Additional Information on this issue:

Transgenic fish proves a regulatory riddle

January 15
Atlanta Journal-Constitution

A salmon that is likely to become the first genetically modified animal grown for human consumption is straining government policies to protect the food supply and the environment, a research group warned Tuesday.

Critics fear that the transgenic salmon, which grow twice as fast as natural ones, might run amok in the wild and damage ocean ecosystems.

But it will not be regulated as either a food or environmental risk.

Instead, it will be treated as a new animal drug, its future determined by the Food and Drug Administration's Center for Veterinary Medicine.

A new report by the Pew Initiative on Food and Biotechnology says the unlikely scenario results from a patchwork of federal regulations outstripped by the rapid progress of biotechnology.

'We seem to be treading in uncharted legal waters,' said Michael Rodemeyer, the group's executive director. 'Regulators will increasingly have to stretch their authority to make old laws and regulations address the next wave of products.'

Researchers have genetically modified at least 14 other fish species. They are also working on engineered chickens, pigs and cows.

The Atlantic salmon, developed by Massachusetts-based Aqua Bounty Farms, is the first food animal to undergo FDA scrutiny. But the Pew report questions whether the agency has the 'expertise, authority and resources necessary to conduct a comprehensive review' of the fish.

If the salmon, which contain a growth gene from the Chinook salmon and another from ocean pout, is approved for commercial use, it would be reared in coastal pens.

Environmentalists fear that escaping 'frankenfish' might interfere with wild salmon, which are already stressed by pollution and overfishing.

Aqua Bounty is engineering the salmon to be sterile, but critics aren't satisfied. Last month, Washington state banned the cultivation of genetically engineered fish.
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Old laws, new fish: Environmental regulation of gene-altered foods is gray area

January 15
Washington Post

Genetically modified salmon and similar food animals could in theory wreak permanent ecological damage, but no federal agency appears to have clear-cut legal authority to regulate or ban them on environmental grounds, according to a report issued yesterday by a biotechnology research group.

The new, man-made animals might, in the worst case, escape into the wild, propagate, and damage or wipe out other species by out-competing them for food or living space, said the report, by the Pew Initiative on Food and Biotechnology, a Washington think tank that has taken a centrist position on the use of genetic engineering. But despite the risks, the Pew report said, the federal government's legal authority to restrict or ban the animals remains highly uncertain.

The finding appears to confirm fears long expressed by environmental activists that federal law on the issue was so vague that the Food and Drug Administration and other agencies would be hamstrung as they attempted to evaluate gene-altered animals meant as food.

Lawyers not involved in preparing the report but knowledgeable in federal food and drug law largely echoed its findings. But a senior FDA administrator disputed them, saying the agency believes it does have sufficient legal authority to regulate or, if necessary, ban gene-altered food animals. Aqua Bounty Farms Inc. of Waltham, Mass., the leading company developing gene-altered salmon, also disputed the idea that the law is weak but added that in any case, the company had no intention of going forward without the full blessing of the FDA.

The report comes as biotechnology companies enter the final stages of testing a slew of genetically altered animals. Most of these are farm animals that have had genes inserted to allow them to produce human drugs in their milk. For these types of animals, there appears to be little question that the FDA has power to regulate.

Other animals -- such as Aqua Bounty salmon, which grow faster than ordinary salmon -- are meant solely as food. The general view is that the FDA has power to require food-safety studies in these cases. But a scientific consensus has already emerged that the biggest risk posed by these animals is to the environment, since they might readily find their way into the wild. And the Pew report raises doubt that the FDA could restrict or stop a gene-altered animal solely on the ground that it would upset the ecological balance.

The problem, several lawyers said, is that the FDA is trying to stretch old laws, written before the advent of genetic engineering, to fit new circumstances -- in this case, the introduction of animals whose basic hereditary material has been tinkered with for improved growth or other traits.

"It is certainly a leap beyond anything that Congress envisioned" when it passed the Food, Drug and Cosmetic Act, the FDA's basic enabling statute, said Michael R. Taylor, a former FDA officer and now a senior fellow at Resources for the Future, a Washington think tank. "I think it is quite clear that there are sharp limits on FDA's ability to fully address environmental and ecological consequences."

