Proposal for a Council Decision establishing guidance notes supplementing Annex VII to Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC
Date: 2002-07-04
Institutions: European Commission
Subjects: data collection, environmental impact, environmental protection, evaluation method, genetically modified organism, information analysis, marketing, public health

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Proposal for a Council Decision establishing guidance notes supplementing Annex VII to Directive
2001/18/EC of the European Parliament and of the Council on the deliberate release into the
environment of genetically modified organisms and repealing Council Directive 90/220/EEC

(2002/C 262 E/21)

COM(2002) 359 final

(Submitted by the Commission on 4 July 2002)

EXPLANATORY MEMORANDUM

1. Directive 2001/18/EC introduces an obligation for notifiers to implement monitoring plans in order to
trace and identify any direct or indirect, immediate, delayed or unforeseen effects on human health or
the environment of GMOs as or in products after they have been placed on the market.

2. Annex VII to the Directive describes in general terms the objective to be attained and the general
principles to be followed in designing the plan referred to in Articles 13(2), 19(3) and 20 of the
aforementioned Directive. The first paragraph stipulates that the Annex must be supplemented by
guidance notes to be drawn up in accordance with the procedure laid down in Article 30.

3. A draft of the measures to be taken has accordingly been submitted for opinion to the committee set
up under Article 30 of the Directive. This draft supplements the information provided in Annex VII
and:

— expands on the monitoring objectives;

— expands on the general principles for monitoring;

— provides an outline for a general framework for the development of appropriate post-marketing

monitoring plans.

4. The committee has not delivered an opinion on the proposal. In such a case, Article 30 stipulates that
the Commission must forthwith propose to the Council the measures to be adopted and inform the
European Parliament thereof. The Council must then act by qualified majority.

5. If, by the expiry of the time limit, the Council has not adopted the proposed implementing measures or
has not indicated its opposition to the proposed implementing measures, they shall be adopted by the
Commission.

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19(3) and 20 of that Directive. Therefore, such notification
must contain a plan for monitoring, including a proposal
for the time-period of the monitoring plan, in accordance
with Annex VII to Directive 2001/18/EC.

(3) Annex VII

to Directive 2001/18/EC should be supple-
mented by notes providing detailed guidance on the
objectives, general principles and design of the monitoring
plan referred to in that Annex.

(4) The committee set up under Article 30(2) of Directive
2001/18/EC was consulted on 12 June 2002 and has not
delivered an opinion on the Commission's proposal for a
Decision,

HAS ADOPTED THIS DECISION:

Article 1

The guidance notes set out in the Annex to this Decision shall
be used as
to Annex VII of Directive
2001/18/EC.

supplement

a

Article 2

This Decision is addressed to the Member States.

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European
Community,

Having regard to Directive 2001/18/EC of
the European
Parliament and of the Council (1) of 12 March 2001 on the
deliberate release into the environment of genetically modified
organisms
and in
and repealing Directive 90/220/EEC,
particular the first paragraph of Annex VII thereto,

Having regard to the proposal from the Commission,

Whereas:

(1) Directive 2001/18/EC stipulates that, before a genetically
modified organism (hereinafter referred to as GMO) as or
in products is placed on the market, a notification must be
submitted to the competent authority of the Member State
where such a GMO is to be placed on the market for the
first time.

(2) According to Directive 2001/18/EC,

the notifier must
ensure that monitoring and reporting on the deliberate
release of GMOs are carried out in accordance with the
conditions specified in the authorisation for the placing
to Articles 13(2),
on the market of a GMO pursuant

(1) OJ L 106, 17.4.2001, p. 1.

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INTRODUCTION

ANNEX

Directive 2001/18/EC introduces an obligation for notifiers to implement monitoring plans in order to trace and
immediate, delayed or unforeseen effects on human health or the environment of
identify any direct or indirect,
GMOs as or in products after they have been placed on the market.

Notifiers are required, under Article 13(2)(e) of that Directive, to submit as part of the notification for the placing on the
market of a GMO, a plan for monitoring in accordance with Annex VII to that Directive. This should include a proposal
for the time-period of the monitoring plan, which may be different from the proposed period for the consent. Annex VII
describes in general terms the objective to be achieved and the general principles to be followed to design a monitoring
plan referred to in Articles 13(2), 19(3) and 20.

