Nano and Other Emerging Chemical Technologies Blog

Nano and Other Emerging Chemical Technologies Blog

Regulatory & legal developments involving nano and other emerging chemical technologies

Germany Publishes Comparison of Inhalation and Intratracheal Instillation as Testing Methods for Characterization of Granular Biopersistent Particles

Posted in EU Member State, International, Occupational Health and Safety Issues, Research

Germany’s Federal Institute for Occupational Safety and Health (BAuA) has published a report entitled Comparison of Inhalation and Intratracheal Instillation as Testing Methods for Characterisation of Granular Biopersistent Particles (GBP).  In Project F 2364, researchers conducted an in vivo validation study to evaluate the consistency of data with results obtained in the preceding intratracheal instillation study in Project F 2336.  The abstract states that the same test items were used, and similar lung loads were achieved by calculating the target values after inhalation with the Multi-Path Particle Dosimetry (MPPD) model.  This approach served as proof of whether the instillation can be a reliable surrogate instead of the physiological inhalation route while assessing the GBP status of dust samples.  According to the conclusion in the abstract, considering the percentual polymorphonuclear neutrophil (PMN), as well as the absolute PMN concentrations, “the predominant observation is that inhalation induced a smaller PMN influx (with exception of biosoluble μ-BaSO4 and nano-SiO2) at similar doses.  This can be expected because of the physiological dust uptake and deposition by inhalation that is more gentle than intratracheal instillation (bolus effect!).”  The conclusion notes that effects detected after instillation will not always allow a “non inert” statement.  The final setting of maximum tolerable clearance t1/2 and PMN levels to define the GBP category should include inhalation.  The conclusion states that “[d]oses at instillation testing of nanoparticles should not exceed volumetric values of 0.3 μl (using the correct agglomerate density).”

NIOSH Publishes Revised Draft CIB on Health Effects of Occupational Exposure to Silver Nanomaterials, Will Hold Online Meeting

Posted in Federal, Legal/Regulatory Issues, Occupational Health and Safety Issues, United States

On September 18, 2018, the National Institute for Occupational Safety and Health (NIOSH) published a Federal Register notice announcing the availability of a draft document entitled Current Intelligence Bulletin:  Health Effects of Occupational Exposure to Silver Nanomaterials.  As reported in our January 22, 2016, blog item, NIOSH published a draft Current Intelligence Bulletin (CIB) on silver nanomaterials on January 21, 2016.  According to the notice, the revised draft CIB provides an updated scientific literature review of information pertaining to occupational exposure to silver nanomaterials.  The literature review includes studies on the toxicological effects of exposure to silver nanomaterials in experimental animal and cellular systems, the effect of particle size and other properties on the toxicological effects of silver, and NIOSH recommendations on the measurement and control of occupational exposures to silver and silver nanomaterials.  NIOSH assessed the potential health risks of occupational exposure to silver nanomaterials by evaluating the scientific literature.  The notice states that studies in animals “have shown adverse lung and liver effects associated with exposure to silver nanoparticles.”  Based on an assessment of these data, NIOSH developed a recommended exposure limit (REL) for silver nanoparticles (<100 nanometers (nm) primary particle size) of 0.9 micrograms per cubic meter (μg/m3) as an airborne respirable eight-hour time-weighted average (TWA) concentration.  The draft REL would apply to processes that produce or use silver nanomaterials.  In addition, NIOSH continues to recommend a REL of 10 μg/m3 for total silver (metal dust, fume, and soluble compounds, as Ag).  NIOSH further recommends the use of workplace exposure assessments, engineering controls, safe work procedures, training and education, and established medical surveillance approaches to prevent potential adverse health effects from exposure to silver nanomaterials.  NIOSH proposes research needs to fill remaining data gaps on the potential adverse health effects of occupational exposure to silver nanomaterials.  The purpose of the public review of the draft CIB is to obtain comments on whether it (1) adequately and clearly describes the scientific literature on the potential adverse health effects of silver nanomaterials, and (2) demonstrates that the NIOSH recommendations on occupational exposure to silver nanomaterials are consistent with current scientific knowledge.  Comments on the draft CIB are due November 30, 2018.

 

NIOSH will hold a public online meeting on October 30, 2018, 1:00 p.m.-4:30 p.m. (ET), or until the last public commenter has spoken, whichever occurs first.  NIOSH states that the public online meeting will be a web-based event available only by remote access.  According to the notice, special emphasis will be placed on discussion of the following questions for reviewers:

  1. Does the draft CIB accurately identify and characterize the health hazards of exposures to silver and silver nanomaterials based on the available scientific literature?
  2. Are the risk assessment and dosimetry modeling methods presented in the draft CIB consistent with current scientific knowledge and practice?
  3. Is the relationship between exposure to silver nanomaterials and biological activity (toxicity) accurately portrayed in the draft CIB?
  4. Is the available scientific evidence fully described regarding the human health relevance of the adverse health endpoints observed in rats associated with exposure to silver nanomaterials?
  5. Is the proposed REL well-supported by the scientific data presented in the draft CIB?
  6. Are the sampling and analytical methods proposed for silver nanomaterials adequate to measure worker exposure?
  7. Are the recommended strategies for controlling exposure to silver and silver nanomaterials (e.g., engineering controls, work practices, personal protective equipment) reasonable?
  8. Are the important data gaps and future research needs complete and clearly described?

