How to Regulate Genome-Edited Animals? A Comment on FDA’s Proposed Guidance

June 19, 2017

Randall Lutter & Lena Lewis

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The FDA has proposed an approach to oversight of genome edited animals that closely follows its current policy regarding genetically engineered animals. Unfortunately, the proposed approach is unwise because the existing policy regarding genetically engineered animals, which it mimics, has itself simply failed. We recommend that FDA conduct an analysis of the benefits and costs of its proposed review of genome edited animals, and develop any mandatory policy regarding regulation of genome edited animals based on the results of such analysis. In addition, FDA should withdraw its draft guidance for genome edited animals and explore publicly the feasibility and practicality of alternative approaches modeled on its existing program overseeing genetically engineered plants. Finally, FDA should participate, along with other federal agencies including EPA, in the development of standards to identify new organisms that pose significant risk and to protect the environment from the release of such organisms, including animals and plants altered with gene drives.


At the end of the Obama Administration, three federal agencies solicited comment on proposed policies to oversee the use of new genome editing techniques—including CRISPR—to develop new varieties of plants, algae, and animals. These proposals, issued by the Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), and the USDA’s Animal and Plant Health Inspection Service (APHIS), have set the stage for a decision by the Trump Administration about whether and how to apply the 1986 Coordinated Framework for Biotech Regulation to newer genome editing technologies. These technologies differ from earlier genetic engineering (GE)—recombinant DNA technology—by depending on edits to an existing genome rather than on the insertion of genetic material taken from organisms belonging to another species or even kingdom. The products of genome editing thus might, in principle, occur naturally, an observation that raises questions about risk, and the proper degree of federal oversight, particularly in the absence of legislation specifically addressing these technologies.

On January 19, 2017, FDA proposed to regulate all genome edited animals under its new animal drug authorities (FDA, 2017c). More specifically, FDA proposed a finding that altered genomic DNA from modern genome editing in an animal is a drug within the meaning of section 201(g) of the FD&C Act because such altered DNA is an article intended to affect the structure or function of the body of the animal. The proposed guidance closely follows the existing guidance finalized on January 15, 2009 for genetically engineered animals, but greatly expands the scope of the guidance to cover not only genetically engineered animals but also all genome edited animals. The final 2009 guidance imposed compliance responsibilities on developers of new animals containing recombinant DNA constructs, i.e., insertion of DNA from another species or even kingdom (FDA, 2009). The guidance FDA proposed in January, 2017 classifies any edits to an animal’s genome as a drug, even if the resulting gene sequences already exist in the animal species’ own genepool.

Here we explore FDA’s regulatory approach and its implications for safety to humans, animals and ecosystems, and for innovation. We conclude that a regulatory approach less stringent than proposed by FDA would be more consistent with longstanding regulatory principles as well as other federal policies. We recommend that

FDA estimate the benefits and costs of any new mandatory premarket review requirements, as required by longstanding executive orders;

FDA withdraw its draft guidance 187 and explore publicly a voluntary approach modeled on FDA’s review of new genetically engineered plants;

FDA, along with other agencies including EPA, work to develop standards to identify new organisms that pose significant risk and to protect the environment from the release of such organisms.