1、STD-BSI BS EN L2305-ENGL 1998 1b2YbbS Ob8970b 720 BRITISH STANDARD Biotechnology - Modified organisms for application in the environment - Guidance for the sampling strategies for deliberate releases of genetically modified plants The European Standard EN 123051997 has the status of a British Standa
2、rd ICs 07.080 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW BS EN 12305:1998 STD-BSI BS EN 12305-ENGL 1778 Lb24bb7 Ob87707 bb7 Amd No. BS EN 12306:1998 Date Textaected National foreword This British Standard is the English language version of EN 123051997. The UK participati
3、on in its preparation was entrusted to Technical Committee CII/58, Biotechnology, which has the responsibility to: - aid enquirers to understand the text; - present to the responsible intemationaUEuropean committee any enquiries on the interpretation, or proposals for change, and keep the UK interes
4、ts informed; - monitor related international and European developments and promulgate them in the UK. A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications refer
5、red to in this document may be found in the BSI Standards Catalogue under the section entitled “InternaionaJ Standards Correspondence Index”, or by using the Find” facility of the BSI Standarb Electronic Catalogue. A British Standard does not purport to include ali the necessary provisions of a cont
6、sact. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legai obligations. Summary of pages This document comprises a hnt cover, an inside front cover, the EN titie page, pages 2 to 7 and a back cover.
7、 This British Standard, having been prepared under the direction of the Sector Board for Materiais and Chemicals, was published under the authority of the Standards Board and comes into effect on 15 March 1998 O BSI 1998 ISBN O 580 29263 O STD-BSI BS EN L2305-ENGL 1998 D Lb24bb7 Ob87708 5T3 EN 12305
8、 Odober 1997 ICs 07.080 Descriptors: Biotechnology, genetics, plants, botany, modified organisms, definitions, sampling, environmental protection English version Biotechnology- Modified organisms for application in the environment - Guidance for the mpling sbnategies for delibemte releases of geneti
9、cally modified plants Biotechnologie - Organismes moditis dissmins dans lenvironnement - Guide des Stratgies dchantillonnage pour les dissminations volontaires de plantes gntiquement modi6es. Biotechnik - Vernderte Organismen zum Einsatz in der Umwelt - Leitfaden fur ProbenahmeStrategien bei der abs
10、ichtlichen Freisetzung gentechnisch vernderter Pfianzen This European Standard was approved by CEN on 21 August 1997. CEN members are bound to comply with the CENKENELEC Internal Regulations which stipuiate the conditions for giving this European Standard the status of a national standard without an
11、y alteration. Up-tedate lists and bibliographical references concerning such national standards may be obtained on application to the Centrai Secretariat or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by
12、translation under the responsibility of a CEN member into its own language and notied to the Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Irelan
13、d, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CEN European Committee for Standardization Comit Europen de Normahsation Europisches Komitee fur Normung Central Secretariat: rue de Stassart 36, B-1060 Brussels O 1997 CEN All rights of exploitation
14、in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 12305:1997 E STD*BSI BS EN L2305-ENGL 1798 Lb24bb7 Ob87707 43T Page 2 EN i2305:1997 Foreword This European Standard has been prepared by Technical Committee CEN/TC 233, Biotechnology, the secretariat of which is he
15、ld by AFNOR. This European Standard shall be given the status of a national standard, either by publidon of an identical text or by endorsement, at the latest by April 1998, and conflicting national standards shall be withdrawn at the latest by April 1998. This European Standard has been prepared un
16、der a mandate given to CEN by the European Commission and the European nee lirade Association, and supports esential requirements of EU Dre b) design and review of sampling protocol; c) execution of the sampling protocol d) appropriate record keeping. Responsibilities should be assigned for each ste
17、p to a specific person. The sampling strategy should be reviewed reguiarb, in the light of field inspections, to ensure its continuing validity. 6.2 Design criteria The design of the sampling protocol should meet dened objectives as determined by the investigator and/or by statutory requirements. Th
18、e design can vary widelx for example, requirements for triais of introduced traits see 4a), for studies of gene transfer see 4b)l or gene behaviour see 4c)l can differ. The protocol for sampling should be part of the preparation and design of the experiment, keeping the flexibility that could be req
19、uired by unexpected observations, and should therefore be supported by a clear design of the experiment The sampling protocol should be documented. Parameters such as when sampiing will take place, the location(s) andor site size, the number of genotypes, number of plots and means of plot identifica
20、tion and the number of treatment(s) are important in the development of the design There are many different techniques available for the detection and identification of genetically modified plants. The following should be considered in the initial phase of the design - will samples be used for quaii
21、tative or quantitative analysis? - will sampling be for expressed charaderistics andor target nucleic acids? - which identification andor detection methods will be applied to the samples? - is the sampiing destructive? - is the protocol practical and feasible? The expression of characteristics in ge
22、netically modified plants is further dependent on the following factQm: - genetic background; - developmental stage of the plant; - plant part of relevance such as whole plant, root, leaf, flower, stem, pollen, seed; - specific environmental or externai constraints on the behaviour of the traits. O
23、BSI 1998 STD-BSI BS EN 12305-ENGL 1998 1bZqbbS Ob89712 TZV Therefore, the following should be considered in the design of a representative and statistically valid sampling protocol - choice of appropriate statistical method - required level of significance; - timing and frequency of sampling; - part
