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Moderated conference on GMOs in the pipeline, hosted by the FAO Biotechnology Forum in 2012

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Biotech-Mod2 <[log in to unmask]>
Mon, 3 Dec 2012 18:48:59 +0100
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This is Aruna Rodrigues again and I am rushing to meet the deadline before this consultation closes in order to reply to Dr Manjunath (ref. his post 87 with regard to the health safety testing of Bt brinjal Event EE-1.).

I reply to 3 points in his post. First the historical claim for safety (50 years?) and that Bt has "has an impeccable global safety record". He then proceeds to draw conclusions from natural Bt sprays and the engineered Bt toxin as though they are no different; second, evidence that "responsible scientists" have examined Bt toxins and Bt brinjal and found it safe; and third the "various allegations made against its safety by certain NGOs have been scientifically examined by the regulatory authorities and found to be baseless".

These statements are factually wrong; the third falls by the wayside based on evidence forced into the public domain under the Right to Information (RTI). We do not even have the means to test for the Bt toxin as became apparent in the cases of animals which died feeding in harvested Bt cotton fields. As for the integrity of our regulators and public institutions, including the Ministry of Agriculture, let me remind Dr Manjunath that the evidence in the SC (which, taking cognisance of the facts, put Drs MS Swaminathan and PM Bhargava as invitees to the GEAC Meetings to observe their  proceedings). And in August 2012, the Parliamentary Standing Committee has unceremoniously indicted our Regulators for a serious conflict of interest calling for a high level inquiry into several matters. It has probed further and uncovered the sheer depth and spread of the conflict of interest that has permeated virtually all public institutions connected with GMOs most especially our agri institutions. In this sorry climate of corruption and it has to be said, of open collusion with the Industry, India exercises only a semblance of regulation to mask and replace fact with a liberal dose of fiction. For whose benefit, is the rhetorical Q? 

The risk assessment and quality of testing in the health safety studies is of a pattern with the molecular analyses and environmental risk analysis (ERA) appraisals by Heinemann and Andow respectively (re posts 65 & 78). Thus, in the health studies as well, there is minimal oversight by the regulators, and Mahyco-Monsanto have been accused of studies which have not been adequately performed, or not done and cover-up (Seralini, Carman & Gallagher in their appraisal of the 'dossier'). There has been no testing what-so-ever for chronic toxicity in long term multigenerational rat feed studies. Instead of this issue being brought up endlessly, why doesn't the Industry along with its proponents who oppose such testing, instead, move to support such testing: provide the reference materials for some really rigorous, independent and peer reviewed test protocols and testing in independent labs. Is there something to hide? With each passing year, and increasingly, the evidence from independent studies points to serious problems and they are from scientists who have more to lose than gain because of the vilification and persecution by the Industry that follows. It should be emphasized that the majority of this material has been published in peer-reviewed journals and reproduced in more than one laboratory, therefore ruling out the possibility of an individual investigator's bias. 

I provide the following evidence to debunk some myths that are used by the proponents of GE brinjal to claim that it is safe (from the submissions by the named scientists to Jairam Ramesh in the review process of Bt brinjal (published in his report and from evidence provided to the Supreme Court of India). 

(a) Cry mode of action and non-target effects (Heinemann, Pusztai, Schubert, Seralini, Carman, Gallagher): The claim made by Mahyco is that the safety of Bt proteins (such as Cry1Ac) "is attributed to the mode of action and specificity". These claims are made on page 93 (section 6.3) of the Toxicology and allergenicity studies vol. 1 and elsewhere. The long-accepted version of Cry toxicity is not the actual mechanism. Thus, the range of organisms that will find Cry toxic may not be predicted from knowledge based on toxicity. "In support of the human data, when animals are exposed to Bt toxins, the toxin also acts as a potent immunogen, eliciting responses from both the blood and gut-based immune systems. Based upon these data, the US Environmental Protection Agency (EPA) recommended extensive safety testing of Bt crops for this trait, but due to the lack of required safety testing for GE food crops in the US, this was never done (Freese W, Schubert D. Safety testing of GE food - Biotechnology and Genetically Engineering Reviews). Claims of safety of Cry endotoxins and therefore Bt brinjal may not be based on either cotton, or maize (in the US) because these are primarily animal feeds, even leaving aside the very good evidence that Bt cotton plants have led to serious health problems in farm animals in India. This conclusion of safety is invalid for several reasons: 

