​​When it comes to safeguarding the public from nanotoxicity, 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

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

1. Preliminary results for salt aerosol production intended for marine cloud brightening, using effervescent spray atomization​

2. ​Experts and professionals in the field of aerosol generation and particle detection. TSI Incorporated​

3. “We had at our disposal at this point two particle size measurement instruments: a NOAA Printed Optical Particle Spectrometer (POPS; Gao et al. 2016)—a laser scattering instrument on loan from Harvard—and a TSI model 3080 Scanning Mobility Particle Sizer (SMPS) that was equipped with a TSI model 3081 Differential Mobility Analyzer (DMA) and a TSI model 3010 Condensation Particle Counter (CPC). As configured, the SMPS covers a particle size range of 0.014–0.735 μm, whereas the POPS covers a range of 0.14–3 μm." Methods for Dispersal of Precipitated Calcium Carbonate for Stratospheric Aerosol Injection​

4. This project used a P-Trak nanoparticle counter which is a device that counts nanoparticles all the way down to 2nm. “…nanoparticles can reach, and wreak havoc in, any organ in the body. And because government authorities monitor PM2.5 by mass (millions of nanoparticles may not even register a measurement by microgram) – their reports underrepresent the true risks.” The toxic killers in our air too small to see​

5. The Three Types of Particulate Matter: All About PM10, PM2.5, and PM0.1

6. ​“PMo.1 is not measured routinely in the United States. The US EPA has recognized that additional monitoring of PMo1 is needed to explore the consideration of a separate regulation for this particle size fraction (US EPA 2010).” Ultrafine Particulate Matter Study Briefing​

7. EPA- State of the art ambient ultrafine particle monitoring:the blind spot of current  methods

8. ​EPA- Particle Pollution Exposure

9. ​Predicted ultrafine particulate matter source contribution across the continental United States during summertime air pollution events​

10. "Exposures to nanoparticles (particles with diameters smaller than 100 nm) have been linked to a number of adverse respiratory and cardiovascular health effects. Once thought to be rare, the formation of nanoparticles by homogeneous nucleation of the products of atmospheric photochemical reactions has now been observed in both pristine remote locations, and in polluted urban environments. The key to this growing understanding of these small particle is instrumentation that enables rapid measurement of particle size distributions in the low nanometer size range using the scanning electrical mobility spectrometer (also known as the scanning mobility particle size, SMPS). Originally limited to particles larger than about 10 nm, recent advances have enabled measurements down to 1 nm diameter, and made possible measurements of incipient particles. Using these tools, we are probing the formation of particles in atmospheric reactions, and examining the role of atmospheric ions in the nucleation process.“ Airborne Nanoparticles

​The National Nanotechnology Initiative, who happens to fund nanotechnology research for the EPA, goes into detail on nanoparticle detection methods in the webinar below:
Nanometrology for Food, Agriculture, and the Environment webinar (2024) (video)​​

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The EPA claims they’re moving toward a regulatory approach on nanoparticles with rules aimed at collecting information on nanoscale materials. Companies manufacturing, processing, or importing nanoparticles are to provide the EPA with information such as exposure information along with information on health and safety. 

Control of Nanoscale Materials under the Toxic Substances Control Act (EPA 2024)

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How much information the EPA collects from companies is questionable, considering an earlier statement from the EPA’s Office of Inspector General: “…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.”

 

The EPA is obviously well aware of the dangers of nanoparticles.

"EPA research on how people and the environment are exposed to nanomaterials, as well as their toxicity, has resulted in more than 500 peer reviewed publications." 

• Advancing Environmental Safety: Celebrating 20 years of Nanotechnology Research at EPA

• Development of New Health Risk Assessment of Nanoparticles: EPA Health Risk Assessment Revised (2023)

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

• “The FDA does not have a legal definition for nanotechnology.” Quote from this FDA document

• Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology

• Guidance for Industry- Safety of Nanomaterials in Cosmetic Products

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Despite the FDA having no established regulatory definitions of “nanotechnology,” “nanomaterial,” “nanoscale” or other related terms, and has no legal definition for nanotechnology, they continue to approve long lists of nanotechnology-based products.