24、 of the plant to be sampled; - separate or pooled samples; - stability of sample; - number and size of samples; - number of plots; - number of plants; - number of samples per plot; - number of samples per plant; - appropriate negative and/or positive controls. The labelling of the samples and the sa
25、mpling of appropriate controls, if necessary, should also be described in the protocol. It should contain clear information on transport and storage requirements of the samples. The storage should be appropriate for the subsequent analysis. Appropriate data should be kept for a reasonable period to
26、allow future inspection: these should include records relating to responsibilities for steps of the protocol. In some cases it is appropriate to keep samples so that they can be tested at a later time. 6.3 Execution of sampling protocol To ensure valid quality assurance and sample traceability durin
27、g the sampling, the investigator should: - collect samples in accordance with the sampling design; - idenQfy and label the samples in accordance with the sampling design; - use precautions to protect the integrity of each sample; - store the samples so that they are not degraded with respect to thei
28、r content of specific DNA or gene products; - keep records of the relevant information regarding the sampling; - record every deviation from the initiai design. Page 5 EN 12305:1997 6.4 Record keeping A record should be kept of ail aspects of sampling as foreseen by the sampling design, including th
29、e following: - identification of the experiment; - date and duration of the sampling; - part of the plant; - location of sample (as precisely as necessary); - sample number, - treatment of sample after the collection; - identity of the person collecting samples; - deviations from the protocol; - sto
30、rage and transportation; - observed anomalies of plants. In addition a record should be kept, indicating the identity of the person) responsible for each step of the sampling strategy Q BSI 1998 Page 6 EN 123W.1997 4 -+zzq pro t o Co I Obtaining data Annex A (informative) Relationship between a vali
31、d sampling and monitoring strategy When geneticaiiy modified plants are subject to experimental release into the environment, the sampling strategy is dependent upon the objectives of the monitoring strategy. Therefore, the monitoring strategy encompasses the sampling sirate, both of which are requi
32、red to meet the objectives of the monitoring. The relationship between the sampling and monitoring strategy for deliberate releases of a genetically modified piant is given in Figure Al. pl analysis objectives objectives Figure A.l - Development of a valid monitoring and sampling strategy for delibe
33、rate releases of genetically modified plants in the environment O BSI 1998 Page 7 EN 12305:1997 Annex B (informative) Bibliography i Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modied organisms. OJEC 08.05.1990, No. L 117 p 15. 2 prEN 1
34、2683, Biotechnology - Modvied o?ya,nimfor appiiculiion in the enwimnment - Guidance for the characterization of genetically modified organisms by analysis of the stability of the genomic modification 3 Directive 94/15/EEC of 15 Aprii 1994 adapting to the technical progress the Directive adapting, fo
35、r the first time, the Council Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms. OJEC, 22.04.94, No. L 103 p 20. 4 IS0 10381-6, Soil quality - Sampling - Part 6: Guidance on the collectian, Itui.ldling and storage of soil for Uze assessment of aero
36、bic microbiaL processes in the laboratory 5 Peterson R.G., 1985. Design and Analysis of experiments. Mace1 Dekker inc., NewYork. 6 Lochow V.J. and Schuster W., 1961. Anlage und Ausioertunq von FeldwsmW. DLG-Verlags- GmbH., Frankfurt. O BSI 1998 BS EN 12305: 1998 BSI 389 Chiswick High Road London w4
37、4AL BSI - British Standards Institution BSI is the independent national body responsible for preparing British standards. It presents the TJK view on standards in Europe and at the international level. It is incorporated by Royal Charter. Revisions British Standards are updated by amendment or revis
38、ion. Users of British Standards should make sure that they possess the latest amendments or editions. It is the constant aim of BSI to improve the quaJity of our products and services. We would be grateful if anyone finding an inaccurxy or ambiguity while using this British Standard would inform the
39、 Secretary of the technical committee responsible, the identity of which can be found on the Wide fi-ont cover. Tel 0181 996 9000. Fax: 0181 996 7400. BSI offers members an individual updating service caled PLUS which ensures that . subscribers automatically receive the latest editions of standards.
40、 Buying standards Orders for all BSI, international and foreign standards publications should be adresed to Customer Services. Tel: O181 996 7000. Fax: 0181 996 7001. In response to orders for international st;uidards, it is BSI policy to supply the BSI implementation of those that have been publish
41、ed as British Standards, unless otherwise requested. Information on standards BSI provides a wide range of information on national, European and international standards through its iibrasy and its Technical Help to Exporters Service. Various BSI electronic information services are also available whi
42、ch give details on all its products and services. Contact the Information Centre. Tel O181 996 7111. Fax: O181 996 7048. Subscribing members of BSI are kept up to date with standards developments and receive substantial discounts on the purchase price of standards. For details of these and other ben
43、efits contact Membership Administratin. Tel: 0181 996 7002. Fax: 0181 996 7001. Copyright Copyright subsists in ail BSI publications. BSI also holds the copyright, in the UK, of the publications of the intemational standarMon bodies. Except as permitted under the Copynght, Designs and Patents Act 19
44、88 no extract may be reproduced, stored in a relrieval system or transmitted in any form or by any means - electronic, photocopying, recording or otherwise - without prior written permission from BSI. This does not preclude the free use, in the course of implementing the standard, of necessary detai
45、ls such as symbos, and size, type or grae designations. If these details are to be used for any other purpose than implementation then the prior written permission of BSI must be obtained If permission is granted, the terms may include royalty payments or a licensing agreement. Details and advice can be obtained from the Copyright Manager. Tek O181 996 7070.
