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December 4, 2003


European Agency Calls Biotech Corn Safe; Tapping the Potential of Biotech


Today in AgBioView: December 5, 2003:

* European Agency Calls Biotech Corn Safe
* Round up ready safe, say EFSA scientists
* EU moves toward lifting ban on genetically modified food
* Applying Science by Public Vote
* Byrne: Europeans must face facts
* BioScience News and Advocate Editorial
* Tapping the Potential of Biotech
* The new medicinals
* CGIAR is not the only problem
* Farmers to control GM contamination, say MEPs


European Agency Calls Biotech Corn Safe

Associated Press, By PAUL GEITNER, December 5, 2003

Adding to pressure on European Union governments to lift their blockade on
new biotech crops, the European Food Safety Authority said Thursday that
Monsanto's Roundup Ready corn is as safe as conventional corn and
"unlikely" to have any negative health effects.

The determination clears the way for the European Commission to draft
proposals for allowing the sale of the herbicide-tolerant corn for food or
feed - but not cultivation. The proposal would then go to EU governments
for approval.

The commission has been anxious to show it is moving to lift the
5-year-old moratorium on approving biotech products because of pressure
from the United States, which has started legal action against it at the
World Trade Organization.

Last month, the commission considered a sweet corn developed by Syngenta,
but postponed a decision because of strong opposition in many EU countries
to genetically modified foods. The application is to be taken up again by
national experts on Monday.

Before Thursday's report, green groups had said the commission should take
a "precautionary approach."

"Public health, not the profits of the biotech industry, should be given
the benefit of the doubt," said Sue Meyer, director of GeneWatch UK, a
British environmental group.

Roundup Ready allows farmers to spray and kill weeds with Monsanto Co.'s
Roundup herbicide without killing the corn plant.


Round up ready safe, say EFSA scientists

FoodNavigator.com, 05/12/2003

After months of risk assessment scientists at Europe?s first food safety
agency have given the green light to Monsanto?s herbicide-tolerant GM
maize. NK 60 is as safe as conventional maize, they declare.

The first GMO opinion from the European Food Safety Authority?s (EFSA)
Scientific Panel on Genetically Modified Organisms (GMO) will open the way
for the Commission to draft proposals on authorising NK 603 maize for
consultation by member states in a regulatory committee, the decision
could be as early as January or February next year.

These opinions relate to the risk assessment of a NK603 ?Roundup Ready?
maize and of food and feed products derived from it. This maize type has
been genetically modified to provide tolerance to the herbicide glyphosate
(commonly formulated as ?Roundup?). The stated purpose of this
modification is to allow farmers to manage weeds more effectively in maize
fields during cultivation.

The risk assessment is based on two questions raised by the Commission
related to applications for the placing of the maize on the market by
Monsanto under Regulation (EC) No 258/97 on novel food and under Directive
2001/18/EC on the deliberate release of genetically modified organisms
into the environment.

?Having considered all of the evidence provided, the Panel concluded that
NK 603 maize is as safe as conventional maize and therefore the placing on
the market of NK 603 maize ? for import for processing and food or feed
use?is unlikely to have an adverse effect on human or animal health, or in
this context, on the environment," Dr Harry Kuiper, chair of the
Scientific Panel on Genetically Modified Organisms told a press

He emphasised the approach of the scientists to adopt a competitivie
assessment of the GM maize, in other words, to look at any differences
which might arise between the nearest conventional line and the GM

Anticipating anti-GM campaigners who will be disappointed by the EFSA
opinion (a 'yes' could ultimately clear the way for the product on the
market) Geoffrey Podger, executive director of EFSA, told the press
conference: "We are very much aware of the sensitivities of the consumer,
and without fear or favour we have carried out the assessment."

Stressing the role of EFSA as concerned with risk assessment rather than
risk management, Podger added: "We are not the risk managers and we do not
have a timetable. Responsibility now falls on the Commission to take it
further in the European Union."


EU moves toward lifting ban on genetically modified food

- Financial Times, By Raphael Minder, December 5 2003 4:00

The European Union yesterday inched towards ending a five-year moratorium
on genetically-modified crops when its food safety agency recommended
approval of a type of maize produced by Monsanto, the US biotechnology

Although Monsanto still requires approval from a separate EU committee
before it can sell the maize in Europe, the recommendation is a further
sign that EU regulators are slowly clearing the way for GM food to reach
European supermarkets.

