On April 6, 2023, NanoHarmony announced publication of a paper in Regulatory Toxicology and Pharmacology entitled “Towards harmonisation of testing of nanomaterials for EU regulatory requirements on chemical safety — A proposal for further actions.” The paper provides an overview of the information requirements across different European Union (EU) regulatory areas. For each information requirement, experts identified potential needs for further action to accommodate guidance and test guidelines to nanomaterials. According to the abstract, 11 different needs for action were identified, capturing 22 information requirements that are specific to nanomaterials and relevant to multiple regulatory areas. These were further reduced to three overarching issues:

  • Resolve issues around nanomaterial dispersion stability and dosing in toxicity testing, in particular for human health endpoints;
  • Further develop tests or guidance on degradation and transformation of organic nanomaterials or nanomaterials with organic components; and
  • Further develop tests and guidance to measure (a)cellular reactivity of nanomaterials.

The abstract states that efforts to address these issues will result in better fit-for-purpose test methods for regulatory compliance. According to the abstract, “[t]he results of the study accentuate the need for a structural process of identification of information needs and knowledge generation, preferably as part of risk governance and closely connected to technological innovation policy.”

The White House Office of Science and Technology Policy (OSTP) published a request for information (RFI) on April 5, 2023, seeking public input in updating the National Nanotechnology Initiative (NNI) Environmental, Health, and Safety (EHS) Research Strategy. 88 Fed. Reg. 20194. OSTP is soliciting public input from a wide variety of stakeholders, including individuals, industry, academia, research laboratories, nonprofits, and think tanks. OSTP states that it is interested in public input to inform an updated nanotechnology EHS research strategy, “specifically a strategy that focuses on the use of science-based risk analysis and risk management to protect public health and the environment while also fostering the technological advancements that benefit society.” OSTP seeks responses to the following questions:

  1. What are the research accomplishments in the following six core research areas identified in the 2011 NNI EHS Strategy? The six core research areas are: (1) Nanomaterial Measurement Infrastructure; (2) Human Exposure Assessment; (3) Human Health; (4) Environment; (5) Risk Assessment and Risk Management Methods; and (6) Informatics and Modeling.
  2. What research gaps remain in addressing the six NNI EHS core research areas listed in question 1?
  3. The ethical, legal, and societal implications (ELSI) of nanotechnology are considered across the core research areas of the 2011 strategy. What additional ways could ELSI be more fully integrated throughout a refreshed NNI EHS research strategy?
  4. What broad themes should the revised strategy adopt to integrate and connect the six research areas?
  5. How should the updated NNI EHS research strategy reflect the evolution of nanotechnology beyond engineered nanomaterials to complex systems, structures, and devices?
  6. The 2011 strategy focused on engineered nanomaterials and did not include incidental nanoscale materials such as nanoplastics and certain nanoscale particulate emissions such as those from 3D printing. If the updated strategy is revised to include some non-engineered or incidental nanomaterials, describe how to scope the strategy in a way that complements rather than being redundant with existing health and environmental research (e.g., by excluding the large body of existing research on air pollution, which can include nanoscale particles).

Comments are due on or before 5:00 p.m. (EDT) on June 2, 2023.

The National Nanotechnology Initiative (NNI) will hold a public meeting May 31-June 1, 2023, to discuss the revision of the 2011 National Nanotechnology Initiative Environmental, Health, and Safety Research Strategy (EHS Research Strategy). NNI encourages individuals, non-governmental organizations (NGO), academic and research institutions, and the private sector interested in the responsible development of nanotechnology to attend and contribute to creating an updated EHS Research Strategy. NNI seeks feedback and perspectives on progress toward the goals set out in the EHS Research Strategy and on remaining research gaps, new challenges, and opportunities. NNI states that by involving the broadest cross section of stakeholders early in the process, it “hopes to prepare a fresh and durable strategic guide that is responsive to the continuing evolution of nanotechnology as an enabling technology.”

Program

Day 1:

  • Assessing the progress in reaching the research goals set in 2011;
  • How NNI’s EHS infrastructure has contributed to understanding the health and safety implications of nanotechnology; and
  • Tackling the ethical, legal, and societal implications (ELSI) as an overarching frame for NNI’s EHS research.

Day 2:

  • Forging the cross-cutting themes and an integrated approach to the research questions, needs, and approaches in the refreshed strategy; and
  • Strategic action post-2023.

More information on NNI’s EHS Research Strategy is available in our October 21, 2011, blog item.

The European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) published its final opinion on hydroxyapatite (nano) on March 23, 2023. As reported in our April 13, 2021, blog item, SCCS released a final opinion in 2021 on the safety of hydroxyapatite (nano) when used in leave-on and rinse-off dermal and oral cosmetic products according to the maximum concentrations and specifications reported, taking into account reasonably foreseeable exposure conditions. In its 2021 final opinion, SCCS stated that having considered the data provided and other relevant information available in scientific literature, it “cannot conclude on the safety of the hydroxyapatite composed of rod-shaped nanoparticles for use in oral-care cosmetic products at the maximum concentrations and specifications given in this Opinion.”

