Nano and Other Emerging Chemical Technologies Blog

Nano and Other Emerging Chemical Technologies Blog

Regulatory & legal developments involving nano and other emerging chemical technologies

EPA Will Publish SNUR for Carbon Nanomaterial (Generic)

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

The U.S. Environmental Protection Agency (EPA) is scheduled to publish on October 3, 2018, a direct final rule promulgating significant new use rules (SNUR) for 26 chemical substances, including carbon nanomaterial (generic), that were the subject of premanufacture notices (PMN).  The chemical substances are subject to orders issued by EPA pursuant to Sections 5(e) and 5(f) of the Toxic Substances Control Act (TSCA).  The direct final rule requires persons who intend to manufacture (defined by statute to include import) or process any of the chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity.  The required notification will initiate EPA’s evaluation of the intended use within the applicable review period.  Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required with that determination.  The direct final rule will be effective 60 days after publication in the Federal Register.  Written adverse comments on one or more of the SNURs must be received within 30 days of publication in the Federal Register.  If EPA receives written adverse comments, it will withdraw the relevant sections of the direct final rule before its effective date.  In addition to the direct final rule, EPA is scheduled to publish a proposed rule on October 3, 2018.  Comments on the proposed rule are due 30 days after publication in the Federal Register.

According to the SNUR, the generic (non-confidential) use of carbon nanomaterial (generic) will be in printing applications.  EPA states that it identified concerns for pulmonary toxicity and carcinogenicity based on analogy to carbon black.  EPA issued an order under TSCA Sections 5(e)(1)(A)(i), based on a finding that the available information is insufficient to permit a reasoned evaluation of the human health and environmental effects of the PMN substance, and 5(e)(l)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health and the environment.  The Order requires:

  1. Submission to EPA of certain health testing and material characterization data before exceeding a specified confidential production volume;
  2. Use of personal protective equipment (PPE) where there is a potential for dermal exposure;
  3. Use of a National Institute for Occupational Safety and Health (NIOSH) certified air purifying, tight-fitting full-face respirator equipped with N100, P-100, or R-100 filter with an Assigned Protection Factor (APF) of at least 50 where there is a potential for inhalation exposure;
  4. No release of the PMN substance to surface waters;
  5. Use of the PMN substance only for the confidential uses specified in the order;
  6. Limiting the manufacture, processing, and use of the PMN substance to industrial uses;
  7. No processing or use of the powder form of the PMN substance outside of the site of manufacture/processing; and
  8. No processing or use of the PMN substance in the liquid resin form using an application method that generates a vapor, mist, or aerosol.

The SNUR designates as a “significant new use” the absence of these protective measures.  EPA states that it has determined that “certain information about the health effects of the PMN substance may be potentially useful to characterize the effects of the PMN substance in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR.”  EPA notes that the submitter has agreed not to exceed certain time limits without performing specific physical-chemical property tests and characterization and pulmonary effects testing.  According to EPA, it also determined that the results of a carcinogenicity study would help characterize the potential health effects caused by the PMN substance.  Although the order does not require this test, EPA states that the order’s restrictions “will remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.”

Nanotechnology Industries Association Will Hold Open Webinar on Regulatory Priorities

Posted in International, Legal/Regulatory Issues, OECD

The Nanotechnology Industries Association (NIA) published an open newsletter on September 19, 2018, that includes an invitation to NIA’s October 11, 2018, open webinar on regulatory priorities.  The open webinar will cover the latest news on the nanomaterials definition, amendments to the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Annexes, the Organization for Economic Cooperation and Development (OECD) Malta project, and the latest news on nanowaste management and transport.  The webinar is free and open to non-members.  Bergeson & Campbell, P.C. is a proud member of NIA.

