Study Concludes FDA GMO Approval Process is Flawed, Outdated, and Unscientific
WASHINGTON, July 14, 2015 /PRNewswire/ -- A new study published today in the peer-reviewed journal AGRICULTURAL SCIENCES reveals genetic engineering of soy disrupts the plant's natural ability to control stress, and invalidates the FDA's current regulatory framework of "substantial equivalence" used for approval of genetically engineered food (GMOs).
The study, led by Dr. V.A. Shiva Ayyadurai, Ph.D., an MIT-trained systems biologist, utilizes his latest invention, CytoSolve, a 21st century systems biology method to integrate 6,497 in vitro and in vivo laboratory experiments, from 184 scientific institutions, across 23 countries, to discover the accumulation of formaldehyde, a known carcinogen, and a dramatic depletion of glutathione, an anti-oxidant necessary for cellular detoxification, in GMO soy, indicating that formaldehyde and glutathione are likely critical criteria for distinguishing the GMO from its non-GMO counterpart.
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A great article explaining the study as well as the history of the Doctrine of Substantial Equivalence:
A Killer-Diller: GMO Soy makes Formaldehyde in our Gut
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How does the United States Food and Drug Administration (FDA), the agency responsible for assuring the safety of the food we eat, currently test GMO seeds before certifying them as safe for humans? Well, it doesn’t test them at all. Run that by again slowly, you say? Not at all? How can this be?
In 1992, President George H. W. Bush held a closed-door White House meeting with the top leadership of Monsanto, the world’s largest GMO purveyor and maker of the world’s best-selling weed-killed paired by contract to all its GMO seeds. At that White House meeting Bush agreed to the Monsanto request that there be no intrusive independent government tests of the health and safety of its GMO seeds. The US President agreed to impose something known as the Doctrine of Substantial Equivalence as the sole “test,” supplemented by test results supplied by Monsanto or other GMO companies.
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Here's the study:
Agricultural Sciences Vol.6 No.7, Pub. Date: July 10, 2015
V. A. Shiva Ayyadurai, Prabhakar Deonikar
Safety assessment of genetically modified organisms (GMOs) is a contentious topic. Proponents of GMOs assert that GMOs are safe since the FDA’s policy of substantial equivalence considers GMOs “equivalent” to their non-GMO counterparts, and argue that genetic modification (GM) is simply an extension of a “natural” process of plant breeding, a form of “genetic modification”, though done over longer time scales. Anti-GMO activists counter that GMOs are unsafe since substantial equivalence is unscientific and outdated since it originates in the 1970s to assess safety of medical devices, which are not comparable to the complexity of biological systems, and contend that targeted GM is not plant breeding. The heart of the debate appears to be on the methodology used to determine criteria for substantial equivalence. Systems biology, which aims to understand complexity of the whole organism, as a system, rather than just studying its parts in a reductionist manner, may provide a framework to determine appropriate criteria, as it recognizes that GM, small or large, may affect emergent properties of the whole system. Herein, a promising computational systems biology method couples known perturbations on five biomolecules caused by the CP4 EPSPS GM of Glycine max L. (soybean), with an integrative model of C1 metabolism and oxidative stress (two molecular systems critical to plant function). The results predict significant accumulation of formaldehyde and concomitant depletion of glutathione in the GMO, suggesting how a “small” and single GM creates “large” and systemic perturbations to molecular systems equilibria. Regulatory agencies, currently reviewing rules for GMO safety, may wish to adopt a systems biology approach using a combination of in silico, computational methods used herein, and subsequent targeted experimental in vitro and in vivo designs, to develop a systems understanding of “equivalence” using biomarkers, such as formaldehyde and glutathione, which predict metabolic disruptions, towards modernizing the safety assessment of GMOs.
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