The Indian government is preparing to act on a request by Big Agra giant Monsanto to approve the country’s first genetically modified food crop designed for human consumption, Bt brinjal.
Brinjal — eggplant — is a staple of the Indian diet, and Monsanto has added genes from a microbe, Bacillus thuringiensis, which produce a pesticide lethal to many insect predators.
The seeds would be sold by a Monsanto subsidiary, Mahyco.
Monsanto’s GMOs use two primary pathways the company assures buyers will give them crops resistant to natural threats. Bt crops focus on thwarting insects, while the company’s Roundup ready crops contain genes that make them resistant to glyphosphate, a powerful pesticide [see this previous post].
Questions have arisen about the safety of both varieties. But the latest challenge comes for a second look at the very data Monsanto submitted to the Indian government with its application for approval.
The study was conducted by Lou Gallagher, an epidemiologist from New Zealand, who told the sponsoring organization, Sunray Harvesters, that
“The safety claims made for these plants are not supported by existing data. On the contrary, there are alarming signs that the consumption of food derived from these plants could result in adverse health effects. In addition the feedings studies show major deficiencies in the protocol used for the feeding trial and do not meet international standards.”
His conclusion: Approval of the crop for sale and consumption should be withheld pending additional research.
Here’s a chart from the report, highlighting areas of concern:
And here are some other findings, drawn from the full 42-page report, which is available as a PDF through a link here:
This evaluation of Bt brinjal studies is based on requirements for a rigorous evaluation of food safety for the people of India and their health. Departures from Indian and international published standards for the 14-day and 90-day studies are a cause for concern.
The current food safety studies for Bt brinjal were not conducted in accordance with published standards, did not accurately summarize results, and ignored toxic endpoints for rats fed Bt brinjal: in particular, rats fed Bt brinjal for 78 out of 90 days (only one dose level) experienced:
- organ and system 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.
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.
Unanswered concerns regarding the safety assessment of Bt Brinjal
Neurological function, behavioral effects, reproductive performance and biological resilience of test animals were not evaluated in these studies. Further research based on properly conducted and supervised studies is needed to resolve indications that Bt brinjal may have adverse effects on these clinical endpoints.
Dietary equivalence of dried brinjal, dried Bt brinjal and control diets was not addressed. Concentrations of the new insecticide protein Cry1A(c) were not measured in dried brinjal powder. It is important to know how much of this new protein was actually in the dried samples fed to the rats, especially since there is data to suggest that Cry1A(c) is at least partially destroyed in laboratory heating conditions. That omission makes it impossible to compare the test diet with insecticide concentrations expected in cooked human food.