The U.S. Food and Drug Administration on Thursday released
for public comment draft guidance on the regulation of genetically engineered
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 Under the draft
guidance, in cases in which the GE animal is intended for food use, producers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The comment period for the draft guidance closes Nov. 18.