中国动物源性食品残留监控体系建设研究
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摘要
我国的动物源性食品残留监控体系始建于1999年,经过近10年的发展,已获得长足进步,监控的动物种类、药物种类、地区和取样数量逐年增长,并多次通过来自欧盟、美国、日本和加拿大等发达国家专家组的考察。但与发达国家相比,中国动物源性食品残留监控体系不够完善,监控计划与日常抽检、进出口检验严重脱节,监控计划在国家动物源性食品残留控制体系中并未起到主导作用,动物源性食品残留监控体系也难以成为控制动物源性食品安全的支持性和基础性体系。随着国际食品安全门槛的不断提高,我国动物源性食品整体安全形势更趋严峻,国内外对动物源性食品中农兽药残留、环境污染物等有害物质残留检测要求多达数百项之多,依靠批批检测或抽样检测已难以保证动物源性食品的安全。因此迫切需要建设和完善我国的动物源性食品残留监控体系和监控计划,以监控代替检测,彻底转变我国的动物源性食品安全监管模式。
论文根据中国近10年来的残留监控计划和总结报告,历年来欧盟、美国等对我国动物源性食品残留监控体系考察报告,欧盟、美国、日本等相互间的考察报告,我国相关专家对典型欧盟成员国、美国、日本等的实地考察报告,质检总局与各国谈判和交流中获得的资料和信息以及各国官方网站上的公开资料等,从法规法规体系、组织实施机构、技术支撑体系、残留监控计划实施等方面对中国、欧盟、美国、日本的动物源性食品残留监控体系及其实施情况进行深入探讨和比较研究,归纳出我国动物源性食品残留监控体系与欧美日发达国家相比存在的差距和不足,并在比较研究的基础上,提出我国动物源性食品残留监控体系的发展思路。论文旨在为完善我国的动物源性食品安全管理体系提供科学依据和决策支持,以建立和完善适合我国现实国情的动物源性食品残留监控体系,实现“从农场到餐桌”全过程安全控制,将动物源性食品中有害物质残留的危害降低到最低限度,并为其它种类食品的安全控制提供示范和借鉴。主要研究内容及结果如下:
1.对中国、欧盟、美国、日本的动物源性食品残留监控体系研究表明:(1)中国动物源性食品残留监控计划经过10年来的不断改进和完善,残留监控物质种类和抽样地区逐年增加,残留监控体系已渐入完善和成熟,残留监控计划的科学性、时效性、合理性不断提高,为促进我国动物源性食品的出口发挥了不可替代的作用,但由于法律地位的缺失,中国动物源性食品残留监控体系在诸多方面存在不足;(2)欧盟是国际上最早提出动物源性食品残留监控计划的地区,已建立起一整套完善的法规和指令,涵盖了残留监控的所有要点,为残留监控计划的有效运行提供了组织和法规上的保证,但由于欧盟成员国众多,而且发展不平衡,在实际运行过程中存在不能完全按照法规的要求实施的情况,另外欧盟成员国之间宽松的食品安全监测制度可能造成一个成员国发生食品安全问题而波及整个欧盟的风险;(3)美国的食品安全体系是一个不断改进、不断完善的动态体系,现已形成了一个运行高效、合作默契的动物源性食品残留监控体系,能够真正做到“从农场到餐桌”的全过程管理,但美国的动物源性食品残留监控体系也存在监控计划的覆盖面不广、部门之间的沟通较少、检测设备投入滞后、监控计划针对性不强、检测质量控制不严等待改善之处;(4)日本是是世界上食品安全保障体系最完善、监管措施最严厉的国家之一,其充分运用风险分析的原理,并按风险级别对进口动物源性食品进行监控检查、强化监控检查和命令检查,但由于其监控计划仅针对进口食品,加之日本厚生劳动省在制定和实施残留监控计划时的“随意性”和“不确定性”,导致其动物源性食品残留监控计划实际上已成为调控动物源性食品进口贸易的技术壁垒手段,而不是控制动物源性食品安全的工具。
2.对欧盟、美国、日本和中国的动物源性食品残留监控体系的比较研究表明,我国动物源性食品残留监控体系在法律法规体系、组织实施机构、技术支撑体系、残留监控计划实施等方面均存在不足,而法律地位的缺失是制约我国动物源性食品残留监控体系进一步发展的最根本问题。
3.由于法律依据的缺失和法律地位不明确是我国动物源性食品残留监控体系不能成为控制动物源性食品安全的支持性和基础性体系的根本原因,因此应重点从完善我国动物源性食品残留监控法律法规支持体系、明确动物源性食品残留监控体系的法律地位、规范兽药管理、加强源头控制、落实企业自检自控责任、规范残留监控计划的制定和实施、建立风险预警电子信息系统、改革实验室体系和检测方法体系、加强检测质量控制等方面完善我国的动物源性食品残留监控体系,并大幅提高残留监控计划的取样量和覆盖范围,发挥残留监控计划在动物源性食品安全控制体系中的主导地位。
