The U.S. Food and Drug Administration presented yesterday the final regulations referring to the approval of genetically engineered animals. According to the new rules, the food from these animals will demand consumer labeling.
The procedure of genetic engineering uses recombinat DNA for introducing new characteristics or traits into an animal. The new information buletin provides all the needed details so that the producers of these animals will know what to do in order to get the bureau’s approval. Moreover, producers of these animals will also have to follow the law and regulations of the National Environmental Policy Act.
"It serves to reassure stakeholders that FDA has clear standards for regulatory decisions on these animals allowing us, when appropriate, to bring safe, effective products to market in a timely manner," explained Randall Lutter, deputy commissioner for policy in the FDA's Center for Veterinary Medicine. The FDA will have to approve all the genetically engineered animals before entering the market.
Even though there are many projects involving the genetically engineered animals, none so far managed to receive the agency’s approval for marketing.
"This technology holds great promise for the health of both animals and humans," noted Dr. Bernadette Dunham, director of the FDA's Center for Veterinary Medicine.
The initiative for genetic engineering was introduced with the hope that it will make animals grow faster, produce significantly healthier food and also make sure that certain diseases, such as the mad cow disease, will no longer be an issue. Another aspect is the ecological one, as it could improve the environment by leading to a less toxic animal waste. "Pigs have been genetically engineered to produce less phosphorus in their waste to address agricultural runoff," explained Bernadette Dunham.
Not everyone embraces this type of actions, as there are many who believe that this alters the traditional genetic structure of animals. In order to allow consumers to choose the right type of food, the FDA demands that all the products coming from genetically engineered animals should be labeled, and present all the needed details about the process, in order to be distinguisable from non-genetically engineered products.
There are several uses for this technology, as certain animals are being genetically altered in order to be used in human transplantations - offering cells, tissues or organs which have a smaller chance of getting rejected by the human immune system. Its applicabilty includes islet cells to help diabetics, skin grafts for burn victims, and liver, kidney or heart replacements for the critically ill. From this point of view especially, the technology apperas to be amazing, offering people a second chance.
Dunham concluded that the safety of genetically engineered animals intended for use as food will be decided on a case-by-case basis. The FDA will also want to make sure that the producers of these animals have all the means to demonstrate that the new genetic traits perform as well as claimed.