Institute for Responsible Technology Spilling the Beans, April, 2005
US Government and Biotech Firm Deceive Public on GM Corn Mix-up
By Jeffrey M. Smith, author of the international bestseller, Seeds
of Deception.
“This seems to be yet another display of deceit, secrecy, incompetence
and arrogance from the GM [genetic modification] industry.” This
condemnation from Francis Blake of the organic farmers association in
Europe was one of several choice comments hurled at the biotech firm
Syngenta after it was revealed that their unapproved genetically
engineered corn variety had contaminated the food supply for four
years. Furthermore, after it was made public, both Syngenta and the US
government misled the public about its composition and safety. The
German consumer protection minister described the whole affair as
“Unbelievable sloppiness!” The European commissioner for
health and consumer affairs said, “We deplore the unauthorized imports
of this corn.”
The controversy, which may eventually cost hundreds of millions of
dollars, is centered on Syngenta’s Bt10, an experimental, unapproved
corn variety genetically, engineered to produce its own pesticide. In
mid December 2004, the company informed the US government that it had
just learned that the corn had been mislabeled in the 1990s as Bt11, an
approved variety. From 2001 – 2004, about 14,000 bags of Bt10
seed were grown on 37,000 acres in the US and the resultant
165,000 tons of corn was sold as food and feed in the US and abroad.
This was not good news for the US government, which vigorously promotes
GM crops and downplays health and environmental concerns. Bt10 is
technically illegal, since it is a pesticide producing crop not
registered by the EPA. News of its contamination ironically coincided
with the public comment period for an FDA proposal, designed to calm
public fears if unapproved GM varieties were discovered in the food
supply. It also came at a time when the US was challenging the EU’s
regulations on genetically engineered crops in the World Trade
Organization.
The FDA, EPA, and USDA, along with the White House, decided to
keep everything secret—for the time being—while they investigated. They
reviewed seven information packets received from Syngenta from Jan. 7
to March 10, 2005. In late March, the story was leaked to the
journal Nature. When their reporter called to check the facts,
the government was forced to go public.
When the story broke, federal agencies assured the public that there
was nothing to worry about. They reasoned that the pesticide that Bt10
produces is the exact same protein produced by Bt11. Since Bt11 is
approved and considered safe, Bt10 must likewise be harmless to health
and the environment. Jeff Stein, head of regulatory affairs at Syngenta
said, “What makes this somewhat unique is that Bt10 and Bt11 are
physically identical and the proteins are identical.”
While these assurances were accepted by the public and repeated in
media reports, experts in genetic engineering knew the statements to be
misleading. As their concerns were made public, Syngenta backed down
from its original position and said Bt10 “differs from approved seeds
only where the foreign genetic material is placed in the plant’s
genome.” They further qualified “that the Bt 10 corn was almost
biologically identical to Bt 11.”
The “almost” is significant.
When the corn was genetically modified, scientists altered a gene from
a soil bacterium, attached an antibiotic resistant marker gene and a
promoter to turn them on, and multiplied this “genetic cassette”
thousands of times. These were then shot through a gene gun into
thousands of corn cells, in the hopes that some of the genes made it
into the DNA of some of the cells. Scientists do not know which cells
get the genes, so they douse them with an antibiotic, killing almost
all of them. The few that survive, do so because the genetic cassette
made it into their DNA, allowing the antibiotic resistant marker gene
to protect the cell from the antibiotic.
The inserted genes function differently depending on where they end up
in the DNA. Natural genes along the DNA can also get deleted,
destroyed, relocated or mutated by the insertion process, and several
genes or gene fragments can be inserted simultaneously. Recent studies
suggest that the DNA of GM crops may typically contain hundreds or
thousands of separate mutations, not found in natural varieties.
Thus, identical genes inserted into the same type of corn will each
bring unique and unpredictable risks. According to an FDA document,
these “unintended changes” are one reason why biotech companies submit
safety information about each GM variety, even if they are engineered
to create the “same intended new trait” as a GM crop that is
already approved. The risks associated with Bt10 are therefore not the
same as Bt11, but this critical difference was not acknowledged by
Syngenta or the US government.
They also ignored recent evidence showing that genes inserted into the
DNA are unstable. Their sequence can rearrange over time.
