The European Union (EU) Observatory for Nanomaterials (EUON) announced on June 17, 2022, that it is looking for topics that could be addressed in its upcoming studies. EUON conducts up to three studies annually to address knowledge gaps on nanomaterials. EUON is looking for study topics that address:

  • Questions related to the health and safety aspects of nanomaterials, including hazard and risk assessment, exposure to nanomaterials, or worker safety and protection;
  • Specific issues surrounding the uses of nanomaterials; or
  • Information about markets for nanomaterials (g., the market for specific materials such as graphene or specific market sectors).

EUON states that the scope of the study can be on nanomaterials in general, a specific nanomaterial, or a defined group of nanomaterials. Studies are run for three to nine months and according to EUON should be based on desk research and surveys (should not require laboratory research). Proposals are due July 18, 2022. The EUON team will assess all proposals. The selected proposals will be carried out through EUON’s existing procurement channels. EUON will make the outcome and study reports publicly available on its website.

On June 17, 2022, Canada published its draft Framework for the Risk Assessment of Manufactured Nanomaterials under the Canadian Environmental Protection Act, 1999 (CEPA) for a 60-day public comment period. The plain language summary states that the framework describes how scientists at Environment and Climate Change Canada (ECCC) and Health Canada (HC) conduct risk assessments on nanomaterials. The draft risk assessment framework outlines approaches and considerations for informing the risk assessment of nanomaterials under CEPA, including both existing nanomaterials on the Domestic Substances List (DSL) and new nanomaterials notified under the New Substances Notification Regulations (Chemicals and Polymers). A substance is assessed as a nanomaterial if it meets the criteria described in HC’s working definition for nanomaterial and particle size distribution threshold (number or mass-based), as stated in both the draft framework and the New Guidance Document for the notification and testing of new substances: chemicals and polymers. Comments are due August 16, 2022.

The framework discusses in detail the nanomaterial-specific considerations for risk assessment, including:

  • The key physical and chemical properties specific for nanomaterial identification and used for grouping or classifying nanomaterials for information gathering;
  • The data considerations used in a nanomaterial risk assessment, such as test data or modeling; and
  • The behavior of nanomaterials throughout the life cycle of the nanomaterial (from production to disposal) and characterizing those potential effects on human health and the environment.

The framework also details the ecological and human health risk characterization of nanomaterials:

  • Ecological risk characterization approach for nanomaterials: The ecological risk characterization of nanomaterials considers relevant ecological processes that may affect the potential exposure and hazardous effects of nanomaterials. This includes investigating how nanomaterials are transported in the environment and their environmental fate. In addition, ECCC scientists investigate how biotic and abiotic components can influence the bioavailability, persistence, or toxicity of a nanomaterial; and
  • Human health risk characterization approach for nanomaterials: Human health risks of nanomaterials are characterized based on nanomaterial-specific hazards and exposures for relevant routes of exposure. Characterization of the risks to Canadians are based on, but not limited to, use of products available to consumers and exposure via food, drinking water, and environmental media. Special consideration is given to the potential risks to vulnerable populations (for example, children, pregnant women).

The draft framework states that the conclusions reached through the assessment process for nanomaterials under CEPA may differ between the traditional chemical form of a substance and the nanomaterial form of the same substance and may differ among different nanoscale forms of the same substance. ECCC and HC scientists use a weight-of-evidence approach to combine the multiple lines of evidence and their uncertainties to conclude if a nanomaterial reaches the environment in a quantity or concentration or under conditions that meet any of the criteria for toxicity as set out under CEPA.

