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6-Regulation: Nebraska farmers upset over GE pharma crop regulations

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TITLE:  Nebraska Farmers Upset Over Restrictions on Pharmaceutical Plant
        Test Plots
SOURCE: Omaha World-Herald, USA, by Bill Hord;
DATE:   Mar 31, 2003

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Nebraska Farmers Upset Over Restrictions on Pharmaceutical Plant Test Plots

Mar. 31--LINCOLN, Neb.--As they offer more protection for the food
supply, new stringent rules for field-tested drugs are slowing progress
toward cheaper and more effective disease therapies.

Farmers and regulators said fewer test plots of pharmaceutical plants are
expected in 2003 as a result of rules released this month by the U.S.
Agriculture Department's Animal and Plant Health Inspection Service.

"We have very few applications," said Cindy Smith, deputy administrator
of the inspection service.

This is at least a temporary setback for an industry that has been
experimenting with crops to grow -- rather than manufacture -- drugs and
industrial products.

Many of these tests have taken place in small, isolated corn plots in
Nebraska and Iowa.

Because of one company's mistakes last year, experimental plots for drug-
producing corn must now be a mile from any conventional corn, a distance
requirement that is hard to comply with in corn-rich Nebraska and Iowa.

Last year, when the distance setback was only a half-mile, one cornfield
in Iowa was ordered destroyed because pollen from a test field by
ProdiGene Inc. might have drifted to neighboring fields.

In another ProdiGene test in Nebraska, volunteer plants from the previous
year's test emerged and were not properly cleaned out of a soybean crop.

To keep that from happening again, the USDA's inspection service now
prohibits growing a food or feed crop for one year on a field that was
used as a test plot.

"Those (ProdiGene) incidents put everybody on notice that this is not
commodity production," said Rockwell City, Iowa, farmer Bill Horan, who
tests a new treatment for cystic fibrosis in his cornfields. "This is a
whole new level of production."

To some farmers who are hoping corn-for-drugs -- or pharming -- will be a
new source of revenue, the new one-mile distance requirement is excessive.

"I think they are being overly cautious," said Aurora, Neb., farmer
Richard Schaffert, who has grown test plots for four years but will not
plant any gene-altered corn this year.

When interviewed four years ago, Schaffert, then 59, said he was never
more excited about farming's potential than he was about pharmaceutical crops.

Last week, he said he was never more disappointed than with rules that
could inhibit the industry's growth.

But to the food industry and other critics, the setback distance is not
enough to guarantee that drugs might not someday contaminate food.

"We are disappointed that they are going to go ahead and issue new trial
permits," said Stephanie Childs, a spokeswoman for the Grocery
Manufacturers of America, which represents food processors.

The grocery group, which supports cautious biotechnology development,
wants the government to develop a comprehensive program for regulating
drugs in plants.

Gregory Jaffe, a biotech specialist for Science in the Public Interest,
said the government should not allow testing of drugs in the same regions
where conventional corn is grown.

"They haven't gone far enough," Jaffe said.

Only one of these plant-grown products has gone through all of the test
stages required by the USDA and the Food and Drug Administration to make
it to commercial production.

That product is ProdiGene's trypsin, an enzyme that is used in
laboratories to speed the production of insulin.

But ProdiGene, of College Station, Texas, which is in a financial
struggle as it tries to pay $3.5 million in government penalties for last
year's problems, is not growing more trypsin or conducting any field
tests this year.

The furthest along of crop-produced therapeutic drugs is the one being
tested in Horan's fields near Rockwell City, Iowa.

The cystic fibrosis treatment being tested in Horan's fields, a protein
developed by Meristem Therapeutics of France, is being tested on humans
in clinical trials. It someday may give a near-normal lifestyle to cystic
fibrosis patients.

"There are products in the pipeline that will take care of high blood
pressure, heart disease . . . and others," Horan said. "When people begin
to realize that these are available and the tremendous benefits, there
will be a demand."

Horan believes the industry will experience only temporary difficulties
and will move forward. To meet the one-mile setback requirement, he said,
farmers may have to work with neighbors about where they will grow their corn.

The new regulatory rules for test plots are not the final word on the
subject, according to Smith of the USDA's inspection service.

"Our regulatory process is something that we evaluate continually, based
on how the technology progresses," Smith said. Even as new rules go into
effect in 2003, they are referred to as "interim rules" while the
inspection service takes comments from the public and the industry until
May 9.

Yet to be resolved is whether the government will allow minor amounts of
a crop-produced drug to appear in food. So far, the tolerance level is zero.

The food industry is wary of anything that would suggest to consumers
that the products in their food packages are not pure.

"All it's going to take is one accident, whether through human nature or
Mother Nature," said Childs, of the Grocery Manufacturers of America, "to
cause an enormous ripple effect."