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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
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Cited by
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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
“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
García, M., Ortego, F., Castañera, P., & Farinós, G. P. (2010) · Biological Control · doi:10.1016/j.biocontrol.2010.08.002 · Cited by 48
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
Devos, Y., Álvarez‐Alfageme, F., Gennaro, A., & Mestdagh, S. (2016) · Journal of Applied Entomology · doi:10.1111/jen.12248 · Cited by 23
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
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
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
Metadata
- 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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