risk assessment and risk management of genetically modified organisms. Monitoring and inspections Based on the scheme specified in the first quarter progress report of 2004 for risk assessment and monitoring of environmental impact, the work of risk assessment and environmental monitoring of transgenic cotton, rape, poplar and soybean will continue. Public information and participation Continued efforts will be devoted to update and maintain the network system of the National Biosafety Clearing-house of China.. 7