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[SANET-MG] confidential business information
Confidential Business Information
May 22, 2005
Prof. Joe Cummins
Confidential Business Information (CBI) is a trade secret :A formula,
process, device, or item of information used by a business that has
economic value because it is not generally known or easily discovered by
observation or examination and for which reasonable efforts to maintain
secrecy have been made - Trade secrets are a form of intellectual
property. Many states have enacted laws which create an action for
damages or injunctive relief against misappropriation of trade secrets
by improper means. Information contained in a patent is not protected as
a trade secret.
Recently CBI has come to prominence in two areas. The first is animal
health studies following consumption of maize containing Mon 863 corn
while the other is in results of studies on the DNA sequence of the Bt10
insert in maize. Before dealing with the maize issues a note on the
CBI designation in regulation of genetically modified (GM) crops and
their field trials. Because the GM crops are prepared using patented
genetic inserts the CBI designation is seldom employed in the petitions
for non-regulated status nor in the regulatory reviews of the crops.
However, USDA has allowed extensive use of CBI in approving field test
releases while European countries do not appear to have used the CBI
designation much at all. The most disturbing aspect of the CBI
designation is that it appears to be being used to hide or conceal
potential adverse health effects associated with injury following GM
food or feed consumption.
An article in the British newspaper The Independent made public the
fact that important health information about the Genetically Modified
(GM) maize Mon863 may have been concealed from the public following
designation of the evidence as CBI. An excerpt of that article is shown
Revealed: health fears over secret study into GM food
Rats fed GM corn due for sale in Britain developed abnormalities in
blood and kidneys
By Geoffrey Lean, Environment Editor
22 May 2005 The Independent
“Revealed: health fears over secret study into GM food When fed to rats
it affected their kidneys and blood counts. So what might it do to
humans? Rats fed on a diet rich in genetically modified corn developed
abnormalities to internal organs and changes to their blood, raising
fears that human health could be affected by eating GM food.The
Independent on Sunday can today reveal details of secret research
carried out by Monsanto, the GM food giant, which shows that rats fed
the modified corn had smaller kidneys and variations in the composition
of their blood. According to the confidential 1,139-page report, these
health problems were absent from another batch of rodents fed non-GM
food as part of the research project. The disclosures come as European
countries, including Britain, prepare to vote on whether the GM-modified
corn should go on sale to the public. A vote last week by the European
Union failed to secure agreement over whether the product should be sold
here, after Britain and nine other countries voted in favour. However,
the disclosure of the health effects on the Monsanto rats has
intensified the row over whether the corn is safe to eat without further
research. Doctors said the changes in the blood of the rodents could
indicate that the rat's immune system had been damaged or that a
disorder such as a tumour had grown and the system was mobilising to
On May 23,2005 Monsanto responded to the independent report.” The full
"rat study" has not been released because it contains confidential
business information which could be of commercial use to our competitors
and exploited by others for commercial advantage, if made available”.
Certainly it is true that the fact that rats fed Mon863 maize caused
detrimental impacts on the kidney and blood of rats could be exploited
by others for commercial advantage. However, that is no real reason for
designating it top be CBI.The Monsanto reply goes on “All qualified
experts concluded that the observed small numerical decrease in rat
kidney weights is not biologically meaningful, and the weights are well
within the normal range of kidney weights for control animals.” However,
the Monsanto report referred to a “secret” report from Dr. Arpad
Pusztai a fully qualified expert in toxicology which had acknowledged
the problem of kidney size and blood abnormality but Monsanto preferred
the opinions of five independent (but unnamed) who agreed that the
noted dysfunctions were within what they considered a normal range.(1).
Experts who reviewed the Pusztai report (itself designated CBI) noted
that there were statistically significant differences between Mon861
fed rats and control for the experiment but the experts argued that the
significant differences were within what they considered a “normal”
range(2). What the experts are saying is disregard statistics and turn
What CBI can there be in the Mon 861 rat feeding studies? The answer
seems clear that the designation is based on the evidence that the rats
were injured by the GM maize. If there is any truly CBI information in
the Mon863 report that information could be covered with black ink
which is the usual practice. The employment of the CBI to designate both
the original rat feeding experiment and the Pusztai report seems
silly at best and a misuse of a process at worst.
