But even as the landmark occasion approaches, AquaBounty continues to face heated opposition. In early November, a federal judge ruled that the Food and Drug Administration (FDA) approved the GE fish in 2015 without considering what would happen if it escaped into the wild. According to AgWeek:
FDA’s analysis, contained in an environmental assessment prepared under the National Environmental Policy Act (NEPA), “essentially stopped without assessing the possibility of harm to the natural salmon species in the unlikely event of [GE] salmon establishing themselves in the wild,” U.S. District Judge Vince Chhabria said in a ruling issued [Nov. 5].
AquaBounty said the ruling, while disappointing, shouldn’t slow its plans to bring AquAdvantage salmon to market, and even judge Chhabria anticipates the FDA can provide the required data since he refused to revoke the agency’s approval. But the decision nonetheless illustrates what happens when politics and legal technicalities (instead of science) guide our biotechnology regulations. Committed anti-GMO groups did a remarkable job of delaying the introduction of AquAdvantage salmon, and they’re determined to halt the approval of any more genetically engineered animals—whatever the benefits to sustainable food production and medicine may be.
Is there a way out of this regulatory morass, or are we determined to deny ourselves the innovations made possible by animal biotechnology?
The promise of genetically engineered animals
Genetic engineering could greatly enhance the animals we rely on for eggs, meat, milk and many other products. Any number of examples makes this patently obvious, but breeding disease-resistant animals is perhaps the most important application, given the enormous losses that farmers sustain trying to keep their animals healthy.
Foot and mouth disease alone, which plagues pigs, sheep and cows, costs an estimated $6.5 billion to $21 billion annually in veterinary bills and production losses worldwide, and gene editing may very well be able to prevent the catastrophic losses caused by this and other conditions. Dan Kovich, director of science and technology for the National Pork Producer Council, summed up the importance of gene editing for disease prevention while discussing the deadly African Swine Fever (ASF):
“We as an industry right now are looking at the potential of a gene-edited pig that is resistant to the African Swine Fever (ASF) virus. The exciting thing about gene-editing is that it allows us to make changes within the animal’s own genome that…will give us a whole new toolbox to deal with these viral diseases. That is something in the future, but we are actively working to try and find a workable regulatory pathway so that when these tools are available, we have a way to be able to utilize them in our herds.”
ASF can have a devastating impact on hogs. In 2019 in China, for example, the virus slashed pork production to a 16-year low, thinning the country’s hog herds by 41 percent compared to previous years. The steep decline in pork output prompted a large increase in consumer prices and an equally large increase in pork imports.
Just like us, farm animals can suffer when temperatures get too high. We just turn down the thermostat during summer heatwaves, but gene editing may actually allow scientists to breed cattle that better withstand sweltering conditions. Using the technology, scientists have bred a Red Angus calf with shorter, slicker hair and other metabolic features that help it survive hotter climates. According to research conducted by the biotech firm Recombinetics, slick-haired animals have internal temperatures about one degree Fahrenheit lower during the summer months than cattle with normal hair coats. This is of particular importance given rising global temperatures fueled by climate change.
Treating human conditions
Immunizing animals against deadly diseases and intense summer heat ultimately benefits consumers, of course, but humans stand to gain tremendously from the use of animal biotechnology in medical research as well. To cite just one example, scientists at the University of Edinburgh’s Roslin Institute in Scotland have developed genetically modified chickens that can lay eggs containing drugs for arthritis and some cancers.
The drugs are roughly 100 times cheaper to produce this way compared to current manufacturing procedures (chicken sheds are less costly to build than sterile factories), meaning gene editing could potentially expand access to life-saving medicines by lowering the prices consumers pay for them. “We are not yet producing medicines for people,” said Roslin Institute Professor Helen Sang, “but this study shows that chickens are commercially viable for producing proteins suitable for drug discovery studies and other applications in biotechnology.”
Activist scare tactics
So what possible objection could there be to these advances in food production and medicine? Corporate conspiracy. The anti-biotech lobby has returned to this classic talking point to block the development of animal biotechnology applications, using lurid language to scare the public without actually evaluating the data scientists have gathered. The Center for Food Safety, which is litigating the suit against the FDA over GM salmon, warns that:
“Genetically engineered (GE) animals are being produced by corporate scientists using biotechnology purporting to generate novel proteins and chemicals for rapid growth better nutrition or pharmaceutical drugs – all of which are intended for mass production via cloning…instead of addressing and changing the unhealthy, inhumane conditions of the nation’s factory farms, agribusiness is redesigning animals to fit an industrial mold with few government safeguards to protect the public and the animals used for our food supply.”
This analysis bears little resemblance to reality. Animal agriculture poses no significant risk to human health, says the CDC. Federal law very tightly regulates how animals are treated, and of course farmers are incentivized to care for their animals; they produce more if they’re healthy, veterinarian and farmer Leah Dorman told the GLP in 2018. But in any event, breeding animals that withstand deadly diseases is anything but “inhumane.”
