In other words, the birds and the bees are about to get a turbo boost. On Prince Edward Island, in a secure facility surrounded by an eight-foot-high chain-link fence and monitored by video cameras and guards, ABT has concocted a "product" (salmon eggs) that it calls a triploid hemizygous all-female Atlantic salmon. Though the president of ABT, Ronald L. Stotish, describes the decidedly unsexy reproductive process as "a very simple thing," it is anything but. Because the growth hormones of regular Atlantic salmon are turned on only about three months out of the year, ABT created a genetic cocktail that makes the fish grow continuously. The company's scientists did this via a new gene construct that combines the growth hormones of a Chinook salmon with a regulator gene from an eel-like fish called an ocean pout. Then they injected the new gene into Atlantic-salmon eggs. The resulting fish reach market size in 18 months, half the usual time—so they can land on our grills faster.
The company claims that the new salmon, with its "shorter production cycles and increased efficiency of production," is one biotechnology answer to a global food problem. That it will provide more food for a hungry world by advancing the already $86 billion farmed-fish business, the fastest-growing segment of the seafood industry worldwide. And that it's perfectly safe for humans to consume. At least, ABT claims, there's no proof that screwing with an animal's genome makes it unsafe to eat.
So far, the FDA agrees. After reviewing and accepting the studies submitted by ABT this past fall, the agency is now considering whether to approve its application. If it does, these new fish could make their way onto our plates in the next few years.
But not without swimming in a sea of Frankenfish controversy. Critics are incensed that the FDA is regulating this transgenic animal food as an animal drug—since the DNA construct inserted into salmon eggs fits the definition of a drug—which means it's not undergoing the standard evaluations that foods typically do. They are concerned about dangerous, unanticipated health problems for humans who eat this food, and worried that an approval will pave the way for the other genetically engineered animals currently in the research-and-development pipeline. And what has them really burning: Consumers won't have the freedom to accept or reject this altered fish, since it most likely won't be labeled as such.
It may seem like a scary new Orwellian world, but futuristic biotechnology has already been replacing traditional agriculture, without the consent of consumers. Until now, however, that technology was confined to the genes of plants we eat. Not animals.
Tampering with Nature
It was in the 1970s that scientists discovered they could transfer genes from the DNA of one species into that of a wholly different one—that they could, in essence, monkey with Mother Nature and bust through the natural barriers created by millions of years of evolution. In the wake of this breakthrough, genetic engineers began creating artificial gene combinations by splicing genetic material from bacteria, viruses, and other organisms and forcibly injecting them into plant genomes to create novel traits.
At the time, the big hope of agricultural biotechnology was to create more nutritious food and more productive crops to feed a hungry world. In reality, what the companies developed were either crops with built-in pesticides (for example, Bt corn, which has genes from a soil bacterium inserted into its DNA so that every cell of the plant produces pesticidal toxins) or herbicide tolerance (such as Roundup Ready soybeans, which are engineered to withstand Roundup weed killer). In other words, the focus wasn't on cultivating food that was better for us, but on increasing profits for these companies.
By the 1990s, companies such as Monsanto, the developer of Roundup Ready seeds, were positioned to bring their products to market, and the U.S. government needed to devise a game plan to oversee these newfangled food crops. "The government decided that biotechnology was the technology of the 21st century and the U.S. had to lead the world," says Bill Freese, a science policy analyst with the Center for Food Safety, a nonprofit for public interest and environmental advocacy. "As part of that commitment, they decided on a very lax regulatory system."
That's because the FDA's 1992 policy on genetically modified (GM) foods was based on this premise: The foods derived from these new methods weren't different from other foods in any meaningful way—or at least, the FDA said, it wasn't aware of any information that indicated they were different. And so no safety studies were necessary, no labels were required, and ultimately, the food producers were responsible for policing themselves.
The regulatory process, says Freese, is a glorified rubber stamp. "It's totally unlike the drug-approval process, in which the FDA actually takes responsibility," he says.
"This is a radical new technology. We need very good, careful, close regulation, and we just don't have that. We can't be assured of the safety of any of these genetically engineered organisms."
In fact, contrary to popular belief, the FDA doesn't have the authority to require that companies seek an approval for GM crops. It provides only voluntary consultations. "So GM varieties that have never been fed to animals in rigorous safety studies, let alone to humans, are approved for sale in grocery stores," says Jeffrey M. Smith, author of Seeds of Deception.
And we have been chowing down on mass quantities of the stuff since the mid 1990s, without any labels to give us pause.
Indeed, as much as 80 percent of the processed foods filling the supermarket aisles and overflowing our shopping carts—including infant formula, salad dressing, bread, cereal, crackers, cookies, veggie burgers, frozen yogurt, protein powder, and alcoholic beverages—contain an engineered ingredient, mostly from soy, canola, and corn.
