Introduction to MRLs Establishment in China

Transcription

1 Nov 4, 2013, Shanghai Introduction to MRLs Establishment in China Dr. Guibiao YE Director of Residue Division, ICAMA Tel: , Fax:

2 Contents 1. Background of MRLs establishment 2. Food safety related laws and regulations 3. Agencies responsible for the management and establishment of MRLs 4. Protocols for the establishment of MRLs 5. Current situation of MRLs 6. Major challenges and future outlook

3 I. Background of MRLs establishment 1. China's population : >1.3billion, around 21% of world population; 2. China has a territory of 9.6 million sq km; 3. China's farmland is around million ha.; 4. Farmland in China is mainly distributed in: The Three River Plain in the Northeast, North China Plain, Yangtze River Delta, Jiang-Han Plain, Dongting Lake Plain, Pearl River Delta and the Sichuan Plain.

4 5. Main crop-food crops Rice Area: around 30 million ha. Yield: more than 200 million tons Wheat Sugar beet Area: around 22.6 million ha. Yield: more than 112 million tons Maize Area: around 32.5 million ha. Yield: more than 210 million tons

5 6. Main crop -oil crops Soybean Peanut Rape Area: around 8.5 million ha. Yield: around 14.2 million tons Area: around 4.5 million ha. Sugar beet Yield: around 16.2 million tons Area: around 3.0 million ha. Yield: around 13.6 million tons

6 7.Main crop -fruits Wheat Potato Apple es Citrus Banana Area: around 2.1 million ha. Yield: around 35.0 million tons Area: around 2.2 million ha. Yield: around 26.4 million tons Area: around 360,000 ha. Yield: around 8.0 million tons

7 8. Main crop -vegetables Cabbage Cucumber Chinese cabbage Pepper Area: 937,000 ha. Area: 552,000 ha. Area: 2.5 million ha. Area: 457,000 ha. Vegetables area is around 19 million ha. in China, with a total yield of 677 million tons.

8 9. Climate zones in China Temperate continental climate Plateau Frigid climate Temperate monsoon climate Sub-tropic monsoon climate Tropic monsoon climate

9 10. Natural regions in China

10 11. Complex farming practices in China

11 12. Diseases, insects, weeds and rats cause severe losses to crop yield. FAO estimates that world losses 14%, 10%, 11% and 20% of its annual food production to insects, diseases, weeds and rats respectively; the world losses 16%, 12% and 5.8% of its annual cotton production to insects, diseases and weeds. The damage of biological disasters to crops in China is similar to this estimation. Wheat Potato es Wheat, million tons Rice, million tons Cotton, %

12 13. Pesticide is the major tool in controlling diseases, insects, weeds and rats The controlling area is around 200 million ha.; 1 million tons of pesticide formulation are used (400, ,000 tons of technical materials.)

13 14. China's pesticide industry 1. There are over 2,000 pesticide manufacturers or formulators in China, over 20 are of large scale and around 300 have manufacture capacity of technical materials. Wheat 2. Around 20,000 products with nearly 600 a.i. have been registered, including public health pesticides, biopesticides; Potato es 3. The production capacity of pesticide formulations is around million tons.

14 II. Food safety related laws and regulations Food Safety Law of the People's Republic of China Promulgated on 28 Feb.2009 and implemented on 1 June 2009; Law on the Quality and Safety of Agricultural Products of the People's Republic of China Promulgated on 29 Apr.2006 and implemented on 1 Nov. 2006; Potato es Pesticide Management Regulations of the People's Republic of China Promulgated and implemented on 8 May 1997; Revised on 29 Nov 2001 and 8 Jan

15 II. Food safety related laws and regulations Food Safety Law Article 19 Food safety standards are compulsory. No other compulsory food standards shall be formulated except the food safety standards. Article 20 Food safety standards shall specify: (1) limits of pathogenic microorganism, pesticide residues, veterinary drug residues, heavy metals, pollutants and other substances that Potato es jeopardize people's health; Limits of residues of pesticides and veterinary drugs in food, methods and protocols of inspection shall be formulated by competent heath and agriculture departments of the State Council.

16 II. Food safety related laws and regulations Food Safety Law Article 23 National food safety standards shall be reviewed and approved by National Standard Review Committee of Food Safety, which is composed of experts on medicine, agriculture, food, nutrition, etc. and representatives of relevant departments of the State Council. The establishment of national food safety standards shall be based on the result of food safety risk assessment, take into full consideration the Potato es result of risk assessment of the quality and safety of agricultural products for food use, refer to the result of relevant international standards and the result of international food safety risk assessment and widely consult opinions of food producers, dealers and consumers.

17 II. Food safety related laws and regulations Law on the Quality and Safety of Agricultural Products Article 11 The state establishes and improves the system of standards of the quality and safety of agricultural products. Standards of the quality and safety of agricultural products are compulsory technical norms. Potato es Article 14 Agricultural competent department and other relevant departments are responsible for the implementation of standards of quality and safety of agricultural products.

