The European Commission (EC) announced on October 8, 2021, that the Standing Committee on Plants, Animals, Food and Feed approved the EC’s proposal to ban the use of titanium dioxide (E171) as a food additive. The EC states that its proposal “is based on a scientific opinion by the European Food Safety Authority, which concluded that E171 could no longer be considered as safe when used as a food additive, in particular due to the fact that concerns regarding genotoxicity cannot be ruled out.” According to the EC, unless an objection is adopted by the end of 2021 by either the Council or the European Parliament, the text will enter into force in early 2022. This will begin a six-month phasing out period after which a full ban will apply in food products. The EC has posted questions and answers (Q&A) regarding its proposal.
On October 8, 2021, the National Nanotechnology Coordination Office (NNCO) announced the release of the 2021 National Nanotechnology Initiative Strategic Plan, which outlines the goals, objectives, and actions for National Nanotechnology Initiative (NNI) over the next five years.
- Goal 1. Ensure that the United States remains a world leader in nanotechnology research and development (R&D): According to NNI, NNI agencies will continue to use their full suite of authorities and mechanisms to fund nanotechnology R&D. More deliberate mechanisms will be used to connect and build communities, both within NNI and with other initiatives and priorities. The Strategic Plan introduces National Nanotechnology Challenges to mobilize the nanotechnology community to help address global issues.
- Goal 2. Promote commercialization of nanotechnology R&D: NNI states that it will enhance efforts to accelerate the scale-up, translation, and commercial application of nanotechnology R&D into the marketplace to ensure that economic, environmental, and societal benefits are realized and to help the country build back better with high-paying jobs. NNI will make more explicit connections to broad agency efforts that support transition of nanotechnologies to the regional ecosystems that exist within the United States. NNI will expand the Nanotechnology Entrepreneurship Network as a forum to connect innovators and share best practices.
- Goal 3. Provide the infrastructure to support sustainably nanotechnology research, development, and deployment: According to NNI, the need for expensive, specialized tools remains a key requirement for nanotechnology R&D. NNI states that it will support the increasing role of the cyber infrastructure (g., models, simulations, and data) that is critical for nanotechnology innovation enhanced by artificial intelligence, machine learning, and advanced design tools. NNI notes that facilities that support prototyping and early stages of the manufacturing process are also important for the development community and will be explored in collaboration with the private sector.
- Goal 4. Engage the public and expand the nanotechnology workforce: NNCO and NNI agencies use a variety of mechanisms to support public outreach and education from “K to grey” and will emphasize opportunities and access to resources, especially for people in traditionally underserved communities. In recognition of the importance of education, workforce development, and public engagement to the entire nanotechnology enterprise, these areas are now a stand-alone goal.
- Goal 5. Ensure the responsible development of nanotechnology: NNI states that the responsible development framework articulated in the Strategic Plan embraces new ideas that have emerged and builds upon concepts originally included in its responsible development efforts. According to NNI, a key tenet of responsible development remains the protection of human health and the environment through an understanding of both the applications of nanomaterials and the potential implications. Responsible development further includes consideration of ethical, legal, and societal implications (ELSI), as well as a new emphasis on inclusion, diversity, equity, and access (IDEA) and the responsible conduct of research.
The European Chemicals Agency (ECHA) has posted a new set of questions and answers (Q&A) for downstream users of nanoforms. The new Q&As, posted under Section I, include:
- What are my obligations as a downstream user purchasing, modifying or creating nanoforms?
- How do I know when I have created a new nanoform from a supplied substance?
- How do I know whether the nanoform I have created is covered by my supplier if I received [a safety data sheet (SDS)] with an exposure scenario attached?
- How do I know whether the nanoform I have created is covered by my supplier if: i) I did not receive an SDS or ii) I received an SDS but it does not contain exposure scenarios?
- How to check if my use and the conditions of use are covered by the exposure scenario received?
- What do I need to do if my nanoform/uses are not covered by my supplier?
- What should the downstream user chemical safety report contain?
- How do I report to ECHA that I have performed a downstream user chemical safety report (or I am relying on an exemption)?
In honor of National Nanotechnology Day, and as part of a series for its 50th anniversary, the National Institute for Occupational Safety and Health (NIOSH) has posted a blog item entitled “National Nanotechnology Day: A big day for small things.” NIOSH states that it has been at the forefront of efforts to characterize the potential hazards for those working with engineered nanomaterials and to ensure safe workplaces since the early 2000s, including the creation of the NIOSH Nanotechnology Research Center in 2004. As reported in our May 20, 2021, blog item, NIOSH published a recommended exposure limit (REL) for silver nanoparticles. NIOSH previously published RELs for nanoscale titanium dioxide and carbon nanotubes/carbon nanofibers.
