Gene-Edited Animals for Agricultural Applications Database
This ISAAA database compiles a list of animals developed through gene editing (also called New Breeding Techniques) for agricultural applications. The information provided in this database is based on the following scientific report:
Van Eenennaam, AL. 2023. New Genomic Techniques (NGT) in animals and their agri/food/feed products. ESFA Supporting Publications, Vol. 20 (Issue 9). https://doi.org/10.2903/sp.efsa.2023.EN-8311.
This database is managed in collaboration with the University of California - Davis, USA
Historically, genetically engineered organisms must be granted regulatory approval for genetically modified organisms (GMOs) to be commercialized or sold in any given country. A database of GM crop events approved worldwide is maintained on the ISAAA website.
Gene-edited products are often not considered for regulatory approval, as many countries and jurisdictions are considering edits that could have been achieved using conventional breeding (e.g., knockouts, intraspecies allele substitutions) as conventional breeding. Most of the gene-edited products do not have to go through a GMO approval process but rather enter into a regulatory process to obtain a determination as to whether they are or are not a GMO. Depending upon the country, this is sometimes based on the Cartagena protocol definition of a living modified organism (LMO) which includes "any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology." This is often interpreted to mean they are free of any "transgene" or "foreign" DNA.
What does undergone regulatory process mean?
Developers of several gene-edited animals have entered a regulatory process in different countries to obtain a determination as to whether they will be regulated as a GMO. This process goes by various names e.g., "prior consolation" in Argentina where all gene-edited products must be submitted on a case-to-case basis to the Argentine Biosafety Commission (CONABIA). CONABIA must respond within 60 days to whether a new product will be subject to GMO regulations (Whelan and Lema, 2016). Products that have gone through this process and received a determination that permits their commercialization in that country are listed as "YES" for having gone through a regulatory process, and products from those gene-edited animals can be sold in that country.
A determination does not necessarily mean products are currently in the marketplace but rather indicates they could be sold there if a developer chooses to do so. Links to the regulatory documents, based on publicly available English (or translatable) decision documents of each approving country, are included where available.
For more information on the regulation of animal biotechnologies please see the following review:
Hallerman, E., Bredlau, J., Camargo, L.S.A. et al. 2024. Enabling regulatory policy globally will promote realization of the potential of animal biotechnology. CABI Agric Biosci 5, 25 https://doi.org/10.1186/s43170-024-00221-6
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