Journal or Publishing Institution: Nutrition Reviews
Study: http://onlinelibrary.wiley.com/doi/10.1111/j.1753-4887.2005.tb00135.x/abstract
Author(s): Pelletier, D.L.
Article Type: Journal Publication
Record ID: 1854
Abstract: The US Food and Drug Administration’s (FDA’s) 1992 policy statement was developed in the context of critical gaps in scientific knowledge concerning the compositional effects of genetic transformation and severe limitations in methods for safety testing. FDA acknowledged that pleiotropy and insertional mu‐tagenesis may cause unintended changes, but it was unknown whether this happens to a greater extent in genetic engineering compared with traditional breeding. Moreover, the agency was not able to identify methods by which producers could screen for unintended allergens and toxicants. Despite these uncertainties, FDA granted genetically engineered foods the presumption of GRAS (Generally Recognized As Safe) and recommended that producers use voluntary consultations before marketing them.
Keywords: Unintended Effects, Food Safety, Scientific Uncertainty; Consultation, Allergens, Breeding, Food, Genetic Engineering, Politics, Safety, Transformation, Genetic, United States Food and Drug Administration, Statutes and Laws, Pleiotropism, Toxicant, Food Safety, Marketing, Policy Statement; Genetically Modified Foods, Laws and Regulations, Food Biotechnology, Food Policy; Humans, Food Legislation, Safety, Biological Toxins, United States, United States Food and Drug Administration
Citation: Pelletier, D.L., 2005. Science, law, and politics in the Food and Drug Administration’s genetically engineered foods policy: FDA’s 1992 policy statement. Nutrition Reviews, 63(5), pp.171-181.