Nano and Other Emerging Chemical Technologies Blog

Nano and Other Emerging Chemical Technologies Blog

Regulatory & legal developments involving nano and other emerging chemical technologies

Registration Opens for NNI Webinar on Measurements of Potential Ecotoxicological Risk

Posted in Federal, Occupational Health and Safety Issues, United States

Registration is now available for the National Nanotechnology Initiative’s (NNI) June 11, 2019, webinar on “Practical Applications of 15 Years of NanoEHS Research:  Measurements of Potential Ecotoxicological Risk.”  The speaker will be Dr. Elijah Petersen, National Institute of Standards and Technology (NIST), and Dr. Treye Thomas, U.S. Consumer Product Safety Commission (CPSC) and NNI Coordinator for Environmental, Health, and Safety (EHS) Research, will moderate.  The webinar will spotlight the progress in addressing the measurement challenges posed by the unique behaviors of engineered nanomaterials.  NNI states that modifications to typical toxicity assays are needed to account for these behaviors, avoid artifacts, and ensure accurate measurements.  Using several practical examples, Dr. Petersen will describe the different artifacts that can occur during measurements and the potential control experiments to assess these artifacts.  Dr. Petersen will also discuss the development of an Organization for Economic Cooperation and Development (OECD) guidance document on aquatic and sediment toxicological testing of nanomaterials.  According to NNI, the webinar will underscore the role of the collaborative U.S.-European Union (EU) Communities of Research in sharing information and best practices for measuring and studying nanomaterials in ecologically relevant scenarios.  Webinar viewers will be able to submit questions for the panelists to answer during the question and answer period.  Submitted questions may be posted on the NNI website.

NIOSH Activities at 2019 AIHce EXP Include Presentations on Nanomaterials

Posted in Federal, Occupational Health and Safety Issues, United States

On May 17, 2019, the National Institute for Occupational Safety and Health (NIOSH) announced that its presentations at the May 20-22, 2019, American Industrial Hygiene Conference & Expo (AIHce EXP) include:

  • 119 — An Evaluation of Engineered Nanomaterial Safety Data Sheets Post [Globally Harmonized System of Classification and Labeling of Chemicals (GHS)]
    Presenter:  Laura Hodson
    Type:  Poster 119, May 20, 2019; and
  • 348 — Comparison of Enhanced Darkfield Microscopy and Hyperspectral Mapping with Electron Microscopy for Analysis of Airborne Nanoparticulate Collected on Filter-based Media
    Presenter:  Adrienne Eastlake
    Type:  Poster 348, May 22, 2019.

NIOSH congratulates Dr. Charles Geraci, Ph.D., Associate Director for Advanced Manufacturing, on being awarded the Henry F. Smyth, Jr. Award for his outstanding ability to recognize technical or scientific challenges that, when solved, benefit the industrial hygiene profession.

Slides Available from ACS Webinar on Working Safely with Nanomaterials in the Laboratory

Posted in Federal, Occupational Health and Safety Issues, United States

The American Chemical Society (ACS) has posted the slides from its May 16, 2019, webinar on working safely with nanomaterials in the laboratory.  Chuck Geraci, Associate Director for Emerging Technologies at the National Institute for Occupational Safety and Health (NIOSH), moderated a panel including:

  • Ken Kretchman, Director of Environmental Health Safety, North Carolina State University;
  • Craig Merlic, Professor of Chemistry, University of California, Los Angeles (UCLA); and
  • Debbie Decker, Safety Manager, Department of Chemistry, University of California (UC), Davis.

The panel members discussed the importance of managing products containing nanomaterials by integrating them into an existing lab safety program.  They highlighted the importance of a strong safety culture that is created and maintained by bench scientists who champion appropriate safety practices.  Free resources for nanotechnology laboratory safety are available on the National Nanotechnology Initiative (NNI) website.

