Hostname: page-component-f7d5f74f5-9ndps Total loading time: 0 Render date: 2023-10-05T03:58:18.841Z Has data issue: false Feature Flags: { "corePageComponentGetUserInfoFromSharedSession": true, "coreDisableEcommerce": false, "coreDisableSocialShare": false, "coreDisableEcommerceForArticlePurchase": false, "coreDisableEcommerceForBookPurchase": false, "coreDisableEcommerceForElementPurchase": false, "coreUseNewShare": true, "useRatesEcommerce": true } hasContentIssue false

Problem formulation and hypothesis testing for environmental risk assessments of genetically modified crops

Published online by Cambridge University Press:  17 March 2007

Alan Raybould*
Syngenta, Jealott's Hill International Research Centre, Bracknell, Berkshire RG42 6EY, UK


Core share and HTML view are not possible as this article does not have html content. However, as you have access to this content, a full PDF is available via the ‘Save PDF’ action button.

Environmental risk assessments can provide high confidence of minimal risk by testing theories, “risk hypotheses”, that predict the likelihood of unacceptable harmful events. The creation of risk hypotheses and a plan to test them is called problem formulation. Effective problem formulation seeks to maximize the possibility of detecting effects that indicate potential risk; if such effects are not detected, minimal risk is indicated with high confidence. Two important implications are that artificial test conditions can increase confidence, whereas prescriptive data requirements can reduce confidence (increase uncertainty) if they constrain problem formulation. Poor problem formulation can increase environmental risk because it leads to the collection of superfluous data that may delay or prevent the introduction of environmentally beneficial products.

