- WASHINGTON DC, BRUSSELS and LONDON - A peer-reviewed scientific paper published today in Biotechnology
and Genetic Engineering Reviews debunks the myth that genetically modified
(GM) crops are thoroughly tested, regulated and proven safe.
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- 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]
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- 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 member states.
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- 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documents and unpublished studies by biotech companies.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]
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- “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.
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- Added Freese: "In one case, the U.S. Environmental
Protection Agency ignored a published study by an 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."
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- 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.
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- "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.
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- "GM food regulation in the U.S. bears as little
relation to good science as the typical used car ad to the true state of
the automobile. Both are designed to sell a product," added Freese.
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- "We outline a testing scheme that would be a first
step toward putting regulation of GM foods on a scientific footing,"
said Schubert. "Quite similar to science-based testing recommended
by several European teams," he added.
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- See 'Key Findings' below for more information on the
paper,
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- NOTES TO EDITORS
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- [1] E-mail one of the contacts below for a copy of the
article, which forms part of Volume 21 of Biotechnology and Genetic Engineering
Reviews .
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- [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?”
The major GM food crops on the market are varieties of soybeans, corn and
canola.
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- [3] About the authors:
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- 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.
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- 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 .
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- [4] In the U.S. regulatory system, the EPA, not the FDA,
has primary responsibility for GM plants that produce insecticides.
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- CONTACT INFORMATION
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- David Schubert (co-author) in California : 858-453-4100
ext. 1528; e-mail: schubert@salk.edu
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- William Freese (co-author) in Washington , DC : 301-985-3011;
e-mail: billfreese@prodigy.net
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- Geert Ritsema, Friends of the Earth Europe, Brussels
( Belgium ), +31-6-29005908; e-mail: geert.ritsema@foeeurope.org
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- Juan Lopez, Friends of the Earth International, London
(UK), +39-333-1498049; e-mail: juan.lopez@foeeurope.org
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- Clare Oxborrow, Friends of the Earth in London ( UK ),
+44-20-75661716; e-mail: media@foe.co.uk
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- Key Findings
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- 'Safety Testing and Regulation of Genetically Engineered
Foods'
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- By William Freese & David Schubert
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- Deficiencies in U.S. government regulation:
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- * The U.S. Food and Drug Administration (FDA) does not
require testing of GM foods, but rather has a 'voluntary consultatio' 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.
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- * 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.
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- * 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.
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- Flaws in biotech company testing practices:
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- * The use of surrogate GM proteins for testing rather
than the GM plant-produced proteins that people actually consume
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- * 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
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- * The tendency of companies to manipulate test conditions
to get the desired results, facilitated by the failure of regulatory agencies
to establish test protocols
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- Case study of GM corn
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- * Evidence that insecticide-producing GM corn may cause
food allergies has been ignored by the EPA
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- * 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)
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- * FDA has fundamentally flawed molecular information
on Monsanto's MON810 corn, reflecting the weakness of its voluntary consultation
process
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- Outline of science-based testing scheme:
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- * Long-term animal feeding trials with the whole GE crop
to test for carcinogenic, reproductive and other adverse effects
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- * Test for potential of GM crop compounds to cause mutations
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- * Test for full range of unintended effects with metabolic
profiling
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- * Test for allergenic potential according to strict,
internationally accepted protocol
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- http://www.foe.org/new/releases/1104gmcrops.html
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