Nano and Other Emerging Chemical Technologies Blog

Nano and Other Emerging Chemical Technologies Blog

Regulatory & legal developments involving nano and other emerging chemical technologies

ECHA Board of Appeal Annuls Four Decisions Requesting Substance Identity Information on a Nano Structured Substance

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

In cases A-008-2015, A-009-2015, A-010-2015, and A-011-2015, the European Chemicals Agency (ECHA) Board of Appeal examined appeals against compliance check decisions made by ECHA requesting further substance identity information from four registrants of a “nano structured” substance.  As reported in our July 29, 2015, blog item, ECHA adopted the contested decisions on December 17, 2014, following a compliance check under the dossier evaluation procedure of the submitted registration.  In each contested decision, ECHA found that the registration did not comply with the requirements of Article 10(a)(ii), as well as Annex VI, Section 2 of the Registration, Evaluation, Authorization and Restriction of Chemicals Regulation (REACH).  ECHA requested that each appellant submit the following information:

  • Name, molecular, and structural formula, or other identifier of the substance (Annex VI, 2.1 and 2.2);
  • Composition of the substance (Annex VI, 2.3); and
  • Description of the analytical methods used (Annex VI, 2.3.7).

ECHA announced in its October 12, 2016, ECHA Weekly that the Board of Appeal found that the contested decisions “breached the principle of legal certainty as some of the terms used, specifically ‘grades’, ‘forms’ and ‘nanoforms’, were not clearly defined and did not allow the Appellants to clearly ascertain what information they were required to provide in order to comply with the Agency decisions.”  The Board of Appeal annulled the contested decisions.  The appellants raised other pleas (e.g., whether ECHA could legally require them to submit further information to allow for a more detailed identification of the nanoforms of the registered substance).  The Board of Appeal concluded that since it is not clear from the contested decisions what information the appellants are required to provide, it was not possible to decide on the legality of those requests.

NIOSH Presentation on Engineering Controls for Nanotechnology Now Available

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

On September 27, 2016, the National Institute for Occupational Safety and Health (NIOSH) Board of Scientific Counselors (BSC) met, and its discussion included engineering controls and nanomaterials.  Kevin H. Dunn, Sc.D., CIH, a NIOSH Division of Applied Research and Technology (DART) mechanical engineer and member of NIOSH’s Nanotechnology Research Center, provided an update to the BSC on NIOSH’s evaluations, findings, recommendations, and guidance for reducing occupational exposures to nanomaterials through engineering controls.  NIOSH recently posted Dunn’s presentation online.  According to the presentation, NIOSH has a good understanding of how exposures occur and how to control them.  NIOSH needs to continue to conduct field studies to identify new processes and materials, however.  The question of whether NIOSH should be doing any laboratory work on quantifying control effectiveness was raised.  In addition, NIOSH needs to have a better understanding of how to communicate with its target audience.  Future plans include developing three additional Workplace Design Solutions (WDS) on common nanotech tasks/processes, including reactor operations (harvesting and cleaning); powder collection/dumping (large bag dumping and powder packing); and large scale material handling.

2016 SNO Conference Will Focus on Sustainable Nanotechnology Systems

Posted in United States

The 2016 Sustainable Nanotechnology Organization (SNO) conference will be held November 10-12, 2016.  The conference sessions will be organized around selected “systems,” and sessions will be populated with talks on applications, effects and implications, analytical methods, and lifecycle aspects of nanomaterials within each system.  The aims are to identity where nanomaterials and nanotechnology can improve the sustainability of each system and to foster integration of knowledge between applications and implications within each system.  SNO’s web page for the conference states that in the following systems of interest, SNO asks how to help reach sustainability through nanotechnology:

  • Food/agricultural systems: Precision agriculture; pesticide delivery, nutrient delivery, improved food packaging and preservation; food fortification; stabilizing soil; and human health and environmental implications;
  • Energy systems: Energy storage; generation by solar and wind; energy transmission; carbon dioxide capture and storage; plant efficiency improvements; system controls; and air pollution control in fossil systems;
  • Air/water systems: Drinking water treatment; air pollution controls, wastewater treatment; groundwater remediation; pollution prevention; disinfection; decreasing the energy footprint of water treatment; distribution systems; source water protection; and lowering demand for water in industry and households, air filtration systems;
  • Industry/manufacturing (in general, not just nanomanufacturing) systems: Lowering process energy requirements; using more benign materials; safety of nanomaterials compared to alternatives; substitution for renewable resources; pollution prevention; monitoring systems for manufacturing; lifecycle releases of nanomaterials and models to predict exposure concentrations; and economic sustainability of nanotechnology;
  • Solid waste (especially e-waste) management: Recycling of nanomaterials; resource recovery from landfills; improved quality of recycled materials; and advanced waste management;
  • Environmental/biological systems: Ecotoxicity; ecosystem responses to nanomaterial releases; improved monitoring tools, exposure routes and exposure models for consumers and the environment; and models for environmental fate and exposures of nanomaterials;
  • Health/medical systems: Diagnostic tools for healthcare; nanomedicine and improved drug delivery; and models for nanotoxicity prediction/reduction;
  • Urban systems: Improving construction materials; building more sustainable residences and commercial buildings; improving energy systems for heating and cooling; and improving transportation systems (including increasing fuel efficiency; decreasing weight of vehicles; building better catalysts);
  • Education systems: Curriculum development for sustainable nanotechnology, case studies, materials development, and informal education networks; and
  • Social systems and governance: Upcoming laws and regulations; systems of governance of nanomaterials; social justice concerns; education; and calculating and communicating benefits (and risks) of nanotechnology.

The conference program will address the above topics from both a fundamental and applied viewpoint.  SNO intends the conference to foster new collaborations between academic and industrial participants.  According to SNO, this community of users, researchers, and developers of engineered nanomaterials will provide a long-term, scientific assessment of where the science is for sustainable nano, where it should be heading, and what steps academics, government agencies, and others can take now to reach targeted goals.  The deadline for hotel registration for conference rates is October 24, 2016.  Late conference registration fees will apply beginning October 29, 2016.

EPA Submits Final TSCA Rule on Nanomaterials to OMB for Review

Posted in Federal, Legal/Regulatory Issues, United States

On October 7, 2016, the U.S. Environmental Protection Agency (EPA) submitted to the Office of Management and Budget (OMB) a final rule that would require reporting and recordkeeping information on certain chemical substances when they are manufactured or processed as nanoscale materials.  EPA issued a proposed rule, under Section 8(a) of the Toxic Substances Control Act (TSCA), on April 6, 2015.  EPA proposed to require persons that manufacture or process certain chemical substances when manufactured or processed at the nanoscale to report electronically to EPA certain information, including the specific chemical identity, production volume, methods of manufacture and processing, exposure and release information, and existing data concerning environmental and health effects.  EPA also proposed to require any persons who intend to manufacture or process chemical substances as discrete nanoscale materials after the effective date of the final rule to notify EPA of the same information at least 135 days before the intended date of commencement of manufacture or processing.  As reported in our May 19, 2016, blog item, OMB’s Office of Information and Regulatory Affairs (OIRA) issued a December 17, 2015, memorandum concerning “Regulatory Review at the End of the Administration,” which states that “agencies should strive to complete their highest priority rulemakings by the summer of 2016 to avoid an end-of-year scramble that has the potential to lower the quality of regulations that OIRA receives for review and to tax the resources available for interagency review.”

Webinar Will Announce NSI on Water Sustainability through Nanotechnology

Posted in Federal, United States

On October 19, 2016, the National Nanotechnology Coordination Office (NNCO) will hold a webinar to announce the Nanotechnology Signature Initiative (NSI):  Water Sustainability through Nanotechnology.  The webinar will highlight the activities of several participating federal agencies.  NNCO states that the webinar will be the first in a series exploring the confluence of nanotechnology and water.  Subsequent webinars will each focus on one of the NSI’s technical focus areas:  increase water availability; improve the efficiency of water delivery and use; and enable next-generation water monitoring systems.  Speakers will include:

  • Nora Savage, National Science Foundation;
  • Daniel Barta, National Aeronautics and Space Administration;
  • Paul Shapiro, U.S. Environmental Protection Agency;
  • Jim Dobrowolski, U.S. Department of Agriculture (USDA) National Institute of Food and Agriculture; and
  • Hongda Chen, USDA National Institute of Food and Agriculture.

