FDA Issues Draft Guidance on Regulating Genetically Engineered Animals

The U.S. Food and Drug Administration, part of the Department of Health and Human Services, today released for public comment draft guidance on the regulation of genetically engineered (GE) animals. The guidance document is intended to clarify the FDA's regulatory authority in this field, as well as the requirements and recommendations for producers of GE animals and products derived from GE animals.

The comment period for the draft guidance, titled "The Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs," runs for 60 days and closes Nov. 18, 2008. The 25-page document is available online at http://www.fda.gov/cvm/GEAnimals.htm.

"Genetically engineered animals hold great promise for improving human medicine, agriculture, the environment, and the production of new materials, and the FDA has long been involved in their scientific evaluation," said Randall Lutter, Ph.D., deputy commissioner for policy. "Our guidance provides a framework for both GE animals and products made from them to reach the market."

Genetic engineering generally refers to the use of recombinant DNA (rDNA) techniques to introduce new characteristics or traits into an organism. 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. A GE animal is one that contains an rDNA construct intended to give the animal new characteristics or traits.

GE animals can be divided into several classes, based on their intended use. They include animals that produce human or animal pharmaceuticals (biopharm animals); animals that serve as models for human diseases; animals that produce high-value industrial or consumer products, such as fibers; and food-use animals with new traits such as improved nutrition, faster growth or lower emission levels of environmentally harmful substances (such as phosphate in their manure).

Genetic engineering already is widely used in agriculture to make crops resistant to pests or herbicides. In medicine, genetic engineering is used to develop microbes that produce drugs and other therapeutic products for use in humans. In food, genetic engineering is used to produce microorganisms that aid in baking, brewing, and cheese-making.

Using the animal drug provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA's Center for Veterinary Medicine (CVM) has been working with developers of GE animals to make them aware of their responsibilities to ensure that food from these animals does not enter the U.S. food supply unless the FDA has authorized such use.

The FD&C Act classifies "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 intended to affect the animal's structure or function meets the definition of a new 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/or any new products expressed from the inserted construct are safe for the health of the GE animal.

Under the draft guidance, in those 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. The FDA will review this information as part of its food safety assessment, consistent with that recommended in the recently adopted Codex Alimentarius Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Animals. Codex is a worldwide food safety organization sponsored by the United Nations.

The draft guidance also describes a sponsor's responsibility in meeting the requirements for environmental assessment under the National Environmental Policy Act.

Depending on the species of animal and its intended use, the FDA will coordinate with agencies in the U.S. Department of Agriculture (USDA) and with other federal departments and agencies, such as the Environmental Protection Agency, in regulating GE animals. The draft guidance indicates the areas in which the FDA will be working with those agencies to develop a coherent policy under the Coordinated Framework for the Regulation of Biotechnology. USDA has published in the same issue of the Federal Register a "Request for Information" that seeks input on what types of actions and approaches it should consider under the Animal Health Protection Act (AHPA) that would complement FDA's guidance. The AHPA gives the Secretary of Agriculture authority to take specific actions to prevent the spread of diseases and pests of livestock.

"This is a cutting-edge technology that has significant implications, including real benefits, not just for human health, but also for animal health, such as developing disease-resistant animals," said CVM Director Bernadette Dunham, D.V.M., Ph.D. "We look forward to the public comments to help refine our thinking and approach."

The draft guidance describes how the FDA may exercise enforcement discretion, that is, not require premarket approval, for some GE animals depending on potential risk, as we did after reviewing information about Zebra danio, aquarium fish genetically engineered to glow in the dark. For example, the draft guidance states the FDA's intent to exercise enforcement discretion for laboratory animals used for research and kept in confined conditions. The agency does not expect to exercise enforcement discretion for animal species traditionally consumed as food and expects to require approval of all GE animals intended to go into the human food supply.

The draft guidance describes how the FDA regulates heritable rDNA constructs, that is, constructs inherited from one generation to the next. Non-heritable constructs, such as those used for gene therapy to treat individual animals, may be the subject of a subsequent guidance.

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