Microsoft Word 曹际娟

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1 7 4 Vol. 7 No Journal of Food Safety and Quality Apr., : 曹际娟 *, 张琳, 赵禹, 徐静, 卲筠乔, 郑江 (, ) 摘要 : (genetically modified organism, GO), GO, GO ; GO, GO 4,,,,, 关键词 : ; ; Sampling for genetically modified organism content analysis in agricultural products-part 1: the international status of sampling standards for genetically modified organisms and the theory of sampling CAO Ji-Juan *, ZHANG Lin, ZHAO Yu, XU Jing, SHAO Yun-Qiao, ZHENG Jiang (Liaoning Entry-Exit Inspection and Quarantine Bureau, Dalian , China) ABSTRACT: Due to the lack of world-wide accepted sampling standard for genetically modified organism (GO), relative standards promulgated in the maor developed countries and international organizations were investigated, especially focusing on the applicability of international standard. The theory of GO sampling was summarized to guide the present sampling study, which included 4 parts: process of analysis on the test portions, process of sampling from analytical sample, process from laboratory sample to analytical sample, and process from lot to laboratory sample. Variance generated in the 4 process was analyzed and combined, in order to provide theory direction for the other parts of this series paper, and promote the formulation of widely accepted international sampling standard for GO. KEY WORDS: genetically modified organism; sampling; standard 基金项目 : (014ZX ) Fund: Supported by the Genetically odified Organisms Breeding aor Proects and Genetically odified Organisms Sample Preparation and Accurate Detection Technology Proects(014ZX ) * 通讯作者 :,,, c0909@163.com *Corresponding author: CAO Ji-Juan, Ph.D., Professor, Liaoning Entry-Exit Inspection and Quarantine Bureau, Dalian , China. c0909@163.com

2 引言, 30, [1] (genetically modified organisms, GOs),, ;,,,,,, ISO 4333:009 Cereals and cereal products -Sampling,,, 世界主要国家和国际组织的转基因谷物和油料抽样标准现状.1 欧盟 1990 [], 0, 1% [3-5], 001, Kay [6] ISO 54:1990 Oilseeds-Sampling [7] ISO 13690:1999 Cereals, pulses and milled products-sampling of static batches [8], LOD 0 copies, LOQ 100 copies [9], ISO, (),,, ISO 003, Paoletti [10] ISO/DIS 1568:003 Foodstuffs-ethods of analysis for the detection of genetically modified organisms and derived products-sampling [11], ISO 54, ISO 664:008, Oilseeds-Reduction of laboratory sample to test sample [1], ISO ISO 859 (all six parts) Sampling procedures for inspection by attributes [13], AQL1%(10%, 4%, %, 1%), [14] 004, Reg. 1830/003 [15], (Rec. 787/004 [16] ), ISTA (international seed testing association) [17] ISO 6644:00 Flowing cereals and milled cereal products- Automatic sampling by mechanical means [18] 005, EC (non-authorised) Bt10 (Decision No. 005/317/EC [19] ), EC (Decision No. 006/578/EC [0], 006/601/EC [1], 006/754/EC [], 007/304/EC [3], 008/89/ EC [4] ), 009, Reg. 15/009 [5],,,, 011,, GO Reg.619/011 [6], , 001, Lischer [7,8] Gy (theory of sampling) [9], GO,, GO 01, Esbensen [30-3] Gy,, ISO. 美国和加拿大,.3 中国, [33,34], 004, GO [35], [36] [37].4 国际标准化组织 (International Organization for Standardization, ISO) 009, ISO 4333 [38], ISO ISO6644, GO 013, ISO/TC34/SC4 ISO 4333 ISO/TR 963 DTR [39], ISO 4333, GO, ISO 国际食品法典委员会 (Codex Alimentarius Commission, CAC) CAC GO, 004 [40] 3 适用于农产品中 GO 的抽样理论 3.1 转基因产品抽样和分析的基本过程 1,

3 4, : - 1 : 1499 Fig.1 1 Typical sampling and analysis processes for solid products 3. 分析试料的过程,, : DNA PCR PCR, 5~100 μl 1~ μl, (GO 10 4 ),, (GO <10 5 ),,,, S r (PCR), 10 4, 5%, sr ( PCR) 5%/ 1.8% ; 10 5,

4 %, sr ( PCR ) 10%/ 3.5%10 6, 30%, sr ( PCR) 30%/ 10.6%, EX 100%~ EX, : sr( EXT) (1 EX)/ 1 (1), ( 10 5 ),, PCR DNA, : s ( AE) sr( EXT) sr( PCR)/ NPCR () 3.3 从分析样品中采取试料的过程,, Gy [9],, (constitution variance) a L ( i) F i a L CH s h N i (3) i al L (distribution variance) a a DH s ( h ) N al L n G n L n n * a L L m L m a L HI CH m al L m L (4) (5) * ln[ DHL] ln[ s ( hn)] ln( HIG) ln m (6), ( ), * m * m, DH L, (6)() HI L,,,,,,,, ( ),, N IT,, : DH AS CHTP DHr DH P / NIT s ( AE) (7), DH P, DH P, DH AS, : s 1 1 ( TP ) HI AS (8) TP AS, ( 6) HI AS, s 0 ( TP), TP,0 : HI AS TP,0 AS (9) AS s0 ( TP ) HI AS TP,0 AS, (9) HI AS TP,0 (10) s 0 ( TP), TP,0,, TP,0, s 0 ( TP ), TP S (TP), TP,0,, N TP, (TAE): S (TP), DNA sr ( EXT) PCR sr ( PCR),,, TAE,,,,, : s ( TAE) AS s ( TP) sr ( EXT) sr ( PCR) (11) NTP NEXT NPCR 3.4 从实验室样品到分析样品的过程, (),,

