Nano and Other Emerging Chemical Technologies Blog

Nano and Other Emerging Chemical Technologies Blog

Regulatory & legal developments involving nano and other emerging chemical technologies

NanoEHS Webinar Will Address How NNCI Nodes Support Environmental Research

Posted in Federal, Research, United States

The National Nanotechnology Initiative (NNI) will hold a webinar on July 27, 2017, entitled “The National Nanotechnology Coordinated Infrastructure (NNCI) Nodes and Environmental Research: Examples from the Field.”  The National Science Foundation (NSF) supports NNCI, which includes 16 user facility sites, their affiliated partners, and a coordinating office.  NNCI sites provide researchers, academics, small and large businesses, and government scientists with access to university user facilities with leading-edge fabrication and characterization tools, instrumentation, and expertise within all disciplines of nanoscale science, engineering, and technology.  The webinar will provide information on how the NNCI nodes can support research.  The webinar will be moderated by Larry Goldberg, Senior Engineering Advisor, Directorate for Engineering, NSF.  Speakers include:

  • Bruce Clemens, Walter B. Reinhold Professor in the School of Engineering and Professor of Photon Science, and Applied Physics, Stanford University; and
  • Michael Hochella, University Distinguished Professor, Geosciences, Virginia Tech; Laboratory Fellow, Geosciences, Pacific Northwest National Laboratory.

Webinar participants will be able to submit questions during the question and answer period.  Submitted questions will be considered in the order received and may be posted on the NNI website.  Registration is required.

EPA’s Regulatory Agenda Includes TSCA Section 8(a) Nanomaterials Rule with TBD Effective Date

Posted in Federal, Legal/Regulatory Issues, United States

On July 20, 2017, the Trump Administration published its Unified Agenda of Regulatory and Deregulatory Actions.  The Agenda includes a U.S. Environmental Protection Agency (EPA) item (RIN 2070-AJ54) concerning the Toxic Substances Control Act (TSCA) Section 8(a) reporting rule for nanoscale materials.  According to the Agenda item, the final rule effective date is “To Be Determined” (TBD).  The January 12, 2017, final rule requires one-time reporting for existing discrete forms of certain nanoscale materials, and a standing one-time reporting requirement for new discrete forms of certain nanoscale materials.  As reported in our May 12, 2017, blog item, on May 12, 2017, EPA published a Federal Register notice delaying the effective date of the January 12, 2017, rule’s reporting requirements from May 12, 2017, to August 14, 2017.  EPA published a draft guidance document entitled “Guidance on EPA’s Section 8(a) Information Gathering Rule on Nanomaterials in Commerce” on May 16, 2017.  Comments on the draft guidance were due June 15, 2017.  While the publication of draft guidance within four months of promulgation of the final rule is an achievement, the draft guidance does not significantly expand upon that which is already known, or make the rule clearer or easier with which to comply.  More information regarding the draft guidance is available in our May 16, 2017, memorandum, “EPA Seeks Comment on Draft Guidance for Nanoscale Materials Reporting Rule.”  More information on the final rule is available in our January 12, 2017, memorandum, “EPA Promulgates Final TSCA Reporting and Recordkeeping Rule for Nanoscale Materials.”

Journal of Nanobiotechnology Publishes Special Issue on Swiss National Research Program on the “Opportunities and Risks of Nanomaterials”

Posted in International, Research

The Journal of Nanobiotechnology published a special issue on the outcome of Switzerland’s five-year National Research Program on the “Opportunities and Risks of Nanomaterials” (NRP 64).  The editorial states that the Program’s primary goal was to investigate potential applications of existing nanomaterials in healthcare, the consumer industry, and in the environment, and to identify, characterize, and minimize the possible risks associated with their use.  The special issue includes the following articles:

  • Effects of silica nanoparticle exposure on mitochondrial function during neuronal differentiation;
  • Swiss National Research Programme “Opportunities and Risks of Nanomaterials” (NRP 64): key findings;
  • Non-invasive continuous monitoring of pro-oxidant effects of engineered nanoparticles on aquatic microorganisms;
  • Interaction of silver nanoparticles with algae and fish cells: a side by side comparison;
  • Transformation of the released asbestos, carbon fibers and carbon nanotubes from composite materials and the changes of their potential health impacts;
  • Interaction of biomedical nanoparticles with the pulmonary immune system;
  • A critical review of the current knowledge regarding the biological impact of nanocellulose;
  • Release of copper-amended particles from micronized copper-pressure-treated wood during mechanical abrasion;
  • Lipid nanoemulsions and liposomes improve photodynamic treatment efficacy and tolerance in CAL-33 tumor bearing nude mice;
  • Photoinduced effects of m-tetrahydroxyphenylchlorin loaded lipid nanoemulsions on multicellular tumor spheroids;
  • Critical review of the safety assessment of nano-structured silica additives in food;
  • Vertical transport and plant uptake of nanoparticles in a soil mesocosm experiment;
  • Effect of nanoparticles on red clover and its symbiotic microorganisms;
  • Probabilistic modelling of prospective environmental concentrations of gold nanoparticles from medical applications as a basis for risk assessment; and
  • Magnetic separation-based blood purification: a promising new approach for the removal of disease-causing compounds?

