Registration is now open for the U.S. National Nanotechnology Initiative’s (NNI) February 9, 2021, webinar, “What We Know about NanoEHS:  How It All Began.”  NNI states that its 2021 NanoEHS webinar series will focus on sharing what it now knows about the environmental, health, and safety aspects of engineered nanomaterials (nanoEHS).  According to NNI, throughout the series, “experts will share the big take-home EHS messages with the broader nanotechnology community and highlight the NNI’s role in answering those questions.”  The February 9, 2021, webinar will “bring[] together several of the pioneering scientists who were pivotal in the emerging field of nanoEHS to share their perspectives on how it all began and to discuss the robust community that has been developed and supports current and future activities in this important area.”  John Howard, M.D., M.P.H., J.D., L.L.M., M.B.A., Director, National Institute of Occupational Safety and Health (NIOSH), will moderate.  Speakers will include:

  • Vicki L. Colvin, Ph.D., Vernon K. Krieble Professor of Chemistry, Professor of Engineering, Professor of Molecular Pharmacology, Physiology, and Biotechnology, Director, Center for Biomedical Engineering, Brown University;
  • Andrew Maynard, Ph.D., B.Sc., Associate Dean of Curricula and Student Success, College of Global Futures, Arizona State University;
  • Güenter Oberdöerster, D.V.M., Ph.D., Professor Emeritus, Department of Environmental Medicine, University of Rochester; and
  • Dave Rejeski, Visiting Scholar, Environmental Law Institute (ELI).

On January 11, 2021, the European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) posted a final opinion entitled Scientific Advice on the Safety of Nanomaterials in Cosmetics.  The EC requested that SCCS determine the nanomaterials, as published in the 2019 catalogue of nanomaterials, for which specific concerns can be identified and justified to establish a priority list of nanomaterials for risk assessment (Article 16(4) Reg. 1223/2009).  The final opinion states that SCCS has identified certain aspects of nanomaterials that constitute a basis for concern over safety to consumers’ health when used in cosmetic products.  These include:

  • Physicochemical aspects relating to: very small dimensions of the constituent particles; solubility/persistence; chemical nature and toxicity of the nanomaterial; physical/morphological features of the constituent particles; and surface chemistry and surface characteristics (surface modifications/coatings);
  • Exposure aspects relating to: the frequency and the amounts used; whether the number/type of consumer product(s) used is relatively high; and whether there is a potential for systemic exposure of the consumer to nanoparticles and potential accumulation in the body; and
  • Other aspects relating to: novel properties; activity or function; and specific concern arising from the type of application.

Annex 1 of the opinion lists the nanomaterials included in the 2019 catalogue of nanomaterials in order of priority according to risk potential.  SCCS states that it used a scoring system to assign a notional score to each listed nanomaterial to indicate the level of concern and listed the nanomaterials in descending order of the scores so that the nanomaterials requiring priority attention for safety assessment could be identified.  The final opinion notes that “the scoring system is also not an alternative to safety assessment, and has only been used to prioritise nanomaterials for a subsequent evidence-based safety assessment.”  The nanomaterials listed in Annex 1 with the highest scores are colloidal copper, methylene bis benzotriazolyl tetramethylbutylphenol, colloidal silver, and silver.

The EC also requested that for nanomaterials with inconclusive SCCS opinions, SCCS assess whether a potential risk can be identified according to Article 16(6) Reg. 1223/2009.  The inconclusive SCCS opinions specified in the request include colloidal silver (nano) (SCCS/1596/18), styrene/acrylates copolymer (nano) + sodium styrene/acrylates copolymer (nano) (SCCS/1595/18), and silica, hydrated silica, and silica surface modified with alkyl silylates (nano form) (SCCS/1545/15).  According to the opinion, SCCS reviewed the previous inconclusive opinions, in conjunction with any further relevant information available in published literature, to identify whether there is a scientific basis for concern over their safety to consumers’ health when used in cosmetic products.  The opinion states that SCCS has identified certain aspects relating to each of the nanomaterials that raise a safety concern.  These have been detailed in three separate annexes to the preliminary opinion.

