Limits...
Problem formulation in the environmental risk assessment for genetically modified plants.

Wolt JD, Keese P, Raybould A, Fitzpatrick JW, Burachik M, Gray A, Olin SS, Schiemann J, Sears M, Wu F - Transgenic Res. (2009)

Bottom Line: A properly executed PF assures the relevance of ERA outcomes for decision-making.Adopting a harmonized approach to problem formulation should bring about greater uniformity in the ERA process for GM plants among regulatory regimes globally.This paper is the product of an international expert group convened by the International Life Sciences Institute (ILSI) Research Foundation.

View Article: PubMed Central - PubMed

Affiliation: Biosafety Institute for Genetically Modified Agricultural Products, Iowa State University, Ames, IA, USA. jdwolt@iastate.edu

ABSTRACT
Problem formulation is the first step in environmental risk assessment (ERA) where policy goals, scope, assessment endpoints, and methodology are distilled to an explicitly stated problem and approach for analysis. The consistency and utility of ERAs for genetically modified (GM) plants can be improved through rigorous problem formulation (PF), producing an analysis plan that describes relevant exposure scenarios and the potential consequences of these scenarios. A properly executed PF assures the relevance of ERA outcomes for decision-making. Adopting a harmonized approach to problem formulation should bring about greater uniformity in the ERA process for GM plants among regulatory regimes globally. This paper is the product of an international expert group convened by the International Life Sciences Institute (ILSI) Research Foundation.

Show MeSH

Related in: MedlinePlus

Problem formulation within the paradigm for environmental risk assessment (ERA). The problem context develops the parameters and identifies constraints for the ERA, which may arise from legal statutes and institutional guidelines. Problem definition shapes the ERA into a manageable form for analysis through consideration of the case-specific attributes of the GM crop being assessed, identification of logically relevant concerns, and description of cause-effect relationships
© Copyright Policy
Related In: Results  -  Collection


getmorefigures.php?uid=PMC2865628&req=5

Fig1: Problem formulation within the paradigm for environmental risk assessment (ERA). The problem context develops the parameters and identifies constraints for the ERA, which may arise from legal statutes and institutional guidelines. Problem definition shapes the ERA into a manageable form for analysis through consideration of the case-specific attributes of the GM crop being assessed, identification of logically relevant concerns, and description of cause-effect relationships

Mentions: This paper proposes a common PF framework for environmental risk assessment of GM plants (Fig. 1). The framework does the following: (i) it provides a common language for the evaluation and communication of similarities and differences among various assessment regimens (see box—Glossary of Terms); (ii) it affords the necessary flexibility for further evolution and improvement of assessments and their harmonization; (iii) it offers a template for environmental assessment that may be applied in emerging national or regional regulatory guidance; and (iv) it aligns with the principles outlined in international conventions such as the Cartagena Protocol on Biosafety (http://www.cbd.int/biosafety/protocol.shtml) and the phytosanitary standards of the International Plant Protection Convention (IPPC 2001). The ERA paradigm described by the US Environmental Protection Agency (EPA) (USEPA 1992, 1998) has been used by the authors as a conceptual and procedural basis for a common framework and terminology that can be applied to ERAs for GM plants.Fig. 1


Problem formulation in the environmental risk assessment for genetically modified plants.

Wolt JD, Keese P, Raybould A, Fitzpatrick JW, Burachik M, Gray A, Olin SS, Schiemann J, Sears M, Wu F - Transgenic Res. (2009)

Problem formulation within the paradigm for environmental risk assessment (ERA). The problem context develops the parameters and identifies constraints for the ERA, which may arise from legal statutes and institutional guidelines. Problem definition shapes the ERA into a manageable form for analysis through consideration of the case-specific attributes of the GM crop being assessed, identification of logically relevant concerns, and description of cause-effect relationships
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC2865628&req=5

Fig1: Problem formulation within the paradigm for environmental risk assessment (ERA). The problem context develops the parameters and identifies constraints for the ERA, which may arise from legal statutes and institutional guidelines. Problem definition shapes the ERA into a manageable form for analysis through consideration of the case-specific attributes of the GM crop being assessed, identification of logically relevant concerns, and description of cause-effect relationships
Mentions: This paper proposes a common PF framework for environmental risk assessment of GM plants (Fig. 1). The framework does the following: (i) it provides a common language for the evaluation and communication of similarities and differences among various assessment regimens (see box—Glossary of Terms); (ii) it affords the necessary flexibility for further evolution and improvement of assessments and their harmonization; (iii) it offers a template for environmental assessment that may be applied in emerging national or regional regulatory guidance; and (iv) it aligns with the principles outlined in international conventions such as the Cartagena Protocol on Biosafety (http://www.cbd.int/biosafety/protocol.shtml) and the phytosanitary standards of the International Plant Protection Convention (IPPC 2001). The ERA paradigm described by the US Environmental Protection Agency (EPA) (USEPA 1992, 1998) has been used by the authors as a conceptual and procedural basis for a common framework and terminology that can be applied to ERAs for GM plants.Fig. 1

Bottom Line: A properly executed PF assures the relevance of ERA outcomes for decision-making.Adopting a harmonized approach to problem formulation should bring about greater uniformity in the ERA process for GM plants among regulatory regimes globally.This paper is the product of an international expert group convened by the International Life Sciences Institute (ILSI) Research Foundation.

View Article: PubMed Central - PubMed

Affiliation: Biosafety Institute for Genetically Modified Agricultural Products, Iowa State University, Ames, IA, USA. jdwolt@iastate.edu

ABSTRACT
Problem formulation is the first step in environmental risk assessment (ERA) where policy goals, scope, assessment endpoints, and methodology are distilled to an explicitly stated problem and approach for analysis. The consistency and utility of ERAs for genetically modified (GM) plants can be improved through rigorous problem formulation (PF), producing an analysis plan that describes relevant exposure scenarios and the potential consequences of these scenarios. A properly executed PF assures the relevance of ERA outcomes for decision-making. Adopting a harmonized approach to problem formulation should bring about greater uniformity in the ERA process for GM plants among regulatory regimes globally. This paper is the product of an international expert group convened by the International Life Sciences Institute (ILSI) Research Foundation.

Show MeSH
Related in: MedlinePlus