Nano and Other Emerging Chemical Technologies Blog

Nano and Other Emerging Chemical Technologies Blog

Regulatory & legal developments involving nano and other emerging chemical technologies

2017 SNO Conference Will Be Held November 5-7

Posted in Legal/Regulatory Issues, United States

The Sixth Sustainable Nanotechnology Organization (SNO) Conference will be held November 5-7, 2017, in Los Angeles, California.  According to SNO, the Conference sessions represent a hybrid of topics on selected “systems” that contribute to sustainability and more traditional topics.  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.  Topics from prior conferences will be addressed under the current session topics.  The Conference sessions include:

  1. Tribute to Pedro Alvarez: Pedro Alvarez has significantly contributed to eco-responsible nanotechnology through pioneering research on how engineered nanomaterials interact with bacteria, elucidating their mode of action and discerning potential impacts to microbial ecosystem services.  He also opened new opportunities for nano-enabled greener disinfection and biofouling control, as well as for enhanced (selective) removal of priority water pollutants.  Recently, Alvarez led a multi-university effort to establish a National Science Foundation Nanosystems Engineering Research Center for Nanotechnology-Enabled Water Treatment, which is developing easy-to-deploy, next-generation modular treatment processes that protect lives and support sustainable development;
  2. Food/Agriculture: This session centers on nanotechnology for food production, pesticide delivery, nutrient delivery, disease suppression, food fortification, and environmental implications;
  3. Water: This session focuses on applications of nanotechnology to address water or air contaminants, including applications in water supply, wastewater treatment, and industrial air quality control;
  4. Fate and Exposure: This session will consider studies addressing nanomaterial release, fate and transport, transformations, and exposure modelling;
  5. Nanotoxicology: This session emphasizes the evaluation of the effects (i.e., positive or negative) that advanced nanomaterials have on the environment and human health;
  6. Life-Cycle: It is important to consider a life-cycle perspective when evaluating the applications of nanotechnology, from raw materials to synthesis, and from product use to end of life.  Papers in this session can address the entire life-cycle of particular applications, or the implications in specific life-cycle phases, including recycling;
  7. Sensors/Measurement: Papers in this session focus on the need to develop sensors, new instruments, approaches, and/or further refinement of existing tools for characterizing nanomaterials and using nanomaterials as sensors to detect chemicals of interest;
  8. Green Synthesis: This session focuses on the synthesis of nanomaterials with lowered energy and fewer polluting by-products and starting materials;
  9. Education/Social Aspects: Papers in this session will address nano-education programs and curriculum development.  In addition, societal aspects, such as laws, regulations, economics, and social issues, will be covered; and
  10. Nanomedicine: This session will accept papers that deal with the use of various types of nanoparticles for use in medicine, particularly to diagnose and treat cancer.

EPA Publishes SNUR for MWCNTs (Generic)

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

The U.S. Environmental Protection Agency published on October 19, 2017, a direct final rule promulgating significant new use rules (SNUR) for 29 chemical substances that were the subject of premanufacture notices (PMN).  The 29 chemical substances are subject to consent orders issued by EPA under Section 5(e) of the Toxic Substances Control Act.  The direct final rule includes a SNUR for multi-walled carbon nanotubes (MWCNT) (generic) (PMN Numbers P-15-487, P-15-488, P-15-489, P-15-490, and P-15-491).  According to the Federal Register notice, the PMN substances will be used as additives for electro-static discharge in electronic devices, electronics, and materials; additives for weight reduction in materials; additives to improve mechanical properties or electrical conductivities; heat-generating elements in heating devices and materials; additives for heat transfer and thermal emissions in electronic devices and materials; semi-conductor, conductive, or resistive elements in electronic circuitry and devices; additives to improve conductivity in electronic circuitry, energy storage systems, and devices; electron emitters for lighting and x-ray sources; additives for electromagnetic interface shielding in electronic devices; additives for electrodes in electronic materials and electronic devices; catalyst support in chemical manufacturing; coating additives to improve corrosion resistance or conductive properties; additives for fibers in structural and electrical applications; additives for fibers in fabrics and textiles; filter additives to remove nanoscale materials; semi-conducting compounding additives far high-voltage cable; and additives for super-hydrophobicity.  The consent order requires:

  1. Use of personal protective equipment to prevent dermal exposure and a National Institute for Occupational Safety and Health-certified respirator with N-100, P-100, or R-100 cartridges with an assigned protection factor of at least 50 (where there is a potential for inhalation exposure);
  2. Use of the PMN substances only for the uses specified in the consent order;
  3. No use in application methods that generate a dust, mist, or aerosol unless such application method occurs in an enclosed process; and
  4. No use of the PMN substances resulting in releases to surface waters and disposal of the PMN substances only by landfill or incineration.

