This series contains brief reports on each of the "600 studies" held on the GENERA database, published at Bifortified.org, in the order in which they were listed on 18 Sept 2013. The general purpose is to counter the extraordinary claims that the entries on this list demonstrate the human food safety of GM crops. See the Introduction to this series [link].
Great Big List of Studies: Entry 12 – Ames 2007
The piece by Ames was one side of a debate on the safety of 'advanced glycation end products" or AGEs. AGEs had been implicated in a range of adverse human health conditions. Initially, looking at the abstract for this report, I could see no reason for its inclusion on this list of studies related to GM crops.
The topic for debate in the journal of "Molecular Nutrition and Food Research" had been "Dietary advanced glycation end products – a risk to human health? A call for an interdisciplinary debate"
See Update below after receipt of full texts.
- The Introduction had been written by Henle (2007) [abstract link – pdf paywall]
- The Pro arguments had been written by Šebeková & Somoza (2007): Dietary advanced glycation endproducts (AGEs) and their health effects – PRO [abstract link – pdf paywall]
- The Contra arguments had been written by Ames (2007): Evidence against dietary advanced glycation endproducts being a risk to human health [abstract link – pdf paywall]
Neither the introduction nor the pro- arguments were included on the Great Big List of Studies. For the Ames (2007) inclusion on the list it seemed that there must have been a GM crop that could produce these AGEs and that someone found an interest in the contra arguments against their risk.
A few minutes later the memories had filtered through. Monsanto had developed a 'high lysine" GM corn crop for use in animal feed, known as LY038 [link]. According to Latham & Wilson at Independent Science News...
- "Lysine is known to react on heating with sugars to form chemical compounds called advanced glycoxidation endproducts (AGEs) that are linked to numerous diseases, including diabetes, Alzheimer's disease and cancer." [link]
The GM crop was not intended for direct human consumption, but rather for animal feed. Nonetheless approval was sought from Australia and New Zealand's food regulator FSANZ, seemingly because it would become a contaminant of global human food trade lines.
The INBI at the University of Canterbury in New Zealand made a submission to the FSANZ approval process. The submission contained in excess of 90 key points for why the crop should not be approved 'for human consumption'. Some of these points related to failure in process – others related to food risk. One of these key points related to the risk of the crop producing increased AGEs.
Beginning in 2005 the INBI and FSANZ went through rounds of submission and rebuttals. The INBI series is here. The FSANZ series is here. Amongst other things it seems the GM crop developers had not conducted a simple cooking test on their GM grains to measure the production of AGEs, and that FSANZ would not ask them to do it.
When the approval of LY038 was pending in Australia in July 2007 INBI put out this media release [pdf link]. The excess production of these AGEs remained as one of the three principal concerns.
The journal debate on AGEs was published in September 2007, and it seems the LY038 crop was finally approved by FSANZ in December 2007.
In November 2009 news emerged that Monsanto had withdrawn their application for approval of LY038 with the European Food Safety Authority, EFSA. Latham & Wilson reported the withdrawal on November 10 at Independent Science News [link]. A day later Ho & Saunders at the Institute of Science in Society also provided a wonderful commentary and produced evidence of withdrawal letters, including a quote from Monsanto's European subsidiary Renessen:
- "In its letter to the EFSA, Renessen Europe stated that "conducting further studies ... can no longer be justified, in view of the additional costs involved and the reduced commercial interest in this product."" [link]
It seems that, unlike FSANZ, ESFA thought further testing was justified. Ho & Saunders provided quotations from the INBI's Prof Jack Heinemann..
- ""Personally, I don't believe the withdrawal of LY038 was for economic reasons," Heinemann said. "Monsanto estimated the street value of LY038 was going to be US$1 billion a year. Do we really believe that a market of US$1bn a year is too small for Monsanto? I don't. The European Food Safety Authority requested more safety data from Monsanto.""
- "Heinemann also indicated that from comments released to him, it appears that Finland for example, was not satisfied with either the number or the quality of animal-feeding studies, and Malta voted to reject the maize on the basis of the INBI submission, "the same science that FSANZ attempted to bury down here.""
The following day EFSA's rejection in the face of FSANZ approval was news in Australia: "Europe rejects GE corn but Australia has 'no concerns'"
I don't think the LY038 crop is in commercial production.
I don't really know why the Ames side to a debate on the dietary safety of AGEs is included on this list. The full argument is behind a paywall - I'll access it at a University and if it contains anything relevant to the human food safety of commercial GM crops I will provide an update here.
UPDATE: I have the pdf's for the three papers above now. They make no mention of GM crops whatsoever. Furthermore the placement of the Ames study on this list seems not only irrelevant but signifies bias. The Henle Introduction defined the 'debate' where the two authors (Ames on one side, and Šebeková & Somoza on the other) were given a task of building a specific argument. Neither author was charged with making a balanced assessment of all the literature. While the two authors cited 21 and 22 studies, they only had three in common. It was like two cherry picked lines of argument. Ames specifically defined her task: "The goal is to provide evidence that dietary AGEs are not a risk to human health". Despite this goal she nonetheless concluded that certain groups of people might be at risk from dietary AGEs, including infants, people suffering from inflammatory bowel disease and those with renal failure. She also concluded that more carefully designed studies were needed.
Although FSANZ did not make a heavy use of scientific literature in its rebuttal of the INBI's concerns about AGEs, it can be pointed out that 2 of the studies it used were also cited by Ames, and that a study FSANZ rejected had been cited by Šebeková & Somoza.
Transgenic High-Lysine Corn LY038 Withdrawn After EU Raises Safety Questions: Latham & Wilson, Independent Science News
High Lysine GM Maize Withdrawn, Safety Concerns: Ho & Saunders, Institute of Science in Society