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Case study 3: Ultra-low Gossypol Cottonseed
FDA
Patrick Cournoyer, Ph.D.
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Elements of a submission • Basic elements • Molecular characterization • Trait stability • Added substances • Endogenous substances
– Nutrients – Toxicants, anti-nutrients
• Suitability for new uses
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Elements of a submission • Basic elements
– The intended trait – Introduced genetic element – Intended uses – New uses
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Gossypol
• Terpenoid • Toxic to monogastrics • Causes infertility in males • Insecticidal
http://udall-lab.byu.edu/Research/CottonResearch /CottonGossypolProject
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Intended trait, inserted genetic element
Sunilkumar et al., 2006
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Existing uses of cottonseed
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Cottonseed linters
• Highly processed into pure cellulose – Food and non-food
uses • Sausage casings • Thickener,
stabilizer, source of dietary fiber – Ice cream – Salad dressing – Grated cheese
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New uses for cottonseed • Cottonseed hulls, cottonseed meal
– Food for animals
• Cottonseed – Food for humans and animals
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Elements of a submission • Basic elements • Molecular characterization • Trait stability • Added substances • Endogenous substances
– Nutrients – Toxicants, anti-nutrients
• Suitability for new uses
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Molecular Characterization
Characterize insertion(s), copy
number Vector Backbone?
New proteins from alternative
open reading frames?
Stability of insertion over
multiple generations?
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Elements of a submission • Basic elements • Molecular characterization • Trait stability • Added substances • Endogenous substances
– Nutrients – Toxicants, anti-nutrients
• Suitability for new uses
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Comparative Approach
Appropriate comparator
(Grown concurrently) To identify changes
Reference varieties (Grown concurrently)
To characterize variation
Published data To characterize variation
New GE variety
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Composition Resources
https://www.cropcomposition.org/query/index.html
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Composition Resources
https://ndb.nal.usda.gov/ndb/search/list
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Composition Resources
Consensus Document on Compositional Considerations for New Varieties of Cotton (Gossypium hirsutum and Gossypium barbadense): Key Food and Feed Nutrients and Anti-Nutrients
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Endogenous Substances: Key Nutrients
• Proximates – Ash – carbohydrates – crude fat – crude protein – crude fiber
• Key amino acids
• Key fatty acids
• Minerals – calcium – phosphorus
• Vitamins
– Tocopherol (vitamin E)
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Endogenous Substances: Toxicants and anti-nutrients
• Gossypol – and related terpenoid phytoalexins
• Cyclopropenoid fatty acids – malvalic, sterculic and dihydrosterculic acids – egg yolk discoloration and reduced hatchability in
chickens – possibly implicated with liver cancer in trout
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New uses
• Exposure estimates: – What are predicted exposure levels (humans and animals)? – Based on possible food uses and use levels
• Nutrition:
– Would cottonseed differ from the grains they would replace in a way that would be consequential for human or animal nutrition?
• Toxicants and anti-nutrients: – Would estimated levels of exposure be safe considering the new
uses?
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Example of new grain in human food: Canaryseed
• Developer – Canaryseed Development Commission of Saskatchewan
• Description
– Historically used only as birdseed due to silica-rich hairs – Mutation breeding eliminated hairs – Now suitable for food use
• Elements of the GRAS notification:
– Breeding approach – Compositional analysis (not comparative) – Nutrients and toxicants – Exposure estimates – Nutritional impact – Toxicological assessment
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Thank you Questions?
Patrick Cournoyer, Ph.D.