QHow did the biotech industry decide that ‘90-days’ would be the norm, or the standard time-frame for testing? And how does that fit in with the universally accepted understanding that disease and pathology often takes many months, sometimes years to

How did the biotech industry decide that ‘90-days’ would be the norm, or the standard time-frame for testing? And how does that fit in with the universally accepted understanding that disease and pathology often takes many months, sometimes years to develop?

AExpert Answer

As with any trial and error testing, there must of course be a starting point and an endpoint where data can be accumulated and tested. While there is nothing in the literature citing specifically why 90 days has been established as a testing period, as in any testing protocol a baseline must be established and data collected over a period of time. This generally results in changes over a period of time during the testing period. But at some point there the law of diminishing returns sets in and additional testing results becomes insignificant to a study’s outcome. It is logical to assume that 90 days has become that standard period of testing in animal feeding studies. According to EFSA (European Food Safety Authority), “90-day animal feeding studies are often used to provide information for the risk assessment of food and feed and/or of individual substances contained therein.” 

A recently published research paper in the journal New Biotechnology suggested that longer term testing rather than the classical 90-day studies be performed on a case by case basis, and should not be the norm. The authors concluded that “long-term and multigenerational studies should only be conducted in a case-by-case approach for GE food/feed safety and nutritional regulatory assessment if some reasonable doubt remains after the 90-day rodent feeding trial.”  In fact, based on their research none of these longer-term assessments “have raised new safety concerns [regarding] marketed GE crop varieties.” They conclude that the data “does not provide evidence that more food safety testing is necessary for GE crop varieties.” In fact they claim that longer term multigenerational data could actually lower the risk assessment of GE crop varieties. And finally, the researchers proclaimed that governments are trying to “demonstrate environmental risks for cultivation of GE crops” which “fail to provide scientifically valid data.”

Additionally, I am not in agreement that it is universally accepted that “disease and pathology often takes many months, sometimes years to develop.”  Changes in cell structure and blood cells occur rather quickly when exposed to pathogens. This effect should not be confused with the diagnosis of such cellular abnormalities which are oftentimes not discovered for possibly months or years later when symptoms from these mutations actually begin to surface. 

Posted on January 31, 2018
Thank you for your question. There are various aspects of your question. I assume your question refers to the use of Agrobacterium rhizogenes by scientists to intentionally transfer genes from the bacterium to plants. Infection and DNA transfer from this bacterium occurs in nature all the time to cause disease. Such transformed plants are not classified as GMOs since transfer occurred naturally. If this is done by scientists then it would be classified as a GMO. Rules and... Read More
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Posted on March 1, 2018
I’m a Monsanto scientist who has more than 20 years of experience with genetic modification of plants. I will try to answer your question, even though I don’t ever do experiments on animals, certainly not on humans, of course! Can humans be genetically modified…but a much bigger question is should humans be genetically modified? There are two ways to think about genetic modification of humans (or any animal). One way is modification of somatic cells, and the other is the... Read More
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Posted on May 10, 2017
The simple answer is that 20+ years of composition assessments of GMO crops have demonstrated that crop composition is not appreciably affected by the GM process (1). In addition, data collected through that time have indicated that general factors such as the growth environment can contribute to notable variation in component levels (2). Plant agglutinins (or lectins) and amylase inhibitors are examples of anti-nutritional compounds that may be present in crops. The relevance of such a... Read More