WA Ag Minister Kim Chance wrong on GM food safety concerns

WA Ag Minister Kim Chance wrong on GM food safety concerns

On March 22nd Western Australia’s Agriculture Minister Kim Chance issued a media release claiming that a “new GM study food study reveals new safety fears”. He went on to conclude that “Until we know more about GM crops, especially GM food crops, I believe that it is wise to continue the moratorium”. He went further by attacking our national regulatory authority, Food Standards Australia – New Zealand (FSANZ) saying: “FSANZ should stop relying on the data supplied by the GM companies and conduct their own independent feeding trials and stringent analysis of the GM products that are proposed for Australia and New Zealand”.

The study in question was not new, but a re-analysis of existing data submitted to the regulatory authorities, conducted by researchers at the Universities of Caen and Rouen in France. The lead researcher, Gilles-Eric Seralini states on his website that he was one of the first to warn public opinion about the dangers of GMO’s, and in an interview (also published on his website) he likens the falsely alleged deaths from GM food to Mad Cow Disease; he erroneously claims that GM crops are only suited to “Western Countries” and are not adapted to “poor countries”; and he claims that in research on GM animals the latter are being “genetically doped” on hormones so that they will grow fat thanks to artificial genes! He finally goes on to say that “southern populations” are missing patented medicines and they are being starved over the long run.

How did the study come about? Monsanto released a product called “Mon 863 YieldGuard” maize with resistance to rootworm. The product received full regulatory clearance and has been grown in the US and Canada since 2003. The data Monsanto submitted to the regulatory authorities was provided by an external company and the protocols and statistical methodology were reviewed by hundreds of scientists in a number of countries. The product was approved for food importation in Australia/ New Zealand, Mexico, The Philippines, Japan, Korea, Taiwan and Russia. Regulatory groups such as FSANZ; The European Food Standards Authority (EFSA); The French Food Safety Agency and the Robert Koch Institute all found that Mon 863 does not pose any nutritional risk.

Seralini and his colleagues used a statistical procedure that qualified statisticians believe to be faulty. They analysed 494 independent measurements made on rats fed for 90 days on a diet of either 11% or 33% GM maize. Dr Chris Preston of the University of Adelaide has drawn attention to the fact that the procedure (more specifically the test for significance) was such that even with 100 comparisons the chances of getting a false positive result was close to 1. The 33 positive (or adverse) results the authors obtained in this re-analysis at the 5% probability level, and the 4 positives at the 1% probability level, very closely mirrored what you would expect by chance (25 and 5 respectively). Quite aside from the statistical procedure used it was found that the adverse toxicology results that they reported occurred only when 11% GM maize was fed – they did not occur when 33% maize was fed. This lack of a dose response alone should have alerted them to the fact that their procedure might be wrong, but it did not stop them publishing without explaining the anomalies! Their publication also contained four totally incorrect statements that have since been addressed by several groups. What is quite extraordinary is that these anomalies were not picked up by the reviewers of their paper.

When the study was going to press both FSANZ and the European counterpart, EFSA, said that they would take a careful look at the methodology used. When faced with several questions in Parliament and from the media, Kim Chance has recently claimed that he has a Ministerial GMO Reference Group that are providing him with advice on GM matters. Did he convey his concerns to either FSANZ or to his reference group? Absolutely not! Instead he chose to undermine public confidence in our national regulatory system, FSANZ by going public right away. It should be noted that Western Australia is a party to the inter-governmental agreement on Gene Technology Regulation and is represented on the Gene Technology Ministerial Council. As a member, this would have been the appropriate forum for Mr. Chance to voice his concerns.

The paper in question has only just been published, but ahead of publication it was released to Greenpeace and appeared as two briefings on their website entitled: 1) “Regulatory Systems for GE Crops a failure: the case of Mon 863”; and “Mon 863 Corn: A case study in incompetence”. So where did Mr. Chance get his information? We do not propose to speculate, but our readers may draw their own conclusions. The Minister may also be trying to justify his “go it alone” policy in which he commissioned Dr Judy Carmen at the Institute of Health and Environmental Research in Adelaide to conduct a so-called independent feeding study. Dr Carmen has refused several requests from industry to make the protocol available, but she is well known for an antagonistic and hyper-critical approach to FSANZ. The process of having states getting involved in what is a Federal jurisdiction could lead to chaos in our industry if each were to set up their own independent regulatory system! Attention was drawn to this last year by a number of eminent scientists worldwide in a letter to Minister Chance.

In summary, there are several problems with Kim Chance’s approach to food safety. When he intimates that companies submit data that is not independent (read biased) in order to gain regulatory approval he is treading on some very dangerous legal grounds. The penalties for any false information submitted to a regulator are draconian, and most companies get outside specialists to provide at least some of the specialized studies required for regulatory clearance. By attacking FSANZ he is undermining public confidence in our regulatory system (widely regarded as one of the most rigorous in the world). By issuing a press release on this highly questionable study without getting verification from other sources he is not being well advised. Finally, as he continues to delay the production of GM crops in Western Australia he is ignoring the majority opinion of our leading farm groups, and he continues to deny growers the right to choose the technology they wish to use on their farms.

Dr Ian B. Edwards
Chairman – AgBio Advisory Group
AusBiotech

• See also Damn Lies and statistics - Analysis of statistical errors in the study Mr Chance mentions.

Update
29th July 2007

The European food safety agency EFSA has just looked at the study by the French group led by Gilles-Eric Seralini and concluded

* The statistical analysis made by the authors of the paper did not take into account certain important statistical considerations. The assumptions underlying the statistical methodology employed by the authors led to misleading results.

* EFSA considers that the paper does not present a sound scientific justification in order to question the safety of MON 863 maize.