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Producers of plant-made pharmaceuticals do not have an easy row to hoe, May
2005 by Ann Bailey.

"There are regulations and safety issues that have created complications
for people to break into that market," says Stephen Howell, director of the
Plant Sciences Institute at Iowa State University in Ames. "There are a lot
of companies that got started in that area then backed off."

The regulations that companies producing the products must follow are so
rigid that Monsanto decided in 2003 not to pursue PMP research. The company
said the potential for making profit was too far into the future, Howell
says. No PMP drugs have been approved for the market, according to USDA's
Animal and Plant Health Inspection Service.

Under state and federal regulations, there is zero tolerance for PMP
contamination of the U.S. food or livestock feed supply. Companies that want
to produce PMPs are regulated by state departments of agriculture and by
APHIS, the Environmental Protection Agency and the Food and Drug
Administration.


Regulations
Farmers who grow the crops, meanwhile, must follow strict guidelines that
include using equipment dedicated solely for the production of PMPs,
planting the crops a certain distance from other crops and keeping
meticulous records.

Last year, 45.19 acres of PMP crops, including corn, safflower and rice,
were grown in the United States. This year Ventria, a California-based
company, received approval to grow 200 acres of PMP rice in Missouri.

However, the company later decided not to plant the GMO rice after it met
with resistance from buyer Anheuser-Busch and had to revise its USDA permit.
The permit process would not have been completed in time for this growing
season, the Associated Press reports.

The concern about PMPs is similar to concerns voiced when any new product is
introduced, Howell says.

"This is a new technology. There are efforts to try to handle it in the very
best ways and safest ways."

Producing PMPs calls for a different kind of agriculture, Howell says.

"This is not just growing No. 2 yellow dent corn anymore." When Iowa farmers
call Howell to ask him about growing PMP crops, he says he tells them the
crops likely will be grown under contract and not for the open market.


Accountability
"What's vitally important is there needs to be a continuous 'chain of
custody.' There has to be a relationship between the producer and the
processor. There needs to be a continuous chain of responsibility as it
passes from hand to hand so it does not get out of the system."

Companies looking for PMP producers are likely to hand pick the farmers with
whom they will form contractual relationships, Howell says.

"I think there should be a lot of good education," he says. Iowa farmers
interested in someday becoming involved in PMP production have formed
organizations so they can become informed more about the complicated PMP
production and grain-handling process.

"There is a lot of contractual interaction that has legal ramifications and
liabilities. Everyone needs to be well aware of what these matters are and
what the safety and regulatory issues are," Howell says.

"We have producers in Iowa who are interested in moving forward. They're
pushing it (PMP production) from a producer angle."

The number of U.S. farmers who would be needed to grow "high-end"
pharmaceuticals would be limited, Howell says.

"The production of high-end pharmaceuticals will never be an agricultural
issue. It will become an industrial issue. You don't need much acreage for
high-end pharmaceuticals," he says.

According to a study by the ISU Plant Sciences Institute, one square mile of
PMP corn acreage - 640 acres - producing monoclonal antibodies would keep a
$10 million processing in plant in operation for one year, he says.


Financial returns
"In our calculation, the return on investment is over 50 percent," Howell
says. According to the Plant Sciences Institute study, the return of farmers
who grow the high-end pharmaceuticals would be about $10,000 an acre, he
says.

Howell didn't have estimates on the potential profit for growers of low-end
pharmaceuticals - including albumin, which has been proposed by a Grand
Forks, N.D., company interested in making the protein from PMP flax - but
says that they are a "much less valuable" product.

Sam Huttenbauer Jr., an owner of Agragen, declines to say how much farmers
would receive per bushel for the PMP flax, but a producer who attended an
Agragen meeting says the company has indicated returns of $600 to $800 an
acre.

Though the hurdles that PMP producers and companies must overcome are
significant, Howell feels certain that pharmaceuticals derived from them
eventually will be on the market.

One of the aims of the ISU Plant Institute is ensure everyone in the
production chain of PMPs meets its particular set of demands, Howell says.

U.S. farmers who could meet those demands could see handsome returns for
their work, he says.

"I think it would be a big opportunity wherever it occurred".

[www.grandforks.com]

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