Problem formulation in the environmental risk assessment for genetically modified plantsAbstractIntroductionProblem formulation frameworkProblem contextProblem definitionExposureReasonable risksDeveloping the problem formulationAssessment endpointsRisk hypothesesThe nature of the plant being modifiedDefining and identifying differences that may plausibly lead to harmLikely environmental interactionsDefining exposure in the PFConceptual modelAnalysis planTiered analysisMeasurement endpointsRisk formulationUncertaintySummary and recommendationsAcknowledgmentsReferencesORIGINAL PAPERProblem formulation in the environmental risk assessmentfor genetically modified plantsJeffrey D. Wolt Æ Paul Keese Æ Alan Raybould ÆJulie W. Fitzpatrick Æ Moise´s Burachik Æ Alan Gray ÆStephen S. Olin Æ Joachim Schiemann Æ Mark Sears ÆFelicia WuReceived: 3 March 2009 / Accepted: 28 August 2009 / Published online: 15 September 2009Ó The Author(s) 2009. This article is published with open access at Springerlink.comAbstract Problem formulation is the first step inenvironmental risk assessment (ERA) where policygoals, scope, assessment endpoints, and methodologyare distilled to an explicitly stated problem andapproach for analysis. The consistency and utility ofERAs for genetically modified (GM) plants can beimproved through rigorous problem formulation (PF),producing an analysis plan that describes relevantexposure scenarios and the potential consequences ofthese scenarios. A properly executed PF assures therelevance of ERA outcomes for decision-making.Adopting a harmonized approach to problemA Report from the ILSI Research Foundation ExpertConsultation on Problem Formulation for ERA of GM Plants.J. D. WoltBiosafety Institute for Genetically Modified AgriculturalProducts, Iowa State University, Ames, IA, USAe-mail: [email protected]. KeeseDepartment of Health and Ageing, BiotechnologyRegulatory Services, Office of Gene TechnologyRegulator, Canberra, ACT, Australiae-mail: [email protected]. RaybouldSyngenta, Berkshire, UKe-mail: [email protected]. W. Fitzpatrick (&)  S. S. OlinILSI Research Foundation, 1156 15th Street,NW, Washington, DC 20005, USAe-mail: [email protected]. S. Oline-mail: [email protected]. BurachikOficina de Biotecnologı´a, Secretarı´a de Agricultura,Buenos Aires, Argentinae-mail: [email protected]. GrayCentre for Ecology & Hydrology, Dorset, UKe-mail: [email protected]. SchiemannJulius Kuehn Institute, Federal Research Centre forCultivated Plants, Quedlinburg, Germanye-mail: [email protected]. SearsDepartment of Environmental Biology,University of Guelph, Ontario, Canadae-mail: [email protected]. WuDepartment of Environmental & Occupational Health,University of Pittsburgh, Pittsburgh, PA, USAe-mail: [email protected] Res (2010) 19:425–436DOI 10.1007/s11248-009-9321-9formulation should bring about greater uniformity in theERA process for GM plants among regulatory regimesglobally. This paper is the product of an internationalexpert group convened by the International LifeSciences Institute (ILSI) Research Foundation.Keywords Ecological risk assessment GMO  Genetically engineered  Hazard identificationIntroductionRisk assessment is widely used in decision-makingconcerning the release of genetically modified (GM)plants into the environment (EFSA 2006). Theprocess of integrating the likelihood and conse-quences of exposure, in terms of harm, forms thebasis of environmental risk assessment (ERA). As thefirst step in ERA, the problem formulation (PF)establishes the parameters that are of greatestrelevance to the assessment.A variety of national, regional, and internationalapproaches to ERA of GM plants are emerging (Hill2005), and these contain differing legislative triggers,terminology, and guidance regarding how the assess-ments are to be performed. The apparent differencesamong various assessment protocols obscure theirsimilar underlying principles of case-by-case compar-ative risk assessment. Clarifying these underlyingprinciples can lead to clearer assessments and improvedcommunication among interested and affected parties.Recognizing common principles for PF will encourageharmonized approaches for risk assessment and mayhelp less developed countries to formulate effective andrelevant biosafety regulations for GM plants.This paper proposes a common PF framework forenvironmental risk assessment of GM plants (Fig. 1).The framework does the following: (i) it provides acommon language for the evaluation and communica-tion of similarities and differences among variousassessment regimens (see box—Glossary of Terms);(ii) it affords the necessary flexibility for furtherevolution and improvement of assessments and theirharmonization; (iii) it offers a template for environ-mental assessment that may be applied in emergingnational or regional regulatory guidance; and (iv) italigns with the principles outlined in internationalconventions such as the Cartagena Protocol onBiosafety (http://www.cbd.int/biosafety/protocol.shtml)and the phytosanitary standards of the InternationalPlant Protection Convention (IPPC 2001). The ERAparadigm described by the US Environmental Pro-tection Agency (EPA) (USEPA 1992, 1998) has beenused by the authors as a conceptual and proceduralbasis for a common framework and terminology thatcan be applied to ERAs for GM plants.An inadequate PF may compromise the entire ERAand add to the level of uncertainty in subsequentdecision-making. Frequent outcomes of this type offailure are continuing requests for more data, dispro-portionate risk mitigation measures and miscommuni-cation of risk findings; this results in increased concernsabout the environmental impact (Johnson et al. 2007;Raybould 2006) and leads to delayed decision-making.Some authors contend that such delays may lead toincreased negative environmental impacts because ofthe consequent delays in the introduction of environ-mentally beneficial products (Raybould 2006, 2007).Additionally, an ERA with a poorly developed PF mayhave inadequately specified or inappropriate expres-sions of the environmental value to be protected(benefits including processes by which the environmentproduces resources), or insufficient clarity regarding thepurpose and use of the data being collected. This reportpresents a framework for constructing PFs that can beapplied to ERAs for GM plants.Problem formulation frameworkThe first step in ERA is problem