Biotechnology is the controlled application of biology to produce industrial enzymes, improved plants and animals, medicines, pesticides, etc., from living organisms or their parts. Genetic engineering, a special application of biotechnology, is the modification of a plant or animal’s genetic (hereditary) material at the molecular level to produce more desirable qualities. Biotechnology involves the use by industry of recombinant DNA (rDNA), cell fusion, and new bioprocessing techniques.
Animal drugs derived from bioengineered pharmaceutical plants intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals, or to alter the structure or function of the animal, are regulated by the Center for Veterinary Medicine (CVM).
All foods, including animal feeds, derived from plant varieties that are developed using rDNA technology are referred to as "bioengineered foods." The FDA recommends that developers who intend to commercialize a bioengineered food should go through a voluntary consultation process. This consultation process entails first meeting with the FDA to identify and discuss relevant safety, nutritional, or other regulatory issues regarding the bioengineered food. A summary of its scientific and regulatory assessment of the food is then submitted to the FDA. Developers are required to submit this scientific and regulatory assessment, a premarket notice, of the bioengineered food 120 days prior to marketing the bioengineered food. Next, the FDA evaluates the submission and responds to the developer by letter.
More information on “Plant Biotechnology for Food and Feed” may be accessed via the following link:
http://www.fda.gov/Food/Biotechnology/default.htm
Research by Diane Meade
