BRITISH STANDARD |

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12685:1998
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Biotechnology Ð Modified |
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organisms for application in |
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the environment Ð Guidance |
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for the monitoring strategies |
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for deliberate release of |
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genetically modified |
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micro-organisms, including |
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viruses |
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The European Standard EN 12685:1998 has the status of a |
British Standard |
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ICS 07.080; 07.100.01 |
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NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW
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Copyright British Standards Institution
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 BS EN 12683:1998

National foreword
This British Standard is the English language version of EN 12685:1998.
The UK participation in its preparation was entrusted to Technical Committee
CII/58, Biotechnology, which has the responsibility to:

Ð aid enquirers to understand the text;

Ð present to the responsible European committee any enquiries on the
interpretation, or proposals for change, and keep the UK interests informed;
Ð 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
referred to in this document may be found in the BSI Standards Catalogue under the
section entitled ªInternational Standards Correspondence Indexº, or by using the
ªFindº facility of the BSI Standards Electronic Catalogue.
A British Standard does not purport to include all the necessary provisions of a
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contract. Users of British Standards 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.

This British Standard, having Amendments issued since publication

been prepared under the
direction of the Sector Amd. No. Date Text affected
Committee for Materials and
Chemicals, was published under
the authority of the Standards
Committee and comes into effect
on 15 December 1998

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 EUROPEAN STANDARD EN 12685
NORME EUROPEÂENNE
EUROPAÈISCHE NORM July 1998

ICS 07.080; 07.100.01

Descriptors: biotechnology, genetics, modified organisms, environments, environmental protection, inspection, experimental design

English version

Biotechnology Ð Modified organisms for application in the

environment Ð Guidance for the monitoring strategies for
deliberate releases of genetically modified micro-organisms,
including viruses

Biotechnologie Ð Organismes modifieÂs disseÂmineÂs Biotechnik Ð VeraÈnderte Organismen zum Einsatz

dans l'environnement Ð Guide des strateÂgies de in der Umwelt Ð Leitfaden fuÈr die
surveillance pour les disseÂminations volontaires de UÈ berwachungsstrategien bei der absichtlichen
micro-organismes geÂneÂtiquement modifieÂs, y Freisetzung gentechnisch veraÈnderter
compris de virus Mikroorganismen einschlieûlich 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. 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 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,
Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and
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United Kingdom.

CEN
European Committee for Standardization
Comite EuropeÂen de Normalisation
EuropaÈisches Komitee fuÈr Normung

Central Secretariat: rue de Stassart 36, B-1050 Brussels

 1998 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national
Members.
Ref. No. EN 12685:1998 E

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 Page 2
EN 12685:1998

Foreword Contents
This European Standard has been prepared by Page
Technical Committee CEN/TC 233, Biotechnology, the
Secretariat of which is held by AFNOR. Foreword 2
This European Standard shall be given the status of a Introduction 3
national standard, either by publication of an identical 1 Scope 3
text or by endorsement, at the latest by January 1999, 2 Normative references 3
and conflicting national standards shall be withdrawn
at the latest by January 1999. 3 Definitions 3
This European Standard has been prepared under a 4 General considerations 4
mandate given to CEN by the European Commission 5 Monitoring strategy 4
and the European Free Trade Association.
Annex A (informative) Relationship
According to the CEN/CENELEC Internal Regulations, between a sampling and monitoring valid
the national standards organizations of the following strategy 9
countries are bound to implement this European
Standard: Austria, Belgium, Czech Republic, Denmark, Annex B (informative) Bibliography 10
Finland, France, Germany, Greece, Iceland, Ireland,
Italy, Luxembourg, Netherlands, Norway, Portugal,
Spain, Sweden, Switzerland and the United Kingdom.

