Created on 2022-08-17 14:30

Recently the oldest player in the #naturalfoods trade circulated a survey seeking comment and opinion on synthetic biology. Unfortunately, the survey was salted with an extremely favorable definition of #syntheticbiology on which respondents were told to base their answers. This article begins by sharing that stilted definition, then examines each claim critically in light of extensive research into the technology and its consequences for people and planet.

Here is the definition that kicks off the survey, with each section numbered for reference:

1. “Precision fermentation technology, also known as GMO 2.0 technology, is a form of synthetic biology that has been around for a few decades, and more recently has been tapped to produce consumables.
2. The technology, which is rapidly entering the mainstream, uses genetic modification to alter bacteria, yeast, algae, or plants, which are then fed water, nutrients, sugar and cultivated in brewery-style fermentation tanks.  
3. These modified microorganisms produce edible fats or proteins, which are biologically similar to plant or animal products.
4. Common applications of this technology have included the production of human insulin for treating diabetes, creating enzymes for food production, manufacturing vitamins and supplements, as well as rennet for cheese production.
5. More recently, the technology has been used to create nutrients, food additives and ingredients for CPG [consumer packaged goods] products (i.e., milk protein, honey, collagen, egg whites, etc.).
6. The FDA does not require these foods to be labeled as GMO because they do not contain genetically engineered organisms; they only contain the edible fats or proteins produced by those organisms.
7. Having said that, such products would not qualify for Non-GMO Project Verification.” (See note at bottom regarding attribution.)

The definition was partly cribbed from this article in Forbes. (The agency that drafted the survey for its client did not ask permission to use the text nor did it attribute the author.)

WHAT’S INSIDE THE BLACK BOX?

An examination of hundreds of patents covering the components of this technology results in a less placating narrative. The diagram below captures many of the processing steps in the value chain for synbio foods, beginning with energy extraction and ending with biohazard remediation. As often as this information has been posted and reposted online, no synbio company or investor has publicly challenged it or provided an factual production flow chart for their products.

Reading through the concerns of industry, food safety, and bio-defense experts can lead to outright alarm. Every book on the subject (a few are shown in the header photo) warns of impending emergencies caused by synthetic biology. Almost every book states that strong industry self-regulation is the answer, but there is a constant call for a “global regulatory framework” as well.

Note: A look at the Ginkgo Bioworks risk factor disclosures provides a quick understanding of the dangers involved and why regulation of any kind is unlikely to do much good. A thumbnail summary of the risks is “we can’t control what this technology does, so you have been warned.”

 Here is the first claims in the definition.

1. “Precision fermentation technology, also known as GMO 2.0 technology, is a form of synthetic biology that has been around for a few decades, and more recently has been tapped to produce consumables.

2. The technology, which is rapidly entering the mainstream, uses genetic modification to alter bacteria, yeast, algae, or plants, which are then fed water, nutrients, sugar and cultivated in brewery-style fermentation tanks.

The artificial environments used in this technology may consist of metal vats containing as much as 100,000 liters or more of highly processed sugars, proteins, antibiotics, hormones, viruses, fungi, antimicrobials, and other substances formulated and infused to promote the expected cellular expression by the target organisms while mitigating the growth of non-target organisms such as mold, pathogens, toxins, or unwanted metabolites.

There are often multiple mutation and fermentation processes used to alter the genetic expression and behavior of target organisms prior to their use in the final fermentation or cloning step.

After the fermentation processes are complete, the resulting sludge must be separated into wanted and unwanted components. This is accomplished with washing, centrifugal separation, settling, and filtration. Not all unwanted components are removed during this processing, which results in unknown molecular adulteration and contamination of the synthetic ingredient used in the finished product. Some entourage components are sterilized to kill living modified organisms that may survive processing. Sterilization does not, however, destroy genetic material like antibiotic resistant coding or growth promotion coding, which can later transfer horizontally to other living organisms through consumption or waste effluent.

3. These microorganisms produce edible fats or proteins, which are biologically similar to plant or animal products.

Under the federal government’s regulatory doctrine of GMO equivalency, these foods made with or derived from GMO plants are considered the same as natural versions and thus not subject to safety review. However, this is a legal doctrine of belief, which is different from a truth established and vetted by repeatable scientific analysis. The safety statements submitted to the USDA by some synthetic biology companies have relied on this loophole, stating that the molecular similarity between their novel molecule synthesized via, say, a gene-edited pathogenic microorganism, is similar enough to a naturally occurring molecule that no safety concerns are warranted.

Of course, consumer scrutiny depends on full on-pack disclosure of these risks, including unknown risks, in plain language.

The use of the equivalency loop-hole and the lack of analysis of the full formulation of these products should trigger caution much greater oversight by regulators and precaution by consumers.

Moreover, the petrochemical-intensive supply chain used to produce the materials needed to make consumables using synthetic biology, and the risk of release of potentially dangerous organisms and substances in the ferments, and the bio-toxicity of the resulting waste stream are neither addressed by any US government regulations nor included in the risk assessments of these products.

4. Common applications of this technology have included the production of human insulin for treating diabetes, creating enzymes for food production, manufacturing vitamins and supplements, as well as rennet for cheese production.

The product most widely produced by this process is human insulin. Prior to fermentation, insulin was extracted from pig carcasses. Fermentation made it possible to standardize insulin manufacturing and lower the cost significantly until US pharmaceutical companies were allowed to monopolize the process and raise prices to over ten times what other countries pay.