This guidance note supplements the information provided in Annex VII, and in the context of the Directive:

— expands on the objectives for monitoring,

— expands on the general principles for monitoring,

— provides an outline for a general framework for the development of appropriate post-market monitoring plans.

Following the placing on the market of a GMO, the notifier, under Article 20(1) of the Directive, has a legal obligation
to ensure that monitoring and reporting are carried out according to the conditions specified in the consent. Article
19(3)(f) details that the written consent should, in all cases, explicitly specify monitoring requirements in accordance
with Annex VII, including obligations to report to the Commission and competent authorities. In addition, to ensure
transparency in accordance with Article 20(4), the results of the monitoring should also be made publicly available.

Monitoring plans for GMOs to be placed on the market will clearly need to be developed on a case-by-case basis taking
account of the environmental risk assessment, the modified characteristics specific to the GMO in question, their
intended use and the receiving environment. This guidance note makes reference to a general framework but does
not attempt to provide explicit details for the development of monitoring plans to cover all GMOs. However, this
framework does not preclude use of more specific, additional information or guidance with regard to specific traits or
GMOs, which clearly could be considered when developing monitoring plans, on a case-by-case basis, for individual
GMOs.

A. OBJECTIVES

Before a GMO or a combination of GMOs as or in products is placed on the market, a notification must be submitted to
the competent authority of the Member State where the GMO is to be placed on the market for the first time. This
notification should,
in accordance with Article 13(2), contain a technical dossier of information including a full
environmental risk assessment.

The environmental risk assessment aims, on a case-by-case basis, to identify and evaluate potential adverse effects of the
GMO, either direct and indirect, immediate or delayed, on human health and the environment arising from its placing
on the market. This assessment may also need to take account of potential
long-term effects associated with the
interaction with other organisms and the environment. The evaluation of such potential adverse effects should be
founded on common methodology based on independently verifiable scientific evidence.

Individual GMOs are likely to differ considerably in terms of the inherent characteristics of the modified species as well
as the specific modification and resultant characteristics. These characteristics will largely determine the nature of any
potential effects arising from the placing on the market of a GMO.

It is also necessary to confirm that the pre-market risk assessment for a GMO is accurate, following its placing on the
market. Moreover, the possibility of the occurrence of potential adverse effects that were not foreseen in the evaluation
cannot be ignored. Post-market monitoring, as required under Article 20 of the Directive, is foreseen for this purpose.

Against this background, it is foreseen that the objectives of post-market monitoring, as detailed under Annex VII, are
to:

— confirm that any assumptions regarding the occurrence and impact of potential adverse effects of the GMO or its

use in the environmental risk assessment are correct, and

— identify the occurrence of adverse effects of the GMO or its use on human health or the environment which were

not anticipated in the environmental risk assessment.

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B. GENERAL PRINCIPLES

Monitoring as detailed in Articles 13, 19 and 20 of Directive 2001/18/EC and in the context of this guidance note refers
to post-market monitoring, which takes place after consent for the placing of a GMO on the market has been granted.

Article 13(2)(e) of the Directive requires notifiers to submit, as part of their notifications, a plan for monitoring in
accordance with Annex VII.

The consent should, under Article 19(3)(f), specify the time period of the monitoring plan and, where appropriate, any
obligations on persons selling the product or any user of it, inter alia, in the case of cultivation, concerning a level of
information deemed appropriate on their location.

On the basis of reports submitted by notifiers, in accordance with the consent and the framework for the monitoring
plan specified, the competent authority receiving the original notification may, as detailed in Article 20(1), adapt the
monitoring plan after the first monitoring period.

Planning is essential with respect to all types of monitoring and when developing monitoring plans, both case-specific
monitoring and general surveillance should be considered. In addition, monitoring of potential adverse cumulative
long-term effects should be considered as a compulsory part of the monitoring plan.

