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6-Regulation: U.S. government plans zero tolerance for "pharma"transgene contamination

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                                  PART I
-------------------------------- GENET-news --------------------------------

TITLE:  US Seeks to Seize Food Tainted with Medicine Crops
SOURCE: Reuters, by Randy Fabi
DATE:   Jun 26, 2003

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US Seeks to Seize Food Tainted with Medicine Crops

WASHINGTON - U.S. food products tainted with traces of pharmaceutical
crops would immediately be seized from grocery store shelves under a
proposal being considered by the Bush administration, government
officials said yesterday.

U.S. food industry groups and consumer advocates have raised concerns
about the possibility new crops engineered to produce medicines could
accidentally seep into the food supply. Pharmaceutical crops, which are
still in the experimental stages, are not approved for human or animal food.

Anticipating these new non-food products, the Bush administration is
currently reviewing federal regulations on agriculture biotechnology.

U.S. government oversight is shared by the Agriculture Department, Food
and Drug Administration and Environmental Protection Agency.

Eric Flamm, FDA senior science policy adviser, said the administration
was considering a proposal that deems all food products that contain
medicine crops as adulterated.

"We would take strong enforcement action," Flamm said at an annual
meeting of the Biotechnology Industry Organization. "We would seize the
product if it was not already removed by the company."

ProdiGene Inc., a privately owned Texas biotech firm, agreed to pay about
$3 million last year after USDA accused it of mishandling its bio-
pharmaceutical corn crop and contaminating other crops.

USDA in March implemented stricter rules on new plantings of medicine
crops to prevent another ProdiGene.

Cindy Smith, USDA deputy administrator of biotech regulations, said she
expects the biotech industry to submit fewer applications this year due
to the new guidelines.

USDA approved 20 applications for the 2002 planting season. As of April,
the department has received seven applications to plant medicine crops,
Smith said.

Separately, USDA in July will issue an interim rule requiring biotech
companies obtain field permits to plant industrial crops. Smith said the
proposed rule, which still faces possible revisions, would be effective

                                  PART II
-------------------------------- GENET-news --------------------------------

TITLE:  Vilsack: Biocrops crucial
SOURCE: DesMoines Register, USA, by Philip Brasher
DATE:   Jun 26, 2003

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Vilsack: Biocrops crucial

06/26/2003 Washington, D.C. - Gov. Tom Vilsack said Wednesday that he
isn't giving up on making Iowa a leading producer of crops for
pharmaceutical and industrial products despite the qualms of the food

"That's the future of our state," Vilsack told reporters at the
Biotechnology Industry Organization's annual convention, which wrapped up

Vilsack, who was using the convention to recruit biotech companies to
Iowa, said adequate regulations are needed to ensure that pharmaceutical
and industrial crops can be kept separate from corn intended for food and
animal feed.

"It doesn't seem to make sense that we would take the most productive
farmers in the world and say, "You can't play that game." We need to
figure out how they can play," Vilsack said.

The food industry's concerns about pharmaceutical and industrial crops
were heightened last year when a small biotech company called ProdiGene
was fined for improperly managing field trials of its crops in Iowa and

The Iowa incident was resolved by destroying a cornfield adjacent to the
test site. But in Nebraska, officials say bits of the ProdiGene corn
plants, which weren't approved for human consumption, contaminated
500,000 bushels of soybeans stored in a grain elevator. As part of its
settlement with the USDA last December, ProdiGene purchased the soybeans.

BIO, a trade industry organization, briefly imposed a moratorium on
growing pharmaceutical corn in the Midwest last fall only to back off
under pressure from Iowa Sen. Charles Grassley, the Republican chairman
of the Senate Finance Committee.

No pharmaceutical corn is being grown in the state this year.

Vilsack envisions Iowa both growing and processing the crops, and he
arrived at the BIO 2003 convention with a significant enticement for
biotech companies - a new $503 million business development fund.

The state has yet to sort out the exact incentives that will be offered
to companies, but Vilsack had meetings scheduled with representatives of
six firms. He declined to identify the companies.

"To see this kind of commitment from a state like Iowa is probably an
eye-opening experience for the state development teams that were at this
convention," said Patrick Kelly, BIO's vice president for state
government relations.

Michigan set up a $1 billion fund for biotech companies three years ago,
using its share of the national tobacco settlement, but has since had to
scale back because of the economy, Kelly said.

Money isn't the only thing companies are seeking. Vilsack said one firm
wanted a "regulatory tweak," but he would not elaborate.

"Every company is going to come through with a different set of issues,"
he said.

Federal officials, meanwhile, told convention delegates they are
considering tighter rules on pharmaceutical and industrial crops.

The U.S. Department of Agriculture tightened planting rules for
pharmaceutical crops and will soon order companies to get permits for
growing crops that are engineered to make industrial products.

The Food and Drug Administration is deciding whether it needs to issue a
rule requiring the seizure of food products that are contaminated with
crops that haven't been approved for food use.

It would "make clear our authority to take action if we find material in
food that is not supposed to be there," said Eric Flamm, a senior science
adviser at FDA.

Corn can be genetically manipulated to produce a wide range of proteins
for the production of medicines and vaccines. The grain is easy to grow
and store.


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