[Gen-Streitfall] GM pharma crops secretly grown and marketed in America

[Andreas Bauer]

Liebe Attacies!

Laut einem gerade veröffentlichten Bericht werden in den USA seit mehreren
Jahren sog. Pharma-crops (also Pflanzen, die medizinische Stoffe
produzieren) kommerziell angebaut, 
- ohne Zulassung durch die Behörden, jedoch mit Wissen der FDA und des US- 
  Landwirtschaftsministeriums
- ohne daß die Bevökerung informiert wurde.
Bei den Pflanzen handelt es sich um Mais (da war doch was mit Pollenflug,
Auskreuzung und Bienen)und Tabak. 
Genaueres über die leckeren medizinischen Stoffe in diesen feinen Pflänzchen
steht im Artikel. 
Da kann man nur hoffen, daß der ein oder andere Politiker, ohne Nennung von
Namen, mal so einen richtig leckeren Maiskolben auf sein Barbecue haut. Mal
gucken, was da so passiert.
Gruß,
Andreas

--- Weitergeleitete Nachricht / Forwarded Message ---
Date: Thu, 27 May 2004 12:09:29 +0100
From: "GM WATCH" <info at gmwatch.org>
Subject: GMW: GM pharma crops secretly grown and marketed in America

GM WATCH daily
http://www.gmwatch.org
-----
".....none of the biopharmaceutical-producing GM crops appears to have gone
through the usual regulatory process. Instead they appeared to have
progressed from field-testing to marketing without the benefit of final
regulatory approval, with apparently full cooperation of the FDA and USDA
(the agriculture department has proprietary interest in some of the
biopharmaceuticals). The biopharmaceuticals have proceeded to the market via
the backdoor, thanks to a loophole in the regulation of field tests.....the
secretive production of dangerous pharmaceuticals in food crops is a truly
disturbing development. The sale of such products without transparent public
approval is adding insult on injury, reinforcing the public perception that
the regulatory authorities are putting corporate profit far above public
safety."
------
The Institute of Science in Society
ISIS Press Release 26/05/04
Pharm Crop Products In US Market

Prof. Joe Cummins discovers that dangerous GM pharmaceutical crops have been
produced and marketed in the United States for at least two years,
unbeknownst to the public, via a gaping loophole in the regulatory process.

A fully referenced version of this article is posted on ISIS members'
website. 
http://www.i-sis.org.uk/full/GMBIMFull.php

There has been a great deal of public opposition recently to the testing of
rice genetically modified to produce the human proteins lysozyme and
lactoferrin in the United States. So far, those tests have been stalled (see
SiS 22).

But, Sigma-Aldrich, a US chemical company, has been marketing the
biopharmaceutical products trypsin, avidin and beta-glucuronidase (GUS)
processed from
transgenic maize, for at least two years. Meanwhile, Prodigene Corporation
and Sigma-Aldrich are marketing aprotinin (AproliZean) from maize and from a
transgenic tobacco.

Trypsin is a digestive enzyme used extensively in research, to treat disease
and in food processing. The product TrypZean is marketed as an animal free
product, and is produced jointly by Sigma-Aldrich and Prodigene (the company
fined for contaminating food crops with biopharmaceuticals in the United
States last year).

The development of genetically modified (GM) food crops generally follows a
certain pattern in the United States: First, controlled field tests are
undertaken for a number of seasons. Then, the proponent applies for
deregulation of the GM crop following reviews by the Animal Plant Health
Service (APHIS) of the Department of Agriculture (USDA), the Food and Drug
Administration (FDA) and by the Environmental Protection Agency (EPA) if the
GM crop includes a plant incorporated bio-pesticide. Upon completion of the
process, the GM crop is deemed to be deregulated and can be grown without
monitoring.

However, none of the biopharmaceutical-producing GM crops appears to have
gone through the usual regulatory process. Instead they appeared to have
progressed from field-testing to marketing without the benefit of final
regulatory approval, with apparently full cooperation of the FDA and USDA
(the agriculture department has proprietary interest in some of the
biopharmaceuticals). The biopharmaceuticals have proceeded to the market via
the backdoor, thanks to a loophole in the regulation of field tests.

According to the Pew Initiative on Food and Biotechnology, "current APHIS
regulations do allow the commercialization of a GE [genetically engineered]
crop without a prior affirmative approval by the agency and without public
notice. Developers are not required to file a petition for non-regulated
status
before they produce a plant commercially. It is possible for developers to
grow
plants at a commercial scale under notification or field trial permits, even
if the plants might pose some identifiable environmental or human health
risk".

