General Surveillance for Import and Processing: the EuropaBio approach

Abstract

Applications for placing on the market of genetically modified organisms (GMOs) for import, food, feed and processing under Directive 2001/18/EC and Regulation (EC) No 1829/ 2003, have to include a monitoring plan conforming with Annex VII to Directive 2001/18/EC. One aspect of this monitoring plan is the need for general surveillance to identify the occurrence of adverse effects of the viable GMO or its use on human and animal health or the environment which were not anticipated in the environmental risk assessment (e.r.a.). Since international grain commodity trade consists of commingled products and the Plant Biotechnology Industry is not directly involved in commodity trade, authorisation holders under Directive 2001/18/EC and Regulation (EC) No 1829/2003 have been working together within the European Association of Bioindustries (EuropaBio) and with European trade associations representing relevant commodity trade operators to develop a harmonised general surveillance methodology for import and processing of viable GMOs. A harmonised industry general surveillance system was agreed upon by the Plant Biotechnology Industry members and the European trade associations and has been operational for several years. This harmonised industry general surveillance system has now been described in a harmonised industry monitoring plan. In line with Decision 2002/811/EC establishing guidance notes supplementing Annex VII to Directive 2001/18/EC and the Guidance Document of the Scientific Panel on Genetically Modified Organisms for the risk assessment of genetically modified plants and derived food and feed, this monitoring plan contains a detailed description of the agreed monitoring methodology together with other specifics, such as the baseline and controls for general surveillance, the time period over which general surveillance will be carried out, the use of existing networks and how the results of monitoring will be reported and reviewed.

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.…”