The U.S. Food and Drug Administration (FDA) published a report entitled Nanotechnology — Over a Decade of Progress and Innovation that highlights FDA’s advancements in the field of nanotechnology since it released its last report in 2007.  The report also reviews FDA’s role in advancing the public health through its regulation of products within its jurisdiction that involve the application of nanotechnology.  According to the report, FDA “will rely on a combination of horizon-scanning activities to stay abreast of new developments and product applications, including by”:

  • Participating in scientific and trade forums;
  • Participating in standards development;
  • Continuing discussions with national and international counterparts;
  • Monitoring scientific and trade literature;
  • Engaging with academia and developers; and
  • Performing prospective regulatory science on emerging technologies.

In addition, FDA states that its Emerging Sciences Working Group, a cross-agency, science-based forum established in 2016, continues to identify science and technology trends of relevance to FDA’s regulatory responsibilities, including those for nanotechnology products.  FDA notes that its “science-based, product-focused regulatory framework is sufficiently flexible and robust to help ensure product safety (and effectiveness, as applicable) while supporting innovation for the development of beneficial nanotechnology products.”

On August 13, 2020, FDA will hold a webinar to present the report.  The webinar will include the basics of nanotechnology and will highlight the facilities, regulatory science research, guidance documents, standards, domestic and international collaborations, and emerging challenges in regulatory science.  The speaker will be Anil K. Patri, Ph.D., Chair, Nanotechnology Task Force, Director, Nanocore, National Center for Toxicological Research (NCTR)/FDA.

The Australian Industrial Chemicals Introduction Scheme (AICIS) took effect on July 1, 2020.  Under AICIS, companies that import or manufacture (including introduce) industrial chemicals, or products that release industrial chemicals, into Australia for commercial purposes should first check whether the industrial chemical is listed on the Inventory.  If the chemical is on the Inventory and the introduction meets the terms of Inventory listing, the introduction is automatically categorized as a “listed” introduction.  If the chemical is not listed, it must be categorized into one of five categories.  On August 3, 2020, Australia published additional guidance for the introduction of industrial chemicals (and products that release industrial chemicals) with at least one external dimension in the nanoscale.  Australia notes that if the chemical is a nano form of a chemical that is listed on the Inventory, “then it is only considered to be on our Inventory[] if the nano form has the same [Chemical Abstracts Service (CAS)] number as the bulk form of the chemical.”  The guidance addresses what is a chemical at the nanoscale; whether the introduction is exempted, reported, or assessed; introductions of chemicals for use in research and development; introductions categorized using steps four through six of the categorization guide; and categorization outcomes.

The guidance states that nanoscale means the particle size range of one to 100 nanometers (nm).  The introduction is a “specified class of introduction” if it is of a chemical that:

  • Is introduced as a solid or is in a dispersion; and
  • Consists of particles in an unbound state or as an aggregate or agglomerate, at least 50 percent (by number size distribution) of which have at least one external dimension in the nanoscale.

The guidance states that Australia has “an increased level of concern” for specified classes of introductions due to a greater potential for particular hazards or high levels of human or environmental exposure.  According to the guidance, Australia’s increased level of concern for chemicals at the nanoscale “is because of uncertainty about the risks of some of these chemicals due to their potentially different properties, such as chemical reactivity, relative to the non-nanoscale forms of the chemicals.”  This uncertainty requires either assessment by Australia or increased reporting or recordkeeping requirements.  The guidance outlines the additional or different requirements arising from these concerns.

In July 2020, the German Environment Agency (UBA) published a report entitled Advanced materials:  Overview of the field and screening criteria for relevance assessment.  The report describes activities within the project “Advanced materials — Thematic conferences:  Assessment of needs to act on chemical safety” to provide discussion input on approaches to describe, cluster, and prioritize advanced materials.  The aim of the report is to identify relevant advanced materials in regard to chemical safety.  The report states that since the term advanced materials is not clearly defined, a major focus of the investigation is to characterize the use of the term to obtain a reasonable separation within the materials sector.  According to the report, a set of criteria that could be applied to assess the relevance of advanced materials regarding chemical safety was developed and is provided for further discussion and refinement.  In addition, a first description of identified advanced material clusters was performed.

