Science Adulterated!
Dr Sagari R Ramdas
Combat Law : The Human Rights & Law Bimonthly, April 2010
http://www.combatlaw.org/?p=258

The inconclusive nature of Bt toxin in cotton and its impact on animals continue to haunt as there has been a persistent reluctance amongst the scientific establishment to respond, investigate and research into the problem. Dr Sagari R Ramdas exposes the mainstream scientific community which has time and again failed to provide any hard evidence to support its claims of safety of GM technology that has already devastated India's biggest commercial crop cotton


The clearance for the commercialisation of Bt brinjal has been stalled, providing a small window and space to push for "accountable science" within a country where for decades "science" and "scientists" have been deified, and excluded/protected from any processes of democratic interrogation.

The proponents of the GM technology accuse all those who question it as being "anti-science", and "anti-development", which is increasingly equated with being "anti-national". "The confidence of the scientific community has been undermined" scream newspaper headlines because of the recent decision to impose a moratorium on Bt brinjal, as also at the audacity of citizens historically on the margins dalit women farmers, shepherds, adivasis, students and other riff-raff "non-scientific" consumers, to question the authority of the scientist fraternity. However, the decision on the Bt food crop is a temporary and possibly a mere cosmetic respite and the State's long-term political commitment to nurture an utterly impenetrable and non-accountable system of science in the public domain is crystal clear with their intention to table the Biotechnology Regulatory Authority Bill, 2009 (BRAB, 2009) in the current parliament session.

The bill promises to provide legal ammunition to muzzle any citizen who dares to question the science of biotechnology, and clearly undermines our fundamental rights enshrined in the Constitution of India. A legal instrument with provisions to punish anyone who "without any evidence or scientific record misleads the public about the safety of the organisms and products"1 or "who conducts field trials with organisms or products"2, and proposes to keep aspects of research on the products out of the purview of the Right to Information Act, will effectively stall the urgent need for democratisation of science and technology.

The complete absence of public scientific accountability as also the manner in which such a legislation (if passed) may be used in future to legally choke the possibilities of conducting any "independent" rigorous scientific investigation are aptly illustrated by the recent experience of Bt cotton and its impact on domestic animals in India, where several unanswered questions about the working of the technology once it was released into the "field", beg to be addressed, and are simply being dismissed as "frivolous" and "unnecessary".

The case of Bt cotton

Since 2005, shepherds and farmers from different parts of India, particularly the states of Andhra Pradesh, Haryana, Karnataka and Maharashtra, have reported their cattle falling sick after it has grazed on genetically modified cotton or have been fed Bt cotton seeds and in some instances have died. Despite several reports and representations to concerned regulatory and research institutions both at national and state levels, alerting them to the seriousness of the issue, there has been a persistent reluctance amongst the scientific establishment to respond, investigate and research the core issue. On the contrary the reaction of the establishment has been bureaucratic and dismissive of the observations. The clinical findings of "non-government" veterinary scientists who have been tracking the problem, describe these as being "unscientific", "exaggerated, blown out of proportion", and not based on sufficient research and "hard facts".

The regulatory authorities such as the Genetic Engineering Approval Committee (GEAC) and top research universities have exhibited incapacity to rigorously investigate the matter and instead consistently argue that because all safety tests in the "pre-commercialisation" stage provided beyond doubt proof of safety of the technology, it simply could not be the cause of morbidity and mortality. Till date not one public research institution has undertaken to systematically investigate the problem in the fields.

Safety of Bt toxin in animals and dismissal by regulatory authorities of the need to conduct further bio-safety tests (such as foliage and shoot toxicity studies) on animals, was the justification used by the Expert Committee on Bt brinjal to dismiss the need to conduct long-term chronic toxicity tests and nutritional impact studies of the toxin on mammals.3

The "evidence" that the deaths were not caused by Bt cotton, which is cited by regulatory authorities with complete impunity, would not stand any kind of international scientific scrutiny based as they are on incomplete testing / investigation protocols, admission by top Indian research institutions of the absence of facilities to test for the effects of the toxin on animals, and citing company data of "toxin-safety levels".

Interrogating science of safety

(i) Field studies point to morbidity and mortality in animals subjected to a cumulative exposure to the Bt toxin, eliciting allergenic reactions in goats and sheep grazing on Bt cotton foliage in Andhra Pradesh, and reproductive disorders in buffalos fed Bt cotton seeds/ cottonseed cake in Haryana and Maharashtra.

