Extensive studies give assurance that this will not happen. First, the genetic material to be introduced is fed to rodents at an extremely high dose. The material is also examined to see whether it has anything in common with known allergens. Once the material has been introduced into a plant, the plant is studied to see if inserting the gene created a new allergen. Several generations of the plant are analyzed for any unexpected changes.
Extensive studies compare the improved plant with a conventionally bred counterpart.
Levels of protein, fat, fiber, starch, amino acids, fatty acids, ash and sugar are all compared with levels in the conventional plant. Levels of anti-nutrients, natural toxicants or known allergens likewise are compared. Field studies compare many biological factors, including height, color, leaf orientation, roots, flowering, shape, strength and grain size. If inserting a new gene causes no change in all of the factors examined, the Food and Drug Administration can conclude with great assurance that the improved crop is substantially equivalent to and as safe as the conventional crop. If the improved plant performs a function formerly performed by a chemical pesticide, such as protecting corn or cotton from insects, the Environmental Protection Agency requires extensive studies to assess the safety to humans as well as non-target insects and other wildlife.