Case-specific monitoring should, when included in the monitoring plan, focus on potential effects arising from the
placing on the market of a GMO that has been highlighted as a result of the conclusions and assumptions of the
environmental risk assessment. However, whilst it is possible to predict that certain effects may occur, on the basis of
risk assessment and available scientific information, it is considerably more difficult to plan for potential effects or
variables that cannot be foreseen or predicted. It may, however, be possible through appropriate planning of monitoring
and surveillance plans to optimise the chances for early detection of such effects. The design of the monitoring plan
should, therefore incorporate general surveillance for unanticipated or unforeseen adverse effects.

The cost-effectiveness of case-specific monitoring and general surveillance should be taken into account in this context.

Member States may themselves also assist with monitoring via the general duty under Article 4(5), which requires that
the competent authority organises inspections and other control measures as appropriate, to ensure compliance with the
Directive. Indeed, Member States are entitled, in accordance with the Treaty, to take further measures for monitoring
and inspection, for example by national authorities, of GMOs as or in products placed on the market. However, it
should be recognised that such action is not a substitute for the monitoring plan for which notifiers are responsible
(although, with the consent of the relevant parties, may form part of it).

Interpretation of the data collected via monitoring should take account of existing environmental conditions and
activities in order to determine an appropriate baseline. General surveillance and environmental monitoring programmes
in general may similarly assist in this context. Where unexpected changes in the environment are observed, further risk
assessment may need to be considered to establish whether they have arisen as a consequence of the placing on the
market of the GMO or as a result of other factors. Against this background, measures necessary to protect human health
and the environment may also have to be considered.

C. DESIGN OF MONITORING PLAN

The design of monitoring plans should be founded on a framework comprising three key sections, namely:

1. Monitoring strategy

2. Monitoring methodology

3. Analysis, reporting, review.

1. Monitoring strategy

The monitoring strategy importantly requires identification of the potential effects that may arise from the placing on
the market of a GMO, the degree to which they need to be monitored and an appropriate approach(s) and time-scale(s)
over which to monitor.

In the first instance, the likelihood of potential direct, indirect, immediate or delayed adverse effects arising from the
GMO should be considered in line with its intended use and the receiving environment.

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Direct effects refer to primary effects on human health or the environment that are a result of the GMO itself and which
do not occur through a causal chain of events. For example, when considering a crop modified for resistance against a
specific insect, direct effects may include death and changes in the population of both target and non-target insects that
arise as a result of the toxin produced by the GMO.

Indirect effects refer to effects on human health or the environment occurring through a causal chain of events. For
example, in the above case indirect effects may arise where a reduction in the population of target insects impacts on
populations of other organisms that normally feed on these insects.

Indirect effects may involve interactions between a number of organisms and the environment making it more difficult
to predict any potential effect. Observations of indirect effects are also likely to be delayed. These factors must, however,
be considered as part of the strategy.

Immediate effects refer to effects on human health or the environment that are observed during the period of the release
of the GMO. Immediate effects may be direct or indirect.

Delayed effects refer to effects on human health or the environment which may not be observed during the period of
the release of the GMO, but become apparent as a direct or indirect effect either at a later stage or after termination of
the release. The build-up of resistance by insects to the Bt-toxin through continued exposure is an example of a delayed
effect.

Immediate and delayed effects may themselves be either direct or indirect but imply a time-scale for change. Direct
effects are more likely to appear in the immediate or short term at a level that can be detected. Indirect effects may take
a longer time period to manifest but nevertheless may need to be taken into account

It is very difficult if not impossible to predict the appearance of potential unforeseen or unanticipated effects that were
not highlighted in the risk assessment. General surveillance for potential unforeseen or unanticipated effects should,
therefore, be considered as a part of the monitoring strategy.

1.1. Risk assessment

The monitoring strategy should identify how evaluations obtained from the risk assessment are to be confirmed in line
with the use of that GMO and the receiving environment. This should take account of the conclusions and assumptions
from the risk assessment, based on scientific evaluation and the recommendations of expert committees. In addition,
issues arising from the risk assessment that are subject to a degree of uncertainty, for example possible effects that may
appear only where releases are of a large-scale, may also be required as part of the monitoring strategy. Reference to the
guidance notes to supplement Annex II, on the principles for the environmental risk assessment, of Directive
2001/18/EC should assist in this respect.