Playing Genetic Roulette
But now the concern that these genetically manipulated foodstuffs are harming human health is growing. Inserting a gene into a plant's genome is a random and haphazard process that allows no control over where the gene actually ends up in the plant's otherwise carefully constructed DNA. Insertions can show up inside other genes, can delete natural genes or permanently turn them on or off, and can cause significant mutations near the insertion site. For instance, one study found that a gene known to be a corn allergen was turned on in GM corn, though it was turned off in its conventional parent.
"It's genetic roulette," says Smith. "You can create carcinogens, anti-nutrients, toxins. We don't understand the language of DNA enough to predict what might happen. It's an infant technology, and we're making changes that are permanent in the gene pool of species."
The potential for allergenicity is an acknowledged problem, says Michael Hansen, Ph.D., a senior scientist at Consumer Union, publisher of Consumer Reports. In fact, food allergies doubled from 1997 (the year Bt corn entered our diets) to 2002. The EPA recently gave the University of Chicago a grant to assess whether the pesticides produced in genetically modified plants might be the culprit.
Agricultural biotechnology companies roundly dismiss these fears, saying that millions of Americans have been eating GM foods without ill effect. So if they are making us sick, why don't we know about it?
"The trouble is we don't have controls. We don't know what we're eating because we don't have labeling, so it's all just sort of a crapshoot," says Freese. "The GM corn is mixed in with regular corn, and then it enters the food supply. It's really impossible to trace the impacts." Since neither consumer nor manufacturer actually knows how much GM content is in their food, it's near impossible to investigate properly and expose a link to illness.
If the lab-created foods currently on the market are causing common diseases, we may not be able to identify the source of the problem for decades, if ever. Still, in May 2009, the American Academy of Environmental Medicine, an international association of physicians interested in environmental impacts on human health, called for an immediate moratorium on GM foods. "Several animal studies indicate serious health risks associated with GM food consumption," it stated in a position paper, citing infertility, immune dysregulation, accelerated aging, insulin regulation, and changes in the liver, kidney, and gastrointestinal systems. The group advised physicians to ask their patients to try to avoid GM foods, as "there is more than a casual association between GM foods and adverse health effects."
And yet, just this year, the USDA approved genetically engineered sugar beets (used to make sugar) and alfalfa. Next up: the first animal genetically engineered for food, in the form of one fast-growing salmon. Swimming in Controversy
At a meeting in September 2010, the FDA—considering whether to approve AquaBounty Technologies' application—presented its analysis of ABT's studies to the committee that evaluates safety data of new animal drugs, feeds, and devices. The FDA had already reached a unanimous preliminary conclusion that the food from the transgenic salmon "is as safe as food from conventional Atlantic salmon" and that "there is a reasonable certainty of no harm from consumption of food from this animal."
At the end of the meeting, 15 scientists and consumer advocates each received five minutes to note their opinions for the record. Nearly all of them called ABT's research sloppy. Among other things, they criticized the extremely small sample sizes used for some of the studies; the absence of key safety-assessment studies; and the use of insensitive detection methods that could easily miss potential health risks (see "Big Fish, Big Concerns," at left, for critics' top qualms).
A week later, 11 senators asked the FDA to immediately "halt all proceedings" on the matter, citing in a letter endorsed by 50 consumer and environmental groups "serious concerns with potential human health and environmental risks that are associated with producing [GM] fish." This past February, two senators from Alaska introduced a bill, endorsed by 64 organizations, that would ban GM fish and require labeling if approved. And 360,000 citizens sent letters to the FDA, demanding that it reject this fish. Despite all this, FDA approval could come any day.
"The FDA did a supposed assessment based almost completely on data from AquaBounty, and in the assessment the FDA repeatedly points out serious problems in the data, and then says it doesn't matter," says Freese. Anne Kapuscinski, a fisheries biologist and professor at Dartmouth College who studies genetically engineered fish, agrees: "There are a lot of problems with the scientific quality of the analysis," she says. "If this application is going to set the precedent for what the FDA will require in the future for approving genetically engineered animals, then the quality of the science is really important."
Even those in support of approving the fish admit the research could have been better. "We're still figuring out how to do these sorts of studies as we go," says Eric Hallerman, Ph.D., a professor of fisheries science at Virginia Tech who was an invited speaker at the September meeting.
Engineering Our Future
Beyond the analytical ruckus, everyone seems to agree on the need for sustainable aquaculture—that is, growing fish in controlled environments, which currently provides almost half of all the fish consumed worldwide. The United Nations has predicted there will be a 25 percent increase in global demand for seafood by 2030, and because we've overfished the oceans, the increase can be met only by aquaculture. Stotish, ABT's president, is convinced that his AquAdvantage fish is the perfect solution. "Our technology allows for a method of production that is land-based, environmentally sustainable, and economical," he says. "This isn't anything to be frightened about."
