Science Society Sustainability
http://www.i-sis.org.uk
ISIS Press Release 27/01/05
ISP Bid to Stop US "Rubber-Stamping" Transgene Contamination
ISP submitted strong objections to US's proposed change in policy
that would allow companies to contaminate the food supply with
unauthorized test crops. <mailto:[EMAIL PROTECTED] sis.org.uk>Mae-Wan Ho,
<mailto:[EMAIL PROTECTED]
sis.org.uk>Sam Burcher and <mailto:[EMAIL PROTECTED] sis.org.uk>Rhea Gala
<http://www.i-sis.org.uk/full/ISPbidFull.php>Sources for this article
are posted on ISIS members website.
<http://www.i-sis.org.uk/membership.php>Details here
The US Food and Drug Administration (FDA) published a proposal on 24
November 2004 that would allow experimental GM crops grown on "test"
sites to legally enter the food chain. The proposal was open for
comment until 24 January 2005.
It came in response to a 2002 Bush administration initiative in the
wake of widespread contamination in 2000 of US food supplies and
exports with unauthorized Starlink GM corn, which continued to be
detected in the US grain supply and in food shipments to Bolivia,
Japan and South Korea as recently as autumn 2003.
FDA Commissioner Lester Crawford described the proposed policy as "a
high priority for the Administration and the industry, to enhance
public confidence, avoid product recalls, and provide an
international model" for similar policies around the world.
Licence to spread contamination
Bill Freese, research analyst with Friends of the Earth (US) said,
"FDA's new proposal has nothing to do with food safety, it's designed
to provide biotech companies with legal cover for contaminating the
food supply with experimental biotech traits. Such contamination has
happened in the past and has cost biotech companies more than
$1billion." Aside from Starlink, another experimental GM corn
containing a pharmaceutical sprouted in a field of soya one year
after the trial crop had been harvested. ProdiGene, the company
responsible, paid out millions of dollars in damages and a $250 000
fine, although the product never reached the food chain.
The US biotechnology and grain industries are already calling on the
US government to "vigorously promote global adoption" of this policy.
It is already virtually impossible to test for the presence of
experimental GM food crops in foods imported from or processed in the
US, because over two- thirds of US field trials of experimental GM
crops involve one or more genes classified as confidential, which
therefore cannot be identified and detected. Adrian Bebb of Friends
of the Earth Europe added: "This will leave consumers worldwide
exposed to new risks from genetically modified foods."
Experiments that are known to the public include crops with radically
altered nutritional content for use as animal feed, or anti-fungal
compounds that resemble food allergens. Others include crops
engineered to be resistant to chemical herbicides, produce their own
insecticides or have sterile pollen or seeds. The FDA is also
considering a similar proposal to allow residues from experimental
pharmaceutical crops to enter the food chain. (See Ban Plant-based
Transgenic Pharmaceuticals
<http://www.i-sis.org.uk/Banpharmcrops.php>).
Juan Lopez from Friends of the Earth International said: "The Bush
Administration, with the active support of the biotechnology
industry, is about to force their untested genetically modified
experiments into the world's food supply. This proposal should be
ringing alarm bells in every consumer, every food company and every
food agency of the planet."
In line with the same policy proposal, Prof. Joe Cummins at the
University of Western Ontario points out, "USDA [US Department of
Agriculture], which regulates organic certification, has proclaimed
that organic food crops polluted with modified genes from wind-borne
pollen released from neighbouring farms will still be certified as
organic food." (See "<http://www.i-sis.org.uk/GMSBGS.php>GM sugar
beet gone sour", this series).
ISP calls for FDA proposal to be withdrawn
The Independent Science Panel (ISP)
(<http://www.indsp.org/ISPMembers.php>), submitted a strongly worded
letter to urge Commissioner Crawford to withdraw the proposals, and
expressed particular concern over the FDA's apparent intention that
the proposals contained in its guidance to industry will provide "an
international model to address the presence of low-level
bioengineered plant material in non- bioengineered crop fields".
As the ISP pointed out, the proposed policy sets out loose "food
safety evaluation" guidelines under which a company may voluntarily
consult with the FDA to have new proteins from experimental GM crops
intended for food use deemed "acceptable" as a food contaminant. The
early "food safety evaluation" suggested in the guidelines consists
largely of paperwork. The proposed scientific evaluation is highly
inadequate, as it fails to specify the tests to be conducted, and
does not include animal feeding trials or tests for unintended
effects caused by genetic modification. "In the absence of a specific
and mandatory test protocol," the ISP letter said, "companies will
fail to prove safety beyond reasonable doubt; but the FDA's new
policy will nevertheless give biotech companies the legal cover for
their experimental GM crops to enter the US food supply."
