Canada’s approval of SmartStax corn exposed just how little Health Canada cares to investigate the potential risks of GM crops and foods – in the case of SmartStax, not at all. Now the process to approve SmartStax in Europe has identified many of the risk issues being ignored on both sides of the ocean. Confidential industry summaries of data as well as critiques by European experts show more studies must be done to determine any potential health and environmental risks.
No risk assessment in Canada
In July 2009, Monsanto and Dow AgroSciences announced they had received approval in Canada and the US to introduce their new eight-trait GM corn SmartStax (it combines technologies from both companies). However, Health Canada did not actually assess SmartStax for human health safety. Because the individual eight GM traits were previously approved in separate crops, Canadian regulators decided there was nothing new in combining the eight together. Health Canada assumed the corn was a harmless amalgam of GM traits and did not even issue any paperwork to rubberstamp its approval.
In September 2010, the GMO Panel of the European Food Safety Authority (EFSA) concluded SmartStax “is unlikely to have adverse effects on human and animal health and the environment, in the context of its intended uses.” Unlike in Canada, the European Authority actually looked at some industry documents (summarizes of studies). The German non-governmental group Testbiotech published a report in June that examined these documents as well as critiques from regulators in European countries. Its report points to many safety questions still not being addressed in Europe – questions Health Canada should have asked but never did (Testbiotech, June 2011, “How industry and EFSA have been systematically undermining the risk assessment of ‘SmartStax” www.testbiotech.de/node/515)
More GM traits, more risks?
SmartStax corn is the first GM crop that has more than three GM traits “stacked” together. SmartStax produces six different insecticidal toxins (Bt toxins) and is tolerant to two herbicides. SmartStax is also known as MON 89034 x 1507 x MON 88017 x 59122, which represents the four GM events or parental lines bred together to make SmartStax. The possible implications of such complexity were entirely overlooked by Health Canada.
Canadian regulation is essentially based on the view that moving genes around is not inherently risky. Instead of examining the process of genetic engineering, Canada evaluates the end product using, in part, the widely discredited concept of “substantial equivalence.” Substantial equivalence allows for a comparison of a GM organism with its “equivalent” already out in the environment with a “history of safe use.” Health Canada’s approval of SmartStax is an extreme application of substantial equivalence. The European Food Safety Authority chose a similar approach. As Christoph Then of Testbiotech explains, “EFSA based its approval of SmartStax to a large extent on data derived from the parental plants. But this approach is highly complicated since SmartStax has many insecticidal toxins, thus more interactions can to be expected. These interactions remain unstudied.” (June 28, 2011, CBAN press release: “Report Exposes Unstudied Risks of Monsanto’s Genetically Modified “SmartStax” Corn: EU Member State Critiques and Leaked Industry Documents Uncover Safety Questions.”)
While insect resistant crops are engineered using genes from the naturally occurring soil bacteria Bacillus thuringiensis (Bt), the risks posed by Bt toxins cannot be assessed by comparing them with the Bt toxins that occur naturally. As the Austrian Federal Ministry of Health states, “concerning all Bt toxins, a history of safe use cannot be argued on the basis of the safety of Bt sprays applied in organic farming. The inserted genes are truncated and arranged with expression modulating DNA parts originating from different organisms and permanently expressed compared to a tight timely Bt spraying schedule.”
Additionally, the Bt toxin Cry1A.105 in SmartStax was artificially synthesized and as stated by Austria, “There is no safe use of the new recombinant protein expressed by an artificially arranged insert such as Cry1A.105.”
In their comments on the EFSA SmartStax decision, regulators from Austria summarized: “A stacked organism has to be regarded as a new event, even if no new modifications are introduced.” This view is consistent with EU regulations and with United Nations Codex guidelines that Canada helped negotiate. Austrian experts take this view because “The gene-cassette combination is new and only minor conclusions could be drawn from the assessment of the parental lines, since unexpected effects (e.g. synergistic effects of the newly introduced proteins) cannot automatically be excluded.”
Unlike Health Canada, the European Food Safety Authority looked at documents supplied by Monsanto and Dow AgroScience. These were largely summaries of tests commissioned by the companies. Like most science behind GM crop approvals, the science submitted by industry was not peer-reviewed. After gaining access to some of the industry documents Testbiotech stated, “The industry dossiers not only have major defects in study design, they also lack independent quality controls.” The reliability of data from the only animal feeding study conducted (it looked at the question of nutrition) was questioned by EU Member States due to issues with the study design, validity of data and statistical analysis.
No animal feeding studies or other in-depth investigations were conducted on the potential health hazards of SmartStax to either humans or animals. Experts from EU Member States criticized the lack of any data on potential health effects. One issue raised was the fact at least one of the Bt proteins in SmartStax is known to show immune reactions. What this means for human consumption of the GM corn was not investigated. A number of countries repeated the recommendation for at least one rodent feeding study in order to examine immune responses.
New approach, more studies needed
The recommendations from EU country experts detail the type of testing that is not being done, but which may be necessary. The basic critique is that no experiments with SmartStax itself were carried out. EU countries argued that, while the data from the parental lines can be informative, it is not sufficient for a risk assessment.
The Belgian Biosafety Advisory Council stated, “The safety aspects of the multiple challenge, due to the combination of the newly inserted proteins, are rather weakly demonstrated… It is highly desirable to refer to studies that have demonstrated that the combination of all these newly inserted proteins is not detrimental.” Similarly, the Austrian Federal Ministry of Health stated, “The possibility of synergistic effects of the transgenic proteins present in GM maize MON 89034 x 1507 x MON 88017 x 59122 should be addressed in an improved way.” The Federal Agency for Nature Conservation in Germany “considers that further information is required before the risk assessment… can be finalized.”
Before GM SmartStax corn is officially approved in Europe, the European Commission is investigating further. Meanwhile, Health Canada remains blind to any and all risk possibilities, deciding instead that risk assessment is unnecessary.
Lucy Sharratt is the coordinator for the Canadian Biotechnology Action Network, www.cban.ca/corn