The National Nanotechnology Initiative (NNI) will hold a public webinar on June 28, 2022, on “Nanotechnology Commercialization: Perspectives from a Regional Innovation Ecosystem.” Participants will hear from members “of a vibrant nanotechnology innovation ecosystem anchored by the Mid-Atlantic Nanotechnology Hub at the Singh Center for Nanotechnology (part of the National Nanotechnology Coordinated Infrastructure).” The speakers will share their perspectives on topics such as nanotechnology research and development (R&D), the technology development pathway, partnerships, funding, and the importance of resources, such as the federally funded user facilities around the country. NNI notes that the webinar supports Goal 2 of the NNI 2021 Strategic Plan to promote nanotechnology commercialization and aims to engage with and enhance connections among regional innovation ecosystems to support nanotechnology commercialization. The panel, moderated by Lisa E. Friedersdorf, Ph.D., Director, National Nanotechnology Coordination Office (NNCO), includes:

  • Anthony P. Green, Ph.D., Chief Scientific Officer, Ben Franklin Technology Partners of Southeastern Pennsylvania;
  • Gerald Lopez, Ph.D., Director, Business Development, Singh Center for Nanotechnology, University of Pennsylvania; and
  • Brendan DeLacy, Ph.D., President and Founder, Ballydel Technologies.

Registration is now open.

The European Union (EU) Observatory for Nanomaterials (EUON) announced on June 10, 2022, that NanoData has been updated with “a new look and feel to improve the user experience.” NanoData is the knowledge base on nanosciences and -technology hosted by EUON. It contains data on different products, research projects, publications, patents, and organizations. According to EUON, users can now visualize statistics through built-in charts and graphs. The data can be easily filtered by different sectors and geographic locations. EUON states that users will be able to benefit from a bulk download feature “at a later date.” To bring users the latest nano-news in one place, EUON has also merged the news sections from the EUON website and NanoData into a new tab on the EUON website. Users can access daily a selection of news about nanomaterials from around the web. Later in 2022, EUON will refresh NanoData “with more and up-to-date information.”

On June 10, 2022, the European Commission (EC) announced that it is clarifying the definition of nanomaterials in a new Recommendation that supports a coherent European Union (EU) regulatory framework for nanomaterials, helping to align legislation across all sectors. The EC states that the new definition should be used in EU and national legislation, policy, and research programs. The Recommendation states:

‘Nanomaterial’ means a natural, incidental or manufactured material consisting of solid particles that are present, either on their own or as identifiable constituent particles in aggregates or agglomerates, and where 50% or more of these particles in the number-based size distribution fulfil at least one of the following conditions:

  1. one or more external dimensions of the particle are in the size range 1 nm to 100 nm;
  2. the particle has an elongated shape, such as a rod, fibre or tube, where two external dimensions are smaller than 1 nm and the other dimension is larger than 100 nm;
  3. the particle has a plate-like shape, where one external dimension is smaller than 1 nm and the other dimensions are larger than 100 nm.

In the determination of the particle number-based size distribution, particles with at least two orthogonal external dimensions larger than 100 μm need not be considered.

However, a material with a specific surface area by volume of < 6 m2/cm3 shall not be considered a nanomaterial.

 
The new definition replaces the definition published in 2011. According to the EC, it developed the revisions following a comprehensive review, and the revisions “should allow easier and more efficient implementation, but will not significantly affect the scope of identified nanomaterials.”

On May 31, 2022, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion entitled “Urinary MicroRNA-based Early Cancer Detection Using Nanowire-based Devices” by Dr. Yasui Takao on using nanowire devices to extract microRNAs (miRNA) from urine to distinguish cancer patients from healthy individuals and improve the early detection of cancer. According to Yasui, researchers designed a device equipped with 100 million zinc oxide nanowires that can extract a significantly greater variety and quantity of miRNAs from only a milliliter of urine compared to conventional methods. Using the device, they revealed that miRNAs in urine could be a promising biomarker to diagnose brain tumors, finding that many miRNAs derived from brain tumors exist in urine in a stable condition. Yasui states that the results showed that the model can distinguish the patients from non-cancer individuals at a sensitivity of 100 percent and a specificity of 97 percent, regardless of the malignancy and size of tumors.

