The German Federal Ministry of Education and Research (BMBF) project (DaNa4.0) is addressing the question of whether new advanced materials, including nanomaterials, can be harmful to humans and the environment and how humans and the environment come into contact with these materials. DaNa has published an August 2022 research spotlight on a “Three-stage model for the formation of micro- and nanoplastic particles.” The paper, “Degradation of low-density polyethylene to nanoplastic particles by accelerated weathering,” investigates how the process of decomposition due to weathering occurs and what happens to nanoplastic particles. According to DaNa, the starting point for the investigation was plastic pellets in the medium size range of 100-200 micrometers (µm), which were exposed to laboratory weathering by water and solar radiation. Researchers divided the degradation into three main stages: in stage one, the large fragments were smoothed by surface abrasion over a period of up to 17 days, and smaller fragments detached; in stage 2, after a period of at least 58 days, cracks formed on the plastic surface; and in stage 3, the cracks led to the detachment of smaller particles. DaNa states that up to 14,000 nano- and microplastic particles could form from one original particle, and the nanoplastic particles subsequently form larger agglomerates with microplastic particles. According to DaNa, environmental organisms will thus be exposed to nanoplastic and microplastic particles simultaneously. At the same time, nanoplastic particles bound to natural particles may also enter the food chain.

On July 29, 2022, the National Institute for Occupational Safety and Health (NIOSH) published a Technical Report: Occupational Exposure Sampling for Engineered Nanomaterials. Since 2010, NIOSH has developed guidance for workplace sampling for three engineered nanomaterials: carbon nanotubes (CNT) and nanofiber (CNF), silver, and titanium dioxide, each of which has an elemental mass-based NIOSH recommended exposure limit (REL). NIOSH has also developed a practical approach to exposure sampling for other engineered nanomaterials that do not have exposure limits. According to NIOSH, occupational health and safety professionals “have expressed a need for one document that explains all of the available nanomaterial sampling techniques, and this document provides a summary of the different sampling techniques.” The document includes recommendations for an exposure monitoring program, CNTs and CNFs, silver, titanium dioxide, use of the nanomaterial exposure assessment technique for other engineered nanomaterials, and optional sampling methods. NIOSH concludes that a comprehensive exposure assessment evaluation for engineered nanomaterials collects information that can be used to identify sources of potential engineered nanomaterial exposures; establish similar exposure groups by area or job tasks; characterize exposures of all potentially exposed workers; and assess the effectiveness of engineering controls, work practices, personal protective equipment (PPE), training, and other factors used in reducing exposures. NIOSH states that using a combination of these techniques can provide an in-depth characterization of potential occupational exposure to engineered nanomaterials. This information is then available for incorporation into risk management strategies to minimize worker exposure to engineered nanomaterials and confirm ongoing control of risk.

The National Nanotechnology Initiative (NNI) and the U.S. Environmental Protection Agency (EPA) will co-host a webinar on August 25, 2022, on Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) funding opportunities for water nanotechnologies. Small businesses and academic researchers will have an opportunity to hear from some of the federal agencies that fund water technologies, with a special focus on investments in nanotechnology-enabled solutions. The SBIR and STTR programs fund a diverse portfolio of startups and small businesses across technology areas and markets to stimulate technological innovation, meet federal research and development (R&D) needs, and increase commercialization to transition R&D into impact. During the webinar, representatives from EPA, the National Institute of Environmental Health Sciences (NIEHS), the National Oceanic and Atmospheric Administration (NOAA), and the National Science Foundation (NSF) will provide an overview of their current and upcoming SBIR/STTR funding opportunities for water nanotechnologies. The agencies’ presentations will be followed by a question and answer session. Jean Balent, EPA Technology Innovation and Field Services Division, will moderate the panel. Speakers will include:

  • April Richards, Program Manager, SBIR Program, EPA;
  • Heather Henry, Ph.D., Health Science Administrator, NIEHS;
  • Genevieve Lind, Ph.D., Program Manager, SBIR Program, NOAA; and
  • Rajesh Mehta, Ph.D., Program Director, SBIR/STTR Program, NSF.

Registration is now open.

