The National Nanotechnology Initiative (NNI) posted a blog item entitled “Impact of the NNI on the U.S. economy: at least $42 billion in one year!” on November 28, 2022. According to NNI, participating government agencies and departments have invested more than $38 billion over the past 20 years in nanoscale research and development (R&D), establishing the United States “as the leader in the field.” In 2014, the Executive Office of the President’s National Science and Technology Council worked with the U.S. Census Bureau to add a specific code to the North American Industry Classification System (NAICS) for the purpose of classifying nanotechnology-related businesses. According to NNI, data from the 2017 Economic Census reveal that over 3,700 companies — with over 171,000 employees — self-identified as primarily being in the business of nanotechnology R&D, reporting $42 billion in revenue and $20 billion in employee salaries. NNI notes that the single-year revenue figure of $42 billion in 2017 exceeds the cumulative 20-year NNI investment of $38 billion. Data from the 2022 Economic Census will be available in two to three years.

NNI states that the revenue figure of $42 billion in one year reflects only companies that categorize themselves as primarily being a nanotechnology R&D company. According to NNI, as companies can select only one NAICS code, this figure does not capture the large number of companies who benefit from nanotechnology R&D or include it among a broader portfolio of R&D activities. A company that works at the nanoscale to develop increasingly smaller microprocessors could select one of the computer or semiconductor categories and not nanotechnology R&D, despite its major investments in the field. Therefore, NNI states, the $42 billion revenue figure “likely does not include the economic impact of nanotechnology on the daily lives of U.S. residents through products such as consumer electronics, advanced computing, COVID-19 vaccines and other nanomedicines, drug delivery systems, display technologies, advanced coatings and materials, water filtration and purification systems, battery and solar technologies, and consumer goods.”

On November 30, 2022, the U.S. Department of Agriculture’s (USDA) Agricultural Research Service (ARS) announced that its scientists have determined that plants could be used to produce nanobodies that quickly block emerging pathogens in human medicine and agriculture. The nanobodies are small antibody proteins naturally produced in specific animals like camels, alpacas, and llamas. ARS researchers evaluated nanobodies to prevent and treat citrus greening disease in citrus trees. The scientists are now using their newly developed and patented SymbiontTM technology to show that nanobodies can be easily produced in a plant system with broad agricultural and public health applications. According to ARS, as a proof-of-concept, researchers showed that nanobodies targeting the SARS-CoV-2 virus could be made in plant cells and remain functional in blocking the binding of the SARS-CoV-2 spike protein to its receptor protein: the process responsible for initiating viral infection in human cells.

AgroSource, Inc. collaborated with ARS to develop the plant-based production system. According to ARS, they are currently taking the necessary steps to see how they can move this advancement into the commercial sector. ARS notes that this research collaboration is in response to the White House’s Executive Order on advancing biotechnology and biomanufacturing innovation for a sustainable, safe, and secure American bioeconomy.

The National Nanotechnology Coordination Office (NNCO) announced on November 28, 2022, that the kickoff workshop for Nano4EARTH will be held January 24-25, 2023. Nano4EARTH will leverage recent investments in understanding and controlling matter at the nanoscale to develop technologies, industries, and training opportunities that address climate change. Nano4EARTH recognizes the role nanotechnology plays in: evaluating, monitoring, and detecting climate change status and trends; averting future greenhouse gas (GHG) emissions; removing existing GHGs; training and educating a highly skilled workforce to harness nanotechnology solutions; and developing higher resilience to, and mitigation of, climate change-induced pressures for improved societal/economic resilience. Members of the National Nanotechnology Initiative (NNI) community — the scientists, engineers, entrepreneurs, and government leaders developing solutions at the nanoscale — are invited to participate in Nano4EARTH. The kickoff workshop will serve as an information-gathering exercise to identify key feasible outputs of the challenge and effective ways to measure success.

