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At the supermarket of the future, succulent, genetically engineered steak sits next to nutrient-enhanced bacon, while fresh transgenic fish can be found one aisle over from human breast milk made by cows. At the moment, though, the Food and Drug Administration is only now weighing whether to approve the first genetically engineered animal designed for people to eat. How the agency rules could open the proverbial barn door to a menagerie of genetically engineered, edible animals, potentially jump-starting a struggling research field while raising fears among critics that a brave new world of groceries is upon us. The animal in question is the AquAdvantage Salmon, a lab-bred fish that its maker says can reach market size twice as fast as a standard salmon. Last September an FDA committee held a hearing to consider safety and environmental issues surrounding the fish. It’s unclear when the agency will render its decision, but it plans to publish an environmental assessment and give the public 30 days to comment before doing so. The decision on the salmon comes at a time when the law surrounding biotechnology and genetics—whether in humans, plants, or animals—faces uncertainty in the courts. It seems plausible that this fish story, too, could ultimately wind up in court. “The big producers who work with genetically modified products have had significant litigation exposure over the years,” says Emily Smith-Lee, a former partner at McDermott Will & Emery in Boston who now runs her own small Massachusetts firm. Smith-Lee served as counsel for the producer of StarLink genetically modified corn in mass tort litigation. She says that producers of genetically modified animals could look to the StarLink matter, which involved allegations of economic harm caused by the intermingling of genetically modified corn not approved for human consumption with the food supply, for an idea about what kind of legal issues they may face. “Given differing levels of acceptance for genetically engineered animals in different markets,” Smith-Lee says, “one should be cognizant of the possibility of similar allegations of market disruption if a whole boatload of salmon contains some genetically modified traits and some country or other turns it away at the door.” The AquAdvantage Salmon is made by Aqua Bounty Technologies, a small biotech company that is based in Waltham, Massachusetts, and publicly traded in London. It has spent more than a decade seeking regulatory approval for its fish. Spurred by the addition of a growth hormone gene from a Chinook salmon and another gene inserted from an ocean pout, the salmon produces growth hormone all year round, according to Aqua Bounty. The result, the company says, is a fast-growing, farm-raised fish that can reach market weight in 16 to 18 months instead of the customary three years. Aqua Bounty, which acquired a license to the patented technology from the University of Toronto and Memorial University of Newfoundland in 1996, hopes to sell AquAdvantage eggs to fish farmers. It has said that once the salmon wins FDA approval, it will be sold in stores within two or three years. (The company did not respond to an interview request.) The FDA appears to be leaning toward approval. In a briefing document released before last fall’s hearing, the agency concluded that “there are no material differences in food from the [genetically engineered salmon] and other Atlantic salmon,” and that “there is a reasonable certainty of no harm” from consuming the salmon. Critics are unmoved. They say that the environmental consequences of farming transgenic fish are unclear and potentially troubling. They fear that the salmon, to be grown and processed in Panama, could escape and outcompete already endangered wild Atlantic salmon for food and mates. Aqua Bounty counters that its fish will be sterile females and raised in a land-based facility, cutting the risk of escape. At the public hearing, critics called Aqua Bounty’s studies lacking and said that adding new genes to the salmon could cause allergies in people. “If you ask, do the data and information demonstrate a reasonable certainty of no harm from consumption of foods derived from AquAdvantage Salmon, I think the answer to that is no, because of insufficient data of poor quality,” said Consumers Union senior scientist Michael Hansen. An FDA spokesman says that “there is no timeline for a decision on the salmon.” He would not comment further because the process is governed by the same rules that apply to new drug approvals: Applications under review are confidential to protect proprietary information. Those who tout the benefits of transgenic technology say there is a danger in the FDA moving too slowly. Regulatory hurdles, the proponents says, have kept researchers in the United States from lining up corporate backers while the rest of the world forges ahead. In April, for instance, scientists in China announced that they had introduced human genes into dairy cows to produce milk with the same properties as human breast milk. Scientists elsewhere are busy engineering everything from pigs enriched with Omega-3 fatty acids to disease-resistant cows and chickens less susceptible to influenza. James Murray, an animal geneticist at the University of California, Davis, runs a transgenic animal research conference there every other year. “When I ran my meeting in 1997 