1.2. Background information

Background information pertaining to the GMO in question, including data and information from experimental releases,
scientific publications and relevant comparable evidence from other releases, may all be used in the planning and design
of the monitoring plan. In particular, data gained through available risk research studies and monitoring of experimental
releases will importantly assist in this context.

1.3. Approach

The approach of the monitoring strategy should be described. In many cases, focus is likely to be placed on primary
concerns (‘needs to know’) and the establishment of a cyclic monitoring process in order to be able to continuously
improve the quality of the programme.

The approach should provide the means to detect potential adverse effects at an early stage of manifestation. Early
detection of any adverse effects attributable to a GMO will allow for more rapid reassessment and implementation of
measures to reduce any consequences to the environment.

The design of monitoring plans for GMOs should be built using a step-by-step approach taking account of existing data
and monitoring methodology. A step-by-step approach will in many cases also need to take account of the scale of
release. The first step may be founded on evidence from experimental trials with subsequent steps based on large-scale
field trials and ultimately to surveys on commercial plots. Experience and information gained through the monitoring of
experimental releases of GMOs is, therefore,
likely to be useful in designing the post-marketing monitoring regime
required for the placing on the market of GMOs.

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Existing observation programmes could also be adapted to the needs of monitoring GMOs as a means to ensure
comparability and to limit the expenditure of resources in developing the approach. This would include existing
environment observation programmes in the field of agriculture, food surveys, nature conservation, soil observation
and veterinary surveys. Inclusion of such programmes as part of the monitoring plan would firstly require that notifiers
gain an appropriate agreement with the persons or organisations, including national authorities, conducting such work.

This section focuses on case-specific monitoring and general surveillance in accordance with the two general objectives
under Annex VII although consideration of other types of monitoring system is not precluded.

1.3.1. Case-specific monitoring

Case-specific monitoring serves to confirm that any assumption,
potential adverse effects arising from a GMO and its use are correct.

in the environmental risk assessment, regarding

The approach should:

— focus on all the potential effects on human health and the environment identified in the risk assessment, and

— define a specified time period in which to obtain results.

The first step in developing a monitoring plan for case-specific monitoring is to determine the case-specific objectives of
the monitoring strategy. This includes determining which assumptions regarding the occurrence and impact of potential
adverse effects of the GMO or its use were made in the environmental risk assessment and should to be confirmed by
the case-specific monitoring. Where the conclusions of the risk assessment identifies an absence of risk or negligible risk,
however, then case-specific monitoring may not be required.

Potential adverse effects that are identified in the environmental risk assessment should only be included in the
monitoring plan on the basis that monitoring could contribute to the confirmation or rejection of the assumptions
associated with these effects.

If the intended use of a GMO includes cultivation, then consideration may have to be given to the monitoring of
potential risks arising from pollen transfer, dissemination and persistence of these GMOs. The degree to which these
phenomena are likely to occur will also be dependent on the scale of this use and the receiving environment including
the proximity to and scale of production of sexually compatible conventional crop species and wild relatives.

Conversely, potential environmental risks arising from GMOs approved only for import and processing will likely often
be assessed as extremely limited given that they will not be intentionally introduced into the environment and that they
are unlikely to disseminate.

Potential effects on human health or the environment arising from the release or placing on the market of a GMO will
firstly depend on the inherent nature of a GMO and its specific genetic modification. For example, potential effects
arising from transfer of pollen from genetically modified crops to non-GM crops or related wild-type plants will, in the
first instance be largely dependent on whether the genetically modified crop is out-crossing or self-pollinating.

However, any subsequent effects for example, the potential development of insect resistance to the Bt-toxin will only be
linked to GMOs modified to express this specific toxin. This would not be the case for GMOs modified for herbicide
tolerance alone, as these GMOs do not contain a Bt-toxin gene. The presence of wild relatives may also need to be
considered in this context.

Similarly, it would only be relevant to monitor the potential transfer of antibiotic resistance genes and the possible
consequences with respect to GMOs that include antibiotic marker genes as part of the modification.

After identification of the objectives on the basis of potential adverse effects, the next step should be to identify the
parameters that need to be measured in order to achieve these objectives. Parameters as well as the methods used to
measure and evaluate them must be valid and fit-for-purpose.