5 4, : - 1 : 1501 (8), : s 1 1 ( SS ) SS HI LS (1) SS LS,, (),, : s ( TAE) LS s ( TAE) AS s ( AS) (13) s ( TAE) AS s ( SS) 3.5 从批到实验室样品的过程,,, ( )( ), ; ;,,,, ()(), GE () SE PE AE, GE SE PE AE (14) 0, 0, ( ), s ( GE) s ( TAE) s ( PE) s ( SE) (15) 由集合样品缩分为实验室样品, 3.3 S (LS), S (LS),, s 1 1 ( LS ) HI L (16) LS CS, () : s ( PE) s ( LS) s ( AS) s ( LS) s ( SS) (17), S (LS): s ( PE) s ( SS) (18) : s ( TPE) s ( TAE) s ( PE) 1 s ( SS) (19) NTP 1 1 s ( TP) sr( EXT ) sr( PCR) NEXT NPCR 3.5. 抽取份样的方差, ( ), (), 0,, h 1 () h () h 3,, h 4 h h h h h (0) m L (), hl mhm 0,, 0, m h m h m h m h m h (1) m : s hm s h1s hs h3 s h4 (), s (h 1 )=s (FE)( s (h ) s (h 3 ), s (h 4 ) : 1- P 1 1 s FE CHL HIL (3) PNF S L 一维批物料抽样方差的估计 (variograph) : V 1 ( ) ( m m) ( N ) h h, =1,,, J (4) U m V( ) V1( ) V( ) V3( ) V4( ) (5) V 1 ()V ()V 3 () h m+ h m, V 4 ()( ), N I 60 J30

6 150 7, V(), : s ( TPE) V(0) V1(0) V4(0) s ( FE) (6) N, S (FE)(37), HI L (6) s ( TPE) V 4 (0)=,, N I N I 60, V 4 (0) : 1) V(0): (6); ) V(): (N I 60), (38) V(), J30; 3): S( ) V( *) d* 0 (7) 1 1 w( ) S( ) V( *) d* 0 (8) S'( ) ( *) * S d 0 (9) S'( 1) S( 1)/ S( )/ w'( ) S'( ) (30) S(*) d* 0 () w''( ) 1 V( 0) V( ) V( 0), R R0 1, R P 1 V( 1 0) V( ) V( 0), R R 0 I (31) 4) : Wsy ( ) w( /) w'( ) (3), w ( 0), 0 w ( /) w ( 01/) S ( 01/)/( 01/), 01 S( 1/) S( ) [ V( ) V( 1/)]/ : Wst ( ) w'( ) : (33) Wra( ) s ( hi ) s ( TPE)/( NI R) sill (34) 5): : : s ( SE) W ( )/ Q (35) sy sy s ( SE) st Wst ( )/ Q (36) : s ( SE) ra Wra( )/ Q (37) 6) W sy ()W st ()W ra () Q=N 1 /,, ;,, (35)(36)(37), (19), : s ( GE) s ( TPE) s ( SE) W ( )/ Q s ( SS) sy (38) s ( TP) sr( EXT) sr( PCR) NTP NEXT NPCR 4 结论与展望, GO, ISO/TC34/SC4 ISO4333, GO,,, 参考文献 [1] ISAAA Brief [EB/OL] [] EC Council. Council directive of 3 April 1990 on the deliberate release into the environment of genetically modified organisms (90-0-EEC) [Z]. [3] Regulation (EC) No 58/97 of the european parliament and of the council of 7 January 1997 concerning novel foods and novel food ingredients [Z]. Official Journal of the European Union L 043, European Union: Luxembourg, [4] Council Regulation (EC) No 1139/98 of 6 ay 1998 concerning the compulsory indication of the labelling of certain foodstuffs produced from genetically modified organisms of particulars other than those provided for in Directive 79/11/EEC [Z]. Official Journal L 159, European Union: Luxembourg, [5] Directive 001/18, On the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/0/EEC [Z]. [6] Kay S, Paoletti C. Sampling strategies for GO detection and quantification, EC directorate general JRC [Z]. [7] ISO 54:1990 Oilseeds-Sampling [S]. [8] ISO 13690:1999 Cereals, pulses and milled products-sampling of static batches [S]. [9] Kay S, Eede GVD. The limit of GO detection [J]. Nat Biotechnol, 001, 19: [10] Paoletti C, Donatelli, Kay S, et al. Simulating kernel lot sampling: the effect of heterogeneity on the detection of GO contaminations [J]. Seed

4, : - 1 : 1503 Sci Technol, 003, 31(3): 69638. [11] ISODIS 1568:003 Foodstuffs-ethods of analysis for the detection of genetically modified organisms and derived products-sampling [S].