The National Institute for Occupational Safety and Health (NIOSH) published a program performance one-pager on July 18, 2022, for the Nanotechnology Research Center (NTRC). NTRC conducts research to understand the potential effects on human health of exposure to engineered nanomaterials and develops methods to control or eliminate exposures. The one-pager lists the following accomplishments:

According to the one-pager, the following actions are next:

  • Publish the document Occupational Exposure Sampling for Engineered Nanomaterials;
  • Publish the document Approaches to Safe 3D Printing: A Guide for Makerspace Users, Schools, Libraries and Small Businesses;
  • Conduct an evaluation of biomarkers of engineered nanomaterial exposure and disease;
  • Issue in final Approaches to Developing Occupational Exposure Limits or Bands for Engineered Nanomaterials; and
  • Publish the first two videos in the series of an Overview of Additive Manufacturing Health and Safety.

The Organization for Economic Cooperation and Development (OECD) has published a document entitled Chemical Accidents Involving Nanomaterials: Potential Risks and Review of Prevention, Preparedness and Response Measures — Project Report. Part of OECD’s series on chemical accidents, the document presents the outcome from a project of the OECD Working Party on Chemical Accidents (WPCA) that aimed to investigate safety issues related to the prevention of, preparedness for, and response to accidents involving manufactured nanomaterials. The objectives of the project were to:

  • Address potential risks for humans and the environment resulting from accidents involving manufactured nanomaterials, for example, accidental releases of larger quantities of nanomaterials into the area surrounding an establishment; and
  • Review measures for prevention of, preparedness for, and response to accidents involving nanomaterials.

The report is aimed at policy makers and regulators in charge of chemical accidents not yet familiar with safety issues regarding nanomaterials. The report was prepared using existing academic papers and relevant reports from governments and international organizations. The report intends to introduce briefly issues related to chemical accidents involving nanomaterials and to serve as a gateway to guide readers into more detailed information sources.

The Scientific Committee on Consumer Safety (SCCS) announced on June 22, 2022, that the European Commission (EC) asked that it reassess the safety of titanium dioxide with a focus on genotoxicity and exposure via the inhalation and oral route (lip care, lipstick, toothpaste, loose powder, hair spray) “since the currently available scientific evidence supports an overall lack of dermal absorption” of titanium dioxide particles.

The request notes that titanium dioxide is authorized both as a colorant under entry 143 of Annex IV and as an ultraviolet (UV) filter under entries 27 and 27a (nano form) of Annex VI to Regulation (EC) No. 1223/2009 (Cosmetics Regulation). The request states that in light of titanium dioxide’s classification as a Carcinogen Category 2 (i.e., suspected human carcinogen) by inhalation route only and its inclusion in Annex VI to Regulation (EC) No. 1272/2008 (Classification, Labeling, and Packaging (CLP) Regulation), SCCS has reassessed titanium dioxide. Subsequently, entry 321in Annex III was introduced and additional provisions in existing entries 143 of Annex IV and 27 and 27a of Annex VI were added that further restricted the use of titanium dioxide in cosmetic products.

As reported in our May 10, 2021, blog item, on May 6, 2021, the European Food Safety Association (EFSA) announced that E171 is no longer considered safe when used as a food additive. According to EFSA, “[a] critical element in reaching this conclusion is that we could not exclude genotoxicity concerns after consumption of titanium dioxide particles.”

According to the request, in May 2022, the EC received a dossier submission by industry accompanied by a comprehensive, up-to-date review of the genetic toxicity database for titanium dioxide “providing scientific evidence to demonstrate the safety of non-nano (pigmentary) and nano form” of titanium dioxide in cosmetic products.

The Institute of Technology Assessment of the Austrian Academy of Sciences has published a NanoTrust Dossier entitled “Advanced Materials.” According to the dossier, advanced materials are “materials or material combinations with improved, novel or unique functionalities or properties” and represent a broad class of materials that include semiconductors, biomaterials, and nanomaterials. The dossier states that in many cases, novel materials offer solutions to environmental problems, e.g., by saving energy and materials because of lighter weight, and they can contribute to “a sustainable development of the environment, economy, and society.” The dossier notes that novel materials and/or new functionalities are also associated with uncertainties regarding human health and the environment. As a result, it is important to highlight safety-relevant aspects at an early stage and to identify potential risks in accordance with the precautionary principle. Because of the complexity of advanced materials, new approaches, such as the concepts of “safe by design” (SbD) and “safe and sustainable by design” (SSbD), are required to gain all the necessary knowledge regarding their safety. The dossier concludes that “[a]t present, it is still unclear whether all advanced materials are covered by existing chemical safety regulations. It is therefore necessary to review relevant regulations and corresponding risk assessment tools in this context to anticipate and fill any potential loopholes.”

