There has, since 2012, been a problem in the biotechnology science community, much akin to the problems faced by the community involved in vaccine research. It is likely that many of you are already aware of the story of Andrew Wakefield and his shoddy study involving fabricated data and made up children where he concluded that vaccine administration plays a role in the development of autism.

He specifically focused on the MMR vaccine as his claimed culprit, since his high stock in an upcoming and competing company with an alternative MMR vaccine would likely net him a ton of money if he introduced public doubt into the efficacy and safety of the commonly used version. You know how the story went from there and how we’ve been dealing with the anti-science fallout ever since and the deaths of many, many people from preventable disease.

Trials and Tribulations

A similar incident befell the biotech community in September of 2012 with the publication of a paper by Gilles-Éric Séralini, a French molecular biologist. His paper has been discussed many a time before and in great detail, but in short, it was an abject mockery of the scientific method. A ton of experimental groups at too small a sample size, an unclear mixing of tests on GM crops versus Roundup herbicide ingestion, and a mess of data that Seralini managed to both badly modify to mix his purposes and yet still was unable to torture into the right configuration, forcing him to write a conclusion statement at direct odds with what the data showed. It was a sad and blatant attempt of doing an experiment to fit a preconceived and desired conclusion.

But it worked nonetheless. Similar to Wakefield, Seralini had an understanding of how to make a panicked public response regardless of the scientific merits of the study and he utilized several pictures of mice with gigantic tumors to push his claims, of course leaving out an image of the control group not fed anything of the sort and yet still grew the same exact tumors. His commercial and monetary connections to many anti-biotechnology environmentalist groups and organic foods companies was an additional benefit to him in spreading his propaganda. And, despite criticism from the scientific community and plenty of other studies directly refuting the claims of his, well, you know how the saying goes: “A lie can travel halfway around the world before the truth can get its boots on”.

The winds, however, may finally be turning. The truth, facts, and evidence may ever so slowly be getting through into the public consciousness. Add to that the fact that the French scientific community in particular and the EU’s groups of the same in general have been feeling a strong desire to clear their name from the pseudoscientific cruft that Seralini had settled on them and you come to today. Or last week, to be more precise.

GMOs and >90 Days

Four major research projects had been started by independent, though somewhat affiliated groups, on the subject of GM crops and any potential harms of them from long term consumption. Three of these are official EU-funded grant projects and, due to that, have no journal published paper, so we’ll discuss them last and in more fleeting detail. The main focus of this article will be on the study conducted by a massive team from multiple French universities and research labs involved in food science, toxicology, and even mathematics. That experiment is known as the GMO 90+ Project.

In a number of ways, the experiment was simple. One of the main claims pushed by Seralini has been that the 90 day testing system for toxicology, as laid out by the OECD for food safety, is too short to accurately pick up on health impacts in the long term. Even though for the rodents tested those 90 days make up a significant portion of their life span. This claim was fairly false on its face, as plenty of longer term and even multi-generational studies had been done on both GM crops and the herbicide glyphosate. But if he wanted even more longer studies, the French scientists were happy to give them to him.

France’s Ministry for an Ecological and Solidary Transition, a department similar to the USA’s Environmental Protection Agency, funded the GMO 90+ study and called for the inclusion of multiple prestigious laboratories across the country. The first step was to extend the testing time to 6 months (180 days) to determine health effects on the rats. It was to be the shorter counterpart to the EU studies, with each of those being 1 year and 2 years respectively and the final one being a more nebulous several years-long monitoring project. But we’ll get to all that.

Setup and Results

Two different GM corn cultivars were grown, along with near-isogenic (similar genomes) non-GM counterparts, while working with one of the other EU studies. One was Roundup-tolerant and the other was insect-resistant through Bt toxin production, thus covering both of the primary types of GM crop that Seralini had complained about. They also were of the most common varieties sold on the commercial market, NK603 and MON810. The study kept a close look on histopathological results, the changes in organs and tissues over time, which was included likely due to another Seralini counterpart by the name of Judy Carman’s sham paper claiming massive organ damage from such crops.

Finally, a general omics analysis of metabolite alterations and other minute changes was done during the time period to find even the smallest of potential impacts. Molecular biomarkers were focused on via transcriptomics and metabolomics was run on blood and urine samples. 30 rats were included of separate male and female sets in 8 overall experimental groups based on different concentrations and which of the corn cultivars they were fed, along with differences in glyphosate content based on whether the corn was sprayed or not during growth. Subgroups were also set up for each so that at 90 days, a third could be dissected and run through the battery of tests and the same done at 180 days with both other subgroups. A double-blind setup was used throughout the entire process so as not to bias the data collected.

The results ended up being fairly straightforward. The differing diets did not show any meaningful change in any of the groups tested and no systemic effects of toxicity were noted in outward health signs. The biochemical and histopathological tests showed that while there were several variables that did change between different groups, none of them showed any sort of correlation with health effects over time. For example, higher calcium and phosphorus levels in some of the rats did not seem to relate to which groups they were in in any meaningful way. Organ size variances were also within normal levels and, upon inspection, the biggest factor seemed to merely be whether they were eating MON or NK corn, regardless of whether they were GM or not. Growth environment also played a large role in changes to nutritional composition more than anything related to transgenic components.

