www.checkbiotech.org ; www.raupp.info ; www.czu.cz

In 2004, 97% of worldwide commercially cultivated, genetically modified
plants (GMP) were grown in five countries, i.e., USA, Argentina, Canada,
Brazil, and China. None of these countries requires legally binding
post-market monitoring (PMM) activities, or they are limited to very
specific areas of concern, such as insect resistance monitoring of Bt maize,
for example, in the United States, December 2005 by Olivier Sanvido.

The regulatory frameworks of these countries recognize GM products that
have received regulatory approval for commercialization if the products are
substantially equivalent to comparable products with a history of safe use,
and thus, do not present a greater risk. Environmental PMM or long-term
health surveillance are therefore not considered necessary.

In regards to the possible environmental effects of GMPs, the principle of
substantial equivalence is not followed in Europe, and a precautionary
approach is chosen instead. Everyone who intends to commercially grow GM
crops in the European Union (EU) is obligated to present a PMM plan to
identify possible adverse effects on human health and the environment, which
could arise directly or indirectly from the released GMP1. To date, no
EU-wide consensus on how to design such PMM programs has been defined,
although monitoring concepts are currently being developed in several
European countries. There is an urgent need for conceptual frameworks and
guidance on how PMM programs should be planned and performed. The aim of our
study was to develop a conceptual framework containing structures and
procedures that could be used to implement such PMM programs2. This
framework should represent a pragmatic approach for feasible PMM programs
that allow the assessment of possible environmental effects during
commercial cultivation of GMP.

Procedure for the approval to cultivate GMPs in Europe

Each approval for commercial cultivation of a specific GMP has to be
preceded by case-by-case risk assessments of potential adverse effects on
the environment. Furthermore, the introduction of GMPs into the environment
should generally be performed according to a step-by-step principle, which
means that the scale of GMP releases can only be increased if a risk
assessment of the preceding step has estimated an acceptable risk for the
next step.

We established a scheme that clearly presents and distinguishes the
different phases and activities of development and commercialization of a
GMP. Pre-market risk assessment (PMRA) is limited to the phase prior to
approval for commercial cultivation, whereas PMM is limited to activities
related to the commercial cultivation of GMPs. According to EU legislation,
PMM is composed of two separate programs with different aims, i.e.,
case-specific monitoring (CSM) and general surveillance (GS).

Principles of environmental monitoring programs

We felt a strong need for a clear definition of the specific functions and
differences of CSM and GS, as well as for a definition of what tasks should
be accomplished in each program. In order to clearly distinguish the
differences between the two programs, we analyzed the general principles of
existing environmental monitoring programs3,4. Based on these general
principles, CSM and GS can be more clearly defined, and their respective
limits can be identified:

1. Case-specific monitoring is intended to assess whether GMP-related
adverse effects on the environment occur.1 It is based on specific risks
that a particular GMP could present. CSM can be regarded as the continuation
of the investigations performed during PMRA where defined hypotheses on
possible anticipated effects are tested. The hypotheses can be confirmed or
rejected after a defined period of time, after which CSM can be terminated.
As CSM is performed in close relation to the cultivation of a certain GMP,
it should be possible to draw conclusions about the causes of detected
changes. The gain of knowledge may lead to new questions, which have to be
answered in specific risk assessment studies. CSM helps to reduce remaining
uncertainties, and its results may influence the PMRA of new GMPs with
comparable properties.

2. General surveillance is intended to detect unanticipated adverse
environmental effects that were not identified and considered during
pre-market risk assessment.1 Results obtained from GS cannot be linked to
any specific attributes of GMP cultivation, since the program provides a
general assessment of the state of the environment, independent of any
preconception. It can provide information on exceptional environmental
changes, and possibly provide basic information to forecast the likely
development of the environment. GS is not designed to determine the cause of
possible environmental changes, as a multitude of factors could be involved.
If environmental changes are observed, and it is considered likely that the
cultivation of a specific GMP has caused them, the causality will have to be
determined through specific risk assessment studies.

Many existing monitoring programs face the problem of providing only limited
information on quality and changes of the environment, because their
purposes have not been exactly defined4. We have identified clear conceptual
differences between CSM and GS and propose to adopt separate frameworks when
developing either of the two programs2. Common to both programs is the need
to put a value on possible ecological effects of GMP cultivation.

