Front page of 11.30.99 Phil. Inquirer

Within the FDA, a dispute on food 
Some scientists disagreed with the agency's stance that
genetically modified food need not be tested.

By Andrea Knox

INQUIRER STAFF WRITER
Government documents unearthed in a lawsuit over genetically
modified food show that some Food and Drug Administration
scientists disagreed with the agency's official stance that the
modified foods do not need special testing.

Steven Drucker, who filed the suit last year, will tell an FDA
hearing today that the agency ignored questions from its own
staff when it issued a policy statement in 1992 saying it had no
information that genetically modified foods differed in any
meaningful way from conventional foods.

The FDA has maintained this stance in the face of growing
criticism of its policy of requiring minimal testing and no
labeling of genetically modified foods. In court filings, the
agency has characterized the dissenters as "low-level FDA
employees" and said their comments were not part of the formal
record on which the agency based its decision. An FDA
spokeswoman said she could not comment further.

Today's hearing in Washington is one of three that the FDA has
scheduled to explain its testing and labeling policies, and to
gather public comment on whether those policies should be
changed.

Genetic modification is a laboratory technique for transferring
genes between species that would not normally mate, such as a
bacterium and a corn plant. An estimated 60 percent of food
processed in the United States contains ingredients from
genetically modified plants, primarily oil, flour, protein or
sweeteners made from either soy or corn.

"The only basis on which the FDA was able to get around the need
to test the safety of each [genetically modified] food was to
claim overwhelming consensus within the scientific community,"
which it did, despite the fact that "scientist after scientist"
on the FDA staff had raised concerns, Drucker said in a
telephone interview yesterday.

Drucker, a former faculty member at Maharishi University in
Fairfield, Iowa, filed the suit in U.S. District Court in
Washington under the aegis of an organization he founded, the
Alliance for Bio-Integrity, in Iowa City. It seeks to force
labeling and stricter testing of genetically modified food.

The alliance's site on the World Wide Web has posted the
responses of 10 FDA staff scientists to the agency's draft
policy on biotech foods, which was circulated for comment within
the agency in 1991 and 1992.

One of the strongest was signed by Louis J. Pribyl, whom the
alliance identifies as a member of the FDA's Microbiology Group.

He commented that it is "industry's pet idea" that genetically
modified food would not produce unintended effects that would be
of concern. "But time and time again, there is no data to back
up their contention, while the scientific literature does
contain many examples of naturally occurring [unexpected]
effects." It would be "premature" for the FDA to "summarily
dismiss" such effects," he added.

Pribyl and several others noted that the unintended effects of
genetic modification might be no more dangerous than the
unintended effects of traditional breeding techniques. However,
they said that was no reason not to evaluate them.

Linda Kahl, a compliance officer, wrote that "for all we know,
the risks may be lower for genetically engineered foods," but
that no data were presented to address the relative magnitude of
risk. She was struck, she said, that the team of technical
experts who drafted the agency's position on biotechnology did
not include anyone whose primary expertise was risk analysis.

The first FDA hearing was in Chicago Nov. 18, and the third will
be in Oakland, Calif., on Friday. 
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