Open AccessScience, Law, and Politics in the Food and Drug Administration's Genetically Engineered Foods Policy: FDA's 1992 Policy Statement
Author(s) -
Pelletier David L.
Publication year - 2005
Publication title -
nutrition reviews
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.958
H-Index - 150
eISSN - 1753-4887
pISSN - 0029-6643
DOI - 10.1111/j.1753-4887.2005.tb00135.x
Subject(s) - food and drug administration , presumption , context (archaeology) , agency (philosophy) , microbiology and biotechnology , unintended consequences , business , genetically engineered , politics , administration (probate law) , law and economics , political science , public economics , risk analysis (engineering) , law , economics , biology , genetics , sociology , paleontology , social science , gene
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.