Challenges for post-market-monitoring programs

According to EU legislation, consent for commercial cultivation is given for
a ten year period, after which the results of PMM and any other new
information have to be presented in an environmental risk assessment to the
competent authority in order to allow renewal of the consent. The time
period chosen for PMM may be shorter than the ten year period given for the
consent, but it could be extended beyond the consent period for detection of
delayed effects5. However, it is important to consider that the life-span of
modern crop varieties may be shorter than the ten year period. For example,
during the 1980s the average life-span of an oilseed rape cultivar was about
ten years, but dropped to three years by 1997. It might therefore become
difficult to perform CSM over an extended period of time for a specific GMP
variety.

In CSM it may be difficult to relate environmental effects unambiguously to
a specific GMP or its cultivation. All crops and all farming systems cause
environmental impacts, and the effects detected could have been caused by
factors other than the GMP. Intensification of agriculture, for example, has
a range of impacts on biodiversity with widespread decline throughout many
groups of organisms associated with farmland in Europe6. An unbiased
evaluation has to consider a reference system that displays the
environmental effects that may occur without the cultivation of GMPs.
Case-specific monitoring requires a comparable cropping system without GMP
as a parallel control, where both crop systems are evaluated in parallel
over the same time period. However, such a paired comparison might become
difficult in practice, if, for example, the non-transgenic control is not
cultivated in the same region or in a comparable agricultural landscape. An
additional difficulty could arise from differences in crop management
techniques for GM and non-GM plants. For example, GM herbicide-tolerant
crops may be best managed by using a no-till strategy, while this technique
may not be advisable for cropping systems based on conventionally bred
plants. If a parallel control with a comparable cropping system without GMP
is not possible, environmental impacts of GMP cultivation need to be
compared based on general information of effects caused by current
agricultural practice. While the cultivation of Bt maize, for example, may
have weak effects on non-target arthropods, the use of a synthetic
insecticide can significantly affect a large number of non-target
arthropods.

Conclusions

Environmental post-market monitoring of genetically modified plants
represents a new challenge for farmers, the agricultural industry,
scientists, and regulators, since comparable environmental monitoring
programs have not been established for conventional crops. However, the
challenge to obtain information on the state of the environment is not new,
and underlying principles have been established. Although these monitoring
programs were originally designed for general environmental protection, the
inherent principles also remain valid for environmental PMM of GMPs. The
existing experience documented in the literature shows that monitoring
programs require defined aims and a rigid structure in order to provide the
desired information. Competent authorities will have to make decisions on
maintaining consents for GMP cultivation based on the results of PMM.
Case-specific monitoring and general surveillance have to be designed and
implemented according to a pragmatic and realistic approach in order to be
feasible. Competent authorities can support this approach by applying
comparable valuation criteria for effects of GMP cultivation and for effects
caused by current agricultural practice. We believe that our conceptual
framework will be of assistance to industry, researchers, and regulators
when assessing possible environmental effects of GMPs during
commercialization.

Acknowledgements

We thank the Swiss Agency for the Environment, Forests and Landscape for
partial funding of this study.

References

1. European Community (2001) Directive 2001/18/EC of the European Parliament
and of the council of 12 March 2001 on the deliberate release into the
environment of genetically modified organisms and repealing Council
Directive 90/220/EEC, European Parliament and the Council of the European
Union

2. Sanvido O, Widmer F, Winzeler M, & Bigler F (2005) A conceptual framework
for the design of environmental post-market monitoring of genetically
modified plants. Environmental Biosafety Research 4, 13-27

3. Hellawell JM (1991) Development of a rationale for monitoring. In
Monitoring for Conservation and Ecology, B. Goldsmith, Editor. Chapman and
Hall: London, 1-14

4. Vos P, Meelis E, & Ter Keurs WJ (2000) A framework for the design of
ecological monitoring programs as a tool for environmental and nature
management. Environmental Monitoring and Assessments 61, 317-344

5. ACRE (2004) Guidance on best practice in the design of post-market
monitoring plans in submission to the advisory committee on releases to the
environment, Department for Environment, Food and Rural Affairs - Advisory
Committee on Releases to the Environment

6. Robinson RA Sutherland WJ (2002) Post-war changes in arable farming and
biodiversity in Great Britain. Journal of Applied Ecology 39, 157-176

The original publication is available at [www.edpsciences.org].

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