Submitted by AP Lewis Alewis3001@gmail.com

1. Describe new or emerging categories of biotechnology products that are relevant to the development and use of modified microorganisms. To assess new and emerging technologies with modified microbes, what expertise and resources are needed in the government to evaluate the overall plant pest risk of modified microbes?

The USDA’s sole focus on plant pest risk establishes a dangerously myopic framework for regulation. Here are the overall concerns that the USDA is glossing over:

1. Living organisms evolve and behave in relationship with an ecosystem that balances their activity. All living organisms affect and respond to all others, while deriving sustenance from the physical environment, other organisms, and the metabolites of other organisms. Thus, introducing an artificially mutated living organism into an ecosystem, for any purpose or intent, disrupts all the relationships and interdependencies that have evolved over millennia.
2. There is no way to predict the immediate off-target effects of artificially mutated organisms, and it is patently impossible to predict how an organism will continue to evolve over time and how the organisms it interacts with will themselves change.
3. The most damaging effects of novel biological organisms do not always take place with the ecosystem of the soil biome and crop production, but occur instead in the outlying animal, and human kingdoms.

Unless the USDA adopts and operates under the precautionary principles that lack of evidence of potential harm is the same as being safe, it will again wreak havoc on environment, communities, biodiversity, and public health. Note the GMO seed companies continue to maintain that GMO food is safe, while refusing to take responsibility of pesticide tolerant insects and weeds, a five-fold increase in pesticide use, a three-fold increase in the application of synthetic nitrogen derived from fracked natural gas, pesticide drift and runoff, and a widening dead zone surrounding river deltas. The USDA considers GMO crops its proudest success, but by any measure its failures are preponderant. Only the 40,000 US farms that control over half of American cropland consider GMOs a success – and that is because they operate by managing third party contract planters, sprayers, and harvesters from their mansions in Florida. They are isolated from the effects their practices have on biological systems, landscapes, biodiversity, human health, and rural socioeconomic vitality. The depopulation of rural America and the destruction of local interdependent food systems are direct effects of the GMO experiment.

2. Describe areas where the clarity and/or efficiency of regulations governing modified microorganisms could be improved (e.g., definitions that need to be provided or revised, barriers to obtaining the data necessary to achieve commercialization).

Properly stated, Murphy’s law states that anything that can happen will happen – eventually, over time, with the right circumstances. There is no more likely place for organisms to express novel traits caused by novel gene sequences than within the myriad environments of global agriculture. The GMO seed trait companies have proven Murphy’s law over and over. So many pests are resistant to their products that they must stack glyphosate, gluphosinate, dicamba, Quizalofop, 2,4-D and other chemicals in their “crop protection” products and in turn can force the adoption by planters of proprietary seeds that can withstand them. The misnamed crop protection industry has abandoned environmental and human health protection altogether.

The clarity and/or efficiency of regulations governing modified microorganisms could be improved by engaging stakeholders and independent outside experts who are familiar with the socio-ecological fallout caused by novel agricultural materials and practices, and listening to them explain the as-yet-uncalculated costs and risks these technologies represent. If the USDA remains dependent on the same staff and compromised industry experts who are responsible for the global GMO disaster, the agency will be the sponsor of the coming synthetic biology disaster as well. Glyphosate resistance — and the catastrophic effects on the human microbiome of glyphosate products — can still, in theory, be mitigated by drawing down glyphosate and ending use of seed stock that fuels the chemical-dependent GMO cropping system. There is no fix for problems caused by living modified organisms created using synthetic biology that are released into nature. With or without USDA oversight, synthetic organisms will do what they do — and generations of other organisms, including humans, will face whatever comes as best they can.

3. Describe key elements of a regulatory framework that would enable a scientifically sound assessment of a modified microorganism’s plant pest risk, in order to inform regulatory decision-making by APHIS.

a. Describe any biological features of microorganisms that APHIS should consider when determining whether a modification changes the plant pest risk, and thus the regulatory status of a modified microorganism (e.g., the potential for horizontal gene transfer, the production of airborne spores, its ecological role, or the ability to remain dormant for long periods of time).

• Horizontal gene transfer is ubiquitous and happens regularly in microbial ecosystems. Once an edited gene or the enhanced expression of it is released into the environment there is no way to estimate the gene flow to other organisms. Similarly, pursuant to the science of evolution, artificially mutated organisms will continue to evolve and adapt their novel genetic makeup, traits, and behaviors in unforeseeable ways.
• Fungi, microbes, insects, animals and humans will react to the novel traits. These reactions will include resistance mechanisms against the foreign traits, and internal immune responses against unrecognized DNA. We have seen this both in herbicides and insecticides for over a century, since targeting structures and functions through presumed genetic pathways always evolves resistance. Human populations are showing the physical stress of unrelenting background exposure to toxicants, and novel microorganisms will further this decay in public health. Engineered microbes will be no different and may be even more problematic as they change over time.
• Replication – microbes replicate and evolve at much faster rates in nature. It follows that an engineered organism is likely to change rapidly once it is in the environment, especially if it has enhanced traits for replication, senescence, and biomic dominance. There is no sufficient means to predict any future outcome.
• Even a slight change in an ecosystem can tip the balance to disaster. Blights are rapidly occurring and spreading infections of plants and are often caused by a single organism with a single mutation. There can be no commercial justification for knowingly taking such a risk.
• A single gene, genetic sequence, or cluster of genes does not define traits or behavior. The idea of marker genes that control single traits in disproven theory that only occurs in PowerPoint pitch decks and investor call. In fact, cells. and groups of cells responsible for a similar function, seek out and call upon DNA strands to build the prions, proteins, and enzymes the cell structure needs. DNA does not drive organism growth, structure, or function: the organism does. The release of novel DNA genes and gene sequences into the natural environment will provide tools to organisms that have never existed before. It follows that organisms will use novel DNA in ways we have never imagined, cannot identify, and have no ready response to.

b. What criteria, data, and information should be considered when assessing a modified microorganism’s plant pest risk?

