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Group Calls for Stricter Review of Transgenic Fish

by Emily Gersema, The Associated Press
Environmental News Network, January 15, 2003

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.

Emily Gersema, Associated Press
Group Calls for Stricter Review of Transgenic Fish
Environmental News Network, January 15, 2003

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