On October 12, 2017, the German Federal Institute for Risk Assessment (BfR) published questions and answers (Q&A) regarding a study on whether nanometric pigments from tattoo inks can permanently accumulate in lymph nodes. BfR states that by using X-rays from a particle accelerator in Grenoble, it discovered where the pigments accumulate in the tissue. According to BfR, until now, the accumulation of pigments from tattooed persons has been known by optical coloring of the lymph nodes only, as they often had been of the same color as the tattoo. Both skin and lymph nodes have now been characterized in terms of their chemical composition, pigment identity, and size. The study, “Synchrotron-based ν-XRF mapping and μ-FTIR microscopy enable to look into the fate and effects of tattoo pigments in human skin,” was published in September 2017.
On October 5, 2017, the United Kingdom’s (UK) Parliamentary Office of Science and Technology (POST) published a POSTnote entitled “Risk Assessment of Nanomaterials.” According to POST, key points include:
- Nanomaterial uses and benefits are diverse and increasing, such as in cosmetics, textiles, electronics, and medicine;
- Current regulatory frameworks applicable to nanomaterials within the UK are mainly set at the European Union (EU) level;
- There are some indications of potential health and environmental risks, but conclusions are limited by insufficient long-term evidence and difficulties in translating results from the laboratory to the real world;
- Post-Brexit, the UK will need to establish regulatory frameworks for nanomaterials; and
- The wide range of forms and uses of nanomaterials present many regulatory challenges, such as ensuring consistency in testing and finding valid ways of grouping nanomaterials so that their risks may be assessed more efficiently.
In October 2017, the International Organization for Standardization (ISO) published standard ISO/TR 19057:2017, “Nanotechnologies — Use and application of acellular in vitro tests and methodologies to assess nanomaterial biodurability.” The standard reviews the use and application of acellular in vitro tests and methodologies implemented in the assessment of the biodurability of nanomaterials and their ligands in simulated biological and environmental media. It is intended to focus more on acellular in vitro methodologies implemented to assess biodurability and, therefore, excludes the general review of relevant literature on in vitro cellular or animal biodurability tests.
The Organization for Economic Cooperation and Development (OECD) has posted an October 30, 2017, report entitled Strategies, Techniques and Sampling Protocols for Determining the Concentrations of Manufactured Nanomaterials in Air at the Workplace. The objective of the report is to contribute to existing knowledge regarding methods for measuring characteristics of airborne nanoparticles and controlling occupational exposure to airborne nanoparticles, and to gather data on nanoparticle emission and transport in various workplaces. The report includes the findings of research undertaken in non-industrial nanotechnology workplaces involving the measurement of nanomaterials emissions and exposures. It presents six case studies that demonstrate how measurement and assessment of nanomaterials can be undertaken and how results can be interpreted: grinding and extrusion of modified titanium dioxide; manufacture of clay-polyurethane nanocomposite material; grinding of titanium dioxide powder; jet milling of modified clay particles; decanting of single- and multi-walled carbon nanotubes; and synthesis of carbon nanotubes using chemical vapor deposition. The report notes that “it is worth mentioning that this document contributed to the development of the document ‘Harmonized Tiered Approach to Measure and Assess the Potential Exposure to Airborne Emissions of Engineered Nano-Objects and their Agglomerates and Aggregates at Workplaces’ published as No.55 in the OECD Series on the Safety of Manufactured Nanomaterials [ENV/JM/MONO(2015)19].”
