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http://www.commondreams.org/headlines03/0115-04.htm

Published on Wednesday, January 15, 2003 by the New York Times
Concerns Raised Over Genetically Altered Fish
by Andrew Pollack

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.

Copyright 2003 The New York Times Company

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