FDA has released new regulatory processes for intentional genomic alterations (IGAs) in animals, citing the need to update due to evolving science and innovations in animal biotechnology. “These updated guidance documents demonstrate our commitment to facilitating innovation while ensuring product safety,” Tracey Forfa, director of FDA’s Center for Veterinary Medicine, said in a prepared statement. “These technologies hold great promise for many uses and public and animal health benefits, such as animal disease resistance, control of zoonotic disease transmission, improved animal husbandry, and increased food production and quality.”
Elizabeth Presnell, an attorney with Food Industry Counsel, tells Food Quality & Safety that IGAs in animals refer to modifications made to an animal’s genomic DNA using advanced molecular technologies, and FDA has established a risk categorization that splits IGAs into three categories based on risk to both animals and the food supply. “Category 1 is alterations not subject to approval; category 2 is going through a partial approval process where FDA will evaluate the risk and then determine whether or not the alteration needs to go through full approval; and then category 3 is where there is a risk to the food supply where a full approval will be undertaken.”
She explains that this will look a lot like what drug approvals currently undergo.
Mike Schmidt, an attorney from Schmidt and Clark who focuses on food safety and regulatory compliance, calls this a significant development that could have profound impacts on food safety in the years ahead. “This modernization could result in greater regulatory flexibility, predictability, and efficiency,” he tells FQ&S. “For example, the FDA may not require developers of specific types of IGAs in animals to file an application or obtain FDA approval before marketing their product. This could speed up the introduction of these products to the market.”
Some experts believe that the expedited process may raise food safety concerns. While genomic changes can provide advantages such as disease resistance, heat tolerance, faster growth, and feed efficiency, they may also introduce new risks. “For example, changes that result in faster growth may have an impact on the nutritional value of the food produced by these animals,” Schmidt says. “Therefore, it’s crucial that these products are thoroughly evaluated for their potential impacts on food safety before they are introduced into the market.”
In this regard, FDA has established a memorandum of understanding with USDA to clarify roles and responsibilities for regulating IGAs in animals. “It’s an interesting action by FDA as there are critics on both sides,” Presnell says. “With animal agriculture geneticists saying this isn’t going far enough, and then people opposing it because some of the processes are easier to achieve.”
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