7 4, : - 1 : 1503 Sci Technol, 003, 31(3): [11] ISODIS 1568:003 Foodstuffs-ethods of analysis for the detection of genetically modified organisms and derived products-sampling [S]. [1] ISO 664:008 Oilseeds-Reduction of laboratory sample to test sample [S]. [13] ISO 859 (all six parts) Sampling procedures for inspection by attributes [S]. [14] Cantrill RC. International development of methods of analysis for the presence of products of modern biotechnology [J]. Asia Pac J Clin Nutr, 008, 17 (S1): [15] Regulation (EC) No 1830/003, Concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 001/18/EC [Z]. [16] European Commission Recommendation EC, on technical guidance for sampling and deterction of genetically modified organisms and material produced from genetically modified organisms as or in products in the context of Regulation (EC) No 1830/003 [Z]. [17] Burg IWJVD. International seed testing association [J]. Lancet, 1979, (8144): 70. [18] ISO 6644:00 Flowing cereals and milled cereal products-automatic sampling by mechanical means [S]. [19] European Commission (005). Decision No. 005_317_EC, on emergency measures regarding the non-authorised genetically modified organism Bt10 in maize products [Z]. [0] Commission Decision No. 578_006_EC, on emergency measures regarding the non-authorised genetically modified organism LL RICE 601 in rice products [Z]. [1] Commission Decision No. 006_601_EC, on emergency measures regarding the non-authorised genetically modified organism LL RICE 601 in rice products [Z]. [] Commission Decision No EC, amending Decision 006_601_EC on emergency measures regarding the non-authorised genetically modified organism LL RICE 601 in rice products [Z]. [3] Commission Decision No EC, on the withdrawal from the market of Bt176 (SYN-EV176-9) maize and its derived products (notified under document number C(007) 1804) [Z]. [4] Commission Decision No. 008_89_EC, on emergency measures regarding the unauthorised genetically modified organism Bt 63 in rice products (notified under document number C(008) 108) [Z]. [5] Commission Decision (EC) No 15_009, laying down the methods of sampling and analysis for the official control of feed [Z]. [6] Commission Regulation (EU) No 619_011, laying down the methods of sampling and analysis for the official control of feed as regards presence of genetically modified material [Z]. [7] Lischer P. Sampling procedures to determine the proportion of genetically modified organisms in raw materials, Part I: correct sampling, good sampling practice [J]. itt Leben Hyg, 001, 9: [8] Lischer P. Sampling procedures to determine the proportion of genetically modified organisms in raw materials, Part II: sampling from batches of grain [J]. itt Leben Hyg, 001, 9: [9] Pierre GY. Sampling for analytical purposes, translated by A. G. Royle []. New York: John Wiley and Sons, [30] Esbensen KH, Paoletti C, inkkinen P. Representative sampling of large kernel lots I. Theory of Sampling and variographic analysis [J]. Trends Anal Chem, 01, 3: [31] inkkinen P, Esbensen KH, Paoletti C. Representative sampling of large kernel lots II. Application to soybean sampling for GO control [J]. Trends Anal Chem, 01, 3: [3] Esbensen KH, Claudia P, Pentti. Representative sampling of large kernel lots III. General considerations on sampling heterogeneous foods [J]. Trends Anal Chem, 01, 3: [33],,. [J]., 009, 5: Liu PL, Li N, Zhou YL. Safety administration system for transgenic organism in America and its enlightenment for China [J]. J Agric Sci Technol, 009, 5: [34],,. [J]., 013, 11: Han Y, Zhai GQ, Xu JF. The evolution of the EU regulation system of transgenic organisms and the enlightenment to our country [J]. J Zheiang Agric Sci, 013, 11: [35] GB/T [S]. GB/T Detection of genetically modified organisms and derived products-ethods for sampling preparation [S]. [36] [Z]. Announcements of inistry of Agriculture , NO.031. Detecion of genetically modified plants and derived products-sampling [Z]. [37] SN/T [S]. SN/T Sampling and preparation method for GO detection in plants and its products [S]. [38] ISO 4333:009 Cereals and cereal products-sampling [S]. [39] ISO DTR963 Cereals and cereal products-sampling studies [S]. [40] Codex alimentarius commission, WHO-FAO General guidelines on sampling (CAC/GL ) [Z] 作者简介 ( 责任编辑 : 金延秋 ) 曹际娟, 女, 研究员, 主要研究方向为食品安全检测与研究 c0909@163.com

Microsoft Word 徐静-二校

Microsoft Word 徐静-二校 7 4 Vol. 7 No. 4 2016 4 Journal of Food Safety and Quality Apr., 2016-2 : * 徐静, 卲筠乔, 赵禹, 张琳, 汪霖, 郑江, 曹际娟 (, 116001) 摘要 : 目的, 方法, 12,,,, ( ) 结果 a AS d AS M TP n IT, 结论,, 关键词 : ; ; Sampling for genetically