Trout with double the usual amount of muscle, pork loaded with omega-3 fatty acids, and beef from cattle resistant to mad-cow disease are just a few products from genetically engineered animals under development in labs around the world.
Now that GE plant products appear in some three-fourths of the processed food in a typical U.S. grocery store, it’s only a matter of time before GE animal products hit the fridge shelves, too.
In fact, a Massachusetts company, AquaBounty Techologies, announced last month that it expects a green light from the Food and Drug Administration “in the near future.” Its product, the AquAdvantage® salmon, is an Atlantic salmon with introduced genes from two other fish species that make it grow to marketable size twice as fast as ordinary Atlantic salmon. If it’s approved, it will probably be the first GE animal out of the gates.
A little over a year ago, the FDA issued its final guidance on genetically engineered animals, laying out the process GE animals will have to go through before they can be brought to market. The agency says developers must show that the introduced genetic material is safe for the animals, human consumers, and the environment. So, all things considered, how long before we find GE meat on our plates?
First of all, to be crystal clear, no GE animals have been approved for human consumption, and the FDA says it is not aware of any that might have circumvented its review process and gone straight to market. The majority of GE animals under development are for so-called biopharm purposes, not straight-up eating. The only animal the FDA has approved so far is a goat engineered to produce a protein in its milk that’s used in a drug for people with a blood-clotting disorder.
Also available commercially are GE lab rats and mice used in research, which do not require formal FDA approval, and GloFish®, an aquarium fish that fluoresces thanks to spliced-in coral DNA. The GloFish snuck onto the market in 2003 and the agency quickly exempted it from the need for a review, contending it poses a negligible risk to the environment, and isn’t intended to be eaten.
Despite the pass given the lab rats and aquarium fish, the FDA’s website states that it “expects to require approval of all GE animals intended to go into the human food supply.” Agency spokesperson Siobhan DeLancey said via email that “Enforcement action may include criminal penalties.”
Controversially, the FDA is regulating GE animals the same way it regulates new drugs for nonhuman animals. It’s the introduced DNA — not the animals themselves — that the agency considers a drug. As with drugs, protection of intellectual property is a top priority, and the FDA cannot disclose which animals have been submitted for review, how far along they are, or even how many are in the approval pipeline.
While the agency says it intends to invite the public to attend meetings and offer comments prior to approving a GE animal, it’s committed to protecting corporate trade secrets, so it may withhold some of the data used to evaluate safety. That lack of transparency has raised serious concerns.
So far, only two developers have made their applications public — though it appears likely that there are other applications in the works. Experts say one of the two will probably be the first to market, and right now that looks to be AquaBounty, developer of the fast-growing AquAdvantage® Salmon.
The company says it began its attempt to gain the FDA’s approval for the fish more than a decade ago, and now believes the process is nearly complete. The FDA’s DeLancey confirms that public meetings may take place this fall, at the earliest. Still, AquaBounty says it will likely take another two to three years after approval for the fish to appear in grocery stores, according to the New York Times, which notes that the company has made “overly optimistic” predictions in the past.
The other known contender is Enviropig™, created by researchers at the University of Guelph in Ontario by inserting mouse and E. coli genes into an ordinary Yorkshire pig’s genome. The pig produces an enzyme that lets it break down phosphorous in plant matter. As a result, it requires fewer nutritional supplements and poops out waste that’s less polluting. In February, the Canadian government cleared Enviropigs for research production, a big step forward. Researchers submitted their Enviropigs to the FDA in 2007 but won’t publicly predict when they might be approved.
“I’m going to be surprised if it takes longer than five years” for either the salmon or the pig to make it to market, says Kevin Wells, an animal biotechnologist at the University of Missouri, who has been involved in GE-animal research for over a decade.
What comes next depends on the public’s reaction. If it’s positive or neutral, Wells expects many more GE critters will follow — after a certain time lag while they wend their way through the FDA’s review process.
Being first may have its disadvantages, says Wells. “Because the first person to bring something to market will have to deal with the public perceptions.”
Indeed, it’s hard to imagine a more contentious consumer topic than GE food. The concerns about GE animals are familiar from the battles over GE plants. Critics cite studies indicating possible adverse health effects from GE plants common in the food supply, and wonder whether GE animals will turn out to be the same. They worry about farming economics, and the environmental consequences should GE organisms escape cultivation and interbreed with their wild relatives. They are openly distrustful of researchers, the corporations that fund research, and the FDA. And they dismiss many of the touted benefits of GE animal foods: better nutritional characteristics, faster growth on less feed, reduced environmental footprints, and disease resistance.
“There’s no good reason to do it,” says Ronnie Cummins, the director of the Organic Consumers Association, which opposes all genetically modified organisms. “Does it increase the quantity of food? No. Does it make crops use less pesticides? No. Does it make animals healthier, happier? No.”
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