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A tiered system for assessing the risk of genetically modified plants to non-target organisms

Published online by Cambridge University Press:  01 March 2007

Monica Garcia-Alonso ,
Erik Jacobs ,
Alan Raybould ,
Thomas E. Nickson ,
Peter Sowig ,
Hilde Willekens ,
Pier Van Der Kouwe ,
Raymond Layton ,
Firoz Amijee  and
Angel M. Fuentes
...Show all authors
Monica Garcia-Alonso
Affiliation:
 Syngenta, Jealott's Hill International Research Centre, Bracknell, RG42 6EY, United Kingdom
Erik Jacobs
Affiliation:
 Monsanto Europe, Avenue de Tervueren 270 – 272, B-1150 Brussels, Belgium
Alan Raybould
Affiliation:
 Syngenta, Jealott's Hill International Research Centre, Bracknell, RG42 6EY, United Kingdom
Thomas E. Nickson
Affiliation:
 Monsanto Company, 800 N. Lindbergh Blvd, St. Louis, MO 63141, USA
Peter Sowig
Affiliation:
 Bayer CropScience, Industriepark Höchst H871, D-65926 Frankfurt am Main, Germany
Hilde Willekens
Affiliation:
 Syngenta International AG, Avenue Louise 240, Box 4, B-1050 Brussels, Belgium
Pier Van Der Kouwe
Affiliation:
 Bayer CropScience, Rue Jean-Marie Leclair 16, CP 106, F-69266 Lyon Cedex 09, France
Raymond Layton
Affiliation:
 Pioneer Hi-Bred International, 7300 NW 62nd Avenue, PO Box 1004, Johnston IA 50131-1004, USA
Firoz Amijee
Affiliation:
 Pioneer Overseas Corporation, Avenue des Arts 44, B-1040 Brussels, Belgium
Angel M. Fuentes
Affiliation:
 Pioneer Overseas Corporation, Avenue des Arts 44, B-1040 Brussels, Belgium
Francesca Tencalla
Affiliation:
 Monsanto Europe, Avenue de Tervueren 270 – 272, B-1150 Brussels, Belgium

Abstract

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Representatives of the developers of modern agricultural biotechnology are proposing a tiered approach for conducting non-target organism risk assessment for genetically modified (GM) plants in Europe. The approach was developed by the Technical Advisory Group of the EuropaBio Plant Biotechnology Unit (http://www.europabio.org/TAG.htm) and complements other international activities to harmonize risk assessment. In the European Union (EU), the principles and methods to be followed in an environmental risk assessment for the placing on the market of GM plants are laid out in Annex II of Directive 2001/18/EC on the deliberate release into the environment of GMOs, Commission Decision 2002/623/EC and Regulation (EC) No. 1829/2003. Additional information is provided in the European Food Safety Authority guidance document of 2004. However, risk assessment for effects to non-target organisms could benefit from further clarification and remains the subject of much discussion in Europe. The industry-wide approach developed by EuropaBio is based on the fundamental steps of risk evaluation, namely hazard and exposure assessment. It follows a structured scheme including assessment planning, product characterization and assessment of hazard/exposure (Tier 0), single high dose and dose response testing (Tier 1), refined hazard characterization and exposure assessment (Tier 2) and further refined risk assessment experiments (Tier 3). An additional tier (Tier 4) was included to reflect the fact that post-market activities such as monitoring are required under Directive 2001/18/EC. The approach is compatible with conditions of commercial release in the EU and around the world.

Keywords

risk assessmenttiered approachEuropean legislationgenetically modified organismsEuropaBio
Type
Research Article
Information
Environmental Biosafety Research , Volume 5 , Issue 2 , April 2006 , pp. 57 - 65
Copyright
© ISBR, EDP Sciences, 2007

