The U.S. Food and Drug Administration is announcing the availability of a pre-recorded webinar for developers who are interested in learning more about the process of requesting an Investigational Food Use Authorization (IFUA) for animals with investigational intentional genomic alterations (IGAs). IGAs in animals are alterations to the animal’s genome that are made using genome editing or rDNA technologies.
An IFUA permits edible tissues (such as meat, milk, eggs, honey) from animal species treated with investigational products like new animal drugs, food additives, and IGAs in animals to be used for food. The FDA will issue a letter authorizing the food use of a specific set of animals after evaluating data to identify any potential food safety hazards and ways to avoid them to ensure the safety of the edible products entering the human food chain. IFUAs are helpful to developers because they allow animals (or their products) to be used for food instead of being wasted.
The webinar covers what an IFUA is; when it is appropriate to make an IFUA request; the types of data and information the FDA reviews in support of an IFUA request; three case study examples that cover different types of scenarios where developers of IGAs in animals might request IFUAs; and administrative procedures that developers of IGAs in animals follow when submitting an IFUA request.
Any developer or sponsor of a genetically altered animal for food use can apply for an IFUA as long as they have an investigational file established with the agency. In order to receive an IFUA, the developer must submit sufficient data to demonstrate that food from these investigational animals is safe for human or animals to eat. The agency reviews the data submitted, and if appropriate, will issue an authorization allowing the developer to send the specified animals to slaughter or rendering for animal food. If an authorization is granted for human food use and slaughter of the animal is subject to inspection by USDA’s Food Safety and Inspection Service (FSIS), the FDA will notify FSIS. The developer or sponsor must also notify FSIS and the FDA 10 days before sending the animals to slaughter. All products must be in compliance with any other applicable USDA requirements.
To watch the webinar, please visit FDA Animal Biotechnology Case Study Webinar for Investigational Food Use Authorizations of Animals with Investigational Intentional Genomic Alterations. Please submit any questions following the webinar to FDA-CVM-Animal-Biotechnology-Feedback@fda.hhs.gov by June 30, 2023. If needed, we will post a follow-up with answers to the commonly asked questions.
For more information:
- Intentional Genomic Alterations (IGAs) in Animals
- CVM GFI #187 Regulation of Intentionally Altered Genomic DNA in Animals