Crop production facilities are permitted as "field tests", but locations of
such facilities are designated "confidential business information" and are
not disclosed to people living nearby, even though the genes and products of
such sites can easily contaminate crops, ground water and surface water.
There
seems to be no direct way to find out where the production facilities are,
except via producers and government regulators.

The US government seems committed to going ahead with a procedure that
bypasses public input and scrutiny, and which if, when disclosed, will
threaten the marketability of US food exports. In contrast, the Canadian
Food Inspection Service maintains that "plant products of test sites cannot
be marketed", even though numerous plant biopharmaceutical products have
been tested.

The regulation of plant-derived biopharmaceuticals was reviewed by the FDA
in 2000; and by the Pew Initiative in 2004. Only the Pew report came to
grips with the practice of marketing virtually untested products
commercialized without public input.

As indicated earlier, test plot permits for crops producing
biopharmaceutical proteins are usually designated confidential business
information so that
the nature of the products is hidden from the public as well as the location
of the test sites. APHIS does, however, record the crop and the state in
which
the modified crop is tested. Between 2003 and 2004, Prodigene had test plots
in Nebraska, Texas, Iowa and Missouri.

Production of the commercial biopharmaceuticals was, for the most part,
achieved using maize, even though it is a food crop of fundamental
importance and
should not have been used to produce biopharmaceuticals, especially when the
products are by no means benign for humans and animals exposed to them.

Trypsin is an enzyme produced in the pancreas to digest proteins. It is
extensively used in laboratory applications, in wound treatment and to treat
diabetes. It is also used in food processing and often put into infant
formulations to aid in digestion. The plant-produced product is desirable
because it is free of prions and animal viruses.

According to the safety data sheets provided by trypsin manufacturers, the
product is capable of causing allergy – it is a skin, eye and respiratory
irritant and may be a mutagen.

Avidin is a protein found in birds' eggs. It functions to bind the vitamin
biotin, which is required for many insect pests. The pests are inactivated
by
the absence of the necessary vitamin. Transgenic maize modified for avidin
production is resistant to storage insect pests.

A case study done by the Friends of the Earth turned up substantial evidence
that the protein avidin caused dangerous biotin deficiency in humans and
animals, leading to immune deficiency and growth retardation. Even marginal
biotin deficiency is linked to birth defects in mice and in humans.

Aprotinin is a protease inhibitor normally prepared from the pancreas and
lung of cows. Recombinant aprotinin produced in plants is currently
marketed.
Bill Freese of Friends of the Earth reviewed the problem of allergy and
pancreatic disease associated with this product.

Aprotinin is also listed as a reproductive hazard. There is serious danger
to those exposed to aprotinin after having had a previous exposure. For
 example, a two-year old child suffered severe anaphylactic shock (a
life-threatening allergic reaction characterized by swelling of body tissues
including the throat, difficulty in breathing, and a sudden fall in blood
pressure) after a test dose of aprotinin. Fatal anaphylaxis followed
aprotinin
exposure in a local application of fibrin glue. A similar application led to
an immediate skin reaction following re-exposure to fibrin sealant.

Secret field testing of plant-based recombinant aprotinin could result in
severe or fatal anaphylaxis, either in a brief exposure in the maize field
of
someone previously treated during surgery, or exposure of someone exposed to
the maize field followed by treatment during surgery.

The final commercial recombinant protein in maize is beta-glucuronidiase
(GUS). The gene is used in a wide range of experimental situations but does
not appear to have therapeutic importance. It has been observed that formula
milk for infants had a low content of GUS while mother’s milk had elevated
GUS.

Elevated GUS has been implicated in bilirubinaemia (jaundice) of breast-fed
infants [24] and breast-fed infants of diabetic mothers [25]. GUS is used
extensively as a marker, believed to have little effect on the phenotype of
the
test organism. However, GUS was found to enhance the feeding activity of the
peach aphid [26], suggesting that the marker may not be entirely without
effect on the phenotype of organisms.

In conclusion, the secretive production of dangerous pharmaceuticals in food
crops is a truly disturbing development. The sale of such products without
transparent public approval is adding insult on injury, reinforcing the
public
perception that the regulatory authorities are putting corporate profit far
above public safety.


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"Wir brauchen keine Bio-Terroristen, wenn wir Gentechniker haben."
Independent Science Panel (www.indsp.org)