The Food and Drug Administration issued on Thursday “The Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs,” which will regulate the production of genetically engineered (GE) animals.

 

Randall Lutter, deputy commissioner for policy at the FDA, released a statement, saying that “genetic engineering is a cutting edge technology that holds substantial promise for improving the health and well being of people as well as animals.”

 

The new guidelines “will help the FDA efficiently review applications for products from GE animals to ensure their safety and efficacy,” Lutter added.

 

The agency released the draft guidance in September 2008 with a 60-day public comment period. About 28,000 comments belonging to several organizations and individual citizens were posted on the agency’s Web site all referring to the possibility of genetically engineered animals entering the public’s food system. Many people believe that genetic engineering is, ethically, wrong and that animals should not be altered.

 

Under the new regulations, a genetically engineered product requires only a label saying it has new nutritional content. For example, if milk were engineered to contain more vitamins, the label would have to say that it has more vitamins, not that it was genetically engineered, a fact that quickly drew consumer groups’ criticism.

 

“FDA claims these foods are not different from conventional food, and therefore don't need to be labeled. This flies in the face of consumer opinion and common sense,” said Jean Halloran, a director at Consumers Union, publisher of Consumer Reports, in a statement.

 

More information can be found at www.fda.gov/cvm/GEanimals.htm.