These GE Animals Don't Come With Lightbulbs

Genetically Engineered Animals

On September 18, 2008, FDA’s Center for Veterinary Medicine released draft Guidance for Industry #187 to clarify the Agency’s regulation of Genetically Engineered (GE) Animals.

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Q:What is genetic engineering?

A: Genetic engineering is a process in which recombinant DNA (rDNA) technology is used to introduce new characteristics or traits into organisms.  When scientists splice together pieces of DNA and introduce a spliced DNA segment into an organism to give the organism new properties, it’s called rDNA technology. The spliced piece of DNA is called the rDNA construct. Genetic engineering has been widely used in agriculture to make crops resistant to certain pests or herbicides, in medicine to develop microbes that can produce pharmaceuticals for human or animal use, and in food to produce microorganisms that aid in baking, brewing, and cheese-making.

Q: What is a genetically engineered animal?

A: A genetically engineered (GE) animal is one that contains an rDNA construct that’s intended to give the animal a new trait or characteristic. Examples of the kind of GE animals that are being developed are provided below.

Q: What kinds of GE animals are being developed?

A: Many kinds of GE animals are in development, although none have yet been approved for commercial use.  

• Biopharm animals are those that have undergone genetic engineering to produce particular substances, such as human insulin, for pharmaceutical use. 

• Research animals may be engineered to make them more susceptible to particular diseases, such as cancer, in order to gain a better basic understanding of the disease for the development of new therapies or in order to evaluate new medical therapies.

• Xenotransplant animals are being engineered so they can be used as sources for cells, tissues or organs that can be used for transplantation into humans.

• Companion animals that are modified to enrich or enhance their interaction with humans (i.e., hypoallergenic pets). 

• Disease resistant animals may be used either for food use or biopharm applications. These animals have received modifications that make them resistant to common diseases, such as mastitis (a very painful infection of the udder) in dairy cows, or particularly deadly diseases, such as bovine spongiform encephalopathy (BSE).

• Food use animals have been engineered to provide healthier meat, such as pigs that contain healthy omega-3 fatty acids at levels comparable to those in fish.

Q: How are GE animals regulated?

A: FDA regulates GE animals under the “new animal drug”1  provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA), FDA’s regulations for new animal drugs. This draft guidance is intended to help industry understand the requirements that are established by statute and regulations as they apply to these animals, including those of the National Environmental Policy Act (NEPA), and to inform the public about the process FDA is using to regulate GE animals. The draft guidance does not create any new obligations. It clarifies how the regulations apply to GE animals.