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A conceptual framework for the design of environmentalpost-market monitoring of genetically modified plants

Published online by Cambridge University Press:  15 August 2005

Olivier Sanvido
Affiliation:
Agroscope FAL Reckenholz, Swiss Federal Research Station for Agroecology and Agriculture, CH-8046 Zurich, Switzerland
Franco Widmer
Affiliation:
Agroscope FAL Reckenholz, Swiss Federal Research Station for Agroecology and Agriculture, CH-8046 Zurich, Switzerland
Michael Winzeler
Affiliation:
Agroscope FAL Reckenholz, Swiss Federal Research Station for Agroecology and Agriculture, CH-8046 Zurich, Switzerland
Franz Bigler
Affiliation:
Agroscope FAL Reckenholz, Swiss Federal Research Station for Agroecology and Agriculture, CH-8046 Zurich, Switzerland

Abstract

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Genetically modified plants (GMPs) may soon be cultivated commercially in several member countries of the European Union (EU). According to EU Directive 2001/18/EC, post-market monitoring (PMM) for commercial GMP cultivation must be implemented, in order to detect and prevent adverse effects on human health and the environment. However, no general PMM strategies for GMP cultivation have been established so far. We present a conceptual framework for the design of environmental PMM for GMP cultivation based on current EU legislation and common risk analysis procedures. We have established a comprehensive structure of the GMP approval process, consisting of pre-market risk assessment (PMRA) as well as PMM. Both programs can be distinguished conceptually due to principles inherent to risk analysis procedures. The design of PMM programs should take into account the knowledge gained during approval for commercialization of a specific GMP and the decisions made in the environmental risk assessments (ERAs). PMM is composed of case-specific monitoring (CSM) and general surveillance. CSM focuses on anticipated effects of a specific GMP. Selection of case-specific indicators for detection of ecological exposure and effects, as well as definition of effect sizes, are important for CSM. General surveillance is designed to detect unanticipated effects on general safeguard subjects, such as natural resources, which must not be adversely affected by human activities like GMP cultivation. We have identified clear conceptual differences between CSM and general surveillance, and propose to adopt separate frameworks when developing either of the two programs. Common to both programs is the need to put a value on possible ecological effects of GMP cultivation. The structure of PMM presented here will be of assistance to industry, researchers, and regulators, when assessing GMPs during commercialization.