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 Page 3
EN 12685:1998

Introduction EN 12686, Biotechnology Ð Modified organisms for

application in the environment Ð Guidance for the
When genetically modified micro-organisms including
sampling strategies for deliberate releases of
viruses (GMMs) are subject to experimental release
genetically modified micro-organisms, including
into the environment, it is important to ensure the
viruses.
validity of a monitoring strategy for testing their
behaviour.
In this European Standard, monitoring refers both to 3 Definitions
the monitoring of the occurrence, persistence and/or For the purposes of this standard, the following
spread of the GMM and/or the gene(s) involved in the definitions apply:
modification and its performance in the environment.
This European Standard is intended to aid the 3.1
experimenter in the design of a monitoring strategy analyte
appropriate to monitoring objectives. The development substance sought or determined
of a monitoring valid strategy is directly linked to the
development of the sampling strategy as described in 3.2
EN 12686. Therefore, this European Standard gives the behaviour
experimenter a list of points that should be considered interaction of the organism(s) with abiotic and biotic
in determining the validity of a monitoring strategy environments, its (their) occurrence, persistence,
comprising valid design, review, execution and multiplication and spreading abilities
documentation of a monitoring protocol.
3.3
1 Scope control
This European Standard provides guidance on factors preparation of known characteristics used to
and criteria considered for the determination of the standardize an analysis
suitability and validity of the design, development and 3.4
execution of a monitoring strategy for GMM.
detection
Monitoring encompasses detection of genotypic and
phenotypic properties, as well as detection of viral recognition of the presence of an organism or of a
material and/or symptoms specific for the infected molecular structure within a sample
host, for the identification of GMMs in an experimental 3.5
release.
genetic modification of interest
This European Standard provides the person
conducting a monitoring programme with a list of conceptual design for altering the genetic material
factors and criteria that should be considered in within an organism
determining the validity of the proposed strategy for NOTE 1 The genetic modification of interest can be described at
different levels of molecular detail.
monitoring.
NOTE 2 The conceptual design can include insertion, substitution
This European Standard is specifically aimed at or deletion of genetic material.
monitoring experimental release of GMMs or their
nucleic acid. 3.6
This European Standard however, does not cover: genetically modified micro-organism
Ð the monitoring of virus-like entities or similar micro-organism in which the genetic material has been
agents; altered in a way that does not occur naturally by
Ð the monitoring of GMMs for food, human health mating and/or natural recombination
and veterinary applications. NOTE Within the terms of this definition genetic modification
NOTE Attention is drawn to national, European and international occurs at least through the use of the techniques listed in the
regulations, and relevant standards covering the monitoring of Directive 90/219/EEC or its appropriate annexes (see annex B [1]).
GMMs in food, human health and veterinary applications.
3.7
2 Normative references genotype
This European Standard incorporates by dated or genetic constitution of an organism
undated reference, provisions from other publications. NOTE The genotype can be described with respect to particular
genes.
These normative references are cited at the
appropriate places in the text and the publications are 3.8
listed hereafter. For dated references, subsequent host
amendments to or revisions of any of these
publications apply to this European Standard only target species for virus replication as defined in the
when incorporated in it by amendment or revision. For experimental design
undated references the latest edition of the publication
referred to applies.
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 Page 4
EN 12685:1998
3.9
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 is affected by the types
and/or number of characteristics investigated.
3.10
micro-environment
defined location in the environment potentially
occupied by an organism
NOTE This ªmicro-environmentº can impart a degree of
confinement on the dispersal of the organism.
3.11
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 organism.
3.12
monitoring protocol
list of sequential steps and methods to be used for
monitoring
3.13
monitoring strategy
procedure for designing, reviewing, executing and
documenting a monitoring protocol
3.14
phenotype
sum of the traits of an organism
NOTE 1 The phenotype can be described with respect to one or
more traits under a given set of conditions.
NOTE 2 In the case of a virus, the phenotype can be described
by one or more traits manifested in the infected host.
3.15
release site
defined area which contains one or more experimental
fields
NOTE Several 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
release 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 functioning 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.
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b) Studies on the effect of the genetic modification
of interest on 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 gene(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 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 strategy 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 the 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;
NOTE The development of a monitoring and sampling valid
strategy for deliberate releases of genetically modified
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, persistence
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, soil movement
activities, meteorological parameters, soil properties;
f) presence of potential hosts, presence of potential
microbial vectors;
g) appropriate choice of monitoring methods.
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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 in 5.3.2 to 5.3.5. The
following lists of factors and criteria should not be
considered as exhaustive.
5.3.2 Considerations with respect to fulfilling the
overall experimental objective
In fulfilment of the overall experimental objective, the
aim of individual experiments can be:
Ð detection;
Ð identification;
Ð determination of the molecular stability of the
gene expression;
Ð determination of the effect of the modification;