The 4th Joint Symposium on Nanotechnology, organized by the German Federal Institute for Risk Assessment (BfR) and the Fraunhofer Network Nanotechnology (FNT), was held May 30-31, 2022. The conference included presentations on topics such as the use of nanotechnology in textiles and packaging, its application in agriculture, the introduction of nanomaterials into the body, and future-oriented assessment approaches. The following presentations from the conference have been posted online.

Presentations from May 30, 2022

Presentations from May 31, 2022

On June 30, 2022, the Organization for Economic Cooperation and Development (OECD) published six new Test Guidelines (TG) and ten updated or corrected TGs. The new TGs include the first two harmonized methods for measuring certain nanomaterial-specific physical-chemical properties. According to OECD, these harmonized methods were developed to respond to regulatory needs in member and adhering countries, specifically for manufactured nanomaterials. The development of these TGs was supported financially by the European Commission (EC):

  • Test Guideline 124 on Volume Specific Surface Area of Manufactured Nanomaterials: This TG describes a procedure to determine the Volume Specific Surface Area (VSSA) of powdered solid manufactured nanomaterials. According to the TG, this physical-chemical property may influence the behavior and biological effects of manufactured nanomaterials and thus can be requested for the safety testing of manufactured nanomaterials. The TG states that data on VSSA or (mass) specific surface area (SSA) may provide information on the characteristic structure of the nanomaterial and can: help identify potential hazards or hazard modifications associated with similar structures; help to estimate nanomaterial fate in the environment; and help to identify modification of exposure site-specific hazards related to the physico-chemical properties. Moreover, in some cases, VSSA or SSA data can be used to relate dose to observed fate, behavior, and effects of a specific nanomaterial, as the surface area may be the toxicologically relevant dose metric.
  • Test Guideline 125 on Nanomaterial Particle Size and Size Distribution of Nanomaterials: The TG states that to address the specific needs of manufactured nanomaterials, the OECD TG No. 110, “Particle Size Distribution/Fibre Length and Diameter Distributions,” was identified as one of the TGs to require an update. The current TG 110, adopted in 1981, is valid only for particles and fibers with sizes above 250 nanometers (nm). The OECD Working Party on Manufactured Nanomaterials (WPMN) prioritized updating TG 110 to be applicable also to particles at the nanoscale or drafting a new nanomaterial-specific TG. The TG states that the WPMN eventually decided to develop a new TG that covers the size range from 1 nm to 1,000 nm, intended for particle sizes and particle size distribution measurements of nanomaterials. This TG overlaps with TG 110 in the size range from 250 nm to 1,000 nm. When measuring particulate or fibrous materials, the appropriate TG should be selected depending on the size range of particles tested. In line with TG 110, the new TG for nanomaterials includes separate parts for particles and fibers.

On June 28, 2022, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion entitled “Models to Characterize Exposures to Manufactured Nanomaterials in OECD” by Vladimir Murashov, Ph.D., Senior Scientist in the Office of the Director, National Institute for Occupational Safety and Health (NIOSH), and John Howard, M.D., Director of NIOSH and Administrator of the World Trade Center Health Program in the U.S. Department of Health and Human Services. The authors describe recently completed international projects conducted under the umbrella of the Organization for Economic Cooperation and Development (OECD). Created in 2007 and led by NIOSH, the OECD Steering Group on Exposure Measurement and Mitigation of Nanomaterials (SG8) addresses the exposure component of the risk assessment and risk management program for manufactured nanomaterials. As reported in our November 23, 2022, blog item, on December 2, 2021, the SG8 organized a webinar to present four recent publications on models to characterize exposures to manufactured nanomaterials in workers, consumers, and the environment.

According to the authors, while the results of these SG8 projects “can help guide private and public sector risk assessment and risk management professionals to choose adequate models to identify exposure to manufactured nanomaterials,” the following challenges remain:

  • There is a paucity of high-quality experimental exposure data and a very limited number of exposure scenarios hindering model performance testing;
  • Most existing models tend to overestimate exposure due to the application of the precautionary approach in the absence of sufficient data; and
  • Existing models do not account for agglomeration and aggregation of nanomaterials.

SG8 plans to continue its activities, building on the outputs of exposure model projects and providing further authoritative guidance on the use of exposure models for specific exposure situations. The authors state that for its part, “NIOSH supports international activities aimed at improving safety and health of workers handling manufactured nanomaterials and nano-enabled products.”