 

“After reviewing the uncertainties associated with the safety of engineered nanomaterials, FDA has decided that it does not need additional authority to regulate products containing such materials. Rather, FDA encourages, but does not require, companies considering using engineered nanomaterials in food to consult with the agency regarding whether such substances might be GRAS [Generally Recognized as Safe]. Because GRAS notification is voluntary and companies are not required to identify nanomaterials in their GRAS substances, FDA has no way of knowing the full extent to which engineered nanomaterials have entered the U.S. food supply as part of GRAS substances…FDA's approach to regulating nanotechnology allows engineered nanomaterials to enter the food supply as GRAS substances without FDA's knowledge.”

Food Safety: FDA Should Strengthen Its Oversight of Food Ingredients Determined to Be Generally Recognized as Safe (GRAS)

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The government agency who produced the above document, the U.S. Government Accountability Office, seemingly attempts to defend the FDA by shifting blame to the food manufacturers and claiming the “FDA's approach to regulating nanotechnology allows engineered nanomaterials to enter the food supply as GRAS substances without FDA's knowledge." Considering it’s the very same FDA approving those nanomaterials in the first place, it would be very hard to believe the FDA has no knowledge, as claimed by the GAO. 

 

Amidst the excuses, ineptitudes and obfuscation, the National Nanotechnology Initiative (NNI) continually funds the nanotechnology research of both the FDA and EPA.

“The NNI's annual budget supplements provide supplemental information to the President’s annual budget. They also serve as the annual report on the NNI called for in the 21st Century Nanotechnology Research and Development Act. The reports summarize NNI programmatic activities for the two previous fiscal years, as well as the address plans for the upcoming fiscal year.”

NNI Budget Supplements

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"The FDA has already reviewed and approved some nanotechnology-based products, and expects a significant increase in the use of nanoscale materials in drugs, devices, biologics, cosmetics, and food."

Nanotechnology Research at NCTR

 

Nanotechnology Products Database

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Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology: Guidance for Industry (2014)

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FDA issued guidance documents on the application of nanotechnology in FDA-regulated products

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Drug Products, Including Biological Products, that Contain Nanomaterials - Guidance for Industry (2022)

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Both EPA and FDA are members of the NNI. All three of these organizations sidestep addressing nanoparticles. The NNI seems to focus 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

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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

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

(CDC) Nanotoxicology Program

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"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:

• National Library of Medicine - titanium dioxide nanotoxicity: 133 results

• Titanium dioxide nanoparticle epidemiology: 44 results

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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

 

The FDA lists titanium dioxide as exempt from certification. 

FDA: Code of Federal Regulations Title 21

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Why the FDA is allowing nanoparticles such as this should concern anyone paying attention. Here is an in-depth look at the toxicity of titanium dioxide:

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Titanium dioxide nanoparticles (TiO2 NPs) are the most commonly produced and ingested nanomaterial. They are used in food additives, cosmetics, personal care products, and many other products 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

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“Titanium Dioxide may be a CARCINOGEN in humans. There may be no safe level of exposure to a carcinogen, so all contact should be reduced to the lowest possible level.”

Titanium Dioxide - Hazardous Substance Fact Sheet

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"in vivo after oral exposure, TiO2 nanoparticles induce DNA strand breaks and chromosomal damage in bone marrow and/or peripheral blood, which may help to further understand potential mechanisms of TiO2 nanoparticles carcinogenicity."

Titanium Dioxide Nanoparticles Induce DNA Damage and Genetic Instability In vivo in Mice

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"…it has been shown that TiO2 NPs can cause DNA damage, oxidative stress, and cell apoptosis in intestinal epithelial cells, potentially compromising the gut barrier and causing gut-associated systemic effects"

Adverse effects of titanium dioxide nanoparticles on beneficial gut bacteria and host health based on untargeted metabolomics analysis

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"In spite of compliance with TiO2 Occupational Exposure Limits, results showed increased direct/oxidative DNA damage and micronuclei frequency in exposed workers. Genotoxicity parameters were associated with oxidative stress/inflammation biomarkers in urine and EBC, thus confirming that TiO2 exposure can affect the oxidative balance."