Overall, the GMO 90+ project found that there were no noticeable health effects of GM corn on the animal test model, even in a longer term 180 day study and that there were no biomarkers found that made such a longer study any more useful than the normal 90 day requirements.

Now, onto the repeatedly teased three other projects of a similar nature.

Saving GRACE

The first we should discuss is one that started right around when the Seralini affair became a part of the public consciousness and there was a need to both retest the health and safety of GM crops and also determine the veracity of 90 day trials as compared to longer term experiments. An additional consideration was modifying the classical form of the studies so that less animal models have to be used for ethical research reasons in toxicity experiments.

This resulted in the GRACE Project, which stands for GMO Risk Assessment and Communication of Evidence. Due to the crops being sourced from Spain for the experiment, the researchers went with MON810 Bt corn and set up four 90 day feeding trials to check for subchronic toxicity, alongside a full year-long trial to look for chronic toxicity impacts. Rats were once again chosen as the animal model. Control groups were fed near-isogenic cultivars as well. Metabolomic samples and tissue samples were taken in much the same manner as the previously discussed study.

The trials were repeated over the course of 3.5 years and resulted in a large collection of data on both 90 day and 1 year long studies. Overall, no toxicological effects were noted, including with in vitro cell tests that were done alongside the normal rat experiments. It did result in a questioning of 90 day studies, but more in the sense of their setup for animal models and whether moving to a full cell system would work better while still remaining accurate for toxin detection.

The Twist of G-TWYST

The second and longer study done by EU researchers was G-TWYST or the GMP Two Year Safety Testing Project. Over the span of four years from 2014 to 2018, German scientists set up experiments with NK603 transgenic corn and also separate groups for Roundup ingestion from crop treatment. That included two 90 day trials, one with groups fed corn that was 11% or 33% of their overall diet, no Roundup, and another group fed corn that was sprayed with Roundup, split into groups fed 11%, 33% and 50% of the corn as their daily diet. The same setup as the former was used for the longer experiment, though with more experimental groups split by sex and by increasing residue amounts.

This treatment was continued over the course of two years and found no major deviations in nutrition, health, or any of the above. Glyphosate residues did not appear to have any change as compared to the groups fed GM corn without the residues included. The histopathology dissection found no meaningful changes to the organs or in the glands or tissues. Heck, the only useful result at all from the trials was the discovery that the higher rate of pituitary neoplasia among the male rats seemed to be due to their higher consumption of the available food over time.This is, of course, unrelated to any concerns of health risk from GM crops or Roundup.

MARLON’s Monitoring

The third and final study was a bit different than the other two and not precisely one with a result to discuss. Rather than being a direct experiment, it was a data collection and tool development project to see if long term consumption of GM crops has any effect on livestock. This was the MARLON or the Monitoring of Animals for Feed-related Risks in the Long Term Project, as done by Dutch scientists. It also began in 2012 and was for the purpose of collecting existing data on livestock animals and their feed, to allow for long-term monitoring of their health on various feedstocks. An epidemiological modeling tool was produced from the study for identifying possible changes in livestock health and linking them, if appropriate, to the feed in question.

These initial pieces of research have been focused on only GM crops, but the scientists plan to use the information gained for general health monitoring of livestock for all food intake. That should help explain in greater detail the connections between health outcomes and what role different food options play in creating healthier animals. For the purposes of GM crops, there were four case study scenarios that were the main focus, since there were not any existing or known cases of harm from GM crops to use as a source on the project.

The first involved checking for possible allergenic responses from GM crops due to the transgenes. The researchers collected data on the risk of this occurrence and compared it to known cases involving non-GM crops. Health indicator possibilities due to this were added to the monitoring model in this regard. The second was the risk of horizontal gene transfer from the crop to the animal consuming it, particularly in regard to antibiotic resistance markers. Since the precise function of the gene in question is the important part here, that was all added to the model.

The third case study actually was to look into a positive impact of GM crops, which is the reduction of mycotoxin buildup in crops thanks to fending off pests that harm the crops and allow for mould infection to set in. Data on insect-resistant corn was pored over and included for investigation, though only aflatoxins were chosen to include in the monitoring tool in the end. The fourth and final case study focused on biofortified crops and overall nutritional improvement and the health benefits those might bring to livestock. A number of parameters and measurements on how to detect this were added to the model.

With all these measurements, the monitoring tool has the power to use input data to detect both positive and negative results from GM crops and the researchers plan to continue using it for future livestock feed analysis. For now, they largely have little to report other than there being no currently found downside results from the use of GM crops in feed.

Science, Food Safety, the EU, and The Future

Together, all of these studies out of the EU cover basically every aspect of GM crops and claimed health hazards resulting from them. There have been plenty of past experiments showing the same thing, but having long-term trials funded entirely by the European Union and its member nations is a big step in fighting back against conspiracy claims and pseudoscience regarding biotechnology. It doesn’t cause those pushing anti-science stances to go away, but it is a powerful weapon in the arsenal of scientific facts and evidence for regulatory institutions and scientific communicators.

Furthermore, it should provide a large measure of comfort to the general public to have strongly definitive results of safety on this topic. Hopefully that will be the case. But, as always, the research must go on.

Press Article Link

Study Link #1

Study Link #2

Study Link #3

Study Link #4

Photo CCs: Feldbefreiung from Wikimedia Commons

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