On January 5, 2021, the National Institute for Occupational Safety and Health (NIOSH) posted a Science Blog item entitled “Understanding the Broad Class of Carbon Nanotubes and Nanofibers (CNT/F) Used or Produced in U.S. Facilities.”  The item summarizes a recently published article in the journal Particle and Fibre Toxicology, “Physicochemical characterization and genotoxicity of the broad class of carbon nanotubes and nanofibers used or produced in U.S. facilities” that addresses whether different-sized CNT/F materials have similar toxicity if inhaled.  For successful commercialization and industrial hygiene, and from a human health perspective, it is important for us to understand the relationship between different physicochemical characteristics of CNT/F and toxicological effects.  The Science Blog item states that the major findings of the study include:

  • Not all CNT/F possess similar toxicity. This will be further illustrated in subsequent publications that evaluate inflammation, pathological changes, and translocation;
  • Detailed physical dimension characteristics, not just the mean length and width, provide a more consistent grouping of CNT/F into toxicologically relevant categories;
  • All CNT/F induced some degree of genotoxicity. Micronuclei formation, combined with cellular oxidative stress and evidence of DNA double-strand breaks, indicated CNT/F with increasing length and diameter caused slightly more toxicity; and
  • Interestingly, even a small percentage of CNT/F with increased length and diameter in a material can alter the toxicity of the material. It does not need to be the primary component of the material.

According to the Science Blog item, depending on the parameter, the toxicity of CNT/F is likely to vary by the component material or group of materials with similar physicochemical characteristics.  NIOSH states that integrating exposure and toxicity assessments provides direct feedback and representative study design, enabling an understanding of the potential for toxicity of a CNT/F in relationship to potential worker or consumer exposure.  NIOSH expects these results to help inform guidance for the responsible handling and commercialization of CNT/F.

The American Conference of Governmental Industrial Hygienists (ACGIH®) Threshold Limit Values for Chemical Substances (TLV®-CS) Committee has included carbon nanotubes on its 2021 list of chemical substances and other issues under study.  Being placed on the under study list indicates that the TLV®-CS Committee has selected carbon nanotubes for development of a threshold limit value (TLV®).  ACGIH® describes TLVs® as health-based values representing the opinion of the scientific community that exposure at or below the level of the TLV® does not create an unreasonable risk of disease or injury.  The TLV®-CS Committee seeks substantive data and comments and will consider only those addressing issues of health and exposure, not economic or technical feasibility.  ACGIH® will update the under study list into a two-tier list by July 31, 2021:

  • Tier 1 entries indicate 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; and
  • 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.

If the Committee decided to proceed with a proposed TLV® for carbon nanotubes, the ACGIH® Board of Directors would first ratify the proposed value, and it would be published as an NIE in the 2021 annual report of the TLV®-CS Committee.  The Committee included carbon nanotubes on its 2018, 2019, and 2020 lists of chemical substances and other issues under study.

On January 26, 2021, the Organization for Economic Cooperation and Development (OECD) will hold a webinar on Guidance Document on Aquatic and Sediment Toxicological Testing of Nanomaterials (No. 317).  The webinar will discuss the scope and use of the guidance document, which addresses practical aspects of carrying out valid tests on nanomaterials, and modifications or additions to OECD Test Guidelines procedures intended to improve the accuracy of test results.  Registration for the webinar is open.

The Organization for Economic Cooperation and Development (OECD) published a report entitled Moving Towards a Safe(r) Innovation Approach (SIA) for More Sustainable Nanomaterials and Nano-enabled Products.  According to the Executive Summary, the report “presents common working descriptions to ensure a common understanding of concepts such as: Safe(r) Innovation Approach and its elements, Safe(r)-by-Design and Regulatory Preparedness.”  The report compiles existing risk assessment tools, frameworks, and initiatives developed for Safe(r)-by-Design.  OECD states that the inventory of risk assessment tools and frameworks should help industry implement a “Safe(r) Innovation Approach” for nanomaterials and nano-enabled products.  This includes a review of lessons learned from applying existing Safe(r)-by-Design concepts and tools and methods applied in hazard, exposure, and risk assessment and management along the innovation value chain.  OECD conducted a review of the applicability of the Safe(r)-by-Design concept, based on feedback gained through case studies and existing initiatives, and analyzed the constraints and limitations on the applicability of these tools and frameworks.  The information is complemented by an inventory of regulatory strategies for raising awareness and improving decision-making, including foresight, horizon scanning, and other methodologies, and of available governance models that incorporate a Safe(r) Innovation Approach and Safe(r)-by-Design concept.  The report also outlines the constraints and limitations on the applicability of these strategies and governance models.  Finally, the report compiles information on regulatory initiatives related to the review of innovative approaches and technologies, assessing whether these concepts are already integrated into current legislation or guidance.  The report proposes a combination of Safe(r)-by-Design and relevant regulatory strategies for awareness raising and decision making to achieve a Safe(r) Innovation Approach, supporting industrial initiatives in adopting a Safe(r) Innovation Approach with descriptors for a Safe(r) Innovation Approach for nanomaterials and nano-enabled products.

