Book contents
- Genetically Modified Organisms in Developing CountriesRisk Analysis and Governance
- Genetically Modified Organisms in Developing Countries
- Copyright page
- Contents
- Contributors
- Foreword
- 1 Introduction
- Part I Risk Analysis Methodology and Decision-Making
- 2 Recent Scientific Developments in Genetic Technologies: Implications for Future Regulation of GMOs in Developing Countries
- 3 A Strategy for Integrating Science into Regulatory Decision-Making for GMOs
- 4 Governance of Benefits and Risks of GMOs in Developing Countries
- 5 The Canadian Experience with the Creation and Implementation of Regulatory Frameworks for the Environmental Release of GM Crops as a Model for Developing Countries
- 6 Labelling of Food from GMOs: Options to Consider by Developing Countries
- 7 Building Human Capacity and Skills in Biosafety: Lessons Learned and Emerging Best Practices
- Part II Diversification of Expertise
- Part III Risk-Analysis-Based Regulatory Systems
- Part IV Case Studies from Developing Countries
- Index
- References
3 - A Strategy for Integrating Science into Regulatory Decision-Making for GMOs
from Part I - Risk Analysis Methodology and Decision-Making
Published online by Cambridge University Press: 05 July 2017
Book contents
- Genetically Modified Organisms in Developing CountriesRisk Analysis and Governance
- Genetically Modified Organisms in Developing Countries
- Copyright page
- Contents
- Contributors
- Foreword
- 1 Introduction
- Part I Risk Analysis Methodology and Decision-Making
- 2 Recent Scientific Developments in Genetic Technologies: Implications for Future Regulation of GMOs in Developing Countries
- 3 A Strategy for Integrating Science into Regulatory Decision-Making for GMOs
- 4 Governance of Benefits and Risks of GMOs in Developing Countries
- 5 The Canadian Experience with the Creation and Implementation of Regulatory Frameworks for the Environmental Release of GM Crops as a Model for Developing Countries
- 6 Labelling of Food from GMOs: Options to Consider by Developing Countries
- 7 Building Human Capacity and Skills in Biosafety: Lessons Learned and Emerging Best Practices
- Part II Diversification of Expertise
- Part III Risk-Analysis-Based Regulatory Systems
- Part IV Case Studies from Developing Countries
- Index
- References
Summary
Risk assessment and the broader process of risk analysis are central to regulatory decision-making for GMOs. However, the process has tended to become rather complex, particularly as GMOs with several gene-trait combinations (e.g. stacked events) reach later stages of development. Fit-for-purpose, practical and integrated risk analysis methods are required to ensure effective and efficient regulatory decision-making, and to make rigorously scientific risk analysis more broadly accessible to diverse stakeholder groups. Given the need to enhance biosafety regulatory decision-making capacity, since the mid-1990s the International Centre for Genetic Engineering and Biotechnology (ICGEB) has organised 5-day workshops on the assessment of safety of GMOs. This has led to the development of a practical strategy for risk assessment, which has proved to be useful not only from a regulatory perspective, but also for the evaluation of potential risks early in the development of a GMO. This chapter presents the risk assessment methodology that has been continuously refined in the ICGEB workshops, including an outline on how this can be integrated into the broader context of risk analysis.