论文首次对中国、欧盟、美国和日本的动物源性食品残留监控体系进行了深入系统的总结和评估研究;首次对中国、欧盟、美国和日本的动物源性食品残留监控法律法规体系和动物源性食品残留监控体系进行了系统比较研究;首次提出了建立既符合我国现实国情,又与欧美等发达国家的监控体系等效和接轨的动物源性食品残留监控体系。
论文的研究目标在于建立既符合我国现实国情,又与欧美等发达国家的监控体系等效和接轨的动物源性食品残留监控体系,从根本上解决制约我国动物源性食品残留监控体系进一步发展的瓶颈问题,为我国动物源性食品残留监控体系的科学发展和监管模式的科学转变提供决策支持,最终形成以源头监控为基础、过程控制为保证、随机抽检为验证的三位一体的动物源性食品安全监管新模式。完善科学的动物源性食品残留监控体系和新的食品安全监管模式不仅将提高我国动物源性食品安全的管理水平和管理效率,而且将大幅降低食品安全的管理成本。因此,论文研究成果的实施必将提高我国动物源性食品的整体安全水平,并为其它种类食品的安全控制提供示范效应,具有广阔的应用前景。
After nearly 10 years' development, the monitoring system of drug residue of animal-origin food in China, established in 1999, has made considerable progress, especially in the increase of monitoring animal species, drug type, region and sampling number year after year. And it has passed the survey of expert groups from the European Union, the United States, Japan and Canada and other developed countries for many times. But compared with developed countries, China's monitoring system of drug residue of animal-origin food has lots of problems: there is a serious discrepancy between monitoring plans and inspections of day-to-day sampling and the import-export sample, the monitoring plans did not play a leading role in the national monitoring system, the monitoring system is also difficult to be a supporting and basic system for monitoring animal-origin food safety. Furthermore, the continuous increment of the threshold of international food safety results in more serious situation of animal-origin food safety. Since hundreds of detections for harmful substances are required, such as agricultural chemicals, veterinary drug residue and environmental pollutants, it is difficult to ensure animal-origin food safety to rely on batch test and sampling detection. Therefore, it is urgent to develop and improve the monitoring system and monitoring plans of drug residue in animal-origin food, and thoroughly change the supervision model of animal-origin food safety by monitoring instead of detection in China.