A significant new use is any use involving an application method that generates a dust, mist, or aerosol.  The SNUR requirements do not apply when the PMN substances have been incorporated into a polymer matrix that has been reacted (cured) or embedded in a permanent solid polymer form that is not intended to undergo further processing except mechanical processing.  EPA states that it determined that a subchronic 90-day inhalation toxicity study (OPPTS 870.3465 or OECD 413), a two-year inhalation bioassay (OPPTS 870.4200), a fish early-life stage toxicity test (OCSPP Test Guideline 850.1400), a daphnid chronic toxicity test (OCSPP Test Guideline 850.1300), and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize possible health and environmental effects of the substances.  Although the consent order does not require these tests, EPA notes that the order’s restrictions on manufacture, processing, distribution in commerce, and disposal will remain in effect until the order is modified or revoked by EPA based on submission of this or other relevant information.

OECD Publishes Summary of Dossier on Silver Nanoparticles

Posted in OECD, Research

The Organization for Economic Cooperation and Development (OECD) published a report entitled Silver Nanoparticles:  Summary of the Dossier.  The Summary states that Korea led the testing of silver nanoparticles under OECD’s Sponsorship Program for the Testing of Manufactured Nanomaterials.  OECD published the dossier on silver nanoparticles in 2016, and the seven-part dossier identifies the U.S. as co-lead.  The Summary includes information on physical and chemical properties; general information on exposure; hazards to the environment; and toxicological information.

EU NanoSafety Cluster Will Hold Webinar on November 20

Posted in International, Legal/Regulatory Issues

The European Union (EU) NanoSafety Cluster will hold the first in a series of webinars on November 20, 2017.  The series will introduce the EU NanoSafety Cluster’s work and the key outcomes from its projects.  The first webinar will present the EU NanoSafety Cluster, what it does, and provide examples of its work.  Future webinars, which will be held every four months, will cover important project outcomes and their impact on the safe development of nanomaterials to consumers across all sectors.  The webinars are open to all interested participants.  Registration for the November 20, 2017, webinar is available online.

OECD Releases Test Guidelines Specifically Developed to Address Nanomaterials

Posted in OECD, Research

On October 12, 2017, the Organization for Economic Cooperation and Development (OECD) announced the release of 17 new, updated, corrected, or deleted Test Guidelines.  The Test Guidelines include three specifically developed for nanomaterials.  OECD states that Test Guideline 318:  Dispersion Stability of Nanomaterials in Simulated Environmental Media provides a simple and effective tool that can analyze the dispersion stability of nanomaterials in aqueous media.  It is one of the prerequisites for a subsequent robust and reliable safety testing of nanomaterials.  The Test Guideline allows users to understand nanomaterials’ fate in natural waters and their potential behavior in test media.  OECD updated Test Guideline 412:  28-Day (Subacute) Inhalation Toxicity Study and Test Guideline 413:  90-Day (Subchronic) Inhalation Toxicity Study to allow testing and hazard identification of inhaled nanomaterials.  According to OECD, the updates concern bronchoalveolar lavage measurements; particle-size distribution for test atmospheres; post-administration duration; and lung burden measurements.  OECD states that the information that will be gathered through these new endpoints make the Test Guidelines applicable for assessing potential inhalation hazards of nanomaterials, while also increasing the understanding on the mode of action by which nanomaterials may act.

EC Proposes to Amend REACH Annexes to Address Nanomaterials

Posted in International, Legal/Regulatory Issues

On October 9, 2017, the European Commission (EC) began a public consultation on a draft regulation that would amend Annexes I, III, VI, VII, VIII, IX, X, XI, and XII of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation to address nanoforms of substances.  The draft regulation states that:

  • Clarifications to requirements for the registration of substances with nanoforms and related downstream user obligations should be included in Annexes I, III, and VI to XII;
  • Manufacturers and importers should assess and, where relevant, generate the necessary information and document in the chemical safety report that the risks arising from the identified uses of the substance with nanoforms are adequately controlled;
  • As the majority of nanomaterials are expected to be nanoforms of phase-in substances, the conditions for the requirements for generation of new toxicological and ecotoxicological information on phase-in low volume substances should be elaborated to ensure that the assessment criteria are based also on the predicted properties of nanoforms;
  • All different nanoforms and sets of nanoforms should be considered by the registrant in the demonstration of safety;
  • To allow efficient assessment of the potential exposure for inhalable nanoforms, in particular in workplaces, information on dustiness should be provided for the different nanoforms or sets of nanoforms;
  • Although acute toxicity testing for the lowest tonnage is required via the oral route, for nanoforms, inhalation or in very specific cases the dermal route may be considered as a more appropriate route of exposure;
  • A number of specific physico-chemical properties, in addition to those used to identify the different nanoform or sets of nanoforms, may be considered relevant for scientific understanding of the properties of a nanomaterial, with the necessary parameters depending on the individual case. For reasons of workability and proportionality, only registrants for higher volume substances than 100 tonnes per year should be required to consider explicitly such further information in case other particle properties significantly influence hazard or exposure to those nanoforms; and
  • Compliance with the provisions of the proposed amendment should not be required immediately to allow all registrants and downstream users adequate time to adapt to the more specific requirements for substances with nanoforms. The amendment would apply from January 1, 2020.

Comments are due November 6, 2017.