EC JRC Announces Publication of Article on Measuring Nanoparticles in Medicinal Products

Posted in International, Research, United States

The European Commission’s (EC) Joint Research Center (JRC) announced on May 10, 2019, publication of an article entitled “Measuring particle size distribution of nanoparticle enabled medicinal products, the joint view of EUNCL and NCI-NCL.  A step by step approach combining orthogonal measurements with increasing complexity” in the April 10, 2019, issue of the Journal of Controlled Release.  JRC, in close collaboration with researchers from the French Commissariat à l’énergie atomique et aux énergies alternatives (CEA), Swiss Eidgenössische Material- und Prüfungs-Anstalt (EMPA), U.S. National Cancer Institute’s Nanotechnology Characterization Laboratory (NCI-NCL), and Irish Trinity College, has developed a common strategy for measuring the particle size distribution of nanomedicines.  According to JRC, “[a] quick preliminary step to assess sample integrity and stability by low resolution techniques is followed by the combination of complementary high resolution sizing measurements performed both in simple buffers and in complex biological media.”  The work is part of the collaboration between NCI-NCL and the European Nanomedicine Characterization Laboratory (EUNCL).  JRC states that it has led to “high quality, accurate, determination of particle size distribution.”  Standard operating procedures for the assessment of nanomedicines, including the measurements of particle size distribution, are publicly available, and EUNCL and NCI-NCL are offering wide access to their “state of the art”’ characterization platforms.

NIA Webinar on Nanosafety Available on YouTube

Posted in International, Legal/Regulatory Issues

The Nanotechnology Industries Association (NIA), a “cross-sectoral, responsible voice for nanotechnology value chains and the global commercial eco-system,” hosts frequent webinars and then posts the webinars on its YouTube channel.  On May 7, 2019, NIA held a webinar on “Nano in Action:  Nanosafety.”  Participants heard about the latest research and support tools intended to advance the development of safe materials from speakers involved in human and environmental safety research and services.  The webinar also addressed how regulations and standards are evolving to build commercial and consumer confidence in nanomaterials.  A list of all NIA webinars is available on NIA’s website, as well as on its YouTube channel.  Bergeson & Campbell, P.C. is a proud NIA member.

Germany Announces Research Project to Establish Criteria for Assessment of the Human Health and Environmental Risks of Novel (Nano) Materials

Posted in EU Member State, International, Research

On April 29, 2019, the German Federal Institute for Risk Assessment (BfR) announced InnoMat.Life, a joint research project to establish criteria for an efficient assessment of the human health and environmental risks of novel (nano) materials.  The Federal Ministry of Education and Research is providing 2.22 million euro to fund the project, which will be coordinated by BfR and includes ten partners from public authorities, academia, and industry.  BfR states that until now, nanosafety research focused mainly on first generation nanomaterials, i.e., mainly round particles of pure substances such as nanosilver, titanium oxide, and zinc oxide.  In real life, far more materials are used, however.  Hybrid materials, consisting of two or more substances, are often applied, and nanoparticles can have many different shapes.  Many industrially used materials cover a broad size distribution from nanometers to micrometers.  Moreover, according to BfR, many industrial applications are based on material systems that alter their structure during manufacturing or use, such as the layer-by-layer assembly of products manufactured with 3D printers.  InnoMat.Life expands the research focus and addresses new material classes, including materials with a broad particle size distribution, such as metals and polymer powders for 3D printing, as well as materials with other shapes and sizes, such as rods, platelets, and fibers.  A third focus area comprises hybrid materials made from two or more substances.  According to BfR, one of the main goals of InnoMat.Life is to establish criteria catalogs such that novel materials can be grouped together with regard to their hazard potential.  This will be done also considering exposure potential for humans and the environment.  The project takes into account the full material life cycle, from synthesis to disposal.