This dissertation is based on lots of data and information, such as Chinese residue monitoring plans and summary reports over the past 10 years, audit reports on monitoring system of drug residue of animal-origin food in China made by the European Union, United States, and et al., audit reports each other from European Union, United States, Japan, and et al., spot-audit report on member countries of European Union, United States and Japan et al. made by our experts, data and information obtained from negotiations and communication of General Administration of Quality Supervision, Inspection and Quarantine of China with other countries and some public information from official website. In this work, the monitoring systems of drug residue of animal-origin food and its implementations in China, European Union, America and Japan were further discussed and comparative studied in regulations and laws system, implementing organizations, technical support system, and implementation of the monitoring plan. It was suggested that the monitoring system of drug residue of animal-origin food in China has a lot of insufficient and defects compared to developed countries. Furthermore, based on the comparative study results, a development strategy of our country's monitoring system of drug residue in animal-origin food was proposed. The objective of this work was to provide the scientific basis and decision-making support for improving of management system of animal-origin food safety in China, establish and improve the monitoring system which accords with national conditions, realize the whole process monitor of animal-origin food safety "from farm to table", reduce the hazards of harmful substances residues in animal-origin food to a minimum and set an example for other food safety monitor. The contents and results of the present study are as follow:
1. The evaluation of the monitoring systems of drug residue of animal-origin food in China, European Union, United States and Japan shows that:
(1) In the past 10 years, China's monitoring plan of drug residue in animal-origin food was continuous improved and played an irreplaceable role in promoting the export of animal-origin food with the increase of monitoring species and sampling area year by year, and the constant improvement of scientific, timeliness, reasonableness of residual monitoring plan. However, the monitoring system of drug residue of animal-origin food in China has a lot of insufficient and defects in many aspects because of unclear of legal status.
(2) The European Union, as the first area which put forward the monitoring plan, has established a set of regulations and directives covering all the main points of residue monitoring, which provided the guarantee of the organization and regulation for effective operation of the monitoring plan. But due to the large numbers of the EU member and the uneven development, the monitoring plan can not be implemented completely according to the regulation in the process of the actual operation. Also, the relaxed monitoring of food safety between EU members may result in the entire European Union affected by food safety issues in a member state of EU.
(3) United States has a dynamic system of food safety with continuous improvement. In U.S., the monitoring system of drug residue in animal-origin food which operates efficiently and cooperates tacitly has been established, and the whole process monitor of animal-origin food safety "from farm to table" has been truly realized. But there are lots of problems in American's monitoring system, such as narrow coverage of monitoring plan, lack of communication between departments, lagging equipment for inspection, less pertinence of monitoring plan and non-strict quality control;
(4) Japan, one of countries with the most perfect security system and the most strictly supervision measures in food safety in the world, divides the inspection of the import animal-origin food into monitoring inspection, strengthen monitoring inspection and order inspection according to the risk level using the principles of risk analysis. However, as a result of its monitoring plan only for imports of food, in addition to the "arbitrary" and "uncertainty" of Japanese Health, Labor and Welfare in the establishing and implementing residue monitoring plans, the monitoring plan of drug residue in animal-origin food has become technical barriers to regulate the import trade of animal origin-food, rather than tools to control the animal-origin food safety.
2. The comparative study of the monitoring system of drug residue of animal-origin food in European Union, United States, Japan and China shows that the monitoring system of drug residue of animal-origin food in China has lots of defects in regulations and laws system, implementing organizations, technical support system, and implementation of the monitoring plan. It is the conclusion that the lack of legal status is the most fundamental reason which restricts the further development of our country's monitoring system of drug residue in animal-origin food.
3. For the lack of legal basis and unclear of legal status are the basic reason that the monitoring plan of drug residue was not the supporting and basic system for monitoring animal-origin food safety, in China, the monitoring plan of drug residue should be improved mainly by improving support system of laws and regulations of the drug residue monitor in animal-origin food, clearing the legal status of the monitoring system, standardizing the veterinary drug management, strengthening the source control, implement the corporation's responsibility for self-inspection and self-control, standardizing the establishment and implement of monitoring plan, developing the electronic information system for risk early warning, reforming lab system and inspection method system and strengthening the control of inspection quality. At the same time, we should increase the sampling number and coverage area of monitoring plan to play its leading role in monitoring system of animal-origin food safety.
In this dissertation, we first in-depth summarize and evaluate the monitoring system of drug residue in animal-origin food in China, European Union, United States and Japan; first comparative study the system of laws and regulations, monitoring system of drug residue of animal-origin food in China, European Union, United States and Japan; first put forward the development strategy of monitoring system of drug residue in animal-origin food, which accords with national conditions and approaches international tendency.
