Institute for Responsible Technology
Spilling the Beans, April, 2005[THE DANGERS OF PESTICIDE GROWN CORN
PRODUCED IN THE U.S.]
----------------------------------------------------------------
US Government and Biotech Firm Deceive Public on GM Corn
Mix-upBy 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,http://service.spiegel.de/cache/international/spiegel/0,1518,352006,00.html
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
Colin Macilwain, US launches probe into sales of unapproved transgenic corn, Published online: 22 March 2005; | doi:10.1038/nature03570, http://www.nature.com/news/2005/050321/full/nature03570.html
Seth Borenstein, Administration kept mum about unapproved modified corn soldKnight Ridder Newspapers, Mar 22, 2005
Personal communication with Jim Rogers, USDA spokesperson, April 2005
Colin Macilwain, US launches probe into sales of unapproved transgenic corn, Published online: 22 March 2005; | doi:10.1038/nature03570, http://www.nature.com/news/2005/050321/full/nature03570.html
Jim Abrams, Swiss Biotech Company Settles Over Corn, Associated Press, Apr 8, 2005
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? Transformation-Induced Mutations in Transgenic Crop Plants, ECONEXUS, Technical Report , October 2004, www.econexus.info
Premarket Notice Concerning Bioengineered Foods, Proposed rule , Food and Drug Administration, 21 CFR Parts 192 and 592, [Docket No. 00N-1396] RIN 0910-AC15
Unstable Transgenic Lines Illegal, ISIS Press Release 03/12/03, http://www.i-sis.org.uk/UTLI.php Syngenta's GM Maize Scandals: A trail of unstable GM maize 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 Press Release 30/03/05
Cows Ate GM Maize & Died, ISIS Press Release 13/01/04
Bill Freese, A Critique of the EPA's Decision to Re-Register Bt Crops and an Examination of the Potential Allergenicity of Bt Proteins, Friends of the Earth. December 9, 2001, http://www.foe.org/camps/comm/safefood/gefood/comments.pdf Don't rely on Uncle Sam, Editorial, Nature 434, 807 (14 April 2005)
Ricki Lewis, The Rise of Antibiotic-Resistant Infections, FDA page, FDA Consumer magazine, September 1995, http://www.fda.gov/fdac/features/795_antibio.html
Murray Lumpkin to Bruce Burlington, "The tomatoes that will eat Akron," December 17, 1992, www.biointegrity.org
Murray Lumpkin to Bruce Burlington, "The tomatoes that will eat Akron," December 17, 1992, www.biointegrity.org
Guidance For Industry: Use of Antibiotic Resistance Marker Genes in Transgenic Plants, Draft released for comment on: September 4, 1998, http://vm.cfsan.fda.gov/%7Edms/opa-armg.html Netherwood, et al, Assessing the survival of transgenic plant DNA in the human gastrointestinal tract, Nature Biotechnology, Vol 22 Number 2 February 2004.
The EFSA Journal (2004) 48, 1-18, http://www.efsa.eu.int 10
Spain to ban Syngenta corn, EU's biggest biotech crop, Checkbiotech.org, (Bloomberg), 30 Apr 2004, http://www.checkbiotech.org/root/index.cfm
Illegal GM ingredient Bt10 unlikely to pose risk, says EFSA , Food Navigator.com, 14/04/2005
Colin Macilwain, Stray seeds had antibiotic-resistance genes, Nature, Published online: 29 March 2005; doi:10.1038/434548a, http://www.nature.com/news/2005/050328/full/434548a.html Michael Wach, USDA, As reported at the BIGMAP symposium in response to a question by this author, Ames, Iowa, April 19, 2005
Wolfgang Reuter, Stalking Genetically Modified Corn, Spiegel Online, April 18 2005, http://service.spiegel.de/cache/international/0,1518,351921,00.html
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, 04/15/05http://ilfb.aghost.net/index.cfm?show=4&id=14047
Syngenta's GM goof temporarily slows Japanese demand for corn, Nikkei English News via NewsEdge Corporation, 4/6/2005
US officials fret over South Korea's response to GM corn mix-up Date Posted: 3/31/2005, Nikkei English News via NewsEdge Corporation (Dow Jones), www.soyatech.com/bluebook/news/viewarticle.ldml?a=20050331-3
Wolfgang Reuter, Stalking Genetically Modified Corn, Spiegel Online, April 18 2005, http://service.spiegel.de/cache/international/0,1518,351921,00.html
Don't rely on Uncle Sam, Editorial, Nature 434, 807 (14 April 2005)
Bruno Waterfield, EU set to ban US maize feed after GM scare, EU Politixhttp://www.eupolitix.com/EN/News/200504/9f014809-1421-430b-b458-73b67a71d3fb.htm
Europe adopts emergency measures for unapproved Bt10 from the US, Third World Network Biosafety Information Service, 19 April 2005
Jeanette Fitzsimons, Syngenta stuff-up raises troubling GE questions for NZ, 24 March 2005
Spain to ban Syngenta corn, EU's biggest biotech crop, Checkbiotech.org, (Bloomberg), 30 Apr 2004, http://www.checkbiotech.org/root/index.cfm
Raf Casert, E.U. Votes Ban on U.S. Corn Gluten, Associated Press, April 16, 2005; washingtonpost.com
Colin Macilwain, US launches probe into sales of unapproved transgenic corn, Published online: 22 March 2005; | doi:10.1038/nature03570, http://www.nature.com/news/2005/050321/full/nature03570.html
Paul Meller, Europe Leaves Modified Corn Inquiry to U.S., New York Times, April 6, 2005