ISP Bid to Stop US Rubber-Stamping Transgene Contamination

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27 Jan 2005 15:24:34 -0000

 

 

 

ISP Bid to Stop US " Rubber-Stamping " Transgene Contamination

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The Institute of Science in Society Science Society Sustainability

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Release 27/01/05 ISP Bid to Stop US " Rubber-Stamping " Transgene

Contamination

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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

http://www.i-sis.org.uk/full/ISPbidFull.php. Details here

http://www.i-sis.org.uk/membership.php 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 http://www.i-sis.org.uk/GMSBGS.php).

 

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 "

(http://www.indsp.org/A%20GM-Free%20Sustainable%20World.pdf) 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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http://www.i-sis.org.uk/ISPbid.php

 

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