The Organization for Economic Cooperation and Development (OECD) has posted a report entitled Ability of biopersistent/biodurable manufactured nanomaterials (MNs) to induce lysosomal membrane permeabilization (LMP) as a prediction of their long-term toxic effects.  The report describes “the expanding knowledge on the implications and biological significance of lysosomal and autophagy dysfunction and the subsequent assembly and activation of inflammasome NLRP3 induced by biodurable manufactured nanomaterials.”  According to the report, different types of biodurable nanomaterials are shown to cause LMP, affect autophagy, and cause NLRP3 inflammasome activation.  OECD intends the compilation of available information in the report to contribute to the development of test systems to predict the long-term toxicity and hence the safety of manufactured nanomaterials.  The report notes that “[k]nowledge derived from the cellular and molecular processes underlying nanomaterial-induced toxic effects will also establish the scientific foundations for the risk assessment of manufactured [n]anomaterials through alternative screening approaches to predict long-term effects.”

In 2016, the Organization for Economic Cooperation and Development’s (OECD) Working Party on Manufactured Nanomaterials (WPMN) included the Advancing Adverse Outcome Pathway (AOP) Development for Nanomaterial Risk Assessment and Categorization (NanoAOP) project in its program of work.  The objective of the project is to contribute to the future development and application of AOPs for manufactured nanomaterial regulatory decision making by following the principles established by the OECD Extended Advisory Group on Molecular Screening and Toxicogenomics (EAGMST).  OECD has published three reports presenting the outcomes of the project:

The European Union (EU) Observatory for Nanomaterials (EUON) is conducting a web satisfaction survey.  EUON provides information on the safety, innovation, research, and uses of nanomaterials on the EU market.  It is intended for stakeholders developing policies in the area, consumers, industry representatives, and non-governmental organizations.  EUON is funded by the European Commission (EC) and hosted and maintained by the European Chemicals Agency (ECHA).  Information from the survey will be used to make improvements to the existing website and prioritize areas of development in the future.  The survey should take only five minutes, and responses are completely anonymous.

On December 1, 2020, the French Agency for Food, Environmental and Occupational Health and Safety (ANSES) announced the results of an assessment of R-Nano, France’s national reporting scheme for substances in nanoparticle form.  In 2013, France began requiring companies that manufacture, import, and/or distribute a “substance with nanoparticle status” in an amount of at least 100 grams per year to submit an annual report with substance identity, quantity, and use information.  The data reported were intended to provide regulatory authorities a better understanding of the nanomaterials placed on the market, enable traceability in the sectors using them, and bring together knowledge for risk assessment and public information purposes.  According to ANSES, while the information collected has helped improve the understanding of population exposure levels, “the overall level of information in the reports is unsatisfactory, meaning that the traceability objective has only been partially achieved.”  ANSES states that the following improvements are necessary to make the system more reliable and optimize its use:

  • Obtain reliable, high-quality data from reporting companies: According to ANSES, the flexibility granted to reporting companies when the system was first set up “now greatly undermines data quality.”  ANSES emphasizes the importance of ending the exemptions granted and increasing reporting requirements;
  • Broaden the scope of reporting to improve traceability of nanomaterials: To obtain full traceability of the nanomaterials on the market, ANSES recommends considering broadening the reporting requirement, lowering the threshold for reporting nanomaterials, and providing additional information, such as the number of workers potentially exposed to nanomaterials and the quantities deployed by type of use; and
  • Improve data provision: ANSES recommends reexamining the confidentiality provisions in the regulations.  According to ANSES, data access needs to be extended to public health players, and the decree listing the organizations with access should be revised to this effect.