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trangenic biopharmaceutical corn spread



The article below is a comprehensive and update report on the problem
with transgenic corn with a pig vaccine protein. Previously the USDA had
refused to say what the gene and its product were but the president of
prodigene indicated the the corn had a gene for vaccine for "a viral
disease of pigs" by studying the publications and web site of the
company the most likely product was a vaccine for Transmissible
Gastroenteritis Virus of pigs. It is not wise to say that the vaccine
antigen was safe for humans and animals such as cattle to ingest. The
response of either animal could have been severe. Prodigene had
commercially produced  biopharmaceutical trypsin. That product seems to
have been presumed safe without testing prior to commercial production.
Humans are certainly the experimental animals of North America.
Please excuse me if I am posting too much on the subject. However, it
seemed to me that the topic is one vital to organic agriculture even
more than gneral food production.
washingtonpost.com

Corn for Growing Far Afield?
A Mishap With Gene-Altered Grain Spotlights the Odds of Contamination

By Justin Gillis
Washington Post Staff Writer
Saturday, November 16, 2002; Page E01

The chief executive of ProdiGene Inc., the company that mishandled
gene-altered corn in Iowa and Nebraska, said yesterday that his
scientists will carefully study the possibility of growing such corn
only in parts of the country where it could not contaminate the food supply.

That pledge by Anthony G. Laos, president and chief executive of the
College Station, Tex., company, was a break from ProdiGene's past
statements claiming that corn altered to make industrial or
pharmaceutical proteins could be a boon for family farmers throughout
the midwestern Corn Belt. Some other companies, fearing that inadvertent
contamination of food crops could lead to multibillion-dollar product
recalls, have committed to growing this type of grain only in states
such as Arizona or Hawaii where little commodity grain is produced.

In an interview with reporters at his attorney's office in Washington,
Laos did not apologize for the incidents in Nebraska and Iowa, which
prompted alarms to be sounded this week among food-processing companies
and environmental groups. But he did say he took ultimate responsibility
for the mishaps, declining to name or to blame the contract farmers that
grew corn on the company's behalf.

Laos did not say precisely how far ProdiGene would go to keep its corn
away from food grains in the future, nor would he say how long the
commitment might last. But he pledged that his company, under
investigation by the U.S. Department of Agriculture, would work closely
with that agency to design more rigorous procedures to contain its
gene-altered grain.

"We are very committed and very serious in working with USDA," Laos said
in the interview. "We don't ever want to be in this situation again."

The Agriculture Department disclosed this week that it had ordered
ProdiGene to destroy several thousand bushels of corn in Pocahontas
County, Iowa, after the company failed to follow stringent procedures
designed to limit the spread of genes foreign to corn. Similarly, at a
grain warehouse in Aurora, Neb., inspectors seized 500,000 bushels of
soybeans because they were mistakenly mixed with a small amount of
leaves and stalks from altered ProdiGene corn. The soybeans, worth more
than $2 million, are to be destroyed or diverted for use as fuel.

Laos said the corn in both cases was genetically modified to grow a
protein that may serve as a vaccine against a viral disease of pigs.
It's highly unlikely such a protein would hurt people even if they ate
large amounts of it, since most proteins are rapidly broken down in the
human digestive tract. But Laos acknowledged that no formal human safety
testing had been done on the protein, and absent such testing, the Food
and Drug Administration would be unlikely to allow even a tiny amount of
it into the food supply. The FDA has been cooperating with the
Agriculture Department in the Iowa and Nebraska investigations.

The privately held ProdiGene has been one of the most aggressive
companies in promoting the idea that grains such as corn can be used to
grow protein-based industrial or pharmaceutical chemicals. The company
has already commercialized two small laboratory proteins and a more
significant one, trypsin, that is used in the production of insulin for
diabetics. The company is driving toward commercialization of a fourth
protein, also useful in manufacturing insulin.

For years, the notion that companies want to do this has alarmed
conservationists, who fear unpredictable effects on the environment as
foreign genes are introduced into crops planted on thousands or even
millions of acres. More recently, food-processing companies have grown
alarmed at potential adulteration of their products. The ProdiGene
incidents in Iowa and Nebraska have infuriated both groups,
demonstrating how readily breakdowns can occur.

"All of a sudden, our what-if scenario was validated -- on a very small
scale, thank goodness," said Rhona Applebaum, executive vice president
of the National Food Processors Association in Washington. "What's going
to happen when we're talking about tens of thousands of acres?"

The food companies support biotechnology in principle. But they want
biotech companies, at minimum, to agree not to plant altered grain near
places where regular grain is grown for food. They would prefer that the
biotech companies find ways to make industrial or pharmaceutical
proteins in plants that are never used as food.

The biotech companies have resisted the latter demand, contending that
many valuable proteins can be produced in the necessary form and
quantity only in oilseed crops like corn, safflower or canola -- all
significant food crops in North America. Laos said yesterday that his
company had studied alternatives, and would continue to do so, but so
far had found nothing to beat corn. Several companies, including
ProdiGene, have invested years and millions of dollars in their corn
research, and fear losing a competitive edge if they have to start over.

In a concession to the food companies, some biotechnology companies have
agreed for now to grow altered corn only in remote areas, away from food
crops. The Biotechnology Industry Organization, a trade group, recently
announced a limited, voluntary moratorium, saying its member companies
would not grow altered corn anywhere in the Corn Belt for the time being.

But that pledge has encountered political resistance, particularly in
Iowa, where many farmers are avidly looking for more valuable crops to
improve their bottom line. And it's not clear how practical the strategy
will be when companies are ready to plant thousands of acres - - some
biotech executives acknowledge they probably will want to grow such
large amounts of corn in the places where corn grows best.

Up to now, ProdiGene has been reluctant to rule the Corn Belt off
limits, and it has seen political support among midwestern farmers as an
asset. In a newsletter last year, Laos extolled the potential grower
profits and mentioned, as an obstacle, government requirements to
isolate the gene-altered corn from ordinary corn by as much as 1,320
feet. "We will be dealing with these distances until we can gain
regulatory approval to lessen or abandon these requirements altogether,"
Laos wrote then.

In the Iowa and Nebraska cases, ProdiGene employed contract farmers who
were supposed to follow rigorous procedures to safeguard the food
supply. In both cases, gene-altered corn crops, containing the pig
vaccine, were planted and harvested in 2001. In 2002, the farmers
planted soybeans in those fields. Corn grains left over from the year
before sprouted amid the soy.

This is an elementary, well-understood risk of such crops -- the farmers
were supposed to diligently remove those plants to keep the gene-altered
corn out of soybeans and nearby food corn. Laos said yesterday that both
farmers had attempted to do so, but he acknowledged they had failed to
remove the corn plants to the satisfaction of the Agriculture Department.

Affected soybeans and nearby food corn were destroyed before harvest in
Iowa, but in Nebraska, 500 bushels of soybeans containing a few leaves
and stalks from gene-altered corn were harvested and mixed into 500,000
bushels of soybeans at a grain warehouse, rendering the entire lot
suspect. ProdiGene has agreed to buy the soybeans and will attempt to
sell them as fuel.

The Agriculture Department argues that crops like ProdiGene's can be
produced safely, anywhere in the country, as long as strict procedures
are followed. The government regards the Nebraska and Iowa incidents as
a success for its enforcement efforts, in that potentially adulterated
food never reached the market.

"I beg to differ," said Gregory Jaffe, director of biotechnology issues
for the Center for Science in the Public Interest, a Washington group
that supports the technology in principle but believes it must be more
strictly regulated. "If the system had worked, this stuff should never
have left the farm."

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