Groups Seek FDA Moratorium On Genetically Engineered Fish 

Jill Carroll / Wall Street Journal 10may01

WASHINGTON -- Foes of a genetically engineered salmon fear the fish will easily swim through the nets of well-meaning federal regulators.

Injected with a growth-enhancing gene from another fish, the salmon, developed by Aqua Bounty Farms Inc. of Waltham, Mass., is the first genetically engineered animal intended for the dinner table. As such, it raises for the first time many thorny issues for the Food and Drug Administration, which is weighing whether, and under what conditions, to let it come to market.

Critics of the fish see the potential for a broad range of catastrophes -- everything from the annihilation of whole fish species to unpredictable side effects in humans. More than 60 consumer and environmental groups (list below) petitioned the FDA and the Agriculture Department yesterday to thoroughly assess such risks. At the same time, they said the potential perils are so complex the agencies should enlist the aid of the Defense, Interior and Commerce departments as well.

A principal concern of critics is environmental -- how to keep the modified fish from escaping into the wild or prevent them from mating with other fish should they get free. A 1999 study by two Purdue University researchers said that a small number of such "transgenic" fish released into the wild could cause the extinction of the species.

The Purdue study used computer simulations to predict that such modified fish would ultimately grow larger than normal, making them more attractive as mates, thereby endangering the species because fewer mixed-breed offspring survive. While Aqua Bounty says its salmon would merely grow faster, not larger when fully grown, such fears still haunt critics.

Aqua Bounty plays down such concerns, saying the salt-water fish would be raised in fenced-in farms in the ocean to prevent their escape and that they would be sterilized so they couldn't reproduce even if they did wriggle free.

The Aqua Bounty salmon, which is injected with genes from the ocean pout fish, grows twice as fast as its unmodified relative. Elliot Entis, the company's president, said a breeding population of the fish would be maintained in an inland salt-water tank, and that their fertilized eggs would be sterilized in a pressure cooker before being sent to the fish farms. To further protect normal salmon, only females would be raised on the farms, because sterile males would still engage in mating behavior, squandering eggs of unmodified female salmon in the process.

Assessing the fish's potential for wreaking environmental havoc is the "most challenging" problem facing regulators, said Stephen Sundlof, director of the FDA's Center for Veterinary Medicine. But he said there also were concerns about food safety.

The gene from the ocean pout fish basically switches the salmon's growth hormone into the "on" position permanently. Dr. Sundlof said one food-safety concern is whether such biological changes in the salmon could cause similar changes in humans.

The FDA said it is taking such concerns very seriously and won't open a Pandora's box of calamities by approving the fish without adequate safeguards. Everyone agrees, for instance, that some of the fish are bound to escape from their farms. But the agency is considering requiring that eggs be sterilized and permitting only female fish to be raised on the farms, to prevent escaped fish from doing any harm.

The FDA also is requiring Aqua Bounty to provide data proving that its salmon is safe and actually does grow faster than normal. The company said it has hired outside researchers to conduct the studies requested by the agency.

Mr. Entis has said he expects an FDA decision on the salmon by 2002 -- after which it would take about a year and a half to bring the fish to the market. Dr. Sundlof called that timetable for an agency decision "optimistic."

Nevertheless, he said he is confident that the FDA is well-equipped to assess problems presented by the salmon. But he warned that "if this technology takes off," a big influx of applications for other genetically engineered animals could overwhelm the agency's current capacities.

Moratorium Sought On Genetically Engineered Fish

AP 9may01

WASHINGTON --A group opposed to biotech foods said Wednesday it is petitioning the government to place a moratorium on genetically engineered fish.

The move was announced by the Center for Food Safety, which said it was leading a coalition of consumer and environmental groups in the effort.

"FDA is not considering the food safety and environmental risks that these animals may pose," said Andrew Kimbrell, executive director of the center.

The Food and Drug Administration declined immediate comment on the petition, saying it had not yet been received.

The FDA's Center for Veterinary Medicine regulates animal biotechnology products. To date, no transgenic animals have been approved for use as human food.

While no transgenic fish have been approved, at least one application, for a variety of salmon, is under review. Various transgenic species of salmon, tilapia, channel catfish and others are being investigated worldwide.

Biotech varieties of corn and soybeans are already in use.

Last fall, the biotech industry was embarrassed when a type of genetically engineered corn that wasn't approved for human consumption was found in taco shells.

And, in April the state of Maryland banned the raising of genetically modified fish unless they are in ponds or lakes that do not connect to other state waterways.

Genetic engineering in agriculture involves splicing a gene from one organism into a different plant or animal to confer certain traits, such as cold tolerance in fish that traditionally live in warm waters.

• Food and Drug Administration: http://www.fda.gov
• Center for Food Safety: http://www.centerforfoodsafety.org/

List of EPA Petitioners

Thanks to the Center for Food Safety for sending mindfully.org this list