It is the objective of this work to develop China monitoring system of drug residue in animal-origin food which accords with national conditions and approaches international tendency, radically solve bottleneck problem which constraints the further development of monitoring system of drug residue in animal-origin food in China, provide decision support for Chinese scientific development of monitoring system of drug residue in animal-origin food and the scientific change of monitoring model, and finally form the trinity management model of animal-origin food safety with the basis of source monitor, guarantee of process control and validation of random sampling in China. It is well known that scientific monitoring system and new monitoring model will not only improve management level and efficiency of animal-origin food safety in our country, but also dramatically reduce the cost of food safety management. Therefore, the research achievement in this work, which will increase overall safety level of animal-origin food of our country and set the example for safety monitor of other food, has wide application prospects.
论文根据中国近10年来的残留监控计划和总结报告,历年来欧盟、美国等对我国动物源性食品残留监控体系考察报告,欧盟、美国、日本等相互间的考察报告,我国相关专家对典型欧盟成员国、美国、日本等的实地考察报告,质检总局与各国谈判和交流中获得的资料和信息以及各国官方网站上的公开资料等,从法规法规体系、组织实施机构、技术支撑体系、残留监控计划实施等方面对中国、欧盟、美国、日本的动物源性食品残留监控体系及其实施情况进行深入探讨和比较研究,归纳出我国动物源性食品残留监控体系与欧美日发达国家相比存在的差距和不足,并在比较研究的基础上,提出我国动物源性食品残留监控体系的发展思路。论文旨在为完善我国的动物源性食品安全管理体系提供科学依据和决策支持,以建立和完善适合我国现实国情的动物源性食品残留监控体系,实现“从农场到餐桌”全过程安全控制,将动物源性食品中有害物质残留的危害降低到最低限度,并为其它种类食品的安全控制提供示范和借鉴。主要研究内容及结果如下:
1.对中国、欧盟、美国、日本的动物源性食品残留监控体系研究表明:(1)中国动物源性食品残留监控计划经过10年来的不断改进和完善,残留监控物质种类和抽样地区逐年增加,残留监控体系已渐入完善和成熟,残留监控计划的科学性、时效性、合理性不断提高,为促进我国动物源性食品的出口发挥了不可替代的作用,但由于法律地位的缺失,中国动物源性食品残留监控体系在诸多方面存在不足;(2)欧盟是国际上最早提出动物源性食品残留监控计划的地区,已建立起一整套完善的法规和指令,涵盖了残留监控的所有要点,为残留监控计划的有效运行提供了组织和法规上的保证,但由于欧盟成员国众多,而且发展不平衡,在实际运行过程中存在不能完全按照法规的要求实施的情况,另外欧盟成员国之间宽松的食品安全监测制度可能造成一个成员国发生食品安全问题而波及整个欧盟的风险;(3)美国的食品安全体系是一个不断改进、不断完善的动态体系,现已形成了一个运行高效、合作默契的动物源性食品残留监控体系,能够真正做到“从农场到餐桌”的全过程管理,但美国的动物源性食品残留监控体系也存在监控计划的覆盖面不广、部门之间的沟通较少、检测设备投入滞后、监控计划针对性不强、检测质量控制不严等待改善之处;(4)日本是是世界上食品安全保障体系最完善、监管措施最严厉的国家之一,其充分运用风险分析的原理,并按风险级别对进口动物源性食品进行监控检查、强化监控检查和命令检查,但由于其监控计划仅针对进口食品,加之日本厚生劳动省在制定和实施残留监控计划时的“随意性”和“不确定性”,导致其动物源性食品残留监控计划实际上已成为调控动物源性食品进口贸易的技术壁垒手段,而不是控制动物源性食品安全的工具。
2.对欧盟、美国、日本和中国的动物源性食品残留监控体系的比较研究表明,我国动物源性食品残留监控体系在法律法规体系、组织实施机构、技术支撑体系、残留监控计划实施等方面均存在不足,而法律地位的缺失是制约我国动物源性食品残留监控体系进一步发展的最根本问题。
3.由于法律依据的缺失和法律地位不明确是我国动物源性食品残留监控体系不能成为控制动物源性食品安全的支持性和基础性体系的根本原因,因此应重点从完善我国动物源性食品残留监控法律法规支持体系、明确动物源性食品残留监控体系的法律地位、规范兽药管理、加强源头控制、落实企业自检自控责任、规范残留监控计划的制定和实施、建立风险预警电子信息系统、改革实验室体系和检测方法体系、加强检测质量控制等方面完善我国的动物源性食品残留监控体系,并大幅提高残留监控计划的取样量和覆盖范围,发挥残留监控计划在动物源性食品安全控制体系中的主导地位。
论文首次对中国、欧盟、美国和日本的动物源性食品残留监控体系进行了深入系统的总结和评估研究;首次对中国、欧盟、美国和日本的动物源性食品残留监控法律法规体系和动物源性食品残留监控体系进行了系统比较研究;首次提出了建立既符合我国现实国情,又与欧美等发达国家的监控体系等效和接轨的动物源性食品残留监控体系。
论文的研究目标在于建立既符合我国现实国情,又与欧美等发达国家的监控体系等效和接轨的动物源性食品残留监控体系,从根本上解决制约我国动物源性食品残留监控体系进一步发展的瓶颈问题,为我国动物源性食品残留监控体系的科学发展和监管模式的科学转变提供决策支持,最终形成以源头监控为基础、过程控制为保证、随机抽检为验证的三位一体的动物源性食品安全监管新模式。完善科学的动物源性食品残留监控体系和新的食品安全监管模式不仅将提高我国动物源性食品安全的管理水平和管理效率,而且将大幅降低食品安全的管理成本。因此,论文研究成果的实施必将提高我国动物源性食品的整体安全水平,并为其它种类食品的安全控制提供示范效应,具有广阔的应用前景。
