US FDA declares genetically modified pork ‘safe to eat’

Genetically modified (GM) pigs have been approved for food and medical use in the US, drawing mixed reactions. The pigs are only the second GM animal to be approved for food after GM salmon in 2015.

The US Food and Drug Administration (FDA) this week approved the GM pigs, which have been engineered to eliminate alpha-gal, a sugar found in pigs that can cause allergic reactions.

The FDA said it was the first time it had approved a GM animal for human food and medical use.

The FDA said it had determined that the food from the GM pigs, known as GalSafe pigs, is “safe for the general population to eat”, and suggested the meat might be sold by mail order.

A spokesperson for United Therapeutics Corp, the GM pig developer, was more cautious. In an email to the Guardian, the company’s head of investor relations said it had no plans to sell meat directly. The more immediate goal, he said, was to focus on alpha-gal free, whole-organ transplants for patients with alpha-gal syndrome.

“We’re looking at the potential for partnering with meat producers, but we have no plans to sell any meat ourselves,” said Dewey Steadman, adding that the “size of the GalSafe herd is limited to one farm and 1,000 head along with one abattoir”, indicating that mass distribution was not possible now.

Steadman said the current gene edit was “just one of 10 edits we are currently using in pigs for our preclinical xenotransplantation [transplants to humans from nonhuman sources] development program that we hope one day will help address the critical shortage of transplantable organs for humans in need.”

Walter Sanchez-Suarez, the veterinary scientist, and animal behaviour and welfare expert, was less upbeat. “Unfortunately, this is another example of how sentient non-humans are systematically exploited in the US,” he said.

Suarez, who works with US NGO Mercy for Animals, said genetic modification was a “complex tool with great potential [but] also one whose use raises serious ethical and practical questions”. That tool, he said, would now be “merely employed to support the financial interests of animal production corporations”.

Consumers interested in alpha-gal free meat might include those who have alpha-gal syndrome, believed to be caused by tick bites. Consumption of standard red meat, which also contains alpha-gal, can then trigger allergic reactions, ranging in severity from hives to difficulty breathing.

The US Center for Food Safety, a non-profit organisation, noted that the meat from the genetically-modified pigs had not yet been tested on people with the allergies. Steadman confirmed that was the case.

Jaydee Hanson, policy director at the center, said he was not aware of any tests being done on the pigs as a source of food or transplants. “We are meeting next week with our legal staff to decide whether to sue the FDA over the GM pig approval,” Hanson said. “My greatest concern is that we don’t know if this is safe to eat, or as an organ transplant source, and no scientists, nor the public, have seen the data. Nor was there any FDA public consultation process, as there normally would be.”

A European Food and Safety Administration (EFSA) spokesperson said that to date, “no GM animal, or food derived from GM animals, have been authorised for placement on the market in the EU, nor have any applications been made by industry for approval”.

A subsidiary of United Therapeutics, Revivicor, is a spin-off from the UK company, PPL Therapeutics, which produced the first cloned sheep, Dolly, in 1996.

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