NIOSH has posted the following materials in Docket ID CDC-2016-0001:

EC Publishes Success Story on Controlling Light at the Nanoscale Thanks to Graphene

Posted in International, Research

The European Commission (EC) has published a success story, “Controlling light at the nanoscale thanks to graphene.”  The EC notes graphene, “an atomically thin lattice of carbon, has many exceptional properties.”  A European Union (EU)-funded project is focusing on the unique capabilities of graphene plasmons to transport and control light emissions at spatial scales far smaller than their wavelength.  They can be exploited in numerous applications, including for infrared biosensing and absorption spectroscopy to identify the chemical information of biomolecules by detecting their vibrational fingerprints, and for subwavelength optical imaging, which enables the imaging of details much smaller than the wavelength of the illuminating light.  These ground-breaking applications rely on the development of techniques to be able to control efficiently the electrical tuning of the graphene plasmons, however, allowing their state to be switched or modulated with low volatility at high speeds.  The two-year research initiative aims to identify, develop, and demonstrate ways to solve that problem, targeting a solution based on the use of switchable phase change materials to control graphene plasmons with non-volatile, ultrafast, and all-optical switching functionalities.  According to the project team, these new functionalities would significantly enhance the application potential of graphene plasmons in many fields, including optical sensing and all-optical plasmonic signal processing for computing and communications, as well as potentially supporting the development of advanced metamaterials with unique structures and characteristics not found in nature.

ECHA Article Addresses New REACH Information Requirements for Nanomaterials

Posted in International, Legal/Regulatory Issues

The September 2018 issue of the ECHA Newsletter includes an article entitled “Are the new REACH information requirements for nanos relevant for you?” written by Jenny Holmqvist, Coordinator for Nanomaterials for the European Chemicals Agency (ECHA).  As reported in our April 26, 2018, blog item, the European Commission (EC) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Committee voted on April 26, 2018, to amend several REACH Annexes to clarify the registration requirements for nanomaterials.  Holmqvist’s article provides answers to what the revised Annexes change, who the changes impact, when the new Annexes come into force, what ECHA is doing to help companies prepare, whether there are test methods already available to comply with the amended requirements, and if the new information requirements imply that nanomaterials on the European Union’s (EU) market are unsafe.  Holmqvist recommends that manufacturers and importers familiarize themselves “at the earliest opportunity, with the introduced changes to assess whether they are relevant for your substances.”  Industry must comply with the new requirements by January 2020.  ECHA is examining which parts of the existing guidance need to be updated or whether new guidance is necessary.  Holmqvist states:  “We also plan to increase our efforts in reaching out to industry organisations both in bilateral meetings and also through our guidance process.  This way, we hope to ensure that there is sufficient support available for companies that are preparing possible updates to their registration dossiers.”  Regarding whether the new information requirements imply that nanomaterials currently on the market are unsafe, Holmqvist notes that “without changing the legal information requirements, it would be very difficult for authorities to verify whether companies registering their chemicals have demonstrated the safe use of nanomaterials throughout the supply chain or whether further regulatory actions for managing their risks would be needed,” emphasizing the word verify.  Holmqvist states:  “I think we all agree that the realisation of the great opportunities that nanotechnology and nanomaterials may offer society should go hand-in-hand with the transparent demonstration by industry of their safety and sustainability.”  The article lists the following guidance that is already available to help companies prepare for the revised information requirements:

Registration Open for NNI Webinar on Technology Pathways Toward Commercializing Nanotechnology

Posted in Federal, United States

Registration is available for the National Nanotechnology Initiative’s (NNI) September 19, 2018, webinar on “Technology Pathways Toward Commercializing Nanotechnology.”  The webinar will focus on quality control in the manufacturing process and builds on NNI’s November 2017 Technology Pathways workshop.  Webinar panelists will engage in a dialogue about the criticality of and issues surrounding quality control in the production of nanomaterials.   Dr. Lisa Friedersdorf, Director of the National Nanotechnology Coordination Office (NNCO), will moderate the discussion.  Panelists will provide a brief overview of their experiences, successes, and challenges in ensuring the quality of manufactured nanomaterials.  This will be followed by a question and answer period.  Questions for the panelists can be submitted to webinar@nnco.nano.gov from now through the end of the webinar at 11:30 a.m. (EDT) on September 19, 2018.  The panelists will include:

  • Katherine Barton, Director of Production and Laboratory Operations, Nano-C; and
  • Doug Singer, Executive Vice President of Manufacturing, Cerion Advanced Materials.

