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Assessment & Impacts » Food Safety

Title: Systems Biology Study Finds GMOs not “substantially equivalent”
Publication date: August 12, 2015
Posting date: August 12, 2015

THIRD WORLD NETWORK BIOSAFETY INFORMATION SERVICE

Dear Friends and Colleagues

Systems Biology Study Finds GMOs not “substantially equivalent”

The safety assessment of genetically modified organisms (GMOs) is a contentious topic. In the U.S., the debate centres around the methodology used to determine the criteria for substantial equivalence (whether GMOs are “equivalent” to their non-GMO counterparts).

A new peer reviewed study (Item 1), based on a computational systems biology analysis, has found that the genetic modification/engineering of soy disrupts the plant's natural ability to control stress and causes an accumulation of formaldehyde, a known Class 1 carcinogen, as well as a dramatic depletion of glutathione, an important anti-oxidant necessary for cellular detoxification. Systems biology looks at the complexity of the whole organism as a system rather than just studying its parts, which the authors contend would provide a framework for more appropriate criteria to measure how GMOs affect the emergent properties of a whole system.

The study concludes the U.S. government's current standard for safety assessment of GMOs, based on the principle of "substantial equivalence," is outdated and unscientific for genetically engineered food as it was originally developed for assessing the safety of medical devices in the 1970s. If formaldehyde and glutathione were used as distinguishing criteria, the GM soy would likely not be deemed "equivalent" to its non-GMO counterpart. This calls into question the FDA's food safety standards for the entire country. (Item 2)

The study underscores the urgent need to modernize safety assessments of GMOs, and the author argues that "This is not a pro- or anti-GMO question. But, are we following the scientific method to ensure the safety of our food supply? Right now, the answer is 'no'. We need to, and we can, if we engage in open, transparent, and collaborative scientific discourse, based on a systems biology approach."

With best wishes

Third World Network
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Item 1

DO GMOS ACCUMULATE FORMALDEHYDE AND DISRUPT MOLECULAR SYSTEMS EQUILIBRIA? SYSTEMS BIOLOGY MAY PROVIDE ANSWERS

by V. A. Shiva Ayyadurai and Prabhakar Deonikar
Agricultural Sciences, 6, 630-662.
http://www.scirp.org/journal/PaperInformation.aspx?PaperID=57871#.VaW8tEsxKFK

Abstract

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.



Item 2

GMO SOY ACCUMULATES FORMALDEHYDE & DISRUPTS PLANT METABOLISM, SUGGESTS PEER-REVIEWED STUDY, CALLING FOR 21ST CENTURY SAFETY STANDARDS

SOURCE Systems Biology Group, International Center for Integrative Systems

http://www.prnewswire.com/news-releases/systems-biology-group-international-center-for-integrative-systems-gmo-soy-accumulates-formaldehyde--disrupts-plant-metabolism-suggests-peer-reviewed-study-calling-for-21st-century-safety-standards-300112959.html

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.

Dr. Ayyadurai stated, "The results demand immediate testing along with rigorous scientific standards to assure such testing is objective and replicable. It's unbelievable such standards for testing do not already exist. The safety of our food supply demands that science deliver such modern scientific standards for approval of GMOs."

"The discovery reported by Dr. Ayyadurai reveals a new molecular paradigm associated with genetic engineering that will require research to discover why, and how much formaldehyde and glutathione concentration, and what other cellular chemicals relevant to human and animal health, are altered. We need the kinds of standards Dr. Ayyadurai demands to conduct such research," stated Dr. Ray Seidler, a former EPA Senior Scientist. "Formaldehyde is a known class1 carcinogen. Its elevated presence in soybeans caused by a common genetic engineering event is alarming and deserves immediate attention and action from the FDA and the Obama administration. Soy is widely grown and consumed in the U.S., including by infants fed baby food products, with 94% of soy grown here being genetically engineered," declared Seidler.

The study concludes the U.S. government's current standards for safety assessment of GMOs, based on the principle of "substantial equivalence," is outdated and unscientific for genetically engineered food since it was originally developed for assessing the safety of medical devices in the 1970s. The current criteria for assessing "equivalence" considers only basic nutritional and superficial characteristics such as taste, sight, smell and touch, for declaring GMOs safe for human consumption, allowing them to be fast-tracked to market without independent scientific testing. If formaldehyde and glutathione were criteria, then the GMO would likely not be deemed "equivalent" to its non-GMO counterpart. This finding calls into question the FDA's food safety standards for the entire country.

The publication of the paper coincides with release of a bulletin by the Obama Administration on July 2, 2015, calling for "Improving Transparency and Ensuring Continued Safety in Biotechnology."

Ayyadurai shares, "This is not a pro- or anti-GMO question. But, are we following the scientific method to ensure the safety of our food supply? Right now, the answer is 'no'. We need to, and we can, if we engage in open, transparent, and collaborative scientific discourse, based on a systems biology approach."


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