Ð rapid screening or detailed investigation;
Ð quantitative or qualitative approach.
5.3.3 Considerations with respect to the genetic
modification of interest
The factor(s) being monitored can be one or a
combination of the following:
Ð gene presence;
Ð gene expression;
Ð presence of the GMM;
Ð behaviour of the GMM in the environment.
5.3.4 Considerations with respect to the release
site
Factors influencing the monitoring strategy with
respect to the release site can be:
Ð methods of application of the GMM to the release
site;
Ð environmental factors such as season, weather;
Ð biological factors such as predation or the
presence of organisms which could displace the
GMM, hosts, or alternatively serve as microbial
vectors;
Ð physical factors such as soil type, water drainage;
Ð presence of populations related to the GMM.
5.3.5 Considerations with respect to the validity
of monitoring methods
5.3.5.1 Key considerations with respect to the
validity of monitoring methods
The following method validation parameters should be
considered to ensure that the performance
characteristics of the method(s) are understood, and to
demonstrate that the method used for monitoring is
scientifically sound and valid under the experimental
conditions in which it is to be applied:
Ð fit for purpose;
Ð feasibility;
Ð limitations;
Ð access to appropriate controls;
Ð selectivity and specificity;
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EN 12685:1998
Ð reproducibility;
Ð repeatability;
Ð limit of detection;
Ð reliability.
NOTE A full definition of several of these parameters is given in
Eurachem guidance document no 1 Ð 1993 (see Annex B [3]). The
following explanations are intended as a guide for the application
of this European Standard.
a) Fit for purpose should address the specific
experimental needs and is relevant to the aim, scope
and available resources of the experiment.
b) Feasibility indicates how workable the method is
in practice.
c) Limitations are the shortcomings of a method and
any restrictions to use.
d) Access to appropriate controls should include the
parent or the non-modified recipient organism.
e) Selectivity of a method refers to the extent to
which it can determine particular analyte(s) in a
complex mixture without interference from the other
components in the mixture. Specificity qualifies a
method which is selective for an analyte or group of
analytes of interest.
f) Reproducibility is the closeness of the agreement
between the results of successive measurements
carried out independently using an identical
experimental protocol but under changed conditions.
The changed conditions can include operator,
location and time.
g) Repeatability is the closeness of the agreement
between the results of successive measurements
carried out under the same conditions. Repeatability
conditions include the same operator, the same
location and repetition over a short period of time.
h) Limit of detection is the smallest amount of
analyte that can be reliably detected. This issue
implies the concept of sensitivity.
i) Reliability qualifies a dependable method which
gives both repeatable and reproducible results.
5.3.5.2 Further factors influencing the choice of valid
monitoring methods
The following considerations can also be relevant to
the choice of valid methods used for monitoring,
depending on the nature and objectives of the
monitoring experiment. Not all the considerations are
applicable for each experimental situation.
a) Many methods can be used to monitor GMMs
released into the field. They can include
microbiological, virological and/or molecular
biological methods. For any method, an appropriate
sampling regime and, if necessary, transport
arrangements should be adopted (see EN 12686).
b) The methods used for monitoring required can
vary from release depending primarily upon the
monitoring objectives and should be identified in
accordance with the validity criteria identified in 5.3.
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EN 12685:1998
c) The choice of methods used for monitoring
depends upon the purpose for which the monitoring
is done and should enable detection of events under
study. The nature of the GMM and its hosts can help
to determine the methods used for monitoring a
release; different types of GMM can require different
techniques for monitoring. Key factors to be
considered in the establishment of a monitoring
strategy would include:
Ð environmental location, e.g. air, soil, water;
Ð type of GMM, e.g. bacteria, fungi;
Ð type and number of hosts;
Ð state of GMM, e.g. spore, vegetative or
ªdormantº cells;
Ð transmission of GMM e.g. seedborne, aphid
transmission;
Ð any symbiotic relationship;
Ð environmental persistence.
Thus GMMs dispersed through the air can require
very different sampling and detection techniques
from soil micro-organisms or those with a symbiotic
relationship with another, higher organism.
d) The validity of any one method, or combination
of methods, can be affected by the ease and
accuracy of identification of the introduced GMMs
and/or the introduced genes. Identification of GMMs
should ideally be by means of easily recognizable
phenotypic or genotypic characteristics (see Annex B
[4], [5]).
e) To facilitate monitoring, the released GMM should
be unequivocally recognizable. Any identifying
characteristic should ideally be stable, and clearly
different from the equivalent characteristic displayed
by local microbial communities or viral populations.
Marker characteristics that are easy to identify can
be suitable for assessing the spread of the GMM or
horizontal transfer of genetic material.
f) For some releases it cannot be possible to detect
GMMs by direct recovery. Once released into the
environment some micro-organisms can undergo
physiological changes which lead to them being no
longer culturable under standard laboratory
conditions. Alternative monitoring techniques can be
at the DNA-level, in which case the experiment can
need to demonstrate that the DNA/RNA target is
associated with or derived from GMMs contained in
the sample, or be related to the effect(s) the GMM
should have, for example its effects as a biocontrol
agent.
g) In many cases, monitoring can need an estimation
of the population size of the released GMMs.
Suitable, quantitative methods can therefore be
necessary, and appropriate statistical analysis
methods can also be required. Such data, gathered
over time can indicate whether the released
population is surviving, multiplying or declining.
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h) Factors to be taken into account include the ease
and simplicity of conventional cultural methods for
microbiology and virology and their ability to screen
large numbers of samples, but sensitivity and
