Abstract
AbstractThe objective of general surveillance is to identify the occurrence of unanticipated adverse effects of GM crops on human health or the environment that were not covered in the environmental risk assessment. EuropaBio is harmonizing an approach to non-hypothesis driven post-market environmental monitoring relating to the cultivation of different GM crops, comprising a farmer questionnaire, existing surveillance systems as well as other data sources. As an unanticipated adverse effect is most likely to occur where the level of environmental exposure is highest, general surveillance focuses on the agricultural environment and those agronomic zones that are representative of commercial GM crop cultivation. The farmer questionnaire is one element of the general surveillance approach, and is largely based on routine observations by farmers cultivating GM crops. It aims at recording data and observations capturing the interaction of one GM event with the agricultural environment. Due to its modular structure, the farmer questionnaire can be used for different GM crops and traits as well as combinations of traits. Existing surveillance systems, which are not GM crop focused, are another element of the harmonized approach to general surveillance and provide information based on e.g. plant health and soil surveys, ecological and environmental observations. The aforementioned elements, in association with the assessment of results from research projects published in peer reviewed publications relating to the environmental safety of GM crops, individual company stewardship activities and issue alerts complete the EuropaBio approach which should allow for the identification of any potential adverse effects arising from the presence of GM crops.
Highlights
Harmonised General Surveillance for cultivationFarmer questionnaireSurveillance networksComplementary elements
Essential part of applications submitted for GM crop authorisations under Directive 2001/18/EC and/or Regulation (EC) No 1829/2003
– Case-specific monitoring (CSM) – to monitor for potential adverse effects of the GMO or its use identified in the environmental risk assessment (e.r.a.)
Summary
Essential part of applications submitted for GM crop authorisations under Directive 2001/18/EC and/or Regulation (EC) No 1829/2003. – EFSA Guidance Document (2006) for the risk assessment of GM plants and derived food and feed. – Case-specific monitoring (CSM) – to monitor for potential adverse effects of the GMO or its use identified in the environmental risk assessment (e.r.a.). – General surveillance (GS) – to anticipate for unintended adverse effects of the GMO or its use on human and animal health or the environment. The five elements are fully complementary tools that are fit for the purpose to identify any potential adverse effects arising from the presence of GM crops. They are science-based, multifunctional, and dynamic to account for experience/advanced methodology. If any of the answers above is different from « As usual », please specify: Fixed Factors
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