Guidance on the Post-Market Environmental Monitoring (PMEM) ofgenetically modified plants

@article{Andersson2011GuidanceOT,
  title={Guidance on the Post-Market Environmental Monitoring (PMEM) ofgenetically modified plants},
  author={Hans Christer Andersson and Salvatore Arpaia and Detlef Bartsch and Josep M Casacuberta and Howard Vivian Davies and Patrick du Jardin and Gerhard Flachowsky and Lieve Maria Herman and Huw Jones and Sirpa O. Kärenlampi and J{\'o}zsef G{\'e}za Kiss and Gijs A. Kleter and Harry A. Kuiper and Antoine Mess{\'e}an and Kaare M Nielsen and J. N. Perry and Annette P{\"o}ting and Jeremy Sweet and Christoph C. Tebbe and Jean Michel Wal},
  journal={EFSA Journal},
  year={2011},
  volume={9},
  pages={2316}
}
The European Commission asked the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) to update its 2006 scientific opinion on Post-Market Environmental Monitoring (PMEM) of Genetically Modified Plants (GMPs). For doing so, the EFSA GMO Panel made use of the experience gained from its assessment of applications on GMPs for cultivation and considered different sources of information such as the PMEM reports on cultivated GMPs, relevant scientific… Expand

Figures and Tables from this paper

Scientific Opinion on the annual post-market environmental monitoring (PMEM) report from Monsanto Europe S.A. on the cultivation of genetically modified maize MON 810 in 2013
TLDR
The EFSA GMO Panel notes a number of shortcomings in the methodology for CSM and GS and gives specific recommendations for improvement of the strategy, methodology and reporting for the post-market environmental monitoring of maize MON810. Expand
The use of existing environmental networks for the post-market monitoring of GM crop cultivation in the EU.
TLDR
It can be concluded that the existing environmental monitoring networks in the EU can only be used, in the context of GMO cultivation monitoring, as secondary tools to collect baseline information. Expand
Risk assessment of genetically modified organisms (GMOs).
TLDR
The main focus of EFSA’s GMO Panel and GMO Unit lies in the evaluation of the scientific risk assessment of new applications for market authorisation of GMOs, and in the development of corresponding guidelines for the applicants. Expand
The post-market environmental monitoring of GM maize in the EU has a limited capacity to identify adverse effects
Abstract The EU legislation requests post-market environmental monitoring (PMEM) of a genetically modified (GM) organism even if its pre-market risk assessment indicated negligible risks. It has beenExpand
Risk assessment of GM trees in the EU: current regulatory framework and guidance
TLDR
The outcome of the assessment is reflected in a published opinion from the EFSA GMO panel that indicates whether the GMP and its products raise any safety issues. Expand
Scientific Opinion on the use of existing environmental surveillance networks to support the post-market environmental monitoring of genetically modified plants
TLDR
PMEM of genetically modified plants would benefit from a move towards open data policies for re-analysis or pooling data collected by different networks, and technical support might be required by networks to transform their data records into workable standards. Expand
Annual post‐market environmental monitoring (PMEM) report on the cultivation of genetically modified maize MON 810 in 2015 from Monsanto Europe S.A.
TLDR
The GMO Panel concludes that the case‐specific monitoring (CSM) and GS activities of maize MON 810 as carried out by the consent holder do not provide evidence that would invalidate previous GMO Panel evaluations on the safety of maizeMON 810. Expand
GMO environmental impact monitoring
When new technologies are introduced and uncertainties for risks exist, appropriate environmental monitoring of potential hazards is needed (EEA 2001). This also applies to genetically modifiedExpand
Assessment of the 2017 post‐market environmental monitoring report on the cultivation of genetically modified maize MON 810
TLDR
EFSA concludes that the evidence reported in the 2017 PMEM report does not invalidate previous EFSA and GMO Panel evaluations on the safety of maize MON 810 and relevant stakeholders should implement a methodological framework to enable making best use of existing networks involved in environmental monitoring for the general surveillance of genetically modified plants. Expand
Advancing environmental risk assessment of regulated products under EFSA's remit
The pre-market environmental risk assessment (ERA) of regulated products such as genetically modified organisms, plant protection products and feed additives is an important process to safeguard theExpand
...
1
2
3
4
5
...

References

SHOWING 1-10 OF 38 REFERENCES
A conceptual framework for the design of environmental post-market monitoring of genetically modified plants.
TLDR
The structure of PMM presented here will be of assistance to industry, researchers, and regulators, when assessing GMPs during commercialization, and proposed to adopt separate frameworks when developing either of the two programs. Expand
Determining indicators, methods and sites for monitoring potential adverse effects of genetically modified plants to the environment: the legal and conceptional framework for implementation
TLDR
Monitoring requirements for GMP monitoring have to be appropriate to detect direct and indirect, immediate and long-term as well as unforeseen effects, and a case-by-case approach is proposed. Expand
Monitoring the commercial cultivation of Bt maize in Europe--conclusions and recommendations for future monitoring practice.
TLDR
This paper reviews and reconsiders PMEM programs of Bt maize in view of existing experiences from cultivation, current monitoring activities initiated by Member States and applicants, proposed monitoring strategies and methods as well as potential environmental impacts of cultivation. Expand
National coordination of GMO monitoring – a concept for Germany
TLDR
The BVL will actively support the development of mechanisms for reporting and collating monitoring data both at Member State and EU level, and facilitate scientific analysis of these data, provide scientific conclusions and enable informed decisions on the future cultivation of GM crops as well as future improvement for risk assessments. Expand
Identifying indicator species for post-release monitoring of genetically modified, herbicide resistant crops
TLDR
The outcome of a modified Event Tree Analysis is described, essentially a funnel-like procedure allowing to reduce the large number of potentially affected non-target species to those with greatest ecological relevance and highest risk to be adversely affected based on a number of ecological criteria. Expand
An approach for post‐market monitoring of potential environmental effects of Bt‐maize expressing Cry1Ab on natural enemies
TLDR
The aims of this study were to identify the necessity for PMM of Bt‐maize expressing Cry1Ab on natural enemies and to develop an appropriate PMM plan, and to propose an approach that consists in indirectly analysing biological control functions by surveying outbreaks of maize herbivores. Expand
Cultivation of GMO in Germany: support of monitoring and coexistence issues by WebGIS technology
TLDR
How GMO monitoring that is required after risk assessment and GMO release can be complemented by a Web-based geoinformation system (WebGIS) is described to show how to support and complement GMO monitoring with the help of the WebGIS application. Expand
Setup, efforts and practical experiences of a monitoring program for genetically modified plants - an Austrian case study for oilseed rape and maize
Background, aim and scopeAccording to the Directive 2001/18/EC, genetically modified plants [GMPs] have to be monitored for unintended ecological impacts during their release. Detrimental effects onExpand
Farm questionnaires for monitoring genetically modified crops: a case study using GM maize.
TLDR
The methodological approach of the monitoring regime, the structuring of the data, and the contents and structure of the questionnaire for GM maize were presented, and it is envisaged that this approach will be developed for monitoring other cultivated GM plants and traits. Expand
Information system for monitoring environmental impacts of genetically modified organisms
TLDR
An ISMO as designed in this paper could support competent authorities in both the GMO notification process and in post-market monitoring and should be implemented on both the national and international level. Expand
...
1
2
3
4
...