GM Free Cymru

Monsanto slammed for highly defective application dossier on stacked GM maize

Analysis of the data submitted by Monsanto to the Indian authorities on genetically engineered maize MON89034 x NK603 2013


Greenpeace India asked Testbiotech to assess data presented by the US company Monsanto to the Indian authorities, for biosafety tests prior to commercial approval of the genetically engineered maize (corn) MON89034xNK603. The said information was obtained through RTI procedure from the Department of Biotechnology and Genetic Engineering Approval Committee (GEAC). This is a stacked event, a combination of genetically engineered plants cross-bred with each other. It produces two insecticidal proteins, one a technically modified version of an existing toxin (Cy2Ab2) and one, which does not occur in nature, produced from synthetic DNA (Cry1A.105). The plants are also herbicide tolerant (glyphosate).

Nearly all the data presented by Monsanto relate to the parental plants (NK603 and MON89034) and not the stacked plants. Monsanto also conducted most of the investigations themselves or with the involvement of their own members of staff. Independent studies are a rare exception.

The data presented so far is on issues such as molecular characterisation, compositional analysis, agronomical performance, genetic stability, expression of the DNA construct, allergenicity, toxicity, nutritional effects and environmental risks. Closer analysis reveals several flaws:

- The molecular data are incomplete and partially outdated.

- More recent technologies such as screening of the activity of the plant's endogenous genes were not applied - The data on the expression of the additional DNA shows a high level of variation. No fully evaluated method was made available for determining the content of newly expressed proteins

- The compositional analysis showed several significant findings that were not investigated further.

- The pepsin digestion assay used for the assessment of allergenic risks does not provide reliable data; publications showing immune reaction after exposure to genetically engineered plants were not mentioned by the applicant - Only proteins produced by bacteria (and not those produced in the plants) were used for acute toxicity tests

- The proteins were not tested systematically to investigate synergistic or combinatorial effects - Feeding studies to investigate health effects were only performed with the parental plants and only for 90 days; the outcome of these investigations is controversial amongst experts

- Nutritional studies were not conducted with animal breeds used in Indian agriculture - No detailed assessment was performed on the residues from spraying with relevant formulations of glyphosate

- No systematic investigations of potential synergistic or combinatorial effects of the plants constituents were performed - Persistence and invasiveness may possibly become a serious issue in India since several plants are known to be compatible with maize plants and could cross breed. Detailed investigations to exclude uncontrolled spread of the transgene into the environment were not performed

- Although the toxins expressed in the plants do not occur in nature, no detailed investigations were performed to exclude risks for non-target organisms, human health and Indian biodiversity

- Recent data on the implications of large-scale applications of glyphosate, such as the emergence of herbicide resistant weeds and biodiversity hazards are completely missing

- There was almost no data made available on the stacked events, most of the data is on the parental plants.

To conclude, based on the data presented by Monsanto, no decisions can be taken on the safety of the plants in regard to open field trials or commercial cultivation. Apart from missing data and inadequate investigations, there are in fact substantial indications for health and environmental risks. Several publications have revealed effects on the immune system, health risks caused by spraying with the complementary herbicide, unexpected toxicity of the synthetic toxin produced in the plants and long-term effects such as losses in biodiversity as well as increasing resistance in weeds and pest insects.