‘GalSafe’ pigs now join salmon as the only genetically modified organisms approved for human consumption in the United States.
The US Food and Drug Administration (FDA) has approved the use of genetically engineered pigs in both food and medical products. These pigs (called ‘GalSafe’) can be used in the production of drugs, to provide organs and tissues for human transplant, and to produce meat that is safe for consumption for people with meat allergies.
Developed by a company called Revivicor, they are the first genetically altered animals the FDA has every approved for both human consumption and medical use. Any parties wishing to use GalSafe pigs for new drugs, transplants or implants in humans will need to seek further FDA approval.
The genetic alternation in GalSafe pigs eliminates the ‘alpha-gal’ sugar found on the surface of pig cells. Some people may have an allergic reaction if they eat the sugar that is found in normal beef, pork, lamb and other red meats. Revivicor initially intends to sell GalSafe pork through delivery and not in stores.
In terms of medical application, the FDA states that GalSafe pigs may potentially provide a source of materials for the production of human medical products, obviously also free of detectable alpha-gal sugar. “For example, GalSafe pigs could potentially be used as a source [for a alpha-gal-free form of] the blood-thinning drug heparin,” stated the FDA in a press release.
In addition, “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. As part of its review, the FDA analysed the potential impact that the approval of the IGA in GalSafe pigs would have on the US environment and determined it is similar to that of conventional pigs. However, the conditions under which GalSafe pigs will be kept are far more stringent than those for conventionally-farmed pigs.
In 2009, the FDA approved GMO goats that produce a drug in their milk for preventing blood clots. In 2015, the agency granted approval for GMO chickens that can make a drug in their eggs, and approval for salmon as the first GMO animal for eating.