Transcript Are They Safe? Biotech Food Crops and Products Karen

Are They Safe? Biotech
Food Crops and Products
February 1, 2002
Karen Pesaresi Penner
Kansas State University
Food Science Institute
Biotech Products in
Food Supply
1. Fermentation products
– Yeasts and molds used to make cheese,
bread, wine, beer, soy sauce
2. Enzymes
– Lactase tablets to breakdown lactose in
milk - for allergies
– Chymosin (rennet) for cheese
manufacture
– Amylase in beer
3. Hormones
Bovine growth hormone
(rbst)
Vitamin D added
to milk
Insulin
4. Whole foods/crops
– FLAVR SAVR,
Endless Summer
tomatoes
– Virus – resistant
squash
– Insect resistant
potatoes, corn
– Herbicide resistant
soybeans, canola
Potential Benefits
IFT Expert Report on Biotechnology and Foods, 2000
• Enhanced food supply
• Improved nutritional quality – rice, other
foods
• Improved shelf life
of fruits & vegetables
• Reduced allergenicity
– rice, peanuts
• Improved production agriculture
• Conversion of toxic soils to
productive soils
• Increased environmentally friendly
practices regarding pesticides
• Development of functional foods,
vaccines, other healthful products
Public Uncertainty
• Public is NOT well-informed
• Public may see little or no benefit from
technologies
• Lack of information and conflicting
information leads to confusion, emotional
reactions and fear for some
Acceptance of Technologies
• Public accepts new technologies with personal
benefits
rInsulin
vs
rBST
Benefits of many
bioengineered
products unknown or not
perceived as personal
FDA and Food Safety
• U.S.Food and Drug Law – requires food
products to be safe
• Traditional foods – considered safe, long
history
• Exceptions
– some “safe” foods affect specific individuals
– “safe” foods may contain small amount of natural
toxins
• New foods – developed with conventional
breeding, or from other parts of the world
considered safe
rDNA Derived Foods and
Ingredients
• Assessed for safety before introduction
into marketplace
• 1992 FDA Risk Assessment – focus on
unique characteristics of product
• Safety standards for bioengineered
products actually greater than for
conventional
Potential Food Safety Effects
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•
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Toxicants
New Substances
Nutrients
Allergenicity
Other Effects - Unintended
-- IFT Expert Report on Biotechnology and Foods, 2000
Considerations in Safety
Evaluations
• Substantial Equivalence – based on
comparison of recombinant product with
traditional product
– Not an absolute guarantee of safety
– Process to establish that no NEW hazards have
been introduced into the plant or product
• Toxins?
• Nutrient Effects?
• Allergens?
Proteins, fats, carbohydrates,
vitamins, minerals
Substantial Equivalence:
“ A comparative approach focusing on the
determination of similarities and differences
between the genetically modified food and its
conventional counterpart aids in the
identification of potential safety and nutritional
issues and is considered the most
appropriate strategy for the safety and
nutritional assessment of genetically modified
foods.” (FAO/WHO 2000)
Assessment beyond
equivalence:
• Completely new food substance
• Changes in concentrations of major
human dietary nutrients
• Increased concentrations of
“antinutritional factors”
• Increased concentrations of toxins
Safety of Genetic Material
Inserted
Characterization of
• Source
• Size
• Number
• Location of insertion
• Identification of sequences in the plant
Safety of DNA itself is not in question
Unintended Effects:
“… the unintended expression of some
unknown or unexpected toxic or
antinutrient factor, or the otherwise
unintended enhanced production of
known toxic constituents.” - (Royal Society,
1998)
Evidence of such effects has not been
found as result of bioengineering.
Effects are less likely in bioengineered
than in conventional products.
Food Allergens:
• All food allergens are proteins: only a small
fraction of food proteins cause allergic
response.
• Common foods with allergenic proteins:
peanuts, milk, seafoods
• Potential allergenicity of genetic material
(proteins) introduced into a plant is an
important part of safety assessment.
Allergenicity Assessment
• Follows a decision-tree process
• Includes:
– Source of the gene
– Sequence homology of newly introduced
protein
– Reactivity of newly introduced proteins with
Immunoglobulin E (IgE) antibodies from
people with known allergies to source
material
– Other properties, such as digestibility of the
protein
Safety Assessments
Refined and adapted and will continue
to change and develop.
Safety assessments are an important
part of the development process.
“FDA’s scientific review continues
to show that all bioengineered
foods sold here in the U.S. today
are as safe as their nonbioengineered counterparts”
Dr. Jane Henney, M.D.
U.S. Commissioner of Food and Drugs, 2000
Questions?