Environmentalists also frequently point to pollution caused by animal waste in their critiques of “factory farming,” but gene editing appears poised to make a major impact here. Scientists at the University of Guelph in Canada have bred an “Enviropig,” a genetically engineered swine with modified salivary glands that help it digest more phosphorus in its feed, reducing the environmental impact of pig waste—the infamous algae blooms that kill all sorts of marine life.
Although studies indicated Enviropig posed no food safety risk to humans, funding for the program ran out in 2012. With regulation blocking the path to commercialization, additional research funding made little sense. Still, this perverse incentive highlights an important question: what do scientists do when their research is viable but the regulatory environment makes their work effectively impossible?
Moving to greener pastures
Nobody understands the situation better than US animal geneticists, whose hands have been tied by the regulatory juggernaut at the FDA. Alison Van Eenennaam, a researcher in the Department of Animal Science at the University of California, Davis, has been particularly critical of the agency’s decision to regulate gene-edited animals as if they were veterinary drugs:
“Ultimately this ruling may hinder the use of gene-editing to introduce useful attributes – like disease resistance – into US livestock populations…Such applications are unlikely to reach the market if intentional alterations are regulated as drugs….There is nothing fundamentally hazardous about genetic alterations variation in food, and suggesting intentional alterations are equivalent to drugs will frighten consumers who might logically infer the presence of drugs in their food.
How can the absence of something, a snippet of DNA – as in the case of a deletion – be considered a drug residue when an analogous deletion in the genome of a mushroom is not?”
Other experts have explained the inevitable results of such confused regulations. James D. Murray, professor of animal sciences at UC Davis, and Jenny Graves, distinguished professor of genetics at La Trobe University noted in a recent article:
“The worldwide regulatory dysfunction around the breeding of GM animals to produce food for human consumption has effectively limited advancement in this field. Expensive delays and uncertainties have stopped work and limited capacity building in virtually all the developed countries…At present, there appears to be little corporate support for using GM animals in agriculture.”
This leaves many researchers with one option: move to one of the few countries with more science-based rules. After Recombinetics unsuccessfully petitioned the FDA in 2016 to approve its gene-edited, hornless dairy cow, the company decided it had no other choice but to transplant its research to Brazil, one of the few countries to break from the US on animal biotech oversight. Regulators in the South American country gave the green light, recognizing that hornless cattle occur naturally and that Recombinetics only had to turn off one gene to express the same trait in its genetically engineered cow.
From this new research base, the company has indicated it will market its hornless and heat-resistant cattle in Brazil, Argentina, Canada and Australia. “We don’t really need the United States,” Recombinetics chief scientific officer Mitch Abrahamsen told Nature in 2019. “It’s just a reality.” Dozens of other research teams have reached the same conclusion.
The way forward
The FDA could entice US scientists home and further facilitate the progress of animal biotechnology by adopting risk-based regulations instead of concerning itself with the breeding technique used to produce an animal. That would allow the agency to ensure public safety without unnecessarily halting important innovations, including applications that can prevent and mitigate the spread of zoonotic diseases like COVID-19.
But the agency seems unlikely to shift its regulatory approach in the foreseeable future. During a September webinar, the FDA’s Center for Veterinary Medicine outlined the approval process for two animals, another transgenic (GMO) fish for human consumption and a gene-edited pig for biomedical research. Any developer would face more or less the same expense and time commitment AquaBounty did to get its salmon approved as an animal drug.
For other researchers, though, the FDA’s requirements are confusing and prohibitive. Scientists looking to commercialize a gene-edited cow to produce meat or milk, for instance, would have to study two non-contiguous generations of cattle and conduct a compositional analysis of their meat and milk, though the agency hasn’t said what the analysis is supposed to detect. Such a study would require a minimum of eight and a half years—a best-case scenario that assumes the animals are born on schedule and male offspring begin producing viable sperm at 14 months old.
Finally, all the animals and their biological products would have to be destroyed at the study’s conclusion. Van Eenennaam told the GLP the approximate cost of raising, feeding and incinerating one animal for the research would be $3,100 per male and $4,450 per female. The FDA gave the example of 8-10 fish for its hypothetical study of GM trout, but Van Eenennaam didn’t know if the same number of animals was required for gene-edited cattle. Responding to the FDA’s September guidelines, she told the GLP by email:
I was disappointed the FDA did not give examples of genome edited animals intended for human consumption with intentional knock-outs. These edits do not involve a transgene, or even a donor template. These are not subject to additional regulatory oversight in a number of countries including Brazil, Argentina and Australia. These are the applications quite a few public sector researchers and companies are working on, and the fate of these animals in our research herds and flocks is unclear. Incinerating animals with a small deletion will make this type of research prohibitively expensive.
Genetic engineering has had a revolutionary impact on crop agriculture in recent decades, and it has the capacity to transform the animals we depend on in much the same way. But this won’t happen as long as heavy-handed regulators unnecessarily complicate an already expensive and time-consuming approval process, robbing researchers of the incentive to develop new products that could directly benefit farmers, consumers and the environment. If this stifling regulatory atmosphere doesn’t change, we will all be the losers.
Steven E. Cerier is a freelance international economist and a frequent contributor to the Genetic Literacy Project.