1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 12468:1998 The Euro
2、pean Standard EN 12468:1997 has the status of a British Standard ICS 07.080 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Biotechnology Modified organisms for application in the environment Guidance for the monitoring strategies for deliberate releases of genetically modifie
3、d plantsThis British Standard, having been prepared under the direction of the Sector Board for Materials and Chemicals, was published under the authority of the Standards Board and comes into effect on 15 April 1998 BSI 1998 ISBN 0 580 29717 9 BS EN 12468:1998 Amendments issued since publication Am
4、d. No. Date Text affected National foreword This British Standard is the English language version of EN 12468:1997. The UK participation in its preparation was entrusted to Technical Committee CII/58, Biotechnology, which has the responsibility to: aid enquirers to understand the text; present to th
5、e responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. A list of organizations represented on this committee can be obtaine
6、d on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” faci
7、lity of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obliga
8、tions. Summary of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 8, an inside back cover and a back cover.CEN European Committee for Standardization Comite Europe en de Normalisation Europa isches Komitee fu r Normung Central Secretariat: rue de Sta
9、ssart 36, B-1050 Brussels 1997 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members Ref. No. EN 12468:1997 E EUROPEAN STANDARD EN 12468 NORME EUROPE ENNE EUROPA ISCHE NORM December 1997 ICS 07.080 Descriptors: Biotechnology, transgenic organisms, tr
10、ansgenic plants, agriculture, experimentation, tests, inspection, sampling, data processing, experimental data English version Biotechnology Modified organisms for application in the environment Guidance for the monitoring strategies for deliberate releases of genetically modified plants Biotechnolo
11、gie Organismes modifie s disse mine s dans lenvironnement Guide des strate gies de surveillance pour les disse minations volontaires de plantes ge ne tiquement modifie es Biotechnik Vera nderte Organismen zum Einsatz in der Umwelt Leitfaden fu r die U berwachungsstrategien bei der absichtlichen Frei
12、setzung gentechnisch vera nderter Pflanzen This European Standard was approved by CEN on 7 November 1997. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteratio
13、n. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central 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 translatio
14、n under the responsibility of a CEN member into its own language and notified 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, Ireland, Italy
15、, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.Page 2 EN 12468:1997 BSI 1998 Foreword This European Standard has been prepared by Technical Committee CEN/TC 233, Biotechnology, the Secretariat of which is held by AFNOR. This European Standard shall be give
16、n the status of a national standard, either by publication of an identical text or by endorsement, at the latest by June 1998, and conflicting national standards shall be withdrawn at the latest by June 1998. According to the CEN/CENELEC Internal Regulations, the national standards organizations of
17、the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Contents Page Foreword 2 Introduc
18、tion 3 1 Scope 3 2 Normative references 3 3 Definitions 3 4 General considerations 4 5 Monitoring strategy 4 Annex A (informative) Relationship between a sampling and monitoring valid strategy 7 Annex B (informative) Bilbiography 8Page 3 EN 12468:1997 BSI 1998 Introduction When the behaviour of gene
19、tically modified plants is tested in an experimental field, it is important that a valid monitoring strategy is used, and that the monitoring strategy has been designed in accordance with the specific plant species and experimental requirements. In this European Standard, monitoring refers both to t
20、he monitoring of the occurrence, persistence and/or spread of the genetically modified plant and/or the gene(s) involved in the modification. This European Standard is intended to aid the experimenter in the design of a monitoring strategy appropriate to the monitoring objectives. Therefore, this Eu
21、ropean Standard gives the experimenter a list of points that should be considered in determining the validity of a monitoring strategy comprising valid design, review, execution and documentation of a monitoring protocol. 1 Scope This European Standard gives guidance on factors and criteria consider
22、ed for the determination of the suitability and validity of the design, development and execution of a monitoring strategy for genetically modified plants. Monitoring encompasses detection of genes and traits, as well as the identification of genetically modified plants in an experimental release. T
23、his European Standard provides the person conducting a monitoring programme with factors and criteria that should be considered in determining the validity of the proposed monitoring strategy. 2 Normative references This European Standard incorporates by dated or undated reference, provisions from o
24、ther publications. These normative references are cited at the appropriate places in the text and the publications are listed hereafter. For dated references, subsequent amendments to or revisions of any of these publications apply to this European Standard only when incorporated in it by amendment
25、or revision. For undated references the latest edition of the publication referred to applies. EN 12305 Biotechnology Modified organisms for application in the environment Guidance for the sampling strategies for deliberate releases of genetically modified plants 3 Definitions For the purposes of th
26、is standard, the following definitions apply. 3.1 analyte substance sought or determined 3.2 behaviour interaction of the organism(s) with abiotic and biotic environments, its (their) occurrence, persistence, multiplication and spreading abilities 3.3 control preparation of known characteristics use
27、d to standardize an analysis 3.4 detection recognition of the presence of an organism or of a molecular structure within a sample 3.5 experimental field area within a release site which contains the plots necessary to standardize the analysis 3.6 genetic modification of interest conceptual design fo
28、r altering the genetic material within an organism NOTE 1 The genetic modification of interest can be described at different levels of molecular detail. NOTE 2 The conceptual design can include insertion, substitution or deletion of genetic material. 3.7 genetically modified plant plant in which the
29、 genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination NOTE Within the terms of this definition genetic modification occurs at least through the use of the techniques listed in the Directive 90/220/EEC or its appropriate annexes (see annex B
30、2). 3.8 identification establishment of identity by comparison with a reference NOTE 1 The reference could be an organism, a molecular structure or the genetic modification of interest. NOTE 2 The certainty of identification can be affected by the types and/or number of characteristics investigated.
