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The U.S. Food and Drug Administration approved a first-of-its-kind intentional genomic alteration (IGA) in a line of domestic pigs, referred to as GalSafe pigs, which may be used for food or human therapeutics. This is the first IGA in an animal that the FDA has approved for both human food consumption and as a source for potential therapeutic uses. The IGA in GalSafe pigs is intended to eliminate alpha-gal sugar on the surface of the pigs’ cells. People with Alpha-gal syndrome (AGS) may have mild to severe allergic reactions to alpha-gal sugar found in red meat (e.g., beef, pork, and lamb).
GalSafe pigs may potentially provide a source of porcine-based materials to produce human medical products that are free of detectable alpha-gal sugar. For example, GalSafe pigs could potentially be used as a source of medical products, such as the blood-thinning drug heparin, free of detectable alpha-gal sugar. Tissues and organs from GalSafe pigs could potentially address the issue of immune rejection in patients receiving xenotransplants, as alpha-gal sugar is believed to be a cause of rejection in patients.
As part of its review, the FDA evaluated the safety of the IGA for the animals and people eating meat from them, as well as the product developer’s intention to market the IGA for its ability to eliminate alpha-gal sugar on pigs’ cells. The FDA determined that food from GalSafe pigs is safe for the general population to eat.
As part of its review, the FDA analyzed the potential impact that the approval of the IGA in GalSafe pigs would have on the U.S. environment and determined it is no greater than from conventional pigs. The conditions under which GalSafe pigs will be kept are far more stringent than those for conventionally farmed pigs. Additionally, no animal safety concerns were noted for GalSafe pigs beyond those that would be expected in well-managed, commercial swine operations.
The FDA also assessed the risk of the IGA to promote the emergence or selection of antimicrobial-resistant bacteria of human health concern in or on GalSafe pigs. The FDA concluded that the microbial food safety risk is low and is mitigated by the low number of GalSafe pigs entering the food supply and the ongoing surveillance for antimicrobial resistance, among other factors.
It’s important to note that these pigs have not been evaluated for use as xenotransplantation products for transplantation or implantation into human subjects. Developers of any such human medical products must first submit an application to, and obtain approval from, the FDA before these products can be used in human medicine.
December 14, 2020/FDA/ USA. https://www.fda.gov/
