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Patents Trump Public Interest in Monsanto's Ag Empire

Special Report: Are Regulators Dropping the Ball on Biocrops?

Carey Gillam

A Romanian farmer shows genetically modified soybeans in the village of Varasti, 130km southeast of Bucharest, in this May 21, 2004 file photo.

COLUMBIA, Missouri - Robert Kremer, a U.S. government
microbiologist who studies Midwestern farm soil, has spent two decades
analyzing the rich dirt that yields billions of bushels of food each
year and helps the United States retain its title as breadbasket of the

Kremer's lab is housed at the University of Missouri and is
literally in the shadow of Monsanto Auditorium, named after the $11.8
billion-a-year agricultural giant Monsanto Co.. Based in Creve Coeur,
Missouri, the company has accumulated vast wealth and power creating
chemicals and genetically altered seeds for farmers worldwide.

But recent findings by Kremer and other agricultural scientists are
raising fresh concerns about Monsanto's products and the Washington
agencies that oversee them. The same seeds and chemicals spread across
millions of acres of U.S. farmland could be creating unforeseen
problems in the plants and soil, this body of research shows.

Kremer, who works for the U.S. Department of Agriculture's
Agricultural Research Service (ARS), is among a group of scientists who
are turning up potential problems with glyphosate, the key ingredient
in Monsanto's Roundup and the most widely used weed-killer in the

"This could be something quite big. We might be setting up a huge
problem," said Kremer, who expressed alarm that regulators were not
paying enough attention to the potential risks from biotechnology on
the farm, including his own research.

Concerns range from worries about how nontraditional genetic traits
in crops could affect human and animal health to the spread of
herbicide-resistant weeds.

Biotech crop supporters say there is a wealth of evidence that the
crops on the market are safe, but critics argue that after only 14
years of commercialized GMOs, it is still unclear whether or not the
technology has long-term adverse effects.

But whatever the point of view on the crops themselves, there are
many people on both sides of the debate who say that the current U.S.
regulatory apparatus is ill-equipped to adequately address the
concerns. Indeed, many experts say the U.S. government does more to
promote global acceptance of biotech crops than to protect the public
from possible harmful consequences.

"We don't have a robust enough regulatory system to be able to give
us a definitive answer about whether these crops are safe or not. We
simply aren't doing the kinds of tests we need to do to have confidence
in the safety of these crops," said Doug Gurian-Sherman, a scientist
who served on a FDA biotech advisory subcommittee from 2002 to 2005.

"The U.S. response (to questions about biotech crop safety) has been
an extremely patronizing one. They say 'We know best, trust us,'" added
Gurian-Sherman, now a senior scientist at the Union of Concerned
Scientists, a nonprofit environmental group.


The World Health Organization has not taken a stand on biotech crops
generally, simply stating "individual GM foods and their safety should
be assessed on a case-by-case basis."

And while many scientists around the world cite research they say
shows health and environmental risks tied to GMOs, many other
scientists say research proves the crops are no different than
conventional types.

With a growing world population and a need to increase food
production in poor nations, confidence in the regulatory system in the
leading biotech crop country is considered critical.

"One of the things that we think is important to do is to have
regular reviews and updates of our strategies for regulating products
of biotechnology," said Roger Beachy, a biotech crop supporter who was
appointed last year as director of the National Institute of Food and

"We want to look carefully to see that they are logical and
science-based but still maintain the confidence of the consumer to
ensure that the projects that are developed and released have the
highest level of oversight," added Beachy.

So far, that confidence has been lacking. Courts have cited
regulators for failing to do their jobs properly and advisers and
auditors have sought sweeping changes.

Even Wall Street has taken note. In January, shares in Monsanto fell
more than 3 percent amid a rush of hedging activity during a morning
trading session after a report by European scientists in the
International Journal of Biological Sciences found signs of toxicity in
the livers and kidneys of rats fed the company's biotech corn.

Monsanto has said the European study had "unsubstantiated
conclusions," and says it is confident its products are well tested and

Indeed, farmers around the world seem to be embracing biotech crops
that have been altered to resist bugs and tolerate weed-killing
treatments while yielding more. According to an industry report issued
in February, 14 million farmers in 25 countries planted biotech crops
on 330 million acres in 2009, with the United States alone accounting
for 158 million acres.