This webinar is free and open to the public with registration on a first-come, first-served basis.  Registration will be capped at 500.

EUON Study Finds Knowledge Gaps Exist in Risk Assessment of Nano-Sized Pigments

Posted in International, Legal/Regulatory Issues, Research

The European Union (EU) Observatory for Nanomaterials (EUON) announced on September 7, 2018, that a new study found gaps in the current knowledge on the hazard and risk assessment of nano-sized pigments.  The study, commissioned by EUON, identified 81 nano-sized pigments currently used in the EU market.  The study was done to collect publicly available information on the identified nano-sized pigments that are on the EU market.  EUON states that the findings “show that the risks of nanopigments cannot adequately be assessed due to missing information on exposure, the absence of reliable nano-specific toxicological data, and a general lack of public-domain data on their uses.”  EUON states that the study found that the available toxicological data are often inconsistent, and that the reported results are often contradictory — “with the exception of a limited number of well-tested substances where general conclusions can still be drawn.”  The study established an inventory of currently known nano-sized pigments used in consumer and professional products on the EU market.  Seventy-seven substances were definitively identified as nano-sized pigments, and an additional four substances were identified as filler pigments used to increase the volume and reduce the overall cost of the ink in which the pigment is used.  The study provides recommendations for further work, including an increased emphasis on exposure assessment and control, as well as “generating well-designed and realistic exposure scenarios on particular nanomaterials for easy access and for benchmarking different safety measures.”

IRSST Publishes Assessment of Methods of Sampling and Characterizing Engineered Nanomaterials in the Workplace in English

Posted in International, Occupational Health and Safety Issues

The Institut de recherche Robert-Sauvé en santé et en sécurité du travail (IRSST) recently published a report, in English, entitled An Assessment of Methods of Sampling and Characterizing Engineered Nanomaterials in the Air and on Surfaces in the Workplace.  As reported in our March 29, 2017, blog item, IRSST first published the report in French.  The research project has two complementary parts:  a laboratory investigation and a fieldwork component.  The laboratory investigation involved generating titanium dioxide nanoparticles under controlled laboratory conditions and studying different sampling and analysis devices.  The fieldwork comprised a series of nine interventions adapted to different workplaces and designed to test a variety of sampling devices and analytical procedures and to measure engineered nanomaterial exposure levels among Québec workers.  The workplace investigations covered a variety of industries (e.g., electronics, manufacturing, printing, construction, energy, research and development) and included both producers and users or integrators of engineered nanomaterials.  In the workplaces investigated, IRSST found nanometals or metal oxides, nanoclays, nanocellulose, and carbonaceous materials, including carbon nanofibers and carbon nanotubes.  Based on IRSST’s investigations, it proposes a strategy for more accurate assessment of exposure to engineered nanomaterials using methods that require a minimum of preanalytical handling.  The recommended strategy is a systematic two-step assessment of workplaces that produce and use engineered nanomaterials.  The first step involves testing with different direct-reading instruments, as well as sample collection and subsequent microscopic analysis, to identify clearly the work tasks that generate engineered nanomaterials.  The second step, once work exposure is confirmed, is specific quantification of the engineered nanomaterials detected.  IRSST states that the following findings are particularly helpful for detailed characterization of exposure to engineered nanomaterials:

  1. The first conclusive tests of a technique using inductively coupled plasma mass spectrometry (ICP-MS) to quantify the metal oxide content of samples collected in the workplace;
  2. The possibility of combining different sampling methods recommended by the National Institute for Occupational Safety and Health (NIOSH) to measure elemental carbon as an indicator of NTC/NFC, as well as demonstration of the limitation of this method stemming from observed interference with the black carbon particles required to synthesis carbon materials;
  3. The clear advantages of using an Mini Particle Sampler® (MPS), which allows quantification of materials;
  4. The major impact of sampling time: a long sampling time overloads electron microscopy grids and can lead to overestimation of average particle agglomerate size and underestimation of particle concentrations; and
  5. The feasibility and utility of surface sampling, either with sampling pumps or passively by diffusion onto the electron microscopy grids, to assess the dispersion of engineered nanomaterials in the workplace.

IRSST states that “[t]hese original findings suggest promising avenues for assessing ENM exposure, while also showing their limitations. Improvements to our sampling and analysis methods give us a better understanding of ENM exposure and help in adapting and implementing control measures that can minimize occupational exposure.”