Government scientists in France and Belgium reported that Syngenta’s
Bt11 had “rearrangements, truncations and unexpected insertions.” In
fact, its DNA was contaminated by Bt176, another Syngenta corn variety
that was also found to be unstable. (Bt176 was quietly removed
from the US market soon after it was discovered that the plant’s pollen
was particularly lethal to monarch butterflies. When Bt176 was the
exclusive diet fed to a herd of cows in Germany, several became
seriously ill and twelve died. Syngenta partially compensated the
farmer’s losses, but critics’ demands for an in-depth investigation
were not met.)
According to tests conducted 11 years ago, Bt10 produces only about
1/7th the amount of the pesticidal protein as Bt11. It is unclear
whether this is due to the placement of the gene, genetic
rearrangements or other reasons. Furthermore, the Canadian Food
Inspection Agency reported that the Bt11 produced four separate Bt
proteins, each of different sizes. Some scientists suggest that the
toxic protein may be “processed or degraded in Bt11.” It is not
clear whether Bt10 exhibits similar mysterious characteristics.
The US government did not discuss these issues with Bt10, in part
because they don’t even deal with them for approved varieties. Their
safety protocols ignore these and many other sources of potential
side-effects. An Austrian government report concluded that claims of
safety for Bt11 were based on assumptions, not scientific evidence.
According to the Institute of Science in Society, “To date there are no
scientific studies on the long-term effects of eating Bt 11 and no
toxicological testing on the whole GM corn plant. Tests for allergic
reactions to Bt 11 were insufficient and relied on theoretical argument
rather than scientific evidence.” Even those theoretical
arguments have been called invalid, since the Bt11 protein has several
characteristics that increase the likelihood that it is
allergenic. The Bt10 protein may similarly be allergenic.
One characteristic of Bt10 that is not shared with Bt11 is its
antibiotic resistant marker (ARM) gene that codes for resistance to
ampicillin. When this fact surfaced a week after the US government and
Syngenta assured the world that the two varieties were identical, it
drew anger and outrage. According to Nature, this is “a difference that
most experts agree is of some significance.” Failure to mention
it was most certainly pre-meditated.
Antibiotic Resistant Markers May Create Super Diseases
The use of ARM genes is highly controversial. Practically every medical
organization that has looked at GM crop safety has expressed concern,
including the American Medical Association, World Health Organization,
UK Royal Society, United Nations Food and Agriculture Organization,
Pasteur Institute, European Food Safety Authority, and Codex
Alimentarius. The British Medical Association even cited ARM genes as
one of their reasons for proposing a ban of GM crops.
The fear is that ARM genes will transfer to pathogenic bacteria in the
gut or environment and unintentionally create a super disease that is
untreatable by antibiotics. Such hard-to-kill infectious bacteria are
already a serious problem, exacerbated by the overuse of antibiotics in
humans and animals. According to the FDA website, such infections
“increase risk of death, and are often associated with prolonged
hospital stays, and sometimes complications. These might necessitate
removing part of a ravaged lung, or replacing a damaged heart
valve.”
The first time the FDA looked at ARM genes, it was in response to plans
by Calgene in the early 1990s to use one that was resistant to the
medicine kanamycin, in their GM FlavrSavr tomato. The Division of
Anti-Infective Drug Products was appalled. In a December 1992 memo that
was later made public by a lawsuit, the division emphasized in all
capital letters, “IT WOULD BE A SERIOUS HEALTH HAZARD TO INTRODUCE A
GENE THAT CODES FOR ANTI-BIOTIC RESISTANCE INTO THE NORMAL FLORA OF THE
GENERAL POPULATION.” After presenting this to their superiors at
the agency, the division director sent it to a colleague with a cover
letter that said, “The Division comes down fairly squarely against the
[kanamycin] gene marker in the genetically engineered tomatoes. I know
this could have serious ramifications.” For emphasis, his letter was
entitled, “The tomatoes that will eat Akron.”
This was a period of time, however, where concerns by FDA scientists
about genetically engineered products were routinely ignored by the
agency’s political appointees, who had been mandated by the White House
to promote the biotech industry (see Seeds of Deception, chapters 3, 4,
and 5). The FDA had even created a special position for Michael Taylor,
a former outside attorney for Monsanto and later their vice president,
to oversee US policy development. Thus, in spite of their scientists’
concerns, and in spite of the fact that other less risky but more
expensive methods were available, the FDA allowed the use of ARM genes.
