What the FDA Isn’t Telling Us About GE Salmon
By Tim Schwab
In September 2010, the U.S. Food and Drug Administration (FDA) appeared primed to approve AquaBounty’s genetically engineered (GE) salmon, the hormone-enhanced fish that, nevertheless, can’t live up to its fast-growth hype. Trumpeting unprecedented transparency, the FDA released to the public hundreds of pages of the agency’s favorable risk assessment, along with an announcement of a days-away public meeting in Rockville, Maryland. The extremely short timeline seemed designed to limit public participation and independent criticisms of the FDA’s scientific work, as few people could drop everything and rush to Maryland.
On the Friday before Christmas 2012, the agency that protects 80 percent of our food supply gave us an encore performance. On a day when few people are at work and many are making plans for extended vacations, the FDA issued its environmental assessment, a 160-page document that basically regurgitates verbatim the agency’s weak 2010 assessment. This moves AquaBounty’s GE salmon within one step of full approval.
The FDA’s risk assessments are noteworthy, not for what they do tell us, but for what they don’t. Instead of scrutinizing the flawed science, limited data, examples of bias and lingering safety concerns that independent scientists have highlighted, the FDA continues to treat its risk assessment as an exercise in churning out the Frankenstein refrain: GE salmon. Safe. Good.
On food safety, the agency only looked at a handful of fish, which exhibited 50 percent higher rates of allergenicity and 40 percent higher rates of a growth hormone linked to cancer in humans. The FDA played with the data to show the differences weren’t “statistically significant,” even though an independent statistician invited by the FDA called the agency’s analysis woefully flawed.
The FDA is also failing to address AquaBounty’s track record of dangerously lax stewardship, which should trigger questions about the likelihood of GE salmon escapes from their facilities. In a 12 to 15-month period between 2008 and 2009, AquaBounty appears to have lost most of its GE salmon to mechanical failures, falling trees, unusual storms and disease.
AquaBounty’s grow-out facility in Panama experienced a devastating storm in 2008, which led the company to report to their shareholders that GE salmon were “lost.” Initially, AquaBounty said the “unusually severe storm” caused a mechanical failure, then later said a tree fell on the facility and the “lost” fish actually died. The FDA has never publicly acknowledged or verified this.
Within about a year of this calamity, AquaBounty’s other experimental facility—in Canada—was being ravaged by deadly disease called infectious salmon anemia virus (ISAV). How it got into AquaBounty’s facilities is a question that, conveniently, remains unasked and unanswered by the FDA. What we do know is that AquaBounty began voluntarily killing most of its broodstock.
Though the catastrophic ISAV outbreak occurred in 2009, the FDA didn’t mention it in its 2010 risk assessment or public meeting. More galling, when AquaBounty’s president spoke at the 2010 meeting, he criticized his competitors—Chilean, English, Scottish and Norwegian salmon growers—for ISAV outbreaks at their facilities. He didn’t mention his own company’s struggles with ISAV.
But what is perhaps most suspect about FDA’s risk assessment is the agency’s failure to verify that GE salmon can actually do what AquaBounty says they can do: grow fast. Many salmon growers and scientists have now labeled GE salmon’s purported growth-rates as little more than hype, with one grower openly challenging AquaBounty.
The flawed scientific work by the FDA on GE salmon sets an extremely dangerous precedent for the future of our food system. The pro-biotech bent at the FDA shouldn’t be terribly surprising given that the agency’s policy makers on GE have historically come from the biotech industry. The Obama administration, likewise, isn’t immune to the half-billion dollars in campaign contributions and lobby money spent by the biotech industry in the last decade. It also isn’t terribly surprising that the FDA waited to issue this controversial risk-assessment until after the election.
Your members of Congress need to know that the FDA has dropped the ball on GE salmon, a dangerous fish that consumers don’t want to eat, growers don’t want to produce, and society doesn’t need. You can also tell the FDA directly to stop the experiment.
Visit EcoWatch’s GENETICALLY MODIFIED ORGANISM page for more related news on this topic.
EcoWatch Daily Newsletter
By Danielle Nierenberg
Following the murder of George Floyd by police in Minneapolis, people around the United States are protesting racism, police brutality, inequality, and violence in their own communities. No matter your political affiliation, the violence by multiple police departments in this country is unacceptable.
