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First EFSA Experiences with Monitoring Plans J. Verbr. Lebensm. 2 (2007) Supplement 1: 33 – 36 1661-5751/07/050033-4 Journal für Verbraucherschutz und Lebensmittelsicherheit DOI 10.1007/s00003-007-0257-9 Journal of Consumer Protection and Food Safety © Birkhäuser Verlag, Basel, 2007 First EFSA experiences with monitoring plans D. Bartsch1, A. Gathmann1, S. Hartley2, N. B. Hendriksen3, R. Hails4, K. Lheureux5, J. Kiss6, S. Mesdagh5, G. Neemann7, J. Perry8, S. Renckens5, J. Schiemann9 and J. Sweet10 1 BVL, Federal Office of Consumer Protection and Food Safety, Berlin, Germany 2 University of Sussex, Biology and Environmental Science, Brighton, BN1 9RH, United Kingdom 3 Department of Environmental Chemistry and Microbiology, National Environmental Research Institute, University of Aarhus, Frederiksborgvej 399, DK-4000 Roskilde, Denmark 4 Pathogen Population Ecology Centre for Ecology and Hydrology Mansfield Rd OXFORD OX1 3SR, United Kingdom 5 EFSA Largo N. Palli 5/A 43100 Parma, Italy 6 Plant Protection Institute, Szent Istvan University, Pater K. street 1, Godollo, Hungary 7Blau-Umweltstudien, Göttingen, Germany 8 Oaklands Barn, Lug’s Lane, Broome, Norfolk NR35 2HT, United Kingdom 9 Federal Biological Research Centre for Agriculture and Forestry, Institute for Plant Virology, Microbiology and Biosafety, Messeweg 11/12, D-38104 Braunschweig, Germany 10 The Green, Willingham, CB4 5JA Cambridge, United Kingdom Correspondence to: PD Dr. Detlef Bartsch, Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, Referat 404, Mauerstr. 39–42, D-10117 Berlin, Germany, Tel.: +49 1888 444 40400, Fax: +49 1888 444 40009, E-Mail: [email protected] Received: September 10, 2007 Key words: Directive 2001/18/EC, General surveillance, Case- is needed. In one case (an application for cultivation of a GM specific monitoring, GMO, Regulation (EC) 1829/2003, GMO Risk crop), the GMO Panel recommended case-specific monitoring. assessment. We explain in more detail how the environmental risk assess- ment of two Bt maize dossiers (maize Bt11 and 1507) were con- Abstract: A plan for Post Market Environmental Monitoring sidered by the GMO Panel in the evaluation of the PMEM plan and (PMEM) of genetically modified (GM) plants is mandatory in all the consequences for the environmental monitoring plan. As applications for deliberate release submitted under EU Directive stated in the EFSA opinion on post-market environmental mo- 2001/18/EC and EU Regulation 1829/2003. PMEM is composed of nitoring, the general surveillance plans shall, when possible, case-specific monitoring and general surveillance of GM plants. make use of existing monitoring systems in addition to more The European Food Safety Authority (EFSA) is responsible for focused monitoring systems. However, the use of these national assessing the scientific quality of PMEM plans submitted with monitoring programmes is outside of the management and each application. In a scientific opinion, the EFSA GMO Panel control of an individual applicant and thus it cannot be the task presented specific guidance for applicants for developing PMEM of an applicant alone to use, modify or improve existing sur- plans. In addition the EFSA GMO Panel explained the scientific veillance systems. The availability of biodiversity monitoring rationale for this guidance and makes a number of recommen- programmes in the EU Member States should be evaluated by dations for the management and conduct of PMEM by both applicants in close liaison with risk managers. applicants and risk managers. Until the end of March 2007, the EFSA GMO Panel gave opinions on 11 PMEM plans submitted under EU Directive 2001/18/EC and another 11 plans submitted 1. Introduction within applications under EU Regulation 1829/2003. Currently 27 applications for GM plants are still in the evaluation process and A plan for Post Market Environmental Monitoring (PMEM) of the EFSA GMO Panel sent 26 questions to the applicants for genetically modified (GM) plants is mandatory in all applica- clarification and additional information during the evaluation tions for deliberate release submitted under EU Directive 2001/ process. Sixteen of these questions were related to General 18/EC (EC, 2001) and EU Regulation 1829/2003 (EC, 2003). PMEM Surveillance (e.g. general structure, farm & operator que- is composed of case-specific monitoring and general surveil- stionnaires, integrations of identity preservation systems, use of lance of GM plants. The European Food Safety Authority (EFSA) existing surveillance systems, feral plant surveillance). Nine is responsible for assessing the scientific quality of PMEM plans questions requested clarification on the environmental risk as- submitted with each application. In a scientific opinion, the sessment, which might effect whether