Abstract
The US regulatory review process for novel crops is accomplished jointly by three federal agencies through a science-based, integrated and multidisciplinary approach. This process assesses safety for inserted genes and recipient plants, potential for allergenicity, integrity for genes, functionality for novel proteins, agronomic characteristics and environmental safety for novel crops, and composition for key nutrients and toxicants for crops and important products. To date, more than 50 crops produced through biotechnology have been approved for commercialization and the vast majority of these have been compositionally comparable to conventional counterparts for nutrient content and known toxicants. Experimental data that are required for the process are clearly defined by a decision-tree approach, and for crops approved to date, feeding studies using livestock have not been required as part of the regulatory process. Further, the United States Food and Drug Administration considers the consumption of DNA to be “Generally Regarded as Safe.” Findings from independently conducted studies have indicated no differences for nutrient composition, digestibilities, and animal performance when livestock were fed feedstuffs from conventional and biotech crops. In addition, in independent studies conducted to determine whether transgenic DNA and proteins can be detected in animal products, no transgenic plant-source DNA and proteins have been found in milk, meat, and eggs.
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