Mangroves play a vital role in capturing carbon from the atmosphere. Mangrove forests are tremendous assets in the fight to stem the climate crisis. They store more carbon than a rainforest of the same size.
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By Jacob L. Steenwyk and Antonis Rokas
From the mythical minotaur to the mule, creatures created from merging two or more distinct organisms – hybrids – have played defining roles in human history and culture. However, not all hybrids are as fantastic as the minotaur or as dependable as the mule; in fact, some of them cause human diseases.
When Looking Through a Microscope Isn’t Close Enough.<p>For the last few years, <a href="http://www.rokaslab.org/" target="_blank">our team at Vanderbilt University</a>, <a href="https://www.researchgate.net/lab/Gustavo-Goldman-Lab" target="_blank">Gustavo Goldman's team at São Paulo University in Brazil</a> and many other collaborators around the world have been collecting samples of fungi from patients infected with different species of <em>Aspergillus</em> molds. One of the species we are particularly interested in is <a href="https://doi.org/10.1006/rwgn.2001.0082" target="_blank"><em>Aspergillus nidulans</em>, a relatively common and generally harmless fungus</a>. Clinical laboratories typically identify the species of <em>Aspergillus</em> causing the infection by examining cultures of the fungi under the microscope. The problem with this approach is that very closely related species of <em>Aspergillus</em> tend to look very similar in their broad morphology or physical appearance when viewing them through a microscope.</p><p>Interested in examining the varying abilities of different <em>A. nidulans</em> strains to cause disease, we decided to analyze their total genetic content, or genomes. What we saw came as a total surprise. We had not collected <em>A. nidulans</em> but <em>Aspergillus latus</em>, a close relative of <em>A. nidulans</em> and, as we were to soon find out, <a href="https://doi.org/10.1016/j.cub.2020.04.071" target="_blank">a hybrid species that evolved through the fusion of the genomes</a> of two other <em>Aspergillus</em> species: <em>Aspergillus spinulosporus</em> and an unknown close relative of <em>Aspergillus quadrilineatus</em>. Thus, we realized not only that these patients harbored infections from an entirely different species than we thought they were, but also that this species was the first ever <em>Aspergillus</em> hybrid known to cause human infections.</p>
Several Different Fungal Hybrids Cause Human Disease.<p>Hybrid fungi that can cause infections in humans are well known to occur in several different lineages of single-celled fungi known as yeasts. Notable examples include multiple different species of <a href="https://doi.org/10.1002/yea.3242" target="_blank">yeast hybrids</a> that cause the human diseases <a href="https://rarediseases.info.nih.gov/diseases/6218/cryptococcosis" target="_blank">cryptococcosis</a> and <a href="https://www.cdc.gov/fungal/diseases/candidiasis/index.html" target="_blank">candidiasis</a>. Although pathogenic yeast hybrids are well known, our discovery that the <em>A. latus</em> pathogen is a hybrid is a first for molds that cause disease in humans.</p>
(Left) Candida yeasts live on parts of the human body. Imbalance of microbes on the body can allow these yeasts, some of which are hybrids, to grow and cause infection. (Right) Cryptococcus yeasts, including ones that are hybrids, can cause life-threatening infections in primarily immunocompromised people. Centers for Disease Control and Prevention<p><a href="https://doi.org/10.1371/journal.ppat.1008315" target="_blank">Why certain <em>Aspergillus</em> species are so deadly</a> while others are harmless remains unknown. This may in part be because <a href="https://doi.org/10.1016/j.fbr.2007.02.007" target="_blank">combinations of traits, rather than individual traits</a>, underlie organisms' ability to cause disease. So why then are hybrids frequently associated with human disease? Hybrids inherit genetic material from both parents, which may result in new combinations of traits. This may make them more similar to one parent in some of their characteristics, reflect both parents in others or may differ from both in the rest. It is precisely this mix and match of traits that hybrids have inherited from their parental species that <a href="https://www.nytimes.com/2010/09/14/science/14creatures.html" target="_blank">facilitates their evolutionary success</a>, including their ability to cause disease.</p>
