Improving oversight of genetically engineered organisms

Abstract

Genetic engineering (GE) has been used to produce plants with desirable qualities for over two decades, and widespread, world-wide market adoption of engineered crops with pest and disease resistance characteristics has occurred. Genetically engineered organisms (GEOs), including GE crops, have been formally overseen by the U.S. government since the mid-1980s. In this article, our previous work on identifying strengths and weaknesses of the U.S. GEO oversight system is reviewed, and a new analysis of the system based on expert and stakeholder interviews is presented. Using both analyses and an examination of historical controversies surrounding GEOs, three categories of improvements to oversight are identified: democratization of oversight processes, establishing clear mechanisms for inter-agency and -organization coordination, and taking on uncertainty through upstream and fluid approaches. The paper also discusses feasibility issues and barriers associated with implementing changes in these areas, notably the overarching U.S. approach to regulation and legal authorities.

Keywords:

• Technology
• Oversight
• Policy
• Biotechnology

Acknowledgements

This work was supported in part by National Science Foundation NIRT Grant SES-0608791 (Wolf, PI; Kokkoli, Kuzma, Paradise, Ramachandran, Co-PIs). Any opinions, findings, and conclusions or recommendations expressed in this article are those of the authors and do not necessarily reflect the views of the National Science Foundation. The University of Minnesota's IRB determined that this study is exempt from review, under 45 C.F.R. Part 46.101(b) category #2. The authors would like to thank the working group participants (note this group is not the same as the expert-stakeholder group surveyed in this study, whose identities remain anonymous): Dan Burk; Steve Ekker; Susan Foote; Ralph Hall; Robert Hoerr, Susanna Priest; Terrance Hurley; Robbin Johnson; Bradley Karkkainen; George Kimbrell; Andrew Maynard; Kristen Nelson; David Norris; David Y.H. Pui; T. Andrew Taton; and Elizabeth J. Wilson; and collaborators Efrosini Kokkoli, Jordan Paradise, Susan M. Wolf, Gurumurthy Ramachandran; Alison W. Tisdale; Rishi Gupta; Gail Maddey Diliberto; Jae Young Choi; and Ralph Hall for their valuable input on the project. Project advisors also contributed to refinement of project methodology including Dave Chittenden; Judy Crane; Michael Gorman, Linda Hogle; William D. Kay; and Maria Powell. The authors would like to thank Audrey Boyle for her project management, Adam Kokotovich, Joel Larson, and Pouya Najmaie for their early work on the expert surveys and elicitation.

Notes

1 Note, we consider all experts to be stakeholders in one way or another. We use the term stakeholder to denote that we sought experts from various stakeholder groups such as academic researchers, consumer organizations, government agencies, and companies involved in producing or using GEOs. Thus, we use both terms to describe our group.

2 Members of the group represent the following affiliations, disciplines, and expertise areas: academic, ecology, GEOs risk assessment; academic, molecular genetics, GEOs risk assessment; academic, sociology, agriculture and development; academic, sociology, public participation; academic, sociology and communications, public perception; government, genetics and forestry, GEOs regulation; industry (consulting), law, GEOs regulation; industry, business, food industry and trade; industry, law, regulatory affairs; NGO, law and biology, biotechnology policy; and NGO (previous government), public policy, agricultural regulatory policy.

3 Coders are the three co-authors.

4 In the case of voluntary components of oversight, non-government institutions may take the lead such as with product stewardship, compliance efforts, education, etc.