REGULATORY ASSESSMENT OF THE FLAVR-SAVR TOMATO

This article provides a case study of the FLAVR SAVR(TM) tomato as a d emonstration of the regulatory procedures and safety assessment necess ary in the USA. The data generated demonstrate that FLAVR SAVR tomatoe s do not significantly differ from traditionally bred tomato varieties , are functionally unchanged except for the intended effects of the FL AVR SAVR and kan(r) genes, and as such remain a food and subject to re gulation as a food. The US Food and Drug Administration is considering the safety of the FLAVR SAVR tomato in a Request for Advisory Opinion . This tomato is expected to be the first genetically engineered whole food on the market.