31、 3.9 monitoring regular or continuous observation or collection of data with respect to an organism, process or procedure NOTE In this standard, monitoring applies to the progress of a released genetically modified plant. 3.10 monitoring protocol list of sequential steps and methods to be used for m
32、onitoringPage 4 EN 12468:1997 BSI 1998 3.11 monitoring strategy procedure for designing, reviewing, executing and documenting a monitoring protocol 3.12 release site defined area which contains one or more experimental fields NOTE Several different trials can occur within a release site. 3.13 trait
33、observable and/or measurable characteristic 3.14 volunteer plant carry-over plant material growing as a weed in a subsequent crop 4 General considerations Monitoring is important in order to test predictions made with respect to the behaviour of the genetically modified plant released into a release
34、 site. The design and execution of a valid monitoring strategy is therefore dependent on the particular objectives of the monitoring strategy. These can include the following. a) Studies on the effect of the genetic modification of interest on the behaviour of the genetically modified plants release
35、d into the environment. The monitoring strategy can include studies on the presence of the genetically modified plant of interest in environmental samples, its performance in the environment and of its effects on the ecosystem considered. b) Studies on the functioning of the genetic modification in
36、the genetically modified plants released into the environment. The monitoring programme can include studies on the molecular stability and functional expression of the gene(s) involved in the genetic modification of interest. c) Studies on the transfer of the gene(s) involved in the genetic modifica
37、tion of interest. The monitoring programme can include studies on transfer to the indigenous plant population cultivated or not. 5 Monitoring strategy 5.1 General It is first necessary to determine the objectives of the monitoring strategy. The main steps in the development of the monitoring strateg
38、y are: a) design and review of the monitoring protocol; b) validation of the monitoring protocol; c) execution of the monitoring protocol; d) appropriate record keeping. Responsibility for these steps should be assigned to a specific authority, organization or person. The monitoring strategy should
39、be reviewed regularly, in the light of the field inspections, to ensure its continuing validity. 5.2 Criteria for the design of the monitoring protocol The following key factors should be considered in the initial design of the protocol to ensure the design correlates with the monitoring strategy ob
40、jectives as determined by the person designing the test: a) sampling strategy appropriate to the objectives and needs of the monitoring strategy as described in EN 12305; NOTE The development of a valid monitoring and sampling strategy for deliberate releases of genetically modified plants in the en
41、vironment is summarized in Figure A.1. b) extent of monitoring necessary to fulfil the requirements of the experiment such as timescale, scale and area of sampling; c) plant species, predicted behaviour of plant, particularly with respect to pollination and pollen dispersal, seed dispersal, dispersa
42、l by vegetative means, competitive ability and weediness; d) relevant area for monitoring in line with the monitoring objectives such as the release site and/or the potential dispersal area; e) particular features of the release site to monitor such as adjacent sites, streams, soil movement activiti
43、es, meteorological parameters, wild relatives; f) appropriate choice of methods used for monitoring with respect to plant species involved in experiments. 5.3 Validity of the design of the monitoring protocol 5.3.1 General Factors and criteria which should be considered for the determination of the
44、suitability and validity of a monitoring protocol are given in 5.3.2 to 5.3.5. These should not be considered as exhaustive lists. 5.3.2 Considerations with respect to fulfilling the overall experimental objective In fulfilment of the overall experimental objective, the aim of individual experiments
45、 can be: detection; identification; determination of the molecular stability of the gene expression; determination of the effect of the modification; rapid screening or detailed investigation; quantitative or qualitative approach.Page 5 EN 12468:1997 BSI 1998 5.3.3 Considerations with respect to the
46、 genetic modification The factor(s) being monitored can be one or a combination of the following: gene presence; gene expression; presence of genetically modified plant; behaviour of the genetically modified plants in the environment. 5.3.4 Considerations with respect to the release site Factors inf
47、luencing the monitoring strategy with respect to the release site can be: environmental conditions; presence of organisms which feed on the plant; presence of organisms that can serve as carriers for genetic material; presence of compatible species within a potential dispersal area. 5.3.5 Considerat
48、ions with respect to the validity of methods used for monitoring 5.3.5.1 Key considerations with respect to the validity of methods used for monitoring The following parameters should be considered for method validation to ensure that the performance characteristics of the method(s) are understood,
49、and to demonstrate that the method used for monitoring is scientifically sound and valid under the experimental conditions to which it is applied: fit for purpose; selectivity; specificity; reproducibility; repeatability; reliability; feasibility; limitations; detection limit; access to appropriate controls. NOTE A full definition of several of these parameters is given in Eurachem guidance document n1 - 1993 (see annex B 5). The following explanations are intended as a