A common complaint is that the U.S. government conducts no
independent testing of these biotech crops before they are approved,
and does little to track their consequences after.

The developers of these crop technologies, including Monsanto and
its chief rival DuPont, tightly curtail independent scientists from
conducting their own studies. Because the companies patent their
genetic alterations, outsiders are barred from testing the biotech
seeds without company approvals.

Unlike several other countries, including France, Japan and Germany,
the United States has never passed a law for regulating genetically
modified crop technologies. Rather, the government has tried to
incorporate regulation into laws already in existence before biotech
crops were developed.

The result is a system that treats a genetically modified fish as a
drug subject to Federal Drug Administration oversight, and a
herbicide-tolerant corn seed as a potential "pest" that needs to be
regulated by USDA's Animal Plant Health Inspection Service (APHIS)
before its sale to farmers.

The process is also costly and time-consuming for biotech crop
developers, which might need to go through three different regulators
before commercializing a new product.

Nina Fedoroff, a special adviser on science and technology to the
U.S. State Department, which promotes GMO adoption overseas, said even
though she is confident that biotech crops are ultimately safe and
highly beneficial for agriculture and food production, an improved
regulatory framework could help boost confidence in the products.

"We preach to the world about science-based regulations but really
our regulations on crop biotechnology are not yet science-based," said
Fedoroff in an interview. "They are way, way out of date. In many
countries scientists are much better represented at the government
ranks than they are here."

Agriculture Secretary Tom Vilsack,
a former governor of top U.S. corn producing state Iowa, also said he
recognizes change is needed. The USDA is in fact developing new rules
for regulating genetically modified crops but the process has dragged
out now for more than six years amid heavy lobbying from corporate
interests and consumer and environmental groups.

"There is no question that our rules and regulations have to be
modernized," Vilsack told Reuters. "The more information you find out,
the more you have to look at your regulations to make sure they are
doing what they have to do. There are some issues we are still
grappling with."


Fourteen years after commercialization of the world's first biotech
crop, the trio of U.S. regulatory agencies charged with overseeing
biotech crops -- USDA, the Environmental Protection Agency, and the
U.S. Food and Drug Administration -- are under attack on several

The USDA is most directly in the line of fire after a string of
federal court decisions found its officials acted illegally or
carelessly in approving some biotech crops.

In one recent case, a federal court banned the sale of a
herbicide-tolerant alfalfa engineered by Monsanto until the government
more thoroughly evaluates its safety.

U.S. District Court Judge Charles Breyer of the Northern District of
California ruled that the USDA violated federal law in allowing
unrestricted commercial planting of "Roundup Ready" alfalfa -- a key
livestock fodder -- without a solid review.

Breyer ordered the USDA to prepare an environmental impact statement
that explores potential negative consequences that critics say could
include contamination of non-GMO alfalfa fields. The spread of
herbicide-tolerant weeds is also a concern and is a mounting problem
that has been reported across the United States in many key farming

Monsanto has appealed the ruling and the U.S. Supreme Court will
hear the case on April 27, marking the first time the high court has
taken up biotech crop concerns.

Meanwhile, the USDA recently completed its Environmental Impact
Statement and took public comments on the report through early March.
The department has yet to issue a final report.

In a similar case, a federal court found that sugarbeets altered to
be "Roundup Ready" were approved without adequate USDA evaluation.

U.S. District Court Judge Jeffrey White said the government's
decision to deregulate Roundup Ready sugar beets "may significantly
affect the environment" and he encouraged growers to "take all efforts,
going forward, to use conventional seed."

Judge White declined to immediately ban all GMO sugarbeet plantings,
but said he would consider a permanent injunction at a hearing on July

Andrew Kimbrell, executive director of the Center for Food Safety,
which filed the sugarbeet lawsuit, said the court actions should be a
"wakeup call" for the U.S. government.

"They will not be allowed to ignore the biological pollution and
economic impacts of gene-altered crops. The courts have made it clear
that USDA's job is to protect America's farmers and consumers, not the
interests of Monsanto," he said.

The USDA, EPA and FDA say they work hard to ensure that crops
produced through genetic engineering (GE) for commercial use are
properly tested and studied to make sure they pose no significant risk
to consumers or the environment.