Between 2005 and 2009 Anthra4, an organisation led by women veterinary scientists researching the impact of Bt cotton on animals in different parts of India, has been closely investigating the reported morbidity and mortality observed in sheep and goat flocks, which have been grazed on harvested Bt cotton crop in Andhra Pradesh. Shepherds unambiguously declared that their animals, which had never died or fallen sick, while being grazed on regular cotton fields since the past 10 years, began to exhibit morbid changes when grazed on the GM crop.

During the first three years of investigation, symptoms reported by shepherds, were confounded by the concurrent incidence of other common contagious diseases that affect small ruminants, such as peste-du petits ruminants (PPR) and blue tongue. By 2008-09 the symptoms could be isolated, due to the in-situ presence of Anthra's veterinary scientists who continuously monitored the village flocks, which we ensured were vaccinated/protected against all other possible preventable contagious diseases, and thus we were able to narrow down and be precise about the specific morbidity exhibited by animals that grazed on harvested Bt cotton. Our clinical findings were that morbidity selectively manifests itself symptomatically in animals by the third day of consuming Bt cotton foliage/ bolls and seeds as nasal discharge, cough, respiratory distress, occasional bloody urine and the absence of fever. Mortality occurs in some animals, especially if untreated, but not in all. Mortality and morbidity
are observed to occur in those animals that have had a cumulative exposure to the Bt toxin in the form of grazing/ being fed the cottonseeds/ cottonseed cake.

In Haryana, there was a strong correlation between feeding Bt cotton seeds and cotton seed cake to milch animals, and drop in milk yield and several reproductive disorders such as prolapse of uterus, premature birth of calves, increase in the incidence of abortions and decrease in conception rate. These symptoms of reduced fertility were found to correspond to results of an inter-generational study of rats fed on Bt maize, which were found to suffer from reduced fertility. (Velimerov, A et al., 2008).

(ii) Premier research institutions lack Bt toxin testing facilities; confirm chronic histo-pathological changes in kidney, liver and intestine of dead animals: Anthra vets carried out post-mortems of dead sheep and goats that had died after grazing on Bt cotton and sent tissue samples to top research institutions of the country such as the Indian Veterinary Research Institute (IVRI), with specific request that these be tested for Bt toxin. In 2008, the IVRI reported their inability to test for Bt toxin.

The IVRI in 2008 and 2009 recorded histo-pathological lesions in the kidney (chronic nephrosis), liver (chronic hepatitis) and intestinal tissues (chronic enteritis) of the post-mortemed sheep/goat, indicative of some kind of "chronic" factor at play. The observations were similar to those recorded in Monsanto’s own dossier of Mon 863, (Bt corn) of 90-day rat feeding studies, subsequently revealed by Pusztai on behalf of the German government and later confirmed also by Seralini et al (2007) after many statistical studies. The company’s hidden raw data were released in the public domain through a German Appeal Court decision (2005). Other studies by different researchers with rats fed Bt corn also revealed hepato-renal toxicity, and damage to liver and kidneys. (Kilic and Akay, 2008, Velimerov, A et al., 2008).

The chronic nature of the tissue lesions should ring alarm bells in the minds of "scientists" sitting within these august institutions as to what could possibly be causing this chronic effect? It matches with the history of mortality in those animals that have been exposed to the Bt toxin over an extended period of time.

(iii) Deceptive proof of safety and serious scientific lapses in the investigation of animal morbidity: The GEAC in its 82nd committee meeting, held in January 2008, reported receiving a dossier of proof of safety from the IVRI and animal husbandry department, Andhra Pradesh (AHD), which overwhelmingly points to deception and serious scientific lapses.

In 2006 and 2007, subsequent to the report of deaths of cattle which had grazed on Bt cotton, the department of animal husbandry in Andhra Pradesh sent plant samples to different national laboratories for testing, which resulted in completely contradictory findings and information5, simply inadequate to arrive at any conclusion on safety of the Bt toxin6 . The results failed to answer many questions including did these laboratories also test the post-mortem animal tissue samples? What was the entire list of test protocols followed by each of the laboratories for animal tissue and plant tissue alike? If we assume it was the identical plant samples sent to all laboratories what explains the different findings? The presence of a mineral (eg nitrate/ nitrite/ organophosphate etc) in the plant sample is completely insufficient evidence to deduce/derive that this mineral was the cause of animal death. This is unscientific and untenable. Further and more importantly, none of the animal
tissue samples were actually tested for Bt toxin or Bt immune response, facilities that simply don't exist at these state and national level "disease investigative laboratories".

