General Surveillance: Roles and Responsibilities The Industry View

Abstract

A General Surveillance plan to monitor for unanticipated adverse effects of genetically modified organisms (GMOs) on human health and the environment is required as part of the EU legislation for imported and cultivated GMOs.Imported GM products: Operators involved in the import, handling and processing of grain commodities entering the EU have monitoring procedures in place to survey products and are organised in associations across the EU Member States. They can therefore be considered as the best placed to monitor for potential unanticipated adverse effects linked to imports of GM products into the EU. Recognising this, the Plant Biotechnology Industry has established a collaboration to cover General Surveillance of grain commodity imports with the relevant associations, which is coordinated by EuropaBio, the European Association for Bioindustries.Cultivated GM plants: Monitoring for unanticipated adverse effects should take place in agronomic zones representative of commercial GM crop cultivation. Farmers are therefore considered to be the most valuable sources of information when it comes to General Surveillance of GM crop cultivation, due to their extensive experience with and direct involvement in cultivation. Acknowledging this, the Plant Biotechnology Industry has developed a harmonised general surveillance approach based on farmer questionnaires.

Assessment of genetically modified soybean MON 87751 for food and feed uses under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2014‐121)

“…The PMEM plan proposed by the applicant for soybean MON 87751 includes: (1) the description of a monitoring approach involving operators (federations involved in import and processing), reporting to the applicant, via a centralised system, any observed adverse effect(s) of GMOs on human health and the environment; (2) a coordinating system newly established by EuropaBio for the collection of information recorded by the various operators; and (3) the review of relevant scientific publications retrieved from literature searches (Lecoq et al, 2007;Windels et al, 2008). The applicant proposes to submit a PMEM report on an annual basis and a final report at the end of the authorisation period.…”

Feral genetically modified herbicide tolerant oilseed rape from seed import spills: are concerns scientifically justified?

“…European operators importing, handling and processing viable oilseed rape commodities have joined with the European Association of Bioindustries (EuropaBio) in developing monitoring systems for imported GM oilseed rape at the main points of entry and along distribution and processing networks (Lecoq et al, 2007;Windels et al, 2008). These monitoring systems are HACCP (Hazard Analysis and Critical Control Points) compliant, and aim to ensure that appropriate procedures are in place to avoid, report and to clean up potential seed spills, as spills can result in fines and the revocation of operating licenses.…”

“…In the annex of its approval decision for the marketing of GT73, the European Commission requested the 21 | P a g e implementation of appropriate management measures to prevent any damage to human and animal health and the environment in case of accidental spillage of GM oilseed rape (EC, 2005). EU Member States that consider seed import spills of GMHT oilseed rape as a major concern also required monitoring to confirm that populations of feral GMHT oilseed rape do not emerge, and to identify areas where feral populations become established to undertake remedial measures (EC, 2004).European operators importing, handling and processing viable oilseed rape commodities have joined with the European Association of Bioindustries (EuropaBio) in developing monitoring systems for imported GM oilseed rape at the main points of entry and along distribution and processing networks (Lecoq et al, 2007;Windels et al, 2008). These monitoring systems are HACCP (Hazard Analysis and Critical Control Points) compliant, and aim to ensure that appropriate procedures are in place to avoid, report and to clean up potential seed spills, as spills can result in fines and the revocation of operating licenses.…”

Application (Reference EFSA-GMO-UK-2005-11) for the placing on the market of insect-resistant genetically modified maize MIR604 event, for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Syngenta Seeds S.A.S on behalf of

“…The general surveillance plan proposed by the applicant includes (1) the description of an approach involving operators (federations involved in maize import and processing), reporting to applicants, via a centralised system, any observed adverse effect(s) of GMOs on human health and the environment; (2) a coordinating system established by EuropaBio for the collection of the information recorded by the various operators (Lecoq et al, 2007;Windels et al, 2008); and (3) the use of networks of existing surveillance systems. The applicant proposes a general surveillance report on an annual basis and a final report at the end of the consent.…”