Study On Biosafety Assessment And Monitoring System Of Transgenic Crops

The current large scale commercialization biotech crops are belong to the first generation of biotech crops—insect resistant and herbicide tolerant biotech crops. A serials of policies and regulations for biosafety assessment and monitoring measurements for the first generation of biotech crops have been published by the international organizations, foreign countries, as well as the Chinese government. With the rapid development of second generation of biotech crops globally, many countries and international communities have published their policies and regulations regarding to the biosafety assessment and monitoring measurements for these new biotech crops. However, the Chinese government did not publish any new policy or regulation yet regarding to the new generation of biotech crops. Therefore, it is very significant to study the biosafety assessment method to the new generation of biotech crops.The objectives of this study are: (1) analyzing and comparing the worldwide policies and regulations on biosafety assessment and monitoring system to the first generation of biotech crops, conclude the achievements and problems in biosafety assessment and monitoring system of China, and provide suggestions to solve the problems existed; (2) investigate and analyzing the international commercial development, biosafety assessment and monitoring measurements of new generation of biotech crops: stack trait and nutritional improved biotech crops and PMPs, provide suggestions to the biosafety assessment method and monitoring measurements to the Chinese government. The main research achievements of this study are as follows:1. Trough the comparison of biosafety assessment principles, contents, methodology and monitoring of biotech crops, the author has evaluated the achievements of biosafety assessment and monitoring of biotech crops in China:(1) China is the first country in the developing world to established the biosafety assessment and monitoring regulation system to biotech crops, and commercialized Bt cotton as early as 1997;(2) China effectively protected and promoted the research, development and commercialization of Bt cotton, great achievements have been made on the environmental , economic and social benefits, the commercialization of Bt cotton has saved the textile industry in China;(3) New model of Bt cotton's field management has been innovated, the"natural refuge"strategy has been demonstrated is a successful model to control the insect resistance to the Bt cotton under the field condition since the Bt cotton has been sustainable commercialization for 11 years in China;(4) The detection system and detection standardization system of biotech crops and their products have been established and perfected step by step: 21 detection centers for GM organisms and their products have been in preparation and some of them have completed the certifying process. In addition, 37 national detection standards for GMOs environmental safety and food safety have been developed and published.(5) The human health safety and environmental safety of GMOs have been protected. It has been demonstrated that all products include imported products as food/feed processing material or products for cultivation, which approved by MOA, are safe.2. The study also pointed out the problems existed in the current biosafety assessment and monitoring system of biotech crop and their products in China, and further improvement suggestions have been provided:a) For the current variety based regulation for the cultivation purpose, the author has suggested that an event based regulation, which is adopted by most of the countries, should be implemented;b) Regarding to the safety certificate for commercial cultivation of new biotech crops by individual province, the author has suggested that a safety certificate for the whole country should be adopted except some special environment safety concerns (wild species of sexually cross pollinated varieties). The field monitoring system by ecological zone would be more reasonable.c) To the issue of mandated labeling and zero threshold of 5 biotech crops and 17 biotech products, the author recommended that a volunteer labeling system should be adopted.d) Regarding to some biosafety debate, the author has suggested that: the unintended effect of should not be overemphasized in the biosafety assessment process of biotech crop and their products; there is scientific evidence shows that the NPTII selectable marker for kanamycin resistance is a safe marker, and it can be used for the biotech crops; there is no need to conduct the animal trial if the gene donor has a safe food use history and the transgenic food is substantial equievlent to the non-transgenic food;e) The commercialization has become the main restriction factor to the development of agricultural biotechnology, the author suggest the government should re-evaluate the benefit and risk of biotech crops, promote the commercialization of biotech rice and corn.3. Through the study of biosafety assessment and monitoring of second generation of transgenic crops: the future development of stack trait biotech crops and the biosafety assessment content and methodology to the stack trait biotech crops from different countries, the author has concluded that there are 3 models to manage the breeding stack trait crops: (1) US and Canada model; (2) Japan and Korea model and (3) EU model. The author has suggested that China should take a position to simplify the assessment by providing bridge data for breeding stacks. 4. Through the evaluation of biosafety assessment to new generation of biotech crops with improved nutrition---high lysine corn and enriched Vitamin A rice, so-called golden rice, recommended by ILSI, the author has suggested the assessment pattern to nutrition improved biotech crops and their products: the assessment of expressed protein should be comprehensive; evaluate the metabolic products of target nutrients; focus on the nutrition composition analysis and nutrition efficacy evaluation.5. Through the comparison and study of risk issue and monitoring measurements of second generation of biotech crops, the author provided the risk management and monitoring measurements to PMPs: develop the regulation to safety assessment of PMPs; set other bioreactor as control when evaluate the intended use; set the non-transgenic iso-line as control when evaluate the food and environment safety; design the product without activity during production of PMPs; using GURT to prevent the gene flow.These recommendations and suggestions have provided very important background information for policy makers to draft the regulations to future biotech crops and products.