Foods produced through agricultural biotechnology, including such staples a
s corn, soybeans, canola, and potatoes, are already reaching the consumer m
arketplace. Agricultural biotechnology offers the promise to produce crops
with improved agronomic characteristics (eg, insect resistance, herbicide t
olerance, disease resistance, and climatic tolerance) and enhanced consumer
benefits (eg, better taste and texture, longer shelf life, and more nutrit
ious). Certainly, the products of agricultural biotechnology should be subj
ected to a careful and complete safety assessment before commercialization.
Because the genetic modification ultimately results in the introduction of
new proteins into the food plant, the safety, including the potential alle
rgenicity, of the newly introduced proteins must be assessed. Although most
allergens are proteins, only a few of the many proteins found in foods are
allergenic under the typical circumstances of exposure. The potential alle
rgenicity of the introduced proteins call be evaluated by focusing on the s
ource of the gene, the sequence homology of the newly introduced protein to
known allergens, the expression level of the novel protein in the modified
crop, the functional classification of the novel protein, the reactivity o
f the novel protein with IgE from the serum of individuals with known aller
gies to the source of the transferred genetic material, and various physico
chemical properties of the newly introduced protein, such as heat stability
and digestive stability. Few products of agricultural biotechnology (and n
one of the current products) will involve the transfer of genes from known
allergenic sources, Applying such criteria provides reasonable assurance th
at the newly introduced protein has limited capability to become an allerge
n.