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Re: [SANET-MG] production and marketing of hazardous biopharmaceuticals



Hi Heide,
I am enclosing  some useful information from the grain growers
association that includes links to those who sell test kits and strip
tests. My thought is that you may wish to  try one of the test strips at
some time but my advise is to avoid spending much on testing.As you will
realize that different antibiotic resistance genes are used in different
GM crops and the different Bt cry genes are numerous, there are no tests
that locate all the genes in one test, only roundup ready offers a shot
at a single test. Anyhow, USDA will  try to ignore results from
individuals or small associations. The best strategy is to try to
convince USDA to do the research (that research should have been done
before the GM crops were deregulated). Organic certification might
require tests before products such as corn gluten meal is approved, but
the surest  way would have USDA research service  do something
benefiting taxpayers rather than corporations.
Hope this helps! sincerely,Joe
http://www.ngfa.org/members/biotech/ngfa%20white%20paper.htm#testing
Companies currently providing protein-based tests are:



AGDIA: 30380 County Road 6, Elkhart, Ill., 46514. Phone: 1
(800)-622-4342; or (219) 264-2014. FAX: (219) 264-2153. Web Site:
www.agdia.com.



EnviroLogix Inc.: 55 Industrial Way, Portland, Maine, 04103. Phone:
(207) 797-0300. Fax: (207) 797-7533. Web Site: www.envirologix.com.



Strategic Diagnostics Inc.: 111 Pencader Drive, Newark, Del.,19802.
Phone: (302) 456-6789. Fax: (302) 456-6770. Web Site: www.sdix.com.
Protein-Based Testing



Protein-based testing uses a specific antibody to detect and sometimes
quantify specific proteins expressed in the plant or seed. Protein-based
tests using ELISA technology have been developed to detect aflatoxin and
deoxynivalenol (vomitoxin) over the last few years. The current testing
methods for biotech-enhanced corn and soybeans were designed as
quality-control tools for seed companies and, thus, may not be fully
compatible for general testing of inbound grain.



Importantly, protein-based "quick" tests currently available are
incapable of distinguishing between all different biotechnology-enhanced
events in corn (e.g., to distinguish between EU- approved versus
unapproved events).



The two types of protein-based tests currently available are:



Lateral Flow Strip: This test uses the immobilized antibody detection
technology. It is similar to the home pregnancy test kit and utilizes a
"dip stick" to provide a "yes/no" answer. Suppliers say that these tests
can be performed in the field and are highly accurate. A variation of
this technology utilizes a cassette rather than a "dip stick" to read
the results. One supplier says the cost is approximately $1 to $3 per
test. Test results can be obtained in 10 minutes for Roundup Ready®
soybeans and within 20 minutes for Bt corn.


Enzyme-Linked Immunosorbant Assay (ELISA): This test was developed in
direct response to European food ingredient labeling requirements and
was designed to check soy flour fat flour, defatted flakes, grits and
flour. It is sensitive within the range of 0.3 percent and 2.5 percent.
This test utilizes the enzyme-linked immunosorbant assay (ELISA)
technology in a series of test wells. It takes up to four hours to
perform. Up to 43 samples can be run at one time. Testing is performed
in a laboratory utilizing special equipment at a cost of about $22.80
per sample. This testing technology is not widely available in the
United States.





Heide Hermary wrote:

Thank you this info, Joe.  As far as I know no testing is being done on
the corn gluten meal for the presence of GM DNA.  Or, if it has been
done, the results are not being communicated.
I would like to test some product I have. I checked the web for ELISA
kits, finding hundreds of different types.  What would I use to test for
Bt and antibiotic resistant genes?  Is there anything  else that might
be of environmental concern if the products are used as fertilizers or
cleaners?
Thanks, Heide

jcummins wrote:

Hy Heide,
Thanks a million for your comments and question. I looked up the wet
milling process for corn and the production of corn gluten meal. First,
gluten meal is used extensively in pig feed, pet food  and food for
farmed fish. It is rich in protein and a bit pricey, I believe , for
garden application.
However, its use as a weed and feed fertilizer is very clever indeed.
There may however be a problem with Bt toxin protein , herbicide
tolerance enzyme and certainly with the biopharmaceutical products.
These proteins can be detected rapidly and relatively inexpensive
detected using ELISA kits, such kits have great sensitivity. The protein
rich corn gluten fraction may be quite rich in  transgenic protein. I
tend to disagree with the other opinion about the presence of transgenic
DNA. The transgenic DNA may be fragmented from the long incubation prior
to gluten recovery but still would be picked up in a sensitive PCR test.
It is best to have precise information prior to application of the
gluten meal, it may form dust that coats the organic crop and later
shows  the transgenes or transgenic protein when tested, causing a big
headache for the organic farmer. Neither the protein nor the DNA in the
gluten meal is likely to be taken up in the plant roots but the dust can
coat and adhere to edible portions of the organic crop. Hopefully, the
promoters of gluten meal will do the appropriate testing and not palm
off the  cost of testing on the organic farmer.
Hope this helps a little, sincerely,Joe

Heide Hermary wrote:

Joe, would these substances, and others such as Bt, still be present or
active in corn gluten meal, which is being marketed extensively as a
pre-emergent weed killer and organic fertilizer for turf?