DNA damage in workers exposed to pigment grade titanium dioxide (TiO2) and association with biomarkers of oxidative stress and inflammation

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More on the toxicity of titanium dioxide:

• Influence of Titanium Dioxide Nanoparticles on Human Health and the Environment

• Oral intake of titanium dioxide nanoparticles affect the course and prognosis of ulcerative colitis in mice: involvement of the ROS-TXNIP-NLRP3 inflammasome pathway

• Titanium dioxide nanoparticles exacerbate DSS-induced colitis: role of the NLRP3 inflammasome

• The Effect of Ingested Titanium Dioxide Nanoparticles on the Course and Prognosis of Ulcerative Colitis in Mice

• Titanium dioxide particles from the diet: involvement in the genesis of inflammatory bowel diseases and colorectal cancer

• "Titanium dioxide (TiO2) nanoparticles are widely used as food additives, but dietary exposure to TiO2 exacerbates dextran sulfate sodium (DSS) colitis and colon tumor formation."
  Nickel particles are present in Crohn's disease tissue and exacerbate intestinal inflammation in IBD susceptible mice

• Food-grade TiO2 impairs intestinal and systemic immune homeostasis, initiates preneoplastic lesions and promotes aberrant crypt development in the rat colon

• Ultrafine titanium dioxide particles in the absence of photoactivation can induce oxidative damage to human bronchial epithelial cells

• Maternal exposure to nanoparticulate titanium dioxide during the prenatal period alters gene expression related to brain development in the mouse

• ​Titanium dioxide Nanoparticles an Oxidative Stress Inducer: A Review on noxious corollary

• Titanium dioxide nanoparticle-based hydroxyl and superoxide radical production for oxidative stress biological simulations

• Crystal phase-dependent generation of mobile OH radicals on TiO2: Revisiting the photocatalytic oxidation mechanism of anatase and rutile

• Estimation of TiO2nanoparticle-induced genotoxicity persistence and possible chronic gastritis-induction in mice

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Silicon dioxide:

“Silicon dioxide nanoparticles (SiO2NPs) are widely used as additive in the food industry with controversial health risk.”

Journal of Nanobiotechnology: Silicon dioxide nanoparticles induced neurobehavioral impairments by disrupting microbiota–gut–brain axis

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“Some in vivo and in vitro studies have shown that SiO2 NPs can cause toxicity to different organs in the human body; toxicity has been demonstrated in lung epithelial cells, liver cells, intestinal cells, the lungs, and kidneys. In addition, SiO2 NPs were found to induce genotoxicity and alterations in gene and protein expression [and can] induce cornea toxicity.”

Journal of Nanobiotechnology: Mechanistic study of silica nanoparticles on the size-dependent retinal toxicity in vitro and in vivo

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A toxicological profile of silica nanoparticles 

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Toxicity of silicon dioxide nanoparticles with varying sizes on the cornea and protein corona as a strategy for therapy

 

The Toxicity of Silica Nanoparticles to the Immune System

 

Astrocytes Are More Vulnerable than Neurons to Silicon 

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Toxicity of nanoparticles

“Nanotoxicity has become the topic of great concern in nanoscience and nanotechnology because of the increasing toxic effects of nanomaterials on living organisms.”

Nanotoxicity: The Dark Side of Nanoformulations

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"…human exposure to nanoparticles is inevitable"
Nanoparticle Toxicology

 

"There’s been a boom in products containing nanoparticles—bits of materials around 100 nanometers or less in diameter. On such small scales, familiar elements and compounds take on novel, often quite useful properties. But it’s unknown how many of these nanoparticles are leaking into the environment, or what harm they might do there; for instance, a few studies have shown that silver nanoparticles, used for their antibacterial qualities, can damage liver and brain cells. Regulations currently treat nano and bulk versions of materials exactly the same.”