Their website claims, “It is highly unlikely that antibiotic resistance
genes could be transferred from plant genomes to gut
microorganisms.” They had accepted industry assurances that DNA
was destroyed during digestion and gene transfer was therefore not a
problem. The only human feeding study on GM crops ever conducted,
published in February 2004, overturned this baseless assumption. Not
only did altered genes in GM soy survive digestion, they spontaneously
transferred into the DNA of gut bacteria in human subjects. No
one has yet commissioned a study to see if ARM genes also transfer.
The FDA does not entirely deny the possibility that ARM genes might
create super diseases by rendering antibiotics powerless. They
acknowledge, therefore, that ARM genes would be more risky if they
threatened the use of popular and important antibiotics. Since
kanamycin is not used much by doctors anymore, they reasoned that it
wouldn’t be too dangerous if kanamycin ARM genes were used. Most of the
GM crops on the market today use Kanamycin resistant genes. But
ampicillin is widely used; it is the drug of choice for several types
of infections. If an ARM gene promoted ampicillin-resistant
infections, it would be serious.
While the FDA simply discusses risks associated with gene altered
crops, it does not establish any requirements for the biotech industry,
just voluntary guidelines. In Europe, they are not so feeble. In April
2004, the European Food Safety Authority declared that ampicillin
resistant marker genes “should be restricted to field trials and not be
present in genetically modified plants placed on the market.” At that
time, about 79,000 acres of GM corn were planted in Spain—the only EU
country growing GM crops commercially. About two thirds of the corn was
a variety that used an ampicillin marker. The government promptly
banned it, setting back the biotech industry’s small foothold in
Europe. The significance of this was certainly not lost on Syngenta. It
was their corn variety Bt176 that was banned.
Despite Syngenta’s intimate knowledge of Europe’s disdain for
ampicillin-resistant markers, and despite the fact that an estimated
1000 tons of Bt10 was shipped to the EU from 2001-2004, and that
batches of the Bt10 were also mistakenly sent to France and Spain “for
research purposes,” the company and the US government left out
the fact that Bt10 contains an ampicillin-resistant gene. When
challenged on this omission by the journal Nature, a Syngenta
spokesperson offered, “it wasn’t relevant to the health and safety
discussion.” According to a USDA official, Syngenta similarly did
not inform the US government about the contentious ampicillin issue
when they first reported the contamination in December 2004. The
information came out sometime over the following months.
It is telling that Syngenta, a Swiss company that was responsible for
illegal GM varieties entering the EU, reported the contamination to US
authorities but not to the Europeans. Likewise, the US government also
withheld the information from their EU counterparts. According to the
German publication Spiegal, “The nonchalant behavior of the Americans
infuriated the environmental protection authorities in Brussels and
Berlin more than anything else.”
On April 15, the EU Commission voted overwhelmingly to enact “emergency
measures. . . in order to achieve the high level of health protection
chosen in the Community.” Since imports of food-grade GM corn has
been virtually nil for years, the commission placed restrictions on the
corn products from the US that are used for animal feed—corn gluten
meal and brewers grain. The US had shipped 3.5 million tons of this to
the EU in 2004 for about $450 million. But all shipments were halted by
April 17, when they were required to be certified free of Bt10.
Japanese authorities have not yet ruled on whether they will also
require certification of US corn imports, but many Japanese buyers have
already delayed their purchases from the US or switched to
non-U.S. sources, especially for food grade. Japan is the biggest
foreign market for US corn, importing approximately 4.4 million tons
for food and 12 million tons for feed. South Korea, the sixth
largest importer of US grain, has also discussed the possibility of
requiring tests.
According to Spiegel, “In addition to the ban on feed, the US faces
recalls, actions for liability and above all enormous damage to the
image of US corn.” The German publication said that the cost of the
Bt10 contamination could be much higher than the $1 billion price tag
for StarLink, “especially if until-now lethargic US consumers begin to
question the safety of genetically modified varieties of grain.”
StarLink was another unapproved GM corn discovered in the food supply
in 2000.
