The National Academies of Sciences, Engineering, and Medicine (National Academies) have published a prepublication copy of A Quadrennial Review of the National Nanotechnology Initiative:  Nanoscience, Applications, and Commercialization.  The National Nanotechnology Coordination Office (NNCO) asked the National Academies to form an ad hoc committee to conduct a quadrennial review of the National Nanotechnology Initiative (NNI) pursuant to the 2003 21st Century Nanotechnology Research and Development Act, which authorized the NNI to coordinate the nanotechnology-related research and development (R&D) of 26 federal agencies.  The statement of task was to analyze the relative position of the U.S. nanotechnology program relative to the programs of other nations, determine whether NNI coordination should continue, and if it should, identify how to improve the NNI’s R&D strategy and R&D portfolio to enhance further the economic prosperity and national security of the United States.  According to the report, the United States maintains a strong nanoscience and technology R&D program.  The report states that this program’s coordination is becoming more critical in the current era of intensifying global competition from developed nations such as Japan and those within the European Union, and from developing nations such as India and especially China.  In the latter case, the report notes that “researchers are witnessing aggressive, and in many cases effective, planning of a national R&D strategy that seeks to harvest the economic, medical, and national security benefits of nanotechnology as quickly as possible.”  This, combined with very large investments in state-of-the-art facilities and the allocation of substantial resources for the education, training, and attraction of top research international talent, “is clearly intended to result in Chinese leadership of this critically important area of technology.”  The report identifies changes to NNI intended to “promote a resurgence of the nation’s nanotechnology program and enable it to respond to the dynamic changes of the new global research environment in which it functions.”

The National Institute for Occupational Safety and Health (NIOSH) has posted two posters from the NIOSH Nanotechnology Research Center (NTRC) on 3D printing:  3D Printing with Filaments:  Health and Safety Questions to Ask and 3D Printing with Metal Powders:  Health and Safety Questions to Ask.  The posters provide health and safety questions with different control options and information intended to reduce exposure to potential hazards.  The questions include:

  • Characterization of Potential Hazards: What potential hazards are associated with 3D printing? Are there known health effects from the filaments or the metals (for example, see safety data sheets)?  What is the work environment like (for example, open or isolated area)?
  • Work Activities: Could the work activities cause exposures?  What is the likelihood of exposure?  Can you change the way you do the activity to reduce the likelihood of exposure (high potential to low)?
  • Engineering Controls: Based on the work activity, what engineering controls will reduce the likelihood of exposure?  What are the key design and operational requirements for the control?
  • Administrative Controls: Have you considered your workplace practices and policies?  Have you set up a plan for waste management?  Have you considered what to do in case of a chemical spill?
  • Personal Protective Equipment (PPE): If the measures above do not effectively control the hazard, what PPE can be used?  Have you considered PPE for other safety hazards?

The U.S. Environmental Protection Agency published a proposed rule on April 1, 2020, that would amend the significant new use rules (SNUR) for certain chemical substances that were the subject of a premanufacture notice (PMN) and a significant new use notice (SNUN), including functionalized multi-walled carbon nanotubes (MWCNT) (generic).  85 Fed. Reg. 18173.  This action would amend the SNURs to allow certain new uses reported in the SNUNs without additional notification requirements and modify the significant new use notification requirements based on the actions and determinations for the SNUN submissions.  Comments are due May 1, 2020.

In 2013, EPA promulgated a final SNUR for functionalized MWCNTs (generic) (PMN Number P-12-44).  In the April 1, 2020, Federal Register notice, EPA states that the generic (non-confidential) use for P-12-44 is an additive for rubber and batteries.  EPA identified concerns for lung effects to workers exposed to the PMN substance and for sublethal effects in fish at levels of 100 parts per billion (ppb).  The SNUR required notification if the chemical substance was used other than for the confidential use described in the PMN, for manufacturing, processing, or use as a powder, and for manufacturing, processing, or use resulting in releases to surface waters.

According to the Federal Register notice, on May 14, 2018, EPA received a SNUN, S-18-4, for the chemical substance for use as a chemical additive in epoxy compounds for transportation, marine and industrial coatings, paints, and manufactured goods.  The 90-day review period for the SNUN expired on February 22, 2019.  Based on the activities described in the SNUN, EPA issued an Order under TSCA Sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on determinations under Sections 5(a)(3)(B)(i) and 5(e)(1)(A)(i), that the use may present an unreasonable risk of injury to human health, and the information available to EPA is insufficient to permit a reasoned evaluation of the environmental effects.  EPA states that it identified concerns for lung effects, carcinogenicity, immunotoxicity, and thymus toxicity.

Due to potential worker exposures, the TSCA Order for S-18-4 allows the use of the chemical substance as a chemical additive for use in epoxy compounds for transportation, marine and industrial coatings, paints, and manufactured goods and requires personal protective equipment (PPE), including respirators, to prevent dermal and inhalation exposure.  The TSCA Order also retains the same requirements as the SNUR for no water release, for no manufacturing, processing, or use as a powder, and allowing the confidential use described in PMN P-12-44.

On May 20, 2019, EPA received a SNUN, S-19-5, for the chemical substance from the same submitter as S-18-4 for use in conductive ink.  The 90-day review period for the SNUN expired on August 9, 2019.  Based on the activities described in the SNUN, including the requirements of the TSCA Order for S-18-4, EPA determined under TSCA Section 5(a)(3)(C) that the use is not likely to present an unreasonable risk.  EPA modified the TSCA Order for S-18-4 to allow the use described in the SNUN.

EPA proposes to amend the SNUR to remove the new uses described in SNUN S-19-5 from the scope of the significant new use and remove the new uses described in SNUN S-18-4 from the scope of the significant new use, except where that use does not include the protective measures described in the TSCA Order for S-18-4.

According to EPA, certain information may be potentially useful to characterize the health and environmental effects of the chemical substance in support of a request to modify the TSCA Section 5(e) Order, or if a manufacturer or processor is considering submitting a SNUN.  EPA states that the results of particle size information, specific organ toxicity, carcinogenicity, and acute and chronic aquatic toxicity testing would help characterize the potential health and environmental effects of the chemical substance.

On March 30, 2020, the National Nanotechnology Initiative (NNI) released a “Nano Matters” podcast episode on “Improving Pesticide Use with Nanotechnology.”  In the episode, Cristina Sabliov, Professor of Biological and Agricultural Engineering at Louisiana State University, explains how nanotechnology can improve pesticide delivery.  She discusses her work on a polymeric nanoparticle delivery system that could reduce the environmental impact of pesticides.  “Nano Matters” is an NNI podcast that explores specific nanotechnology topics for a broad audience.  NNI notes that any opinions, findings, conclusions, or recommendations expressed in the podcast are those of the guest and do not necessarily reflect the views of the National Nanotechnology Coordination Office or U.S. government.

On March 9, 2020, the Canadian Center for Occupational Health and Safety (CCOHS) posted a podcast entitled “The Hazards of Nanomaterials and How to Control Exposure.”  CCOHS states that nanomaterials have many useful properties, but the same properties that make them desirable in manufacturing present unique potential safety hazards when workers are exposed to them.  In this episode, Todd Irick from the Occupational Health Clinics for Ontario Workers’ Nanotechnology and Health Network explains why nanotechnology is a health and safety concern in the workplace and how exposure to nanomaterials can be controlled.

On March 23, 2020, the European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) announced that the fact sheet on the SCCS Guidance on the safety assessment of nanomaterials in cosmetics is now available in French, German, Italian, and Spanish.  The guidance provides recommendations for the safety assessment of nanomaterials intended for use in cosmetics and covers the main elements of risk assessment of nanomaterials in relation to possible use as cosmetic ingredients, i.e., general safety considerations, material characterization, exposure assessment, hazard identification and dose-response characterization, and risk assessment with due consideration of the animal testing ban in place for cosmetics.  SCCS states that the guidance should be used in conjunction with the general guidance for the submission of safety dossiers of cosmetics ingredients, “The SCCS notes of Guidance for testing of cosmetics ingredients and their safety evaluation” (SCCS/1602/18).

On March 16, 2020, the Dutch National Institute for Public Health and the Environment (RIVM) announced publication of an article in the May 2020 issue of Environmental Research entitled “Nanoparticle exposure and hazard in the ceramic industry:  an overview of potential sources, toxicity and health effects.”  In the article, the researchers provide an overview of the current knowledge on occupational exposure to nanoparticles in the ceramic industry and their impact on human health.  The researchers present possible sources and exposure scenarios, a summary of the existing methods for evaluation and monitoring of airborne nanoparticles in the workplace environment, and proposed nano reference values for different classes of nanoparticles are presented.  The article describes case studies on occupational exposure to airborne nanoparticles generated at different stages of the ceramic manufacturing process.  Finally, researchers discuss the toxicological potential of intentional and unintentional airborne nanoparticles that have been identified in the ceramic industry workplace environment based on the existing evidence from in vitro and in vivo inhalation toxicity studies.

The International Organization for Standardization (ISO) has published standard ISO/TS 19808:2020, “Nanotechnologies — Carbon nanotube suspensions — Specification of characteristics and measurement methods.”  The standard specifies the characteristics to be measured of suspensions containing multi-walled carbon nanotubes (carbon nanotube suspensions).  The standard includes the essential and additional characteristics of the carbon nanotube suspension, and the corresponding measurement methods.  ISO notes that characteristics specific to health, environmental, and safety issues are excluded from the standard.

The European Commission’s Scientific Committee on Consumer Safety (SCCS) announced on March 3, 2020, that the April 2020 issue of Regulatory Toxicology and Pharmacology includes “The SCCS guidance on the safety assessment of nanomaterials in cosmetics.”  The highlights state that:

  • The guidance provides an overview of the key issues and data requirements relating to the safety assessment of nanomaterials;
  • The guidance facilitates the applicants and the risk assessors in preparing and assessing safety dossiers on nanomaterials; and
  • The guidance is complementary to the SCCS general Notes of Guidance.

The article is available for purchase through the Regulatory Toxicology and Pharmacology website.

As reported in our November 5, 2019, blog item, SCCS published an updated Guidance on the Safety Assessment of Nanomaterials in Cosmetics.  The Guidance updates SCCS’s 2012 Guidance (SCCS/1484/12) on the safety assessment of nanomaterials in cosmetic products.  It covers the main elements of safety assessment — general considerations (Section 2), material characterization (Section 3), exposure assessment (Section 4), hazard identification and dose-response characterization (Section 5), and risk assessment (Section 6).

On March 3, 2020, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion entitled “‘Nanoplastics’ — it’s a name game.”  Claire Skentelbery, Director General, Nanotechnology Industries Association (NIA), reviews the difference between engineered (manufactured) nanomaterials and naturally originating (incidental) nanomaterials.  Skentelbery notes that use of the term “nanoplastics,” without describing their origins, “risks the perception that the plastic particles now being found throughout our ecosystems were intentionally produced.”  Skentelbery suggests that researchers and companies in the engineered nanomaterials sector can “play a very positive role in helping to identify and understand the incidental nanoplastics that are increasingly visible to us in our landscape.”  Rapid advances in characterizing and understanding engineered nanomaterials will help scientists worldwide to find, identify, and understand the biological interactions of incidental nanoplastics and address their impact on the environment.  Skentelbery concludes that “[t]his can enable all measures necessary to reduce their occurrence, reaching back up through the long industrial and societal pathway through which they were produced.”  Bergeson & Campbell, P.C. is a proud NIA member.