A critical assessment of regulatory triggers for products of biotechnology: Product vs. process

Alan McHughen
2016 GM crops & food  
Regulatory policies governing the safety of genetic engineering (rDNA) and the resulting products (GMOs) have been contentious and divisive, especially in agricultural applications of the technologies. These tensions led to vastly different approaches to safety regulation in different jurisdictions, even though the intent of regulations-to assure public and environmental safety-are common worldwide, and even though the international scientific communities agree on the basic principles of risk
more » ... sessment and risk management. So great are the political divisions that jurisdictions cannot even agree on the appropriate triggers for regulatory capture, whether product or process. This paper reviews the historical policy and scientific implications of agricultural biotechnology regulatory approaches taken by the European Union, USA and Canada, using their respective statutes and regulations, and then critically assesses the scientific underpinnings of each.
doi:10.1080/21645698.2016.1228516 pmid:27813691 pmcid:PMC5161003 fatcat:7qwwwudt2fd7jk7gqllhvwc5qy