Nano and Other Emerging Chemical Technologies Blog

Nano and Other Emerging Chemical Technologies Blog

Regulatory & legal developments involving nano and other emerging chemical technologies

“Stories from the NNI” Discusses Nanotechnology and Workplace Safety with Dr. Chuck Geraci

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

The March 18, 2019, episode of the National Nanotechnology Initiative’s (NNI) podcast series, “Stories from the NNI,” is a conservation with Dr. Chuck Geraci, Associate Director for Emerging Technologies at the National Institute for Occupational Safety and Health (NIOSH).  Dr. Lisa Friedersdorf, Director of the National Nanotechnology Coordination Office (NNCO), and Dr. Geraci discuss how NIOSH works with industry to ensure workplace safety, the progress that has been made in the environmental, health, and safety effects of nanomaterials (nanoEHS) over the last 15 years, and areas where nanotechnology can help solve problems in the future.  Other recent episodes include guests such as Dr. Marcie Black, Chief Executive Officer (CEO) and Co-Founder of Advanced Silicon Group, Martin Ben-Dayan, CEO and Founder of MetaShield LLC, and Professor Pedro Alvarez of Rice University.

CPSC Will Hold Public Hearing on Its Agenda and Priorities for FYs 2020 and 2021

Posted in Federal, Research, United States

The U.S. Consumer Product Safety Commission (CPSC) published a March 19, 2019, Federal Register notice announcing that it will hold a public hearing on May 1, 2019, to receive views from all interested parties about the CPSC’s agenda and priorities for fiscal years (FY) 2020, which begins on October 1, 2019, and 2021, which begins on October 1, 2020.  CPSC seeks comment on the following questions:

  1. What are the priorities CPSC should consider emphasizing and dedicating resources toward in the FY 2020 Operating Plan and/or the FY 2021 Congressional Budget Request;
  2. What activities should CPSC consider deemphasizing in the FY 2020 Operating Plan and/or the FY 2021 Congressional Budget Request;
  3. What retrospective review of rules should CPSC consider in the FY 2020 Operating Plan and/or the FY 2021 Congressional Budget Request; and
  4. The CPSC’s programs will align with the strategic goals outlined in the CPSC’s 2018-2022 Strategic Plan. The CPSC’s FY 2020 Budget Request is based on four agency priorities:  (1) focusing CPSC’s resources on the highest-priority consumer product safety risks; (2) continuing to support import surveillance by operating, maintaining, and developing the Risk Assessment Methodology system to identify and stop noncompliant imported products from entering the U.S. marketplace; (3) emphasizing collaboration, outreach, and education by engaging all stakeholders through forums, advisory groups, seminars, webinars, technical stakeholder-to-government discussions, and workshops; and (4) expanding the sources and types of data analysis used to identify and assess hazards and inform solutions to address identified hazards.  CPSC requests comments on the priorities as presented in the FY 2020 Budget Request.  CPSC also requests comments on whether it should consider making any changes or adjustments to its proposed or ongoing safety standards activities, regulation, and enforcement efforts in FYs 2020 and 2021.  Comments are welcome on whether particular action items should be higher priority than others, should not be included, or should be added to the FY 2020 and/or FY 2021 agendas.

CPSC’s 2018-2022 Strategic Plan notes that CPSC “is the only agency with mission responsibility for addressing unreasonable risks associated with human exposure to nanotechnology in consumer products.”  Given CPSC’s size and budget, partnering with a wide range of government, academic, and private sector entities to research the implications of nanomaterial use in consumer products is a key element to achieving mission success.  CPSC states that future work will focus on developing robust test methods to determine and characterize human exposure to nanomaterials from consumer products; characterizing and understanding consumer use of products containing nanomaterials; and providing support to manufacturers, especially small businesses, by developing approaches to testing products to determine release of, and potential for exposure to, nanomaterials.  According to CPSC’s FY 2020 Budget Request, CPSC intends to establish or maintain three collaborations with other organizations to work on nanotechnology research or issues affecting consumer products in FYs 2019 and 2020.  Requests to make oral presentations and written comments are due April 17, 2019.

NNI Will Hold First 2019 NanoEHS Webinar on April 9

Posted in Federal, Research, United States

The National Nanotechnology Initiative’s (NNI) 2019 public webinar series on the environmental, health, and safety effects of nanomaterials (nanoEHS) will begin on April 9, 2019, at 12:00 p.m. (EDT) with a presentation by Dr. Robert MacCuspie (Natural Immunogenics Corp.) on “Characterization and Quantification of Engineered Nanomaterials:  Drivers of NanoEHS Research.”  Upcoming webinars will include “Environmental, Health, and Safety Resources for Handling, Transporting, and Disposing of Nanomaterial-Containing Products” on May 16, 2019, at 1:00 p.m. (EDT) and “Nanomaterials in the Environment” on June 11, 2019, at 12:00 p.m. (EDT).  NNI will post more details on its website, including registration information, in the future.