(b) Ref. Prof Schubert document to Jairam Ramesh in the review process of Bt brinjal: First, in the US the  maize containing the Bt protein that is consumed is largely in the form of highly processed corn chips and related snack foods that are not major components of the diet. In contrast, the Bt protein in brinjal will be directly consumed in massive quantities and in an infinite number of ways (because the vegetable is a significant component of the Indian diet) leading to potential chemical changes in the protein causing unknown toxicology and immunogenicity; Second there are no labelling laws in the US. A major concern with the introduction of any GE food is that even if it did cause an illness, it would not be detected because of the lack of epidemiological studies and the technical limitations for detecting such an illness. For example, to detect an epidemic of a disease, an incidence of at least of two fold above the background rate of the disease is required. Therefore, if Bt brinjal were to cause a disease like Parkinson's, which has in an incidence of about 20 new cases per year per 100,000 people, then in India 200,000 new cases per year would have to be diagnosed and tabulated in order to identify a significant increase, and there would still be no way to associate the disease directly with a Bt crop. In addition, many environmentally caused diseases take many decades of exposure to develop symptoms. Clearly, once Bt brinjal is commercially released, there will be no way to monitor adverse health effects caused by the product. 

- There are at least four mechanisms by which the introduction of the Bt toxin gene into the Brinjal genome can cause harm. These include (1) the random insertion of the Bt gene into the plant DNA and the resulting unintended consequences, (2) alterations in crop metabolism by the Bt protein that results in new, equally unintended and potentially toxic products, (3) the direct toxicity of the Bt protein, and (4) an immune response elicited by the Bt protein. There are scientifically documented examples of all four toxic mechanisms for Bt crops.
- Allergies are complex responses of the immune system to foreign substances and vary widely between individuals in an unpredictable manner. Bt toxins have long been used as insecticidal sprays on a variety of crops, but the spray is a less toxic form of the protein than that made by GE plants. Even though the spray is not ingested by farm workers, there is solid evidence that the Bt proteins elicit a strong immune response in some workers after a few months exposure, and it is likely that many more workers are affected, but associate their allergic response with the spray and decide to work elsewhere (Bernstein 1999). Since Bt proteins have amino acid sequence homology with known allergens, allergic reactions in some individuals are not unexpected. Most importantly, it should be emphasized that the concentration and amount of Bt toxin protein that people will eat in Bt brinjal will be thousands of times higher than the exposure levels of farm workers. 

(c) Allergy studies: Since the test substance was only applied once, they cannot be regarded as allergy studies. Allergies generally require repeated exposure to a substance before an allergy can be developed. The more often the exposure, the worse the allergic reaction tends to get (Carman)

(d) Lou Gallagher: Bt brinjal Event EE-1: The Bt brinjal Toxicology Assessment: She analysed the raw data of the 14 and 90-day studies of the Bt brinjal dossier. She confirms: 
- organ and systems damage: Ovaries at half their normal weight, enlarged spleens with white blood cell counts at 35 to 40 percent higher than normal with elevated eosinophils, indicating immune function changes
- toxic effects to the liver as demonstrated by elevated bilirubin and elevated plasma acetylcholinesterase
- International published standards flouted. 

Gallagher states: "Major health problems among test animals were ignored in these reports. The single test dose used was lower than recommended by the Indian protocols. Release of Bt brinjal for human consumption cannot be recommended given the current evidence of toxicity to rats in just 90 days and the studies' serious departures from normal scientific standards". 

Aruna Rodrigues
Sunray Harvesters,
Bungalow 69
Mhow - 453441
M.P. India
e-mail: arunarod (at) gmail.com

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