What is of serious concern is that in the name of scientific enquiry we have instead, clear evidence of deception and fraud on the part of all the regulatory bodies in India, to pass off the non-testing of a toxin and hence its “non-detection” as evidence of proof of safety. What we have is (a) No tests to assess immune responses to the Bt toxin/ presence of Bt toxin, but (b) Nevertheless, the unfounded claim of a "negative result of having not detected Bt toxin" which is passed off as proof of safety. It is scientifically untenable that without performing any tests, its absence is cited as evidence that the toxin is safe.

This circular argument of "safety" is the basis on which the GEAC claims that reports of animal deaths are "unsubstantiated", and reversed its decision to carry out further risk assessment tests.

The other “proof of evidence of safety of Bt toxin” in the letter of the director, animal husbandry department AP, states:

"The Bt protein levels detected in the samples of Bt cotton bolls and leaves sent for analysis was recorded as 5 m/gm. This level is within the tolerable range which is said to be "5-10 m/gm."

In reply to a RTI appeal filed to the department of agriculture biotechnology by Anthra, to obtain the source of this "tolerable" range, the department responded that this was Mahyco's data of safety, accessible on the official IGMORIS website . They also mentioned that Bt cotton had been well tested, including testing of foliage, which is a blatant piece of mis-information as the protocols of testing were on cotton seeds/ cotton seed cake and not foliage. Hence, what we have is the public sector research institutions citing company data as proof of safety, once again exhibiting complete scientific incompetency in conducting their own research and evolving their own protocols.

The Bt protein content (of Bt brinjal) reported in the expert committees report (point 3.1.5) describes the level of Bt protein (Cry1Ac protein) found in different parts of the crop to vary between 5 to 47 ppm in shoots and fruits.

For the sake of argument, if we are to go by the earlier submission of all institutions concerned including GEAC that the reports of Bt toxin (Cry1Ac protein) are safe and tolerable if they are between 5-10 ppm then it follows that the levels detected in Bt brinjal reported in the bio-safety studies and expert committee report, are not tolerable as it is way above the supposed permissible levels, which are cited as being safe for sheep!

This raises serious questions on supposed "tolerable" and safe levels of Bt toxin in plants. Who has decided on this safe levels for Bt toxin? What is the scientific evidence for safety? How can there be a safe level of "toxin" with a food product, when the very definition of a "toxin" indicates a poison, or something that is harmful?

The GEAC consistently referred to these Bt protein levels as proof of safety of the GM strain to animals, and the "evidence" that death in animals was due to nitrate/ nitrite/organophosphates or other diseases.

(iv) In 2007, the Sri Venkateshwara veterinary university, Andhra Pradesh initiated a season-long study on Bt cotton and sheep. While the university states that the study indicates that “all is well” as far as the Bt cotton goes, there are several aspects in the results, which warrant urgent attention and further investigation:

(a) The presence of higher toxic heavy metals in Bt plants (842.25 ppm of lead in Bt cotton as compared to 134.62 ppm of lead in non-Bt cotton after 45 days), which is 6.25 times higher after 45 days, as compared to the non-Bt cotton .

(b) The liver marker AST which is known to increase after hepato-cellular injury, as the author of the experiment indicates, is increased in the protocol by 37 percent in Bt treated sheep in comparison to the untreated group of sheep fed on regular cotton, by the second month.

It is evident from the above that there is much to worry about. There are obvious lies and a host of contradictions within the "safety" parameters being presented to common man by those who are "regulating" the technology.

There is clearly a total failure and inability of our existing public research institutions and national regulatory bodies (GEAC), to investigate/ test/ rigorously examine, prove or disprove these field observations, preferring to dismiss the reports as "unsubstantiated", "exaggerated, and unscientific", refusing to conduct a single field-based study and instead placing the onus of "proof" on shepherds, farmers and civil society groups who have reported the problem.

The argument that the latest guidelines do not require the suggested new risk assessment tests and hence have been dispensed with negate and ignore the field realities where "non-target organisms" have been affected by the Bt toxin. On the contrary, these unique field experiences and observations, urgently invite new and additional specific regulatory and risk assessment protocols.