OECD Chemical Safety and Biosafety Progress Report Includes Update on Work Regarding Manufactured Nanomaterials

Posted in International, OECD, Research

The Organization for Economic Cooperation and Development’s (OECD) April 2019 issue of its Chemical Safety and Biosafety Progress Report includes an update on OECD’s work to determine the safety of manufactured nanomaterials.  The Report notes that the applicability of OECD Test Guidelines for nanomaterials continues to be a major concern of the work of the Working Party on Manufactured Nanomaterials (WPMN).  WPMN agreed to work on three new projects related to testing manufactured nanomaterials and addressing:  (1) the determination of concentrations of nanoparticles in biological samples for (eco)toxicity studies; (2) the determination of dissolution rates of nanomaterials in environmental media (dynamic method); and (3) supplementary guidance for the use of Test Guidelines 201, 202, and 203 for the determination of the ecotoxicity of manufactured nanomaterials.  Work will continue to complete the compilation of information on biopersistent/biodurable manufactured nanomaterials, as well as on the development of a project proposal to address the toxicokinetics of manufactured nanomaterials.  In addition, the WPMN identified a number of issues relevant for the development of all the Test Guidelines for nanomaterials (i.e., updating the Guidance on Sample Preparation and Dosimetry and the section on nanomaterials in the Guidance on Grouping).

The Report states that the objective of WPMN’s work on exposure measurement and exposure mitigation is to exchange information on (or develop) guidance for exposure measurement and mitigation.  WPMN is working on three complementary projects:  (1) assessing the global readiness of regulatory and non-regulatory models for assessing occupational exposure to manufactured nanomaterials; (2) compilation of available tools and models used for assessing consumer exposure to manufactured nanomaterials; and (3) compilation of available tools and models used for assessing environmental exposure to manufactured nanomaterials.  These projects aim to evaluate the performance of available exposure models to estimate nanomaterial exposure for three target population groups:  workers, consumers, and the environment.  To conduct the evaluations of the models, WPMN “is collecting/generating exposure data in a structured format.”  At WPMN’s February 2019 meeting, it discussed ways to structure the exposure data so that they can be collected by existing OECD Harmonized Templates for Reporting Chemical Test Summaries (OHT), as well as potential areas of work to be considered in collaboration with the Working Party on Exposure Assessment.

According to the Report, WPMN continues to implement the project “Moving towards a ‘Safer Innovation Approach’ for more sustainable NMs and nano-enabled products:  Overview of existing risk assessment tools and frameworks, and their applicability in industrial settings” led by France, the Netherlands, and Business at OECD (BIAC).  The Report states that WPMN expects that the outcomes of this project can further the knowledge to anticipate regulatory challenges posed by innovations, in this case from nanomaterials and nano-enabled products.

The Report lists the upcoming following workshops and meetings regarding nanomaterials:

  • September 10-12, 2019, Workshop on Advancing Adverse Outcome Pathways Development for Nanomaterial Risk Assessment and Categorization (NanoAOP);
  • December 16-18, 2019, WPMN Roadmap Program of Work (and back-to-back meetings for the projects); and
  • June 16-19, 2020, WPMN 20th Meeting.

ISO Issues Method to Quantify Air Concentrations of Carbon Black and Amorphous Silica in the Nanoparticle Size Range in a Mixed Dust Manufacturing Environment

Posted in International, Occupational Health and Safety Issues, Research

The International Organization for Standardization (ISO) has published standard ISO/TS 21361:2019, “Nanotechnologies — Method to quantify air concentrations of carbon black and amorphous silica in the nanoparticle size range in a mixed dust manufacturing environment.”  The standard provides guidelines to quantify and identify particles of carbon black and/or amorphous silica in air samples collected in a mixed dust industrial manufacturing environment.  The guidelines describe air sample collection and the characterization of the particles in the air samples by both particle size and elemental composition.  ISO notes that although the technique described is for carbon black and amorphous silica, the technique can be applied to the measurement of other particle types, provided they are in the size range of six nanometers (nm) to 2.5 micrometers (µm) and can be observed by Transmission Electron Microscopy (TEM)/Scanning Electron Microscopy (SEM) and chemically characterized by Energy Dispersive Spectrometry (EDS).  ISO states that at this time, the methodology represents one of the methods available to quantify chemical‐specific exposures to nanoparticles by size with this degree of sensitivity.  Many of the other existing methods that can speciate and quantify chemical exposure in this size range are mass‐based, and thus are limited by mass‐based detection limits that are high when compared to the mass of particles in this size range.  Furthermore, according to ISO, while other sampling methods may be amenable to the techniques described in the standard, none have been evaluated or validated for this purpose.  ISO suggests that the methodology could be implemented as a higher tier step in an occupational exposure assessment sampling strategy for nanomaterials, particularly in the event that hot spots for exposure are identified using other methods and there is an interest in understanding the nature of the exposure.  Results from the analysis can be used to compare to health benchmarks, as they become available, to understand potential health risk of workers.  In addition, it could be useful in selecting appropriate personal protective equipment (PPE) at a very early stage of the manufacturing process, when required.

