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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA Releases Final Guidance on Genetically Engineered Animals

FDA Veterinarian Newsletter 2008 Volume XXIII, No IV

The Food and Drug Administration issued a final guidance in January 2009 to clarify FDA’s approach to the regulation of genetically engineered (GE) animals and to provide industry and other stakeholders an overview of how producers of these animals can meet their responsibilities and obligations as they develop these animals. This guidance, and accompanying information, including a series of question and answer documents can be found at www.fda.gov/cvm/GEAnimals.htm.

According to the Federal Food, Drug, and Cosmetic Act (FFDCA), the “recombinant DNA (rDNA) construct” that is engineered to introduce a new trait into an animal fits the legal definition of a new animal drug because it is an article other than food intended to affect the structure or function of an animal. When scientists introduce a new rDNA construct into an animal, the animal is then often referred to as a GE animal.

FDA’s Center for Veterinary Medicine has the authority under the FFDCA to regulate the commercialization of new animal drugs. The guidance says that CVM will continue to use this authority to review animals carrying the genetically engineered constructs.

According to Dr. Randall Lutter, FDA’s Deputy Commissioner for Policy, FDA has been using this approach since producers of GE animals began to approach the Agency. “This draft guidance should clarify for all of our stakeholders the approach the FDA has been using to regulate GE animals for some time,” he said. “The goal of the guidance is to explain to producers of GE animals how to meet their obligations under the existing laws and regulations,” Dr. Lutter said. FDA issued the guidance at this time because the technology has evolved to a point where commercialization of these animals is rapidly approaching reality.

In addition, the guidance should help consumers understand how FDA is overseeing the commercialization of GE animals and what protections are in place, Dr. Lutter added.

CVM is in the best position to provide oversight for this technology, according to CVM Director Dr. Bernadette Dunham. “CVM is comprised of a dedicated staff of professionals trained to examine the impact of new science on the health of humans and other animals,” Dr. Dunham said during a January 15, 2009, media teleconference about the final GE animal guidance. “We have assembled a multi-disciplinary group of individuals from across the Center who work together to address the complex and often novel issues that this technology can pose. That group includes molecular biologists, veterinarians, environmental specialists, animal scientists, professors, and board certified toxicologists,” she said.

What is a GE animal?

GE animals “are simply animals such as cattle, pigs, fish, and goats that have had a piece of DNA added to them to introduce a desirable trait,” according to Dr. Larisa Rudenko, CVM’s Senior Advisor for Biotechnology. She added, “The GE animals themselves are not drugs; rather they contain new animal drugs.”

GE animals were first produced in the 1980s, and since then the technology has expanded. Some animals were developed to produce pharmaceuticals for human use in their milk or blood, or provide cells, tissues, or organs for human transplantation. Some GE animals will be better able to resist disease, possibly including bovine spongiform encephalopathy, also known as “mad cow disease.” Other animals are being developed so that they can produce high-value products for industrial use or for consumers. Some are being developed because they will have less of an effect on the environment. And others will produce food products with desirable attributes, such as pork with higher levels of Omega-3 fatty acids.


As with any review of a new animal drug, CVM will be considering the safety of the gene construct to the animal, the safety of any food derived from the animal (if it is intended to enter the food supply), the effectiveness of the construct, and any possible threat to the environment.

Transparency is a frequently cited concern about the approval of GE animals. In the final version of the guidance, the Agency announced its intent to hold public advisory committee meetings prior to approving any GE animal. These meetings are open to the public and will aid in informing the public about the product that FDA is reviewing and how the Agency has conducted its review. Once an animal drug is approved and notice of the approval appears in the Federal Register, CVM publicly releases key information about the approval, which is posted on its Web site.

Addressing environmental concerns will be an important part of the pre-approval process, Dr. Rudenko said. The pre-approval process that will apply to GE animals “is really quite rigorous,” she said. “We are very concerned about appropriate record keeping, and that the appropriate studies be conducted to determine safety to the animal, food safety if the GE animal is intended for food, and making sure that the GE animal exhibits the traits that the sponsor intends them to exhibit.” GE animal sponsors also will have to perform an environmental assessment including providing sufficient information for CVM to be able to examine the possibility of a GE animal escaping, potentially interbreeding with wild populations, and assessing the risk(s) that may pose.

If a food produced from a GE animal is materially different from food derived from non-GE animals, it will have to be labeled. Dr. Eric Flamm, Senior Science Policy Advisory at FDA, said that, if a GE pig produces meat with more omega3-fatty acids than is contained in meat from non-GE animals, the meat would have to be labeled as containing the higher levels. “If you have changed the food in a material way, that change has to be indicated in labeling,” he said. Labeling would not be required, though, to indicate only that a food was derived from GE animals.

Dr. Rudenko added that, based on risk, the Agency might decide to apply enforcement discretion to some GE animals. For instance, animals of species not traditionally consumed as food, used for laboratory research, and kept in highly contained conditions would not need to be approved. In addition, some other non-food animals, once subject to a risk-based review, might also be marketed without a formal approval (e.g., GloFish).

However, she added, any sponsor developing a GE animal, no matter what the use, should discuss the development with CVM to determine what requirements the sponsor will have to follow.


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