In 1992, FDA analyzed the potential hazards for the safety of foods from new plant varieties in a policy and guidance document. The potential safety hazards included the possibility of introducing new substances that would be toxic or allergenic and the possibility of increases in endogenous toxicants or anti-nutrients. The guidance portion of the document provided advice about consulting with the agency when the objective characteristics of the plant would warrant agency evaluation of potential safety or regulatory concerns, including labeling. As a model, FDA has evaluated developer's submissions on food from over 150 events in genetically engineered (GE) plants for almost 25 years. The U.S. government has taken considered an approach that applies existing laws and regulations to new technologies since 1986, when the Coordinated Framework for Biotechnology was implemented. The Coordinated Framework has recently been updated and a National Strategy for Modernizing the Regulatory System for Biotechnology Products has been published. FDA has also evaluated safety submissions on a variety of products using genetic engineering, from enzymes produced by microbes bearing enzymes from other organisms, to pure substances, to engineered yeast having altered metabolic capabilities based on introduced enzymes. As applications of genome editing come into the marketplace, the agency is working on adapting its existing, but flexible regulatory tools to ensure that foods marketed in the United States continue to be safe, nutritious, and wholesome.

Ensuring the food safety of the products of modern biotechnology: Applying FDA’s 1992 policy on food derived from new plant varieties from genetically engineered plant foods to developing technologies

256th National Meeting (2018)

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