Canada Intends to Publish Nanoscale Prioritization Results in 2018

Posted in International, Legal/Regulatory Issues

According to the July 7, 2017, issue of the Chemicals Management Plan Progress Report, Health Canada and Environment and Climate Change Canada are in the process of prioritizing nanoscale forms of substances on the Domestic Substances List.  As reported in our July 27, 2015, blog item, Canada conducted a mandatory information-gathering survey under Section 71 of the Canadian Environmental Protection Act, 1999.  Canada states that the survey identified 53 substances as being manufactured and/or imported at the nanoscale in Canada.  Canada expects to publish the results of prioritization in spring 2018.  According to the item, Canada is working towards developing a scientific risk assessment framework for nanomaterials, and continues to work with the Organization for Economic Cooperation and Development to promote consistency with other jurisdictions.  The goal of Canada’s initiative is to identify the potential risks to human health and the environment that may be posed by nanomaterials in commerce in Canada.

IARC Will Convene Advisory Group in 2018/2019 to Consider Nominations

Posted in International, Legal/Regulatory Issues

To assist the International Agency for Research on Cancer (IARC) in selecting agents for review in future Monographs, IARC regularly convenes international, interdisciplinary Advisory Groups to review all public nominations and to recommend those it considers to be of high priority.  According to information on its website, IARC will convene its next Advisory Group in 2018/2019.  IARC encourages the general public, the scientific community, national health agencies, and other organizations to nominate agents for review in future IARC Monographs.  IARC states that nominations may include chemicals, mixtures, occupations, physical agents, biological agents, lifestyle factors, and anything else suspected of causing cancer in humans.  IARC will select agents for review based on:  (a) evidence of human exposure; and (b) evidence or suspicion of carcinogenicity.  IARC notes that in response to new scientific information or an urgent public health need, it may schedule nominated agents for review at any time.

ECHA Announces Two Decisions on Appeals Related to Nanomaterials

Posted in International, Legal/Regulatory Issues

On June 30, 2017, the European Chemicals Agency (ECHA) Board of Appeal published two decisions related to nanomaterials.  In the July 5, 2017, issue of ECHA Weekly, ECHA states that the Board of Appeal “largely upheld the appeals and annulled most of the requests for information.”  In Cases A-014-2015 and A-015-2015, registrants appealed the same 2015 ECHA decision requesting information on synthetic amorphous silica (SAS) following a substance evaluation by the Netherlands Competent Authority.  ECHA requested information on the physicochemical properties and uses of different types of SAS and surface-treated SAS.  According to ECHA, the Board of Appeal annulled these requests “as it was not clear how the information would be used to clarify the potential concerns which in any case had not been sufficiently demonstrated.”  ECHA notes that the Board of Appeal upheld one request in the contested decision — for information on the inhalation toxicity of one type of SAS, following repeat exposure.

CEINT Seeks Comments on Proposed ISA-TAB-Nano Templates

Posted in International, Research

The Center for the Environmental Implications of NanoTechnology (CEINT) seeks comments on the NANoREG-proposed ISA-TAB-nano templates.  According to CEINT, the ISA-TAB-nano file sharing format, developed under the National Cancer Informatics Program Nanotechnology Working Group (NCIP NanoWG), is an accepted ASTM standard (ASTM International E2909-13).  In 2016, the European Union NANoREG project adopted and adapted the ISA-TAB-nano format to organize consistently the results of their network of researchers.  According to CEINT, to create the templates, NANoREG followed the logic of the original ISA-TAB-nano formatting, but drew upon relevant existing ontologies and extended it to incorporate additional endpoints and methods not addressed in the original standard.  CEINT is working with researchers at Oregon State University and the NCIP NanoWG to update and extend the ISA-TAB-nano templates.  CEINT seeks comments on the following proposed templates:

  • Physical-chemical characterizations comment forms;
  • In vivo mammalian toxicity comment forms;
  • In vitro mammalian toxicity comment forms; and
  • General feedback regarding expanded (nonstandard) ISA-TAB-nano templates.