The FDA claimed several years ago that it had full jurisdiction over gene-altered animals, including environmental questions. Stephen F. Sundlof, director of the FDA's Center for Veterinary Medicine, said yesterday that the position has not changed. The agency's review of new types of animals will include thorough environmental assessments, he said, and animals that don't pass muster will be turned down.

"We are going to operate on the assumption that we do have that authority," Sundlof said. "We will certainly live up to the standards the public expects of us."

Genetically engineered plants have been on the market for years, and while they have provoked significant controversy in Europe, American consumers have largely accepted them. But no gene-altered animal has been commercialized. Dozens of companies are tweaking insects, fish, livestock and other animals for numerous purposes, particularly to cut the cost of producing food.

Aqua Bounty Farms is the first company known to have filed an application to commercialize such an animal with the FDA. It is conducting large-scale tests on salmon with a modified growth-hormone gene. The salmon grow faster than natural salmon and eat less for each pound of flesh they produce.

Biotechnology companies consider the engineered salmon a key test of whether such animals can gain regulatory approval and public acceptance. Environmental groups, dubbing the fish "Frankensalmon," have devoted themselves to stopping it.

The salmon would probably be raised in pens off the coast, possibly in Maine, Washington state or Chile. Fish inevitably escape from such pens, and much of the concern centers on what would happen if the gene-altered fish were to start competing for food and mating opportunities with their wild cousins. The great Atlantic salmon, a barometer of the health of that ocean, has been reduced to tiny numbers in Maine but still thrives in Canada and northern Europe.

Eric Hallerman, a fish biologist at the Virginia Polytechnic Institute and State University in Blacksburg, is both a leading voice of caution on the issue and an unpaid adviser to Aqua Bounty. The unlikely worst-case scenario, he said, would be that gene-altered salmon would wipe out the entire population of natural Atlantic salmon. Far more likely, he said, would be that escapees would threaten small local populations.

The Maine salmon is listed as an endangered species, which means any application to produce gene-altered salmon in that state would trigger the Endangered Species Act, giving the U.S. Fish and Wildlife Service and the National Marine Fisheries Service veto power. But the Pew report says this restriction might not apply if the salmon were grown elsewhere, and it would not apply to most types of genetically altered animals.

Partly because of Hallerman's prodding, Aqua Bounty has gone to considerable lengths to try to answer concerns about the engineered salmon. The gene-altered fish used in ocean pens would be all female and all sterile, for instance, to reduce their impact on wild breeding populations. How reliably Aqua Bounty can sterilize and feminize its fish is one of the key issues before the FDA.

Aqua Bounty has also gone much further than required by law in publicizing the details of its research. Joseph McGonigle, vice president of business development, said the company would continue to make all relevant information public in a bid to assuage concerns. But he disputed the idea that the FDA lacks appropriate regulatory authority and said his company was proceeding on the assumption that it would be able to commercialize the salmon only under stringent conditions imposed by the agency.

"I understand the argument, but as a practical matter, the FDA has asserted jurisdiction," McGonigle said. "The only way that's going to change is if somebody like me is stupid enough to sue them. I'm not going to do that."
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Group calls for stricter review of transgenic fish

January 15
AP

WASHINGTON — New fish varieties genetically engineered in laboratories to grow faster and larger should be kept off the market until the federal Food and Drug Administration addresses their potential threat to wild species, a private research group said Tuesday.

The Pew Initiative on Food and Biotechnology questioned the adequacy of FDA regulations in assessing the risks of such transgenic fish escaping pens and taking over the habitat of nongenetically engineered varieties. "FDA needs to be able to answer these questions in a sort of open and transparent manner before these products hit the marketplace," said Michael Fernandez, the Pew group's science director.

The agency has before it an application by Aqua Bounty Farms Inc., a Waltham, Massaschusetts, biotech firm, to begin marketing genetically modified Atlantic salmon. The company said it plans to submit an environmental risk assessment this spring.

Although Pew researchers are uncertain what would happen if biotech fish were to be released into the ocean and other bodies of water, they speculate that the new varieties would mate with wild relatives, eventually eliminating diversity. They also ponder a scenario in which biotech fish would cause weaker species to die out because they would take over their food and breeding areas.

Dr. Stephen Sundlof, director of FDA's Center for Veterinary Medicine, said the agency is aware of such worries. "We do have the authority to regulate these adequately, both from the environmental impact side and from the food safety side and animal safety aspect," Sundlof said.

