Genetically engineered animals face daunting regulatory process

By Joan Conrow

March 27, 2019

As AquaBounty navigated an $80 million, 20-year effort to secure approval for its fast-growing salmon, the company knew it was pioneering a process for other animals developed through biotechnology.

Its persistence paid off earlier this month when the US Food and Drug Administration (FDA) finally allowed the company to start farming and marketing AquAdvantage salmon in the US.

Those who believe biotechnology holds promise for improving animal welfare and breeding healthier livestock with a smaller environmental impact take heart that AquaBounty has opened the door.

Still, a daunting regulatory process stands in their way.

It’s been more than two decades since Dr. Matt Wheeler of the University of Illinois and other American researchers developed the first transgenic food animal — a female pig genetically engineered to produce more milk, thus reducing piglet mortality caused by starvation.  Wheeler estimates it could save some 2.68 million piglets that die annually from failure to thrive.

But his work and other important animal research has failed to advance due to regulatory uncertainty. Meanwhile, he struggles to find the funding to keep his animals alive.

“It’s hard to go into the barn because I’m depressed for two or three days afterward,” Wheeler told an international audience of scientists, students and food industry representatives a few years back. “There’s an economic and also a personal cost to this.”

In the years since Wheeler developed his “mini-Holstein” pig, the technology and research have continued to advance, breeding animals with traits that confer disease-resistance without veterinary drugs, reduce the environmental impacts of livestock production, benefit human health and improve animal welfare.

As Pacific Standard recently reported, Randall Prather, animal science professor at the University of Missouri and director of National Swine Resource and Research Center, developed a pig resistant to porcine reproductive and respiratory syndrome (PRRS), a serious disease that costs North American and European farmers some $6 million per day.

Other researchers are working to breed pigs that produce less phosphorous pollution, pigs that develop more and leaner muscle, pigs resistant to African swine fever, cattle that cannot get or transmit mad-cow disease, cattle resistant to sleeping sickness, heat-tolerant cattle and poultry resistant to avian flu.

Still others are pursuing research intended to benefit human health, such as pigs that can grow organs for human transplant, goats that produce milk containing an enzyme that could prevent deadly diarrhea in more than a million children annually in developing countries and pigs that generate their own heart-healthy omega-3 fatty acids.

A number of animal welfare projects also are under way. Dr. Alison Van Eenennaam, a cooperative extension specialist in animal genomics and biotechnology at the University of California-Davis, successfully silenced the gene that produces unwanted horns in Holstein dairy cows, which would thus spare cows the ordeal of dehorning and protect farm workers from the threat of being gored.

While some of these improved animals are still in the research stage, others have been ready to go for a decade or more. It’s largely agreed that the regulatory process is the primary hang up. In response, the National Pork Producers Council has already begun pushing to have the US Department of Agriculture, which regulates genetically engineered crops, assume authority over biotech livestock, too.

That approach would likely bolster the commercialization of gene-edited animals, as the USDA has taken the stance that gene-edited crops should be regulated in the same manner as those bred through traditional methods.

The FDA, however, is lumping all biotech tools together and subjecting gene-edited animals to the same regulatory process that’s used to approve veterinary drugs. Van Eenennaam is ardently opposed to that regulatory stance, and has spearheaded a petition calling for the US to harmonize its gene editing regulations.

Robbie Barbero, who led efforts to modernize biotech regulations in the Obama White House, agrees that it’s time for some clarity, according to a report in Wired. “In the absence of a regulatory path that’s rational and easy to understand, it will be almost impossible for any animals to make it to market,” he said.

And that worries researchers like James Murray and Jenny Graves, who argue that animal biotechnology is crucial to producing more climate-resilient food with fewer environmental impacts. In other words, it’s a tool that a warming planet with a growing population likely can’t afford to ignore.