After nearly 10 years' development, the monitoring system of drug residue of animal-origin food in China, established in 1999, has made considerable progress, especially in the increase of monitoring animal species, drug type, region and sampling number year after year. And it has passed the survey of expert groups from the European Union, the United States, Japan and Canada and other developed countries for many times. But compared with developed countries, China's monitoring system of drug residue of animal-origin food has lots of problems: there is a serious discrepancy between monitoring plans and inspections of day-to-day sampling and the import-export sample, the monitoring plans did not play a leading role in the national monitoring system, the monitoring system is also difficult to be a supporting and basic system for monitoring animal-origin food safety. Furthermore, the continuous increment of the threshold of international food safety results in more serious situation of animal-origin food safety. Since hundreds of detections for harmful substances are required, such as agricultural chemicals, veterinary drug residue and environmental pollutants, it is difficult to ensure animal-origin food safety to rely on batch test and sampling detection. Therefore, it is urgent to develop and improve the monitoring system and monitoring plans of drug residue in animal-origin food, and thoroughly change the supervision model of animal-origin food safety by monitoring instead of detection in China.
This dissertation is based on lots of data and information, such as Chinese residue monitoring plans and summary reports over the past 10 years, audit reports on monitoring system of drug residue of animal-origin food in China made by the European Union, United States, and et al., audit reports each other from European Union, United States, Japan, and et al., spot-audit report on member countries of European Union, United States and Japan et al. made by our experts, data and information obtained from negotiations and communication of General Administration of Quality Supervision, Inspection and Quarantine of China with other countries and some public information from official website. In this work, the monitoring systems of drug residue of animal-origin food and its implementations in China, European Union, America and Japan were further discussed and comparative studied in regulations and laws system, implementing organizations, technical support system, and implementation of the monitoring plan. It was suggested that the monitoring system of drug residue of animal-origin food in China has a lot of insufficient and defects compared to developed countries. Furthermore, based on the comparative study results, a development strategy of our country's monitoring system of drug residue in animal-origin food was proposed. The objective of this work was to provide the scientific basis and decision-making support for improving of management system of animal-origin food safety in China, establish and improve the monitoring system which accords with national conditions, realize the whole process monitor of animal-origin food safety "from farm to table", reduce the hazards of harmful substances residues in animal-origin food to a minimum and set an example for other food safety monitor. The contents and results of the present study are as follow:
1. The evaluation of the monitoring systems of drug residue of animal-origin food in China, European Union, United States and Japan shows that:
(1) In the past 10 years, China's monitoring plan of drug residue in animal-origin food was continuous improved and played an irreplaceable role in promoting the export of animal-origin food with the increase of monitoring species and sampling area year by year, and the constant improvement of scientific, timeliness, reasonableness of residual monitoring plan. However, the monitoring system of drug residue of animal-origin food in China has a lot of insufficient and defects in many aspects because of unclear of legal status.