1.3.2. General surveillance

General surveillance is largely based on routine observation (‘look — see’ approach) and should be used to identify the
occurrence of unforeseen adverse effects of the GMO or its use for human health and the environment that were not
predicted in the risk assessment. This is likely to involve observation of phenotypic characteristics but more detailed
analyses are not precluded.

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In contrast to case-specific monitoring, general surveillance should:

— seek to identify and record any indirect, delayed and/or cumulative adverse effects that have not been anticipated in

the risk assessment,

— be carried out over a longer time period and possibly a wider area.

The type of general surveillance, including locations, areas and any parameters to be measured, will largely depend on
the type of unanticipated adverse effect being surveyed. For example, any unanticipated adverse effects on the cultivated
ecosystem such as changes in bio-diversity, cumulative environmental impacts from multiple releases and interactions
may require a different approach to general surveillance of other effects arising from gene transfer.

General surveillance could, where compatible, make use of established routine surveillance practises such as monitoring
of agricultural crops, plant protection, veterinary and medical products as well as ecological monitoring, environmental
observation and nature conservation programmes. The monitoring plan may also provide details as to how relevant
information collected through established routine surveillance practices conducted by third parties will be retrieved by,
or made available to, the consent holder.

If established routine surveillance practise is used in the general surveillance, this practise should be described as well as
the changes in the practise needed to fulfil a relevant general surveillance.

1.4. Baselines

Determination of the baseline status of the receiving environment is a pre-requisite for the identification and evaluation
of changes observed via monitoring. In short, the baseline serves as a point of reference against which any effects arising
from the placing on the market of a GMO can be compared. This baseline should, therefore, be determined prior to
attempting to detect and monitor any such effects. Parallel monitoring of ‘GMO areas’ and comparable ‘non-GMO
reference areas’ may provide an alternative and may be important where environments are highly dynamic.

Reliable information about the status of the receiving environment, on the basis of adequate environmental observation
systems, may, therefore, be required prior to implementation of monitoring programmes and environmental policy
actions. Environment observation programmes are designed to take proven or suspected and plausible ecosystem
relationships into account and may assist in the determination of the:

— status of the environment and changes therein,

— causes of such changes, and

— expected development of the environment.

Examples of indicators of the status of the receiving environment may include animals, plants and micro-organisms
from different organism groups and ecosystems. Relevant indicators may be considered on the basis of the charac-
teristics of the GMO in question and the parameters to be monitored. Sexual compatibility of other organisms with the
GMO may also be relevant in this context. For a particular indicator species, a number of possible measurement
parameters or fitness variables will exist, including the likes of numbers, growth rate, biomass, reproductive effort,
population rate of increase/decrease and genetic diversity.

It may also be appropriate to consider baselines in relation to changes in management practice resulting from the use of
GMOs. This could include changes in pesticide usage with respect to the cultivation of crop species modified for
tolerance to herbicides and resistance to insects. It may also be appropriate when considering the monitoring plan
for herbicide-tolerant genetically modified crops, to consider herbicide use for conventional crops as part of an
appropriate baseline.

1.5. Time-period

Monitoring should be carried out over a time period of sufficient length to detect not only immediate potential effects,
where appropriate, but also delayed effects which have been identified in the environmental risk assessment.
Consideration should also be given to the interplay between the estimated level of risk and the duration of the
release. A prolonged period of release may increase the risk of cumulative effects. The non-appearance of immediate
effects over a prolonged period, on the other hand, may allow monitoring to focus on delayed and indirect effects. It
should also be considered whether it is necessary to extend the monitoring plan beyond the period of the consent. This
may be the case, for example, where the persistence of GMOs in the environment has the potential to be significant.

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The proposed time-period of the monitoring plan should be indicated, including an outline of the likely frequency of
visits/inspections and any intervals for review of the monitoring plan. This should take account of the likely appearance
of any potential effects as highlighted in the risk assessment. For example, consideration should be given to any adverse
effect resulting from the dissemination, reproduction and persistence/survival of a GMO in the environment following its
placing on the market. This may be a matter of days or months for genetically modified microbes released in
bio-remediation programmes but could extend to a number of years where certain crop species are concerned. The
likelihood of dissemination and persistence of the modified sequences themselves should also be considered in terms of
crosses with sexually compatible species.

