media advisory
friends of the earth international
biotech crop safety tests flawed, new
scientific paper shows
approval of widespread g.m. corn
questioned
WASHINGTON,DC (US) /BRUSSELS (BELGIUM)/
LONDON (UK) November 16, 2004-– A
peer-reviewed scientific paper published
today in Biotechnology and Genetic
Engineering Reviews debunks the myth that
biotech or genetically modified (GM) crops
are thoroughly tested, regulated and proven
safe.
The paper, “Safety Testing and Regulation
of Genetically Engineered Foods” [1], reveals
fundamental flaws in how biotech companies
test and the U.S. government regulates GM
crops. The paper thus raises serious
questions about whether GM foods, which have
been on the market since 1994, are in fact
safe, as claimed by the biotech industry and
U.S. regulators. [2]
The scientific paper includes a
comprehensive case study of two types of
insecticide-producing GM corn (chiefly the
MON810 variety of biotech giant Monsanto
Co.), showing 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 countries.
Authors Dr. David Schubert (cell biologist
and medical researcher at California's Salk
Institute) and William Freese (research
analyst with Friends of the Earth U.S) base
their meticulously documented, 25-page paper
on nearly 100 sources, including little-known
U.S. regulatory documents and unpublished
studies by biotech companies. [3]
“One thing that surprised us 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,”
said co-author Schubert.
Added Freese: “In one case, 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 US is the world's largest exporter of
GM crops and accounts for nearly two-thirds
of all biotech crops planted globally.
GM soy and GM corn account for 83 percent of
all GM crops planted on the planet.
“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.
“GM food regulation in the U.S. bears as
little relation to good science as the
typical used car advert to the true state of
the automobile. Both are designed to sell a
product,” added Freese.
“We outline a testing scheme that would be
a first step toward putting regulation of GM
foods on a scientific footing,” said
Schubert. “It's quite similar to
science-based testing recommended by several
European teams,” he added.
See “Key Findings” below for more
information on the paper
notes to editors
[1] E-mail one of the contacts above for a
copy of the article, which forms part of
Volume 21 of Biotechnology and Genetic
Engineering Reviews
http://www.intercept.co.uk/gb/not.asp?id=RS6LS3L6S6ROFD&rec=oui&pos=0&referer=%2Fgb%2Fdetail.asp%3Faction%3Dcurrent
[2] An independent study by UK-based
Econexus released in October has come to very
similar conclusions regarding the safety of
existing GM crops; see “Genome Scrambling –
Myth or Reality?” at:
http://www.econexus.info/pdf/ENx%20-%20Genome%20Scrambling%20Summary.pdf
[3] About the authors:
David Schubert, Ph.D is on the faculty of
the Salk Institute of Biological Studies in
San Diego, California, where he is head of
the Cellular Neurobiology Laboratory.
He has a B.A. in chemistry and a Ph.D. in
cell biology. Dr. Schubert's fields of
scientific expertise are molecular genetics,
cell biology, and protein chemistry. He
has published over 200 reviewed manuscripts
in these areas and has written and lectured
on the potential health hazards associated
with genetically modified crops.
William Freese has worked as research
analyst with Friends of the Earth since July
2000. He was part of the team that
discovered GM StarLink corn, unapproved for
human consumption, in the food supply.
He has helped inform the public and the food
industry about the irresponsible practice of
“biopharming” (
www.foe.org/biopharm
), and has written and lectured on many
aspects of GM crops and their
regulation. Freese has a B.A. in
chemistry from Grinnell College.
[4] In the U.S. regulatory system, the
EPA, not the FDA, has primary responsibility
for GM plants that produce insecticides.
contact information:
David Schubert (co-author) in California:
858-453-4100 ext. 1528; e-mail:
schubert@salk.edu
William Freese (co-author) in Washington,
DC: 301-985-3011; e-mail:
billfreese@prodigy.net
Geert Ritsema, Friends of the Earth
Europe, Brussels (Belgium), +31-6-29005908;
e-mail:
geert.ritsema@foeeurope.org
Juan Lopez, Friends of the Earth
International, +39-333-1498049 (Italy);
e-mail:
juan.lopez@foeeurope.org
Clare Oxborrow, Friends of the Earth in
London (UK), +44-20-75661716; e-mail:
media@foe.co.uk
key findings
“Safety Testing and Regulation of
Genetically Engineered Foods”
By William Freese & David Schubert
Deficiencies in U.S. government
regulation:
* The U.S. Food and Drug Administration
(FDA) does not require testing of GM foods,
but rather has a “voluntary consultation”
process.
Companies that voluntarily consult with
the FDA sometimes fail to respond to FDA
requests for additional information.
FDA reviews “summary data,” not full studies,
making a critical review impossible. FDA does
not approve GM crops as safe; instead, the GM
crop developer is made responsible for the
safety of its product.
* The U.S. Environmental Protection Agency
(EPA) regulates insecticide-producing GM
plants. EPA often fails to collect data
for review of potential human health impacts
and accepts substandard testing by biotech
companies. EPA has ignored evidence
from independent researchers that conflicts
with company-provided information. EPA
raises the maximum permissible levels of
herbicide residues on crops to facilitate
introduction of herbicide-tolerant GM
crops.
* The U.S. Dept. of Agriculture (USDA) has
not established rigorous rules to prevent GM
crops from contaminating conventional crops,
even when the contamination could lead to
creation of difficult to control
“superweeds.” USDA permits cultivation
of GM pharmaceutical crops, despite two
contamination incidents necessitating
destruction of large quantities of corn and
soybeans. The USDA does not test
neighboring fields for GM contamination or
require companies to supply test kits.
Flaws in biotech company testing
practices:
* The use of surrogate GM proteins for
testing rather than the GM plant-produced
proteins that people actually consume
* The failure of companies to test for
most possible unintended effects of the
unpredictable genetic engineering process; in
particular, there is a lack of long-term
animal feeding studies
* The tendency of companies to manipulate
test conditions to get the desired results,
facilitated by the failure of regulatory
agencies to establish test protocols
Case study of GM corn:
* Evide nce that insecticide-producing GM
corn may cause food allergies has been
ignored by the EPA
* Increased lignin levels in some GM corn
varieties was not detected before commercial
sale and has still not been explained (lignin
is the woody substance in stalks)
* FDA has fundamentally flawed molecular
information on Monsanto's MON810 corn,
reflecting the weakness of its voluntary
consultation process
Outline of science-based testing
scheme:
* Long-term animal feeding trials with the
whole GE crop to test for carcinogenic,
reproductive and other adverse effects
* Test for potential of GM crop compounds
to cause mutations
* Test for full range of unintended
effects with metabolic profiling
* Test for allergenic potential according
to strict, internationally accepted
protocol
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