Article: The current status of the debate on socio-economic regulatory assessments: positions and policies in Canada, the USA, the EU and developing countries Journal: World Review of Science, Technology and Sustainable Development (WRSTSD) 2013 Vol.10 No.4 pp.203 - 227 Abstract: Article 26.1 of the Cartagena Protocol on Biosafety has the option of considering socio-economic issues in biosafety regulatory approval processes related to genetically engineered organisms. National laws and regulations in some countries have already defined positions and may have enacted policies dealing with socio-economic assessments. Many more countries, especially developing countries, are building their biosafety regulatory systems. This paper considers issues related to socio-economic assessments inclusion in biosafety processes by describing the current status and issues in Canada, USA, EU and selected developing countries. There is broad variation amongst examined countries in terms of inclusion modalities and guidance for assessment implementation. The need exists to define scope and if assessments are strictly socio-economic or expanded to include broader considerations such as ethical, religious, or cultural issues. Countries need to define clearly decision making rules and standards by which to render decisions as unclear procedures can lead to negative outcomes. Inderscience Publishers - linking academia, business and industry through research

Title: The current status of the debate on socio-economic regulatory assessments: positions and policies in Canada, the USA, the EU and developing countries

Authors: José Falck-Zepeda; Justus Wesseler; Stuart J. Smyth

Addresses: International Food Policy Research Institute (IFPRI), 2033 K Street NW, Washington, DC 20006-1002, USA ' Technische Universität München, Weihenstephaner Steig 225354 Freising, Bavaria, Germany ' Department of Bioresource Policy, University of Saskatchewan, 51 Campus Drive, Saskatoon, Saskatchewan, Canada

Abstract: Article 26.1 of the Cartagena Protocol on Biosafety has the option of considering socio-economic issues in biosafety regulatory approval processes related to genetically engineered organisms. National laws and regulations in some countries have already defined positions and may have enacted policies dealing with socio-economic assessments. Many more countries, especially developing countries, are building their biosafety regulatory systems. This paper considers issues related to socio-economic assessments inclusion in biosafety processes by describing the current status and issues in Canada, USA, EU and selected developing countries. There is broad variation amongst examined countries in terms of inclusion modalities and guidance for assessment implementation. The need exists to define scope and if assessments are strictly socio-economic or expanded to include broader considerations such as ethical, religious, or cultural issues. Countries need to define clearly decision making rules and standards by which to render decisions as unclear procedures can lead to negative outcomes.

Keywords: socio-economic assessment; biosafety regulatory approval; developing countries; regulation; regulatory assessments; Canada; USA; United States; EU; European Union; genetic engineering.

DOI: 10.1504/WRSTSD.2013.057690

World Review of Science, Technology and Sustainable Development, 2013 Vol.10 No.4, pp.203 - 227

Accepted: 17 May 2013
Published online: 28 Feb 2014 *

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Title: The current status of the debate on socio-economic regulatory assessments: positions and policies in Canada, the USA, the EU and developing countries

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