The planning of inspections will largely be dependent on the type of effect to be monitored. For example, effects arising
from pollen transfer will only be visible following flowering although it would be pertinent to visit a site prior to
flowering to establish the extent to which sexually compatible species are present in the vicinity. Similarly, monitoring
for the appearance of volunteers in subsequent growing seasons will be linked to the time of seed shed and persistence
and germination of the subsequent seed bank.

Prior visits may also be necessary, as appropriate, prior to the onset of monitoring in order to establish relevant
baselines.

Monitoring plans and their time-periods should not be fixed indefinitely but reviewed and amended in light of results
obtained during the monitoring programme.

1.6. Assigning responsibilities

Ultimately, it is the notifier/consent holder who is responsible, under the Directive, for ensuring that a monitoring plan
is included in the notification, put in place and appropriately implemented.

In the first instance, responsibility is placed on notifiers to submit as part of their notification, under Article 13(2)(e) of
the Directive, a plan for monitoring in accordance with Annex VII. The suitability of the proposed monitoring plan is
one of the criteria by which any application for the placing on the market of a GMO should be judged. The plan should
be judged solely on the basis of whether or not it is adequate, which requires fulfilment of the requirements laid down
in the Directive itself as opposed to strict alignment with this guidance note.

Article 20(1) subsequently requires that following the placing on the market of a GMO as or in a product, the notifier
shall ensure that monitoring and reporting on it are carried out according to the conditions specified in the consent.
This should be achieved through appropriate implementation of the monitoring plan.

Responsibilities for each step of the monitoring plan should, therefore, be clearly assigned in the notification. This would
apply to both case-specific monitoring and also general surveillance as part of the monitoring plan. Whilst the notifier
retains responsibility for ensuring that monitoring is carried out, this does not preclude that third parties such as
consultants and users could be involved in the monitoring by carrying out various tasks the monitoring plan requires.
Where third parties are employed or contracted to conduct monitoring studies, the structure of their involvement should
be detailed. Consent holders should additionally ensure that appropriate systems are in place to ensure transmission of
relevant information between concerned parties, particularly with respect to the identification of any adverse effects.

It should similarly be noted that it is not precluded that Member States carry out additional monitoring in the form of
case-specific monitoring or general surveillance. This should not, however, be considered a substitute for the monitoring
plan, which remains under the responsibility of the notifier for implementation (although, with the consent of relevant
parties, may form part of it).

1.7. Existing systems

It may be possible to extend existing monitoring or general surveillance systems to address potential adverse effects
arising from the placing on the market of GMOs. These systems may include observation programmes in the field of
agriculture, food surveys, nature conservation, soil observation and veterinary surveys.

For example, seed production systems that follow OECD certification rules and therefore include routine inspections of
fields and surrounding areas could be adapted to on-field monitoring for specified parameters.

Monitoring and surveillance of conventional commercial crops is already carried out, as a matter of course in Member
States, with regard to calculation of fertiliser application as well as pest, disease and weed control. This type of
monitoring and surveillance is conducted on a regular basis throughout the growing season by consultants selling
the relevant agronomic products and the growers themselves.

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It may, therefore, be possible to attach a similar service to sales of genetically modified seed, where representatives of the
company, or contracted consultants, to provide at least some form of general surveillance. Instruction concerning
surveillance and monitoring could be distributed to growers purchasing genetically modified seed stocks and contractual
agreements could be formulated as a condition of sale or use.

It is certainly feasible that growers or agronomic consultants could conduct surveys of major unforeseen changes or
effects such as dissemination and establishment of volunteer plants in adjacent areas if clear instructions are provided.
Under these circumstances, it is foreseen that monitoring and surveillance for adverse effects could be incorporated into
routine practices for determining agronomic inputs for pest and weed control.

2. Monitoring methodology

This section provides guidance as to the types of parameters and elements that may need to be identified and monitored
as part of a monitoring programme as well as the means to conduct such monitoring, including areas to monitor and
frequency of monitoring.

