Source: Friends of the Earth
Posted by: Friends of the Earth International - archive
Posted on: Nov 16, 2004 @ 11:12 am

BIOTECH CROP SAFETY TESTS FLAWED,
NEW SCIENTIFIC PAPER SHOWS
Approval of Widespread GM Corn Questioned

CONTACT INFORMATION - KEY FINDINGS

WASHINGTON,DC (US) /BRUSSELS (BELGIUM), 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documents and unpublished studies by biotech companies.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 Œapproval 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] Contact one of the authors for a copy of the article, which forms
part of Volume 21 of Biotechnology and Genetic Engineering Reviews
online here:
http://www.intercept.co.uk/gb/not.asp?id=RS6LS3L6S6ROFD&rec=oui&pos=0&refere
r=%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:

* Evidence 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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