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6-Regulation: FDA takes steps to control GE research



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TITLE:  FDA takes steps to control genetic engineering research
SOURCE: USA Today, by Elizabeth Weise
        http://www.usatoday.com/news/health/2003-05-18-fda-research_x.htm
DATE:   May 18, 2003

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FDA takes steps to control genetic engineering research

The government is flexing its oversight muscles with universities
involved in genetic engineering, responding to a controversy this year in
which investigators feared the offspring of transgenic pigs had entered
the food supply.

The Food and Drug Administration sent a letter to 70 university
presidents and chancellors last week, reminding them that scientists who
are genetically engineering animals that would otherwise be used for food
are required to inform the FDA and document plans for the disposal of the
animals when the research is done.

The letter appears to be a surprising acknowledgment that the agency must
do a better job of ensuring that those involved in this growing field
know what they're required to report. Critics have long accused the FDA
of failing to control this potentially dangerous area of biotechnology.
They worry that such animals, or products made from them, may be harmful
to humans, and they say testing to alleviate those fears might not be
possible.

Dated May 13, the letter refers to an "unfortunate situation," first
reported in February, in which pigs involved in studies at the University
of Illinois at Urbana-Champaign may not have been properly disposed of.
The government was unable to track down several hundred offspring of pigs
that were genetically modified. The university said it sold only piglets
that did not have the altered genes.

The letter states that "the FDA is proactively informing other
universities of this incident and asking for your help to raise awareness
about your collective responsibilities." It is signed by Stephen Sund-
lof, director of the FDA's Center for Veterinary Medicine.

"This points to the need for greater clarity from the agencies that
regulate these issues," says Mike Fernandez of the Pew Initiative on Food
and Biotechnology.

It is unlikely that the letter will mollify the FDA's critics. The
critics are apprehensive about the dramatic increase expected in genetic
research projects as scientists learn how to turn animals into living
factories that produce useful, expensive chemicals and drugs in their
blood, milk and even semen.

Groups concerned about genetic engineering have long expressed concern
that although the FDA claims authority to regulate under the new animal-
drug provision of the Food, Drug and Cosmetic Act, there are no clear,
written guidelines for the regulation of research. Though the agency has
been working on a written policy for years, it has never been released.

Instead, says Jean Halloran of Consumers Union, "they've just acted on
it, so it's like their secret policy. They said, 'We tell people when we
go to conferences,' so it's a kind of word-of-mouth policy."

Says Greg Jaffe of the Center for Science in the Public Interest:
"Although this letter is helpful in showing that FDA wants to regulate
these animals, there are still no guidances, regulations or official
pronouncements." The FDA declined further comment.

The letter did not address the many small start-up companies engaged in
this kind of research.