2.1. Monitoring parameters/elements

Firstly, it will be necessary to identify the relevant parameters/elements to be monitored with appropriate justification
for their selection. This will largely be dependent upon the conclusions of the environmental risk assessment. Decisions
as to the parameters or elements to be monitored must be taken on a case-by-case basis in line with the modified
characteristics of the GMO in question. This would include the likes of monitoring of intended effects on target
organisms arising from the modification, an example of which would be monitoring of corn borer populations with
respect to the cultivation of Bt-maize varieties.

However, non-specific elements may also need to be considered as part of the monitoring plan and examples of such
elements are presented as follows although others are not precluded.

— Effects on non-target organisms arising from the modification, including development of resistance in wild relatives
or pest organisms, change in the host range or in the dispersal of pest organisms and viruses, development of new
viruses

— Dispersal, establishment and persistence into non-target environments or eco-systems

— Out-crossing/breeding (e.g. occurrence, means and rates of out-crossing/breeding), with sexually compatible wild

relatives in natural populations

— Unintended changes in the basic behaviour of the organism, for example, changes in reproduction, number of

progeny, growth behaviour and survival ability of the seeds

— Changes in bio-diversity (e.g. in number or composition of species).

2.2. Areas/samples

The monitoring plan may include details as to where the monitoring will be carried out and over what area. This may
be at the level of individual Member States, geographical regions, individual sites, plots or any other area(s) deemed
appropriate.

The areas and/or samples to be monitored with respect to possible effects arising from the placing on the market of the
GMO should be identified, including those for the purpose of reference or control. Any reference or control areas and/or
samples must be sufficiently representative in terms of environment and conditions of use for meaningful conclusions to
be drawn. Moreover, any sampling methodology should be scientifically and statistically sound. On this basis, such data
can provide important information on the variation of indicators, which will increase the power of the effect detection.

When considering the areas to be monitored with regard to, for example, a genetically modified crop species,
its
characteristics (both inherent and modified) as well as its reproduction and dissemination and the types of ecosystems
that may be affected could be considered in determining the habitats selected for monitoring. Relevant areas to monitor
would include selected agricultural fields where the crop is commercially grown as well as surrounding habitats.

It may also be necessary to extend monitoring/surveillance to adjacent or neighbouring cultivated and non-cultivated
areas, post-harvest surveillance areas for volunteer plants and protected areas. Certain types of habitats, such as disturbed
areas and species-rich plant communities, are more prone to invasion than others. Disturbed areas with low vegetation
and high abundance of herbs and grasses are particularly suitable for the purpose of monitoring. Firstly, they are widely
distributed and often found close to more intensively cultivated agricultural areas. Secondly, these areas are often typical
of roadsides, ditches and edges of fields where accidental loss and dispersal of seeds is most likely to occur in the first
instance.

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Monitoring for the possibility of transfer of genetic material to sexually compatible organic and conventional crops may
also be considered. This will require evaluation of the extent to which such crops are grown in adjacent or neighbouring
areas.

2.3. Inspections

The monitoring plan should indicate the likely frequency of inspections. This may include a timetable to indicate the
timing and number of intended visits to a site. In this respect, as detailed in sections 1.5 and 2.2 above, consideration
should importantly be given to the time when potential adverse effects are most likely to appear as well as the area(s) to
be monitored.

2.4. Sampling and analysis

The methodology to subsequently monitor these parameters/elements should also be clearly identified and outlined,
including techniques for sampling and analysis. Standard methodology, as provided for by the likes of European CEN
Standards and OECD-methods for monitoring organisms in the environment, should be followed where appropriate and
reference to the source of the methodology provided. Methods used for monitoring should be scientifically sound and
valid under the experimental conditions in which they are to be applied; therefore consideration should be given to the
characteristics of the methods, such as selectivity, specificity, reproducibility, any limitations, detection limits, and the
availability of appropriate controls.

The monitoring plan should also indicate how the methodology is expected to be updated, if appropriate, according to
the selected monitoring approach/strategy.

Statistical analysis could also be employed when designing the appropriate sampling and testing methodology, in order
to determine optimal sample sizes and minimum monitoring periods for the required statistical level of effect detection.