OECD Publishes Case Study on Grouping and Read-Across for the Genotoxicity of Nano Titanium Dioxide

Posted in International, OECD, Research

On September 21, 2018, the Organization for Economic Cooperation and Development (OECD) announced four new case studies on integrated approaches for testing and assessment (IATA), including a Case Study on Grouping and Read-Across for Nanomaterials — Genotoxicity of Nano-TiO2.  The European Union (EU) Joint Research Center (JRC) developed the case study for the genotoxicity of nano-titanium dioxide (TiO2) for illustrating the practical use of IATA.  The case study applies the workflow for grouping and read-across proposed in the European Chemicals Agency’s (ECHA) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) guidance update for nanomaterials and explores the extent to which ECHA’s Read-Across Assessment Framework (RAAF) is applicable to nanoforms for identifying sources of uncertainty associated with the read-across.  According to the case study, the purpose of the read-across exercise was to determine the genotoxic hazard potential of two nano-TiO2 target substances based on the in vitro comet assay results from other TiO2 nanoforms.  Overall, the case study shows the practical application of the ECHA guidance for grouping and read-across of nanomaterials, which was slightly adapted for the case study.  Furthermore, the case study states, it demonstrates the usefulness of cheminformatics techniques to support the grouping hypothesis by identifying the differences between nanoforms and by supporting the weight of evidence.  JRC successfully applied the ECHA RAAF for evaluating the confidence in the read-across argumentation of nanomaterials.  According to the case study, some nanospecific issues were identified for further specification of the RAAF for nanomaterials, in particular the concept of similarity, which cannot be based only on structural similarity for nanomaterials.

OECD states that the objective of the IATA Case Studies Project is to increase experience with the use of IATA by developing case studies that constitute examples of predictions fit for regulatory use.  The aim is to create common understanding of using novel methodologies and the generation of considerations/guidance stemming from these case studies.  OECD published the following three case studies with the case study on nano-TiO2:

  1. Case Study on the Use of Integrated Approaches for Testing and Assessment (IATA) for Estrogenicity of the Substituted Phenols;
  2. Prioritisation of Chemicals Using the Integrated Approaches for Testing and Assessment (IATA)-Based Ecological Risk Classification; and
  3. A Case Study on the Use of Integrated Approaches for Testing and Assessment for Sub-Chronic Repeated-Dose Toxicity of Simple Aryl Alcohol Alkyl Carboxylic Esters: Read-Across.

OECD also published a considerations document summarizing the learnings and lessons of the review experience of the case studies, Report on Considerations from Case Studies on Integrated Approaches for Testing and Assessment (IATA) — Third Review Cycle (2017).

CPSC’s FY 2019 Operating Plan Includes Collaborative Nanotechnology Research Activities

Posted in Federal, Research, United States

On September 26, 2018, the U.S. Consumer Product Safety Commission (CPSC) will discuss the Fiscal Year 2019 Operating Plan.  According to the Operating Plan, in fiscal year (FY) 2019, CPSC will continue supporting nanotechnology research and working with other federal agencies under the National Nanotechnology Initiative (NNI) to minimize duplication and overlap of existing research efforts.  CPSC will undertake the following collaborative research activities:

  • Develop tools to prioritize and investigate human exposures to nanomaterials;
  • Characterize the use and release of nanomaterials during the lifecycle of additive manufacturing systems and investigate the potential for consumer exposure;
  • Co-sponsor the Workshop “Quantifying Exposure to Engineered Nanomaterials (QEEN) from Manufactured Products II”;
  • Investigate the release and toxicity of silver nanowires from touchscreen displays;
  • Assess the potential release of nanoparticles from selected consumer products, develop methods that assess the presence of nanomaterials in the home environment, and determine the applicability of existing alternative test methods for predicting nanomaterial toxicity;
  • Collaborate with federal partners to maintain a nanotechnology consumer product database; and
  • Continue the collaborations to develop indoor air models, characterize the release of nanomaterials from consumer products into indoor air, and determine the potential exposures to consumers.

The Operating Plan states that CPSC intends to establish or maintain three collaborations with other organizations to work on nanotechnology research or issues affecting consumer products and to produce reports on the collaborations.  In FY 2019, CPSC intends to release an updated nanotechnology statement.  A decisional meeting for the FY 2019 Operating Plan is scheduled to be held October 10, 2018.

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.”