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1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 12685:1998 The Euro
2、pean Standard EN 12685:1998 has the status of a British Standard ICS 07.080; 07.100.01 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 release of genetical
3、ly modified micro-organisms, including viruses Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 14:45:18 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 12683:1998 This British Standard, having been prepared under the direction of the Sector Committee for Materials and Chemicals, was publishe
4、d under the authority of the Standards Committee and comes into effect on 15 December 1998 BSI 1998 ISBN 0 580 30178 8 Amendments issued since publication Amd. No.DateText affected National foreword This British Standard is the English language version of EN 12685:1998. The UK participation in its p
5、reparation was entrusted to Technical Committee CII/58, Biotechnology, which has the responsibility to: aid enquirers to understand the text; present to the responsible European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor relate
6、d 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 referred to in this document may b
7、e found in the BSI Standards Catalogue under the section entitled International Standards Correspondence Index, or by using the Find facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standar
8、ds are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 10, an inside back cover and a back cover. Lice
9、nsed Copy: sheffieldun sheffieldun, na, Sat Oct 28 14:45:18 GMT+00:00 2006, Uncontrolled Copy, (c) BSI CEN European Committee for Standardization Comite Europe en de Normalisation Europa isches Komitee fu r Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1998 CEN All rights of explo
10、itation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 12685:1998 E EUROPEAN STANDARDEN 12685 NORME EUROPE ENNE EUROPA ISCHE NORM July 1998 ICS 07.080; 07.100.01 Descriptors: biotechnology, genetics, modified organisms, environments, environmental protection, i
11、nspection, experimental design English version Biotechnology Modified organisms for application in the environment Guidance for the monitoring strategies for deliberate releases of genetically modified micro-organisms, including viruses Biotechnologie Organismes modifie s disse mine s dans lenvironn
12、ement Guide des strate gies de surveillance pour les disse minations volontaires de micro-organismes ge ne tiquement modifie s, y compris de virus Biotechnik Vera nderte Organismen zum Einsatz in der Umwelt Leitfaden fu r die U berwachungsstrategien bei der absichtlichen Freisetzung gentechnisch ver
13、a nderter Mikroorganismen einschlielich Viren This European Standard was approved by CEN on 1 July 1998. 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 alteration
14、. 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 translation
15、 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,
16、 Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 14:45:18 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 2 EN 12685:1998 BSI 1998 Foreword This European Standard has been prepared by Technical Committee
17、 CEN/TC 233, Biotechnology, the Secretariat of which is held by AFNOR. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by January 1999, and conflicting national standards shall be withdrawn at the la
18、test by January 1999. This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement th
19、is 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 Foreword2 Introduction3 1Scope3 2Normative references3 3Definitions3
20、 4General considerations4 5Monitoring strategy4 Annex A (informative) Relationship between a sampling and monitoring valid strategy9 Annex B (informative) Bibliography10 Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 14:45:18 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 3 EN 12685:1998 BS
21、I 1998 Introduction When genetically modified micro-organisms including viruses (GMMs) are subject to experimental release into the environment, it is important to ensure the validity of a monitoring strategy for testing their behaviour. In this European Standard, monitoring refers both to the monit
22、oring of the occurrence, persistence and/or spread of the GMM and/or the gene(s) involved in the modification and its performance in the environment. This European Standard is intended to aid the experimenter in the design of a monitoring strategy appropriate to monitoring objectives. The developmen
23、t of a monitoring valid strategy is directly linked to the development of the sampling strategy as described in EN 12686. Therefore, this European Standard gives the experimenter a list of points that should be considered in determining the validity of a monitoring strategy comprising valid design,
24、review, execution and documentation of a monitoring protocol. 1 Scope This European Standard provides guidance on factors and criteria considered for the determination of the suitability and validity of the design, development and execution of a monitoring strategy for GMM. Monitoring encompasses de
25、tection of genotypic and phenotypic properties, as well as detection of viral material and/or symptoms specific for the infected host, for the identification of GMMs in an experimental release. This European Standard provides the person conducting a monitoring programme with a list of factors and cr
26、iteria that should be considered in determining the validity of the proposed strategy for monitoring. This European Standard is specifically aimed at monitoring experimental release of GMMs or their nucleic acid. This European Standard however, does not cover: the monitoring of virus-like entities o
