GM Corn Safety Study a Challenge for the Biotech Industry, Regulators and the Food Movement

Lucy Sharratt, Coordinator, Canadian Biotechnology Action Network www.cban.ca coordinator@cban.ca

A groundbreaking study on the safety of a genetically modified (GM or genetically engineered) food – the first study of a GM corn over the lifespan of laboratory rats - has been published and the resulting international controversy has only just started. The credibility of the study is being questioned and the results disputed. While debate and follow-up are a necessary part of the scientific process, coordinated dismissals from “experts” and character assassinations are a predictable part of the biotech industry backlash.

Sorting out legitimate scientific questions from red herring arguments[i] is ongoing[ii]. In the meantime, the new study clearly exposes a long-standing problem with government regulation for genetically modified organisms (GMOs), and legitimately poses the question of GM food safety.

A team of French researchers, led by molecular biologist and endocrinologist Professor Gilles-Éric Séralini of the University of Caen in France, has published a two-year study of Monsanto’s genetically engineered herbicide-tolerant corn NK603. The researchers studied the impacts of GM corn consumption on rats, with and without Monsanto’s Roundup herbicide, and of Roundup alone. The feeding trial was conducted over the entire lifetime of laboratory rats and showed adverse health impacts after the 90-day period when most studies end. The researchers observed mammary tumors and kidney and liver damage, leading to premature death. The study was published in the peer-reviewed journal “Food and Chemical Toxicology”, the same journal that published Monsanto’s own 90-day test on their NK603 GM corn in 2004 (Monsanto’s study used the same type of rat, and measured the same sample size[iii]).

Health Canada approved NK603 in 2001 and this Roundup Ready GM trait is incorporated into many of the GM corn hybrids currently on the market in Canada though it is not yet part of Monsanto’s new GM sweet corn series (first released for the 2012 growing season). Roundup Ready crops are the most widely grown GM crop in the world and Roundup is the world’s largest selling pesticide.

The new study suggests that possible adverse health impacts may not be detected in animal feeding trials that end after 90 days. It suggests that government regulators such as Health Canada need to require feeding trials, and make sure that the trials are long enough to explore possible chronic health impacts. Health Canada currently does neither. In fact, not only does Health Canada not require animal feeding trials to assess the safety of a new GM food, all data submitted to the department comes from the proponent itself and is classified as “Confidential Business Information.” Health Canada’s 2001 approval of this GM corn perfectly illustrates this fundamental problem, a problem exposed by the Séralini et al. study.

Health Canada did not conduct any of its own tests on Monsanto’s GM Roundup Ready Corn Line 603 (or on any other GM food) but, instead, approved it for human consumption based on data submitted by Monsanto itself. In Health Canada’s 3-page summary of their decision we see no reference to a feeding trial (Monsanto’s 90-day trial was published three years later, in 2004). Health Canada instead refers to a gavaging study in which mice were force-fed a high dose of the single purified protein coded for by the modified Roundup Ready gene.

Ironically, the same year that Health Canada approved this GM corn, the Royal Society of Canada’s Expert Panel on the Future of Food Biotechnology (commissioned by the government) published 58 recommendations for reform of the system. The Expert Panel recommended that the design and execution of all testing regimes for new GMOs be conducted in open consultation with the expert scientific community and that analysis of study results be monitored by an “arms-length” panel of experts from all sectors, and reported in a public forum. (Needless to say, the recommendations were not implemented[iv].) The global fight now is to see an arms-length review of the Séralini et al. study.

The Governments of France and Germany are reviewing the study and the French Minister of Agriculture has already said that Europe needs to change the way it regulates GM foods. In the meantime, the European Food Safety Authority (EFSA) is set to release an initial opinion on the study this week. But just like Health Canada, the EFSA approved NK603 and is unlikely to want to contradict its earlier decision and concede negligence. Health Canada has said they will review the study and if they see a demonstrated risk to Canadians, they will take “appropriate action”. Demonstrated risk is likely to remain elusive however and replicating the Séralini et al. study alone would take at least two years. So what’s next? Thankfully, the most complex questions raised by GM have already been examined by The People’s Food Policy which recommends that, “existing GM crops should be phased out and there should be no further approvals of GM crops and animals.”