for the first time, there was no one from China. When I ran it two years ago in 2009, outside the United States the highest number of attendees were from China,” he says. “It’s because they’re funding the research. They’re developing the labs. They’re training people. We aren’t.” Murray, who is engineering transgenic goats to create a protein called lysozyme in their milk that helps fight diarrhea in children, says that he is shipping his research to Brazil. “We can get funding there to carry the work forward, which we haven’t been able to obtain here,” he says. “If you look back to the late 1980s, there were about 15 labs in the Western world doing this work. There’s none left in Britain for agriculture purposes. We’re down to only a couple labs left in North America, and there’s none left in Australia.” China, meanwhile, has gone from having one lab at the end of the 1980s to having at least seven different major labs operating with significant government backing, Murray says. Similar labs are opening in Brazil, Uruguay, Argentina, and Chile. “It’s not that the development is not going on. It’s just not going to go on in the West,” Murray says. Why not? The regulatory system is too cumbersome and politically charged, he says. He notes that the FDA decided in 2006 that it was safe to consume milk and meat from cloned animals and their offspring, but didn’t release its decision for nearly two years. The challenges don’t end with the FDA. “It’s a kind of a regulatory no-man’s-land,” says Smith-Lee, noting that the FDA, the U.S. Department of Agriculture, and the Environmental Protection Agency all have roles to play. “There are more places than a creative person can think of to challenge the introduction of such a thing into the food stream.” Patent law adds another wrinkle. “People are applying for IP on these animals,” says Murray. His team applied for a number of patents, only to learn that a Dutch biotechnology company called Pharming already holds the patent on lysozyme in milk for food applications. In order to sell his transgenic milk, Murray would need a license from Pharming. Patents present other issues. “Some of these patents could be expired before you ever get through the regulatory process,” Murray says. The underlying patent on Aqua Bounty’s salmon, for instance, was issued in 1996 and could expire as soon as 2016. Cecil Forsberg, a professor at the University of Guelph who is working on a genetically engineered pig that excretes less phosphorus in its manure, says that his team has secured patents on their so-called Enviropig in Canada, the U.S., and China. Forsberg says that he and his colleagues have also received interest from a corporate partner he declined to identify. He is sanguine about the pig’s supermarket prospects: “As environmental issues become more of a concern and demand for pork remains high, the apprehension with transgenic food animals probably will dissipate.” The Enviropig is reportedly next in line behind Aqua Bounty’s salmon for FDA approval, though the agency won’t comment on pending applications. It’s possible that any new lab-to-table movement will have to wind through the courts, thanks to the legal debate over genetics now unfolding in the U.S. In the course of just one week this spring, there were developments in two major biotech cases. In one, the U.S. Court of Appeals for the Federal Circuit heard oral arguments in Association for Molecular Pathology, et al. v. USPTO, et al., a case in which the court is weighing whether human genes qualify as patentable subject matter. Days earlier, the Public Patent Foundation—one of the plaintiffs seeking to uphold a federal district court ruling invalidating Myriad Genetics, Inc.’s patents on two genes related to breast cancer as mere products of nature—filed suit on behalf of 60 organic farmers, seed businesses, and agricultural organizations in the Southern District of New York. The suit seeks a declaratory judgment that Monsanto Company, the world’s largest seed producer, doesn’t have the right to sue organic farmers for patent infringement if its transgenic seeds end up on their land. The plaintiffs in that case argue that Monsanto’s patents on transgenic seeds are invalid and unenforceable because they fail the utility requirement under patent law and the social usefulness test elaborated by U.S. Supreme Court justice Joseph Story in 1817. That test rejects inventions that “poison people” or are “injurious to the well-being, good policy, or sound morals of society.” Rather than increasing crop yield, plaintiffs claim that Monsanto’s seeds and its weed killer Roundup have only increased plants’ tolerance to pesticide and led to the growth of superweeds, forcing farmers to spray their crops with more toxic herbicides and exacerbating health and environmental concerns. Daniel Ravicher, PubPat’s executive director, sees similarities between transgenic seeds and animals. He thinks that patents on genetically modified animals, like those on Monanto’s seeds, could be challenged on the theory that they fail the social usefulness requirement. “I think the parallels go without saying,” he says. At the same time, Ravicher refuses to speculate on whether his group will sue over genetically modifed animals. Still, should the FDA give its blessing to the AquAdvantage Salmon, there’s no guarantee that he or someone else won’t take the bait.

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