Note: TJ Higgins, a plant molecular biologist, is Deputy Chief of Commonwealth Scientific and Industrial Research Organization (CSIRO) Plant Industry, Canberra, Australia. He is the developer of GM peas.
The November/December 2005 newsletter article, Genetically Modified Peas Caused Dangerous Immune Response in Mice, discusses in detail the research done on GM peas.
December 21, 2005
Thank you for taking the time to discuss with me important issues related to the genetically modified peas that you have worked on for about 10 years. I deeply appreciate your decision to test the peas on mice for immune responses. Since the peas did elicit a response and therefore may cause allergic reactions in humans as well, your decision to stop the development of the peas was certainly a good one. If those peas had been widely commercialized and did cause allergies, they might have killed people. (Specifically, you mentioned that more than 60 percent of the Australian pea exports are consumed in India. Clearly if Indians developed anaphylactic shock from an allergic reaction to the peas, emergency response would not be available in many cases. Furthermore, without labels identifying the peas as different, it would be difficult to even identify the GM peas as the cause of allergic reactions.)
Your recently published study showed that natural beans and GM peas produced the same protein, but it had subtle differences in the way sugar chains were attached. You said you believe that this difference in sugar chains, or glycosylation, was probably responsible for the unique immune response. What about other GM crops already on the market? If you came to realize that they might also contain uniquely processed proteins that may be immunogenic, would you raise a voice of warning? Failure to do so might contribute to sickness or death.
I am certain that other GM crops have not been adequately tested for changes in their transgenic proteins. Most GM crops on the market, for example, have never been subjected to animal model tests looking at allergenicity. No regulatory system requires them, in spite of WHO recommendations that they do so. Instead, most have only been subject to a decision tree analysis and possibly a gel test. You yourself told me that when you looked at a gel test for your GM peas several years ago, you were convinced that there was no glycosylation differences. Thus, if your peas had only used the gel test, even you would have waved them on with a vote of confidence. Relying on that method alone would clearly have been dangerous in the case of your peas and is dangerous with the other GM crops.
I am therefore alarmed by your statements in the newspaper The Age, in which you claim that your finding “shows that the regulatory system works.” In your case, your assessment—not the regulatory system—did find problems and the development of the GM crops was fortunately terminated. But your public comments generalize beyond your own experience to claim that the regulations per se are effective and adequate. Consider this quote attributed to you in the Courier-Mail: “The regulatory system works. It ensures we have food from GM plants as safe as we get from conventional plants. Anything that has a slight risk is picked up.”
I believe your findings show the exact opposite. They expose gaping holes in the regulations and provide a mandate to immediately re-test all GM crops on the market.
To be clear, you discovered that your peas may be harmful by using immune tests that are routinely applied in medical testing. You demonstrated your confidence in these tests by canceling plans to market your peas. These tests, however, are not required by the regulatory systems and have never been used on GM food crops already on the market. By not requiring these sorts of tests, the regulatory system may have approved crops that, like your peas, process foreign proteins differently. They may be creating allergies. Thus, inadequate regulatory requirements approve GM foods that might harm or even kill people.
I am guessing that your expressions of confidence in GMO regulations were made because you are unaware of the actual requirements around the world and of the flimsy safety assessments that are routinely done. To be fair, only a handful of experts have studied this in detail, and they are often appalled by what is not required or tested for.
When a person in your position gives public endorsements to such regulations, you promote the status quo—and its consequences. In this case, your statements may have potentially lethal results. I urge you, therefore, to do a proper evaluation of assessments, correct your statements, and hopefully initiate actions to better protect the public.
My task is to provide evidence that the regulatory system is inadequate. I don’t need to prove that all GM crops in every regulatory system put the public at risk. Rather, I need only to demonstrate that a single GM food has made it onto consumers’ plates without the minimum testing that your own research now suggests is necessary to protect human health. If so, then it would be justified to say that your research exposed the flaws in the system, not its strength.