However, a much more important test will come on Monday, when the EU will
decide whether to authorise the sale of a different type of maize from
Syngenta, the Anglo-Swiss company.

In its first opinion on a GM crop, the recently-created European food
safety authority decided that Monsanto's NK603 field corn was "as safe as
conventional maize and therefore that its placing on the market - for
import for processing and food or feed use - is unlikely to have an
adverse effect on human or animal health, or on the environment".

However, the outcome of Monday's vote concerning Syngenta's product
appears too close to call, with the result resting in the hands of six EU
member states that have been ambivalent about the issue, including France
and Germany.

Germany is now likely to abstain while the French state food agency
recommended this week that more tests be carried out on Syngenta's Bt-11

A qualified majority is needed on Monday to give the green light to
Syngenta's maize, which is insect and herbicide-resistant and is already
available in the US as tinned sweetcorn or popcorn.

The EU specialist committee, which is made up of representatives from the
15 member states, met last month to discuss Syngenta's maize, but called
off a formal vote amid signs that the corn would not gather the required

The EU has maintained a de facto ban on imports of GM food for the past
five years, in response to widespread criticism about GMOs from consumer
organisations and environmental lobby groups, which has angered
biotechnology companies and some of its main trading partners, in
particular in North America.

The US has lodged a complaint with the World Trade Organisation, with the
backing of Canada and Argentina, putting further pressure on the EU to
review its position on GM food before a ruling by the Geneva-based trade

David Byrne, the EU commissioner in charge of consumer protection,
repeated yesterday his earlier stand that it was time for the EU "to move
on", having now put in place an effective set of rules to guarantee the
traceability and labelling of GM products.

He said he expected consumer mistrust about GM products to decline over
time, even if recent surveys suggest that most Europeans remain firmly
opposed to genetically modified products.

Applying Science by Public Vote

- The San Diego Union-Tribune, Henry I. Miller, Dec. 2 2003

'How can you tell whether a whale is a mammal or a fish?" a teacher asks
her third-grade class.

"Take a vote?" pipes up one of the pupils.

This idea might be amusing coming from a child, but it's a lot less funny
when applied by governments to the formulation of complex policies that
involve science and technology. And it's an approach that is becoming
increasingly common around the world.

Britons had their say during the summer, for example, on whether they want
biotechnology-derived (or gene-spliced) products in their fields and their
food. In order to gauge public opinion in advance of a decision scheduled
later this year on whether to allow commercial planting of gene-spliced
crops, at great expense the British government and local authorities
sponsored a series of public discussions around the country.

The head of the British debates' organizing committee, Professor Malcolm
Grant, called them a "unique experiment to find out what ordinary people
really think once they've heard all the arguments."

Mark Henderson, science correspondent for the Times, offered this view of
the U.K.'s half-million pound initiative: "The exercise has been farce
from start to finish. I'm not sure I want the man in the street to set
Britain's science, technology and agriculture policy. One of the six
meetings ... spent much of its time discussing whether the SARS virus
might come from (gene-spliced) cotton in China. It's more likely to have
come from outer space." Henderson went on to observe that the meetings
were dominated by anti- technology zealots, the only faction that was
well-enough organized and cared enough about the issue to attend.

The urge to make policy based on public opinion about such issues
flourishes on this side of the Atlantic as well. The National Science
Foundation, whose primary mission is to support laboratory research across
many disciplines, is funding a series of "citizen technology forums," at
which average, previously uninformed Americans come together to solve a
thorny question of technology policy.

At a time when federal budgets are under pressure and laboratory research
funding is tight, the National Science Foundation has seen fit to spend
almost half a million taxpayer dollars on this politically correct but
dubious project.

Getting policy recommendations on complex technical questions like the
safety of biotechnology and nanotechnology from groups of citizen
non-experts (who are recruited by newspaper ads) is sort of like going
from your cardiologist's office to a diner, explaining to the waitress the
therapeutic options for your chest pain, and asking her whether you should
have the angioplasty or just take medication.