Comments are due August 1, 2017.

NanoDefine Will Hold Workshop on Measurement and Classification of Nanomaterials According to the EC Definition

Posted in International, Legal/Regulatory Issues

On October 24, 2017, NanoDefine will hold a one-day workshop in Frankfurt/Main, Germany.  The main purpose of the workshop is to provide a practical demonstration of newly developed measurement techniques to end-users who have to implement the European Commission’s (EC) recommendation on the definition of a nanomaterial (2011/696/EU).  NanoDefine experts have developed a wide panel of new validated measurement methods, techniques, instruments, and software to classify existing and new advanced materials, including a two-tiered analytical approach consisting of:  (1) rapid and cost-effective screening methods; and (2) more in-depth confirmatory methods.  In particular, according to NanoDefine, the NanoDefiner e-Tool will help practitioners to determine reliably “whether a material or product is or contains nano.”  The workshop will address the following questions:

  • How to address the analytical challenges caused by the EC definition;
  • How to handle the diversity and complexity of commercially relevant products and materials that have to be classified; and
  • How to meet the needs of industry for quick and unambiguous measurement tools.

Registration is free but spaces are limited.  According to the May-June 2017 issue of the NanoDefine Bulletin, an open beta version of the NanoDefiner e-Tool will be available online later in 2017.  Users will be invited to test the beta version and to provide feedback that will be used to prepare the final public version

Germany Publishes Meeting Report from Expert Dialogue on Application of Nanotechnologies in the Construction Sector

Posted in International, Legal/Regulatory Issues

On June 1, 2017, the Federal Ministry for the Environment, Nature Conservation, Building and Nuclear Safety published meeting documents from the Expert Dialogue on “Opportunities and Risks of the Application of Nanotechnologies in the Construction Sector.”  The documents include a summary of discussion, meeting agenda, and report, Regulation of construction products and possibilities to address (new) risks from nanomaterials.  During the Expert Dialogue, participants examined and discussed regulations for placing building products on the market and the general test procedures for reviewing their impact on the environment and human health.  Topics covered included approaches that consider the whole life cycle of building products and the current status of knowledge about risks for workers and the environment.  The summary states that participants saw potential risks in the production and application of nano construction products that could be managed using conventional protection measures.  To date the particularities of nanomaterials have not been explicitly considered in the assessment of environmental and health impacts.  An integration of respective requirements into the European Union (EU) standards is possible, according to the summary, but would require a longer process, which the EU Member States need to start.  A stronger consideration of nanomaterials in national authorizations of construction products could be implemented in Germany via the principles for authorization or the integration of specific requirements in the model building law, respectively.  Several stakeholders wished for more transparency on the benefits from the use of nanomaterials, as well as on the types and amounts of nanomaterials used in construction products.  The summary states that “[a] comprehensive assessment and an understandable communication of benefits from nanomaterial-containing products as well as the potentially related risks from them, including from their disposal, was stated to be important for the acceptance of such products.”

ISO Standard Describes Aerosol Generation for Air Exposure Studies of Nano-Objects and Their Aggregates and Agglomerates

Posted in International, Research

The International Organization for Standardization (ISO) recently published standard ISO/TR 19601:2017, “Nanotechnologies — Aerosol generation for air exposure studies of nano-objects and their aggregates and agglomerates (NOAA).”  ISO states that, to evaluate the inhalation toxicity of NOAA, it is important to consider certain parameters that make the toxicity testing relevant to human exposure.  Three critical aspects to consider when designing and conducting an inhalation toxicity study are:

  • Uniform and reproducible nano-object aerosol generation that is relevant to realistic exposures,
  • Thorough characterization of nanomaterials throughout the duration of testing including starting and generated materials; and
  • Use of occupational exposure limits and reference concentrations (as derived from existing studies and/or real-time exposure monitoring data) for dosimetry.

Therefore, according to ISO, to conduct in vitro and in vivo NOAA studies, “it is important to choose an appropriate NOAA aerosol generator and use online and off-line techniques for nano-object characterization.”  The standard describes methods for producing NOAA aerosols for in vivo and in vitro air exposure studies.  The purpose of the standard is to aid in selecting an appropriate aerosol generator to fulfill a proposed toxicology study design.  The standard describes characteristics of aerosol generation methods, including their advantages and limitations.  ISO notes that the standard does not provide guidance for aerosolization of specific nano-objects.