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Hazardous Biotech Corn Pharm Crops Secretly Cultivated in U.S.

The Institute of Science in Society

<http://www.i- sis.org.uk>

Pharm Crop Products In US Market Posted 5/28/04

Prof. Joe Cummins <mailto:jcummins@uwo.ca> 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 <http://www.i-sis.org.uk/full/GMBIMFull.php> version
of thisarticle is posted on ISIS members¹ website. Details here <http://www.i-
sis.org.uk/membership.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
<http://www.i-sis.org.uk/isisnews/sis22.php>).

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 birds¹ 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 mother¹s milk had elevated GUS.

Elevated GUS has been implicated in bilirubinaemia (jaundice) of breast-fed
infants and breast-fed infants of diabetic mothers. 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 in the peach
aphid, suggesting that the marker may not be entirely without effect on the
organism.

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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This article can be found on the I-SIS website at
http://www.i-sis.org.uk/GMBIM.php