application to viable non-culturable micro-organisms
could be limited. Molecular amplification techniques
are usually more rapid and sensitive, but cannot
readily be used to estimate population sizes and are
very prone to inhibition and reduced detection limits
due to typical environmental matrix components.
Moreover, they do not generally give an indication of
the potential viability of the GMM.
i) Although observation of the trial site is unlikely to
be able to provide confirmation of the presence of
the released GMM, this observation can give the first
indication of an expected or unexpected effect.
j) The transfer of the inserted gene(s) from the
released GMM to a resident recipient should result
in the appearance of the gene(s) of interest in a new
genetic background. For example, for viruses, the
inserted gene can code for an insect specific toxin,
insect hormone, pharmaceutically active protein; for
bacteria and fungi, the inserted gene can code for
heavy metal or other resistance, or the ability to
degrade a particular xenobiotic compound.
Micro-organisms possessing the genes can be able to
grow on the appropriate selective or elective media
containing the particular heavy metal, antibiotic or
xenobiotic compound. If the released GMM has a
well-defined genetic background such as
chromosomal markers, the appearance of
characteristics of the transgene(s) in a different
genetic background can indicate that the transgenes
have been transferred into (resident) recipient
organisms. If the released GMM does not have a
well-defined genetic background, the appearance of
the transgene in a recipient organism should be
verified by appropriate molecular methods. However,
it should be noted that in environmental samples
such as soil, the majority of viable micro-organisms
present cannot be cultured by conventional
laboratory techniques, or cannot express the
transferred gene. In such cases, appropriate
molecular methods should also be applied.
k) The reacquisition of deleted gene(s) from
endemic populations into the GMM should be
assessed using molecular biology or cultural
methods.
l) Other characteristics which can be suitable for
monitoring purposes include biochemical
characteristics or end-products of the gene product
or micro-organism (for example, alloenzyme analysis,
or metabolic properties used in micro-organism
identification), and DNA characteristics, including
RFLP and RAPD profiling analysis and DNA
amplification (see Annex B [5]).
The validity of the initial design of the monitoring
protocol should be re-assessed, based on a review of
the above considerations, prior to the final definition of
the monitoring protocol before execution.
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5.4 Execution of the monitoring protocol
5.4.1 General
The monitoring protocol should be executed in three
stages:
a) sampling (see 5.4.2);
b) obtaining data (see 5.4.3);
c) valid analysis of data (see 5.4.4).
5.4.2 Sampling
It is essential that sampling regimes for collection of
relevant material and/or observations for monitoring
purposes are valid and realistic. Sampling should be
carried out in accordance with EN 12686.
5.4.3 Obtaining data
Monitoring data should be obtained by the method(s)
determined in the monitoring protocol, over the
appropriate timescale and relevant area.
The frequency and extent of monitoring during the
release should be adequate to ensure that the
objectives of the monitoring strategy can be met, and
should take into account the estimated growth,
survival and/or transfer abilities of the micro-organism
in field conditions. It should be noted that estimates
obtained in laboratory conditions are not necessarily
relevant for the field situation.
Monitoring should be carried out over the relevant
area, in accordance with the objectives of the
experimental design; in general, monitoring should
concentrate on the release site, plus the likely dispersal
area. The following factors should be considered when
estimating how far the micro-organism is likely to be
dispersed.
a) The size of the potential dispersal area depends
on the type of GMM, host and possibly the scale of
the proposed release, and the way in which the
GMM is released. For example, a large area used for
the release, or application by a spray could increase
the potential for spread.
b) In some cases, if a micro-organism, a host or a
microbial vector occupies a particular niche, the
micro-environment of the niche can be significantly
different from the wider environment of the release
site. This can impart a degree of confinement on the
dispersal of the micro-organism.
c) Estimates of the size of the dispersal area should
be based both on practical and on theoretical
considerations. They should include the scale of the
proposed release. Dispersal can be influenced by the
ability of either the GMM, its host or its microbial
vector to form spores, resting forms and other
specialized structures.
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EN 12685:1998
d) It can also be relevant to consider mechanisms of
dispersal such as by physical means (wind or water
dispersal) or via microbial vectors which can be
biological (insects and other animals), or man-made
(vehicles).
e) It should be noted that some released GMMs may
not remain associated with a fixed physical site; for
example, micro-organisms which are released into a
water course.
Other factors can also affect the dispersal,
establishment and/or persistence of the GMM or its
host and the ability to detect and monitor these events.
Abiotic factors can include:
Ð pH;
Ð light;
Ð temperature;
Ð humidity;
Ð soil drainage characteristics;
Ð micro-climate including shelter or exposure;
Ð prevailing wind direction (important if the
micro-organism could be dispersed by wind);
Ð macro-climate;
Ð site security and access.
Biotic factors can include:
Ð trophic interactions;
Ð fitness;
Ð competition;
Ð human intervention.
5.4.4 Valid analysis of data
The data analysis, regardless of the method(s) applied,
should be regarded as valid if:
a) the experiment has been performed according to
the written protocol or any deviations from the
protocol have been indicated;
b) samples and appropriate controls are analysed
simultaneously using the same methods;
c) all controls give expected results;
d) sensitivity and reproducibility of the applied
method(s) are appropriate;
e) where required, a statistically relevant number of
samples and controls has been analysed;
f) relevant external factors which can affect the
analysis and/or interpretation of the results have
been taken into account; and
g) results are recorded and appropriately expressed
and realistically assessed with regard to the
information value of the applied method.
 Page 8
EN 12685:1998

