Jakub Sobkowicz

Associate Editor

Loyola University Chicago School of Law, JD 2027

On April 7, 2025, Colossal Biosciences announced that it had successfully created dire wolves, a species that had been extinct for over 10,000 years, in what is considered a breakthrough in the science of de-extinction. Although it sounds like a work of science fiction, Colossal used dire wolf DNA found in a 13,000-year-old tooth and a 72,000-year-old ear bone to make 20 edits to the DNA of modern gray wolves leading to the birth of 3 dire wolf puppies in the fall and winter of 2024. While the science community both celebrates the breakthroughs in genetic engineering, considers the benefits that this technology can have on modern endangered species, and debates the validity of calling genetically modified gray wolves true dire wolves, it is clear that the regulatory framework of the United States is not yet sufficiently prepared to examine the legal and ethical considerations that come with de-extinction technologies. Though dire wolves were the breakthrough, they are not the end goal for Colossal as it now turns its focus to other popular extinct species such as the wooly mammoth, dodo bird, and Tasmanian tiger. To adequately keep up with these changes in genetic and environmental science, the United States must act quickly to develop an agile multi-agency regulatory framework that can guide the country and world as a whole safely into the new age of de-extinction.

Regulatory and ethical concerns of de-extinction

At its core, de-extinction science appears to have pure intentions to resurrect extinct species while also creating innovative technologies to support species currently on the brink of extinction, such as red wolves, of which only 20 remain in the wild. However, this advancement in biotechnology comes with numerous associated risks and ethical considerations that must be addressed before expanding the use of this technology.

The first primary consideration is the potential impacts and suffering caused by humans trying to “play God.” For example, while Colossal refers to its wolf puppies as dire wolves, they are more accurately genetically modified gray wolves to look like what scientists understand dire wolves to have looked like. This technique of genetically modifying a modern animal related to the extinct species would be the case for any other species that Colossal attempts to resurrect, which comes with unknown consequences for the health and well-being of the animals being created. Colossal’s dire wolves are not the first attempt at de-extinction; the first attempt occurred in 2003 when researchers attempted to resurrect a Pyrenean ibex, a species that went extinct in 2000. After multiple failed pregnancies, researchers managed to facilitate the birth of 1 live ibex that died after just a few minutes due to genetic deformities in its lungs. Severe and painful genetic mutations are commonplace in genetically modified animals. Without regulation on how this type of research is conducted, the pain and suffering may outweigh the benefits of de-extinction. While the dire wolves appear healthy currently, there is no way to know the long-term health implications of the modifications done to the gray wolf DNA.

A second concern is the funding structure of de-extinction projects. By extrapolating the costs of preserving newly resurrected species and comparing that with the costs of safeguarding currently endangered species, researchers conclude that the economically logical funding structure would be to allow de-extinction projects to remain funded by private companies instead of government-led. Suppose the government were to assume responsibility for de-extinction projects out of the existing conservation budget. In that case, researchers estimate that two modern species would go extinct for every one species that is resurrected. While researchers found that private funding is more likely to lead to positive outcomes in increasing biodiversity, this approach emphasizes the need for a robust regulatory framework to allow government oversight of these projects. Still, many argue that any investment in de-extinction, regardless of the source, is money wasted that could be used to help conservation efforts of animals nearing extinction today and will lead to an overall loss in biodiversity.

Which regulatory bodies should be involved?

Although there is no legislation or regulation specifically targeted towards de-extinction, multiple agencies are already involved in aspects of environmental conservation and biotechnology that could be involved in developing the necessary guardrails for this type of research. First, the U.S. Fish and Wildlife Service (FWS) currently manages conservation efforts, law enforcement related to endangered species, and understanding the effects of climate change on biodiversity. This agency should lead the regulation of which animals can be considered for de-extinction without intolerable risk to existing ecosystems and maintain the enforcement of de-extinction regulation. Second, the U.S. Department of Agriculture (USDA) already regulates the use of biotechnologies on plants and can apply a similar framework to the expanding uses of biotechnology on animals as well. Next, as de-extinction expands, it could reach a point where de-extinct species are farmed as a food source. This evolution in de-extinction would require regulation by the U.S. Food and Drug Administration (FDA) and an application of the rules created for current genetically modified organisms. Finally, the National Institute of Health (NIH) must oversee the potential application of genetic research learnings from de-extinction projects to human health outcomes to ensure extended research into human genetics is approached safely and correctly.

How to approach building a regulatory framework collaboratively

Overall, while the significant advances in de-extinction are exciting to some and terrifying to others, the key to approaching this new technology starts with ensuring a robust and collaborative regulatory framework from all relevant government agencies, including the FWS, USDA, FDA, and NIH. This cooperative effort may be complex but can be achieved through clear direction from the executive and legislative branches while following the seven organizational processes that foster cross-agency collaboration: setting significant goals, specifying roles and responsibilities, formalizing agreements, developing shared operations, obtaining adequate resources, creating effective communication channels, and adapting through shared learning. Through successful cross-agency collaboration, the United States has a pathway to becoming a global leader in de-extinction research and effective de-extinction regulation that holistically accounts for impacts on current ecosystems while exploring the potential benefits of increasing biodiversity in environmental conservation.