2007 Progress Report: 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 Period Covered by this Report: October 1, 2006 through September 30,2007
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 allergy is a serious public health problem of international significance that is growing world-wide. Specific reasons for this increase in food allergy are not completely understood at present. Whether genetically engineered (GE) foods contribute to this problem is largely unknown. Assessment of allergenic potential of GE foods is a major challenge facing the regulatory agencies and the agro-biotech industry. Although WHO/FAO developed decision-tree approach suggests the use of animal models as one of the methods for assessment of allergenic potential of GE foods, validated animal models are not available at present. The goal of this project is to test the validity of a novel adjuvant-free mouse model of food allergy that we have recently reported (Birmingham et al 2007; Navuluri et al 2006), for this purpose. Here we have been testing the hypothesis that this mouse model will be highly reliable in discerning food proteins that have or do not have intrinsic allergenic sensitization potential in humans. The two specific objectives for this project are: 1) Determine the positive predictive value (i.e., sensitivity) of the mouse-model; and 2) Determine the negative predictive value (i.e., specificity) of the mouse model for testing allergenicity of dietary proteins.

Progress Summary:

The data obtained during this reporting period demonstrate that: (1) the allergenicity readouts in this mouse model are dependent on the number of exposures to the allergenic protein; 2) three human allergenic proteins produce all three readouts of allergenicity in this mouse model; an 3) two out of three human non-allergenic proteins were non-allergenic in this model based on clinical scores and hypothermia readouts but not based on IgE data. These data suggest further evaluation of additional dietary proteins for allergenicity in this mouse model.

The expected outcome from this project will be a validated adjuvant-free mouse model for allergenicity hazard identification of novel dietary proteins including pesticidal proteins used in genetically engineered foods. This outcome will enhance our ability to quantitatively assess allergenic potency of novel proteins relative to known allergenic and non-allergenic proteins in a rational, reproducible and cost effective manner. Finally this research will advance our basic knowledge on how environmental dietary proteins might interact with the immune system and adversely impact human health.

Future Activities:

We plan to test allergenicity of 6 additional dietary proteins in our mouse model during the next reporting period.

Journal Articles:

No journal articles submitted with this report: View all 23 publications for this project

Supplemental Keywords:

food allergy, food safety, allergen, systemic anaphylaxis, exposure, hazard assessment, mouse model, potency testing, dose-response, genetic engineering, allergenicity,, 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:

Original Abstract
  • 2008 Progress Report
  • 2009 Progress Report
  • Final Report