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.

According to a May 9, 2022, news item published by the U.S. Environmental Protection Agency (EPA), “Advancing EPA’s Understanding of the Next Generation of Pesticides,” over the past decade, EPA “has received an increasing number of pesticide product applications that potentially contain nanomaterials.” The article notes that EPA’s current pesticide review method was not designed for nanomaterials, so each product is reviewed on a case-by-case basis. An EPA research team led by EPA scientist Dr. Chunming Su conducted an exhaustive search for patents and published literature related to nanopesticides to understand the state of the science. The item states that the team found and analyzed more than 36,000 patents and 500 peer-reviewed journal articles. The team established two general categories of nanopesticides to help inform EPA’s regulatory reviews: products with mostly metal-based nanomaterials as the active ingredient, like nanosilver and nanocopper oxide/hydroxide; and products that encapsulate and carry the active ingredient using nanomaterials (mostly carbon based) like graphene and carbon nanotubes. According to the item, the research team also developed a review framework “that includes a simple decision tree to determine what products should be classified and evaluated as a nanopesticide.” Products determined to contain nanomaterials are subject to additional assessment or data needs from the manufacturer. Dr. Andrew Byro of EPA’s Office of Pesticide Programs (OPP) states that the framework “represents a major steppingstone in the development of a method for identification of nanomaterials.” EPA will use this framework as a platform to help inform its data needs and future determinations regarding the evaluation of nanomaterials in antimicrobial pesticides.

EPA’s research team collected their findings related to the physical and chemical properties and efficacy of nanopesticides in a peer-reviewed journal article in Nature Nanotechnology, “Nano-enabled pesticides for sustainable agriculture and global food security.” According to EPA’s news item, the team “found that nano-enabled pesticides adhere better to plant surfaces and have a reduced impact on non-target organisms. Nanopesticides may also enhance plant resilience against stressors from heat or drought.” EPA states that these benefits “could lead to higher crop yield and provide more agricultural resilience to address climate change and weather extremes.” EPA notes that the research team’s findings “also highlight the data gaps and the need for additional research on potential adverse impacts of nanopesticides.”

The NanoHarmony and NANOMET projects are holding their first face-to-face joint workshop on the development of Organization for Economic Cooperation and Development (OECD) test guidelines (TG) for nanomaterials back-to-back with the OECD Working Party on Manufactured Nanomaterials (WPMN) at the OECD Conference Center in Paris on June 29-30, 2022. NanoHarmony aims to facilitate and improve the development process of TGs from the perspective of the developers, users, and harmonization body. NANOMET supports OECD to identify and develop standardized methods for nanomaterials.

During the workshop, participants will discuss the challenges and best practice approaches for the development of TGs. There will be a special focus on the use of TGs in regulation from an international point of view. NanoHarmony and NANOMET will inform participants about the different steps of the TG development process, potential process improvements, and ongoing TG developments for nanomaterials. The open discussions will be used to obtain input from stakeholders on the OECD process and to gather input on current OECD projects towards the development of TGs and guidance documents.

Places at the workshop may be limited, depending on any local restrictions that may be in force at the time, so registration does not guarantee a place at the workshop. Delegates will be selected to ensure a balanced representation between countries and stakeholder types. There will also be the possibility of participating at the meeting online and registrants can select this option on the order form. Registration will close June 8, 2022, at 15:00 (CEST) to ensure time for OECD to make relevant security checks.

On April 20, 2022, Germany’s Federal Institute for Risk Assessment (BfR) announced that the fourth joint symposium on nanotechnology will be held May 30-31, 2022. During the symposium, experts will present their findings on topics such as the use of nanotechnology in textiles and packaging, its application in agriculture, the effects of nanomaterials on the body, and future-oriented assessment approaches. BfR notes that with nanotechnology, consumer protection is expanding into new scientific realms in many areas. BfR is researching a variety of projects to elucidate the modes of action, to analyze complex samples, and to perform grouping approaches to advance health-related risk assessments of new materials. With the nanotechnology symposium, BfR will foster a regular, interdisciplinary, and interdepartmental exchange of knowledge. The symposium is open to the public. The registration deadline is May 20, 2022.

The U.S.  Food and Drug Administration (FDA) announced on April 22, 2022, the availability of a final guidance for industry entitled “Drug Products, Including Biological Products, that Contain Nanomaterials.” 87 Fed. Reg. 24169. FDA states that the guidance applies to human drug products, including those that are biological products, in which a nanomaterial is present in the finished dosage form. The guidance discusses both general principles and specific considerations for developing drug products containing nanomaterials through abbreviated pathways, as well as considerations for quality, nonclinical, and clinical studies as they relate to drug products containing nanomaterials throughout product development and production.

FDA issued a draft version of the guidance on December 18, 2017. According to FDA, it made two “noteworthy” changes from the draft version to the final guidance in response to stakeholder comments. First, the final guidance provides a glossary of terminology to assist in understanding how important terms are used in the document. Second, FDA made several revisions to reflect FDA’s current thinking with respect to abbreviated applications, including abbreviated new drug applications (ANDA), for products containing nanomaterials. In addition to changes in response to comments, FDA notes that it updated the final guidance document’s discussion regarding over-the-counter (OTC) monograph drugs for consistency with the enactment of OTC reform provisions of the Coronavirus Aid, Relief, and Economic Security Act (Pub. L. 116-136).