The U.S. Environmental Protection Agency (EPA) filed a complaint with the Environmental Appeals Board on March 15, 2022, pursuant to Section 16(a) of the Toxic Substances Control Act (TSCA). According to the complaint, as the result of an EPA inspection of the Vorbeck Materials facility on June 20, 2019, and its follow-up actions, EPA alleges that Vorbeck has violated TSCA Section 12(b) and the Notice of Export rule requirements at 40 C.F.R. Part 707, Subpart D, thereby violating TSCA Section 15(3)(B). EPA notes that TSCA Section 12(b), and the regulations set forth at 40 C.F.R. Section 707.60, require any person who exports or intends to export a chemical substance or mixture for which a rule has been proposed or promulgated under TSCA Sections 5 or 6 to notify EPA of such exportation to a particular country. According to EPA, Vorbeck exported a carbon nanomaterial substance that is subject to a TSCA Section 5(e) consent order on one occasion to one country without prior notification to EPA as required by TSCA Section 12(b) and 40 C.F.R. Section 707.60, and as specified in 40 C.F.R. Sections 707.65 and 707.67. The complaint states that Vorbeck has claimed the identity of the carbon nanomaterial as TSCA confidential business information (CBI). Vorbeck has subsequently submitted a TSCA Section 12(b) export notification for the carbon nanomaterial.

Based upon the facts alleged in the complaint, and upon the nature, circumstances, extent, and gravity of the violations alleged, as well as Vorbeck’s ability to pay, effect on ability to continue to do business, any history of prior such violations of TSCA, the degree of culpability, and such other matters as justice may require, EPA proposed a penalty of $8,277 for the alleged violations. According to the April 19, 2022, final order of the Environmental Appeals Board, EPA received full payment of the penalty ($8,277), and the case is resolved.

The International Organization for Standardization (ISO) recently published ISO/TR 23463:2022, “Nanotechnologies — Characterization of carbon nanotube and carbon nanofibre aerosols to be used in inhalation toxicity tests.” The standard reviews characterization of carbon nanotube (CNT) and carbon nanofiber (CNF) aerosols for inhalation exposure studies. According to the standard, the framework for material characterization for inhalation studies consists of:

  • Characterization of as-produced (pristine) or supplied material;
  • Characterization of administered material;
  • Characterization of material following administration; and
  • Human exposure characterization.

The standard focuses on the first two characterization needs, which include physicochemical properties (e.g., size, size distribution, aggregation/agglomeration, and shape) and measurement of concentration (e.g., mass, number, surface area, and volume). The standard states that these parameters can be measured by direct (on-line) or indirect (off-line) methods and each technique needs specific sampling procedures. The standard notes that the limited technologies in the generation and characterization of nanofibers make it difficult to perform inhalation toxicity studies, however, “although the inhalation exposure to CNT and CNF is highly likely in the workplace, and research facilities, where they are in use.” The standard provides the current status of CNT and CNF aerosol characterization used in the inhalation toxicity tests, as well as the physicochemical properties of CNTs and CNFs and their relationship with toxicity end points. ISO notes that the standard neither provides guidance on aerosol characterization for other carbon nanomaterials, nor provides guidance for characterization of CNT and CNF aerosols in the workplace or ambient air.

The European Chemicals Agency (ECHA) has made recent improvements to its chemicals database. For nanomaterials on the European Union (EU) market, the details page of the database now includes information on the nanomaterial form characterization. According to ECHA, the results page also has an improved display, allowing better access to the data and improved user interaction options. Other improvements to the database include:

  • Properties of concern on infocards now link to more information on the origins of each property of concern;
  • Standard unified date formats in regulatory lists; and
  • All lists feeding the public activities coordination tool (PACT) have a first publication date, allowing the entry date of a substance in the PACT list to be shown.

The French Agency for Food, Environmental and Occupational Health and Safety (ANSES) has posted “important information” for the 2022 reporting period under R-Nano, France’s national reporting scheme for substances in nanoparticle form. ANSES states that it is asking providers to give an updated declaration number to their customers upon request, “even if they have no declaration to perform.” To do so, providers “must ‘duplicate’ the substance identity information entered in [fiscal year (FY)] 2021, without submitting it.” According to ANSES, this will create a declaration number that allows the client to import the substance identity data and declare their professional activity with the substance acquired in 2020. The declaration in “draft” status will not be considered in the database for FY 2022. ANSES has extended the declaration period to May 31, 2022. For producers and importers that have difficulties in characterization with one of the methods listed in the declaration form, ANSES suggests they follow the procedure detailed in the document published in the help section.