The first of these foundation-funded groups tackled regulatory policy
toward agricultural biotechnology and recommended that the government
tighten regulations for growing gene-spliced crops, including a new
requirement that the foods from these crops be labeled to identify them
for consumers. They got it wrong: Their proposals are unwarranted,
inappropriate and contrary to the recommendations of experts, including
those within the government and in the scientific community.

Science is not democratic. The citizenry does not get to vote on whether a
whale is a mammal or a fish or on the temperature at which water boils.
Legislatures cannot repeal laws of nature.

We should be wary of attempts to sample public opinion as a prelude to
setting public policy on highly technical subjects. The goal of policy
formulation should be to get the right answers -- in this case, that
gene-splicing is essentially an extension, or refinement, of less precise
genetic techniques that have been around for at least half a century; that
gene-spliced plants can make critical contributions to farmers, consumers
and the health of the natural environment; and that, except as science
dictates in specific cases, the products of gene-spliced organisms should
be regulated no differently than other, similar agricultural and food

The formulation of public policy toward science and technology can be
difficult, to be sure, but if democracy is to take public opinion
appropriately into account, good government must discount ignorance and
prejudice. The 18th-century Irish statesman and writer Edmund Burke
emphasized the government's responsibility to make such determinations. He
observed that in republics, "Your representative owes you, not only his
industry, but his judgment; and he betrays, instead of serving you, if he
sacrifices it to your opinion."


Byrne: Europeans must face facts

- EUPolitix.com, Dec 4, 2003

Europe must take care not to foster an anti-science culture, health
commissioner David Byrne has warned.

Speaking at a conference on European risk perception, Byrne said the
public had to learn to base their opinion of food safety on science rather
than fear.

?If we fail to make progress, there is a very real danger that an
anti-science agenda may take root in European society.?

He said that this could ?lead to a society hampered and restricted by a
collective neurosis; lacking in self confidence; resistant to innovation
and unwilling to embrace change.?

To this end, said Byrne, ?a key feature of my approach to policy formation
is that it should be underpinned by reliable science.?

But he added that the scientific community will have its work cut out to
get the public on its side.

?The scientific community is often viewed as being remote from the

As regards genetically modified foods, he said ?the science-based message
simply fails to get across.?

?Citizens seem, by and large, to have made up their minds.?

?Further attempts at public persuasion might even prove to be
counter-productive if citizens feel they are being leant on or otherwise
coerced into changing their views.?

Speaking at the same conference, the Spanish agriculture and food minister
Arias Cańete backed up Byrne?s comments.

He said that scientists based their opinions on the probability of risk,
whilst the public were influenced by a number of less predictable factors.

These included the degree of control they felt they had on a situation,
and whether or not a new product was manmade.

And he added that ?risk is often perceived as danger by a large sector of
the government.?

His German counterpart Reanate Künast said that governments should be open
about gaps in their scientific knowledge.

She said there were situations, particularly relating GMOs, in which
governments have to talk about risk ?without having full scientific
information available.?

She said governments should have the courage to say their policies might
be changed in the future ?if science demands it.?

BioScience News and Advocate


Biotechnology is an important part of New Zealand's future and I welcome
the arrival of the BioScience News and Advocate as a new vehicle for news
and debate.

I hope this publication reaches a wide audience. New Zealand needs to reap
the benefits of biotechnology in a responsible and sustainable way. That
requires engagement and understanding between the bioscience sector and
the community.

We are in an age where the life sciences are surging ahead in scope and
power. This is tremendously exciting for many of us. The biotechnologies
that spring from this new knowledge seem to have enormous potential for
enhancing the quality of human life and our environment.

But because this new knowledge concerns the nature of living things, there
is also a widespread uncertainty about how far we should reach. For many
people it is more than uncertainty: it is anxiety, or fear.

If there is a failing in the way the scientific community considers its
relationship to society, I think it is the assumption that when a gap
opens up it is because science has moved ahead of the community. Science
advocates often assume that uncertainty, anxiety or fear is always due, at
some level, to ignorance: that if only the public can be made to
understand the science, their concerns will evaporate.

It is better, I think, to acknowledge simply that science and society
sometimes move apart. The public can become uncertain and anxious about
scientific advances for good reason. And science cannot win trust from a
position of arrogance or condescension.

