FDA issues draft guidance on genetically engineered animals


By Ann Bagel Storck on 9/18/2008


Source of Article:  www.meatingplace.com


The U.S. Food and Drug Administration on Thursday released for public comment draft guidance on the regulation of genetically engineered (GE) animals.

The guidance is intended to clarify FDA's regulatory authority in this area, as well as requirements and recommendations for producers of GE animals and products derived from GE animals. To read the FDA document, click here.

Genetic engineering generally refers to the use of recombinant DNA techniques to introduce new characteristics or traits into an organism. Under the draft guidance, in cases in which the GE animal is intended for food use, producers will have to demonstrate that food from the GE animal is safe to eat. FDA will review this information as part of its food safety assessment. Depending on the species of animal and its intended use, FDA will coordinate with agencies in the U.S. Department of Agriculture and with other federal departments and agencies in regulating GE animals.

The comment period for the draft guidance closes Nov. 18.




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