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.

On March 4, 2020, the National Institute for Occupational Safety and Health (NIOSH) published a Federal Register notice announcing the availability of its Current Intelligence Bulletin 69:  NIOSH Practices in Occupational Risk Assessment.  85 Fed. Reg. 12786.  The Current Intelligence Bulletin (CIB) describes the process and logic NIOSH uses to conduct risk assessments, including the following steps:

  • Determining what type of hazard is associated with a chemical or other agent;
  • Collating the scientific evidence indicating whether the chemical or other agent causes illness or injury;
  • Evaluating the scientific data and determining how much exposure to the chemical or other agent would be harmful to workers; and
  • Carefully considering all relevant evidence to make the best, scientifically supported decisions.

Appendix C of the CIB includes sections addressing nanomaterials risk assessment and alternative methods for nanomaterials.  The CIB states that “[g]iven the large and growing number of engineered nanomaterials (ENMs) with limited data, as for other emerging and existing substances produced or used in the workplace, alternative test strategies (i.e., toxicological approaches other than primary animal testing) such as high-throughput screening and in vitro exposures may help to fill the gaps by providing data that could be used in validated hazard and risk assessment models.”  The CIB section on nanomaterials risk assessment includes subsections on dose normalization in vitro and in vivo and correlation of in vitro and in vivo responses.  The section on alternative methods for nanomaterials includes subsections on comparative potency estimation, hazard classification/clustering, and validation.  The CIB notes that a key challenge to using alternative test strategies data is the development and application of validation criteria.

As reported in our February 13, 2020 blog item, the U.S. Environmental Protection Agency (EPA) announced on February 12, 2020, that it is seeking public input on a proposal to incorporate a new nanosilver pesticide product into textiles to combat odors, discoloration, and other signs of wear.  The proposed registration decision is for NSPW Nanosilver, and the proposed pesticide product, Polyguard-NSPW Master Batch (Polyguard), will be incorporated into textiles to suppress bacteria, algae, fungus, mold, and mildew, which cause odors, discoloration, stains, and deterioration.  According to EPA, based on its human health and ecological risk assessment, it has preliminarily determined that the new active ingredient in Polyguard meets the regulatory standard under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) for use as a materials preservative in textiles.  According to a February 27, 2020, memorandum placed in Docket ID EPA-HQ-OPP-2020-0043, EPA received a request to extend the comment period 30 days to allow additional time to review the documentation contained in the docket.  The memorandum states that EPA “feels that 15 additional days should be sufficient to allow for adequate review of the Proposed Decision and supporting documentation.”  Comments are now due March 30, 2020.