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DRUGS & PHARMACROPS: GE pharma crops grown in Chile by SemBioSyscannot enter Canada

------------------------------- GENET-news -------------------------------
TITLE:  Modified seeds cause regulation woes here
SOURCE: The Leader-Post (Regina), Canada
AUTHOR: CanWest News Service, Canada, by Margaret Munro
DATE:   30.04.2007

Modified seeds cause regulation woes here

VANCOUVER -- Close to 200 tonnes of a genetically modified seed, which
is not allowed anywhere near Canadian dinner tables or farm fields, is
sitting at a Chilean port waiting to be loaded onto a ship for Vancouver.

The safflower seed, laden with fish growth hormone, was due to leave
today, slip into Vancouver in a few weeks and be trucked to Calgary for
processing, say the Canadian entrepreneurs who engineered the seed for
use in aquaculture.

But their plan is in limbo because the federal government late last week
refused to issue the permit needed to import the seed into Canada.

"All of a sudden all these red flags have gone up at CFIA (Canadian Food
Inspection Agency)," says Rick Keon, of SemBioSys Genetics Inc., whose
shipment is stuck on a dock.

Welcome to molecular farming, or biopharming, in which plants are used
to "grow" pharmaceuticals. It's a world in which Canadian officials are
being asked to allow large quantities of drug-producing seed, which
cannot be commercially grown in this country, to move back and forth
across the Canadian border.

And it's a world in which entrepreneurs at SemBioSys, one of the
darlings of Canada's biotechnology sector, say they have had little
choice but to grow their high-tech crops offshore because of the endless
and unresolved debate about whether to allow molecular farming in Canada.

"The discussion has gone on for years," says Keon, SemBioSys' manager of
planting operations and field regulatory affairs.

Millions of Canadian tax dollars have been spent engineering drug-
producing plants, long touted as one of the boons of the genetics era.
SemBioSys' safflowers, which produce growth hormone, human insulin and
drugs for heart disease, have been developed through government-funded
research at the University of Calgary.

Everyone agrees drug-producing plants should not get loose in the
environment or become mixed in the food supply. "Just by definition,
drugs are harmful to humans and animals unless they're administered in a
controlled fashion," says Stephen Yarrow, director of CFIA's plant
biosafety office.

Many critics want biopharming restricted to greenhouses and non-food
crops. Proponents say drug-producing plants can be safely grown outdoors.

Along with the 200 tonnes of seed the company has just harvested from
300 acres of fish-hormone-producing safflower in Chile, Keon says
SemBioSys has been growing its high-tech plants in Washington State in
acreages much bigger than those allowed in Canada.

The U.S. Department of Agriculture has in recent years approved more
than 100 applications to grow drugs in corn, rice, barley and tobacco,
most of them small trials. The U.S. is also open to larger proposals,
such as an application from SemBioSys to grow up to 404 hectares of
hormone-producing safflower in Washington State this summer, which is
currently under review.

The U.S. reviews applications on a case-by-case basis, an approach many
would like to see adopted in Canada along with a clearer policy on the
types of molecular farming that will be allowed.

"Everybody is waiting," says Louis-Philippe Vezina, co-founder and chief
scientific officer at Medicago Inc., a biotech company growing flu
vaccines in alfalfa in Quebec City.

Viral compounds from the plants can be purified into vaccines that
stimulate the body to produce antibodies against disease.

Because of the "confusing" situation in Ottawa, Vezina says Medicago
opted to confine its plants to a high-security greenhouse and sidestep
the regulatory uncertainty that spooks investors.

And since a square metre of alfalfa can generate 1,000 to 5,000 doses of
vaccines, he says the company's kilometre-square greenhouse can produce
all the alfalfa they need at this stage.

But Medicago is working on genetically engineered alfalfa that can
produce industrial enzymes for the biofuel industry that Vezina says
would have to be grown outdoors.

While critics like Josh Brandon at Greenpeace oppose the notion of
growing industrial enzymes and drugs in plants, it appeals to farmers
like Brian Otto, who grows safflowers for birdseed.

Otto has grown SemBioSys plants as part of CFIA-approved field trials on
his acreage south of Lethbridge, Alta., and had hoped to increase
production of the hormone-producing safflowers.

Instead, he has watched the opportunity migrate out of the country.

"I am just baffled, " says Otto about the way the Canadian government
invested so much in research and development only to nip biopharming in
the bud.

Not only are farmers missing out on the opportunity to grow value-added
crops, he says, but the related drug processing facilities are sure to
follow the crops out of the country.

Keon says SemBioSys, with a staff of about 60 and headquarters in
Calgary, is still keen to grow crops here. Within weeks, Otto will seed
a small CFIA-approved experimental plot with safflower SemBioSys has
engineered to produce the precursor of human insulin. The "pro-insulin"
in the seed is a "completely benign protein" and only becomes
biologically active after it has been purified and chemically
manipulated, says Keon.

Symbiosis has approached U.S. Food and Drug Administration about
starting human trials of its insulin next year. Company scientists say a
few thousand hectares of the safflower should be enough to meet a
substantial portion of the world's demand for insulin at a much lower
cost than current industrial processes. The plan is to "scale up here in
Canada, or the U.S., or both, depending on at the status of the
regulations," says Keon.

Meantime, he is working overtime to convince CFIA to allow the 200
tonnes of seed now stuck in Chile into Canada.

The CFIA wants SemBioSys to spell out how it plans to transport and
process the seed "without spilling a drop" before it will be granted the
necessary import permit, says Yarrow.

Greenpeace's Brandon says allowing seed that cannot be grown in Canada
to be shipped into the country makes no sense, and poses risks of
contamination to the environment and food supply.

"This is something the Canadian government needs to take seriously and
act upon immediately. I definitely want them to stop it," he says.

Transporting genetically engineered crops is one of the main ways
contaminations occur, he says, highlighting several instances where
genetically engineered seed and plant material has accidentally gone
astray in the U.S.

Keon says plenty of safety precautions have been taken to contain the
Chilean seed. It has been poured into double nylon bags, labelled as
genetically modified and placed in lined containers that would be
transferred onto trucks once it reached Vancouver. Chilean inspectors
have sealed and quarantined the containers, says Keon.

SemBioSys' plans to process and grind up the seed in Calgary to make
feed for shrimp at aquaculture farms in Mexico. Keon says the carp
growth hormone does not make shrimp grow bigger or faster, but has been
shown to boost the immunity of shrimp prone to viral infections.

The company insists carp growth hormone does not affect mammals and
poses no dangers to animals or the environment.

And Keon says some of the seed from Chile is to be sent to a
Saskatchewan lab and fed to broiler chickens "to show once and for all"
there is no ill effect.

While the CFIA has in the past allowed SemBioSys to import seed grown in
Chile into Canada, Yarrow says the latest shipment is on "a whole
different scale."

"It's one thing to process a few tonnes, it's a whole other matter to be
dealing with hundreds of tonnes," he says.

Yarrow adds that the CFIA may issue an import permit once SemBioSys
clearly details its plan for transporting and processing the seed
without releasing any into the environment.

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