SAN DIEGO, California, November 16, 2004 (ENS):
Evidence that food allergies may be caused by corn genetically
modified to produce its own insecticides has been ignored
by the U.S. Environmental Protection Agency (EPA), according
to a peer-reviewed scientific paper published by two
U.S. scientists today.
The paper, “Safety Testing and Regulation of
Genetically Engineered Foods,” documents fundamental
flaws in how biotech companies test and the U.S. government
regulates genetically modified crops. The authors raise
serious questions about whether biotech foods, which
have been on the market since 1994, are in fact safe,
as claimed by the biotech industry and U.S. regulators.
It is published in "Biotechnology and Genetic Engineering
Lead author Dr. David Schubert is on the faculty of
the Salk Institute of Biological Studies in San Diego,
where he is head of the Cellular Neurobiology Laboratory
and specializes in molecular genetics, cell biology,
and protein chemistry.
“One thing that surprised us," he said,
"is that U.S. regulators rely almost exclusively
on information provided by the biotech crop developer,
and those data are not published in journals or subjected
to peer review."
Instead, the U.S. Food and Drug Administration (FDA)
has a voluntary consultation process when deciding whether
or not permit marketing of genetically modified (GM)
Companies that voluntarily consult with the FDA sometimes
fail to respond to FDA requests for additional information.
The FDA reviews “summary data,” not full
studies, making a critical review impossible, the authors
say. The FDA does not approve genetically modified crops
as safe. The crop developers are made responsible for
the safety of their products.
In addition, the authors found, when testing does take
place, researchers use "surrogate GM proteins"
for testing rather than the genetically modified plant-produced
proteins that people actually consume.
The paper includes a comprehensive case study of two
types of insecticide-producing genetically modified
corn - Monsanto's MON810 variety and Syngenta's Bt11
variety. The study demonstrates how flawed testing and
regulation permitted these varieties onto world markets
despite evidence that they could cause food allergies.
The European Union recently approved 17 corn hybrids
derived from MON810 over the objections of several European
Dr. Schubert collaborated with co-author William Freese,
a research analyst with Friends of the Earth U.S. with
a BA in chemistry. Freese was part of the team that
discovered GM StarLink corn, unapproved for human consumption,
in the food supply. Schubert and Freese base their paper
on nearly 100 sources, including little known U.S. regulatory
documents and unpublished studies by biotech companies.
They found that the EPA "often fails to collect
data for review of potential human health impacts and
accepts substandard testing by biotech companies."
The EPA has ignored evidence from independent researchers
that conflicts with information provided by biotech
Schubert and Freese found that the EPA raises the maximum
permissible levels of herbicide residues on crops to
facilitate introduction of herbicide tolerant genetically
“In one case," said Freese, "the U.S.
Environmental Protection Agency ignored a published
study by a Food and Drug Administration (FDA) scientist
suggesting that GM corn could cause food allergies,
and instead asked Monsanto and Syngenta to essentially
re-do FDA’s analysis.”
The authors advocate required testing of genetically
modified crops. They say a science based testing regime
would include long term animal feeding trials with the
whole genetically modified crop to test for carcinogenic,
reproductive and other adverse effects.
There would be testing for the potential of genetically
modified crop compounds to cause mutations.
There would be testing for a full range of unintended
effects with metabolic profiling, most important to
allergy sufferers, there would be testing for allergenic
potential according to strict, internationally accepted
But that type of testing is not likely to happen any
time soon in the United States, Dr. Schubert told ENS.
"It's very politicized," he said, " and
there's a lot of input from the biotech industry. They
initially wrote the laws a long time ago, and they control
a lot of what's going on."
It would take new legislation to get required tested,
and that is not likely, given today's political climate,
Dr. Schubert said.
For people who are prone to allergies, Dr. Schubert
says it is possible that drinking a beverage sweetened
with corn syrup from genetically modified corn could
cause an allergic reaction.
"The possiblity is there," he said. "The
problem with allegies is it takes such a minute amount
of material, especially that MON810. People have looked
at that and the possiblity is there that this is allergenic,
but the FDA ignored the evidence."
“The picture that emerges from our study of U.S.
regulation of GM foods is a rubber-stamp ‘approval
process’ designed to increase public confidence
in, but not ensure the safety of, genetically engineered
foods,” said Schubert.
For organic farmers trying to maintain the purity of
their crops, genetically modified fields are "a
serious problem," Schubert said. He suggests that
the goal of genetically modified crop producers might
be to saturate the system by getting so much GM material
out there, that it is difficult to keep anything pure.
"I don't know if you can protect organic crops,"
he said. "There are rules on distance that genetically
modified crops must be from other fields, but it is
Even in the case of conventional crops, it is difficult
to keep them from becoming contaminated with pollen
from genetically modfied plants.
The U.S. Dept. of Agriculture (USDA) has not established
rigorous rules to prevent this contamination, even when
the contamination could lead to creation of difficult
to control “superweeds,” the authors say.
Dr. Schubert is most concerned about biopharmaceuticals
as a major problem for the future. "Those things
can be deadly if they get into food crops, and eventually
they will," he told ENS.
Biopharmaceuticals are proteins produced by living
organisms that have medical or diagnostic uses.
The USDA permits cultivation of biopharmaceutical crops,
despite two contamination incidents necessitating destruction
of large quantities of corn and soybeans, the authors
point out. The USDA does not test neighboring fields
for GM contamination or require companies to supply
Nobody knows where the biopharmaceutical test plots
are planted, as the USDA has allowed the companies to
keep that information secret, citing fears of espionage,
vandalism and civil unrest. However, a judge in Hawaii,
which has more biopharmaceutical plots than any other
state, has ordered that the locations of these test
plots be made public.
When other scientists have criticized the biotech industry
and the way it is regulated, they have drawn intense
criticism themselves. Dr. Schubert says he is in a situation
that enables him to present evidence untainted by politics.
His primary research is medical, and he is not dependent
upon the biotech industry for research funding.
"I'm in a unique situation, an old, tenured, senior
faculty in a prestigious institution," he said.
"I have freedom that younger people would not have."
The United States is the world’s largest exporter
of genetically modified crops and accounts for nearly
two-thirds of all biotech crops planted globally.
While the National Corn Growers Association says it
supports "the positive contributions" of biotechnology
as it relates to "human health, the environment,
grain quality and production benefits," the association
is insisting on tests to detect the presence the protein
Cry9C, a modification of StarLink corn.
This protein, intended to be toxic to insect pests
of corn, is believed to pose what the EPA calls a “medium
likelihood” of allergenic risk to humans. It was
approved in 1998 for animal feed, but found its way
into taco shells and other food products. The foods
were recalled, and the crop producer Aventis is not
longer permitted to plant Cry9C modified corn.
Copyright Environment News Service (ENS) 2004. All