Genetic engineering is a process in which recombinant DNA (rDNA) technology is used to introduce desirable traits into organisms. A genetically engineered (GE) animal is one that contains a recombinant DNA (rDNA) construct producing a new trait. While conventional breeding methods have long been used to produce more desirable traits in animals, genetic engineering is a much more targeted and powerful method of introducing desirable traits into animals.
FDA issued guidance for industry on the regulation of genetically engineered (GE) animals. The guidance explains the process by which FDA is regulating GE animals and provides a set of recommendations to producers of GE animals to help them meet their obligations and responsibilities under the law. While the guidance is intended for industry, FDA believes it may also help the public gain a better understanding of this important and developing area.
Under the new animal drug provisions of the Federal Food, Drug and Cosmetic Act (FFDCA). The guidance, titled “The Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs,” clarifies the FDA’s statutory and regulatory authority, and provides recommendations to producers of GE animals to help them meet their obligations and responsibilities under the law.
When scientists splice together pieces of DNA and introduce a spliced DNA segment into an organism to give the organism new properties, it is called rDNA technology. The spliced piece of DNA is called the rDNA construct. A GE animal is one that contains an rDNA construct intended to give the animal new characteristics or traits.
“Genetic engineering is a cutting edge technology that holds substantial promise for improving the health and well being of people as well as animals. In this document, the agency has articulated a scientifically robust interpretation of statutory requirements,” said Randall Lutter, Ph.D., deputy commissioner for policy. “This guidance will help the FDA efficiently review applications for products from GE animals to ensure their safety and efficacy.”
The FDA’s Center for Veterinary Medicine (CVM) has been working with developers of GE animals on both early stage and more mature applications.
“At this time, it is our intent to hold public scientific advisory committee meetings prior to making decisions on GE animal-related applications” said Bernadette Dunham, D.V.M., Ph.D., director of CVM.
The FFDCA defines “articles (other than food) intended to affect the structure or any function of the body of man or other animals” as drugs. An rDNA construct that is in a GE animal and is intended to affect the animal’s structure or function meets the definition of an animal drug, whether the animal is intended for food, or used to produce another substance. Developers of these animals must demonstrate that the construct and any new products expressed from the inserted construct are safe for the health of the GE animal and, if they are food animals, for food consumption.
The guidance also describes the manufacturer’s responsibility in meeting the requirements for environmental review under the National Environmental Policy Act.
Benefits of GE Animals
GE animals hold great promise for human and animal health, the environment, and agriculture.
Health protection of animals – Animals are under development to be more resistant to very painful and harmful diseases, such as infection of the udder (mastitis) in dairy cows and bovine spongiform encephalopathy (widely referred to as “mad cow” disease) in all cattle.
New source of medicines – Animals can be engineered to produce particular substances, such as human antibodies, to make infection-fighting drugs for people. These “biopharm” animals can change the way we treat chronic diseases, such as bleeding disorders, by providing large quantities of safe, health-restoring proteins that previously were available only from human cadavers.
Transplantation – Pigs are being engineered so that their cells, tissues, or organs could be transplanted into humans with a reduced risk of immune rejection.
Less environmental impact – Food animals are being engineered to grow more quickly, require less feed, or leave behind less environmentally damaging waste.
Healthier food – Food animals, such as pigs, are under development to contain increased levels of omega-3 fatty acids, providing a more healthful product. Livestock can also be engineered to provide leaner meat or more milk.
Buckey and Tucker have been engineered so that their female offspring will be able to express spider silk proteins in their milk. These proteins can then be used to spin silk fibers that have many applications, including artificial ligaments and bulletproof vests. Buckey, Tucker, and their mother, Virtue (top left), are part of a promising research program at the University of Wyoming.
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