EC Committee Accepting Comment on Preliminary Opinion on Solubility of Synthetic Amorphous Silica

Posted in International, Legal/Regulatory Issues, Research

On March 15, 2019, the European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) published its preliminary opinion on the solubility of synthetic amorphous silica (SAS).  The EC asked whether the SCCS considers that SAS are soluble (100 milligram per liter (mg/L) or higher) or degradable/non-persistent in biological systems in light of the nanomaterial definition of the Cosmetics Regulation.  Having considered the data provided in this dossier and that available in published literature, the SCCS concluded that:

  1. The solubility values for hydrophilic SAS materials have been reported to range from 22 mg/L to 225 mg/L for the solubility tests performed in aqueous media, or following the enhanced Organization for Economic Cooperation and Development (OECD) Test Guideline (TG) 105 (0.5 percent ethanol). The latter protocol has been noted to increase the solubility by a factor of ten for some hydrophilic SAS materials.
  2. The solubility values of hydrophobic surface-treated SAS materials have been reported to range from 0.4 to 180 mg/L for solubility tests performed in aqueous media, or following a modified enhanced OECD TG 105 protocol (i.e., using ten percent ethanol). The latter protocol has been noted to strongly increase the solubility of some hydrophobic SAS materials (by a factor up to 173).

The preliminary opinion states that the hydrophilic and hydrophobic SAS materials can therefore be regarded as “insoluble” (i.e., below 100 mg/L) to “very slightly soluble” (i.e., 100 mg/L to 1,000 mg/L) based upon the terminology used in USP 38 and USP 38 NF33.  According to the preliminary opinion, in regard to the nanomaterial definition in the Cosmetics Regulation, none of the SAS materials (hydrophilic or hydrophobic) included in the dossier can be regarded as soluble.  No data were provided to help establish whether the SAS materials could be regarded as degradable/non-persistent in biological systems.

The EC asked whether SCCS could indicate to which kind of silica this solubility applies.  The preliminary opinion states that the solubility values reported in the dossier are applicable when SAS materials are subject to the following conditions:

  • Hydrophilic SAS: Silica and hydrated silica when solubilized in aqueous media containing up to 0.5 percent ethanol;
  • Hydrophobic surface treated SAS: When solubilized in aqueous media containing up to ten percent ethanol;
  • At temperatures between 19.5 to 20.5°C;
  • With a pH level of between three and eight; and
  • Over a period between three days (hydrophilic SAS) up to 49 days (hydrophobic SAS).

The EC asked whether SCCS has any further scientific concerns with regard to the solubility of SAS.  SCCS states that the solubility values considered in its opinion may not be valid in situations where the SAS materials are formulated/used under conditions that are different from those used in the solubility tests — e.g., when used in a less/non aqueous formulation, or at a different temperature.  According to SCCS, in the context of the definition of nanomaterial under the Cosmetics Regulation, which relates to insoluble materials in conjunction with other size/particle related parameters, the question of solubility of a nano-structured material needs to be seen in perspective for use in cosmetics. For nano-structured materials, with the exception of the materials that are completely soluble, SCCS states that “it is important to establish whether a proportion of these materials would still exist in undissolved form comprising nanoparticles, at the given use level in a cosmetic formulation.”  SCCS noted that the protocols used for solubility tests have a strong influence on the solubility of SAS materials.  Comments on the preliminary opinion are due May 17, 2019.

2019 NanoEHS CORs Workshop Will Be Held in October

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

The 2019 U.S.-European Union (EU) NanoEHS Communities of Research (COR) Workshop will take place October 15-16, 2019, at the Europole de l’Arbois in Aix en Provence, France.  The workshop is organized by the U.S. National Nanotechnology Initiative (NNI) and the European Commission (EC).  The agenda for the October 2018 Bridging NanoEHS Research Efforts Joint Workshop and the following presentations are available:

ISO Publishes Standard on Considerations for the Measurement of Nano-Objects and Their Aggregates and Agglomerates in Environmental Matrices

Posted in International, Research, United States

The International Organization for Standardization (ISO) has published standard ISO/TR 21386, “Nanotechnologies — Considerations for the measurement of nano-objects and their aggregates and agglomerates (NOAA) in environmental matrices.”  The standard provides some considerations for the collection of environmental samples to be analyzed for manufactured NOAA, considerations to distinguish manufactured NOAA from background levels of naturally occurring nanoscale particles of the same composition, and preparation procedures to aid in the quantification of manufactured nanomaterials in environmental matrices.

The ISO standard builds on the work of the Industry Consortium for Environmental Measurement of Nanomaterials (ICEMN), a consortium of stakeholders involved with the production, assessment, and use of nanomaterials working collectively and cooperatively to provide information that would address environmental measurement of nanoscale materials and to enhance the state of the science in this regard.  The Consortium included representatives from industry, academia, and government groups, and was managed by B&C® Consortia Management, L.L.C.

