case study 3: ultra-low gossypol cottonseed · pdf file• toxicants and anti -nutrients:...

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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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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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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https://ndb.nal.usda.gov/ndb/search/list

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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

Thank you Questions?

Patrick Cournoyer, Ph.D.

case study 3: ultra-low gossypol cottonseed · pdf file• toxicants and anti -nutrients:...

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