A Regulatory amp Public Policy Perspective for GenomeEdited Crops Jeff Wolt Iowa State University IowaBIO Innovation Advancement Workshop November 2017 httpcropbioengineeringiastateedu ID: 662107
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http://cropbioengineering.iastate.edu/
A Regulatory & Public Policy Perspective for Genome-Edited CropsJeff WoltIowa State UniversityIowaBIO Innovation Advancement WorkshopNovember 2017
http://cropbioengineering.iastate.edu
/
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Genome editing has rapidly emerged as a leading technology for crop improvement.1999, initial proofs of concept
2004, first regulatory inquiries2013, plant applications of CRISPR/Cas9multiple crop applications to date – barley, canola, camelina, lettuce, maize, mushroom, poplar, rice, sorghum, tobacco, tomato, wheat, sugarcane, citrus …The ability to precisely edit plant genomes affords significant opportunities for both discovery of gene function and for the identification and development of useful crop traits.Slide3
Genome-edited plants
gene discovery, function, phenotypetraits for plant breedingbiosafety regulation & governance issuespermits for field research & transfers of viable plant materialWill regulation impact research & development?Slide4
http://cropbioengineering.iastate.edu/
Dr. Bing Yang and his team
“
Based
on the information cited in your letter, APHIS has determined that the five rice lines were developed using plant pests and genetic material from plant pests. However, the final rice plants do not contain any inserted genetic materials and APHIS has no reason to believe that the plants of these rice lines are plant pests. Therefore, consistent with previous responses to similar letters of inquiry,
APHIS does not consider the five rice lines as described in your February 17, 2014 letter to be regulated under 7 CFR part 360
, and APHIS has no reason to believe that the genetic engineering of your GE rice would increase the
weediness
of rice
.
”
– Dr. Michael
Firko
(APHIS Deputy Admin), May 22, 2015
Disease Resistant RiceSlide5
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DuPont Pioneer high quality waxy cornU Penn browning resistant white button mushroomNature (April 21, 2016)
Business Insider (April 20,
2016)Slide6
http://cropbioengineering.iastate.edu/
Good news for biotechnology…Slide7
http://cropbioengineering.iastate.edu/
Good news for biotechnology…or reason for public concern?Slide8
Public confusion & genome-edited cropsIsn’t it just another GMO?Genome editing foodsIssues in human genome editing = issues in crop genome editingRegulators have not considered the safety of these cropsSlide9
Public confusion & genome-edited cropsIsn’t it just another GMO?Genome editing foodsIssues in human genome editing = issues in crop genome editingRegulators have not considered the safety of these crops
Addressing the confusion … its complicatedSlide10
Genome editing entails a variety of reagents & a continuum of approaches extending from point mutations to transgene insertions.
CRISPR applicationhttp://cropbioengineering.iastate.edu/
Template addition
DSB
Indels
NHEJ
HR
HR
Gene Addition
g
RNASlide11
Direct
introductionDNA, transgene-free progeny DNA, progeny with transgene IndelsFamiliar insertsNovel inserts
Transgene inserts
EU
EU
US
US
Wolt
et al.
Plant
Biotechnol
J
2016
Regulatory significance of GEEN Slide12
In the US, there are regulatory precedents – Phenotype does not contain foreign DNA
a plant phenotype that is indistinguishable from those developed through conventional selective plant breeding methodsexamples – Post-edit segregation to remove foreign DNADirect introduction of RNP & sgRNAnot subject to regulationPhenotype contains foreign DNAa plant phenotype may contain foreign (synthetic or transgenic) DNA, i.e., the result is a genetically engineered productexamples –GEEN reagent remains in productforeign template or transgene introducedsubject to regulationSlide13
Proposed shift from regulation of ‘GE organisms’ to ‘products of biotechnology’genetically engineered organisms – genetically modified by rDNA techniquesproducts of biotechnology – laboratory-based techniques to create or modify a genome that result in a viable organism with intended altered phenotypes
techniques include, but are not limited to, deleting specific segments of the genome, adding segments to the genome, directed altering of the genome, creating additional genomes, or direct injection and cell fusion beyond the taxonomic family that overcomes natural physiological reproductive or recombination barriersthis definition does not include and is intended not to include traditional breeding, marker assisted breeding, or chemical or radiation-based mutagenesisSlide14
Proposed shift from regulation of ‘GE organisms’ to ‘products of biotechnology’genetically engineered organisms – genetically modified by rDNA techniquesproducts of biotechnology – laboratory-based techniques to create or modify a genome that result in a viable organism with intended altered phenotypes
techniques include, but are not limited to, deleting specific segments of the genome, adding segments to the genome, directed altering of the genome, creating additional genomes, or direct injection and cell fusion beyond the taxonomic family that overcomes natural physiological reproductive or recombination barriersthis definition does not include and is intended not to include traditional breeding, marker assisted breeding, or chemical or radiation-based mutagenesisWithdrawn 6 Nov 17Slide15
Does absence of regulatory concern… translate to absence of public concern?Slide16
Does absence of regulatory concern… translate to absence of public concern?
What should be the basis of regulation? Perceived risk – Intrinsic concerns reflecting beliefs Real risk – Extrinsic concerns reflecting human health and the environment Slide17
Horse Race for Public Acceptance
ScienceApplicationsPublic Concern RegulationRegulatory ScienceTrifecta – Science, Regulation, ApplicationsSlide18
Horse Race for Public Acceptance
ScienceApplicationsPublic Concern RegulationRegulatory ScienceTrifecta – Science, Regulation, ApplicationsThe research community and developers of genome-edited crops must anticipate significant engagement and investment to address questions of regulators and civil society.Slide19
Iowa corn field by Scott Shephard
Thank youA Regulatory & Public Policy Perspective for Genome-Edited CropsAcknowledgementsKan WangBing YangCarolyn Lawrence-DillDipa SashitalHui
Zhao