The European Union (EU) Observatory for Nanomaterials (EUON) announced on November 7, 2022, that it published a study on the EU market for nanomaterials, including substances, uses, volumes, and key producers, traders, and users. The study also covers the European Economic Area (EEA) countries and Switzerland. EUON states that according to the study, which was carried out in 2021 as a combination of literature research, surveys, and interviews, the European nanomaterial market is expected to grow in the next five years in both volume and value. According to EUON, although Brexit had an impact on this projection, interview participants did not perceive the COVID-19 pandemic to lead to a market slow-down. EUON notes that the study was conducted “before the crisis arising from the war in Ukraine, and hence its impact on the study outcomes is not known.” EUON states that while the largest segment is currently the metal oxides market, “growth is predicted to be driven mainly by nanoclays, nanocellulose and carbon-based nanomaterials.”

Technological advancement and public demand for functional, lightweight, and affordable state-of-the-art products are seen as the main drivers for growth. The industries most likely to drive market growth are aerospace, automotive, energy, food packaging, and construction. The use of nanomaterials in medicine and personal care are also expected to give the market a boost. EU and national public funding was identified as a significant enabler for the continued development and commercialization of new nanomaterials.

According to EUON, study participants perceived the current regulatory landscape, “which does not allow products containing nanomaterials to be easily commercialised,” as a significant barrier to growth. EUON states that potential upcoming changes in regulatory requirements and relatively high scale-up costs were also mentioned as “dampening the interest of companies in ramping up production. On the other hand, it was noted that a stricter regulatory regime can also help increase public trust in nanomaterial products.” According to respondents, the relatively negative public opinion toward nanomaterials is among other factors hindering growth.

EUON states that according to the study, there are approximately 2,200 existing products containing nanomaterials in the EU, EEA, and Swiss markets. According to EUON, more than 90 nanomaterial substances that are available in these markets have not been listed by any of the inventories on which EUON reports. EUON notes that some of the discrepancy can be due to regulation-specific conditions under which substances in nanoform need to be registered and/or notified.

On October 31, 2022, the U.S. Environmental Protection Agency (EPA) proposed significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for a number of chemical substances that were the subject of premanufacture notices (PMN) and are also subject to Orders issued by EPA pursuant to TSCA. 87 Fed. Reg. 65548. The proposed SNURs include four chemical substances identified as:

  • Multi-walled carbon nanotubes (MWCNT); closed; 4.4-12.8 nanometer (nm) diameter; bundle length 10.6-211.1 micrometer (µm); Grade: Jenotube 6 (PMN P-20-62);
  • MWCNTs; closed; 5.1-11.6 nm diameter; bundle length 1.9-552.0 µm; Grade: Jenotube 8 (PMN P-20-63);
  • MWCNTs; closed; 7.9-14.2 nm diameter; bundle length 9.4-106.4 µm; Grade: Jenotube 10 (PMN P-20-64); and
  • MWCNTs; closed; 17.0-34.7 nm diameter; globular shape; Grade: Jenotube 20 (PMN P-20-65).

According to EPA, the PMNs state that the use of the substances will be as electrically conductive materials; heat dissipation materials; heat generation materials; additives for weight reduction; additives to improve physical or mechanical properties; additives in batteries, energy storage, and electrode applications; and additives in field emission applications. According to the notice, based on analogy to asbestos fibers and data for other MWCNTs, EPA identified concerns for lung effects (lung overload and lung carcinogenicity) if poorly soluble, respirable particulates and fibers are inhaled. Based on comparison to analogous chemical substances, EPA identified concerns for eye irritation and systemic effects. Based on the presence of cobalt oxide as a residual at 2.1%, EPA identified concerns for the P-20-64 chemical substance for acute neurotoxicity, dermal and respiratory sensitization, mutagenicity, and carcinogenicity. EPA states that it was unable to estimate the environmental hazard of these new chemical substances. EPA issued the Order under TSCA Sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substances may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the Order requires:

  • No domestic manufacture (e., import only);
  • No processing or use of the PMN substances in an application method that generates a vapor, mist, dust, or aerosol unless such application method occurs in an enclosed process;
  • Use of personal protective equipment where there is a potential for dermal exposure;
  • Use of a National Institute for Occupational Safety and Health (NIOSH)-certified respirator with an assigned protection factor (APF) of at least 50 where there is a potential for inhalation exposure;
  • No manufacture of the PMN substances with a maximum weight percent of cobalt oxide impurity in exceedance of 2.1%;
  • Process and use of the PMN substances only as electrically conductive materials; heat dissipation materials; heat generation materials; additives for weight reduction; additives to improve physical or mechanical properties; additives in batteries, energy storage, and electrode applications; or as additives in field emission applications;
  • Establishment of a hazard communication program, including human health precautionary statements on each label and on the safety data sheet (SDS); and
  • No release of the PMN substances, or any waste stream containing the PMN substances, into water.

The proposed SNURs would designate as a “significant new use” the absence of these protective measures.

EPA states that it determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a significant new use notice (SNUN) for a significant new use that will be designated by this SNUR. EPA determined that the results of specific target organ toxicity, carcinogenicity, eye irritation, and aquatic toxicity testing may be potentially useful to characterize the human health and environmental effects of the PMN substances. Although the Order does not require these tests, the Order’s restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information. Comments are due November 30, 2022.

NanoHarmony and NANOMET have published a status report summarizing the current status of projects aiming to develop or adapt Organization for Economic Cooperation and Development (OECD) Test Guidelines (TG) and Guidance Documents (GD) for nanomaterials, as well as the outlook for each project as of July 2022. The status report is intended to be a living document that will be updated regularly. A large part of the status report comprises activities in European Union (EU) projects like NanoHarmony, Gov4Nano, RiskGONE, and NANORIGO, and national projects that contribute within the Malta Initiative to the development of TGs and GDs for nanomaterials. Apart from the projects supported by the OECD Working Group of National Co-ordinators of the TGs program (WNT) or OECD Working Party on Manufactured Nanomaterials (WPMN), an additional number of standardization activities are presented that develop test methodologies for which the initiators foresee an OECD project status in the near future.

The U.S. Environmental Protection Agency (EPA) will hold a webinar on November 1, 2022, on a new research funding opportunity, “Developing and Demonstrating Nanosensor Technology to Detect, Monitor, and Degrade Pollutants.” EPA states that environmental pollutants such as pesticides, insecticides, dyes, phenols, endocrine disrupters, polycyclic aromatic hydrocarbons, per- and polyfluoroalkyl substances (PFAS), heavy metals, and nitrogen compounds can have adverse effects on human health even at low concentrations. Efforts are consistently being made to develop reliable and simple sensors to detect pollutants even at low levels. According to EPA, environmental remediation technologies cover a vast range of applications that require tailored engineering solutions for successful implementation. Technologies applied for the treatment of water, soil, or air involve contaminant degradation or sequestration and often use related processes, such as adsorption or reduction/oxidation (redox) reactions. During the webinar, EPA will provide an overview of the research grant funding opportunity, and attendees will have a chance to ask questions. EPA will post a copy of the webinar slides on the funding opportunity’s web page. Registration is open.

The Organization for Economic Cooperation and Development will hold a webinar on November 3, 2022, on the safer and sustainable innovation approach (SSIA) for more sustainable nanomaterials and nano-enabled products. According to OECD, SSIA is an approach aiming to boost safer and sustainable innovations by integrating safety and sustainability at an early stage of the design phase of innovative materials, products, applications, and processes. SSIA combines the Safe-and-Sustainable-by-Design (SSbD), Regulatory Preparedness (RP), and Trusted Environment (TE) concepts to identify and minimize sustainability impacts, as well as potential health and environmental risks in the innovation process. OECD states that SSIA relies on early dialogue between industry and regulators and is facilitated by a “Trusted Environment.” SSIA aims to anticipate the regulatory challenges posed by innovative nanomaterials, nano-enabled products, or other advanced materials by minimizing the gap between technological innovations and the development of suitable risk assessment tools and frameworks. OECD notes that it is organizing the webinar to increase awareness of this approach and gather input from potential users, such as innovators and regulators, to ensure its applicability.