References

Andow, D and Zwahlen C (2006) Assessing environmental risks of transgenic plants. Ecol. Lett. 9: 196–214 CrossRef
Barret KL, Grandy N, Harrison EG, Hassan S, Oomen P (1994) Guidance document on regulatory testing procedures for pesticides with non-target arthropods. Society of Environmental Toxicology and Chemistry (SETAC) – Europe. From the European Standard Characteristics of Beneficials Regulatory Testing (ESCORT I) Workshop, March 1994
BSP (2000) Cartagena Protocol on Biosafety to the Convention on Biological Diversity. http://www.biodiv.org/biosafety/protocol.asp
Calow P (1998) Handbook of Environmental Risk Assessment and Management. In Calow P, ed, Blackwell Science, Oxford, UK
Candolfi M, Barret KL, Campbell PJ, Forster N, Grandy N, Huet MC, Lewis G, Oomen PA, Schmuck R, Vogt H (2000) Guidance document on regulatory testing and risk assessment procedures for plant protection products with non-target arthropods. From the European standard characteristics of non-target arthropod regulatory testing (ESCORT II) Workshop, March 2000
Commission Decision 2002/623/EC 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. Official Journal of the European Communities L 200/22–33 (30.7.2002)
Council Decision 2002/811/EC 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. Official Journal of the European Communities L 280/27–36 (18.10.2002)
Directive 2001/18/EC of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EC. Official Journal of the European Communities L 106/1–38 (17.4.2001)
Dutton, A, Romeis, J, Bigler, F (2003) Assessing the risks of insect resistant transgenic plants on entomophagous arthropods: Bt maize expressing Cry1Ab as a case study. BioControl 48: 611–636 CrossRef
EC (2000) 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 – 26–27 October 2000. http://europa.eu.int/comm/food/fs/sc/ssc/out83_en.pdf
EFSA (2004) Guidance document of the Scientific Panel on Genetically Modified Organisms for the risk assessment of genetically modified plants and derived food and feed. The EFSA Journal 99: 1–94
Marvier, M (2002) Improving risk assessment for non-target safety of transgenic crops. Ecol. Applications 12: 1119– 1124 CrossRef
Newman NC (1998) In Fundamentals of Ecotoxicology. Ann Arbor Press, Chelsea, MI
Nickson T, McKee M (2002) Ecological assessment of crops derived through biotechnology. In Biotechnology and Safety Assessment, 3rd edition, Thomas J.A. and Fuchs R.L., eds, Academic Press, Amsterdam, pp 233–252
OECD (1993a) Safety considerations for biotechnology: scale-up of crop plants. http://www.oecd.org/dataoecd/26/26/1958527.pdf ?channelId=34537&homeChannelId=33703&fileTitle=Safety+Considerations+for+Biotechnology+Scale-up+of+Crop+Plants
OECD (1993b) Safety evaluation of foods derived by modern biotechnology: concept and principles. http://www.oecd.org/dataoecd/57/3/1946129.pdf ?channelId=34537& homeChannelId=33703&fileTitle=Safety+Evaluation+of+Foods+Derived+by+Modern+Biotechnology+-+Concepts+and+Principles
Regulation (EC) 1829/2003 of the European Parliament and the Council of 22 September 2003 on genetically modified food and feed. Official Journal of the European Communities L 268/1–23 (18.10.2003)
Rose, RI (2006) Tier-based testing for potential effects of proteinaceous insecticidal plant-incorporated protectants on non-target arthropods in the context of regulatory risk assessments. IOBC WPRS Bulletin 29: 145–152
Schuler, T, Poppy, GM, Denholm, I (2000) Recommendations for assessing effects of GM crops on non-target organisms. British Crop Protection Council Conference: Pest and Diseases 3: 1221–1228
US EPA (1998) Guidelines for Ecological Risk Assessment. U.S. Environmental Protection Agency, Risk Assessment Forum, Washington, DC, 175 pp. http://oaspub.epa.gov/eims/eimsapi.dispdetail?deid=12460
US EPA (1999) Draft ECOFRAM Aquatic Report. P. Hendley and J. Giddings, eds. http://www.epa.gov/oppefed1/ecorisk/aquareport.pdf
US EPA (2001) Biopesticides Registration Action Document – Bacillus thuringiensis Plant Incorporated Protectants. http://www.epa.gov/oppbppd1/biopesticides/pips/bt_brad.htm
Van Leuven CJ (1996) In Risk Assessment of Chemicals: An Introduction
WHO/FAO (2000) Safety aspects of genetically modified foods of plant origin. Report of a joint FAO/WHO expert consultation on foods derived from biotechnology, 29. http://www.fao.org/es/ESN/food/pdf/gmreport.pdf
Wilkinson MJ, Sweet JB, Poppy G (2003) Preventing the regulatory log jam; the tiered approach to risk assessments. Trends Plant Sci. 8: 208–212