ISIS Report 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. Mae-Wan
Ho, Sam Burcher and
Rhea Gala
Sources for this article
are posted on ISIS members website.
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
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 "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 "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 –
including feeding trials presented by companies to regulatory authorities under
"confidential business information" – 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
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