Gov4Nano, NANORIGO, and RiskGONE, three projects funded by the European Union (EU), are working together “to develop and establish a robust public policy framework for the use of nanomaterials based on scientific evidence supporting a clear understanding of risks, their assessment and management within wider societal considerations.” The projects are conducting a survey to understand better how the needs of different stakeholders can be addressed through the outputs of the projects. According to the survey, these projects have produced:

  • A blueprint for an organization to govern nanotechnology-related risk comprising individuals (experts, stakeholders) who provide “problem-solving capacity” to support decisions on new/emerging risks from engineered nanomaterials. The form of this organization could be:
    • Option A: A permanent structure (“House”) that develops and offers access to a risk governance framework and a range of data and tools (see below), as well as a series of activities and services, including advice, expert opinion, or technical assistance; or
    • Option B: A “Taskforce” or committee, mobilized by the European Commission (EC) or others, to respond to specific needs or challenges, like the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER);
  • A Risk Governance Framework that guides users in the identification, assessment, management, and communication of risks;
  • Data from experiments using engineered nanomaterials that link material properties with observed effects in humans, living organisms, and the environment; and
  • A set of tools that can be used to analyze the quality and suitability of the available data, make comparisons and predictions, and support decision making. These will be available via an online portal.

All responses will remain confidential, and no specific comments will be attributed to any individual. Responses are due September 30, 2022.

The U.S. Food and Drug Administration (FDA) will hold the “FDA NanoDay Symposium 2022” on October 11, 2022. The symposium will address the following topics:

  • An overview and discussion of the recent “Guidance for Industry: Drug Products, Including Biological Products, that Contain Nanomaterials.” More information on the guidance is available in our April 24, 2022, blog item;
  • A contextualized discussion of the development of the COVID mRNA lipid nanoparticle vaccine products;
  • A nonclinical perspective of developmental challenges of products that contain nanomaterials; and
  • The development of regulatory standards and methods for controlling products that contain nanomaterials.

According to FDA, the intended audience includes:

  • Regulatory science and regulatory affairs professionals working on drug products, including biologicals, that contain nanomaterials and submit IND/NDA/BLA/ANDA applications for FDA review;
  • Researchers working on applications of nanotechnology for pharmaceutical products, analytical methodology for control of pharmaceuticals that contain nanomaterials, and nonclinical studies to support human clinical trials; and
  • Foreign regulators who review comparable pharmaceutical products that contain nanomaterials.

 

On September 13, 2022, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion entitled “Can the Brain’s Gatekeeper Fight a Nano-Attack?” by Dr. Eugenia (Éva) Valsami-Jones, Professor of Environmental Nanoscience at the University of Birmingham, who co-authored an article entitled “Biotransformation modulates the penetration of metallic nanomaterials across an artificial blood–brain barrier model.” The researchers set out to explore systematically how different nanoparticle properties play a role in their potential to be transported across the blood-brain barrier (BBB). To be able to test their hypotheses, they constructed a model BBB inside a special permeable well, on which human cells representative of the BBB were cultured and tested to ensure their function precisely replicated that of the real barrier. The researchers then investigated what factors affect the ability of a number of model nanoparticles, specifically cerium oxide, iron oxide, zinc oxide, and silver in different particle sizes and shapes, to cross the model BBB. Valsami-Jones states that the researchers discovered that silver and zinc oxide nanoparticles, “which are often used in consumer goods, including healthcare products, have the potential to cross the BBB and enter the brain in the form of both particles and dissolved ions, depending on the size, shape and exposure concentration.” These nanoparticles can also affect cellular function and integrity of the BBB. The study revealed how nanoparticles may gain access to the brain and how they might bypass the brain’s guardian BBB. According to Valsami-Jones, “[t]he knowledge acquired can help make the use of nanoparticles safer, by ensuring, for example, that properties that facilitate crossing of the BBB are designed out of products that could come to direct contact with our bodies. In contrast, if nanoparticles are used as vehicles for drug delivery, for example in order to fight diseases such as Parkinson’s and Alzheimer’s, then we should design in the properties that give them easy passage through the BBB.”