18 II. Food safety related laws and regulations Pesticide Management Regulations Article 2 The Ministry of Agriculture is responsible for pesticide registration, use, supervision and management in China, and shall develop or participate in the development of national and industrial standards on pesticide safe use, pesticide product quality and pesticide residues. Article 3 ICAMA is responsible for nation wide pesticide Potato registration. Institutes es for the control of agrochemicals affiliated to agricultural departments of the people's governments of provinces, autonomous regions and municipalities directly under the central government shall assist in pesticide registration within their administrative regions.

19 II. Food safety related laws and regulations Diagram of legal basis Pesticide Management Regulations Food Safety Law Law on the Quality and Safety of Agricultural Products Pesticide registration Pesticide MRLs Data requirements for pesticide registration (residue): Metablic mechanism in Potatoe plants and animals; Methods of analysis; s Field trial; GAP; Storage stability; Processing study Data requirements: Toxicology Residue data Pesticide registration Labeling Prescribed use frequency and PHI Release MRLs and analysis method

20 III. Agencies responsible for the management and establishment of MRLs 1. National Food Safety Commission (Feb. 2010) Director: Li Keqiang Deputy Director: Hui Liangyu, Wang Qishan members: 15 governmental departments Responsibilities: Analyze food safety situation; Study, plan and provide guidance to food safety related work; Put forward important policy measures concerning food safety supervision; Urge the implementation of responsibilities of food safety supervision. Top food safety administration in China China Food and Drug Administration was established in March 2013

21 III. Agencies responsible for the management and establishment of MRLs 2.National Standard Review Committee of Food Safety (20 Jan. 2010) Composition: 350 members from 10 specialized sub-committees and 20 departments in the fields of industry and information, agriculture, trade, industry and commerce, quality inspection, food and drug supervision, etc. Responsibilities: Review national food safety standards; Put forward suggestions for the implementation of national food safety standards; Provide consultation on major issues related to national food safety standards; Undertake other work related to food safety standards.

22 III. Agencies responsible for the management and establishment of MRLs National Standard Review Committee of Food Safety (20 Jan. 2010) Sub-committees: 10 specialized sub-committees were established under the committee, namely sub-committees for food production, microorganisms, codes of production and operation, nutrition and special dietary foods, methods and protocols of inspection, pollutants, food additives, food-related products, pesticide residues and residues of veterinary drugs; Sub-committees for pesticide residues and veterinary drug residues were set up within MOA;

23 III. Agencies responsible for the management and establishment of MRLs 3 National Review Committee of Pesticide Residue Standards ( ) Composition: 42 members from departments of agriculture, health, industry and information, commerce, quality inspection, food and drug, etc and 7 agency members. Responsibility: review national standards of pesticide residues, review plan for the establishment and revision of national pesticide residue standards and long-term program, put forward suggestions concerning the implementation of policies of pesticide residue standards and technical measures, and provide consultation to major issues related to national pesticide residue standards. The Secretariat: set up within ICAMA, is responsible for routine management of the committee.

24 III. Agencies responsible for the management and establishment of MRLs Structure of the National Review Committee of Pesticide Residue Standards Chairman of the Committee Secretariat ICAMA Toxicological expert panel Residue chemistry expert panel Analytical method expert panel

25 III. Agencies responsible for the management and establishment of MRLs Institute for the Control of Agrochemicals, Ministry of Agriculture National authority for pesticide registration and management Over 150 staff 13 divisions Undertake relevant responsibilities of the secretariat of the National Pesticide Review Committee

26 III. Agencies responsible for the management and establishment of pesticide MRLs in China Organizational Structure of ICAMA General Office Division of Planning and Finance Director General Deputy Director Generals Registration Division Product Quality Division Efficacy Division Residue Division & Secretariat Health Division Environment Division Re-Evaluation Division Supervision and Regulation Division International Cooperation Division Information Division CCPR Liaison Office

27 III. Agencies responsible for the management and establishment of MRLs Laboratory(Residue, quality control and environment impact) Equipment GC HPLC GC/MS LC/MS/MS LC/Q/TOF ASE SPE GPC

28 IV. Protocols for MRL establishment 1. Guidelines Guidelines for MRL Establishment Practical Guideline for Risk Analysis on Pesticide Residues in Agricultural Commodities and Foods Guideline for Establishment of MRLs for Pesticides in Agricultural Commodities and Foods Crop Categorization for Establishment of Pesticide MRLs

29 IV. Protocols for MRLs establishment 1. Guidelines for MRLs establishment Guidelines for Trials Guidelines for Pesticide Residue Trials (NY/T ) Sampling Methods for Pesticide Residue Analysis (NY/T ) Good Laboratory Practice for Pesticide Residue Trials (NY/T )

