Outreach, society, policy

Global Regulatory Frameworks for Gene Edited Food Animals

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Abstract

The advent of gene editing (GnEd) offered an opportunity to reconsider whether the introduction of targeted edits should be regulated in the same way as traditionally genetically engineered (GMO) plants and animals carrying a recombinant transgenic DNA construct. Regulatory approaches can be divided into four general categories, ordered from most stringent to least as 1) regulating all GnEd products as GMO requiring safety assessment and approval prior to commercialization, 2) applying simplified GMO regulations to GnEd products, 3) exempting GnEd products that could have been achieved using conventional breeding from GMO regulations following confirmation of non-GMO status by a regulatory body prior to commercialization, and 4) GnEd products are exempt from GMO regulations based on a self-determination by the developer. In 2015 Argentina enacted a Category 3 regulation that allowed developers to submit their proposed or developed products derived using GnEd to Argentine regulators to determine on a case-by-case basis whether they fit the definition of a GMO meaning harboring "a novel combination of genetic material". A decade later, this approach has encouraged both public sector scientists and small to medium sized companies to develop innovative gene edited applications in food animals. Prior to 2015 Argentina approved no genetically engineered animal applications, but to date over 20 GnEd animal applications have received a non-GMO determination Similarly, since it adopted a Category 3 approach in 2018, Brazil has seen approximately 63 requests from 26 different biotechnology companies for commercial release of GnEd organisms. Globally, non-GMO determinations that allow commercialization have been made for several GnEd knockout food animal applications including myostatin cattle, horses and fish; porcine respiratory and reproductive syndrome virus-resistant pigs, leptin receptor knockout fish; and both slick and polled cattle. However, not all countries are following this non-GMO approach. For example, the United States Food and Drug Administration (FDA) regulates heritable "intentional genomic alterations" (IGAs) in animals as new animal drugs. This approach does not distinguish between GMO and GnEd products, and diverges from that used for GnEd plants. In the United States GnEd crops are regulated by the Department of Agriculture using a Category 4 approach, whereas the FDA uses Category 3 for food derived from GnEd plants, but Category 1 for GnEd animals and their products. This results in a much lower regulatory burden to commercialize a simple edit in a GnEd crop as compared to a GnEd animal. Differing safety data requirements for GnEd plants, GnEd animals, and conventionally-bred animals should be triggered by any unique evidence-based safety hazard(s) of the product, rather than an arbitrary categorization based on kingdom (plant/animal) or process (GMO/GnEd/conventional). Mandating the collection of data unrelated to identified hazards unnecessarily adds to the regulatory costs of commercializing GnEd animals in global markets.

Keywords: 2026

How to Cite:

Van Eenennaam, A., (2026) “Global Regulatory Frameworks for Gene Edited Food Animals”, World Congress on Genetics Applied to Livestock Production Digital Archive 2026(1): 2292794. doi: https://doi.org/10.31274/wcgalp.24308

Rights: 1