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GE Pharm Drugs in Your
Corn Flakes?

USDA toughens rules on biotech crops
By PHILIP BRASHER
Des Moines Register Washington Bureau

06/14/2002
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Washington, D.C. - The government is tightening planting restrictions on
corn engineered for pharmaceutical uses to ensure the crops don't
contaminate grain supplies and end up in food.

The U.S. Department of Agriculture's rules are meant to prevent biotech
corn from cross-pollinating with other crops or from getting mixed with
other grain. Corn and other crops are being developed to provide vaccines
as well as products needed in manufacturing drugs.

The USDA is requiring the biotech corn to be planted at different times
than corn in nearby fields so that the crops don't pollinate
simultaneously. Beginning next year, there also will be a tougher
restriction on the distance between biotech crops and other corn fields.

Jim White, who oversees the department's evaluations of new biotech crops,
said the rules are strict and intended to bolster public confidence in the
government's regulating of pharmaceutical crops. "They're not going to be
in your food supply. They're not going to be in your cornflakes," he said.

The biotechnology industry was rocked in 2000 when anti-biotech activists
discovered StarLink corn in taco shells and other products. StarLink, one
of several varieties of corn developed to produce its own pesticide, had
never been approved for human consumption because of concerns about its
potential to cause allergic reactions. The discovery prompted massive food
recalls, forced processing plants to shut down, and reduced U.S. corn
exports.

StarLink was withdrawn from the market, but farmers, scientists and
government officials fear the incident could be repeated if crops
engineered for pharmaceutical uses aren't carefully controlled. Much of the
StarLink problem was due to poor grain-handling practices, but officials
believe that contamination also resulted from cross-pollination between
StarLink corn and other varieties growing in nearby fields.

"We don't want another StarLink," said Dave Miller, director of commodity
services for the Iowa Farm Bureau.

The USDA has issued six permits over the past year for tests of various
types of bioengineered corn with pharmaceutical uses, mostly on small plots
of no more than a few acres. Vaccines against a variety of diseases,
including hepatitis B, are being developed using corn.

In Iowa, at least two companies contracted with farmers to grow plots of
pharmaceutical corn last year, and researchers at Iowa State University
also are experimenting with the crop.

The Agriculture Department's Animal and Plant Health Inspection Service has
been setting restrictions for field tests of pharmaceutical crops on a
case-by-case basis. A May 21 document issued by the department made the
rules public for the first time while also standardizing the restrictions
and adding some new ones. Violators can be fined up to $500,000.

"It looks like they're addressing the concerns that we have had," Miller
said. "These are the kinds of things in clarity that we were looking for
from the agency."

Jane Rissler, a biotech critic with the Union of Concerned Scientists, said
that the planting rules were "definitely stronger," but that the department
should have sought outside scientific advice and public comment to make
sure they are adequate.

"The government is unprepared to regulate these products," Rissler said.
"They're talking about cancer drugs, potent drugs, drugs that are active in
very small amounts. It's potentially troublesome to think of these genes
falling into the food supply, like StarLink."

The USDA's rules will generally prevent biotech corn from being planted
within a half-mile of any other corn to prevent the crops from
cross-pollinating. This year, the USDA is allowing an exception to the
half-mile limit if the biotech corn is surrounded by a "buffer" of
non-biotech varieties. But the department says it will "discourage" the use
of buffer crops beginning next year. That would reduce the chance "for
inadvertent mixing of transgenic and nontransgenic plant materials," the
department said.

The rules also require the biotech crops to be planted at least three weeks
before or three weeks after other corn in the area to further guard against
cross-pollination. Corn that's grown for seed must be kept a mile away from
the biotech plots.

There are additional rules for other crops that are being developed for
pharmaceutical uses, including barley, rice and tobacco.

The Agriculture Department and the Food and Drug Administration are working
on a broader policy for regulating pharmaceutical crops that could include
rules for how the FDA will regulate the new products.

The planting rules are "all very reasonable," said Mike Phillips, executive
director for food and agriculture of the Biotechnology Industry
Organization. "They make a lot of sense."



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