The Organization for Economic Cooperation and Development (OECD) Series on the Safety of Manufactured Nanomaterials is to provide up-to-date information on the OECD activities related to human health and environmental safety. In September 2022, OECD has published two new reports. Advanced Materials: Working Description (No. 104) aims to illustrate the content of the advanced materials playing field and the purpose of the Working Party on Manufactured Nanomaterials’ (WPMN) engagement regarding these materials. In this context, advanced materials are understood as materials that are rationally designed to have new or enhanced properties and/or targeted or enhanced structural features with the objective to achieve specific or improved functional performance. This includes both new emerging manufactured materials, and materials that are manufactured from traditional materials. This also includes materials from innovative manufacturing processes that enable the creation of targeted structures from starting materials, such as bottom-up approaches. The report acknowledges that what are currently considered as advanced materials will change with time. The report includes examples of possible cases of advanced materials.

Sustainability and Safe and Sustainable by Design: Working Descriptions for the Safer Innovation Approach provides working descriptions for sustainability and safe and sustainable by design (SSbD). These working descriptions will be used for the further development of the OECD Safer Innovation Approach (SIA) and the implementation of the concept of SSbD for nanomaterials and advanced materials in the context of the work of the OECD WPMN:

  • Sustainability supports societal, economical, and environmental United Nations (UN) Sustainable Development Goals for the planet and for present and future generations. It relates to/is about minimizing the environmental footprint, in particular regarding climate change, pollution, and resource use, protecting ecosystems, and biodiversity. Sustainability should prevent waste in the first place (zero waste) and include material loops and processes that support the “waste hierarchy” that ranks waste management options according to what is best for the environment, giving top priority to durability and repairability. It has three main aspects, all of them overlapping and cross linked by safety: planet/biosphere/environment; people/society; and prosperity/economy. The report states: “In summary, sustainability could be described as the ability of a material or chemical to provide products/services with desired functionalities without exceeding planetary boundaries, while ensuring wellbeing and other socio-economic benefits.”
  • SSbD can be described as an approach that focuses on providing a function (or service), while avoiding onerous environmental footprints and chemical properties that may be harmful to human health or the environment. According to the report, for SSbD, three pillars of design can be specified:
  • Safe and sustainable material/chemical/product: Minimizing, in the research and development (R&D) phase, possible hazardous properties and sustainability issues (promoting traceability, sustainable sources of raw materials/natural resources, minimizing resource consumption and sources, promoting social responsibility) of the designed material/chemical/product while maintaining its function;
  • Safe and sustainable production: Ensuring industrial safety during the production of materials/chemicals/products, more specifically occupational, environmental, and process safety aspects. The pillar should also ensure processes for the production of materials/chemicals/products minimize emissions and resource consumption, and optimize waste management; and
  • Safe and sustainable use and end-of-life: Minimizing exposure and associated adverse effects through the entire use life, recycling, and disposal of the material/chemical/product. Materials/chemicals/products should be designed in a way that demand of resources is minimized during the use phase as well as during recycling, and that the material/chemical/product supports the waste hierarchy and circular economy.

The National Academies of Sciences, Engineering, and Medicine (NASEM) released on August 9, 2022, a report entitled Review of Fate, Exposure, and Effects of Sunscreens in Aquatic Environments and Implications for Sunscreen Usage and Human Health. NASEM was tasked by Congress and funded by the U.S. Environmental Protection Agency (EPA) to undertake a consensus study of the potential risk of ultraviolet (UV) filters on already threatened aquatic environments and the potential consequence to human health should sunscreen usage or composition be modified. NASEM’s report reviews the state of science on the sources and inputs, fate, exposure, and effects of UV filters in aquatic environments, and the availability and applicability of data for conducting ecological risk assessments (ERA). It also reviews the epidemiological and clinical literature on the efficacy of sunscreen in preventing UV damage to human skin, the state of knowledge on potential human behavior changes, and the resulting health impacts related to skin cancer prevention from changes in sunscreen usage (e.g., reducing sunscreen use or switching to sunscreens with different active ingredients).

