Health and Food Safety of Genetically Modified Foods

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Health and Food Safety of Genetically Modified
Foods
Dr. Roy L. Fuchs Regulatory Science / Scientific
Outreach Agricultural Products
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Biotech Regulations
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Three Phases of Safety Assessment
Discovery
Line Selection
Product Advancement
Post Market

• Phase II
• Biological / agronomic equivalence
• Stringent agronomic performance and efficacy
  criteria
• Greater than 99 of all events are eliminated
• Key step in product evaluation for conventional
  varieties

• Phase III
• Detailed product safety
• Food
• Feed
• Environmental

• Phase I
• Safety of gene, protein, crop
• Choice of genes / proteins
• - mechanism of action
• Source of genes
• history of safe use
• ethics
• Environmental / ecological considerations

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Monsanto Has Carefully Selected the
ProteinsProduced in our Plant Biotechnology
Products
Type of
Protein1 Product Bt EPSPS NPTII Roundup Ready
Soybean 4 NewLeaf Potato 4 4 Bollgard
Cotton 4 4 Roundup Ready Cotton 4
4 MaisGard Corn 4 Roundup Ready Corn
4 Roundup Ready Canola2 4 1 All have a long
history of safe consumption 2 Also contains
naturally occurring glyphosate degradation
protein (GOX)
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Cry or Bt Proteins Have a Long Historyof Safe
Consumption

• Derived from naturally occurring Bacillus
  thuringiensis
• Present in commercial microbial products used
  globally for gt 35 years, organic growers
• Microbial products contain mixtures of Bt
  proteins
• Subjected to extensive safety testing around the
  world
• Acute (LD50s gt3 to gt5 g/kg)
• Subchronic (NOELs 0.5 to gt8.4 g/kg/day)
• Chronic (NOEL 8.4 g/kg/day)
• Humans (no effect at 1 g/day for up to 5 days)

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Safety Assessment - Phase II
Discovery
Line Selection
Product Advancement
Post Market

• Biological / agronomic equivalence
• Stringent agronomic performance and efficacy
  criteria
• Greater than 99 of all events are eliminated
• Key step in product evaluation for conventional
  varieties

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The Approach to Assess Food / Feed Safety of
GMPlant Products is Consistent Globally and
DevelopedOver More Than a Decade

• International scientific organizations
• UN Food and Agricultural Organization (FAO) -
  1991, 1996, 2000
• UN World Health Organization (WHO) - 1991, 1993,
  1995
• International Life Science Institute (ILSI) -
  1996, 1997
• Organization for Economic Cooperation and
  Development (OECD) - 1993, 1996, 1997, 2000
• International Food Biotechnology Council (IFBC) -
  1990

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General Conclusions by National and International
Scientific Organizations (FAO / WHO / OECD / ILSI)

• Food from GM crops are not inherently less safe
  than those developed by conventional breeding
• Types of risks for food from GM crops are of the
  same nature as those from conventional breeding
• Same food safety assessment principles and
  standards apply (reasonable certainty of no
  harm)
• Extensive safety assessments conducted with plant
  biotechnology products provide equal or greater
  assurance of safety of food products

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Assessment of Food Safety

• Standard - Reasonable certainty that no harm
  will result from intended uses under the
  anticipated conditions of consumption
• Food is not inherently safe
• Considered to be safe based on experience
• Not absolute but relative safety

Ô . . . as safe as . . .
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Use Concept of Substantial Equivalence to
Confirm . . . as safe as . . .

• Compare food or food components from
  genetically-modified crop to conventional
  counterpart
• Origin of genes
• Agronomic parameters
• Composition (key nutrients / anti-nutrients)
• Intended use
• Consumption
• Ô confirmation of substantial equivalence
  results in same treatment with respect to safety

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Outcomes of Substantial Equivalence Assessments

• Substantially equivalent to conventional
  counterpart
• Ô no further testing
• Substantially equivalent to conventional
  counterpart except for introduced trait(s)
• Ô focus assessment on trait(s) / gene
  product(s)
• Not substantially equivalent to accepted food or
  food component
• Ô combined nutritional / toxicological
  assessment

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The Safety of Biotech Products is
EstablishedThrough the Following Approach
Food / Feed / Environmental Safety

