Global regulatory burden for field testing of genetically modified trees

Abstract

Field trials are widely known to be essential for understanding the value and adaptability of trees produced via conventional and transgenic biotechnologies. However, obtaining permission for transgenic field trials is often considered to be very difficult in many countries. To understand the extent of regulatory requirements around the world and the burdens they impose, we surveyed 36 scientists and practitioners from 20 different countries who had experience or direct knowledge of regulatory compliance with field trials of transgenic trees. Results showed that permits and monitoring were universally required, and that public disclosure of field trial locations was required in three quarters of countries. Other major findings were that: separate approvals for different constructs, tree species, and trial locations were required in more than three quarters of the countries; characterization of each transgene insertion event was required as part of the application in four fifths of countries; and the application process itself was perceived as the largest single burden. Regulatory tiers that differentiate different kinds of transgenic trees based on perceived risk were present in only one fifth of countries. The data confirm the widespread perception among scientists that the costs and burdens of conducting field trials with transgenic trees are nearly universal substantial impediments to scientific and breeding progress.