www.checkbiotech.org ; www.raupp.info ; www.czu.cz

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 by Margaret Munro .
The safflower seed, laden with fish growth hormone, was due to leave Monday,
April 30, 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 this 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 Mr. 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.

But there is no end of discussion about how best to control plants that
carry genes derived from microbes, animals and humans.

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

And CFIA officials say they are waiting for ?guidance? from the government
policy makers and public consultations to gauge ?how comfortable Canadians
are with this new form of agriculture.?

Meantime SemBioSys is keen to move beyond the confined field trials CFIA now
allows, which are restricted to isolated plots no larger than one hectare.

The Canadian system ?essentially keeps it in a research phase, it keeps the
whole thing academic,? says Mr. Keon. Scientists working with SemBioSys have
run small trials in B.C., Alberta and Saskatchewan over the last 10 years.
But they have been stymied in their bid to increase production, resulting in
what Mr. Keon describes as the company?s ?slow migration out of Canada.?

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

Mr. Yarrow is well aware the burgeoning industry is expanding and says there
is a need for a ?broader regulatory framework? in Canada and
internationally. The issue ?is definitely going to be on the agenda? when
CFIA officials meet with their U.S. counterparts in a few weeks, he says.

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, Mr. 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 Mr. 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.

Mr. 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 Mr. 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.

Mr. Keon says SemBioSys, with a staff of about 60 and headquarters in
Calgary, is still keen to grow crops here. Within weeks, Mr. 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 Mr. 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 Mr. 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 Mr. Yarrow.

Greenpeace?s Mr. 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.

Mr. 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 Mr. Keon.

SemBioSys? plans to process and grind up the seed in Calgary to make feed
for shrimp at aquaculture farms in Mexico. Mr. 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 Mr. 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, Mr. 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.

Mr. Yarrow adds 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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