Smart Cities & Biodigital Convergence

Toxicity of Nanoparticles

Dennis Bushnell, former Chief Scientist NASA Langley Research Center: “98% of all of the studies I’ve seen say that nanoparticles are BAD for human physiology.”(2018 Fireside Conference)

When it comes to safeguarding the public from nanotoxicity through surveying, monitoring, regulating, or even defining nanoparticles, the EPA, FDA, CDC, NNI, U.S. Federal Government, and EU all fail.

The EPA's own Inspector General: "EPA Lacks Regulation of Nanomaterials.”

According to a report from the EPA’s Office of Inspector General:

"We found that EPA does not currently have sufficient information or processes to effectively manage the human health and environmental risks of nanomaterials."

"The Environmental Protection Agency doesn’t have the data or ability to manage the challenges associated with nanomaterials.”

Office of Inspector General:

Report: EPA Needs to Manage Nanomaterial Risks More Effectively

Why is the EPA not managing or monitoring nanoparticles?

The EPA claims it has inadequate technology to detect nanoparticles in the air, despite the technology being readily available. This document clearly shows how easily nanoparticles in aerosol can be analyzed, counted and monitored using various particle sizing instruments.

“Preliminary results for salt aerosol production intended for marine cloud brightening, using effervescent spray atomization”

One example of the available technology:

“Experts and professionals in the field of aerosol generation and particle detection. TSI Incorporated”

Another reason the EPA gives for not managing or monitoring nanoparticles: “…most companies are unwilling to share information. As much as 90 percent of industry data was labeled as confidential and therefore not accessible to the agency”, according to the report from the EPA’s Office of Inspector General.

The FDA has no legal definition for nanotechnology. Nor has the FDA established regulatory definitions of “nanotechnology,” “nanomaterial,” “nanoscale” or other related terms.

Since the FDA has not established regulatory definitions of “nanotechnology,” “nanomaterial,” “nanoscale” or other related terms, and has no legal definition for nanotechnology, there is no regulation by the FDA of nanoparticles in the food, drug, and cosmetic sectors. Despite this, there is a long list of FDA certified products containing nanomaterials: Nanotechnology Products Database.

The FDA is a member agency of the National Nanotechnology Initiative (NNI), a regulatory organization. NNI also seems to sidestep addressing nanoparticles, given their focus seems to be only on nanoparticles in the 1-100 nm range, ignoring the 101-1,000 nm range. Plenty of government and private laboratory documents list nanoparticles that fall in the 1-1,000 nm range. NNI defines nanotechnology: “Nanotechnology is the understanding and control of matter at the nanoscale, at dimensions between approximately 1 and 100 nanometers, where unique phenomena enable novel applications."

NNI: About Nanotechnology

Nanoparticles do not just exist in the 1-100 nm range. In fact, most of the engineered nanomaterials in foods fall within 101-1,000 nm. For example, the most commonly ingested nanoparticle titanium dioxide (TiO2) range in size from 200-300 nm.

Critical Review of Public Health Regulations of Titanium Dioxide, a Human Food Additive

According to the Centers for Disease Control (CDC), the keeper of epidemiological data, “epidemiological data for TiO2 NPs is still missing.”

(CDC) Nanotoxicology Program

"Epidemiology is the study and analysis of the distribution, patterns and determinants of health and disease conditions in a defined population. It is a cornerstone of public health, and shapes policy decisions and evidence-based practice by identifying risk factors for disease and targets for preventive healthcare."

-Wikipedia

“The Federal Government is saying its own information on titanium dioxide toxicity is still missing, meanwhile, that data can be found on/in PubMed/National Center for Biotechnology Information's website. This makes the US Federal Government not wrong, but a flat out liar. The plausible deniability is in lack of inter-agency communication, in-turn, lack of informing the general public. Posting information on the internet isn't exactly informing the public, when the general public doesn't use the internet for educational purposes, but for entertainment. Nor does the general public care to be informed on such matters - even with evidence in hand.”

-Pete Ramón

The aforementioned evidence in hand:

European Union (EU) Commission and the Federal Office of Public Health in Switzerland’s definition of the nanoscale is limiting, to say the least. The definition of a nanomaterial according to the Swiss Chemicals and Plant Protection Products Ordinance mostly falls within the 1-100 nm range, as well.

“Definition according to the Swiss Chemicals and Plant Protection Products Ordinance”

The very complex analysis of nanoparticles involves definitions, regulations, and standards. The physical and chemical properties of nanoparticles can vary widely. Only a small handful of laboratories offer the specialized instruments and methods that are required.

Swiss NanoAnalytics, for example, provides nanomaterial analysis for manufacturers and research institutes. This includes nanomaterial characterization, analysis of nanomaterials in foods and commercial products, as well as testing of nanomaterial stability in biological fluids such as blood serum.

The Swiss NanoAnalytics platform within the Adolphe Merkle Institute's BioNanomaterials group

(H/T Pete Ramón for uncovering the above)

Meanwhile, nanoparticles such as this remain unaccounted for:

Titanium dioxide nanoparticles (TiO2 NPs) are the most commonly produced and ingested nanomaterial. They are used in food additives, cosmetics, and personal care products, and many things at the commercial level. Such widespread usage has a major toxicological impact on humans. Many studies show TiO2 NPs accumulate after being exposed orally or inhaling them. Accumulation is found in the heart, lungs, liver, kidneys, spleen, cardiac muscle, and alimentary canal. They also cause cell damage, inflammation, genotoxicity, adverse immune responses, DNA strand breaks and chromosomal damages.

“Toxicological Consequences of Titanium Dioxide Nanoparticles (TiO2NPs) and Their Jeopardy to Human Population” (2021)