Science based evaluation of potential risks of food allergy from genetically engineered crops

India developed a safety assessment process to evaluate food safety of genetically engineered (GE) crops around the same time as the Food and Drug Administration was developing a process for the US. The Indian guideline for allergenicity adopted in 1989 was based on the toxicity assessment for chemical pesticides rather than risks of allergy from dietary proteins. Under the 1989 Indian guidelines the only GE crops approved for cultivation in India were two varieties of cotton containing genes from Bacillus thuringiensis (Bt) that encode specific crystal proteins that are toxic to caterpillars that consume the GE cotton plants in 2002 and 2005. While a number of scientists in India have worked on development of GE crops (brinjal, cauliflower, cotton, mustard, peanuts, potatoes, rice and wheat) to improve crop production or improve safety, none have been approved for commercial production or human consumption. Regulatory and public opinion hurdles in India in addition to a less developed commercial seed industry have blocked progress. However, recent increased demand for Indian agricultural products and the need to reduce dependence on chemical pesticides along with increasingly unstable environmental conditions brings pressure for change. The safety assessment of genetically engineered (GE) food crops was outlined by the Codex Alimentarius Commission, a body of the World Health Organization (WHO) and the Food and Agricultural Organization (FAO) of the United Nations adopted a comprehensive guideline in 2003, reaffirmed in 2009, includes evaluating potential risks of food allergy and toxicity of GE crops based on extensive scientific knowledge of allergies and allergens as well as the toxicity of proteins and specific metabolites. The assessment also considers the nutritional properties of complex foods. The Indian Council of Medical Research adopted a similar guideline for the safety assessment of GE crops in 2008. The primary concern for food allergy is whether the newly transferred protein is known to cause any type of IgE mediated allergy (food, contact or inhalation), or whether the protein is sufficiently similar to any known allergen to suspect potential IgE cross-reactivity. The goal is to prevent the transfer of a protein that would cause immediate reactions in those who are already allergic as they must avoid the proteins that cause their allergies to remain symptom free. The guidelines also recommend steps intended to identify proteins that may have a higher probability of becoming allergens based on stability of the protein in pepsin at low pH, and the abundance of the protein in the food since many important food allergens are stable and abundant in the food source. They also recommend evaluating potential changes in endogenous allergen expression for commonly allergenic crops that are modified (e.g., soybeans, wheat, peanuts). The safety assessment is intended to ensure the GE crops are as safe as conventional counterparts as discussed here for allergenicity.