Journal für Verbraucherschutz und Lebensmittelsicherheit Journal of Consumer Protection and Food Safety A framework for the design of general surveillance of genetically modiied crops based on a concept for environmental post-market monitoring O. Sanvido, F. Widmer, M. Winzeler and F. Bigler Agroscope FAL Reckenholz Zurich, Switzerland Correspondence to: Dr. Olivier Sanvido, Agroscope FAL Reckenholz, Swiss Federal Research Station for Agroecology and Agriculture, CH-8046 Zurich, Switzerland, Tel.: +41-44-377 73 04, Fax: +41-44-377 72 01, E-mail: olivier.sanvido@fal.admin.ch Received: September 8, 2006 Key words: Environmental monitoring, EU Directive 2001/18/EC, genetically modiied crops, post-market monitoring, general sur - veillance. Abbreviations: CSM = case-speciic monitoring; GM = genetically modiied; PMM = post-market monitoring; PMRA = pre-market risk assessment Abstract: A framework for the design of general surveillance dur- ing commercial cultivation of genetically modiied (GM) crops according to current EU legislation 2001/18/EC is presented. The framework is based on a previously established concept for envi- ronmental post-market monitoring (PMM), which identiied clear conceptual differences between case-speciic monitoring (CSM) and general surveillance. While CSM focuses on anticipated ef- fects of a speciic GM crop, general surveillance is designed to detect unanticipated effects on the environment. Two separate frameworks are proposed for developing either of the two pro- grammes. Considering its focus, general surveillance has to be based both on the subjects of environmental concern (safeguard subjects) that should not be adversely affected by GM crop culti- vation and on the environmental quality that should be preserved therein. Unanticipated effects in the deined safeguard subjects may be detectable by using existing monitoring networks and by establishing appropriate reporting systems. Results from general surveillance can, however, not be linked to any speciic attribute of GM crop cultivation, and causality to environmental damages will have to be determined via speciic risk assessement studies. The proposed structure for general surveillance represents a pragmatic approach to a realistic and feasible PMM programme and will be of assistance to industry, researchers, and regulators when assessing GM crops during commercialisation. 1. Introduction According to the new Directive 2001/18/EC of the European Un- ion (EU), post-market monitoring (PMM) must be implemented in order to detect and prevent adverse effects on human health and the environment possibly deriving from commercial cul- tivation of genetically modiied (GM) crops (European Com- munity, 2001). However, PMM programmes are not mandatory for the GM crops that are currently commercially cultivated in some member states of the EU, because these GM crops re- ceived approval for commercial cultivation under the former legislation 90/220/EEC, not requiring PMM. Because currently no GM crop has been approved according to the new Directive and since comparable PMM programmes are not required for conventional crops, environmental PMM of GM crops repre- sents a new challenge for farmers, the agricultural industry, scientists and regulators. Although monitoring concepts have been developed in several European countries by various or- ganisations, no general PMM strategies have been established so far. There is an urgent need for conceptual frameworks and guidance on how PMM programmes should be planned and performed. The need for information on the state of the envi- ronment, however, is not new, and the underlying principles have been established for other monitoring programmes. Although these monitoring programmes were originally de- signed in the context of environmental protection, the inher- ent principles remain also valid for environmental PMM of GM crops. Based on this existing knowledge we developed a con- ceptual framework proposing structures and procedures that could be used to implement such PMM programmes to detect potential adverse effects on the environment possibly deriving from commercial cultivation of GM crops (Sanvido et al., 2005). J. Verbr. Lebensm. 1 (2006) Supplement 1: 5–10 1661-5751/06/040005-6 DOI 10.1007/s00003-006-0061-y © Birkhäuser Verlag, Basel, 2006