• DNA Damage and Nanoparticles​

• OSHA: “Workers who use nanotechnology in research or production processes may be exposed to nanomaterials through inhalation, skin contact, or ingestion."
  OSHA Fact Sheet: Working Safely with Nanomaterials​

• Nanoparticles in Daily Life: Applications, Toxicity and Regulations

• Toxicity of Low-dose Graphene Oxide Nanoparticles in an in-vivo Wild Type of Caenorhabditis elegans Model

• Impact of Nanoparticles on Brain Health: An Up to Date Overview

• Nanoparticles and female reproductive system: how do nanoparticles affect oogenesis and embryonic development

• “Die hard: cell death mechanisms and their implications in nanotoxicology”

• Nanotoxicity and Nanoecotoxicity: Introduction, Principles, and Concepts (article)

• Nanotoxicology in Safety Assessment of Nanomaterials, 1st ed. 2022 (book purchase link)

• Nanotoxicology - Toxicity Evaluation of Nanomedicine Applications (book purchase link)

• Nanotoxicology and Nanoecotoxicology Vol. 2 (book purchase link)

• Toxicity of Novel Nanosized Formulations Used in Medicine

• Nanotoxicology - Characterization, Dosing and Health Effects (book purchase link)

• Relative potency factor approach enables the use of in vitro information for estimation of human effect factors for nanoparticle toxicity in life-cycle impact assessment

• Nanotoxicology and Nanosafety: Safety-by-Design and Testing at a Glance

• Lecture: Introduction to Nanotoxicology (video)

• Impact of electromagnetic fields on in vitro toxicity of silver and graphene nanoparticles

• Nallathamby Laboratory - Modular and scalable nanotechnology for imaging, sensing and therapeutics: Nanotoxicology

• In Vivo Quantitative Study of Sized-Dependent Transport and Toxicity of Single Silver Nanoparticles Using Zebrafish Embryos

• Study of Charge-Dependent Transport and Toxicity of Peptide-Functionalized Silver Nanoparticles Using Zebrafish Embryos and Single Nanoparticle Plasmonic Spectroscopy

• Food-Grade Metal Oxide Nanoparticles Exposure Alters Intestinal Microbial Populations, Brush Border Membrane Functionality and Morphology, In Vivo

• Ultrasmall iron oxide nanoparticles cause significant toxicity by specifically inducing acute oxidative stress to multiple organs

• Engineered nanomaterials and human health: Part 1. Preparation, functionalization and characterization (IUPAC Technical Report)

• Engineered nanomaterials and human health: Part 2. Applications and nanotoxicology (IUPAC Technical Report)

 

Microplastics:

“‘Microplastic’ is a term for plastic particles for which no universally established definition exists. In the literature, microplastic is often defined as plastic particles up to 5 mm in dimensions with no defined lower size limit. ‘Nanoplastic’ is a term for plastic particles in the submicron range, <1 μm. In the nanotechnology field, ‘nanoplastic’ may refer to engineered particles <100 nm, i.e. the nanotechnology application size limit. To circumvent the ambiguity of the terms microplastic and nanoplastic particles in this article we will refer to ‘plastic particles’ and where appropriate define the size or size range. Our study was concerned with plastic particles that can be absorbed across membranes in the human body. Our operationally defined method targeted particles that could be retained on a filter with pore size of 700 nm, i.e. particles ≥700 nm in dimension.“

Discovery and quantification of plastic particle pollution in human blood

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Microplastics found in human bloodstream

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"A second study…on the presence of micro and nanoplastics in human blood confirms the team’s previous findings.”

Micro and nanoplastics in human blood detected again

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Quantitation of micro and nanoplastics in human blood by pyrolysis-gas chromatography–mass spectrometry

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“Over the last several decades, pregnant women and children globally have been exposed to an extraordinary diversity of plastics. We believe that children are unique in terms of their exposures and vulnerabilities to NMPs. Yet foundational evidence on children’s exposure to NMPs, as well as child-specific toxicology, is sorely lacking. Our assessment of the fragmented (but growing) evidence base around early life exposures to NMPs provides cause for concern.”

A Children’s Health Perspective on Nano- and Microplastics

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Nanotoxicity is a subject studied by the U.S. Environmental Protection Agency (EPA) and major universities around the world, including nanotoxicites of airborne nanomatierials.