Nano and Other Emerging Chemical Technologies Blog

Nano and Other Emerging Chemical Technologies Blog

Regulatory & legal developments involving nano and other emerging chemical technologies

NIOSH Submits Proposed Survey to OMB, Will Accept Comments for 30 Days

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

On July 17, 2017, the National Institute for Occupational Safety and Health (NIOSH) published a Federal Register notice announcing it submitted a proposed information collection to the Office of Management and Budget for review and approval.  The proposed project is “Survey of Engineered Nanomaterial Occupational Safety and Health Practices.”  As reported in our February 14, 2017, blog item, NIOSH invited comment on the proposed survey on February 10, 2017.  NIOSH will survey companies that manufacture, distribute, fabricate, formulate, use, or provide services related to engineered nanomaterials.  NIOSH will compile a sample of 600 companies from lists of industry associations, research reports, marketing databases, and web-based searches.  Of the 600 selected companies, NIOSH states that it anticipates that 500 will complete the survey within two years.  The goal of the project is to assess the relevance and impact of NIOSH’s contribution to guidelines and risk mitigation practices for safe handling of engineered nanomaterials in the workplace.  The intended use of the data is to inform NIOSH’s research agenda to enhance its relevance and impact on worker safety and health in the context of engineered nanomaterials.  Publication of the July 17, 2017, Federal Register notice began a 30-day comment period.

EC Publishes Final Report of Nanocomput Project

Posted in International, Legal/Regulatory Issues, Research

In July 2017, the European Commission’s (EC) Joint Research Center (JRC) published a report entitled Evaluation of the availability and applicability of computational approaches in the safety assessment of nanomaterials:  Final report of the Nanocomput project.  The main aims of the Nanocomput Project were to review and assess the current status of computational methods that are potentially useful for predicting the properties of engineered nanomaterials to provide advice on the use of these approaches for the purposes of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation.  The Project emphasized quantitative structure-property relationship (QSPR) and quantitative structure-activity relationship (QSAR) models, and their potential role in predicting nanomaterial properties.  In addition, the Nanocomput Project assessed the status of a diverse array of compartment-based mathematical models.  These models comprised toxicokinetic, toxicodynamic, in vitro and in vivo dosimetry, and environmental fate models.  The report includes overall conclusions from the Nanocomput Project, including lessons learned in conducting literature reviews and research-based case studies on grouping and read-across.  It offers a number of recommendations intended to overcome current shortcomings in the knowledge of nanomaterial behavior and in the availability of tools (such as databases and predictive models) and practical guidance to use such tools in the regulatory assessment of nanomaterials.

NIOSH Publishes Chapter on Analysis of Carbon Nanotubes and Nanofibers on Filters by Transmission Electron Microscopy

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

The National Institute for Occupational Safety and Health (NIOSH) has published a chapter in the fifth edition of the NIOSH Manual of Analytical Methods (NMAM) entitled “Analysis of Carbon Nanotubes and Nanofibers on Mixed Cellulose Ester Filters by Transmission Electron Microscopy.”  The draft chapter provides standardized approaches for the analysis of carbon nanoparticles.  The chapter provides detailed guidance on effective means to perform transmission electron microscopic analysis on carbon nanotubes and nanofibers that are sampled from occupational atmospheres.  The chapter notes that, with respect to quantification, it is important to recognize the limitations of a particle counting method.  According to the chapter, because of the heterogeneity of carbon nanotube powders, particles in the same size bin can vary greatly in their properties.  Complex structures of varying mass, density, shape, and composition (e.g., amorphous carbon, residual catalyst) can fall into the same size bin, and dissimilar particles (e.g., cluster and matrix) in a given bin may have different toxicological effects.  Thus, the chapter states, “even for a given material, particle envelope size alone may not be an adequate risk indicator.”  Given the heterogeneity and variety of the carbon nanotube/carbon nanofiber products to which workers are exposed, “it is important to apply several methods to assess worker exposure, through inhalation and other routes.”

EPA Regulatory Agenda Item Revised to Remove, Then Add Back TBD Effective Date

Posted in Federal, Legal/Regulatory Issues, United States

Since July 20, 2017, when the Trump Administration published its Unified Agenda of Regulatory and Deregulatory Actions, the entry for the U.S. Environmental Protection Agency’s (EPA) item (RIN 2070-AJ54) concerning the Toxic Substances Control Act (TSCA) Section 8(a) reporting rule for nanoscale materials has been revised at least twice.  As reported in our July 20, 2017, blog item, the Unified Agenda item stated that the final rule effective date is “To Be Determined” (TBD).  On July 22, 2017, the timetable in the Unified Agenda entry, which listed the TBD effective date, had been removed.  Today, July 24, 2017, the timetable is visible again.  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.  More information regarding the draft guidance on the rule 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.”

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.