Of course science should make an effort to explain itself to the public.
But that is not enough.

The public are only too aware of the power of scientific knowledge. It is
a power they are not prepared to leave entirely in the hands of scientists
and their clients, and rightly so. Science is society's tool and the
scientific community must share its power, not expect to be trusted with
it in return for some patient explanation.

Politics and government are the means by which we collectively express
where we want to go and where we do not want to go as a society. Some say
politics and government should not be able to "interfere" with the
progress of science, as if science was an independent cell in the body
politic. I am not one of them.

Democracy is slow, messy and frustrating. It is not a handbrake on
science, however: it's the road. Science, like business, needs the
stability, confidence and trust built by democratic processes if it is to
advance sustainably.

Certainly we have not perfected the democratic processes that connect
science and society and help us bridge the gap when they drift apart. Yet
nor are we failing dismally. The Royal Commission on Genetic Modification
was a process whose value I think will endure. The ERMA approval process
is one whose value I hope will be proven. For technological optimists like
me, who reach instinctively for the future, processes such as these are

I am sure this publication will be a valuable information resource on the
biosciences. Perhaps it will also help build acceptance within the
biosciences community of the need to engage constructively with legitimate
public and political processes. I would like to think so.

Hon Pete Hodgson, Minister of Research, Science and Technology


Tapping the Potential of Biotech

- Truth About Trade, by Bill Horan, December 4, 2003

ROCKWELL CITY, IA - The comedian Steven Wright once cracked that 99
percent of lawyers give the rest a bad name.

That joke came to mind the other day when I read about a collection of
anti-biotech groups suing the Department of Agriculture over important
crop research that is now being conducted in Hawaii. It?s not the first
lawsuit they?ve filed, nor will it be their last. But each one is
fundamentally misguided.

For years, Hawaii has served as an important site for agricultural
research in the United States. Hawaii?s agriculture sector and its
important research have reinforced the essential role the islands play ?
not only for Americans but for people throughout the world.

The tropical island environment is unique in the United States. Nowhere
else can scientists conduct open-field research on plant breeding
throughout the year. As a result, there have been more than 4,000 trials
of genetically enhanced crops in the state.

Hawaii?s advantages don?t end with the climate. To be sure, there are
other places in the world where year-round research is possible. They just
aren?t in the United States. Innovators need to have their ideas
protected, and only Hawaii combines the benefits of an ideal environment
with the American system of intellectual property rights that underpin so
many advances in agricultural research.

What?s more, the federal government demands massive safeguards for any
biotech project. If researchers want to test a new variety of biotech
corn, for instance, they must first embark on a thorough review of
everything modern science tells us about a plant?s biology and its
genetics. Then they must conduct a series of internal tests to learn more
about what further experimentation might reveal. Next come greenhouse
tests that allow the crops to grow but also keep them sealed off from the
outside world.

When these steps are complete--in a process that can take several
years--scientists are allowed to try open-air field tests. Even then, they
must comply with lots of restrictions. In Hawaii, for instance, some
permits require that the field be surrounded by a thick line of trees that
serve as windbreaks, to prevent pollen from escaping.

When biotech crops move into fields, they occasionally attract interest
from the media. There?s no problem with this, except that everything in
the ?news? is supposed to seem ?new.? By the time the public hears about
these plants for the first time--generally because they?re showing
promising commercial value--they?ve actually compiled long and detailed
histories. They?re new only to the people who haven?t been studying them
for years, or in my case, planting them on my farm.

Biotechnology, in fact, is becoming downright ordinary. Biotech enhanced
plant breeding contributes to thousands of consumer products, from beer to
cheese. The same is true for about one-third of all our drugs.

And here?s where the latest lawsuit in Hawaii enters the picture. The
plaintiffs have targeted permitted trials for crops that may one day help
us produce wonder drugs that would make a significant difference in the
lives of patients who need it. I know a lot about this process because
I?ve grown them on my own farm in Iowa.

We have not even begun to tap the remarkable potential of these plants.
Suffice it to say that some of humanity?s worst afflictions may one day be
treated because these special crops make it possible.