NASEM notes that the scope of the study is limited to the United States. According to the report, there are currently 16 UV filters allowed by the U.S. Food and Drug Administration (FDA) for use in any sunscreen sold in the United States, plus an additional proprietary UV filter, ecamsule, approved for use in limited products. While UV filters are used in a broad range of products, NASEM’s scope was to focus on their use in sunscreens. The 16 UV filters include two inorganic UV filters, titanium dioxide and zinc oxide. The summary of the attributes of UV filters relevant for assessment of environmental risk includes the following information for titanium oxide and zinc oxide:

  • Titanium Dioxide: This is a metal oxide solid and as such will have different characteristics than organic compounds in that it exists in several particulate sizes and crystalline forms that impact its behavior and effects on organisms. Occurs in many consumer products and foods in both the macro and nano forms for applications other than as a UV filter. Effectively removed during wastewater treatment and occurs in low concentrations (< 10 [micrograms per liter (μg/L)]) in wastewater treatment plants [(WWTP)] effluent, no environmental degradation but aggregation with particles in surface waters, can exceed 1 μg/L in surface waters with higher concentrations noted in rivers and beach areas, potential for bioaccumulation but limited data on tissue levels, aggregates will deposit in sediments, effects on apical endpoints are greater than 1,000 μg/L in acute laboratory toxicity tests for the nano form and ten-fold or more higher for the macro form and less than 1,000 μg/L for chronic assays. However, in select studies in the presence of UV, some data on acute and chronic effects are available and indicate toxicity < 100 μg/L. Data are available for other biological responses.
  • Zinc Oxide: This is a metal oxide solid placed in sunscreen in macro and nano particulate forms and as such will have characteristics different from organic compounds. Effectively removed by and low potential to be present in WWTP effluent, no environmental degradation but aggregation and dissolution of particles into the ionic form of zinc in the environment, can exceed 1 μg/L in surface waters with higher elevations noted in rivers and beach areas, potential for bioaccumulation supported by tissue studies, aggregates will deposit in sediments, effects on apical endpoints exhibit a wide range including effects at concentrations < 1,000 μg/L can be due to particulate or dissolution of the particulate internal or external to the organism, some data on chronic effects are available, data are available for modes of action and other biological responses.

The German Federal Ministry of Education and Research (BMBF) project (DaNa4.0) is addressing the question of whether new advanced materials, including nanomaterials, can be harmful to humans and the environment and how humans and the environment come into contact with these materials. DaNa has published an August 2022 research spotlight on a “Three-stage model for the formation of micro- and nanoplastic particles.” The paper, “Degradation of low-density polyethylene to nanoplastic particles by accelerated weathering,” investigates how the process of decomposition due to weathering occurs and what happens to nanoplastic particles. According to DaNa, the starting point for the investigation was plastic pellets in the medium size range of 100-200 micrometers (µm), which were exposed to laboratory weathering by water and solar radiation. Researchers divided the degradation into three main stages: in stage one, the large fragments were smoothed by surface abrasion over a period of up to 17 days, and smaller fragments detached; in stage 2, after a period of at least 58 days, cracks formed on the plastic surface; and in stage 3, the cracks led to the detachment of smaller particles. DaNa states that up to 14,000 nano- and microplastic particles could form from one original particle, and the nanoplastic particles subsequently form larger agglomerates with microplastic particles. According to DaNa, environmental organisms will thus be exposed to nanoplastic and microplastic particles simultaneously. At the same time, nanoplastic particles bound to natural particles may also enter the food chain.