I am therefore attaching the peer-reviewed paper “Safety Testing and Regulation of Genetically Engineered Foods,” which exposes dangerous inadequacies of the regulatory approval process in the United States. It points out, for example, that “Biotechnology companies rarely test the transgenic protein actually produced in their engineered crops.” Instead they “use surrogate proteins” derived from bacteria. But, “Immunologic differences between plant-produced and bacterial surrogate proteins could have serious medical consequences.” If your immune tests had used only the bean protein instead of the pea protein, for example, the mice would not have shown a reaction and your peas might have been approved. Similarly, many GM crops were approved based on tests that used substitute proteins, not the ones that people actually consume.
The attached paper also offers a case study of Monsanto’s GM corn called Mon 810. When the gene was inserted into the corn, it was inadvertently truncated. The result is that it produces a fusion protein, created by a combination of the foreign gene and native corn DNA. Remarkably, researchers ignored this and still used a substitute bacteria-derived protein for its safety assessment. Thus, they not only ignored the subtle types of changes that you found to be potentially dangerous, they ignored very gross changes as well.
The approval process for Mon 810 did not involve testing for immune response in animals. Independent tests, however, showed that Bt-toxin—the pesticide that this corn is engineered to produce—elicited immune responses in both animals and humans. These were ignored by regulators.
Regulators also approved the corn in spite of the fact that the Bt protein failed the criteria recommended by the WHO: It does not break down sufficiently in test tube simulations of digestion and it contains amino acid sequences identical to known allergens.
The authors also show how several potential dangers from GM crops, not just allergies, can go undetected through the testing and approval system. This article is one of many, which make it absolutely clear that the regulatory system doesn’t work and that anything that has a risk is not necessarily picked up. I am confident that after reading this article, you will agree with the authors that the tests used for approving this Bt corn, as well as other varieties, were not sufficient to protect the public. I ask that you then make corrective statements, to undo the potential damage that your recent quotes may have created.
Moreover, I challenge you to propose that your institution, CSIRO, sponsor those important independent studies that were never done on the already approved GM crops, to make sure that the public is not being exposed to allergens, toxins, or anti-nutrients. I use the word “challenge” because I understand that CSIRO has business relationships with Bayer Crop Science and Monsanto. Raising a question about the safety of their GM foods is certain to infuriate them. Proposing new tests that might force a product’s withdrawal could turn them absolutely ballistic.
Therefore, to do any of what I suggest here may be very difficult for someone in your delicate “political” position. For that very reason, I have chosen to use strong words and to paint the accurate picture that your response to my challenge may be a matter of life or death for those eating GM foods. I hope that serves as sufficient motivation.
I am aware that some industry proponents promote GM products indiscriminately. They might answer my letter by saying, for example, “I am confident that the industry will do the assessments necessary to protect the health of the public, even if they are not required.” They might also avoid commenting on the attached case study, claiming that Mon 810 is not their project or the US is not their country. I think you will agree that our exchange requires a more specific, scientific basis.
You indicated in our conversation that as a plant physiologist, aspects of safety assessments are clearly outside your area of expertise. You also mentioned that your colleague on an earlier pea study, Dr. Arpad Pusztai, is one of the most important toxicologists in this arena. You said you have a very positive opinion of Dr. Pusztai and have been a great admirer of his work. It will therefore be of interest to you that as an expert and authority in safety assessments and one who has reviewed countless GM food submissions to various regulatory agencies, he is 100% percent convinced that crops could easily get through those approvals and end up creating serious, even lethal long term consequences. I am sure he would be happy to share his knowledge with you in this regard. I have also spoken with experts on GMO submissions to the EU, the US, and Australia. All concur that the tests currently used to get products approved allow for serious problems to go unnoticed, including those uncovered in your own pea study.
I will post this letter on my website and refer to it in my article. I think this is a fair response to your recent public statements. I look forward to receiving your feedback to these points and to the attached article.
Thank you again for generously spending time with me on the phone, and for your breakthrough research.
Jeffrey M. Smith
 William Freese and David Schubert, Safety Testing and Regulation of Genetically Engineered Foods, Biotechnology and Genetic Engineering Reviews—Vol. 21, November 2004
from December 21, 2005 Spilling the Beans newsletter