As reported in our February 5, 2020, blog item, the American Conference of Governmental Industrial Hygienists (ACGIH®) Threshold Limit Values for Chemical Substances (TLV®-CS) Committee included carbon nanotubes on its 2020 list of chemical substances and other issues under study.  Being placed on the under study list indicated that the TLV®-CS Committee had selected carbon nanotubes for development of a threshold limit value (TLV®).  ACGIH® has now released its two-tier under study list.  Tier 1 lists the chemical substances and physical agents that may move forward as a notice of intended change (NIC) or notice of intent to establish (NIE) in the upcoming year, based on their status in the development process.  Tier 2 consists of those chemical substances and physical agents that will not move forward, but will either remain on or be removed from the under study list for the next year.  Carbon nanotubes are included in Tier 2.  If carbon nanotubes are included on the 2021 under study list, stakeholders will have an opportunity to submit substantive data and comments.

The Organization for Economic Cooperation and Development (OECD) recently published two guidance documents in its series on testing and assessment:

  • Guidance Document on Aquatic and Sediment Toxicological Testing of Nanomaterials (No. 317): The guidance document addresses practical aspects of carrying out valid tests with manufactured nanomaterials, as well as modifications or additions to OECD Test Guideline procedures intended to improve incrementally the accuracy, intra-laboratory repeatability, inter-laboratory reproducibility, and intra-laboratory reproducibility of test results.  The guidance document considers initial characterization of test materials, preparation of test dispersion, monitoring the behavior of manufactured nanomaterials in the test dispersion throughout the duration of the test, and quantifying exposure and exposure-response.  The focus of the guidance document is on measurements of worst-case hazard using traditional population level endpoints, including survival, growth, and reproduction, and does not provide guidance on making formal risk assessments.  OECD states that since the focus is on the most conservative assessment of hazard, the guidance within involves efforts to disperse manufactured nanomaterials into laboratory media that may not always be realistic to environmental dispersal.
  • Guidance Document for the Testing of Dissolution and Dispersion Stability of Nanomaterials and the Use of the Data for Further Environmental Testing and Assessment Strategies (Excel) (No. 318): The guidance document provides guidance for the methods to address dissolution rate and dispersion stability for nanomaterials, with a focus on environmental aqueous media.  OECD states that the guidance provided is relevant for solids in the nanoscale, as well as their aggregates and agglomerates, and it focuses on their fate and behavior in aqueous media.  In particular, the guidance document presents the influence of various experimental conditions on the performance and outcomes of the discussed methods.  In addition, the guidance document addresses modifications or additions to the methods and aims to give support for the interpretation of the test results.

On July 23, 2020, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion entitled “Material manufacturing from nano-scaled particles:  moving forward using plants” by Dr. Blaise Tardy, Research Fellow, Bio-Based Colloids and Materials Research Group — Aalto University in Finland.  Dr. Tardy notes that bio-based nanomaterials such as nanocellulose “have shown great promise in forming high performance materials, with the potential to replace plastics.”  In addition to replacing hazardous synthetic materials such as single-use, disposable materials, these biomaterials could be used in car parts, 3D-printable bioinks, reflective coatings, adhesives, and high-strength filaments.  According to Dr. Tardy, these bio-based nanoparticles offer the promise of large-scale nanomanufacturing using water-based systems.  Dr. Tardy states that “[u]sing water as the solvent to assemble these fibers results in a myriad of material types, with increasingly versatile properties as associated with ongoing worldwide nanomaterials research and developments.”  As the field of nanotechnology moves forward, integrating the use of green, bio-based nanoparticles will become increasingly beneficial, particularly for materials with a short service lifetime, such as packaging, single-use personal protective equipment, and disposable filters.  Dr. Tardy concludes that “finding ways to facilitate nanomanufacturing will become as important as the development of these outstanding nanoparticles, which are essential for future developments in materials science.”