case-specific monitoring EFSA GMO Panel presented specific guidance for applicants for 34 D. Bartsch et al. developing PMEM plans (EFSA, 2006a). In addition, the EFSA the USA or in Europe (Evans, 2002; Tabashnik et al., 2005; GMO Panel explained the scientific rationale for this guidance Bourguet et al., 2002; Farinós et al., 2004, Saeglitz et al., 2006, and makes a number of recommendations for the manage- Eizaguirre et al., 2006). In the Bt11 and 1507 maize notifica- ment and conduct of PMEM by both applicants and risk ma- tions, insect-resistance management (IRM) plans, including nagers (Bartsch et al., 2006). the high dose/refuge resistance management strategy, were provided by the applicants. The GMO Panel supports these approaches to minimize/delay the potential resistance deve- 2. Recent experience of applications for import and lopment of target organisms. The GMO Panel also points out processing and for cultivation of GM plants that the use of non-GM border rows as refuges would also have the effect of reducing exposure of field margin weeds (and Until the end of March 2007, the EFSA GMO Panel gave opi- hence non-target Lepidoptera, see Schmitz et al., 2003) to pol- nions on 11 PMEM plans submitted under EU Directive 2001/18/ len from Bt maize. EC and another 11 plans submitted within applications under Therefore, the GMO Panel has recommended that case- EU Regulation 1829/20031. Currently 27 applications for GM specific monitoring for resistance development in target or- plants are still under scientific evaluation by the GMO Panel ganisms is a requirement for Bt resistant genetically modified and the EFSA GMO Panel sent 26 questions to the applicants for Bt11 and 1507 maize crops cultivated in the EU (EFSA, 2005a, clarification and additional information during the evaluation 2005b). process. Sixteen of these questions were related to General Surveillance (e.g. general structure, farm & operator ques- 3.2 General Surveillance tionnaires,ACHTUNGRE integrations of identity preservation systems, use of As indicated in its earlier opinion, the EFSA GMO Panel re- existing surveillance systems, feral plant surveillance). Nine commends that General Surveillance for unanticipated ad- questions requested clarification on the environmental risk verse effects of GM plants for cultivation should be protection assessment which might influence decisions on the need for goal oriented to allow for an efficient use of potentially limited case-specific monitoring (e.g. environmental exposure of ex- resources within new and existing surveillance systems (EFSA, pressed proteins or accidental release of GM seeds). In one case 2006b). In addition, the GMO Panel recommended that gen- (an application for cultivation of a GMP), the GMO Panel re- eral surveillance in the Member States should make full use of commended case-specific monitoring. More details on the existing and on-going monitoring studies that can supply re- nature of the environmental risk assessment and its conse- levant data. Three examples are described: quences for risk management measures are given for two examples in the following chapter. (1) One of the best-known examples for connecting environ- mental monitoring of biodiversity to potential needs of general surveillance comes from Switzerland (not a 3. Specific comments on Bt11 and 1507 maize PMEM plans – Member of the EU). The Swiss Biodiversity Monitoring applications for cultivation Programme (BDM) has carried out measurements of bio- logical diversity since 2001 using evenly-spread random 3.1 Case specific monitoring plots all over the country which are sampled to draw The risk assessment of Bt11 (EFSA, 2005a) and 1507 maize (EFSA, conclusions about Switzerland as a whole (Bühler, 2006). A 2005b) indicated a risk that the target organisms might de- central coordination office compiles data collection, ana- velop resistance to the Cry proteins (Cry1Ab protein expressed lysis and publication. Vascular plants, breeding birds and in Bt11 maize and Cry1F protein expressed in 1507 maize). This butterflies are assessed. From a conceptional point of view, triggered the need for specific monitoring for resistance of the the sampling strategy of BDM meets the basic principles of target species (lepidopteran pest species like Ostrinia nubilalis general surveillance (EFSA, 2006b). The BDM provides ba- (European Corn Borer, ECB), and Sesamia nonagrioides (West seline information that can be used to detect unanticipa- African Pink Borer) and implementation of risk management ted consequences of the cultivation of GM plants (Bühler, strategies to reduce the likelihood of resistance developing. 2006). The BDM uses no predictions about the changes Recent resistance monitoring measures conducted on Bt that might happen to infer
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