And how about in these products? The cleaners produced by 1st
envirosafety that have been mentioned on this list are also made from
genetically modified corn and soy. We are very intersted in using /
promoting these products, but are not sure how to even test for the
presence of GM DNA in such a product, or whether that should even be
necessary.   We checked with one of the science board members of the
company (University of Georgia) and were told that "there should be no
DNA present, but no thorough testing has been done". Colloidal
chemistry, which is described as follows:
/
/"The heart of this new chemistry is the technology used to create a
"colloidal micelle." Sub-microscopic particles are created in a
microscopic field similar to a magnetic field. It differs from
traditional chemistry in that the molecular attraction is not the usual
attraction between positive and negative poles. Rather, it is between
like poles. //

//An analogy would be that negative attracts negative and positive
attracts positive. The micelle has a hydrophilic (water seeking) pole
and a hydrophobic (water repelling) pole. The hydrophobic poles attract
each other, thus forming the interior of the micelle. The hydrophilic
poles form a tough outer surface. //

//When a micelle comes in contact with a hydrocarbon molecule the
center
of the micelle bonds to a similar hydrophobic hydrocarbon. It disrupts
the attraction to other hydrocarbon molecules and/or to the surface.//

//The action of a single micelle is multiplied by billions of other
micelles. The molecular level emulsification process penetrates highly
viscous and sticky materials, lifting them from the surface to which
they are adhered."/
/

Heide

jcummins wrote:

May 14, 2004

Prof. Joe Cummins

“ Production and marketing of hazardous biopharmaceuticals without
evident final regulation approval”

Genetic Engineering News (May 1,2004 page34) has a full page
advertisement for animal free recombinant proteins from Sigma-Aldrich
chemicals. The proteins include trypsin (TrypZean) and Aprotinin. A
number of other recombinant proteins produced in rice or maize have
been
marketed by Sigma-Aldrich. The advantage of recombinant proteins
produced in plants includes the belief that hose proteins will be free
of prions that spread BSE. A search of FDA and USDA public records did
not turn up any evidence that the modified crops or the protein
product
had been finally approved for commercial production. However, the
United
States allows marketing of transgenic products produced in field test
releases. The extent and nature of the field test releases are
considered confidential business information (CBI). Exposure of the
public to the toxic products is virtually impossible to trace back to
the secret field tests. It appears as though the government regulators
have a collusive arrangements with corporations to protect the
corporations from liability to persons injured by the recombinant
products in the field or contaminated food.

Trypsin is an enzyme produced in the pancreas and it breaks down
proteins in digestion. The enzyme is used in a number of laboratory
applications, it is used in wound treatment and to treat diabetes. The
enzyme is 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.. The method for modifying crop
plants and preparation of the gene for trypsin is described in US
patent
6,087,558 . The gene for trypsin is isolated from bovine pancreas, the
gene is actually to produce trypsinigen which has six additional amino
acids at the start of the enzyme (these amino acids are cleaved to
make
active trypsin).The DNA inserted into the corn plans comprises the
ubiquitin promoter, including the first exon and intron; the barley
alpha amylase export signal sequence; a trypsinogen encoding sequence;
pinII terminator(potato protease inhibitor II terminator); 35S
promoter
and terminator with the moPAT (maize optimized PAT) selectable marker.
The PAT gene is for glufosinate resistance the maize is herbicide
tolerant but the gene is mainly for selecting transformed cells.

According to material data safety sheets provided by trypsin
manufacturers the product is capable of causing allergy is a skin, eye
and respiratory irritant and may be a mutagen . Known allergens should
not be produced in food crops.

Aprotinin is a protease inhibitor normally prepared from bovine
pancreas
and lung. Recombinant aprotinin produced in plants is currently
marketed
as indicated above. Aprotinin is listed as a reproductive hazard .
There
is serious danger to those exposed to aprotinin after having had a
previous exposure. Fore example a two year old child suffered severe
anaphylactic shock after a test dose of aprotinin . Fatal anaphylaxis
followed aprotinin exposure in a local application of fibrin glue or a
similar application led to an immediate skin reaction following
re-exposure to fibrin sealent . 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 one previously treated
during
surgery or exposure of one exposed to the maize field then treated
during surgery.

Recombinant aprotinin derived from the bovine gene was produced in
maize
. The genetic construction was similar to those described above for
maize based biopharmaceuticals. The ubiquitin promoter along with the
ubiquitin intron was linked to a signal sequence from barley amylase,
the aprotinin sequence was followed by the transcription terminator
for
potato protease II. A selectable marker, bar (glufosinate tolerance)
was
added along with the double CaMV promoter , tobacco mosaic virus omega
leader and intron from maize alcohol dehydrogensase along with the
potato protease II terminator . The recombinant aprotinin does not
appear to have been extensively tested using animals even though its
glycosylation pattern may differ from the animal product and effect
its
allergenicity and stability.

Field test releases of hazardous, life threatening ,
biopharmaceuticals
are being conducted secretively with collusive consent of government
regulators. The products of such field test releases may be marketed,
indeed, the loophole that allows marketing of the products of field
tests seems to allow corporations to undertake production and sale
without expensive safety evaluation and testing. The secrecy and
extensive use of CBI designation in field test releases of recombinant
biopharmaceuticals is frequently justified by a perceived threat of
vandalism. Government bureaucrats provide CBI designation and secrecy
even though the corporations undertaking field test releases should be
providing adequate security for their field test releases. Bureaucrats
do not appear to be acting in the interest of the public by providing
secrecy in cases where the public interest is best served by full
disclosure. Efforts should be made to require full disclosure of field
test releases to those potentially injured or killed by the
products of
the field test releases.

Reference

Cummins,J .“Genetically modified biopharmaceutical products are being
produced and marketed in the United States of America” April 12,2004

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