(2) The European Union, as the first area which put forward the monitoring plan, has established a set of regulations and directives covering all the main points of residue monitoring, which provided the guarantee of the organization and regulation for effective operation of the monitoring plan. But due to the large numbers of the EU member and the uneven development, the monitoring plan can not be implemented completely according to the regulation in the process of the actual operation. Also, the relaxed monitoring of food safety between EU members may result in the entire European Union affected by food safety issues in a member state of EU.
(3) United States has a dynamic system of food safety with continuous improvement. In U.S., the monitoring system of drug residue in animal-origin food which operates efficiently and cooperates tacitly has been established, and the whole process monitor of animal-origin food safety "from farm to table" has been truly realized. But there are lots of problems in American's monitoring system, such as narrow coverage of monitoring plan, lack of communication between departments, lagging equipment for inspection, less pertinence of monitoring plan and non-strict quality control;
(4) Japan, one of countries with the most perfect security system and the most strictly supervision measures in food safety in the world, divides the inspection of the import animal-origin food into monitoring inspection, strengthen monitoring inspection and order inspection according to the risk level using the principles of risk analysis. However, as a result of its monitoring plan only for imports of food, in addition to the "arbitrary" and "uncertainty" of Japanese Health, Labor and Welfare in the establishing and implementing residue monitoring plans, the monitoring plan of drug residue in animal-origin food has become technical barriers to regulate the import trade of animal origin-food, rather than tools to control the animal-origin food safety.
2. The comparative study of the monitoring system of drug residue of animal-origin food in European Union, United States, Japan and China shows that the monitoring system of drug residue of animal-origin food in China has lots of defects in regulations and laws system, implementing organizations, technical support system, and implementation of the monitoring plan. It is the conclusion that the lack of legal status is the most fundamental reason which restricts the further development of our country's monitoring system of drug residue in animal-origin food.
3. For the lack of legal basis and unclear of legal status are the basic reason that the monitoring plan of drug residue was not the supporting and basic system for monitoring animal-origin food safety, in China, the monitoring plan of drug residue should be improved mainly by improving support system of laws and regulations of the drug residue monitor in animal-origin food, clearing the legal status of the monitoring system, standardizing the veterinary drug management, strengthening the source control, implement the corporation's responsibility for self-inspection and self-control, standardizing the establishment and implement of monitoring plan, developing the electronic information system for risk early warning, reforming lab system and inspection method system and strengthening the control of inspection quality. At the same time, we should increase the sampling number and coverage area of monitoring plan to play its leading role in monitoring system of animal-origin food safety.
In this dissertation, we first in-depth summarize and evaluate the monitoring system of drug residue in animal-origin food in China, European Union, United States and Japan; first comparative study the system of laws and regulations, monitoring system of drug residue of animal-origin food in China, European Union, United States and Japan; first put forward the development strategy of monitoring system of drug residue in animal-origin food, which accords with national conditions and approaches international tendency.
It is the objective of this work to develop China monitoring system of drug residue in animal-origin food which accords with national conditions and approaches international tendency, radically solve bottleneck problem which constraints the further development of monitoring system of drug residue in animal-origin food in China, provide decision support for Chinese scientific development of monitoring system of drug residue in animal-origin food and the scientific change of monitoring model, and finally form the trinity management model of animal-origin food safety with the basis of source monitor, guarantee of process control and validation of random sampling in China. It is well known that scientific monitoring system and new monitoring model will not only improve management level and efficiency of animal-origin food safety in our country, but also dramatically reduce the cost of food safety management. Therefore, the research achievement in this work, which will increase overall safety level of animal-origin food of our country and set the example for safety monitor of other food, has wide application prospects.
引文
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