Workshop Report Published on EU-U.S. Priorities in Nanosafety

Posted in Federal, Legal/Regulatory Issues, Research, United States

On March 5-6, 2019, a workshop on “Fostering EU‐U.S. Cooperation in Nanosafety” was held.  According to the workshop report, the workshop intended to answer two main questions:

  1. What should be the future research priorities in nanosafety and other advanced materials; and
  2. What are the opportunities for European Union (EU)‐U.S. cooperation priorities in nanosafety.

The discussion was based on the state of implementation of the 2013 report, Nanosafety in Europe 2015‐2025:  Towards Safe and Sustainable Nanomaterials and Nanotechnology Innovations, and current nanosafety activities coordinated by U.S. federal agencies participating in the U.S. National Nanotechnology Initiative (NNI).  More than 30 participants from academia, industry, and policy drafted recommendations to be shared with both the European Commission (EC) and the relevant U.S. funding agencies in view of the upcoming Horizon Europe.  The following seven research priorities were identified:

  1. Environment and human hazards;
  2. Emerging nanomaterials and potential risks;
  3. Social and natural science research to support balanced risk governance of emerging materials;
  4. Nanoinformatics;
  5. Exposure assessment at both environment and human population levels;
  6. Standard methodologies, reference materials, and harmonization; and
  7. Life cycle/transformation/value chain/stewardship.

In addition, during the discussion, workshop participants highlighted the following potential instruments for advancing EU‐U.S. cooperation:

  • Twinning of existing projects;
  • Exchange of young scientists and mobility of researchers;
  • Participation of U.S. to Horizon 2020 and future Horizon Europe. The U.S. Environmental Protection Agency (EPA), National Institute of Environmental Health Sciences (NIEHS), National Science Foundation (NSF), and other federal agencies could fund the U.S. participation in EU-initiated nanosafety programs;
  • Establishment of joint EU‐U.S. research programs;
  • Promotion of the Malta Initiative and opening to the U.S.;
  • Future potential European Cooperation in Science and Technology (COST)‐like projects; and
  • Inducement prizes.

Recommendations on Priorities for IARC Monographs Include Multi-Walled Carbon Nanotubes, Nanomaterials

Posted in International, Legal/Regulatory Issues

An Advisory Group of 29 scientists from 18 countries met on March 25-27, 2019, to recommend priorities for the International Agency for Research on Cancer (IARC) Monographs program during 2020-2024.  The Advisory Group assessed the response to a public call for nominations and considered more than 170 unique candidate agents, including the recommended priorities remaining from a similar Advisory Group meeting convened in 2014.  The Advisory Group deliberated on all nominated agents both by evidence stream and by type of agent to inform development of priority recommendations.  The Advisory Group recommended a broad range of agents with high, medium, or low priority for evaluation.  The Advisory Group assigned priority on the basis of evidence of human exposure and the extent of available evidence for evaluating carcinogenicity.  Agents without evidence of human exposure or evidence for evaluating carcinogenicity were not recommended for further consideration.  The Advisory Group notes that it recognized that agents related to the identified priorities might also warrant evaluation.  Furthermore, additional agents might merit consideration if new relevant evidence indicating an emerging carcinogenic hazard becomes available in the next five years.  IARC announced on April 18, 2019, that the recommendations were published in The Lancet Oncology, “Advisory Group recommendations on priorities for the IARC Monographs.”  The list of agents previously evaluated by IARC Monographs and recommended for evaluation with high priority includes multi-walled carbon nanotubes.  The list of medium priority agents includes nanomaterials, “e.g., titanium dioxide or nanosilica.”