PowerPoint Presentation

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

OutlineIntroductiona brief history of GM regulation in the USThe problemold legislation, new crops, new techTwo examplesAmerican chestnut, Kentucky bluegrassFraming policy change in the USThe future?

IntroductionUS biotech regulatory stance established in 1986Coordinated Framework for Regulation of Biotechnology Products (51 Fed. Reg. 23,303)Rejected the idea that biotech requires new laws

Images from Pew 2001The problemsThe current framework is controversialAnd different from most other countriesPre-existing legislation not designed for GMPPA and FIFRARegulatory hurdles are expensive

$$$$$American chestnut (Castanea dentata)

Cryphonectria parasitica

http://botit.botany.wisc.edu/toms_fungi/images/stroma.jpg

http://en.wikipedia.org/wiki/Chestnut_blight

http://coo.fieldofscience.com/2009/10/if-they-only-wood-taxon-of-week.html Cause of Chestnut Blight which has altered the eastern United States forests forever. Fungus grows into wounds, kills the cambium of twigs, stem. First report 1904 in New York City, by 1926 it covered the entire range of the chestnut. In 1912 the Plant Quarantine Act was passed.

Destruction of native Dogwood populations in the USA. Introduction in 1970s to Connecticut. Leaf blotching leads to stem cankers and tree death in 1-3 years. Asexual spore dispersal by rain and birds.The American Chestnut Foundation (TACF)

TACF and biotechnology

Polin et al. 2006Enter the EPA

Federal Register, March 2011Cisgenics

respect species barriers (Schoten et al. 2006)EPA and ChestnutsI 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 andRestoration ProjectSUNY College of EnvironmentalScience andForestry

Chestnut questionsIs 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?

?Kentucky bluegrass (Poa pratensis)

US seed market value = approx. $70 million per yearScotts MiracleGro Inc.

Scotts and GM turfgrass

Scotts seeks decision of non-regulation from USDA for Kentucky bluegrassIn September, 2010, Scotts informed USDA that it had developed a glyphosate tolerant Kentucky bluegrassScotts argued that this product should not be regulated because it didnt trigger the PPA:No plants or genes from pests or weedy speciesBiolistics used for transformation (not Agrobacterium)Presidence Petunia hybrida, 2008 New Zealand Crop and Food Ltd.Intragenic except for E. coli nptII gene with petunia promoterUSDA agreed with Scotts letter from July, 2011Bluegrass question: Is USDA setting a precedent of non-regulation?Plum null-segregants (NS) developed by ARSOctober, 2011Tobacco NS developed by NC-StateOctober, 2011Meganucleases developed by CellectisDecember, 2011No regulation for targeted knockoutsCase by case for targeted mutagenesis by homologous recombinationZinc finger nuclease (EXZACTTM) induced deletionsMay 2010, March 2012 (case by case for insertions)GM babys breath cut flowers produced outside the US by Danzinger Flower FarmFebruary, 2012Intragenic and cisgenic grapevines by U. of FloridaApril, 2012Biolistic GM switchgrass with Sorghum, Arabidopsis and E. coli genesApril, 2012

Framing Policy Change in the USUS Political system fragmented no central bureaucracyrole of government contested (Radin and Boase, 2000)No true predictable policy processPolicy Window Theory of Policy Change (Kingdon, 1984)Three independent streams must coincide for policy change to occur in US systemProblem Stream: problems from sudden events come to the attention of policy makers, or via feedback from existing programsPolicy Stream: Experts and analysts propose solutionsPolitical Stream: The national attention span must be able to focus on problem and solutionAll streams must coincide, generally through the activates of policy entrepreneurs, who create policy windows by linking all three streams togetherWindows open due to luck, fate, crisis, or election and budgetary cycles

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 inactionUS characterized by inability to formulate and execute policiesEnergy and immigration as examplesToo many actors and interest groups creates intense debate but no resolutionPrognosisPolicy 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

The future? Are these game changers?No Large scale regulatory changes are unlikelyBut some changeUSDA decisions of non-authority will continueErosion of product (vs. process) orientation at EPA?More access for small value cropsnon-edibleExpanding GM technology for non-commercial purposesEcological restoration

AcknowledgmentsMy collaborator: William Bolund

Useful conversations:Josh HonigBill MeyerCharles MaynardMatt Koch

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