5.5 Record keeping

A record should be kept of the monitoring strategy.
This should include:
a) description of any sampling protocol employed
(see EN 12686);
b) description of the monitoring protocol:
Ð identification of the experiment;
Ð identity of the persons performing the
monitoring;
Ð identification and description of the release
site;
Ð method(s) chosen for monitoring;
Ð origin of samples;
Ð controls used;
Ð number of samples analysed;
Ð deviations from the strategy;
Ð registration of unexpected incidents;
c) description of the analysis and results of the
execution of the monitoring of the GMM;
d) any other specific details which can be relevant
to the specific monitoring strategy and subsequent
interpretation of results obtained.
NOTE This list should not be considered as exhaustive.

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EN 12685:1998

Annex A (informative)
Relationship between a sampling and monitoring valid strategy
When genetically modified micro-organisms 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 strategy both of which are required to meet the objectives of the monitoring. The
relationship between the sampling and monitoring strategy for deliberate releases of a genetically modified
micro-organism is given in Figure A.1.

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Figure A.1 Ð Development of a monitoring and sampling valid strategy for deliberate
releases of genetically modified micro-organisms in the environment

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EN 12685:1998

Annex B (informative)
Bibliography
[1] Council Directive 90/219/EEC of 23 April 1990
on the contained use of genetically modified
micro-organisms. OJEC 08.05.1990,
no. L 117, p 1.
[2] Council Directive 90/220/EEC of 23 April 1990
on the deliberate release into the environment
of genetically modified organisms OJEC
08.05.1990, no. L117, p 15.
[3] International vocabulary of basic and general
terms in metrology. ISO 1993, Eurachem

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guidance document no 1 Ð 1993
[4] EN 12682, Biotechnology Ð Modified
organisms for application in the
environment Ð Guidance for the
characterization of genetically modified
organism by analysis of the functional
expression of the genomic modification
[5] EN 12687, Biotechnology Ð Modified
organisms for application in the
environment Ð Guidance for the
characterization of genetically modified
organism by analysis of the genomic
modification

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