Abstract
In many countries there are increasing calls for the benefits of genetically modified organisms (GMOs) to be considered as well as the risks, and for a risk-benefit analysis to form an integral part of GMO regulatory frameworks. This trend represents a shift away from the strict emphasis on risks, which is encapsulated in the Precautionary Principle that forms the basis for the Cartagena Protocol on Biosafety, and which is reflected in the national legislation of many countries. The introduction of risk-benefit analysis of GMOs would be facilitated if clear methodologies were available to support the analysis. Up to now, methodologies for risk-benefit analysis that would be applicable to the introduction of GMOs have not been well defined. This paper describes a relatively simple semi-quantitative methodology that could be easily applied as a decision support tool, giving particular consideration to the needs of regulators in developing countries where there are limited resources and experience. The application of the methodology is demonstrated using the release of an insect resistant maize variety in South Africa as a case study. The applicability of the method in the South African regulatory system is also discussed, as an example of what might be involved in introducing changes into an existing regulatory process.
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Notes
In this paper, the following definitions have been applied:
Hazard The potential of an organism to cause harm
Harm The magnitude of the consequences of a negative effect, if it should occur
Risk The combination of the magnitude of the consequences of a hazard, if it occurs (i.e. harm), and the likelihood that the consequences will occur
Positive effect The potential of an organism to cause beneficial effects or reduce adverse effects, i.e. the opposite of hazard
Potential benefit The magnitude of the consequences of a positive effect, if it should occur, i.e. the opposite of harm
Benefit The combination of the magnitude of the consequences of a positive effect, if it occurs (i.e. potential benefit), and the likelihood that the consequences will occur, i.e. the opposite of risk.
Bt11 information available from http://www.cera-gmc.org/?action=gm_crop_database&.
Abbreviations
- GMO:
-
Genetically modified organism.
- CPB:
-
Cartagena protocol on biosafety
- UNCED:
-
United Nations conference on environment and development
- PP:
-
Precautionary principle
- Bt:
-
Bacillus thuringiensis
- EFSA:
-
European food science authority
- RIAM:
-
Rapid impact assessment matrix
- EIA:
-
Environmental impact assessment
- SEA:
-
Strategic environmental assessment
- RBS:
-
Risk-benefit score
- AS:
-
Agriculture score
- FS:
-
Food score
- ES:
-
Environment score
- HS:
-
Health score
- SS:
-
Socio-economic score
- P:
-
Probability or likelihood
- NEMBA:
-
National environmental management biodiversity act
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Acknowledgments
I wish to thank the following for their valuable comments and inputs into this paper: Dr E. Barros, Ms W. Janssen van Rijssen, Ms G. Christians, Ms C. Arendse, Ms W. Mandivenyi, Dr R. Westfall, Ms M. Koch. Ms M. Koch contributed the analysis of Ventria rice. I also wish to thank the reviewers of the original manuscript for their insightful contributions.
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The African Centre for Gene Technologies is a joint initiative of the Council for Scientific and Industrial Research (CSIR), University of Pretoria and University of the Witwatersrand, Johannesburg.
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Morris, E.J. A semi-quantitative approach to GMO risk-benefit analysis. Transgenic Res 20, 1055–1071 (2011). https://doi.org/10.1007/s11248-010-9480-8
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DOI: https://doi.org/10.1007/s11248-010-9480-8