27、r similar agents; the monitoring of GMMs for food, human health and veterinary applications. NOTEAttention is drawn to national, European and international regulations, and relevant standards covering the monitoring of GMMs in food, human health and veterinary applications. 2 Normative references Th
28、is European Standard incorporates by dated or undated reference, provisions from other 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 publi
29、cations apply to this European Standard only when incorporated in it by amendment or revision. For undated references the latest edition of the publication referred to applies. EN 12686, Biotechnology Modified organisms for application in the environment Guidance for the sampling strategies for deli
30、berate releases of genetically modified micro-organisms, including viruses. 3 Definitions For the purposes of this 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) occu
31、rrence, persistence, multiplication and spreading abilities 3.3 control preparation of known characteristics used to standardize an analysis 3.4 detection recognition of the presence of an organism or of a molecular structure within a sample 3.5 genetic modification of interest conceptual design for
32、 altering the genetic material within an organism NOTE 1The genetic modification of interest can be described at different levels of molecular detail. NOTE 2The conceptual design can include insertion, substitution or deletion of genetic material. 3.6 genetically modified micro-organism micro-organi
33、sm in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination NOTEWithin the terms of this definition genetic modification occurs at least through the use of the techniques listed in the Directive 90/219/EEC or its appropriate annexes
34、 (see annex B 1). 3.7 genotype genetic constitution of an organism NOTEThe genotype can be described with respect to particular genes. 3.8 host target species for virus replication as defined in the experimental design Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 14:45:18 GMT+00:00 2006, U
35、ncontrolled Copy, (c) BSI Page 4 EN 12685:1998 BSI 1998 3.9 identification establishment of identity by comparison with a reference NOTE 1The reference could be an organism, a molecular structure or the genetic modification of interest. NOTE 2The certainty of identification is affected by the types
36、and/or number of characteristics investigated. 3.10 micro-environment defined location in the environment potentially occupied by an organism NOTEThis micro-environment can impart a degree of confinement on the dispersal of the organism. 3.11 monitoring regular or continuous observation or collectio
37、n of data with respect to an organism, process or procedure NOTEIn this standard, monitoring applies to the progress of a released genetically modified organism. 3.12 monitoring protocol list of sequential steps and methods to be used for monitoring 3.13 monitoring strategy procedure for designing,
38、reviewing, executing and documenting a monitoring protocol 3.14 phenotype sum of the traits of an organism NOTE 1The phenotype can be described with respect to one or more traits under a given set of conditions. NOTE 2In the case of a virus, the phenotype can be described by one or more traits manif
39、ested in the infected host. 3.15 release site defined area which contains one or more experimental fields NOTESeveral different trials can occur within a release site. 4 General considerations Monitoring is important in order to test predictions made with respect to the behaviour of the GMM in a rel
40、ease site. The availability and use of adequate controls is essential for the validity of the results. The design and execution of a monitoring valid strategy is therefore dependent on the particular objectives of the monitoring strategy. These can include the following. a) Studies on the functionin
41、g of the genetic modification in the GMM, released in 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. b) Studies on the effect of the genetic modification of interest o
42、n the behaviour of the GMM, released in the environment. The monitoring strategy can include studies on the presence of the GMM of interest or its hosts in environmental samples or its performance in the environment including effects on the ecosystem considered. c) Studies on the transfer of the gen
43、e(s) involved in the genetic modification of interest. The monitoring programme can include studies on transfer to the indigenous microbial population. 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
44、 the monitoring strategy are: a) design and review of the monitoring protocol; b) validation of the monitoring protocol; c) execution of the monitoring protocol; d) record keeping. Responsibility for these steps should be assigned to a specific authority, organization or person. The monitoring strat
45、egy should be reviewed regularly, in the light of the inspections of the release site, 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 t
46、he monitoring strategy objectives 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 12686; NOTEThe development of a monitoring and sampling valid strategy for deliberate releases of genetically m
47、odified micro-organisms in the environment 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) predicted behaviour of GMM, particularly with respect to competitive ability, dispersal, persistenc
48、e and the ability to form spores, resting forms and other specialized structures; 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
49、, soil movement activities, meteorological parameters, soil properties; f) presence of potential hosts, presence of potential microbial vectors; g) appropriate choice of monitoring methods. Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 14:45:18 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 5 EN 12685:1998 BSI 1998 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 suitability and validity of a monitoring protocol are given