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.