Why are genetically engineered crops considered “substantially equivalent” to conventional crops at the FDA yet “markedly different” at the U.S. patent office? It seems they cut both ways depending on which government office you are standing in (if you represent a biotechnology company, that is).
If the same rules were applied by the FDA to approve Genetically Modified Orgnaisms (GMOs) as the U.S. Patent Office uses, the FDA approval would be revoked until a full, independent formal review of safety is undertaken.
Genetically engineered (GE) crops intended for food are able to be lawfully marketed today without having been formally reviewed by the FDA and without being the subject of a food additive regulation. Genetically engineered crops have been approved with no formal pre-market review by the FDA to assure their safety “because the nature of the substance and the information generally available to scientists about the substance are such that the substance simply does not raise a safety concern worthy of premarket review by FDA.”