The editors of Nature have urged European regulators to “pursue their
own investigation,” since “their US equivalents show little sign of
rising to the challenge.” Friends of the Earth, the Third World
Network and others, demand that Syngenta pay for the costs of testing
their products. , And everyone appears to be calling for
Syngenta to provide their safety studies, molecular characterization,
genetic profile, and complete history of the planting and shipments of
Bt10. They have not been forthcoming. This is not the first time
Syngenta was unresponsive to government and consumer demands. In 2000,
they imported an illegal corn variety into New Zealand and, according
to member of parliament Jeanette Fitzsimons, “refused to allow our
Parliament to see lab records or talk to the company who did the
testing that showed Bt contamination.” She said. “Syngenta has
developed a reputation for thinking it is above the law, and for
refusing to provide regulatory bodies with information that is needed
to assess whether its activities are in the public interest.”
Syngenta is one of the five agricultural biotech companies and the
world’s largest agro-chemical company. Their sales were $6.6 billion
last year. They settled with the US for the Bt10 contamination by
agreeing to pay a fine of $375,000 and to “teach its employees the
importance of complying with all rules.”
Both a Syngenta representative and a USDA spokesperson claimed that
since Syngenta promptly reported the contamination to the government as
soon it was discovered, it shows “that the system is working.” ,
With that criterion, the system also appears to be working in China,
where it was revealed on April 13, 2005 that about 1,000 tons of
unapproved GM rice were sold locally and possibly shipped worldwide.
Let’s hope the system doesn’t work quite so well for Ventria. The
company has requested a permit from the USDA to plant rice in Missouri
that is genetically engineered with human genes in order to create
pharmaceutical drugs.
Spilling the Beans is a monthly column available at www.seedsofdeception.com. Publishers and webmasters may offer this article or monthly series to your readers at no charge, by emailing column@seedsofdeception.com. Individuals may read the column each month by subscribing to a free newsletter at www.seedsofdeception.com. Also on the site, you will find these columns formatted as a two page handout.
© Copyright 2005 by Jeffrey M. Smith. Permission is granted to reproduce this in whole or in part.
MEMBER STATES URGED TO BLOCK ILLEGAL
US MAIZE IMPORTS: EU should go beyond crisis management, Press release,
Brussels, 15 April 2005, Friends of the Earth Europe, EURO COOP, EEB,
IFOAM EU
GMO CORN BLOCKADE. German Consumer Protection Minister:
“Unbelievable Sloppiness!” Spiegel International, Germany, April
18 2005,
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Paul Meller, Europe Leaves Modified Corn Inquiry to U.S., New
York Times, April 6, 2005
Tom Wright, U.S. Fines Swiss Company Over Sale of Altered Seed,
New York Times April 9, 2005
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transgenic corn, Published online: 22 March 2005; |
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Seth Borenstein, Administration kept mum about unapproved
modified corn sold
Knight Ridder Newspapers, Mar 22, 2005
Personal communication with Jim Rogers, USDA spokesperson, April
2005
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transgenic corn, Published online: 22 March 2005; |
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Jim Abrams, Swiss Biotech Company Settles Over Corn, Associated
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Tom Wright, U.S. Fines Swiss Company Over Sale of Altered Seed,
New York Times April 9, 2005
Allison Wilson and others, Genome Scrambling - Myth or Reality?
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varieties, dead cows, cross-contamination and misinformation, ISIS
Press Release 30/03/05
Cows Ate GM Maize & Died, ISIS Press Release 13/01/04
Syngenta’s GM Maize Scandals: A trail of unstable GM maize
varieties, dead cows, cross-contamination and misinformation, ISIS
Press Release 30/03/05
Syngenta’s GM Maize Scandals: A trail of unstable GM maize
varieties, dead cows, cross-contamination and misinformation, ISIS
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10
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Draft, COMMISSION DECISION on emergency measures regarding the
non authorised genetically modified organism “Bt10” in maize products,
THE COMMISSION OF THE EUROPEAN COMMUNITIES
Syngenta's GM goof temporarily slows Japanese demand for corn,
Nikkei English News via NewsEdge Corporation, 4/6/2005
Japan Wary of Making New Purchases of U.S. Corn, Illinois Farm
Bureau, 04/15/05
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Syngenta's GM goof temporarily slows Japanese demand for corn,
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Don’t rely on Uncle Sam, Editorial, Nature 434, 807 (14 April
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US, Third World Network Biosafety Information Service, 19 April 2005
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questions for NZ, 24 March 2005
Spain to ban Syngenta corn, EU's biggest biotech crop,
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