A summary of OECD’s report entitled Sustainability and Safe and Sustainable by Design: Working Descriptions for the Safer Innovation Approach is available in our September 12, 2022, blog item. More information on OECD’s report entitled Moving Towards a Safe(r) Innovation Approach (SIA) for More Sustainable Nanomaterials and Nano-enabled Products is available in our December 29, 2020, blog item.

On October 7, 2022, the White House Office of Science and Technology Policy (OSTP) and the National Nanotechnology Coordination Office (NNCO) made key announcements intended to advance the Biden Administration’s efforts “to leverage the promise of science and technology to benefit all Americans.” They also complement the Administration’s ongoing Creating Helpful Incentives to Produce Semiconductors (CHIPS) and Science Act implementation efforts “that will ensure the United States remains a world leader in the industries of tomorrow.” The announcements include:

  • Nano4EARTH: NNCO announced the inaugural National Nanotechnology Challenge, Nano4EARTH. Nano4EARTH will leverage recent investments in understanding and controlling matter at the nanoscale to develop technologies and industries that address climate change. Nano4EARTH recognizes the role nanotechnology plays in: evaluating, monitoring, and detecting climate change status and trends; averting future greenhouse gas emissions; removing existing greenhouse gases; training and educating a highly skilled workforce to harness nanotechnology solutions; and developing higher resilience to, and mitigation of, climate change-induced pressures for improved societal/economic resilience. Members of the National Nanotechnology Initiative (NNI) community — the scientists, engineers, entrepreneurs, and government leaders developing solutions at the nanoscale — are invited to participate in Nano4EARTH. The Nano4EARTH kickoff workshop (to be held in early 2023) will serve as an information-gathering exercise to identify key feasible outputs of the challenge and effective ways to measure success.
  • NNCO Leadership: OSTP and NNCO announced Dr. Branden Brough as the new Director of NNCO and Dr. Quinn Spadola as its Deputy Director. Dr. Brough joins NNCO from the Molecular Foundry, a U.S. Department of Energy-funded nanoscale science research center that provides users from around the world with access to cutting-edge expertise and instrumentation. He will also serve as OSTP’s Assistant Director for Nanotechnology. Dr. Spadola was the Associate Director of Education for the National Nanotechnology Coordinated Infrastructure (NNCI), a network of open nanotechnology laboratory user facilities supported by the National Science Foundation, and the Director of Education and Outreach for the Southeastern Nanotechnology Infrastructure Corridor NNCI site at the Georgia Institute of Technology.

According to a September 29, 2022, press release, the Japan Business Council in Europe (JBCE) has proposed a harmonization of the classification of multi-walled carbon nanotubes (MWCNT) “based on the latest knowledge on the effects of carbon nanotubes (CNTs) in organisms.” JBCE notes that this classification is consistent with the classification of the International Agency for Research on Cancer (IARC). JBCE states that “the morphologies, physicochemical properties, and effects on the human organism depend on the different methods for carbon nanotube production” and that “from a chemical management perspective, different types of CNTs should be evaluated depending on their characteristics instead of simply grouping them all together under the category ‘CNTs.’” JBCE proposes that:

  • MWCNTs similar to MWCNT-7 should be classified as suspected human carcinogens (Carc. 2) in the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) classification. According to JBCE, “[t]herefore, straight CNTs, that are neither particularly long nor particularly short, should be considered possibly carcinogenic, as they might have asbestos-like effects in humans even though this has not been scientifically proven yet”; and
  • MWCNTs other than MWCNT-7 should be classified as non-carcinogenic in the GHS classification.