The July 2020 issue of the National Institute of Environmental Health Sciences (NIEHS) Environmental Factor includes an item on a new database that facilitates nanomaterial research.  According to the article, NIEHS grantees constructed PubVINAS, “a large database of structure, chemical property, and activity information on 705 nanomaterials, covering 11 material types.”  The article states that the extensive data on each material “allows scientists to use the structures of new nanomaterials to predict their critical properties and potential toxicity.”  PubVINAS “draws upon thousands of scientific papers and contains 705 unique nanomaterials, 1,365 physicochemical properties of those materials, and 2,386 data points related to their bioactivity, including whether the nanomaterials can be taken up by cells and lead to cell death.  The nanostructures are stored as data files that can be downloaded by researchers worldwide.”  The NIEHS article cites a Nature Communications article, “Construction of a web-based nanomaterial database by big data curation and modeling friendly nanostructure annotations.”

The European Food Safety Authority (EFSA) has begun a public consultation on a draft document entitled “EFSA Guidance on Technical Requirements for Regulated Food and Feed Product Applications to Establish the Presence of Small Particles Including Nanoparticles.”  The draft Guidance sets out information requirements for applications in the regulated food and feed product areas and establishes criteria for assessing the presence of a fraction of small particles.  EFSA states that these requirements apply to particles requiring specific assessment at the nanoscale in conventional materials that do not meet the definition of engineered nanomaterial as set out in the Novel Food Regulation (EU) 2015/2283.  The draft Guidance outlines appraisal criteria, grouped in three sections, to confirm whether the conventional risk assessment should be complemented with nanospecific considerations.  The first group addresses solubility and dissolution rate as key physicochemical properties to assess whether consumers will be exposed to particles.  The second group establishes the information requirements for assessing whether the conventional material contains a fraction or consists of small particles, and its characterization.  The third group describes the information to be presented for existing safety studies to demonstrate that the fraction of small particles, including particles at the nanoscale, has been properly evaluated.  In addition, to guide the appraisal of existing safety studies, the draft Guidance provides recommendations for fulfilling the data gaps while minimizing the need for conducting new animal studies.  EFSA states that the draft Guidance complements the “Guidance on Nanoscience and Nanotechnology” adopted by the EFSA Scientific Committee in 2018.  It advises applicants to consult both guidance documents before conducting new studies.  Comments are due September 9, 2020.

On August 19 and 20, 2020, the American National Standards Institute Nanotechnology Standards Panel (ANSI-NSP) will hold a virtual workshop on advanced materials.  ANSI states that advanced materials are of growing interest as there is increasing recognition that size alone does not define the unique properties of a material.  More and more, governments and organizations that originally focused on nanomaterials are now also focusing on advanced materials and emerging technologies.  The workshop will focus on whether existing nanotechnology standards bodies should address advanced materials and how the gaps and needs relative to advanced materials standards can best be identified and prioritized.  Panelists will include representatives from the National Nanotechnology Coordination Office (NNCO), the U.S. Environmental Protection Agency (EPA), the U.S. Consumer Product Safety Commission (CPSC), The Chemours Company, the Society of Toxicology, and the Organization for Economic Cooperation and Development (OECD).  ANSI-NSP invites interested stakeholders, including industry, government representatives, representatives from non-governmental organizations, and academics, to participate.  Online registration is now open.

The International Organization for Standardization (ISO) has published two nanotechnology standards:

  • ISO 21363:2020, “Nanotechnologies — Measurements of particle size and shape distributions by transmission electron microscopy”: The standard specifies how to capture, measure, and analyze transmission electron microscopy images to obtain particle size and shape distributions in the nanoscale.  According to ISO, the standard is broadly applicable to nano-objects, as well as to particles with sizes larger than 100 nanometers (nm).  ISO states that the exact working range of the method depends on the required uncertainty and on the performance of the transmission electron microscope.  These elements can be evaluated according to the requirements described in this document; and
  • ISO/TS 21975:2020, “Nanotechnologies — Polymeric nanocomposite films for food packaging with barrier properties — Specification of characteristics and measurement methods”: The standard specifies characteristics, including barrier properties, to be measured of polymeric nanocomposite films used for improving food packaging.  ISO states that the barrier properties cover gas (oxygen), water vapor transmission, and ultraviolet (UV)-Vis light transparency.  The standard also describes the relevant measurement methods.  ISO notes that the standard addresses neither safety and health issues related to the food packaging nor environmental aspects.