It is, he says, the fear of technology—of folks in white lab coats playing God with living creatures—that sounds the Frankenfish alarm. Some think it's a fear that we just need to get over. "[It's important to] focus on the source of the fear and investigate its basis," says Alison Van Eenennaam, Ph.D., a biotechnology extension specialist at the University of California at Davis, who served on the committee that evaluated the data. "There are legitimate questions, but they have been thoroughly investigated, and where risks were identified, mitigation measures have been proposed [by the FDA]."
But, says Seeds of Deception author Smith, "if you're going to introduce a food into the food supply, it should not be allowed to have dangers. Otherwise, why would you introduce it?" he asks. "With drugs, the side effects are known and people can choose to take the risks in exchange for the benefits. If unexpected problems arise, the drug can be recalled. With GM food, however, it's not labeled, everyone's eating it, and because it cross-pollinates and self-propagates, it can't be recalled. If there are side effects, we might never know."
Dartmouth's Kapuscinski says the folks in favor of genetically engineered fish are missing the point. Of course we need aquaculture, she says, but we need to figure out a method that is truly sustainable, citing a new area of work in which fish waste becomes nutrients for plants and other organisms. "The answer isn't patenting these animals and then getting rich off the royalties," she says. "That's like having a tool and looking for a reason to justify its use."
If consumers would rather not play Russian roulette with their health, if they'd rather take a pass on this fish until they're assured of its safety, that's too bad. Although a 2008 poll by CBS News found that 87 percent of people want food with GM ingredients to be labeled—just as they are for trans fats, MSG, and aspartame—these fish, like GM crops, probably won't be. "That's a very complicated issue," says Stotish. "Our product is identical in every measurable way to the traditional food. I don't want to trivialize it, because we know this is an emotional issue. We do understand people's concerns, but it's a distinction without a difference. It implies something is different, that something may be wrong. We don't want what is basically the equivalent of a warning."
If the FDA approves the technology, the door will be open to all sorts of other genetically engineered animals being developed as food. Stotish says ABT has already put the same genetic "cassette" into other fish with the same effects, and the company is developing other engineered traits, such as improving flesh qualities.
Indeed, a large international effort is aimed at developing at least two dozen different transgenic fin fishes, seven mollusks, and six crustaceans. And it's not just the surf, but also the turf: A genetically engineered pig that produces less-polluting manure is in the works, as well as cattle that are resistant to mad cow disease. "This is brand-new, and if this is the kind of shoddy testing the FDA is accepting for the very first GM animal, then God help us for others that come down the line," says Freese.
A key question left unanswered in the hubbub: What, exactly, is food anymore? Sadly, we may have already moved beyond that point. "Most people don't know where their food comes from. My kids think beef comes from cellophane-wrapped packages in a cold case," says Stotish. "They don't associate it with a living thing." But perhaps we all would be better off if we did. Big Fish, Big Concerns
According to critics of modified animals, three factors are creating the potential for health issues.
1 Not Testing for Allergens
This is a serious worry, as it is with genetically modified crops. Supporters of the new salmon brush off the fears: "If a person is allergic to fish, they wouldn't buy the product," says Eric Hallerman, Ph.D., a fisheries science professor at Virginia Tech. But critics claim the issue is much more complex than that. "AquaBounty Technologies didn't adequately test whether an allergen that's known to be in salmon is increased or not, or whether novel allergens and toxins have been created. And the FDA acknowledges that," says Bill Freese, of the Center for Food Safety.
2 Creating Possible Cancer Risks
The potential increase in igf-1 (an insulin-like growth factor that has been linked with cancer at elevated levels) has Wenonah Hauter, executive director of Food & Water Watch, an independent public-interest organization, very concerned. "We question the safety of genetically engineered salmon because there is enhanced hormonal activity that allows the fish to grow so rapidly, and no research was done as to whether these hormones could be passed on to the consumer," she says. "It's poorly understood how it could affect people. We just don't know."
3 Putting Growth on a Fast Track
Disrupting an animal's growth process and forcing it to mature twice as fast as nature intended can cause all sorts of nasty problems, say some scientists. For instance, ABT's data from fish grown in 2005 show that only 16 percent were normal; 13 percent of the salmon had severe irregularities (which ABT didn't describe), and 71 percent had moderate ones. "Physically visible abnormalities make you wonder what's going on biochemically," says Freese. The growth process for any organism is incredibly complex and very finely tuned; various organs and tissues must develop in proper coordination or else abnormalities develop. "That could make the salmon more vulnerable to infection," says Freese.
It's one of the many safety issues that weren't researched, says Michael Hansen, Ph.D., of the Consumer Union. "ABT's own data showed that these fish had higher focal inflammations, a form of infection," he says. This was statistically significant but not explained. As a result, the fish may require more antibiotics and other drugs, like cancer-causing formaldehyde.