Every healthy ecosystem has within it the material and organisms to operate successfully and support competition and survival of all its beneficial populations from fungi to footsteps. The conceit that nature is “broken,” and that only novel DNA technologies can “fix” it, is merely the delusion of those seeking fortune and fame. If humans feel destined to tinker with natural systems they do not comprehend, then at least they should use naturally occurring organisms that will likely promote ecological balance rather than planetary calamity. There exist tens of millions of unclaimed natural organisms on the planet that may or may not help rebalance specific parts of nature put into dysbiosis by human activity. The only reason to artificially mutate them is to patent them and profit from them. Monetary and hubristic gain drive this the obsession with this technology – not an understanding of genetics or a desire to fix anything that is not profitable to fix.

• The USDA should not allow release of novel microorganisms if there is availability of a naturally occurring organism that already has the target genetic capabilities that have evolved naturally in the environment
• Novel organisms should not be introduced into the environment. The number of microorganisms, weeds and insects introduced into ecosystems that have been destructive; history is littered with examples from smallpox to COVID variants to kudzu to invasive aquatic species.
• Given that antibiotic resistance remains the number one public health threat to humanity, antibiotic resistance genes must not be engineered into the fermentation vector or microorganism. Antibiotic resistance genes can carry through to the target microbe and are extremely likely to transfer horizontally.
• There is no such thing as a pure solution of target microorganisms. The grow-out step always generates unexpected and sometimes unidentified substances and organisms that were not intended to grow. There is no way to remove these non-target entities from the final commercial product. It takes only one living organism to replicate in nature, and there is no way to predict its behavior in nature. Release of artificially mutated microorganisms amounts to contaminating the workings of key metabolic pathways with implications in the health and function of the environmental and human microbiomes.
• The best approach to clarify plant pest risk would be to remove the corporate liability protections and place financial and moral responsibility on the principle actors and their investors. If the instigators of the release of novel organisms do not believe the potential benefits outweigh the bast unknown risks, making them take direct responsibility will expose that belief. The USDA must make it clear that externalized risk to people, animals and planet is not acceptable. At very least, each release should be accompanied by the following:
  • Cash or security bond equal to the revenue gained from release.
  • Registry of key genetic markets of a novel microorganism to allow crisis response teams to identify and track the presence and growth of each release.
  • Perform replication in culture 1,000 times to measure how fast the novel microorganism mutates and what mutations occur.

c. What should APHIS consider when determining whether modification of a biocontrol organism could result in it posing a plant pest risk? Provide scientific evidence to support which types of biocontrol organisms and methods could or could not pose a plant pest risk.

Plant pest risks are the least of our worries, but will certainly occur both immediately and slowly over time. Consider your kids and grandkids. Consider how the risks run far beyond the yield of a few row crops. Nature is barely functioning now due to the damage caused directly and indirectly by these technologies. One accidental tweak on fusarium, one damaged or missing gene in a insect, one misfired RNAi application – small things can trigger death. That’s how close APHIS is to being responsible for the disaster.

4. How should modified microorganisms with multiple uses (e.g., developed for both biomedical or pharmaceutical purposes and agricultural purposes) be regulated and evaluated by APHIS? What steps should APHIS take to ensure efficient and appropriate oversight and evaluation when a product is subject to regulation and review by both USDA and another Federal agency?

They are one and the same once released into the environment. Pharmaceuticals pass through animals into excrement and urine, and then into the ground water either raw, via direct elimination and collection in manure lagoons, or through municipal water treatment and recovery. Municipal treatment applies alum to induce sedimentation, anti-microbials to decrease pathogen load, and filtration to improve appearance. It was not designed and is not capable of containing or removing genetic material, metabolites, or hormones. Heavy metals and toxic chemical residues, including pesticides, are shrugged off. These treatment system were built in the 1970s based on 1950s science. Whatever the pathway, artificially mutated genetic material in pharmaceuticals and agricultural microorganisms enters the planet’s ecosystem and contaminates it permanently.

5. Should APHIS consider risk-based exemptions for certain types of microorganisms, or for certain modifications in microorganisms? If so, please provide examples of the types of modified microorganisms that should be exempt from regulation and provide scientific evidence to support which modifications and types of microorganisms should or should not be exempt.

Since there is no way to evaluate the current or future risk posed by the microorganism created using these technologies, the concept of exempting any one of them would be rationalized based on pure ignorant hopefulness or the grasping promise of financial gain.

6. Are there any other specific issues or topics APHIS should consider in developing a regulatory framework for assessing the plant pest risk of modified microorganisms, or possible pathways to commercialization for modified microorganisms?

Bad things have happened, are continuing to happen and will continue to happen long after those responsible for reckless strain release and failed regulatory safety oversight are long gone. No human society in the future will praise those who blindly patented and promoted mutated DNA instead of using their resources to cure the hurt already done to the planet.

We welcome all comments on the issues outlined above.

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