Using genetically manipulated pig stem cells to clone pork protein only replaces pork. However, properly raised pigs serve important positive ecological services, so growing GMO sugars to create fake pork is counterproductive to environmental goals, including control of climate change. In fact, the conversion of GMO sugars into protein via fermentation is notoriously inefficient, beginning with the conversion of petrochemicals to synthetic nitrogen and toxic fertilizers for GMO crops and ending with biohazard waste from contaminated leftover steep.

5. More recently, the technology has been used to create nutrients, food additives and ingredients for CPG products (i.e., milk protein, honey, collagen, egg whites, etc.

More recently, the technology has been used to create nutrients, food additives and ingredients for CPG products (i.e., milk protein, honey, collagen, egg whites, etc., mostly at very small scale and at very high cost.

Drug oversight.

Bad logic. We are dong so it’s ok to do.

Most of these materials have yet to receive approval from government safety agencies anywhere in the world, and are thus, as a public health precaution, withheld from sale to the public. In fact, limited the uncertainty of regulatory approvals is one of the key risk factors in materials provided to investors and potential investors by synthetic biology companies.

Global public health authorities are still untangling the slew of safety issues created by synthetic materials first fabricated in the mid-1900s. Hydrogenated “trans” fats, artificial sweeteners, highly refined sugar, synthetic colors, preservatives, stabilizers and other miracle ingredients cause slow but unrelenting incremental damage to human health, in spite of reassurances by corporate scientists and paid advocates that their safety was assured. The recent discovery of the importance of the human gut microbiome, including its critical role in immune response and its production and/or suppression of metabolites that support health, has reemphasized that the contamination of consumables with novel and toxic substances often results in poor outcomes.

6. The FDA does not require these foods to be labeled as GMO because they do not contain genetically engineered organisms; they only contain the edible fats or proteins produced by those organisms

Note that the FDA is primarily the arbiter of *drug* safety, which informs the agency’s lax assessment of food ingredients. For drugs, the severe risks, including death, inherent in the use of many pharmaceuticals is weighed against the potential treatment of disease or mitigation of disease symptoms. However, economic benefit is also taken into account, since the expensive investment in drug development and marketing must be repaid. Efficacy and return-on-investment are offset against adverse events, inefficacy, and death that may ensue.

The FDA has applied the drug risk assessment model to food, so it now acknowledges the economic benefit of allowing the use harmful artificial substances (such as trans fats and synthetic sweeteners) in food formulation, and uses that calculus to justify potential negative health consequences. The novel, unknown, and untested entourage materials that result from successive precision feeding of gene-edited organisms in GMO 2.0 synthetic biology technologies are not recognized by or considered in any government regulation of the resulting foods containing them. It’s just a very expensive highly processed food.

Novel synthetic food ingredients are not reviewed by competent government authorities for identity, safety, or adulteration. Instead, the marketers are allowed to compile their own dossier of studies of related materials that may minimize the significance of risks and thus undermine precautions that would normally be required. Safety monographs prepared by patent holders also typically analyze the safety of the individual target molecules rather than all of the constituents in the final product. In Monsanto’s original safety analysis of RoundUp herbicide, for instance, only the isolated glyphosate molecule was selected for study. The human, animal and environmental safety of the caustic adjuvants and arsenic in the full formulation were not assessed. Subsequent independent studies identified the presence of these materials in RoundUp and determined the dangers associated with them.

Given the high likelihood of novel materials in these products, and the difficulty of removing them from final formulations, consumables made with these novel synthetic materials should undergo significantly higher level of scrutiny prior to being sold into the market.

7 .”Having said that, such products would not qualify for Non-GMO Project Verification.”

The Non-GMO Project will not verify products made using new gene modification methods regardless of the lack of detectable GMO content in the finished product. As a reminder, GMO ingredients are not allowed under the Non-GMO Project standard, so fermentation or gene-edited organisms using steeps derived from GMO corn, beets, cane, soy or other GMO crops are doubly nonconforming.

The USDA National Organic Program also does not allow the use of GMO methods. However, the certification protocols are not specific enough to verify the entire supply chain for a particular product. The Program undertakes periodic surveillance testing for know GMO ingredients, seeds, and inputs, but this results in almost no enforcement activity.

If the presence of genetically modified material can be proven through laboratory analysis, which is highly *likely* using recent developments in Full Spectrum Molecular Analysis technology, these ingredients and the products containing them may have to be labeled ‘Bioengineered” under the rules of the US National Bioengineered Food Disclosure Act.

Animal cell replication, which depends on changing the genetic expression of organisms through exposure to radiation, antibiotics, gene editing, and other artificial stressors, is in a gray area that marketers of synthetic proteins are taking advantage of. The US GMO label disclosure regulations exempt from labeling products derived from whole animals whose genes have been modified artificially, but the use of mutated animal cell lines is not specifically addressed. The USDA has never used the precautionary principle in these matters, so we should assume they will continue to take a hands-off approach to regulation.

Note that a key tool used to scale up cellular clone production to improve profitability is to circumvent growth regulation factors within the genome of animal cell lines. Similar to cancer tumors, cells thus modified can replicate without limit until the nutritive feed available to the cells is depleted. It has not been established if this genetic characteristic is present in the finished protein product, or if the genetic coding can be prevented from transferring horizontally to other organisms in the environment, food supply, or gut microbiome.