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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.
( http://www.answers.com/topic/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 below:
	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 fight it.” 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 to intuition. 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 Zealand. “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 November 2004 3.Ho.M. and Cummins,J.Bt10 detection method unacceptable ISIS press release http://www.i-sis.org.uk/



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