But a November 2008 report by the Government Accountability Office,
the investigative arm of the U.S. Congress, cited several problems.
Among the shortcomings mentioned in the report is a lack of a
coordinated program to determine whether the "spread of genetic traits
is causing undesirable effects on the environment, non-GE segments of
agriculture, or food safety."

The GAO took the FDA to task for not requiring companies like
Monsanto and other GMO developers to notify the agency before selling
new products, relying on only voluntary notice. It recommended the FDA
publicize the results of food safety assessments of genetically
engineered crops and advised the three agencies to develop a risk-based
strategy to monitor use of GE crops.

But more than a year later, most of the recommendations remain
unimplemented, according to Lisa Shames, director of the natural
resources and environment arm of the GAO.

"We can only influence agencies to take action. We can't compel them to," she said.


Since 1987, the USDA has overseen genetically modified organisms
through the Animal and Plant Health Inspection Service. APHIS's
Biotechnology Regulatory Services (BRS) regulates GE organisms based on
"plant pest risk."

Monsanto and other biocrop developers must petition APHIS to grant
their genetically altered organisms "nonregulated status" -- that is,
permission to grow these plants without official oversight. To win
approval, the companies must demonstrate that their tests show the new
varieties do not pose a risk to plant health.

"APHIS grants nonregulated status only when it determines that the
new genetically engineered variety is unlikely to pose a plant pest
risk," said USDA spokesman Michael Pina, who labeled the current
regulatory system "strong."

USDA has said it wants to make changes that ensure safety while
making the process more transparent to the public, and more efficient
and easier for the companies developing the technologies to navigate.

Still, the USDA has been formally debating regulatory changes for
more than six years and issued proposed new rules in fall 2008,
allowing public comment through last summer, as it must under the law.

The proposed overhaul drew more than 15,000 comments, many of them
expressing fears that the regulatory changes as laid out would not
address key concerns.

In one public comment, physician Amy Dean, a board member for the
research and education group American Academy of Environmental Medicine
which is seeking a moratorium on GM food, said the proposed changes
would "significantly weaken or eliminate oversight of GM crops."

And Robert Peterson, a Montana State University scientist and leader
of the university's "biological risk assessment" program, told
regulators that while he agreed with some of the proposed regulatory
changes, he thought the agency's risk assessment protocols were
"fundamentally flawed."

"Recent research reveals that the approach advocated by APHIS is not
scientifically sound and can lead to bad decisions," Peterson said.

At the FDA, genetically engineered organisms are treated much the same as foods from all other plant varieties.

GE developers are not required to consult with FDA on safety issues,
and the agency sees no need now for risk-based monitoring efforts for
GE crops because there are no current safety concerns, FDA spokeswoman
Rita Chappelle said.

The agency stressed that the burden for ensuring safety lies with
the companies. "Manufacturers have an obligation to ensure that their
products continue to be safe each and every day," Chappelle said.

At the EPA, officials also say the burden of proof is with the
corporate developers of the technology. And they say they have at least
20 scientists conducting comprehensive analyses for the products that
come before the agency, such as BT corn and BT cotton, which are
altered to protect the plants against pests. The agency also routinely
seeks outside advice from experts who sit on its scientific advisory

Over the last several months, the EPA has also started allowing more public input into its review of new products.

"Transparency and open government is a major priority of the Obama
administration. We are adding a significant amount of public
participation," said Keith Matthews, acting director of the U.S.
Biopesticides and Pollution Prevention Division.

Further to its mission of environmental protection, EPA officials
said the agency reviews products every 15 years for adverse effects.
EPA senior policy advisor Bill Jordan said glyphosate, the popular
weed-killing chemical, could come under review soon.

"We have an ongoing responsibility to make sure products that are in
the marketplace continue to meet the safety standards of the pesticide
law," he said. "We have a program called registration review. Sometime
soon we'll be getting to glyphosate. I would expect that we would look
at emerging research on its environmental effects and see whether that
leads us to change the terms and conditions of registration or limit
its use in some way."

Concerns about genetically altered crops and the lack of broad
testing hit a boiling point last year. In February 2009, 26 leading
academic entomologists -- scientists specializing in insects -- issued
a public statement to the Environmental Protection Agency complaining
that they were restricted from doing independent research by technology
agreements Monsanto and other companies attach to every bag of biotech
seed they sell. The agreements disallow any research that is not first
approved by the companies.

