title: Science, law, and politics in the Food and Drug Administration's genetically engineered foods policy: FDA's 1992 policy statement.
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 mutagenesis 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.
authors.affiliation: Division of Nutritional Sciences, Cornell University, 378 MVR Hall, Ithaca, NY 14853, USA. dlp5@cornell.edu
authors.forename: David L
authors.initials: DL
authors.lastname: Pelletier
mesh_terms: D000485:Allergens / Q000032:analysis; D030841:Food, Genetically Modified / Q000009:adverse effects / Q000592:standards*; D006801:Humans; D007881:Legislation, Food; D012449:Safety; D014118:Toxins, Biological / Q000032:analysis; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000485:Allergens; D014118:Toxins, Biological