Type
Research Article
Copyright
© ISBR, EDP Sciences, 2005

References

ACRE (2004) Guidance on best practice in the design of post-market monitoring plans in submission to the advisory committee on releases to the environment. Department for Environment, Food and Rural Affairs – Advisory Committee on Releases to the Environment, London, published at: http://www.defra.gov.uk/environment/acre/postmarket/acre_ postmarketmonitor-guidance.pdf
Ammann K (2004) The role of science and discourse in the application of the precautionary approach (PA). In Fischer R, Schillberg S, eds, Molecular farming, plant-made pharmaceuticals and technical proteins. Vol. 1. Wiley-VCH Verlag GmbH & co. KGaA Weinheim, pp 291–302
Candolfi, MP, Brown, K, Grimm, C, Reber, B, Schmidli, H (2004) A faunistic approach to assess potential side-effects of genetically modified Bt-corn on non-target arthropods under field conditions. Biocontrol Sci. Technol. 14: 129170 CrossRef
CBD (2000) Cartagena protocol on biosafety to the Convention on Biological Diversity. Secretariat of the Convention on Biological Diversity, Montreal, published at: www.biodiv.org/ doc/legal/cartagena-protocol-en.pdf
Conner, AJ, Glare, TR, Nap, J-P (2003) The release of genetically modified crops into the environment. Part II. Overview of ecological risk assessment. Plant J. 33: 1946 CrossRef
Dale, PJ, Clarke, B, Fontes, EMG (2002) Potential for the environmental impact of transgenic crops. Nat. Biotechnol. 20: 567574 CrossRef
Dietl, W (1995) Wandel der Wiesenvegetation im Schweizer Mittelland. Z. Ökol. Natursch. 4: 239249
Duelli, P (1997) Biodiversity evaluation in agricultural landscapes: an approach at two different scales. Agric. Ecosyst. Environ. 62: 8191 CrossRef
Duelli, P, Obrist, MK (1998) In search for the best correlates for local organismal biodiversity in cultivated areas. Biodiversity Conserv. 7: 297309 CrossRef
Duelli, P, Obrist, MK (2003a) Biodiversity indicators: the choice of values and measures. Agric. Ecosyst. Environ. 98: 8798 CrossRef
Duelli, P, Obrist, MK (2003b) Regional biodiversity in agricultural landscape: the contribution of seminatural habitat islands. Basic Appl. Ecol. 4: 129138 CrossRef
European Commission (2000a) Communication from the Commission on the precautionary principle. Commission of the European Communities, Brussels, published at: http://europa.eu.int/comm/dgs/health_consumer/library/pub/pub07_ en.pdf
European Commission (2000b) First report on the harmonisation of risk assessment procedures – Part 1 : The Report of the Scientific Steering Committee's Working Group on Harmonisation of Risk Assessment Procedures in the Scientific Committees advising the European Commission in the area of human and environmental health. European Commission – Health & Consumer Protection Directorate-General, Brussels, published at: http://europa.eu.int/comm/food/fs/sc/ssc/out83_en.pdf
European Commission (2002) Commission decision of 24 July 2002 establishing guidance notes supplementing Annex II to Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC. Commission on the European Communities, Brussels
European Community (2001) Directive 2001/18/EC of the European Parliament and of the council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC. European Parliament and the Council of the European Union, Brussels
European Council (2002) Council decision of 3 October 2002 establishing guidance notes supplementing Annex VII to Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC. The Council of the European Union, Luxemburg
European Union (2003a) Regulation (EC) No. 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC. European Parliament and the Council of the European Union, Brussels
European Union (2003b) Regulation (EC) No. 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed. European Parliament and the Council of the European Union, Brussels
Fairweather, PG (1991) Statistical power and design requirements for environmental monitoring. Aus. J. Mar. Fresh. Res. 42: 555567 CrossRef
FDA (2005) How to report problems with products regulated by FDA. US Food and Drug Administration. www.fda.gov/opacom/ backgrounders/problem.html
FrSV (SR 814.911) Verordnung über den Umgang mit Organismen in der Umwelt (Freisetzungsverordnung). Systematische Sammlung des Bundesrechts, Bern
GTG (SR 814.91) Bundesgesetz über die Gentechnik im Ausserhumanbereich (Gentechnikgesetz). Systematische Sammlung des Bundesrechts, Bern
Hails, RS (2002) Assessing the risks associated with new agricultural practices. Nature 418: 685688 CrossRef
Hellawell JM (1991) Development of a rationale for monitoring. In Goldsmith B, ed, Monitoring for Conservation and Ecology. Chapman and Hall London, pp 1–14
Hill, RA, Sendashonga, C (2003) General principles for risk assessment of living modified organisms: Lessons from chemical risk assessment. Environ. Biosafety Res. 2: 8188 CrossRef
Hintermann U, Weber D, Zangger A, Schmill J (2002) Biodiversity Monitoring in Switzerland BDM – interim report. Environmental series. No. 342 Swiss Agency for the Environment, Forests and Landscape, Berne, published at: www.umwelt-schweiz.ch/buwal/shop/files/pdf/phpamJ0T6.pdf
Hunsaker CT (1993) New concepts in environmental monitoring: the question of indicators. Sci. Tot. Environ. Supplement: 77–95
Jaffe, G (2004) Regulating transgenic crops: a comparative analysis of different regulatory processes. Transgenic Res. 13: 519 CrossRef
James C (2004) Preview: Global status of commercialized transgenic crops 2004. ISAAA Briefs No. 32, ISAAA, Ithaca, NY
Jeanneret, P, Schüpbach, B, Luka, H (2003) Quantifying the impact of landscape and habitat features on biodiversity in cultivated landscapes. Agric. Ecosyst. Environ. 98: 311320 CrossRef
Lang, A (2004) Monitoring the impact of Bt maize on butterflies in the field: estimation of required sample sizes. Environ. Biosafety Res. 3: 5566 CrossRef
Levidow, L (2003) Precautionary risk assessment of Bt maize: what uncertainties? J. Invertebr. Pathol. 83: 113117 CrossRef
Lindner B (2004) Economic issues for plant breeding – public funding and private ownership. Agribusiness Review 12: Paper 6
Marvier, M (2002) Improving risk assessment for nontarget safety of transgenic crops. Ecol. Appl. 12: 11191124 CrossRef
MHRA (2005) Reporting adverse incidents. UK Medicines and Healthcare products Regulatory Agency. www.medical-devices.gov.uk/mda/mdawebsitev2.nsf/webvwSectionsMDA/ Reporting+adverse+incidents?Open
National Research Council (2002) Environmental effects of transgenic plants – the scope and adequacy of regulation. National Academy Press, Washington DC
Noss, RF (1990) Indicators for Monitoring Biodiversity – a Hierarchical Approach. Conserv. Biol. 4: 355364 CrossRef
OECD (1997) Environmental Indicators for Agriculture, Volume 1: Concepts and Framework. Organisation for Economic Co-Operation and Development, Paris
Pearson DL (1995) Selecting indicator taxa for the quantitative assessment of biodiversity. In Hawksworth DL, ed, Biodiversity, Measurements and Estimation. Chapman and Hall London, pp 75–79
Perry, JN, Rothery, P, Clark, SJ, Heard, MS, Hawes, C (2003) Design, analysis and statistical power of the Farm-Scale Evaluations of genetically modified herbicide-tolerant crops. J. Appl. Ecol. 40: 1731 CrossRef
Pretty, J (2001) The rapid emergence of genetic modification in world agriculture: contested risks and benefits. Environ. Conserv. 28: 248262 CrossRef
Robinson, RA, Sutherland, WJ (2002) Post-war changes in arable farming and biodiversity in Great Britain. J. Appl. Ecol. 39: 157176 CrossRef
Schifferli, L (1999) Distribution and habitat use of bird species breeding on Swiss farmland in relation to agricultural intensification. Vogelwelt 120: 151161
Schifferli, L (2001) Birds breeding in a changing farmland. Acta Ornith. 36: 3551 CrossRef
Stork NE, Samways MJ (1995) Inventorying and Monitoring. In Heywood VH, Watson RT, eds, Global biodiversity assessment. Cambridge University Press, pp 453–542
Studer-Ehrensberger, K (1995) Geschichte und Naturschutz von artenreichen Kulturwiesen in der Schweiz: eine Zusammenschau. Bot. Helvet. 105: 316
Swiss Web Flora (2004) Swiss Federal Institute for Forest, Snow and Landscape Research, 2000. www.wsl.ch/land/products/webflora/welcome-de.ehtml
Vos, P, Meelis, E, Ter Keurs, WJ (2000) A framework for the design of ecological monitoring programs as a tool for environmental and nature management. Environ. Monit. Assess. 61: 317344 CrossRef
Wolfenbarger, LL, Phifer, P (2000) The ecological risks and benefits of genetically engineered plants. Science 290: 20882093 CrossRef