"No truly independent research can be legally conducted on many
critical questions regarding the technology," the scientists said in
their statement.

University of Minnesota entomologist Ken Ostlie, who co-authored the
statement, said some of the concerns involve corn engineered to resist
corn rootworm pests. Biotech corn crops in Minnesota, Iowa, and parts
of Wisconsin and South Dakota harvested last fall showed damage and
disease, and some fear the biotech corn could sicken livestock.

"We don't know if something is going on with the plant and the
technology or with the insect. We just know things didn't work the way
they were supposed to," said Ostlie. "It would be nice to have
independently verifiable information going into EPA's decision-making
beyond just what the company provides."

Christian Krupke, an entomologist at Purdue University, said the
technology engineered into the plants has many benefits, but more
research is needed on effects.

"We are all fans of this technology. The problem is we are not
getting access to ask the questions that need to be asked that maybe
the companies don't want to ask," Krupke said.


A backlash against biotech crops has swept many countries. India
became one of the latest hot spots in February when biotech opponents
created such an uprising that the Environment Minister, Jairam Ramesh,
blocked the release of a genetically modified eggplant made by

India already allows planting of altered cotton, but Ramesh said
there was not enough public trust to support the introduction of a GM
food crop until more research was done.

Among the critics of the engineered eggplant was Tiruvadi Jagadisan, a former managing director of Monsanto's India operations.

In an interview with Reuters, Jagadisan, who worked with Monsanto
for 18 years, said he believed there were "very many legitimate
concerns about the safety of GM food crops for humans, animals and the
environment." He said Monsanto did not give "accurate information to
the public" about its eggplant.

"No extensive tests have been done to assess the effect of consuming
GM crops on future generations," Jagadisan said, an assertion common
among critics, but one Monsanto has repeatedly denied.

Monsanto called Jagadisan's assertions "baseless" and said India's
regulatory regime requires "extensive and rigid crop safety
assessments, following strict scientific protocols."

The state department's Fedoroff, a supporter of Monsanto's
technology, called the incident "one little setback" to gaining
worldwide acceptance of biotech crops.

She said with rising food prices and population growth, biotech crop
technology will become increasingly important, and criticisms of
Monsanto and its technology were unfair.

"They've certainly made mistakes but they've done a whole lot more
good than harm. They are investing more in crop improvements than our
government is," she said.


Back in his USDA laboratory, Kremer's assigned government work is
focused on general soil quality. As a side project in support of that
research, he has spent the last several years studying soil and plant
growth tests that appear to show ravaged root systems in biotech
"Roundup Ready" plants.

The crops have been subjected to glyphosate applications and on the
surface appear to be impervious to the weed-killing treatments as the
genetic alteration allows. But the roots seem to tell a different

"This is supposed to be a wonderful tool for the farmer ... but in
many situations it may actually be a detriment," Kremer said. "We have
glyphosate released into the soil which appears to be affecting root
growth and root-associated microbes. We need to understand what is the
long-term trend here," he said.

The development of crops engineered to tolerate glyphosate spurred a
surge in use of the chemical -- some 383 million pounds were sold from
1996 to 2008, according to a report released by The Organic Center
(TOC), the Union for Concerned Scientists (UCS) and the Center for Food
Safety (CFS).

Monsanto says the chemical binds tightly to most types of soil, is not harmful and does not harm the crops.

But some scientists say there are indications of increased root
fungal disease as well as nutrient deficiencies in Roundup Ready crops.
They say manganese deficiency in soybeans in particular appears to be
an issue in key farming areas that include Indiana, Michigan, Kansas
and Wisconsin.

Outside researchers have also raised concerns over the years that
glyphosate use may be linked to cancer, miscarriages and other health
problems in people.

Monsanto says extensive research shows glyphosate is safe for humans
and the environment, and has an entire section on its website devoted
to refuting the reports. Monsanto says extensive investigation of
questions about changes in soil micro-organisms has found no long-term
ill effects.

Peering into his petri dishes, Kremer isn't so sure.

"Science is not being considered in policy setting and
deregulation," said Kremer. "This research is important. We need to be

(Reporting by Carey Gillam; editing by Jim Impoco and Claudia Parsons)

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