NNCO encourages participation from representatives of the National Nanotechnology Initiative (NNI) member agencies participating in the NSI, the nanotechnology business community, and interested members of the general public, media, academia, industry, non-governmental organizations, and federal, state, and local governments.  Following speaker presentations, the panelists will answer questions from the audience.  Questions for the panel can be submitted to through the end of the webinar.  Registration is limited to 500 and is open on a first-come, first-served basis.

NIOSH Announces Recent Publications on Nanotechnology and Certain Types of Carbon Nanotubes

Posted in Federal, Research, United States

The National Institute for Occupational Safety and Health (NIOSH) recently announced the availability of the following publications:

  • Nanotechnology: Delivering on the Promise is a two-volume American Chemical Society symposium report that discusses advances in nanotechnology and the value of precautionary risk management.  Editors include NIOSH Associate Director for Nanotechnology Charles L. Geraci, Ph.D., CIH.  Lynn L. Bergeson wrote a chapter entitled “Opportunities and Challenges for Health, Safety, and the Environment:  The Regulatory Void?,” which surveys the governance approaches that are emerging, with particular emphasis on the need for regulatory measures in targeted areas to ensure the integrity of core governance principles and provide some measure of commercial predictability; and
  • NIOSH scientists and external partners authored a critical review, update, and expansion of whether certain types of carbon nanotubes pose a risk of cancer in “Evaluating the mechanistic evidence and key data gaps in assessing the potential carcinogenicity of carbon nanotubes and nanofibers in humans,” published in Critical Reviews in Toxicology. When the International Agency for Research on Cancer (IARC) evaluated carbon nanotubes in October 2014, it concluded the mechanistic evidence was considered to be not strong enough to alter the evaluations based on the animal data.  The authors examine the in vivo and in vitro experimental studies according to current hypotheses on the carcinogenicity of inhaled particles and fibers.  The authors cite additional studies of carbon nanotubes that were not available at the time of the IARC meeting, and extend their evaluation to include carbon nanofibers.  The authors identify key data gaps and suggest research needs to reduce uncertainty.  The abstract states:  “The findings of this review, in general, affirm those of the original evaluation on the inadequate or limited evidence of carcinogenicity for most types of [carbon nanotubes] and [carbon nanofibers] at this time, and possible carcinogenicity of one type of [carbon nanotube] (MWCNT-7).”  According to the authors, the key evidence gaps to be filled by research include:  investigation of possible associations between in vitro and early-stage in vivo events that may be predictive of lung cancer or mesothelioma, and systematic analysis of dose-response relationships across materials, including evaluation of the influence of physico-chemical properties and experimental factors on the observation of nonmalignant and malignant endpoints.

Minnesota Adds Several Nanomaterials to List of Chemicals of High Concern

Posted in State, United States

On September 13, 2016, the Minnesota Department of Health (MDH) announced the availability of an updated list of chemicals of high concern.  Chemicals added to the list of chemicals of high concern include silicon carbide whiskers (Chemical Abstracts Service (CAS) Number 409-21-2), carbon nanotubes, multi-walled MWCNT-7 (CAS Number 308068-56-6), and silicon carbide, fibrous (CAS Number 308076-74-6).  MDH added these nanomaterials based on their International Agency for Research on Cancer (IARC) classifications.  As reported in our November 3, 2014, blog item, the IARC Working Group met on September 30-October 7, 2014, to review the carcinogenicity of fluoro-edenite, silicon carbide fibers and whiskers, and carbon nanotubes.  The Working Group classified carbon nanotubes, multi-walled MWCNT-7 as Group 2B (possibly carcinogenic to humans); carbon nanotubes, multi-walled, other than MWCNT-7 as Group 3 (not classifiable as to its carcinogenicity to humans); carbon nanotubes, single-walled as Group 3; silicon carbide, fibrous as Group 2B; silicon carbide whiskers as Group 2A (probably carcinogenic to humans); Acheson process, occupational exposure associated with as Group 1 (carcinogenic to humans); and fluoro-edenite fibrous amphibole as Group 1.  MDH reviewed chemicals classified as Group 1, 2A, or 2B for addition to the list of chemicals of high concern.