The Evolutionary Origin of an Aspergillus Hybrid.<p>Multiple evolutionary paths can lead to the emergence of hybrids. One path is through mating, just as the horse and donkey mate to create a mule. Another path is through the merging or fusion of genetic material from cells of different species.</p><p>It is this second path that appears to have been taken by our fungus. <em>A. latus</em> appears to have two of almost everything compared to its parental species: twice the genome size, twice the total number of genes and so on. But unlike other hybrids, which are often sterile like the mule, we found that <em>A. latus</em> is capable of reproducing both asexually and sexually.</p><p>But how distinct were the parents of <em>A. latus</em>? By comparing the parts contributed by each parent in the <em>A. latus</em> genome, we estimate that its parents are approximately 93% genetically similar, which is about as related as we humans are with lemurs. In other words, <em>A. latus</em>, an agent of infectious disease, is the fungal equivalent of a human-lemur hybrid.</p>
How A. Latus Differs From its Parents.<p>Elucidating the identity of closely related fungal pathogens and how they differ from each other in infection-relevant characteristics is a key step toward reducing the burden of fungal disease. For example, we found that <em>A. latus</em> was three times more resistant than <em>A. nidulans</em>, the species it was originally identified as using microscopy-based methods, to one of the most common antifungal drugs, <a href="https://www.drugbank.ca/drugs/DB00520" target="_blank">caspofungin</a>. This result provides a clear example of the potential importance of accurate identification of the <em>Aspergillus</em> pathogen causing an infection.</p><p>We also examined how <em>A. latus</em> and <em>A. nidulans</em> interact with cells from our immune system. We found that immune cells were less efficient at combating <em>A. latus</em> compared to <em>A. nidulans</em>, suggesting the hybrid fungus may be trickier for our immune systems to identify and destroy.</p><p>In the midst of the COVID-19 pandemic, our quest to understand <em>Aspergillus</em> pathogens is becoming more urgent. Growing evidence suggests that <a href="https://doi.org/10.1111/myc.13096" target="_blank">a fraction of COVID-19 patients are also infected with <em>Aspergillus</em>.</a> More worrying is that these <a href="https://doi.org/10.3201/eid2607.201603" target="_blank">secondary <em>Aspergillus</em> infections</a> can worsen the clinical outcomes for those infected with the novel coronavirus. That being said, we stress that little is known about <em>Aspergillus</em> infections in COVID-19 patients due to a lack of systematic testing, and none of the infections identified so far appear to have been caused by hybrids.</p><p>So, when it comes to hybrids, some are fantastic (the minotaur), some are helpful (the mule) and some are dangerous (<em>Aspergillus latus</em>). Understanding more about the biology of <em>Aspergillus latus</em> may help in our understanding of how microbial pathogens arise and how to best prevent and combat their infections.</p>
This Saturday, June 6, marks National Trails Day, an annual celebration of the remarkable recreational, scenic and hiking trails that crisscross parks nationwide. The event, which started in 1993, honors the National Trail System and calls for volunteers to help with trail maintenance in parks across the country.
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By John Letzing
This past Wednesday, when some previously hard-hit countries were able to register daily COVID-19 infections in the single digits, the Navajo Nation – a 71,000 square-kilometer (27,000-square-mile) expanse of the western US – reported 54 new cases of what's referred to locally as "Dikos Ntsaaígíí-19."
The Navajo Nation covers the corners of three different states. Google Maps
Growing Contribution<img lazy-loadable="true" src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMzM3NDY5Ny9vcmlnaW4ucG5nIiwiZXhwaXJlc19hdCI6MTY0NjM4MTgyM30.IuQTKQs1stvYYKD6vaVTrqAyoBsUG0BhDvlhxsyKwPA/img.png?width=980" id="02a05" class="rm-shortcode" data-rm-shortcode-id="2841f82b1785df5d5ed7bf64d3bb882b" data-rm-shortcode-name="rebelmouse-image" />
World Economic Forum
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World Environment Day: A Time to Consider the Planet We’ll Return To, and Decide How to Care for It Going Forward
It's a different kind of World Environment Day this year. In prior years, it might have been enough to plant a tree, spend some extra time in the garden, or teach kids the importance of recycling. This year we have heavier tasks at hand. It's been months since we've been able to spend sufficient time outside, and as we lustfully watch the beauty of a new spring through our kitchen's glass windows, we have to decide how we'll interact with the natural world on our release, and how we can prevent, or be equipped to handle, future threats against our wellbeing.