On July 29, 2022, the National Institute for Occupational Safety and Health (NIOSH) published a Technical Report: Occupational Exposure Sampling for Engineered Nanomaterials. Since 2010, NIOSH has developed guidance for workplace sampling for three engineered nanomaterials: carbon nanotubes (CNT) and nanofiber (CNF), silver, and titanium dioxide, each of which has an elemental mass-based NIOSH recommended exposure limit (REL). NIOSH has also developed a practical approach to exposure sampling for other engineered nanomaterials that do not have exposure limits. According to NIOSH, occupational health and safety professionals “have expressed a need for one document that explains all of the available nanomaterial sampling techniques, and this document provides a summary of the different sampling techniques.” The document includes recommendations for an exposure monitoring program, CNTs and CNFs, silver, titanium dioxide, use of the nanomaterial exposure assessment technique for other engineered nanomaterials, and optional sampling methods. NIOSH concludes that a comprehensive exposure assessment evaluation for engineered nanomaterials collects information that can be used to identify sources of potential engineered nanomaterial exposures; establish similar exposure groups by area or job tasks; characterize exposures of all potentially exposed workers; and assess the effectiveness of engineering controls, work practices, personal protective equipment (PPE), training, and other factors used in reducing exposures. NIOSH states that using a combination of these techniques can provide an in-depth characterization of potential occupational exposure to engineered nanomaterials. This information is then available for incorporation into risk management strategies to minimize worker exposure to engineered nanomaterials and confirm ongoing control of risk.

The National Nanotechnology Initiative (NNI) and the U.S. Environmental Protection Agency (EPA) will co-host a webinar on August 25, 2022, on Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) funding opportunities for water nanotechnologies. Small businesses and academic researchers will have an opportunity to hear from some of the federal agencies that fund water technologies, with a special focus on investments in nanotechnology-enabled solutions. The SBIR and STTR programs fund a diverse portfolio of startups and small businesses across technology areas and markets to stimulate technological innovation, meet federal research and development (R&D) needs, and increase commercialization to transition R&D into impact. During the webinar, representatives from EPA, the National Institute of Environmental Health Sciences (NIEHS), the National Oceanic and Atmospheric Administration (NOAA), and the National Science Foundation (NSF) will provide an overview of their current and upcoming SBIR/STTR funding opportunities for water nanotechnologies. The agencies’ presentations will be followed by a question and answer session. Jean Balent, EPA Technology Innovation and Field Services Division, will moderate the panel. Speakers will include:

  • April Richards, Program Manager, SBIR Program, EPA;
  • Heather Henry, Ph.D., Health Science Administrator, NIEHS;
  • Genevieve Lind, Ph.D., Program Manager, SBIR Program, NOAA; and
  • Rajesh Mehta, Ph.D., Program Director, SBIR/STTR Program, NSF.

Registration is now open.

The National Institute for Occupational Safety and Health (NIOSH) published a program performance one-pager on July 18, 2022, for the Nanotechnology Research Center (NTRC). NTRC conducts research to understand the potential effects on human health of exposure to engineered nanomaterials and develops methods to control or eliminate exposures. The one-pager lists the following accomplishments:

According to the one-pager, the following actions are next:

  • Publish the document Occupational Exposure Sampling for Engineered Nanomaterials;
  • Publish the document Approaches to Safe 3D Printing: A Guide for Makerspace Users, Schools, Libraries and Small Businesses;
  • Conduct an evaluation of biomarkers of engineered nanomaterial exposure and disease;
  • Issue in final Approaches to Developing Occupational Exposure Limits or Bands for Engineered Nanomaterials; and
  • Publish the first two videos in the series of an Overview of Additive Manufacturing Health and Safety.

The Organization for Economic Cooperation and Development (OECD) has published a document entitled Chemical Accidents Involving Nanomaterials: Potential Risks and Review of Prevention, Preparedness and Response Measures — Project Report. Part of OECD’s series on chemical accidents, the document presents the outcome from a project of the OECD Working Party on Chemical Accidents (WPCA) that aimed to investigate safety issues related to the prevention of, preparedness for, and response to accidents involving manufactured nanomaterials. The objectives of the project were to:

  • Address potential risks for humans and the environment resulting from accidents involving manufactured nanomaterials, for example, accidental releases of larger quantities of nanomaterials into the area surrounding an establishment; and
  • Review measures for prevention of, preparedness for, and response to accidents involving nanomaterials.

The report is aimed at policy makers and regulators in charge of chemical accidents not yet familiar with safety issues regarding nanomaterials. The report was prepared using existing academic papers and relevant reports from governments and international organizations. The report intends to introduce briefly issues related to chemical accidents involving nanomaterials and to serve as a gateway to guide readers into more detailed information sources.