Swiss biotech firm Syngenta had accidentally sold illegal GM maize Bt10
in the US for the past four years, resulting in about 133 million
kilograms of the maize making its way into food and feed. There has been
extensive contamination of the food supply and there has been
reluctance to provide full information about the polluting strain to
allow independent identification of the polluting genetic material.
Syngenta’s reports sent to the US Environment Protection Agency earlier
this year have been leaked to ISIS even though it has been designated
CBI in North America and the European Union, but not in Australia-New
“The first report dated 28 January 2005 is intended to present the DNA
sequence of Bt10 compared with Bt11, the GM maize line that Bt10 had
contaminated by accident. The Bt10 insert was mapped to chromosome 1 of
the maize genome, while Bt11 insert had been mapped to chromosome 8.
This alone will indicate that Bt10 is completely different from Bt11. In
addition, there were three nucleotide changes in Bt10 compared with
Bt11: two in an unspecified sequence contained within the Bt10 insert ,
and one located in the nos terminator associated with the crylAb gene.
No nucleotide changes were identified in any of the coding sequences and
promoters within the Bt10 insert.
However, the map of the Bt10 insert presented can only be partial, as
it did not include the ampicillin antibiotic resistance marker gene,
unless that marker gene has inserted elsewhere in the genome. The map
presented also contained at least three unspecified, unknown sequences
The second report from Syngenta to the EPA is of a study comparing the
transgenic proteins expressed in Bt10 compared with those in Bt11 . The
proteins were extracted from leaves of the plants, and subjected to
western blot analyses, a technique dependent on staining the protein
bands with specific antibodies after separating them by migration in an
electric field through a gel matrix.
This report claims that the analyses “revealed similar dominant
immunoreactive bands” in both Bt11 and Bt10 corresponding to the
predicted Cry1Ab protein (for insect resistance) and phosphinothricin
acetyltransferase (PAT) (for tolerance to the herbicide glufosinate
ammonium) of about 69 000 and 22 000 daltons respectively.
However, the photographs of the western blots contained in the report
tell a different story. Bt11 showed a series of bands at 46 000, 63 000
and 52 000 daltons (in order of strength of staining) besides the
dominant 63 000 daltons band, whereas Bt 10 only had the 63 000 daltons
fragment besides the main predicted band. The PAT protein bands in Bt10
and Bt 11 were also different from each other and from the purified
standard, with many high molecular weight bands reacting to the antibody.
Neither report contains information on the breeding history of the GM
maize lines analyzed, such as the number of generations since the
transformation event; nor data from appropriate reference material.
These are sure signs of sloppy science” (3).
The designation of the material in these reports to be CBI appears to
be extra ordinarily silly. As in the case of the CBI designations in the
Mon863 rat study the CBI designation seems to be a collusive arrangement
between government and corporation to conceal the marketing of toxic
products and to evade detection of polluting genetic material. The
excessive use of CBI designations is particularly offensive in the
testing and production of modified pharmaceutical crops because
bystanders have no way of knowing the nature and threat to their health
The abuse of CBI is playing out like a Monty Python sketch in which the
government regulators play the patsy role.
It seems unlikely that those injured by the abusive CBI designation
will be able to seek damages for their injury, unless there is a clear
determination that both corporate promoters and government regulators
face retribution for harm they will inflict on the public and on the
environment. In the cases described above and in the field test releases
CBI designation should be open to scrutiny by independent bodies
including representatives from the public.
1.Monsanto UK Monsanto response on MON863 maize 90-day rat reeding study
Pressd Release 23 May 2005
2.Knudson,I Considerations regarding the scientific assessment of the
safety of food and feed from genetically modified plants, exemplified
with genetically modified insecticidal corn (MON 863) as a case 13
3.Ho.M. and Cummins,J.Bt10 detection method unacceptable ISIS press
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