So I?m always astonished to hear the enemies of biotechnology assert that
only farmers benefit from genetic enhancement. I?ll gladly admit that
farmers reap tremendous rewards--our yields are up and our fields are weed
free. But it?s silly to suggest that only farmers gain. Of all people,
Hawaiians must know this--a few years ago, the state?s $19 million papaya
industry was saved from destruction because biotechnology figured out a
way to protect papaya trees from the deadly ringspot virus.

Did farmers benefit from this? They most certainly did. But so did all the
people whose jobs depend on these papayas, from those who work on the
farms to those who package and ship the fruits. And consumers, too--at
least if they like the taste of papayas.

When biotechnology flourishes, everybody will win--except perhaps the
opportunistic lawyers who continue to attack the science that makes it all


The new medicinals

Bio-engineered plants promise a new era of innovative medicine. If
regulators don't muck things up.

- Red Herring, November 22, 2003

In 1798, the perennially cheery Reverend Thomas Malthus came to a simple
conclusion: we?re all going to starve to death. In his famous social and
economic treatise, Essay on the Principle of Population, Malthus proposed
that as human population increases, vast pressure is placed on the earth?s
limited agricultural resources to keep up. It can't. The result would be
mass starvation.

But Malthus did not foresee the dawn of modern agriculture and the
significant technological improvements that averted his dire prediction.
By the middle of the 20th century, farming land had expanded about
five-fold and was able to keep in step with the rising population demand
for food.

Researchers and scientists say the next phase of the so-called Green
Revolution will be driven by innovations from the new science of
agricultural biotechnology. These advancements brought about by
recombinant DNA technology permit gene sequences from other plants and
organisms to be inserted into plants to produce characteristics that would
not come about through traditional crossbreeding.

The science behind genetically modified organisms (GMO) will not only
transform and reshape agriculture, it should also spawn a new way of
producing pharmaceuticals. The idea is simple: use plants as bio-reactors
to produce human proteins, anti bodies, vaccines, in large quantities at
relatively low costs. "Our basic knowledge of plant metabolism during the
coming decades will provide the tools necessary to more effectively modify
the content of crops to have a positive effect on many aspects of human
and animal health," says Martina Newell-McGloughin, director of University
of California Systemwide Biotechnology Research and Education Program.
"The greatest adoption of GMO will occur in developing countries," says
Ms. Newell-McGloughin.

The demand for more efficient and higher crop yields is one of the drivers
pushing agricultural biotechnology. The Food and Agriculture Organization
(FAO) of the United Nations reports that global demand for food could
easily double by 2030, with an estimated three-fold demand increase in the
poorest countries.

To meet those needs, some 6 million farmers in 16 countries grew GM crops
in 2002; three-quarters of the farmers reside in resource-poor developing
countries. What is more, the global acreage of genetically modified crops
increased by 12 percent or 15 million acres in 2002, according to a 2003
report released by the International Service for the Acquisition of
Agri-biotech Applications. It found that more than half of the world's
population lives in countries where GM crops have been officially approved
and grown. More than one-fifth of the global crop area of soybeans, maize,
cotton, and canola is now produced using modern biotechnology. Today,
eighty percent of processed food eaten in the U.S. contains ingredients
from genetically modified crops.

Over the past decade, researchers have refined biotechnology methodologies
so that plants and animals can be used as living factories for the
commercialization and production of vaccines, therapeutics, and other
products like industrial enzymes and biosynthetic feed-stocks. In tobacco
plants, for example, scientists used the tobacco mosaic virus (TMV) to
produce a therapeutic vaccine against non-Hodgkin's B-cell lymphoma. "The
search for new compounds to treat human disease has led to the formation
of specialized biotechnology firms searching for nutraceuticals," says Ms.

For example, scientists have proposed that tobacco plants could be used to
create antibodies and be used as a bactericidal mouthwash to stem the
colonization of micro organisms that are responsible for the development
of dental caries. Soybeans also have the potential to produce antibodies
that fight against infection by genetal herpes. In comparison to the
antibodies produced in mammalian cells, plant-based antibodies exhibit no
differences in binding and neutralizing herpes simplex virus. These immune
functions are of keen interest to pharmaceutical and biotechnology
companies like Centocor, Abgenex, and Immunex (which was acquired by

Still, there are a number of unanswered questions and ethical concerns
about this relatively new science. One incident that sparked widespread
concern involved StarLink corn, a genetically engineered maize. In the
fall of 2000, StarLink was detected in a major U.S. consumer food product,
Kraft taco shells. It occurred because genetically modified corn approved
for animal feed ended up contaminating nearby crops intended for human
consumption. The incident led to a recall of more than 300 food products.