Public research institutions are losing their legitimacy as independent institutions working in the interest of the citizens. It is our appraisal that scientists are occupied in lab-based science sponsored by corporations, rather than conducting citizens-based research and apply their science to address and investigate problems that are experienced by farmers in distress.

The inconclusive nature of Bt toxin in cotton and its impact on animals continue to haunt. There is clearly a stress factor that is eliciting a morbid possible allergenic response in the cattle. Is it Bt toxin? Is it some unknown/new toxin? Is it a new allergenic protein? Is it macro/micro mineral imbalances in the Bt cotton plant, (eg excess or deficiency of nitrate, nitrite, selenium etc) as a result of the Bt protein, which elicits a response from the animal? These are questions that the shepherds, farmers and "independent scientists" continue to ask and demand answers. As a first step there is immense need for a comprehensive review of the Bt cotton experience in India, particularly with respect to health and other bio-safety issues. Tomorrow a bill like the BRAB would definitely qualify that we uniformly get punished, imprisoned, and jailed for life as “we don’t have the evidence” to suggest that the products are harmful! It would also deter responsible scientists and
government officials from publicly voicing their concerns, as they have done in the past.

The author is a trained veterinarian and co-director of Anthra.

References

Velimerov, A et al., 2008. Biological effects of transgenic maize NK603*MON810 fed in long term reproduction studies in mice. Bundesministerium fur Gesundheit, Familie und Jugend Report, Forschungsberichte der Sektion IV Band 3/2008, Austria. 2008.

Seralini, et.al. 2007. New Analysis of a Rat Feeding Study with Genetically Modified Maize Reveals Signs of Hepatorenal toxicity. Arch.Environ.Contam.Toxicol.52, 596-602.

Kilic A. and Akay MT. 2008. A three generational study with genetically modified Bt corn in rats: Biochemical and histopathological investigations. Food and Chemical Toxicology, 46:1164-1170.

Reddy Gopal, A. et. al. 2008. Studies on the toxicity of Bt cotton plants incorporated in the feed of small ruminants. Project Report. Venkateshwara Veterinary University, Tirupati. Department Of Pharmacology & Toxicology, College Of Veterinary Science; Rajendranagar , Hyderabad-30.

Ramdas, Sagari R. 2009. Bt Cotton and Livestock: Health Impacts, Bio-safety concerns and the Legitimacy of Public Scientific Research Institutions. Paper presented at National workshop on genetically modified crops/foods & Health Impacts. Centre for Sustainable Agriculture, Doctors for Food & Bio-Safety, Greenpeace India and Sustainet on July 8-9 at India International Centre, New Delhi

Endnotes

1 BRAB, 2009. Chapter XIII, 63

2 BRAB, 2009. Chapter XIII, 62

3 Section V, Issue 8, pp 58-59 of the Report of the Expert Committee (EC-II) on Bt Brinjal event EE-1, wherein the committee refutes the need to conduct long-term studies for assessment of chronic toxicity and nutritional impact on mammals.

4 Anthra is an organisation led by women veterinary scientists, works on issues related to livestock, peoples livelihoods and the environment and has been researching the impact of Bt cotton on animals in different parts of India

5 Letter sent to the GEAC by the Director, Animal Husbandry Department (AHD), Andhra Pradesh, dated May 2007 ref: No 3531/Epid/2006.dated 9/5/2007.

6 In 2006: Letter from Director, AHD to Commissioner Agriculture, also quoted in letter to GEAC. Letter roc no: 14627/Epid/2006/, dated 20/9/2006. Bt cotton samples were sent to different laboratories. Andhra Pradesh Forensic Science Laboratory, Red Hills found plant samples positive for organophosphates and the Western Regional Disease Diagnostic Laboratory (WRDDL), Pune found plant samples positive for nitrite and nitrate and negative for HCN. The Veterinary Biological Research Institute found plant tissue samples positive for Nitrite and positive for HCN. In 2007: The plant tissue tested "positive" for HCN but the animal tissues tested "negative" for HCN. None of these results disprove the role of Bt protein.

7 Studies on the toxicity of Bt cotton plants incorporated in the feed of small ruminants. Project Report. Sri Venkateshwara Veterinary University, Tirupati page 27, table 18

8 Studies on the toxicity of Bt cotton plants incorporated in the feed of small ruminants. Project Report. Sri Venkateshwara Veterinary University, Tirupati page 20, table 20