Safety Evaluation of Genetically Engineered Enzymes for Food Use

Abstract

The enzyme producers for the food industry are already harvesting the fruits of recombinant DNA technology. With the FDA's acceptance for filing in 1986 of the first petition for affirmation of GRAS status where this new technology was utilized, both the agency's capability to regulate food products involving recombinant technology and the industry's ability to use these techniques responsibly and judiciously were established. Since the first petition, involving the transfer of information from one procaryote to another, other petitions involving eucaryote to procaryote transfers and eucaryote to eucaryote transfers have been accepted, validating the FDA's commitment to regulate food safety in a dynamic technological environment. Safety evaluation aspects of the first petition will be presented to reveal the information entering the analyses. Other petitions will be summarized to indicate the extent of progress in the safety evaluation process.