• Gene(s)
• Source(s)
• Molecular characterization
• Insert / copy number / gene integrity
• Protein(s)
• History of safe use and consumption
• Function / specificity / mode-of-action
• Levels
• Toxicology / allergenicity testing

• Food / Feed Composition
• Proximate analysis
• Key nutrients
• Key anti-nutrients
• Animal performance assessment
• Environmental Studies
• Safety to non-target organisms
• Soil degradation
• Outcrossing
• Susceptibility to disease

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Insect-Protected Corn Targets (YieldGard)

• Field
• European Corn Borer
• Pink Borer
• Asian Corn Borer
• Fall Army Worm

Larvae

• Stored Grain
• Indian Mealmoth
• Angoumois Grain Moth

Adult

• Advantages
• Reduction in pesticide use
• Improved insect control
• Increased yield
• Reduction in mycotoxin content

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The Food and Feed Safety Assessment of
Insect-Protected Corn

• Molecular Characterization of MON 810
• Compositional equivalence to the parental and
  commercial varieties
• Safety of the CryIA(b) protein
• Wholesomeness studies in animals

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Detailed Molecular Analysis of Insect-Protected
Corn Line MON 810

• One DNA insertion
• Only the cryIAb gene
• Completely sequenced cryIAb gene
• The cryIAb gene encodes the nature-identical
  CryIAb protein
• CryIAb protein has gt 40 year history of safe use
  (Dipel and other commercial microbial products)

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The Food and Feed Safety Assessmentof
Insect-Protected Corn

• Compositional equivalence to the parental and
  commercial varieties
• Safety of the CryIAb protein

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Compositional Analyses Established Substantial
Equivalence
Grain Forage - Protein - Protein -
Fat - Fat - Fiber - Fiber - Starch -
Amino acid composition - Fatty acid
composition - Ash - Sugars - Calcium -
Phosphorous
Field tests conducted in the US and Europe
over multiple years Published Sanders, et al.
1999
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Amino Acid Analysis of Grain FromInsect-Protected
Corn Line MON 810
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Fatty Acid Analysis of Grain FromInsect-Protected
Corn Line MON 810
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Proximate Composition of Forage From
Insect-Protected Corn Line MON 810
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Protein Safety Assessment Shows CryIAb

• Rapidly digested in simulated gastric juice (lt 15
  seconds)

Allergen CryIAb Allergenic source of
gene yes no Similar sequence to allergens
yes no Stable to digestion yes no Prevalent
protein in food yes no History of safe use in
microbial products

• No deleterious effects on mammalian species in
  acute tests at gt 20 million fold exposure from
  the expected use level

• No significant allergenic concerns

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Principles of Food Allergy Assessment

• Avoid transfer of known allergens
• Assume genes from allergenic sources encode an
  allergen until proven otherwise
• Assess the allergenic potential of all introduced
  proteins

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Safety Assessment Summary for Insect-Protected
Corn
Component Changed Unchanged Morphology 4 Dise
ase susceptibility 4 Non-target organism
safety 4 Environmental safety 4 Agronomics
4 Composition 4 One additional gene
/ protein 4 Control of target insects 4
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Regulatory Clearances
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Are Biotech Plant DNA or Proteins Detectable in
Meat, Milk or Eggs?

• Not a safety issue
• Bt corn products have been shown to be safe
• DNA and proteins are present in all plant
  material and are part of the diet
• Biotech plant DNA or proteins have not been
  detected in milk, meat and eggs
• Animal digestive systems are a hostile
  environment which degrades DNA and proteins
• Unless rigorous precautions are taken during
  sampling and analysis, contamination may lead to
  detection

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Summary

• Plant biotechnology products must meet stringent
  performance standards during development
• All products are thoroughly assessed for food,
  feed and environmental assessment prior to
  regulatory approval
• Food / feed safety based on substantial
  equivalence and safety of expressed traits
  (proteins)
• Composition and wholesomeness studies show that
  Bt corn is substantially equivalent to and as
  nutritious as conventional corn

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Summary

• Bt proteins produced in plants have a history of
  safe use
• Bt corn is as safe as conventional corn varieties
• Food / feed safety based on substantial
  equivalence and safety of expressed traits
  (proteins)
• Bt proteins in MON 810 has a history of safe use