Lawns and chestnut trees: game changers in u.s. plant biotechnology regulation?

1. Lawns and chestnut trees: game changers in u.s. plant biotechnology regulation? 25 June, 2012 Ari Novy, Rutgers University, New Brunswick, NJ, USA William Bolund, University of Saskatchewan, Saskatoon, Canada

2. Outline • Introduction • a brief history of GM regulation in the US • The problem • old legislation, new crops, new tech • Two examples • American chestnut, Kentucky bluegrass • Framing policy change in the US • The future?

3. Introduction • US biotech regulatory stance established in 1986 • Coordinated Framework for Regulation of Biotechnology Products (51 Fed. Reg. 23,303) • Rejected the idea that biotech requires new laws Images from Pew 2001

4. The problems • The current framework is controversial • And different from most other countries • Pre-existing legislation not designed for GM • PPA and FIFRA • Regulatory hurdles are expensive $ $$$$

5. American chestnut (Castaneadentata)

6. Cryphonectriaparasitica http://botit.botany.wisc.edu/toms_fungi/images/stroma.jpg http://coo.fieldofscience.com/2009/10/if-they-only-wood-taxon-of-week.html http://en.wikipedia.org/wiki/Chestnut_blight

7. The American Chestnut Foundation (TACF)

8. TACF and biotechnology Polin et al. 2006

9. Enter the EPA Federal Register, March 2011

10. Cisgenics “respect species barriers” (Schoten et al. 2006)

11. EPA and Chestnuts “I remember a meeting several years ago where we met some folks from EPA, and FDA as well as USDA, APHIS-BRS. I remember being mildly surprised and pleased: surprised that they had even heard of the chestnut project and pleased because they seemed to have a quite favorable mindset. Somebody had clearly been in contact with EPA and FDA and had done a very good job of explaining our project.” -Dr. Charles Maynard Co-Director, American Chestnut Research and Restoration ProjectSUNY College of Environmental Science and Forestry

12. Chestnut questions • Is EPA paying more attention to process? • Motivated by biotech with direct environmental benefits? • Would EPA exemption of cisgenics lead USDA and FDA to follow suit? • Would that open up breeding opportunities for a variety of crops? • Transgenics for ecological restoration? ?

13. Kentucky bluegrass (Poapratensis) US seed market value = approx. $70 million per year

14. Scotts MiracleGro Inc.

15. Scotts and GM turfgrass

16. Scotts seeks decision of non-regulation from USDA for Kentucky bluegrass • In September, 2010, Scotts informed USDA that it had developed a glyphosate tolerant Kentucky bluegrass • Scotts argued that this product should not be regulated because it didn’t trigger the PPA: • No plants or genes from pests or weedy species • Biolistics used for transformation (not Agrobacterium) • Presidence • Petunia hybrida, 2008 – New Zealand Crop and Food Ltd. • Intragenic except for E. coli nptII gene with petunia promoter • USDA agreed with Scotts – letter from July, 2011

17. Bluegrass question: Is USDA setting a precedent of non-regulation? • Plum null-segregants (NS) developed by ARS • October, 2011 • Tobacco NS developed by NC-State • October, 2011 • Meganucleases developed by Cellectis • December, 2011 • No regulation for targeted knockouts • Case by case for targeted mutagenesis by homologous recombination • Zinc finger nuclease (EXZACTTM) induced deletions • May 2010, March 2012 (case by case for insertions) • GM baby’s breath cut flowers produced outside the US by Danzinger Flower Farm • February, 2012 • Intragenic and cisgenic grapevines by U. of Florida • April, 2012 • Biolistic GM switchgrass with Sorghum, Arabidopsis and E. coli genes • April, 2012

18. Framing Policy Change in the US • US Political system fragmented • no central bureaucracy • role of government contested (Radin and Boase, 2000) • No true predictable policy process • Policy Window Theory of Policy Change (Kingdon, 1984) • Three independent streams must coincide for policy change to occur in US system • Problem Stream: problems from sudden events come to the attention of policy makers, or via feedback from existing programs • Policy Stream: Experts and analysts propose solutions • Political Stream: The national attention span must be able to focus on problem and solution • All streams must coincide, generally through the activates of policy entrepreneurs, who create “policy windows” by linking all three streams together • Windows open due to luck, fate, crisis, or election and budgetary cycles

19. Framing Policy Change in the U.S. • Issue Networks and Complexity (Helco, 1978) • Complex problems, American pluralism and the absence of centralized political authority lead to inaction • US characterized by inability to formulate and execute policies • Energy and immigration as examples • Too many actors and interest groups creates intense debate but no resolution • Prognosis • Policy and regulatory change unlikely without a “policy entrepreneur” from the public or private sectors, or in the absence of a crisis that attracts the required attention to facilitate change

20. The future? Are these game changers? • No • Large scale regulatory changes are unlikely • But some change… • USDA decisions of non-authority will continue • Erosion of product (vs. process) orientation at EPA? • More access for small value crops • non-edible • Expanding GM technology for non-commercial purposes • Ecological restoration

21. Acknowledgments My collaborator: William Bolund Useful conversations: Josh Honig Bill Meyer Charles Maynard Matt Koch