Affiliations 

  • 1 Industry Affairs and Regulatory, DuPont Pioneer , Johnston, IA , USA
  • 2 Advisor in Regulation, Science and Government (Formerly affiliated with the Office of the Gene Technology Regulator) , Canberra, ACT , Australia
  • 3 Plant and Biotechnology Risk Assessment Unit, Canadian Food Inspection Agency , Ottawa, ON , Canada
  • 4 Department of Biosafety, Ministry of Natural Resources and Environment , Putrajaya , Malaysia
  • 5 Office of the Gene Technology Regulator , Canberra, ACT , Australia
  • 6 Ministry of Agriculture, Livestock and Fisheries of Argentina , Buenos Aires , Argentina
PMID: 26301217 DOI: 10.3389/fbioe.2015.00110

Abstract

Risk assessment is a reasoned, structured approach to address uncertainty based on scientific and technical evidence. It forms the foundation for regulatory decision-making, which is bound by legislative and policy requirements, as well as the need for making timely decisions using available resources. In order to be most useful, environmental risk assessments (ERAs) for genetically modified (GM) crops should provide consistent, reliable, and transparent results across all types of GM crops, traits, and environments. The assessments must also separate essential information from scientific or agronomic data of marginal relevance or value for evaluating risk and complete the assessment in a timely fashion. Challenges in conducting ERAs differ across regulatory systems - examples are presented from Canada, Malaysia, and Argentina. One challenge faced across the globe is the conduct of risk assessments with limited resources. This challenge can be overcome by clarifying risk concepts, placing greater emphasis on data critical to assess environmental risk (for example, phenotypic and plant performance data rather than molecular data), and adapting advances in risk analysis from other relevant disciplines.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.