In 2022, the EC asked SCCS whether hydroxyapatite (nano) is safe when used in oral cosmetic products according to the maximum concentrations and specifications as reported in the industry submission, taking into account reasonably foreseeable exposure conditions. According to the March 2023 final opinion, based on the data provided, SCCS considers hydroxyapatite (nano) safe when used at concentrations up to ten percent in toothpaste, and up to 0.465 percent in mouthwash. The final opinion notes that this safety evaluation applies only to hydroxyapatite (nano) with the following characteristics: composed of rod-shaped particles of which at least 95.8 percent (in particle number) have an aspect ratio less than three, and the remaining 4.2 percent have an aspect ratio not exceeding 4.9; and the particles are not coated or surface modified. The EC also asked if SCCS has any further scientific concerns with regard to the use of hydroxyapatite (nano) in oral cosmetic products. SCCS notes that its final opinion is not applicable to hydroxyapatite (nano) composed of needle-shaped particles. The final opinion states: “Although the use of hydroxyapatite (nano) is indicated also for breath spray, no data were provided to allow assessment of consumer safety from inhalation exposure. Therefore, this Opinion is not applicable to sprayable products that might lead to exposure of the consumer’s lungs to nanoparticles by inhalation.”

The European Union (EU) Observatory for Nanomaterials (EUON) has posted two Nanopinions:

  • “Graphene Electronic Tattoos,” posted on February 20, 2023, by Dr. Dmitry Kireev. “Graphene Electronic Tattoos (GETs) are a type of skin-wearable electronic device that can be used for personalized healthcare by transmitting the bio-electrical activity of the human body in measurable electrical signal. […] The GETs are optically transparent, lightweight, and flexible, making them adhere and conform to the micro-curvature of the skin, which helps them to remain at the exact positions during use and transmit bioelectrical signals during movements (which would not be possible with other, thick and rigid materials such as gold or silver/silver chloride (Ag/AgCl) gel electrodes). GETs have been used to monitor electrophysiological signals such as the brain (EEG), heart (ECG), muscle (EMG), and ocular (EOG) activities, as well as skin temperature and hydration level.”

The European Union (EU) Observatory for Nanomaterials (EUON) has issued a call for study proposals. EUON is looking for studies on:

  • 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 (e.g., the market for specific materials such as graphene or specific market sectors).

According to EUON, the scope of the study can be on nanomaterials in general, a specific nanomaterial, or a defined group of nanomaterials. EUON will assess all proposals, and if selected, they will be carried out through EUON’s existing procurement channels. EUON will post the outcome and study reports on its website. EUON states that it usually conducts two studies each year to address knowledge gaps on nanomaterials. EUON notes that studies are based on desk research and surveys and should not require laboratory research.

The Organization for Economic Cooperation and Development (OECD) held a webinar on February 7, 2023, to present the methods described in Test Guideline (TG) No. 125 to determine the size and size distributions of nanomaterial particles and fibers spanning from one nanometer (nm) to 1,000 nm. It also presented the use and limitations of this TG, as well as of the validation exercise that was done to support its development. OECD organized the webinar to increase awareness of the newly adopted TG. The webinar is available for replay, and the presentations are available online.

The Nanotechnology Industries Association (NIA) has posted a recording of its March 6, 2023, webinar on “Nano in Action: Antimicrobial Treatment.” The webinar explored a topic where relevance has been amplified by the COVID-19 pandemic, but that has long been on the to do list of the public building and transport sectors. Subjects covered included the current cleaning and sanitation protocols of public spaces; the kind of nano-based solutions available to meet this need; and how to measure the efficacy of an antimicrobial treatment. Bergeson & Campbell, P.C. (B&C®) is a proud member of the NIA.

The National Nanotechnology Initiative (NNI) will hold a webinar on “What’s Next in NanoEHS: The Young Professional’s Perspective” on March 28, 2023. NNI’s 2023 nano environmental, health, and safety (nanoEHS) webinar series will focus on the questions, challenges, and breakthroughs needed to continue advancing the responsible development of nanotechnology. According to the National Nanotechnology Coordination Office’s (NNCO) announcement, the 2023 theme complements the NNI’s effort to refresh its 2011 nanoEHS research strategy. NNCO states that during the inaugural webinar, “rising experts in nanoEHS will share their perspectives on the pressing issues and the main questions driving their research.” NNI recognizes the work of new investigators and emerging experts as vital to progress and innovation in this field and to inspiring the next generation of researchers. Quinn Spadola, Deputy Director, NNCO, will moderate a panel that includes:

  • Adeyemi Adeleye, Assistant Professor, Department of Civil and Environmental Engineering, University of California, Irvine;
  • Marissa Giroux, Oak Ridge Institute for Science and Education (ORISE) Postdoctoral Research Fellow, U.S. Environmental Protection Agency (EPA), Office of Research and Development (ORD), Atlantic Coastal Environmental Sciences Division; and
  • Joana Sipe, Postdoctoral Associate, Duke University, Wiesner Research Group.

Registration is now open.

The March 2023 issue of the National Institute for Occupational Safety and Health’s (NIOSH) eNews includes an item announcing publication of an article entitled “Results of the 2019 Survey of Engineered Nanomaterial Occupational Health and Safety Practices” in the International Journal of Environmental Research and Public Health. According to the abstract, the survey aimed to understand whether workers follow the recommendations of NIOSH’s Nanotechnology Research Center (NTRC). From September to December 2019, NIOSH worked with RTI International to administer an online survey about workplace safety and health practices related to nanomaterials. The abstract states that 45 U.S. and Canadian companies completed the survey developed by RAND Corporation. More than a third (37.8 percent) of the respondents reported using at least one NIOSH resource to acquire information about safe handling of engineered nanomaterials. The abstract notes that the small number of companies that responded to and completed the survey “is a considerable limitation to this study.” The abstract states that the survey data “are valuable for gauging the reach and influence of the NIOSH NTRC on nano OHS and for informing future outreach, particularly to small businesses.”