- Type
- Chapter
- Information
- Genetically Modified Organisms in Developing CountriesRisk Analysis and Governance, pp. 26 - 38Publisher: Cambridge University PressPrint publication year: 2017
References
Animal and Plant Health Inspection Service (1996). USDA/APHIS Petition 95–352–01P for the Determination of Nonregulated Status for CZW-3 Squash. [Online]. Available from www.aphis.usda.gov/brs/aphisdocs2/95_35201p_com.pdfGoogle Scholar
Convention on Biological Diversity (2000). Cartagena Protocol on Biosafety to the Convention on Biological Diversity. Text and Annexes. [Online]. Available from www.cbd.int/doc/legal/cartagena-protocol-en.pdfGoogle Scholar
Craig, W. et al. (2008). An overview of general features of risk assessment of genetically modified crops. Euphytica 164, 853–880.CrossRefGoogle Scholar
EFSA (2010). Guidance on the environmental risk assessment of genetically modified plants. EFSA Panel on Genetically Modified Organisms (GMO), European Food Safety Authority (EFSA), Parma, Italy. EFSA Journal 8(11), 1879–1990.Google Scholar
EPA (1998). Guidelines for Ecological Risk Assessment. EPA/630/R-95/002F. Federal Register 63(93), 26846–26924.Google Scholar
Fitzpatrick, J. et al. (2009). Problem formulation in environmental risk assessment of genetically modified crops: a Brazilian workshop. BioAssay 4, 5.Google Scholar
García-Alonso, M. (2013). Safety assessment of food and feed derived from GM crops: using problem formulation to ensure ‘fit for purpose’ risk assessment. Collection of Biosafety Reviews 8, 72–101.Google Scholar
Gray, A. (2012). Problem formulation in environmental risk assessment for genetically modified crops: a practitioner's approach. Collection of Biosafety Reviews 6, 14–65.Google Scholar
Halpin, C. (2005). Gene stacking in transgenic plants – the challenge for 21st century plant biotechnology. Plant Biotechnology Journal 3, 141–155.CrossRefGoogle ScholarPubMed
Herman, R. A. et al. (2013). Bringing policy relevance and scientific discipline to environmental risk assessment for genetically modified crops. Trends in Biotechnology 31, 493–496.CrossRefGoogle ScholarPubMed
James, C. (2012). Global Status of Commercialized Transgenic Crops. [Online]. Available from www.isaaa.org/resources/publications/briefs/44/executivesummary/default.aspGoogle Scholar
James, C. (2014). Global Status of Commercialized Transgenic Crops. [Online]. Available from www.isaaa.org/resources/publications/briefs/49/executivesummary/pdf/B49-ExecSum-English.pdfGoogle Scholar
Johnson, K. L. et al. (2007). How does scientific risk assessment of GM crops fit within the wider risk analysis? Trends in Plant Science 12, 1–5.CrossRefGoogle ScholarPubMed
Julié-Galau, S. et al. (2014). Evaluation of the potential for interspecific hybridization between Camelina sativa and related wild Brassicaceae in anticipation of field trials of GM camelina. Transgenic Research 23, 67–74.CrossRefGoogle ScholarPubMed
Naqvi, S. et al. (2009). When more is better: multigene engineering in plants. Trends in Plant Science 15, 48–56.CrossRefGoogle ScholarPubMed
Office of the Gene Technology Regulator (2005). Risk Analysis Framework 2005. [Online]. Available from www.ogtr.gov.au/internet/ogtr/publishing.nsf/content/raf-3/$FILE/raffinal2.2.pdfGoogle Scholar
Office of the Gene Technology Regulator (2013). Risk Analysis Framework 2013. [Online]. Available from www.ogtr.gov.au/internet/ogtr/publishing.nsf/content/raffinal5-tocGoogle Scholar
Que, Q. et al. (2010). Trait stacking in transgenic plants – challenges and opportunities. GM Crops 1(4), 220–229.CrossRefGoogle ScholarPubMed
Rajan, R. S. and Letourneau, D. K. (2012). What risk assessments of genetically modified organisms can learn from institutional analyses of public health risks. Journal of Biomedicine and Biotechnology 203093, 8 pages, doi:10.1155/2012/203093.CrossRefGoogle Scholar
Raybould, A. (2007). Ecological versus ecotoxicological methods for assessing the environmental risks of transgenic crops. Plant Science 173, 589–602.CrossRefGoogle Scholar
Stein, A. J. and Rodriguez-Cerezo, E. (2009). The global pipeline of new GM crops: implications of asynchronous approval for international trade. [Online]. Available from http://ipts.jrc.ec.europa.eu/publications/pub.cfm?id=2420Google Scholar
Tepfer, M. et al. (2013). Putting problem formulation at the forefront of GMO risk analysis. GM Crops & Food 4, 10–15.CrossRefGoogle ScholarPubMed
Tepfer, M. et al. (2015). A critical evaluation of whether recombination in virus-resistant transgenic plants will lead to the emergence of novel viral diseases. New Phytologist 207, 536–541.CrossRefGoogle Scholar
Tepfer, M. and García-Arenal, F. (2015). Does recombination in virus-resistant transgenic plants lead to emergence of novel viral diseases? ISB News Report, June.CrossRefGoogle Scholar
Wolt, J. D. et al. (2010). Problem formulation in the environmental risk assessment for genetically modified plants. Transgenic Research 19(3), 425–436.CrossRefGoogle ScholarPubMed
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