2.5. Collection and collation of data

The monitoring plan should, for both case-specific monitoring and general surveillance, identify how, by whom and
how often data is to be collected and collated. This may be of particular importance where third parties are employed or
contracted to collect data. Notifiers may need to provide standard mechanisms, formats and protocols for data collection
and recording as a means to ensure consistency. For example, standardised recording sheets or direct logging or
registration of data on standardised ‘spread-sheets’ via portable computers could be provided. The notifier may also
need to detail how the data will be collated, importantly how information is to be retrieved from third parties, such as
consultants or users.

Deadlines and intervals for reports detailing the results of the monitoring should also be indicated.

3. Analysis, reporting, review

The monitoring plan should indicate how often the data is reviewed and discussed in an overall analysis.

3.1. Evaluation

Evaluation of data should, where appropriate, include statistical analysis with appropriate standard error values to enable
subsequent decisions to be taken on a sound basis. These will include decisions as to whether evaluations highlighted in
the risk assessment are correct. In this respect, correct baselines and/or controls relating to the status of the receiving
environment are also paramount for accurate evaluations. Use of statistical analysis should also provide information as
to whether the type of methodology, including sampling and testing, is appropriate.

The evaluation of results from monitoring and surveys may reveal whether other parameters should be monitored under
the programme. Appropriate responses to any preliminary findings may also need to be examined, in particular, where
potential negative impacts on vulnerable habitats and organism groups are suggested.

The interpretation of the data collected by monitoring may need to be considered in the light of other existing
environmental conditions and activities. Where changes in the environment are observed, further assessment may be
required to establish whether they are a consequence of the GMO or its use, or whether such changes may be the result
of environmental factors other than the placing of the GMO on the market. It may be necessary to re-evaluate the
baselines used for comparison in this respect.

The monitoring plan should be structured in such a way, that the results of both the case-specific monitoring and
general surveillance as well as additional research could clearly be used in the decision-making process for renewal of
approval for products.

29.10.2002

EN

Official Journal of the European Communities

C 262 E/335

3.2. Reporting

Following the placing on the market of a GMO, the notifier under Article 20(1) of the Directive, has a legal obligation to
ensure that monitoring and reporting are carried out according to the conditions specified in the consent. The reports of
this monitoring must be submitted to the Commission and the competent authorities of the Member States although no
time frame for submission is laid down. This information should also be made publicly available in line with the
requirements of Article 20(4) of the Directive. Against this background, notifiers should describe the conditions of
reporting in the monitoring plan.

In addition, an indication as to how relevant information collected through any established or routine surveillance
practises will be made available to the consent holder and competent authorities should also be provided in the
monitoring plan.

Notifiers/consent holders should ensure transparency of the results and measures of the monitoring programmes and the
monitoring plan should identify how the gathered information is reported/published. This could for example be
achieved via;

— information sheets to users and other stakeholders,

— workshops to present and exchange information with stakeholders,

— archived in-company documents,

— inclusion on company web-sites,

— publication of information in trade and scientific publications.

The provisions of Article 20 of the Directive also relate to reporting.
if new
information concerning risk becomes available from users or other sources, the notifier is immediately required to
take the measures necessary to protect human health and the environment, and inform the competent authority thereof.

In accordance with Article 20(2),

In addition, the notifier is also required to revise the information and conditions specified in the notification.

3.3. Review and adaptation

Monitoring plans should not be viewed as static. It is fundamental that the monitoring plan and associated methodology
is reviewed at appropriate intervals and updated or adapted as necessary.

Article 20(1) of the Directive allows the competent authority receiving the original notification, on the basis of reports
submitted by notifiers and in accordance with the consent and the framework for the specified monitoring plan, to
adapt the monitoring plan after the first monitoring period. However, implementation of the revised monitoring plan
again remains under the responsibility of the notifier.

Reviews should examine the effectiveness and efficiency of data measurements and collection, including sampling and
analysis. The review should also evaluate whether the monitoring measures are effective in addressing the evaluations
and any questions arising from the risk assessments.

For example, if specific models are used for predictive purposes, a validation based on the data collected and subsequent
appraisal may be conducted. Similarly, new developments and progress in sampling and analytic techniques should also
be taken into account where appropriate.

Following such reviews, the adjustment of methods, monitoring goals and the monitoring programme may be necessary
and should be adapted or upgraded as appropriate.