2008 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: Laessig, Susan A.
Project Period: October 1, 2006 through September 30, 2009 (Extended to March 31, 2010)
Project Period Covered by this Report: October 1, 2007 through September 30,2008
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 previously 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 so far from this project demonstrate that:  (1) the allergenicity readouts in this mouse model are dependent on the number of exposures to the allergenic protein; (2) five human allergenic proteins (hazelnut, cashew nut, milk, shellfish, egg) produce all three readouts of allergenicity in this mouse model; (3) five human non-allergenic proteins (kidney bean, Pinto bean, blue berry, sorghum, pigeon pea) were non-allergenic in this model based on clinical scores and hypothermia readouts; and (4) Amaranth seed protein that has no history of human allergenicity and therefore presumed to be non-allergenic, tested positive for all three readouts of allergenicity. These data suggest further evaluation of additional dietary proteins for allergenicity in this mouse model.

A positive 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 do follow-up work on the manuscripts/abstracts that have been submitted or in preparation for publication. We plan to do follow-up work on pinto bean, kidney bean, pigeon pea, blue berry, and sorghum proteins. In addition, we plan testing allergenicity of six additional dietary proteins during the next reporting period.

Journal Articles on this Report : 1 Displayed | Download in RIS Format

Other project views: All 20 publications 5 publications in selected types All 5 journal articles
Type Citation Project Document Sources
Journal Article Parvataneni S, Gonipeta B, Tempelman RJ, Gangur V. Development of an adjuvant-free cashew nut allergy mouse model. International Archives of Allergy and Immunology 2009;149(4):299-304. R833133 (2008)
R833133 (Final)
  • Abstract from PubMed
  • Abstract: Karger-Abstract
  • 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
    2007 Progress Report
    2009 Progress Report
    Final Report