luccioli food allergies safety considerations · biotechnology and food allergy transgenic...
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Food Allergies and Safety Considerations for Biotechnology
Stefano Luccioli, MDOffice of Food Additive Safety
US Food and Drug Administration
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Goals
• Define food allergy
• Discuss prevalence, pathogenesis and key difficulties in assessing allergenicity
• Allergenicity considerations for foods derived from biotechnology– Novel food proteins – new allergenic risk?– Modification of known allergens in food
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http://www.cfsan.fda.gov/~dms/alrgn2.html#ii
Adverse reactions to food
Peanuts, egg, milk, soy, etc.
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Food allergy“Adverse reaction to food mediated by IgE antibody”
Typical symptoms - immediate and life-threatening!
Over 150 foods – most commonly consumed in dietUS: peanut, soy, egg, milk, wheat, tree nuts, fish, shellfishEurope: ... sesame, mustard, celeryJapan: ... buckwheat
Genetic AND environmental
No effective treatment – Labeling/ avoidance is key!
Lifetime risk for many
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-No
No
No
20%60-70%
80%
Outgrown?
3.7%6%Other(Fruit)
2.0%0.1%Shellfish
0.4%0.1%Fish
0.5%0.2%Tree nut
0.6%0.8%Peanut0.2%1.3%Egg
0.3%2.5%Milk
AdultsChildrenFood
Food allergy prevalence4% of total population: Infants (6-8%) >> adults (2%)Anaphylaxis: 30,000 cases, 2000 hospitalizations, 150 deaths/yr
Sampson, JACI, 2004
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B cell T cell
Food protein/ pollen
IgEAntibody
Mast cell/ Basophil
Sensitization
Challenge
and Elicitation
ALLERGY
•Skin- itchiness, flushing, hives, swelling, eczema•GI- nausea, vomiting, abdominal pain, diarrhea•Respiratory- runny nose, wheezing, throat closing/ swelling•Vascular- dizziness, faintness, arrhythmias, shock
AnaphylaxisFood
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Difficulties in allergenicity assessmentAllergenic food << proteins <<<< epitopes
Not all allergenic proteins nor epitopes identifiedConcentrations vary between foods/ productsHeterogeneous sensitized population
Sensitization (i.e. IgE) and elicitation can be mutually exclusiveReactivity is amplified – severity is unpredictableNo known allergen threshold level or minimum amount to trigger reactivityNo validated animal models
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Biotechnology and food allergy
Transgenic modification of crops and/or introduction of uncommon proteins derived through biotechnologyNovel food protein exposures
Transferring an existing allergen or cross-reactive protein from one crop to anotherCreating de novo food allergens
Modification of known food allergensAltering or quantitatively increasing an endogenous (existing) allergen in the food cropIncrease exposure to allergenic protein previously consumed at low concentrationsTransgenic manipulation to make “allergen-free”foods
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Novel food proteins Does the transgenic protein have allergenic characteristics or bind IgE? (it is assumed they will then elicit reactions)2003 Codex Alimentarius approach:
Source of proteinAmino acid sequence homologyPepsin resistanceSpecific serum screening
Crossreactivity(?): plant-derived proteins/ pollen allergyIdentification of allergenic protein familiesTargeted serum studiesOther protein modifications/ glycosylation?
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Will it ↑ or ↓ reactions in sensitized individuals? ↓ reactiomseasier to assess; absence of reactions difficult to confirmSerum studies provide limited data; human food challenge data provides most confirmatory evidenceAssessment considerations:– Type of food protein or crop– What are the relative concentrations of existing allergenic
proteins in food? How modified? • Depends on good analytical methods – limitations?
– Use in more sensitive populations (i.e. infants)?– What is the final exposure to protein concentrations per
meal? Evidence of prior human exposure? How does exposure compare to food challenge “thresholds”
o Animal dose-response models?
Modification of known food allergens