According to NIOSH, companies can use the Nanomaterial Exposure Assessment Technique (NEAT 2.0) to identify the potential for exposure to a workplace engineered nanomaterial. The poster, Controlling Health Hazards When Working with Nanomaterials: Questions to Ask Before You Start “is a helpful visual resource for use in the workplace.” NIOSH states that in the past year, it has published two workplace posters: 3D Printing with Metal Powders: Health and Safety Questions to Ask and 3D Printing with Filaments: Health and Safety Questions to Ask. NIOSH notes that it also published the first paper describing an engineering control for three-dimensional (3D) printers.
The White House Office of Science and Technology Policy (OSTP) published a request for information (RFI) on October 5, 2021, requesting input on the development of a National Strategic Plan for Advanced Manufacturing. 86 Fed. Reg. 55022. Through the RFI, OSTP seeks input from the public on ways to improve government coordination and on long-term guidance for federal programs and activities in support of U.S. manufacturing competitiveness. According to the RFI, advanced manufacturing is a family of activities that: depend on the use and coordination of information, automation, computation, software, sensing, and networking; and/or make use of cutting-edge materials and emerging capabilities enabled by the physical and biological sciences, for example, nanotechnology, chemistry, and biology. Advanced manufacturing involves both new ways to manufacture existing products and the manufacture of new products emerging from new advanced technologies.
OSTP seeks responses to the following questions:
- Which emerging science and technology areas will be key to the next generation of advanced manufacturing for global competitiveness, sustainability, and environmental challenges?
- What should be the near-term and long-term technology development research and development (R&D) priorities for advanced manufacturing, the anticipated timeframe for achieving the objectives, and the metrics in assessing progress toward the objectives?
- What are examples of technological, market, or business challenges that may best be addressed by public-private partnerships and are likely to attract both participation and primary funding from industry?
- How can federal agencies and federally funded R&D centers supporting advanced manufacturing R&D facilitate the transfer of research results, intellectual property, and technology into commercialization and manufacturing for the benefit of society and ensure sustainability, national security, and economic security?
- What is the state of the domestic advanced manufacturing workforce in the United States? How can federal agencies and federally funded R&D centers develop, align, and strengthen all levels of advanced manufacturing education, training, and certification programs to ensure a high-quality, equitable, diverse, and inclusive workforce that meets the needs of the sector and drives new advanced manufacturing jobs into the future?
- How can the federal government assist in the development of regional public-private partnerships to achieve greater distribution of advanced manufacturing clusters or technology hubs, particularly in underserved regions of the country? What outreach and engagement strategies are most useful in promoting development in underserved regions of the country?
- How should the adequacy of the domestic advanced manufacturing supply chain and industrial base be assessed? How can federal agencies assist small- and medium-sized manufacturing companies to adopt advanced technologies and to develop a robust and resilient manufacturing supply chain? What steps can these agencies take to promote the development and diffusion of technology that augments worker skills (rather than substituting for them) and ensures that manufacturing jobs are good jobs?
- Are there useful models (at the international, national, state, and/or local level) that should be expanded?
- The current Strategy for American Leadership in Advanced Manufacturing has three top-level goals, each with objectives and priorities: (1) develop and transition new manufacturing technologies; (2) educate, train, and connect the manufacturing workforce; and (3) expand the capabilities of the domestic manufacturing supply chains. Are these goals appropriate for the next four to five years? Are there additional top-level goals to consider?
- Is there any additional information related to advanced manufacturing in the United States, not requested above, that should be considered?
OSTP states that the public input provided in response to the RFI will inform OSTP and the National Science and Technology Council (NSTC) as they work with federal agencies and other stakeholders to develop the strategic plan. Responses are due December 17, 2021.
The Swedish National Platform for Nanosafety (SweNanoSafe) will hold a workshop on November 29, 2021, on “Safe and Sustainable by Design: a prerequisite for achieving a circular economy.” SweNanoSafe states that “Safe and Sustainable by Design (SSbD) is based on the consideration and minimization of uncertainties and risks to human health and the environment from an early stage of the innovation process and throughout the lifecycle of the innovation product.” The concept of SSbD stems from the development of safe-by-design approaches within the nanosafety field and is a component of the Safe(r) Innovation Approach (SIA) for more sustainable nanomaterials and nano-enabled products, which was recently described in detail by the Organization for Economic Cooperation and Development (OECD). The workshop aims to orient Swedish authorities in the ongoing development and implementation of the SSbD concept to face regulatory challenges related to nano- (and advanced) materials with the purpose of advancing circular economy.
Speakers will include:
- Andrea Haase, Head of the Unit Fiber and Nanotoxicology, Department of Chemical and Product Safety, German Federal Institute for Risk Assessment (BfR);
- Lya Hernandez-Soeteman, Senior risk assessor, Dutch National Institute for Public Health and the Environment (RIVM), and Lead expert in the OECD Working Party on Manufactured Nanomaterials (WPMN) Safe Innovation Approach Steering Group;
- Xenia Trier, Expert on Chemicals, Environment and Human Health at European Environment Agency (EEA); and
- Mar Gonzalez, Secretariat to the WPMN, Environment Directorate, OECD.
