Safety Assessment of Dietary Proteins for Allergenicity Using an Adjuvant-Free Mouse Model

EPA Grant Number: R833133
Title: Safety Assessment of Dietary Proteins for Allergenicity Using an Adjuvant-Free Mouse Model
Investigators: Gangur, Venugopal , Tempelman, Robert J.
Institution: Michigan State University
EPA Project Officer: Hahn, Intaek
Project Period: October 1, 2006 through September 30, 2009 (Extended to March 31, 2010)
Project Amount: $447,774
RFA: Biotechnology: Potential Allergenicity of Genetically Engineered Foods (2006) RFA Text |  Recipients Lists
Research Category: Food Allergy , Health Effects , Health


Food allergies are significant public health hazards worldwide with potential for fatal outcome. Nearly 6% children and 4% adults in the United States are afflicted with food allergies. A major concern of genetically engineered (GE) foods is that allergenic proteins might be introduced into the environment (food chain) via GE foods leading to new and widespread life-threatening food allergies. Towards the goal of predicting allergenic potential of novel dietary proteins, we have recently developed a novel adjuvant-free mouse model of allergenic sensitization to food proteins {Birmingham et al (2005) Int. Arch. Allergy & Immunol. 137(4):295-302; Navuluri et al (2006) Int. Arch. Allergy & Immunol. 140(3):270-276}. Here we propose to test the hypothesis that this adjuvant-free mouse model of transdermal food protein sensitization will be highly reliable in the identification of food proteins with and without intrinsic allergenic sensitization potential in humans.


1) Determine the positive predictive value (i.e., sensitivity) of the mouse based adjuvant-free transdermal food protein sensitization method. A panel of 10 consensus human allergenic food proteins will be tested for allergenicity in this model; dose-responses and relative sensitizing potencies will be determined; and 2) Determine the negative predictive value (i.e., specificity) of this method. A panel of 10 rationally chosen human non-allergenic food proteins will be tested for non-allergenicity in this model; dose-responses will be studied.

Expected Results:

A positive outcome from this research will be a validated adjuvant-free mouse model for hazard identification of novel dietary proteins including pesticidal proteins used in GE foods. This outcome will also enhance the ability to estimate the potency of unknown proteins relative to known allergenic and non-allergenic proteins in a logically feasible and cost effective manner. In addition, this research will advance our basic knowledge on how environmental dietary proteins might interact with the immune system and adversely impact human health.

Publications and Presentations:

Publications have been submitted on this project: View all 23 publications for this project

Journal Articles:

Journal Articles have been submitted on this project: View all 8 journal articles for this project

Supplemental Keywords:

food allergens, risk assessment, immunoglobulin E, susceptibility, environmental hazard, anaphylaxis, immediate hypersensitivity,, Health, Scientific Discipline, Health Risk Assessment, Risk Assessments, Allergens/Asthma, Biochemistry, dietary protein, food allergenicity, genetically engineered food, oral allergy syndrome, bioinformatics, allergic response

Progress and Final Reports:

  • 2007 Progress Report
  • 2008 Progress Report
  • 2009 Progress Report
  • Final Report