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.
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