30 IV. Protocols for MRL establishment 2. Procedures for MRLs development Release WTO notification Recording Committee Review Opinion solicitation MRLs drafting Project for MRLs establishment Plan for MRLs establishment

31 IV. Protocols for Pesticide MRL establishment 3. Procedures for the establishment of MRLs in foods Residue assessment Evaluate data of residue behavior of pesticides and its metabolites in food and environment: metabolic study of plants and animals, field residue trial, residue analysis methods, feeding study, processing and environmental behavior trials Toxicology assessment Review pesticide toxicological data: 评审农药毒理学资料 toxic-kinetics trials : and 毒代动力学试验 毒理学试验 toxicological trials Recommend ADI and ARfD Recommend STMR and HR Dietary intake assessment State of Nutrition and Health of Chinese Residents (Released in 2004) dietary intake risk evaluation Recommend MRL

32 IV. Protocols for Pesticide MRL establishment Toxicology expert panel Toxico-kinetics evaluation Toxicological evaluation acceptable daily intake ADI ARfD acute reference dose

33 IV. Protocols for Pesticide MRL establishment in China Residue chemistry expert panel Metabolic study of plants and animals, Residue definition Residue behavior evaluation Processing Evaluation Animal feeding study evaluation Supervised residue trials evaluation Sample storage stability evaluation residue analysis method evaluation

34 IV. Protocols for Pesticide MRL establishment Analytical method expert panel Propose the residue analysis methods for monitoring evaluation of new residue analysis methods evaluation of existing residue analysis methods evaluation of reference residue analysis methods

35 IV. Protocols for Pesticide MRL establishment FAO-Panel Accept national registered uses as GAP WHO-Panel Review pesticide toxicology Estimate likely residues (STMR) and max. residues (MRL) for GAP Estimate values for ADI and ARfD RISK ASSESSMENT Are the toxicology and dietary intake of residues compatible? Propose MRL

36 农药残留标准数量 V. Current situation of MRLs in China A. MRLs established in foods 2,293 MRLs covering 322 pesticides in around 260 crops or foods (groups) have been established and implemented by 1 March 2013; 94.7% MRLs are for vegetables, fruits, cereals and oil crops 蔬菜水果谷物及制品油料及制品 百分比 39.9% 29.0% 16.4% 9.4% MRL 数量

37 V. Current Situation of Pesticide MRLs B. Impacts of MRLs establishment 1. Provide scientific basis for market supervision of quality and safety of agricultural commodities or food; 2. Provide guidance on good application of pesticide for farmers; 3. Promote food producers to monitor quality and safety during the whole process of production; 4. Provide basis for supervision for food import and export; 5. Enhance the food safety awareness of the whole society; 6. Provide guarantee for health and safety of consumers;

38 VI. Challenges and future outlook A. Challenges 1. Thousands of agricultural commodities and even more processed products; 2. Complex and diversified farming system and cultivating practices ; 3. A huge number of pesticide applicators and disparity in equipment and skills; 4. Increasing of International Trade of food; 5. Lack of basic data and good communication with pubic ; 6. People pay more and more attention on food safety.

39 VI. Challenges and future outlook A. Challenges 1. Thousands of agricultural commodities and even more processed products; 2. Complex and diversified farming system and cultivating practices ; 3. A huge number of pesticide applicators and disparity in equipment and skills; 4. Increasing of International Trade of food; 5. Lack of basic data and good communication with pubic ; 6. People pay more and more attention on food safety.

40 VI. Challenges and future outlook 7. Lack of practical analysis method of pesticide residue Requirement Reliability: precision, recovery, repeatability, etc. Cost-effective Easy to conduct, for grass root test center Stage Supervised residue trial stage Monitoring or compliance stage Target : Parent pesticide or metabolite

41 残留限量数量 VI. Challenges and future outlook B. Future outlook 1. accelerate establishment of MRL in agricultural commodities By the end of the Twelfth Five-Year Plan period, 7,000 MRLs will be established, basically covering all agricultural commodities. Straighten up, integrate, research to develop national MRLs system; Synchronize registration review and MRLs establishment MRL 数量

42 VI. future outlook 2 Gradually realize synchronization of national and international standards; Accelerate the conversion of CAC standards to national standards; Convert over 1,000 CXLs of 103 pesticides into national standards in 2013; Actively participate in the establishment of international standards, in particular CAC standards; 3 Strengthen international exchange and cooperation; Conduct bi-lateral exchange and workshop; Seminar on MRLs establishment for minor crops with the US; Conduct technical training.

43 VI. Future outlook 4 Accelerate the development of pesticide residue analysis methods; Multi-residue analysis methods; Special analysis methods; Priority for compliance test 5 Improve standards for setting procedures and technical norms, technical protocols or normative documents; revise pesticide residue trial guidelines; establish SOPs; 6 Improve fundamental data: toxicological, dietary residue trials

44 Dr. Guibiao YE Director of Residue Division, ICAMA Tel: Fax: