According to the Toxics Use Reduction Institute’s (TURI) website, the Toxics Use Reduction Act (TURA) Program in Massachusetts has received a petition to list carbon nanotubes (both single-walled and multi-walled) and carbon nanofibers.  The TURA Science Advisory Board (SAB) is beginning the process of reviewing these substances and seeks additional information from stakeholders.  SAB’s primary role is to consider petitions to add or delete chemicals from the TURA list and make recommendations to TURI accordingly.

Massachusetts enacted TURA in 1989.  TURA established a Toxic or Hazardous Substance List, often referred to as the TURA list.  Companies subject to TURA are required to file an annual Toxics Use Report that identifies:

  • Every TURA-listed chemical the company manufactures, processes, or otherwise uses above applicable thresholds;
  • All production processes and products that use one or more listed chemicals; and
  • The amount of each listed chemical generated as byproduct (wasted), shipped in product, and released to the environment.

On October 27, 2020, the U.S. National Nanotechnology Initiative published the National Nanotechnology Initiative Supplement to the President’s 2021 Budget (Supplement), which serves as the annual report for NNI, called for under the provisions of the 21st Century Nanotechnology Research and Development Act.  According to the Supplement, the President’s 2021 budget requests more than $1.7 billion for NNI, with an increased investment in the foundational research intended to lead to discoveries that will advance a wide range of areas.  Cumulatively totaling more than $31 billion (including the 2021 request), the Supplement states that “this support reflects the importance of investments that advance the fundamental understanding of and ability to control matter at the nanoscale, as well as the translation of that knowledge into technological breakthroughs that benefit the American people.”  The Supplement notes that past research has led to applications in areas as diverse as consumer electronics, energy, water purification, aerospace, automotive, infrastructure, sporting goods, textiles, agriculture, and medicine.  Current efforts are using nanotechnology in the development of vaccine candidates, sensors for testing strategies, and preventive measures such as masks, filters, and antimicrobial coatings.

According to the Supplement, the NNI investments in 2019 and 2020 and those proposed in 2021 reflect a sustained emphasis on broad, fundamental research in nanoscience.  The President’s Budget includes nanotechnology investments intended to further the progress of NNI “to advance a world-class research portfolio, facilitate commercialization of nanotechnology-enabled applications, support a dynamic infrastructure and skilled workforce, and ensure responsible development of nanotechnology.”  The Supplement states that these efforts “underpin key Industries of the Future by, for example, using artificial intelligence (AI) to design nanostructured materials, devices, and systems; developing specialized nanoscale computing hardware for AI systems; utilizing the NNI infrastructure and atomically precise nanoscale methods to manufacture quantum components for sensing, communication, and computing; and enabling sustainable nanomanufacturing such as cellular nanobiomanufacturing.”

The U.S. National Nanotechnology Initiative (NNI) will hold a virtual stakeholder workshop January 11-13, 2021.  NNI states that over the past 20 years, it has supported nanotechnology discovery, development, and deployment and has nurtured the strong ecosystem that exists today.  Building on this foundation, nanoscience will underpin a wide range of advanced technologies and enable solutions to challenges into the future.  As NNI enters its third decade, conversations at the January 2021 workshop will identify effective mechanisms to advance research and development, strategies for communication, and priority topics to shape future directions.  The workshop will take place virtually, and registration information will be available soon.

The U.S. National Nanotechnology Initiative (NNI) will hold a webinar on November 4, 2020, on “Implantable Nanosensors:  A Forward-Looking View on Technical and Non-Technical Challenges.”  According to NNI, implantable nanosensors could revolutionize healthcare and improve real-time health monitoring.  NNI states that while there have been significant advances in developing implantable sensors for monitoring and responding to tissue growth, infection, and inflammation surrounding implants, as well as communicating such responses to hand held devices for real-time responses, obstacles include the use of non-toxic sensor chemistries, information storage, healthcare privacy, and longevity of sensor function in the body.  The webinar will summarize some of these challenges, placing them into the context of the promise implantable sensors possess across all of medicine.  The speaker will be Dr. Thomas Webster, Art Zafiropoulo Chair in Engineering at Northeastern University’s Department of Chemical Engineering.  Dr. Webster’s research focuses on the use of self-assembled chemistries, nanoparticles, and nanostructured surfaces in the design, synthesis, and evaluation of nanomaterials for various medical applications.  His work targets health threats associated with bacteria-resistant surfaces, inflammation, and advances to promote tissue growth.  Dr. Webster is also developing in situ sensors that can sense biological responses to medical devices and respond in real time to ensure implant success.

The webinar is part of NNI’s Sensors Nanotechnology Signature Initiative (NSI) Webinar Series.  According to NNI, federal nanotechnology research and development programs have provided support for the development of sensor technology.  NNI agencies participating in the Sensors NSI coordinate efforts and stimulate existing and emerging projects to explore the use of nanotechnology for the development and commercialization of nanosensors.

The U.S. Environmental Protection Agency (EPA) announced on October 15, 2020, a settlement with Electrolux Home Products, Inc., to resolve alleged violations of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  As part of the settlement, Electrolux will pay a civil penalty in the amount of $6,991,400.

EPA states that the settlement resolves claims that Electrolux imported unregistered pesticides in violation of FIFRA Section 12(a)(1)(A) and failed to file the required Notice of Arrival in violation of FIFRA Section 12(a)(2)(N).  According to EPA, Electrolux imported approximately 420,000 Frigidaire brand dehumidifiers and air conditioners that contained filters incorporating an unregistered nanosilver and that were labeled and marketed with pesticidal claims.  The claims included “antibacterial filter” and “helps eliminate bacteria in the air that can make breathing difficult.”  EPA worked with U.S. Customs and Border Protection to prevent the unregistered pesticide products from entering U.S. commerce.  Electrolux agreed to remove the filters with the unregistered nanosilver, systematically replacing the filters manufactured with nanosilver, and removed the online and on-box pesticidal claims for the products it had imported, as well as for some additional products already in the United States.  EPA states that to date, Electrolux has returned more than 500,000 air conditioners and dehumidifiers to compliance.

EPA notes that applicants for pesticide registration are required to submit efficacy data to substantiate any public health claims they intend to make for their pesticide products.  Before EPA can register a pesticide, it must determine that no unreasonable adverse effects on human health and the environment will occur when the pesticide product is used according to its label directions.  According to EPA, “[t]he only nanosilver pesticides that are currently registered with the EPA are approved solely for incorporation into textiles to protect those articles themselves from antimicrobial pests such as mold and bacteria that can cause deterioration, discoloration or odors.  No nanosilver pesticide is registered with the EPA for use in home appliances to disinfect the ambient air or protect the health of the user.”

On October 13, 2020, the Nanoscale Science, Engineering and Technology (NSET) Subcommittee published a request for information to inform the development of the 2021 National Nanotechnology Initiative (NNI) Strategic Plan.  85 Fed. Reg. 64535.  According to the Subcommittee, a restructuring of the NNI is under consideration.  The Subcommittee seeks response to the following questions to identify effective mechanisms, strategies for communication, and priority topics to inform the future directions of the NNI:

Mechanisms

  • What is your understanding of how the federal government has supported the nanotechnology community since the launch of the NNI?
  • How should this support evolve into 2030 and beyond? What mechanisms and programs are necessary to support the broad NNI research and development (R&D) portfolio?
  • What key elements and intersections are necessary to form an agile framework that will enable response to new developments along the nanotechnology continuum, from discovery and design to development and deployment?
  • How can the government engage effectively with stakeholders in industry and academia to advance nanotechnology research, development, and eventual commercialization? What are some best practices for this kind of engagement?
  • How could public-private partnerships contribute to progress towards the NNI goals? Are there any examples (domestic or international) of productive partnership mechanisms that should be considered as a model?
  • What are exemplary models (domestic or international) for accessing NNI resources, including user facilities and laboratories?

Communication

  • How can the National Nanotechnology Coordination Office (NNCO) facilitate communication and collaboration throughout the nanotechnology R&D ecosystem to enhance research and ultimately commercialization? How can the NNI/NNCO best communicate opportunities, resources, and advancements to the community?  How can the NNI/NNCO best engage with the stakeholder community to understand their advancements and needs?
  • Beyond the media platforms used by NNCO, what additional means should be considered to reach better the public and various stakeholder groups?
  • What are effective strategies for improving communication of desired nanotechnology workforce skills and capabilities between industry and academia?
  • How can the NNI participating agencies or NNCO best raise awareness among teachers regarding the educational resources that have been developed over the past 20 years and help get these resources into their classrooms?

Topics

  • What are the high priority open scientific questions in nanoscience and nanotechnology?
  • What are challenges facing the United States and the world where nanotechnology is poised to make significant contributions?
  • What nanotechnology-enabled “moonshots” should be considered?
  • How does nanotechnology support other foundational fields/initiatives? What future technical topics are likely to emerge from advancements in nanotechnology?
  • What are the gaps in the fabrication, characterization, and modeling and simulation tools available through the NNI user facilities (listed on Nano.gov)? What other tools are necessary to conduct nanotechnology R&D?
  • What specific nanotechnology topics could be accelerated to commercialization by public-private partnerships?
  • As concepts surrounding responsible development have evolved over the past 20 years, what factors may contribute to the responsible development of nanotechnology going forward?

Responses are due November 9, 2020.

The European Parliament (EP) announced on October 8, 2020, that it objected to a European Commission (EC) proposal to amend the specification for the use of titanium dioxide (E171) in food products.  The EP rejected the EC’s proposal to reduce the amount of titanium dioxide (E171), instead calling on the EC “to apply the precautionary principle and to remove E171 from the EU list of permitted food additives that are currently used mainly to colour confectionery, bakery and pastry products as well as chewing gum, candies, chocolates, and ice cream.”  The adopted resolution describes titanium dioxide (E171) as “a food additive partly made of nanoparticles,” and states that “most Member States have been struggling to enforce the requirement to label nanoparticles in food so far; whereas tests by consumer groups carried out in Spain, Belgium, Italy and Germany have found nanoparticles of titanium dioxide (E 171) in proportions greater than 50 %, without the additive being labelled as ‘nano’, including in foodstuffs such as sweets, chewing-gums, and cakes frequently consumed by children and other vulnerable sections of the population.”  The EP notes that France banned sales of food products containing titanium dioxide as of January 1, 2020, and that 85,000 European citizens have signed a petition supporting the French ban.  The EC cannot proceed with the proposed amendment and must now amend or withdraw it.

The European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) began a public consultation on October 5, 2020, on a preliminary opinion entitled Scientific Advice on the Safety of Nanomaterials in Cosmetics.  The EC requested that SCCS determine the nanomaterials, as published in the 2019 catalogue of nanomaterials, for which specific concerns can be identified and justified to establish a priority list of nanomaterials for risk assessment (Article 16(4) Reg.1223/2009).  The EC asked that SCCS provide a description of the specific concerns that have been identified.  The preliminary opinion states that SCCS has identified certain aspects of nanomaterials that constitute a basis for concern over safety to consumers’ health when used in cosmetic products.  These include:

  • Physicochemical aspects relating to: very small dimensions of the constituent particles; solubility/persistence/potential accumulation in the body; chemical nature and toxicity of the nanomaterial; physical/morphological features of the constituent particles; and surface chemistry and surface characteristics (surface modifications/coatings);
  • Exposure aspects relating to: the frequency and the amounts used, whether the number/type of consumer product(s) used is relatively high; and whether there is a potential for systemic exposure of the consumer to nanoparticles; and
  • Other aspects relating to: novel properties, activity, or function, and specific concern arising from the type of application.

Annex 1 of the preliminary opinion lists the nanomaterials included in the 2019 catalogue of nanomaterials in order of priority according to risk potential.  SCCS used a scoring system proposed by Brand et al. (2019) “that combines consideration of the key aspects of nanomaterials that can trigger a ‘signal’ for risk, which when combined with expert judgment can help assign an arbitrary score for prioritisation on the basis of risk potential for human health.”  The preliminary opinion notes that “the outcome of such a scoring system is not meant to be an alternative to evidence-based safety assessment, but to provide a means for prioritising nanomaterials so that they can be subjected to proper safety assessment.”  The nanomaterials listed in Annex 1 with the highest scores are methylene bis benzotriazolyl tetramethylbutyl phenol; colloidal silver; and silver.

The EC also requested that for nanomaterials with inconclusive SCCS opinions, SCCS assess if a potential risk can be identified according to Article 16(6) Reg.1223/2009.  The inconclusive SCCS opinions specified in the request include colloidal silver (nano) (SCCS/1596/18), styrene/acrylates copolymer (nano) + sodium styrene/acrylates copolymer (nano) (SCCS/1595/18), and silica, hydrated silica, and silica surface modified with alkyl silylates (nano form) (SCCS/1545/15).  According to the preliminary opinion, SCCS reviewed the previous inconclusive opinions (SCCS/1596/18, SCCS/1595/18, and SCCS/1545/15), in conjunction with any further relevant information available in published literature to identify whether there is a scientific basis for concern over their safety to consumers’ health when used in cosmetic products.  The preliminary opinion states that SCCS has identified certain aspects relating to each of the nanomaterials that raise a safety concern.  These have been detailed in three separate annexes to the preliminary opinion.  Comments on the preliminary opinion are due November 2, 2020.

The U.S. Food and Drug Administration (FDA) Nanotechnology Task Force is celebrating NanoDay on October 9, 2020, by hosting a virtual research symposium to showcase more than a decade of progress and innovation in nanotechnology at FDA.  The agenda lists the following presentations:

  • A Decade of Progress and Innovation in Nanotechnology at U.S. FDA;
  • Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology;
  • Regulatory Science Research in Nanotechnology;
  • Drug Products That Contain Nanomaterials;
  • Nanotechnology and Medical Devices: A Regulatory Science Approach Involving Research, Standards, and Risk Assessment;
  • Food Ingredients and Food Contact Substances Containing Nanomaterials: Guidance for Manufacturing Process Change;
  • Use of Nanomaterials in Foods and Drugs for Animals;
  • Virtual Tour of the Nanocore Facilities (five-minute video);
  • Biological Products That Contain Nanomaterials;
  • Office of Regulatory Affairs (ORA) and Nanomaterials;
  • Safety of Nanomaterials in Cosmetic Products;
  • Liposome Drug Products Guidance;
  • Standards in Nanotechnology;
  • Collaborative Opportunities for Research Excellence in Science (CORES) Intramural Grants Program; and
  • Highlights of Nanotechnology Research at FDA.

Registration is now open.

The Developmental and Reproductive Toxicant Identification Committee (DARTIC) of California’s Office of Environmental Health Hazard Assessment (OEHHA) will meet on December 10, 2020, to discuss the prioritization of 22 chemicals or chemical groups, including titanium dioxide nanoparticles.  DARTIC will provide OEHHA with advice on the prioritization of these chemicals for listing consideration at future meetings.  No listing decisions will be made at the meeting.  According to OEHHA’s prioritization document for these chemicals, in the most recent application of the prioritization process, OEHHA applied both a human and an animal data screen to candidate chemicals in its tracking database.  OEHHA identified 22 chemicals or chemical groups for DARTIC discussion, advice, and consultation.  The prioritization document presents information on the identified chemicals or chemical groups.  For each, OEHHA presents an initial, abbreviated appraisal of the scientific information identified through the screening-level literature search and the preliminary toxicological evaluation.

Interested parties may provide comments on the potential for exposure in California and the extent of the scientific evidence pertaining to the selection of any of the 22 chemicals or chemical groups for possible preparation of hazard identification materials.  Written comments and any supporting documentation are due November 16, 2020.  OEHHA will forward public comments to DARTIC members prior to the December 10, 2020, meeting.  After the meeting, OEHHA will choose chemical(s) for which to prepare hazard identification materials summarizing the available scientific evidence on the chemicals’ potential to cause developmental or reproductive toxicity following a comprehensive search and evaluation of the scientific literature.  OEHHA will provide these materials to DARTIC and release them for public comment prior to the public meeting at which DARTIC deliberates on a listing decision.