Download Regulatory Steps for Controlling Field Trials of GMO Plants

Regulatory Steps for Controlling
Field Trials of GMO Plants
Greg McCollum
USDA-ARS
Ft. Pierce, FL
What are GMO plants?
Genetically Modified Organism = GMO (Transgenic)
• An organism (citrus tree) whose genetic material has
been altered using genetic engineering techniques
• Insertion of a foreign gene to confer desirable trait
• Desirable traits
— Pest resistance (insects, virus, fungi, bacteria)
— Herbicide resistance
— Food quality
Why are we concerned with GMO citrus?
Huanglongbing disease, canker, next crisis (?)
HLB is having devastating impacts
on the Florida citrus industry
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•
•
•
•
Loss of yield
Loss of quality
Increased cost of production
Loss of infrastructure
Loss of the industry (?)
HLB Management Practices
• Intensive insecticide applications for vector control
• Scouting / tree removal
• Production of disease-free nursery trees
Production costs
Pre-HLB: $790/acre
Post-HLB: $1600/acre
Why are GMOs the best approach?
• Disease resistance is the ultimate
management strategy
• No known resistance to HLB in citrus
• Citrus sinensis not amenable to breeding
• Citrus is clonally propagated
How are genes transferred from one
organism to another?
Agrobacterium – a plant pathogen with the
capacity to transfer DNA
Plasmid containing gene(s)
for desired trait
Citrus Transformation
Transformation
Evaluation
Selection
Regeneration
Time frame for producing transgenic citrus
• 12 months – Transformed plants
• 18 months – Transformants propagated
• 24 months – Disease screening
• 36 months – Field ready transgenics
Commercialized GMOs currently being produced
2008 — Global commercial value of
GM crops $130 billion
2010 — 29 countries, 15 million farmers
Transgenic fruit crops
Papayas
Papaya ring spot
Viral disease
Apples
Fire blight
Bacterial disease
Plums
Plum pox
Viral disease
Slow-browning apples
Brazilians have reported on transgenic
‘Hamlin’ resistant to canker
“Transgenic crops face a daunting array of
pre-commercialization regulatory
requirements and post-commercialization
market restrictions”
Bradford et al. 2005 Nature Biotechnology
GMOs = Potential plant pest, pesticide, and food
• Potential plant pest
Agrobacterium tumefaciens
a plant pathogen
• Pesticide
Bactericide, insecticide
• Food
Three Federal Agencies Regulate GMOs
Animal and Plant Health Inspection Service (APHIS)
• Potential agricultural plant pests
• Biotechnology Regulation Services
• {Food Safety and Inspection Service (FSIS)}
Environmental Protection Agency
• Pesticides Tolerances of pesticide residues in food
• Non-pesticidal toxic substances
• Plant incorporated protectants (PIPs)
Food and Drug Administration
• Food additives
• Center for Food Safety and Applied Nutrition (CFSAN)
Principal Regulatory Agency for GMOs
Animal and Plant Health Inspection Service (APHIS)
• Potential agricultural plant pests
• Biotechnology Regulatory Services
• {Food Safety and Inspection Service (FSIS)}
Plant Protection Act (Title 7 U.S.C. Sections 7701 et seq.)
Safe introduction (confined field testing,
interstate movement, and importation) of new
GM plants with significant safeguards to
prevent the accidental release of any GM
material.
Environmental Protection Agency
• Pesticides
• Toxins
• Plant incorporated protectants (PIPs)
produced by plants and the genetic material
necessary for the plant to produce the substance.
Federal Insecticide, Fungicide and Rodenticide Act
Toxic Substances Control Act
Responsible for ensuring that pesticides engineered
and used in living plants can be safely used in the
environment.
GMO field trials - 2012
Information Systems for Biotechnology
http://www.isb.vt.edu/
Intellectual Property
• Four firms (and subsidiaries)
Bayer Cropscience
DuPont
Monsanto
Syngenta
• Own or co-own 80% of all biotech
traits that have received regulatory
approval
Infrastructure for GMO research
Laboratories
Greenhouses
Growth room
Growth chambers
Secure farm sites with ample space
GM Citrus currently being evaluated in
at several sites in Florida
Timeline for Development of Transgenics
(Sexually propagated crops)
RESEARCH
Research in
the Lab
5 – 10 years
Research in
the
Greenhouse
1–3
years
Initial
Field
Trials
3 - 5 years
PRODUCT
DEVELOPMENT
COMMERCIALIZATION
Additional
Field &
Regulatory
Work
Breeding,
Multiplication
& Distribution
4 – 6 years
5 – 10 years
------------------------18 – 34 years--------------------
Citrus is asexually propagated –
no breeding will be required
GMO citrus
• Potential sustainable solution for HLB
• Potential environmental benefits – reduced
pesticides
• Regulatory system - safety and environmental
impacts of GMOs
• History with crops, but a much shorter history with
trees.
• Features different from most crops
— Perennial
— Little chance for “escape”
— Clonally propagated