12th International Nano-Authorities Dialogue Held in Germany in June

Posted in International, Legal/Regulatory Issues

The 12th International Nano-Authorities Dialogue was held in Germany on June 7-8, 2018.  According to the Federal Ministry for the Environment, Nature Conservation and Nuclear Safety (BMU), environmental, health, and occupational safety authorities, as well as industry, science, and civil society organizations from Germany, Austria, Luxemburg, Liechtenstein, and Switzerland, discussed current topics in the area of nano governance.  Meeting participants evaluated the state of play of nano regulation and focused discussions on recommendations on how to improve the implementation of European and national regulations.  BMU states that the results and recommendations that were supported by all stakeholders will be the basis for further discussions on the regulatory action needs and are documented in “Roadmap 2025.”  The 2015 draft of the Roadmap will be further developed to support the specification and coordination of measures and activities of the participating countries.  BMU notes that the question of whether the regulation of novel materials, also known as “advanced materials,” should be included in the discussions and “Roadmap 2025” was discussed at the 12th International Nano-Authorities Dialogue for the first time.  Presentations from the Dialogue are available, in German.

Austrian Academy of Sciences Publishes English Version of Dossier on Nanotechnological Applications for Food Contact Materials

Posted in EU Member State, International, Legal/Regulatory Issues

In July 2018, the Institute of Technology Assessment of the Austrian Academy of Sciences published an English version of Dossier No. 49, “Nanotechnological Applications for Food Contact Materials.”  The Dossier concludes that nanomaterials can significantly improve the properties of plastic materials, making nanocomposites “increasingly interesting for manufacturers, especially for food packaging.”  Nanomaterials used in food contact materials (FCM) in the European Union (EU) require authorization, and the European Food Safety Authority (EFSA) is responsible for assessing their safety.  The Dossier states that “[a]t present, little is known about the environmental behaviour of nanomaterials during the end of life phase of FCMs.  Nor have many studies been carried out to investigate the possible release of nanoscale additives during waste treatment processes or the question of the exposure of workers during such processes.”  Further studies and exposure assessments are needed here. According to the Dossier, “[i]f nanotechnology is to be made sustainable there is a need to ensure that, in the framework of a circular economy, plastic materials with nano-scale additives can also be recycled or used for energy recovery in a secure way.”

NNI Publishes Supplement to President’s 2019 Budget Request

Posted in Federal, Research, United States

The National Nanotechnology Initiative (NNI) has published The National Nanotechnology Initiative Supplement to the President’s 2019 Budget.  The August 2018 document not only supplements the President’s budget request for fiscal year 2019, but also serves as NNI’s annual report and addresses the requirement for Department of Defense (DOD) reporting on its nanotechnology investments.  President Trump requests nearly $1.4 billion for NNI, “a continued investment in basic research, early-stage applied research, and technology transfer efforts that will lead to the breakthroughs of the future.”  According to the document, the actual NNI investments are higher for 2017 than the estimated and requested levels.  For example, the participating agencies reported $1.55 billion in actual NNI investments for 2017, “significantly larger than 2017 estimated investments previously published in the 2018 Budget ($1.47 billion) and 2017 requested investments published in the 2017 Budget ($1.44 billion).”  The President’s 2019 budget, which requests nearly $1.4 billion for NNI, supports nanoscale science, engineering, and technology research and development (R&D) at 12 agencies.  The five federal organizations with the largest investments (representing 95 percent of the total) are:

  • Department of Health and Human Services (HHS)/National Institutes of Health (nanotechnology-based biomedical research at the intersection of life and physical sciences);
  • National Science Foundation (fundamental research and education across all disciplines of science and engineering);
  • Department of Energy (fundamental and applied research providing a basis for new and improved energy technologies);
  • DOD (science and engineering research advancing defense and dual-use capabilities); and
  • Department of Commerce/National Institute of Standards and Technology (fundamental R&D of measurement and fabrication tools, analytical methodologies, metrology, and standards for nanotechnology).

The report states that other agencies and agency components investing in mission-related nanotechnology research are the Consumer Product Safety Commission; HHS/Food and Drug Administration; HHS/National Institute for Occupational Safety and Health; Department of Homeland Security; Department of Justice; Department of Transportation/Federal Highway Administration; U.S. Environmental Protection Agency; National Aeronautics and Space Administration; U.S. Department of Agriculture (USDA)/Agriculture Research Service; USDA/Forest Service; and USDA/National Institute of Food and Agriculture.  Appendix A provides an overview of nanotechnology R&D by agency.  The document also provides highlights illustrating progress toward each of the four NNI goals:

  • Goal 1. Advance a World-Class Nanotechnology R&D Program;
  • Goal 2. Foster the Transfer of New Technologies into Products for Commercial and Public Benefit;
  • Goal 3. Develop and Sustain Educational Resources, a Skilled Workforce, and a Dynamic Infrastructure and Toolset to Advance Nanotechnology; and
  • Goal 4. Support Responsible Development of Nanotechnology.