title: Product development strategies for foods in the era of molecular biotechnology.
abstract: Breakthroughs in science and technology are accelerating development of new products that are impacting our regulatory systems. Genetically modified or bioengineering plant varieties have entered the food supply on a global basis, especially in the U.S. The U.S. Food and Drug Administration regulates on the premise of 'substantial equivalence' and has developed premarket notification procedures and voluntary labeling guidelines. Japan's Ministry of Health, Labor and Welfare regulates biotechnology products and has imposed biotechnology labeling regulations. However, the EU continues to be in a regulatory gridlock between member states and has proposed strict traceability and labeling guidelines. These requirements are currently restricting imports of bioengineered foods and are creating an international debate. In contrast to bioengineered plant varieties, to our knowledge, there are no strains of lactic acid bacterial starter cultures on the market that contain rDNA. The majority of strains have been improved via selection and mutagenesis. However, conjugation and electroporation have been used to transfer native lactococcal phage resistance plasmids to industrial strains. In addition, plasmids have been introduced to allow for selection of certain characteristics and then been eliminated by curing. The potential benefits of bioengineered foods are far reaching and are one of the most important opportunities of this century. However, bioengineered foods remain an emotional debate that is affecting world trade.
mesh_terms: D001709:Biotechnology / Q000379:methods; D019649:Food Industry / Q000592:standards; D005515:Food Labeling / Q000592:standards; D008967:Molecular Biology / Q000379:methods; D012449:Safety; D014481:United States; D014486:United States Food and Drug Administration