Registration Open for NNI Workshop on Open Technology Development Pathways

Posted in Federal, Research, United States

As reported in our August 30, 2017, blog item, the “Technology Development Pathways:  Case Studies from the [National Nanotechnology Initiative (NNI)]” workshop will be held November 1, 2017.  According to NNI, the workshop will showcase application areas where nanotechnology has had commercial impact.  Keynote presentations will highlight the pathways companies have taken to get from research to commercialization.   Panel discussions will focus on specific steps of the development pathway, such as scale up and quality control/measurement systems.  The goal of this workshop is to provide case studies and facilitate the exchange of technical information among private sector participants.  NNI notes that federal government representatives will also participate, enabling attendees to learn of ongoing research activities, agency needs, and funding opportunities.  The workshop is free and open to the public.  Registration is on a first-come, first-served basis, but space is limited.

JRC Publishes NANoREG Toolbox for the Safety Assessment of Nanomaterials

Posted in International, Legal/Regulatory Issues

The European Commission (EC) Joint Research Center (JRC) has published the NANoREG Toolbox for the Safety Assessment of Nanomaterials.  As reported in our May 8, 2017, blog item, JRC previously published a Science for Policy report entitled NANoREG framework for the safety assessment of nanomaterials.  The report was developed within the NANoREG project, “A common European approach to the regulatory testing of nanomaterials.”  The NANoREG framework represents the project’s proposal for a common understanding in the field of environmental health and safety assessment of nanomaterials under the current European regulatory framework, with focus on the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation.  The Toolbox supports the implementation of the framework by providing an overview of available tools (test methods, datasets, models, guidance documents, and decision trees) useful to regulators and other stakeholders in the European REACH context.  The tools consist not only of those released in the scientific deliverables of NANoREG, but include those from other initiatives, at the European level and beyond, that have addressed one or more “nano-specific hurdles” in safety assessment.  The Toolbox distinguishes between current (presently available and accessible) tools and prospective (promised) ones.  The resulting two Excel® workbooks, zipped into a single file, contain a wide review of categorized tools, with descriptive information and metadata attached to them.  The dataset “is freely available to the global nanoEHS community, be it regulators or industry, for further expansion and exploitation.”

EPA Promulgates Final SNUR for Bimodal Mixture Consisting of MWCNTs and Other Classes of CNTs

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

On October 3, 2017, the U.S. Environmental Protection Agency (EPA) promulgated a final significant new use rule (SNUR) under Section 5(a)(2) of the Toxic Substances Control Act (TSCA) for the chemical substance identified generically as bimodal mixture consisting of multi-walled carbon nanotubes (MWCNT) and other classes of carbon nanotubes (CNT), which was the subject of premanufacture notice (PMN) P-11-482.  This action requires persons who intend to manufacture (defined by statute to include import) or process the chemical substance for a use that is designated as a significant new use by this final rule to notify EPA at least 90 days before commencing that activity.  Manufacture and processing for the significant new use is unable to commence until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required with that determination.  According to the June 8, 2017, proposed SNUR, the generic use of the PMN substance will be as a specialty additive.  Based on test data on analogous respirable, poorly soluble particulates and nanocarbon materials, EPA identified concerns for pulmonary toxicity and oncogenicity.  Based on test data for other nanocarbon materials, EPA identified concerns for environmental toxicity.  Under the SNUR, significant new uses are:

  1. Protection in the workplace: Requirements as specified in 40 C.F.R. Section 721.63(a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), (a)(6) (particulate), and (c).  When determining which persons are reasonably likely to be exposed as required for Section 721.63(a)(1) and (a)(4), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible.  A National Institute for Occupational Safety and Health (NIOSH)-certified air purifying, tight-fitting full-face respirator equipped with N-100, P-100, or R-100 cartridges, or power air purifying particulate respirator with an Assigned Protection Factor (APF) of at least 50 meets the requirements of Section 721.63(a)(4);
  2. Industrial, commercial, and consumer activities: Requirements as specified in Section 721.80(k) and (q).  A significant new use is any use involving an application method that generates a vapor, mist, or aerosol;
  3. Disposal: Requirements as specified in Section 721.85(a)(1), (a)(2), (b)(1), (b)(2), (c)(1), and (c)(2); and
  4. Release to water: Requirements as specified in Section 721.90(b)(1) and (c)(1).  Any predictable or purposeful release of a manufacturing stream associated with any use of the substance from any site is a significant new use other than the water releases described in the manufacturing process of PMN P-11-482.

This final rule is effective November 2, 2017.

NIA Will Hold Webinar on Safe by Design for Nanomaterials

Posted in International, Legal/Regulatory Issues, Research

On October 24, 2017, the Nanotechnology Industries Association (NIA) will hold a webinar on Safe by Design for nanomaterials.  NIA states that the webinar is free and open to all actors interested in nanomaterials and their safe management throughout their lifecycle, using the principles of Safe by Design from the earliest development stages.  According to NIA, the webinar will bring together projects active in the creation of Safe by Design across Europe to inform participants of the long-term benefits and commercial sustainability that Safe by Design brings to product development.  Registration is available online.