A similar situation happened with ProdiGene, a company that produces
animal vaccines in maize. In September 2002, the company's farm in Iowa
accidentally contaminated 500,000 bushels of harvested soybeans with small
amounts of GM maize, which had been grown a year earlier in 2001 on the
same plot of land. Because the corn had already matured in the field, its
pollen was blown to nearby fields. The U.S. Department of Agriculture
ordered ProdiGene to harvest and destroy 155 acres of crop. Regulators
said the contamination violated regulations established under the Plant
Protection Act.

The debate raging over GM products is contentious and polarized, with
agriculture science pitted against a public that distrusts private
industry, activist organizations and regulatory agencies. "One of the
major general concerns from activists is that the GMO product will lead to
greater monopolization of the agricultural industry,? says Gregory Mandel,
assistant professor of law at the Albany Law School in Albany, New York.
"It is an area that is very hard to find a balanced point of view.?

Stalled regulatory processes in Europe, as well as public outcry for
greater oversight of this new technology could slow the progress of the
industry. Such concerns will have to be addressed to satisfy public
anxiety regarding the fast pace of technology and the potential risks it
poses to the environment and our foodstuffs.

For example, a genetically modified version of the Atlantic salmon is
expected to be the first genetically modified animal approved for sale and
human consumption in the U.S. These bioengineered salmon contain genes
that help them grow faster and use food more efficiently. These changes,
however, have raised concerns about its potential environmental impact on
existing wild fish and the possibility that non-GM salmon could be wiped
out. Worse still: regulators are confused about who should be handling the
issue. Both the Environmental Protection Agency (EPA) and USDA say that
they do not have regulatory authority over transgenic Atlantic salmon.

Such confusion could spook potential investors. "Numerous statutory and
regulatory gaps must be closed to provide an adequate regulatory structure
for genetically modified products," says Mr. Mandel. "VCs have to be
concerned that the startup next door is not properly regulated,? says Mr.

From: "Gordon Couger"
Subject: CGIAR is not the only problem
Date: Thu, 4 Dec 2003

CGIAR is not the only problme in ag research. For the last ten years ag
departments have been cannibalizing themselves by not replacing retiring
researchers using "salary savings" to operate on. Ten years ago OSU was
turning away researcher because it lacked time and resources to do it and
today people wonder if they will have jobs tomorrow and are doing anything
they can to stay busy. There is no money for research and the recent
ruling at Texas Tec send cold chills though the spines of those involved
doing research for industry.
as I understand it most of the guilty charges are on fraud based on
dealing with outside research. I am sure this won't have a positive effect
on industry university cooperation regardless of the out come.

Public research in agriculture are dying the death of a thousand cuts.
Funding, persona, increasing over head costs and now the courts and law
enforcement are providing disincentives to research.

If anyone wants an alternative to private ownership of seed stock they
should put their money where their mouth is and help fund public
facilities to provide them.

Gordon Couger Stillwater, OK www.couger.com/gcouger


Farmers to control GM contamination, say MEPs

- FoodNavigator.com, 05/12/2003

The Agriculture Committee of the European Parliament has adopted an own
initiative report calling on the Commission to make farmers of genetically
modified (GM) crops liable for the contamination of organic and
conventional products, reports CORDIS.

The report urges the drafting of 'a proposal on Community wide civil
liability and insurance in respect of possible financial damage in
connection with coexistence' and insists that the provisions be made
'workable and legally enforceable'.

The highly contested report by German MEP and organic farmer
Friedrich-Wilhelm Graefe zu Baringdorf also rejects Commission plans to
allow Member States to set their own rules on the coexistence of GM and
non-GM crops.

Mr Graefe zu Baringdorf's report demands that 'rules be established
without delay at Community level on the coexistence of genetically
modified crops and [non-GM products].'

The final key provision contained in the report states that Member States
should be free to decide themselves whether or not to declare certain
geographical areas free of GM cultivation, an idea so far opposed by the