Organic Consumers Association

FDA Advisory Committee Wary on Safety of Cloned Meat

November 10, 2003

More clone data needed
FDA advisory committee not satisfied with available data on cloned
animal products
| By Merrill Goozner

The US Food and Drug Administration (FDA) is promising to come up with
more studies on the safety of food products derived from cloned animals
after half the members of a key advisory committee said last week that
they didn't have enough information to sanction the move.

"We promised to get the information out to the committee by the end of
this year," said Stephen Sundlof, director of the FDA Center for
Veterinary Medicine. The FDA is under pressure from the nascent cloning
industry to treat meat and dairy products from cloned animals and their
offspring the same as other food. A staff report released in late
October said that the FDA's review of the scientific literature turned
up no evidence that food products derived from cloned animals should be
regulated, or even labeled.

But several scientists at last week's Veterinary Medicine Advisory
Committee meeting were deeply troubled by the lack of scientific
evidence backing the staff report.

"The assumption made was that there would be no problem, but they didn't
present any real evidence one way or the other," said Sherman Jack, a
professor of pathobiology at the College of Veterinary Medicine at
Mississippi State University. "The FDA made a plea several times during
the hearing that [the industry] come up with more data." The FDA usually
follows the recommendations of its outside advisory committees.

Top FDA officials are confident that they will be able to answer the
questions raised by the 12-member advisory committee. Sundlof said the
FDA still plans to make its final cloned foods risk assessment available
for public comment before the end of the year. If the assessment
concludes the risks are minimal, the FDA's risk management strategy,
which it hopes to release next spring, could forgo additional regulation
or labeling.

"We have not identified any hazard that is contributed by the cloning
process to this point," Sundlof said. "We still need to know if the food
is identical. The information presented this week suggested it is not
different from traditional foods."

The major roadblock is the paucity of studies. There are only a handful
of companies involved in cloning. And since cloning a single cow or pig
under existing technology costs nearly $20,000 and companies have
voluntarily held off from introducing the progeny of cloned animals
(their most likely use) into the food supply, there are very few animals
to test.

"Most of the data presented this week was based on the result of one
company's work," said Jack. "There's no evidence yet to base a go/no-go

The one consumer advocate on the committee, Richard Wood of the
Chicago-based Food Animal Concerns Trust, echoed Jack's concerns about
the lack of data on food safety. He also questioned whether the FDA was
the only agency with the authority to regulate food derived from clones.

Several outside consumer groups that testified at the hearing suggested
the Department of Agriculture should require labeling on food products
derived from clones. Even the Environmental Protection Agency may be
asked to get involved. "Does this cloning process change the flora in
the guts of the clones, and does this change the pathogen mix in such a
way that it represents a threat to humans once it is in the
environment?" Wood asked. "We need more data."

Demands for more studies and the specter of court challenges to the
FDA's sole jurisdiction over cloned foods could postpone their arrival
until 2005 or later.

Links for this article

US Food and Drug Administration Center for Veterinary Medicine

J. Lucentini, "Clone products okay to eat," The Scientist, October 31,

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