A tiered system for assessing the risk of genetically modified plants to non-target organisms
Open accessAbstract
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.
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Toxicity of the insecticidal protein to natural enemies is typically evaluated in a tiered risk assessment approach conceptually similar to that used for pesticides.
“Toxicity of the insecticidal protein to natural enemies is typically evaluated in a tiered risk assessment approach that is conceptually similar to that used for pesticides.”
From Genetically engineered crops help support conservation biological control (2019) · cites this paper as Garcia-Alonso et al., 2006
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Cites
Fundamentals of Ecology (1953)
Odum, E. P. (1955) · Yale University Press eBooks · doi:10.12987/9780300188479-022 · Cited by 5,021 · see citing works
Risk assessment of chemicals : an introduction
van Leeuwen, K., & Vermeire, T. G. (2007) · Springer eBooks · Cited by 577 · see citing works
Assessing environmental risks of transgenic plants
Andow, D. A., & Zwahlen, C. (2006) · Ecology Letters · doi:10.1111/j.1461-0248.2005.00846.x · Cited by 327 · see citing works
Handbook of environmental risk assessment and management
Calow, P. (1998) · Cited by 189 · see citing works
Dutton, A., Romeis, J., & Bigler, F. (2003) · BioControl · doi:10.1023/a:1026313719424 · Cited by 170 · see citing works
Andersson, C., Bartsch, D. K., Buhk, H.-J., Davies, H. V., Loose, M. D., Gasson, M. J., Hendriksen, N. B., Hill, C., Kärenlampi, S. O., Kryspin-Sørensen, I., et al. (2004) · Cited by 145 · see citing works
Risk assessment of GM plants: avoiding gridlock?
Wilkinson, M. J., Sweet, J., & Poppy, G. M. (2003) · Trends in Plant Science · doi:10.1016/s1360-1385(03)00057-8 · Cited by 125 · see citing works
Leeuwen, C. J., & Hermens, J. L. M. (1995) · Springer eBooks · doi:10.1007/978-94-015-8520-0 · Cited by 116 · see citing works
IMPROVING RISK ASSESSMENT FOR NONTARGET SAFETY OF TRANSGENIC CROPS
Marvier, M. (2002) · Ecological Applications · doi:10.1890/1051-0761(2002)012[1119:irafns]2.0.co;2 · Cited by 92 · see citing works
Ecological Assessment of Crops Derived through Biotechnology
Nickson, T. E., & McKee, M. J. (2003) · Elsevier eBooks · doi:10.1016/b978-012688721-1/50009-x · Cited by 18 · see citing works
Self-citation(1999) · Wiley eBooks · doi:10.1002/9781444311471 · Cited by 10 · see citing works
Recommendations for assessing effects of GM crops on non-target organisms.
Schuler, T. H., Poppy, G. M., & Denholm, I. (2000) · Rothamsted Repository (Rothamsted Repository) · Cited by 3 · see citing works
Flagged first, then by citations
Research works printed but not linked: 5
- 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
- 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)
- 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
- Newman NC (1998) In Fundamentals of Ecotoxicology. Ann Arbor Press, Chelsea, MI
- 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
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Genetically engineered crops help support conservation biological control
Romeis, J., Naranjo, S. E., Meissle, M., & Shelton, A. M. (2019) · Biological Control · doi:10.1016/j.biocontrol.2018.10.001 · Cited by 231 · see citing works
“Testing starts with laboratory studies representing highly controlled, worst-case exposure conditions and progresses to bioassays with more realistic exposure to the toxin and semi-field or open field studies carried out under less controlled conditions (Garcia-Alonso et al., 2006; Romeis et al., 2008a).”
BackgroundCarstens, K., Anderson, J., Bachman, P., De Schrijver, A., Dively, G., Federici, B., Hamer, M., Gielkens, M., Jensen, P., Lamp, W., et al. (2012) · Transgenic Research · doi:10.1007/s11248-011-9569-8 · Cited by 90 · see citing works
García, M., Ortego, F., Castañera, P., & Farinós, G. P. (2010) · Biological Control · doi:10.1016/j.biocontrol.2010.08.002 · Cited by 48 · see citing works
Carstens, K., Cayabyab, B., De Schrijver, A., Gadaleta, P. G., Hellmich, R. L., Romeis, J., Storer, N., Valicente, F. H., & Wach, M. (2014) · GM Crops & Food · doi:10.4161/gmcr.26560 · Cited by 36 · see citing works
Devos, Y., Álvarez‐Alfageme, F., Gennaro, A., & Mestdagh, S. (2016) · Journal of Applied Entomology · doi:10.1111/jen.12248 · Cited by 23 · see citing works
Wach, M., Hellmich, R. L., Layton, R., Romeis, J., & Gadaleta, P. G. (2016) · Transgenic Research · doi:10.1007/s11248-016-9945-5 · Cited by 22 · see citing works
Self-citationGuo, Y.-Y., Tian, J.-C., Shi, W.-P., Dong, X.-H., Romeis, J., Naranjo, S. E., Hellmich, R. L., & Shelton, A. M. (2016) · Transgenic Research · doi:10.1007/s11248-015-9917-1 · Cited by 14 · see citing works
Wang, Z., Li, Y., He, K., Bai, S., Zhang, T., Cai, W., & Wang, Z. (2017) · Insect Science · doi:10.1111/1744-7917.12352 · Cited by 14 · see citing works
- Authors
- Garcia-Alonso, M., Jacobs, E., Raybould, A., Nickson, T. E., Sowig, P., Willekens, H., Van Der Kouwe, P., Layton, R., Amijee, F., Fuentes, A. M., & Tencalla, F.
- Affiliations
- Syngenta (United Kingdom) (GB)
- Bayer (Germany) (DE)
- Pioneer Hi-Bred (US)
- Venue
- Environmental Biosafety Research
- Publisher
- EDP Sciences
- Published
- 2006-04
- Volume
- 5
- Issue
- 2
- Pages
- 57-65
- ISSN
- 1635-7922 (ISSN-L)
- 1635-7930
- OpenAlex
- W2052686119
- Cited by
- 161
- References
- 12
- Citations by year
- 2026: 2 · 2025: 4 · 2024: 4 · 2022: 5 · 2021: 2 · 2020: 5 · 2019: 8 · 2018: 7 · 2017: 4 · 2016: 15 · 2015: 15 · 2014: 10 · 2013: 12 · 2012: 9
- FWCI
- 11.87
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Environmental Biosafety Research (publishedVersion)
- PubMed (publishedVersion)
- Springer Link (Chiba Institute of Technology) (submittedVersion)
- Topics
- Life Sciences › Agricultural and Biological Sciences › Plant Science › Genetically Modified Organisms Research
- Life Sciences › Agricultural and Biological Sciences › Food Science › Agricultural safety and regulations
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Insect Resistance and Genetics
- Keywords
- transgenic plants, non-target organisms, environmental risk assessment, tiered risk assessment, hazard assessment, exposure assessment, Directive 2001/18/EC, post-market monitoring
- MeSH terms
- Animals, Environmental Exposure, European Union, Genetic Engineering, Risk Assessment, Plants, Genetically Modified
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