On October 24, 2017, the Nanotechnology Industries Association (NIA) held a webinar on Safe by Design for Nanomaterials. The webinar was 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. The webinar included the following presentations:
Session 1: Introduction to Safe by Design
- EU Research Strategy — Nanotechnologies and Advanced Materials 2018-2020: Safe Nanotechnology — Dr. Georgios Katalagarianakis, European Commission
- The Safe-by-Design Concept and its relevance across sectors — Blanca Suarez-Merino, Peter Weiersmüller, Karl Höhener, TEMAS AG
- Safe by Design: Long term legal and corporate social responsibility impacts — Anthony Bochon, Squire Patton Boggs (UK) LLP
Session 2: Tools and Frameworks for Product Development Available for Safe by Design
- Combined slides: Single file containing introduction, Stoffenmanager-Nano, LICARA Nano Scan, NanoSafer v.1.1β, and the Safe-by-Design Implementation Platform
Session 3: The Future of Safe by Design
- A vision of monitoring nanomaterials through the lifecycle — Stephen Lofts, NERC Center for Ecology and Hydrology, U.K.
- The NanoSafety Cluster supporting Safe by design and data alignment — Éva Valsami-Jones, University Birmingham, Coordinator of European Union (EU) – NanoSafety Cluster
- EU Observatory for Nanomaterials — Abdelqader Sumrein, European Chemicals Agency
- Webinar Summary — Dr. Claire Skentelbery, NIA
The European Trade Union Institute (ETUI) recently published a policy brief entitled “EU Observatory for Nanomaterials: a constructive view on future regulation.” The policy brief provides information about the European Union (EU) Observatory for Nanomaterials (EUON), how it is being developed, its limitations, and “why it is not an ideal option.” According to the policy brief, the absence of risk information regarding nanomaterials in safety data sheets (SDS) “is one of the main reasons why trade unions, environmental associations and consumer groups are in favour of a nano-registry, similar to those already established in several Member States such as France, Belgium, Denmark and Sweden (countries which make up a large part of the EU nano-market).” The policy brief states that the European Chemicals Agency (ECHA) “should focus on its core business by demanding registration dossiers of sufficient quality on nanomaterials or the nanoform of substances” under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. The EUON should support ECHA by making information on risks and health effects more widely available to employers. The policy brief suggests a different monitoring scenario, based on rules that would ensure transparency, improve the ability of national authorities to track different types of nanomaterials along the supply chain, make information visible, and guarantee an adequate exchange of information on safety at all stages. ETUI’s recommendations include creating a framework to trace where nanomaterials are being produced and how they are used, and establishing worker exposure registries at the company level. The policy brief “urges policy-makers to make use of foresight and ethics to address fast-moving technological convergence and the new frontiers of science and technology.”
As reported in our October 20, 2017, memorandum, “California and New York Require Manufacturers to Disclose Ingredients in Cleaning Products,” on April 25, 2017, New York Governor Andrew Cuomo (D) announced the Household Cleansing Product Information Disclosure Program. The Program will require manufacturers of household cleansing products sold in New York to disclose the chemical ingredients on their websites. Under the draft 2017 Household Cleansing Product Information Disclosure Program Certification Form and Guidance Document, information regarding certain ingredients, including nanomaterials, would have to be disclosed. The draft Guidance states: “For each ingredient that is a nanomaterial, a term describing the nanomaterial should be disclosed. For example, if the nanomaterial is carbon, the disclosure should use the term ‘nano’ carbon.” Comments on the draft Guidance were due July 14, 2017. Final Guidance is expected soon.
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:
- 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;
- Food/Agriculture: This session centers on nanotechnology for food production, pesticide delivery, nutrient delivery, disease suppression, food fortification, and environmental implications;
- 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;
- Fate and Exposure: This session will consider studies addressing nanomaterial release, fate and transport, transformations, and exposure modelling;
- Nanotoxicology: This session emphasizes the evaluation of the effects (i.e., positive or negative) that advanced nanomaterials have on the environment and human health;
- 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;
- 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;
- Green Synthesis: This session focuses on the synthesis of nanomaterials with lowered energy and fewer polluting by-products and starting materials;
- 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
- 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.
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:
- 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);
- Use of the PMN substances only for the uses specified in the consent order;
- No use in application methods that generate a dust, mist, or aerosol unless such application method occurs in an enclosed process; and
- 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.
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.