The FDA plans to use the same approval process for transgenic fish that it uses for new animal drugs, Sundlof said. It means a company seeking approval to sell transgenic fish would have to provide proof that the fish would do no harm to other animals and would not become hazardous to the environment.

"We've maintained ever since the early '90s that modifying the genetic makeup of an animal is modifying the structure and function of the animal and therefore qualifies as an animal drug," Sundlof said. The Pew report noted that the animal drug approval process does not allow the public to attend meetings between federal regulators and the company. Sundlof acknowledged that is true but said the FDA's criteria for determining whether to let a product be sold is available to the public.

Industry officials said they were disappointed with the Pew report, saying it appeared to criticize the FDA and the industry.

"I don't agree with their critique or their conclusions that there's any serious problem with FDA's ability to require or enforce its standards or judgments," said Joseph McGonigle, vice president of business development for Aqua Bounty, which is awaiting FDA approval for marketing a transgenic variety of Atlantic salmon. McGonigle said other agencies, including the Fish and Wildlife Service, oversees animals in the wild and have regulations that may deal with environmental problems.

He also said Aqua Bounty is raising transgenic female fish that are sterile, so they will not be able to reproduce should they escape their pens. Without taking those precautions, "the public blowback from that would be devastating for our product," McGonigle said.
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Concerns raised over altered fish

January 15
New York Times

A new study maintains that the government is poorly structured to assess possible environmental hazards posed by genetically modified fish.

The study, being issued today by the Pew Initiative on Food and Biotechnology, a nonprofit group, comes as the Food and Drug Administration is considering whether to approve a salmon genetically engineered to grow twice as fast as regular salmon.

The study notes that oversight of the fledgling field is left largely to the F.D.A., which regulates such fish under the rules covering drugs for animals. But the study says that those rules may not allow the agency to consider fully the environmental risks of such fish and that even if it can, it lacks the expertise.

"Regulators will increasingly have to stretch their authority to make old laws and regulations address the evolving next wave of products," Michael Rodemeyer, executive director of the Pew Initiative, said in a statement. "We seem to be treading in uncharted legal waters."

While some genetically engineered fish are being grown experimentally, none have been approved for use as food. But the F.D.A. is considering an application from Aqua Bounty Farms, a company in Waltham, Mass., for the fast-growing salmon.

The Pew Initiative, based in Washington and backed by the Pew Charitable Trusts, says it is not against genetic engineering but wants to promote public discussion about biotechnology and its regulation.

Indeed, the report said there could be benefits from genetically engineered fish. Faster-growing fish could make fish farming more productive. Efforts are also under way to get fish to produce human drugs like a blood clotting factor, to make fish disease-resistant and to make shellfish that will not provoke allergic reactions.

But there could also be hazards, the report notes. Some studies suggest that if the engineered fish escape from pens they could out-compete wild fish for mates or food, endangering wild populations. Another question is whether the genetic engineering affects the rate at which a fish accumulates toxins like mercury from the environment.

The report, based on a review of legal and scientific literature and interviews with experts, says the F.D.A.'s effort to regulate genetically modified fish as drugs might not withstand a legal challenge. Yet another problem with the arrangement, it said, is that drug applications are kept confidential, denying the public a chance to comment. Such secrecy, the report said, could undermine public confidence in the regulatory system.

Many of these concerns have been voiced in the past by opponents of genetically modified food and by the National Research Council in a report issued last year.

Dr. Stephen Sundlof, director of the Center for Veterinary Medicine at the F.D.A., said the agency believed its regulations were adequate.

"We've required environmental assessments on animal drugs as long as I can remember and they are substantial," Dr. Sundlof said.

He added that the F.D.A. could also seek input from other agencies, like the Fish and Wildlife Service.

Joseph B. McGonigle, vice president of Aqua Bounty Farms, said the argument by Pew that the F.D.A.'s authority might not withstand a legal challenge was a "debating exercise" because no company would mount such a challenge.

"In the real world," Mr. McGonigle said, "I don't see a commercial company benefiting in any way from challenging the F.D.A. and taking on the publicity damage with their customers."

He also said that the company had commissioned Harvard scientists to do an environmental assessment of the company's plans and that it would eventually make that report public.