ISP objections based on scientific evidence
The ISP drew attention to a review on the hazards of GM crops
published in its report "<http://www.indsp.org/A%20GM-
Free%20Sustainable%20World.pdf>The case for a GM-Free Sustainable
World" in June 2003; the key findings of which were as follows:
Regulations over the releases of GM crops and products have been
highly inadequate. Few feeding studies have been carried out, but
they raised serious doubts over the safety of the transgenic process
itself, which have yet to be followed up by dedicated research. GM
varieties are unstable; and this may enhance the horizontal spread of
transgenes, with the potential to create new viruses and bacteria
that cause diseases; and to disrupt gene function in animal and human
cells. Many GM crops contain gene products known to be harmful. For
example, the Bt proteins that kill insect pests include potent
immunogens and allergens; and food crops are increasingly engineered
to produce pharmaceuticals, drugs, and vaccines in the open
environment, exposing people to the danger of inappropriate
medication and their toxic side effects. Herbicide tolerant GM crops
- accounting for 75% of all GM crops worldwide - are tied to the
broad- spectrum herbicides glyphosate and glufosinate ammonium, and
will probably increase their use. Both herbicides are systemic
metabolic poisons linked to spontaneous abortions, birth defects and
other toxicities for human beings and laboratory animals. They are
also harmful to wildlife and to beneficial organisms in the soil. GM
crops have resulted in no benefits to the environment. There has been
no reduction in the use of pesticides, while herbicide tolerant weeds
and volunteers have emerged, and highly toxic herbicides have had to
be brought back in use.
Since its publication, all the major findings of the ISP report have
been further corroborated; and the inadequacies of the US regulatory
system identified by two US scientists.
The ISP called attention to new evidence that most, if not all GM
varieties may be unstable. French government scientists examined five
GM varieties already commercialised, and found all the GM inserts had
rearranged themselves. Belgian government scientists confirmed these
results, and found some of the GM varieties were also non-uniform.
A paper published in 2002 reported that 22 out of 33 transgenic
proteins have runs of 6 or 7 amino acids identical to known
allergens. These include all the Bt toxins (Cry proteins), the CP4
EPSPS and GOX conferring glyphosate tolerance, the coat protein of
the papaya ringspot virus, and even marker proteins such as GUS
(b-glucuronidase). A follow-up study confirmed those results,
highlighting the inadequacy of current methods to predict the
allergenic potential of proteins new to our food chain, and the need
to take these positive findings seriously until they can be ruled out
by further tests to be "false positives". "This warning is
particularly significant", the ISP warned, "as a string of anecdotal
evidence ö including feeding trials presented by companies to
regulatory authorities under "confidential business information" ö
continue to raise serious doubts over the safety of GM crops and GM
food and feed."
There have been more reports from the scientific literature
indicating that the natural toxin is not the same as, or
"substantially equivalent" to, the GM toxin. Green lacewings suffer
significantly reduced survival and delayed development when fed an
insect pest that has eaten GM maize containing the Bt toxin Cry1Ab,
but not when fed the same pest treated with much higher levels of the
natural toxin in bacteria. These findings again suggest that the
genetic modification process itself may be unsafe.
Finally, a new report drawing on nine years of US Dept of Agriculture
data concludes that overall, GM crops have increased pesticide use by
122 million pounds weight since 1996.
The FDA "irresponsible"
In view of all these known problems and uncertainties over the safety
of GMOs, the ISP letter stated, "it would be irresponsible for the
FDA to yet further relax regulation, which will almost certainly
result in widespread transgene contamination."
In ignoring the threat of serious irreversible damage to human health
from unknown and untested GM material, the proposed change in FDA
policy is also a clear breach of the Precautionary Principle
enshrined in the Cartagena Protocol on Biosafety, the only
international law regulating genetic engineering.
As people will be eating these foods for generations once they are
released into the environment, the ISP pointed to the need for safety
assessments to be "long term, intergenerational and on the whole
food, not on just the new substance that the GM organism is designed
to produce."
Not only should the FDA withdraw the policy changes proposed in its
Draft Guidance for Industry, the ISP said it should be devising
strict rules and procedures to prevent contamination of the food
supply with experimental transgenic proteins and to replace its
current non-rigorous "voluntary consultation" process with a
mandatory, science-based review process designed to guarantee that
the GM crops are safe for food and feed.
ISP letter in full at <http://www.indsp.org/USFDALetter190105.php>
This article can be found on the I-SIS website at
http://www.i-sis.org.uk/ISPbid.php
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