ISO Publishes Standard for Compilation and Description of Sample Preparation and Dosing Methods for Engineered and Manufactured Nanomaterials

Posted in Research

The International Organization for Standardization (ISO) published ISO/TR 16196:2016, “Nanotechnologies — Compilation and description of sample preparation and dosing methods for engineered and manufactured nanomaterials.”  The goal of the standard is to assist scientists and experts to understand, plan, choose, and address issues relevant to nanomaterials before and during toxicological testing.  The descriptions of sample preparation method factors for both in vitro and in vivo toxicological testing of engineered and manufactured nanoscale materials include considerations about physico-chemical properties, media, methods for transformation and accumulation studies, health effects, and dosimetry.  According to ISO, the standard focuses on factors that might lead to results that are not relevant to safety evaluations.  When featured, the standard considers referenced methods for their general interest and potential applicability.  ISO states that it is likely that most of the described methods are not generally applicable to all nanomaterials, but they do demonstrate important factors and limitations that are common for a variety of nanomaterials.  ISO notes that the standard is not intended to be a literature review nor a thorough assessment of the quality of the methods or data generated.  The standard is intended to complement other international efforts.

Germany Publishes Review of the Joint Research Strategy of the Higher Federal Authorities

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

Germany Publishes Review of the Joint Research Strategy of the Higher Federal Authorities


On September 19, 2016, the Federal Institute for Occupational Safety and Health (BAuA) published a report entitled Review of the joint research strategy of the higher federal authorities — Nanomaterials and other advanced materials:  Application safety and environmental compatibility.  The report states that in a long-term research strategy, the higher federal authorities responsible for human and environmental safety — the German Environment Agency (UBA), the Federal Institute for Risk Assessment (BfR), BAuA, the Federal Institute for Materials Research and Testing (BAM), and the National Metrology Institute (PTB) — are accompanying the rapid pace of development of new materials from the points of view of occupational safety and health, consumer protection, and environmental protection.  The report states that the goals of application safety and environmental compatibility for advanced materials and derived products are intended to reduce significantly unacceptable risks to humans and the environment.  According to the report, this can be achieved by:

  1. Using safe materials without hazardous properties for humans and the environment (direct application safety); or
  2. Product design for low emissions and environmental compatibility over the entire product lifecycle (integrated application safety); or
  3. Product stewardship, where producers support users in taking technical, organizational, and personal safety measures for the safe use and disposal of products (supported application safety).

As a comprising part of the federal government’s Nanotechnology Action Plan 2020, the update of the joint research strategy aims to contribute to governmental research in the following main areas:

  • Characterizing and assessing the human and environmental risks of advanced materials;
  • Supporting research institutions and business enterprises;
  • Science-based revision of legal requirements and recommendations; and
  • Public acceptance.

The report states that the research strategy will be implemented in projects and other research-related activities, including governmental research, tendering and extramural research funding, and participation in mostly publicly supported projects with third-party funding.  Agencies will use interdisciplinary and transdisciplinary approaches to connect better risk and safety research with innovation research and material development.  To keep up with the pace of development, the time horizon for the research strategy extends to 2020.  The research objectives in the report address the research approaches likely to be actionable in this period.  The research strategy will be supported by a working group and be evaluated and revised by the end of the Nanotechnology Action Plan 2020.

EPA Researches How Sunscreens Containing Engineered Nanomaterials Might Change When Exposed to Chemicals in Pool Water

Posted in Federal, Research, United States

An August 15, 2016, U.S. Environmental Protection Agency (EPA) blog item describes EPA’s research on sunscreens containing engineered nanomaterials and how they might change when exposed to chemicals in pool water.  According to EPA, many sunscreens contain titanium dioxide engineered nanomaterials, which are often coated with other materials such as aluminum hydroxide to shield skin from reactive oxygen species.  EPA researchers are testing to see whether swimming pool water degrades the aluminum hydroxide coating, and if the extent of the degradation is enough to allow the production of potentially harmful reactive oxygen species.  Results show that after three days, pool water caused the aluminum hydroxide coating to degrade, which can reduce the coating’s protective properties and increase the potential toxicity.  EPA notes that even with degraded coating, the toxicity measured from the coated titanium dioxide was significantly less than the uncoated material, and “these sunscreens still provide life-saving protection against UV radiation.”  According to EPA, the study provides evidence that when released into the environment, nanomaterials undergo physical and/or chemical transformations — “an important consideration when measuring the impact of these materials on public health and the environment.”