Research Article
© ISBR, EDP Sciences, 2007


Cross, FB (1996) Paradoxical perils of the precautionary principle. Wash. L. Law Rev. 53: 851925
Estruch, JJ, Warren, GW, Mullins, MA, Nye, GJ, Craig, JA, Koziel, MG (1996) Vip3A, a novel Bacillus thuringiensis vegetative insecticidal protein with a wide spectrum of activities against lepidopteran insects. Proc. Natl. Acad. Sci. 93: 53895394 CrossRef
European and Mediterranean Plant Protection Organization (2003) Environmental risk assessment scheme for plant protection products. EPPO Bull. 33: 133-114
Garcia-Alonso, M, Jacobs, E, Raybould, A, Nickson, TE, Sowig, P, Willekens, H, van der Kouwe, P, Layton, R, Amijee, F, Fuentes, AM, Tencalla, F (2006) A tiered system for assessing the risk of genetically modified plants to non-target organisms. Environ. Biosafety Res. 5: 57-65 CrossRef
Giles, J (2003) Biosafety trials darken outlook for transgenic crops in Europe. Nature 425: 751
Gray, AJ (2004) Ecology and government policies: the GM crop debate. J. Appl. Ecol. 41: 1-10 CrossRef
Green, RE, Cornell, SJ, Scharlemann, JPW, Balmford, A (2005) Farming and the fate of wild nature. Science 307: 550-555 CrossRef
Groot, AT, Dicke, M (2001) Insect-resistant transgenic plants in a multi-trophic context. Plant J. 31: 387-406 CrossRef
Hill, RA, Sendashonga, C (2003) General principles for risk assessment of living modified organisms: Lessons from chemical risk assessment. Environ. Biosafety Res. 2: 81-88 CrossRef
James, C (2003) Global review of commercialized transgenic crops. Curr. Sci. 84: 303-309
Johnson, KL, Raybould, AF, Hudson, MD, Poppy, GM (2007) How does scientific risk assessment of GM crops fit within the wider risk analysis? Trends Plant Sci. 12: 1-5 CrossRef
Kuiper, HA, Kleter, GA, Noteborn, HP, Kok, EJ (2002) Substantial equivalence – an appropriate paradigm for the safety assessment of genetically modified foods? Toxicology 181-182: 427-431 CrossRef
Magee B (1985) Popper. Fontana Press, London
Mendelsohn, M, Kough, J, Vaituzis, Z, Matthews, K (2003) Are Bt crops safe? Nature Biotech. 21: 1003-1009 CrossRef
Miller HI, Conko G (2004) The Frankenfood Myth. Praeger, Westport, CT
Naranjo, SE, Head, G, Dively, GP (2005) Field studies assessing arthropod nontarget effects in Bt transgenic crops: introduction. Environ. Entomol. 34: 1178-1180 CrossRef
Okubara, PA, Blechl, AE, McCormick, SP, Alexander, NJ, Dill-Macky, R, Hohn, TM (2002) Engineering deoxynivalenol metabolism in wheat through the expression of a fungal trichothecene acetyltransferase gene. Theor. Appl. Genet. 106: 74-83 CrossRef
Patton, DE (1998) Environmental risk assessment: tasks and obligations. Hum. Ecol. Risk Assess. 4: 657-670 CrossRef
Peters RH (1991) A Critique for Ecology. Cambridge University Press, Cambridge
Popper KR (1959) The Logic of Scientific Discovery. Hutchinson, London
Power, M, Adams, SM (1997) Perspectives of the scientific community on the status of ecological risk assessment. Environ. Manag. 21: 803-830 CrossRef
Raybould, AF (2004) A decade of gene flow research: improved risk assessments or missed opportunities? Aspect Appl. Biol. 74: 27-33
Raybould, AF, Cooper, JI (2005) Tiered tests to assess the environmental risk of fitness changes in hybrids between transgenic crops and wild relatives: the example of virus resistant Brassica napus. Environ. Biosafety Res. 4: 125-140 CrossRef
Raybould AF, Wilkinson MJ (2005) Assessing the environmental risks of gene flow from genetically modified crops to wild relatives. In Poppy GM, Wilkinson MJ, eds, Gene Flow from GM Plants. Blackwell Publishing, Oxford, pp 169-185
Romeis, J, Meissle, M, Bigler, F (2006) Transgenic crops expressing Bacillus thuringiensis toxins and biological control. Nature Biotech. 24: 63-71 CrossRef
Schnepf, E, Crickmore, N, Van Rie, J, Lereclus, D, Baum, J, Feitelson, J, Ziegler, DR, Dean, DH (1998) Bacillus thuringiensis and its pesticidal crystal proteins. Microbiol. Mol. Biol. Rev. 62: 775806
Sears MK, Hellmich RL, Stanley-Horn DE, Oberhauser, KS, Pleasants JM, Mattila HR, Siegfried BD, Dively GP (2001) Impact of Bt corn pollen on monarch butterfly populations: a risk assessment. Proc. Natl. Acad. Sci. USA 98: 11937-11942
Squire GR, Brooks DR, Bohan DA, Champion GT, Daniels RE, Haughton AJ, Hawes C, Heard MS, Hill MO, May MJ, Osborne JL, Perry JN, Roy DB, Woiwood IP, Firbank LG (2003) On the rationale and interpretation of the Farm Scale Evaluations of genetically modified herbicide-tolerant crops. Phil. Trans. R. Soc. Lond B 358: 1779-1799
Stern PC, Fineberg HV, eds (1996) Understanding Risk: Informing Decisions in a Democratic Society. National Academy Press, Washington, DC
Suter, GW (1990) Endpoints for regional ecological risk assessments. Environ. Manage. 14: 9-23 CrossRef
Touart, LW, Maciorowski, AF (1997) Information needs for pesticide registration in the United States. Ecol. Appl. 7: 1086-1093 CrossRef
US Environmental Protection Agency (1998) Guidelines for ecological risk assessment. Fed. Regist. 63: 26846-26924
US Environmental Protection Agency (2001) Regulations under the Federal Insecticide, Fungicide and Rodenticide Act for Plant-Incorporated Protectants (formerly Plant-Pesticides) Fed. Regist. 66: 37772-37817
Wolt, JD, Peterson, RKD (2000) Agricultural biotechnology and societal decision-making: the role of risk analysis. AbBioForum 3: 39-46
Wu, F, Miller, DJ, Casman, EA (2004) The economic impact of Bt corn resulting from mycotoxins reduction. J. Toxicol. Toxin Rev. 23: 397-424 CrossRef