Allergy, Asthma and Immunology

July 30, 2014

Evaluation of Endogenous Allergens for the Safety Evaluation of Genetically Engineered Food Crops: Review of Potential Risks, Test Methods, Examples and Relevance

Food Allergy Research and Resource Program,University of Nebraska—Lincoln, 143 Food Industry Complex, Lincoln, Nebraska 68583-0955, United States

Rakhi Panda ,

Food Allergy Research and Resource Program,University of Nebraska—Lincoln, 143 Food Industry Complex, Lincoln, Nebraska 68583-0955, United States

Harsha Ariyarathna

Department of Veterinary Pathobiology, University of Peradeniya, Peradeniya, Sri Lanka

J. Agric. Food Chem., 2013, 61 (35), pp 8317–8332

DOI: 10.1021/jf400952y

Publication Date (Web): July 15, 2013

*(R.E.G.) E-mail: rgoodman2@unl.edu.

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This article is part of the Safety of GM Crops: Compositional Analysis special issue.

Abstract

The safety of food produced from genetically engineered (GE) crops is assessed for potential risks of food allergy on the basis of an international consensus guideline outlined by the Codex Alimentarius Commission (2003). The assessment focuses on evaluation of the potential allergenicity of the newly expressed protein(s) as the primary potential risk using a process that markedly limits risks to allergic consumers. However, Codex also recommended evaluating a second concern, potential increases in endogenous allergens of commonly allergenic food crops that might occur due to insertion of the gene. Unfortunately, potential risks and natural variation of endogenous allergens in non-GE varieties are not understood, and risks from increases have not been demonstrated. Because regulatory approvals in some countries are delayed due to increasing demands for measuring endogenous allergens, we present a review of the potential risks of food allergy, risk management for food allergy, and test methods that may be used in these evaluations. We also present new data from our laboratory studies on the variation of the allergenic lipid transfer protein in non-GE maize hybrids as well as data from two studies of endogenous allergen comparisons for three GE soybean lines, their nearest genetic soy lines, and other commercial lines. We conclude that scientifically based limits of acceptable variation cannot been established without an understanding of natural variation in non-GE crops. Furthermore, the risks from increased allergen expression are minimal as the risk management strategy for food allergy is for allergic individuals to avoid consuming any food containing their allergenic source, regardless of the crop variety.

Keywords:

genetically modified; IgE; food allergy; soybean; maize; risk management

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Prevalence of asthma and allergic diseases in adolescents: nine-year follow-up study (2003-2012)

Current issue

July 2014 - August 2014
Vol. 90. Num. 04.
Pages 325-429

Dirceu Solé, Nelson A. Rosário Filho, Emanuel S. Sarinho, Inês C. Camelo-Nunes, Bruno A Paes Barreto, Mércia L. Medeiros, Jackeline M. Motta, Paulo A. Camargos, Javier Mallol, Ricardo Gurgel, Djanira M. de Andrade, Fernanda P. Furlan, Almerinda R. Silva, Cristina Cardozo, Cláudia Andrade

Abstract

Objective
to determine the prevalence of symptoms of asthma, rhinitis, and atopic eczema in adolescents (AD; 13-14 years) living in seven Brazilian cities, by applying the standardized written questionnaire (WQ) of the International Study of Asthma and Allergies in Childhood (ISAAC), and to evaluate the time trend nine years after the last assessment of ISAAC phase 3 (ISP3).

Methods
the ISAAC-WQ was answered by 20,099 AD from the Northern, Northeastern, Southeastern, and Southern Brazilian regions. Values obtained were compared to those observed in ISP3 using nonparametric (chi-squared or Fisher) tests, and the ratio of annual increment/decrement was established for each of the centers, according to the symptom assessed.

Results
considering the national data and comparing to values of ISP3, there was a decrease in the mean prevalence of active asthma (18.5% vs. 17.5%) and an increase in the frequency of severe asthma (4.5% vs. 4.7%) and physician-diagnosed asthma (14.3% vs. 17.6%). An increase in prevalence of rhinitis, rhinoconjunctivitis, and atopic eczema was also observed.

Conclusions
the prevalence of asthma, rhinitis, and atopic eczema in Brazil was variable; higher prevalence values, especially of asthma and eczema, were observed in regions located closer to the Equator.

Tools

Auto-injector needle length may be inadequate to deliver epinephrine intramuscularly in women with confirmed food allergy

Research

Gina Tsai¹, Laura Kim², Immaculate FP Nevis¹³, Arunmozhi Dominic¹, Ryan Potts⁴, Jack Chiu¹ and Harold L Kim¹³⁵^*

*Corresponding author: Harold L Kim hlkimkw@gmail.com

Author Affiliations

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Allergy, Asthma & Clinical Immunology 2014, 10:39 doi:10.1186/1710-1492-10-39

Published: 22 July 2014

Abstract

Background

Epinephrine auto-injectors are the standard first aid treatment for anaphylaxis. Intramuscular delivery into the anterolateral aspect of the thigh is recommended for optimal onset of action of epinephrine. The most frequently prescribed auto-injector in North America and Canada is the EpiPen^®, which has a needle length of 15.2 mm. Currently, it is unknown whether this needle length is adequate for intramuscular delivery of epinephrine in adult patients at risk of anaphylaxis.

Methods

One hundred consecutive adult patients with confirmed food allergy requiring an epinephrine auto-injector were recruited. Skin to muscle depth (STMD) at the right mid-anterolateral thigh was measured using ultrasound under minimal (min) and maximum (max) pressure. The EpiPen^®needle length was considered adequate if STMD_max was ≤15.2 mm. Baseline characteristics including age, gender, ethnicity, and body mass index (BMI) were compared in patients with STMD_max -15.2 mm vs. >15.2 mm.

Results

The EpiPen^® needle length of 15.2 mm was inadequate for intramuscular delivery in 19 of the 100 enrolled patients (19%), all of whom were female; 28% of women had a STMD_max >15.2 mm. The mean STMD_max in the ≤15.2-mm and >15.2-mm groups were 9 ± 4 mm and 20 ± 4 mm, respectively (p = 0.0001). Linear regression analysis found BMI to be significantly associated with STMD_max after adjusting for age (p - 0.001).

Conclusions

The needle length of the epinephrine auto-injectors may not be adequate for intramuscular delivery of epinephrine in a large proportion of women with food allergy; this may impact morbidity and mortality from anaphylaxis in this patient population.