The Institut de recherche Robert-Sauvé en santé et en sécurité du travail (IRSST) announced on August 9, 2021, publication of a study entitled Characterization of Unintentionally Released Nanometric Particles in Various Workplaces. The study characterizes unintentionally released nanoparticles (URNP) found in six workplaces — an underground mine, a truck repair shop, an underground transportation network, a foundry, a machine shop, and a wax casting shop — on the basis of a broad range of indicators. IRSST assessed concentrations according to numerical and mass metrics, using an array of direct reading instruments. IRSST also took time-averaged measurements, based on the type of contaminant specific to each workplace. In parallel, IRSST took measurements for microscopy characterization in the same six workplaces. According to IRSST, workers exposed to diesel exhaust fumes (an underground mine, truck repair shop, and underground transportation network) “are exposed to mostly nanometric-size airborne particles whose mass concentration is largely in the submicron fraction.” In the presence of foundry fumes, IRSST states that “workers are exposed to airborne particles that are mostly nanometric in size and whose mass concentration is chiefly in the submicron fraction for chromium, cobalt, copper, iron, manganese, lead, vanadium and zinc.” The workers in the machine shop are exposed to fumes and dust particles from machining, most of which are nanometric in size, but IRSST notes that “some of the processes they use generate larger, micrometric particles. The contribution of larger particles to the mass concentration is significant in this environment and, as a result, the mass concentration is to be found in the inhalable fraction, especially for chromium, copper, iron and nickel.” Workers in the wax shop are exposed to fumes that are chiefly nanometric in size and whose mass concentration is mostly in the submicron fraction. IRSST states that its “innovative strategy” enabled it to characterize the URNPs released in the different workplaces with respect to both numerical and mass concentrations. IRSST used microscopy studies on particle samples from the microscope grid taken with a Mini Particle Sampler® to characterize the particles collected based on their morphology and chemical composition.
On September 7, 2021, the European Commission (EC) Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) posted a preliminary opinion on “Draft Environmental Quality Standards for Priority Substances under the Water Framework Directive” for silver and its compounds. The Water Framework Directive requires the EC to identify priority substances among those presenting significant risk to or via the aquatic environment and to set environmental quality standards (EQS) for those substances in water, sediment, and/or biota. The Directorate-General for Environment (DG Environment) asked SCHEER to review the draft EQSs for proposed priority substances, including silver and its compounds. According to SCHEER, the issues that need to be revised include whether silver nanomaterials should “be considered as silver compounds or should nanomaterials, of any origin, be considered as particular compounds to be assessed separately?” SCHEER notes that the health and environmental effects of nanosilver, including the role in antimicrobial resistance, were evaluated in two Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR, 2014) and Scientific Committee on Consumer Safety (SCCS, 2018) opinions. SCHEER states that “this is a relevant issue that should be at least mentioned in the dossier.” Comments on the preliminary opinion are due October 7, 2021.
Registration has opened for a September 22, 2021, webinar held by the National Nanotechnology Coordination Office (NNCO) on “What We Know about NanoEHS: Measurement and Characterization.” The webinar’s speakers will explore the impact of advances in nanomaterial measurement and characterization on the safe and responsible development of nanotechnology. Vincent Hackley, Research Chemist, National Institute of Standards and Technology (NIST), will moderate. The panel will include:
- Jo Anne Shatkin, President and Founder, Vireo Advisors; and
- Wendel Wohlleben, Senior Principal Scientist, BASF.
NNCO held the following technical webinars in 2021 on the environmental, health, and safety implications of nanomaterials (nanoEHS):
- What We Know about NanoEHS: Human Health, June 8, 2021, Video with Closed Captioning;
- What We Know about NanoEHS: Environment, April 27, 2021, Video with Closed Captioning;
- What We Know about NanoEHS: Human Exposure, March 23, 2021, Video with Closed Captioning; and
- What We Know about NanoEHS: How It All Began, February 9, 2021, Video with Closed Captioning.
As reported in our May 7, 2021, blog item, the European Commission (EC) held a targeted stakeholder consultation as part of its review of the Recommendation on the definition of a nanomaterial. The EC held the consultation to update, test, and verify the preliminary findings of its review, gathering further evidence and feedback from a wide range of stakeholders who have a role in application of the harmonized regulatory definition of nanomaterial in the European Union (EU). The EC compiled the 136 non-duplicated replies in an XLS spreadsheet. The EC has posted an additional contribution by the French authorities, as well as supplemental information provided by the Industrial Minerals Association Europe (IMA-Europe) and the German Federal Institute for Risk Assessment (BfR). The EC is currently analyzing the responses in detail to help conclude its review. The EC states that it will publish the outcome of the review, including a summary of the feedback and statistical analysis of the responses, as an EC Staff Working document in 2021. At that time, the EC “will also indicate the plans for potential revision or replacement of the Recommendation 20122/696/EU.”