Why was there a fast-track approval of a new genetic technology as a pesticide?
If the use of RNA-based pesticides concerns you, you have until the 30th October to make your voice heard.
By Christof Plothe, DO and World Council for Health Steering Committee member and Scientist
The Environmental Protection Agency (EPA) has fast-tracked the approval of Ledprona, a novel pesticide based on RNA interference (RNAi) technology, and wants to approve a biopesticide to kill potato beetles with unknown consequences for humans, animals and the environment.
Introduction
In an unprecedented move, the Environmental Protection Agency (EPA) has fast-tracked the approval of Ledprona, a novel pesticide based on RNA interference (RNAi) technology. This decision has potentially far-reaching implications for environmental toxicology, ecosystem health, and human well-being. The biopesticide, if approved, will be the world's first commercially sprayable dsRNA pesticide that can be used on plants.
The pesticide contains ledprona, an active ingredient with double-stranded RNA (dsRNA) ingredient. Ledprona works by silencing a specific gene in the Colorado potato beetle, which is essential for the production of a key protein. By turning off this gene, the pesticide disrupts the insect's normal functioning and ultimately leads to its death.
Without further information, it is difficult to determine the exact reason for the urgency mentioned by the EPA to initiate a fast-track approval, especially in the light that a gene therapy in humans (mRNA vaccine technology) has demonstrated unprecedented damage.
Understanding RNAi Pesticides
RNA interference (RNAi) technology is a biological process that manipulates gene expression in plants and animals. It works by interfering with messenger RNA (mRNA), which carries genetic instructions from DNA to make proteins.
RNAi uses small RNA molecules, like small interfering RNA (siRNA) or microRNA (miRNA), to bind to specific mRNA and prevent its translation into proteins. This process involves two steps: the RNA is processed into siRNA, and then the siRNAs are loaded into a complex called RISC, which recognizes and degrades target mRNA. RNAi technology is a selective interference with genes with so far unknown effects on the species affected and the environment.
GreenLight Biosciences, a biotech company based in Massachusetts promoting a pesticide called "Calanthra" containing ledprona, asserts that dsRNA technology offers several advantages over chemical pesticides used in potato farming. One key advantage they claim is that dsRNA technology rapidly breaks down in the environment, leaving behind no discernible residues on food, soil, water, or in the atmosphere.
EPA's Stunning Regulatory Bypass
The EPA granted Ledprona an Experimental Use Permit (EUP), allowing GreenLight Biosciences two years to gather data from limited test plots. Astonishingly, the agency has also green-lit Ledprona for three years of commercial use—before the standard testing period is even complete. This deviation from established regulatory norms raises questions about the EPA's commitment to science-based policy.
The Risks Involved
The producer of Ledprona claims that the technology is a new frontier in pest control, but it does present unknown risks. For instance, the pesticide could trigger unintended immune responses in humans.
Environmental risks are also a concern; the technology could potentially harm off-target insect species, disrupting ecosystems in unforeseen ways. Several experts and studies have already questioned the safety and efficacy of this new class of pesticides, emphasizing the need for rigorous testing.
Andre Leu (PhD), international expert in regenerative farming and animal husbandry, who is the author of the book "The Myths of safe pesticides" told The Defender of Children's Health Defense (CHD, 2023) that Ledprona should be banned until there is "clear evidence" that it is safe for people.
Leu says "Many living species, including humans, share an enormous amount of similar DNA and genes. RNA can adversely affect these off-target genetic sites."
"Despite the industry claims, RNA can interfere with gene expression in many species, causing a variety of unintended adverse health and reproductive effects such as cancers, metabolic disorders, hormone disruptions, organ damage, and numerous other diseases."
The potential dangers can involve the following topics and should be addressed before ever releasing a novel gene-altering technology.
Inhalation of synthetic RNAi
There are concerns about the potential inhalation exposure to synthetic interfering RNAs, particularly for farmers, farm workers, production workers, and rural communities. The risks associated with inhalation exposure are not yet fully understood (FOTE, 2023).
Altering the genetic composition of crops
Unwanted gene silencing through RNAi could alter crops' genetic composition, raising safety concerns. This includes the possibility of altering levels of toxins or allergens in crops (FOTE, 2023).
Dietary consumption of synthetic RNAi
Preliminary research suggests that naturally occurring interfering RNAs in our diet play a role in regulating physiological or pathological conditions in our bodies. This raises concerns that synthetic RNAi products may interfere with human gene regulation, potentially leading to unforeseen health implications. Further investigation is needed to fully understand the safety implications of consuming synthetic interfering RNAs (FOTE, 2023).
Mutations and insertional mutagenesis
There is a risk of mutations in viral sequences when using RNAi technology, which could lead to insertional mutagenesis or trigger aberrant gene expression (Castanotto, 2009).
It is important to note that risk assessments are conducted to evaluate the potential risks associated with RNAi technology. Organizations like the European Food Safety Authority (EFSA) and the Office of the Gene Technology Regulator (OGTR) consider these risks when preparing risk assessments for RNAi technology. However, it will still take years to become conclusive.
Who owns the crops or insects that are modified by RNAi spray?
Ownership of genetically modified crops or insects modified using RNAi technology would depend on various factors, including intellectual property rights, patents, and agreements between the parties involved. Legal frameworks and contractual agreements typically determine ownership rights.
So-called siRNAs and shRNAs can compete with the endogenous microRNA pathway, potentially affecting our bodies' normal cellular miRNA processes. Additionally, a 2006 publication reported that certain shRNA sequences were able to block the activity of a liver-specific miRNA called miR122, leading to severe liver toxicity and death in some treated mice.
Why This Matters to Everyone
The fast-tracking of Ledprona serves as a case study of the importance of environmental toxicology in public policy. The field provides the tools to critically evaluate new technologies like RNAi pesticides, assessing their impact on human health and the environment.
Call to Action
Now is the time to make your voice heard. Participate in the public comment process and demand a science-based, transparent approach to pesticide approval.
Conclusion
The EPA's decision to fast-track Ledprona is not just about this one class of pesticides; it represents a dangerous precedent that will gut public concerns over the public health effects of all future EPA decisions. Right now, this demands public scrutiny, your voice, and scientific rigour. Your engagement can make a difference. Your voice is needed today.
The Extended Public Comment Period
Due to efforts by the US-based environmental organization Friends of the Earth, the EPA has extended the public comment period until October 30. This is your opportunity to weigh in on national environmental and public health significance. Consider raising questions about the expedited approval process, the potential for unintended ecological consequences, and the lack of comprehensive human health studies.
Please comment here: https://www.epa.gov/pesticides/epa-opens-public-comment-period-proposal-register-novel-pesticide-technology-potato
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The devastation wrought by these super pesticides has decimated birds here in the USA. Prior to round up everything we would have days on end in the fall od birds gathering setting on power lines and flying south. All kinds, now if you see a couple hundred it's rare. Rabbits, pheasants and other wildlife are a rare sight. The corn and bean fields are clean as a whistle, but no wildlife. Birds and other animals need cover, small seed, grass that harbors bugs. Now we have none of that. Our ravenous appetite to have picture perfect monoculture with no weeds, no life will destroy us someday. I farm using no chemicals, you can feel the soil teaming with life when you touch and walk on it, vs the chemically treated fields that are dead.