JRC Opens Calls for the Nanobiotechnology Laboratory

Posted in International, Research

The European Commission’s (EC) Joint Research Center (JRC) opens its scientific laboratories and facilities, including its Nanobiotechnology Laboratory, to people working in academia and research organizations, industry, and small and medium enterprises (SME).  JRC opened a call on February 1, 2019, for the Nanobiotechnology Laboratory for the following priority topics:

  • Nanomaterial characterization, including their interactions with biological systems (culture media, proteins);
  • Detection of nanomaterials and microplastics in complex matrices;
  • Surface chemical analysis of macro and nanomaterials;
  • Surface modification and nano-fabrication. Biosensor platform characterization;
  • Cell cultures of adherent cells. Material biocompatibility studies.  In vitro assays for assessing nanomaterial genotoxicity, cytotoxicity, and uptake studies.  Transcriptomics; and
  • Advanced material characterization for non-bio-applications (energy, transport).

The call ends on May 3, 2019.

JRC opened a call on March 4, 2019, for the following training and capacity building topics for the Nanobiotechnology Laboratory:

  • Hands-on training on nanomaterials sizing using state-of-the-art instrumentations such as dynamic light scattering, disk centrifuge sedimentation, asymmetric and sedimentation field flow fractionation with different detectors, and analytical ultra-centrifuge;
  • Introduction into commonly used in vitro assays for studying nanomaterial-cell interactions and highlighting pitfalls occurring during assay development due to the specific nature of nanomaterial (in vitro dosimetry, interaction of nanomaterial with cell reagents);
  • Hands-on training on biomolecular interaction studies using surface plasmon resonance and quartz microbalance techniques;
  • Hands-on training on Raman spectroscopy, ellipsometry, electron microscopy, and an introduction to surface chemistry analysis using XPS and/or ToF-SIMS; and
  • Hands-on training on ICP-MS, including single particle detection.

Applications are due June 3, 2019.

For each call, JRC requires that the lead user institution and user institutions be from a country associated to the European Union (EU) Research Program Horizon 2020.  The lead user institution must be from a university, research or public institution, or from an SME.

NNCO Celebrates NNI’s 15th Anniversary

Posted in Federal, Research, United States

The National Nanotechnology Coordination Office (NNCO) announced on February 28, 2019, that it is planning a number of activities to celebrate the 15-year anniversary of the National Nanotechnology Initiative (NNI).  Upcoming events will include:

  • Special anniversary episodes of “Stories from the NNI” podcast series. Experts from academia, government, and industry share their perspectives on key research and development advances in nanotechnology.  They also discuss how the NNI has changed the nanotechnology landscape.  The most recent episode features Dr. Lisa Friedersdorf, NNCO Director, and Professor Pedro Alvarez, Rice University, discussing the use of nanotechnology in water applications, as well as Pedro’s thoughts on the NNI’s contributions during the past 15 years.  The episode is available on a variety of podcast platforms;
  • Plenary keynote panel at Nanotech 2019, part of TechConnect World Innovation Conference & Expo, June 17-19, 2019, in Boston, Massachusetts. This panel will engage prominent experts to highlight recent nanotechnology advances, and perhaps more importantly, the future opportunities, challenges, and societal impact nanoscience and technology has in store; and
  • The NNI at 15: A Stakeholder Workshop on the Past, Present, and Future of the NNI, August 1-2, 2019, in Washington, D.C.

ECHA Interview Focuses on Research on Safety of Nanomaterials

Posted in International, Research

The February 2019 issue of the European Chemicals Agency’s (ECHA) Newsletter includes an interview with Eva Valsami-Jones, Professor of Environmental Nanoscience at the University of Birmingham and leader of the European Union (EU) NanoSafety Cluster Coordination Team, on research on the safety of nanomaterials.  The NanoSafety Cluster coordinates the funding of research projects at the European level that address the safety aspects of nanomaterials and the related technologies, such as toxicity, exposure, and standardization.  In the interview, Valsami-Jones states that “[t]he greatest information-based need we currently have is a better ability to perform read-across between datasets.”  When asked what the future of nanoresearch looks like, Valsami-Jones responded that nanomaterials “are increasingly becoming part of the big picture on chemicals.  In the near future, I expect there will be a need to study them as a part of a larger family of chemicals, rather than as a distinct entity.”  According to Valsami-Jones, in terms of determining the safety of nanomaterials, there has been a lot of concerted effort in the EU, and a lot of good science has been carried out.  She notes that as a consumer, “I can say that I feel safe when buying products on the EU market, and that I trust that the manufactured nanomaterials I come into contact with in my daily life are safe.”

White House OSTP’s Science and Technology Highlights Include Advances in Nanotechnology

Posted in Federal, Research, United States

On February 21, 2019, the White House Office of Science and Technology Policy (OSTP) posted a report entitled Science & Technology Highlights in the Second Year of the Trump Administration.  The report highlights science and technology achievements, including the following under “R&D Fundamentals”:

Supporting and celebrating key advances in nanotechnology.  In December, OSTP’s National Nanotechnology Coordination Office celebrated the 15-year anniversary of the establishment of nanotechnology as a national initiative by President George W. Bush.  The Office launched a series of podcasts with experts from academia, government, and industry to highlight key advances in nanotechnology catalyzed by the National Nanotechnology Initiative and how nanotechnology will enable breakthroughs and applications of the future.  In 2018, the Administration invested approximately $1.4 billion of Federal R&D in nanotechnology, advancing knowledge and providing new capabilities to a wide range of existing and emerging technologies.