Ethiopia goes organic to feed herself - The Institute of Science In ...

28
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.
Pharm Crop
Products
in US Market
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, plans to
commercialize this rice 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 biopesticide.
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 nonregulated
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 pan-
SCIENCE IN SOCIETY 23, AUTUMN 2004