The European Chemicals Agency (ECHA) has made recent improvements to its chemicals database. For nanomaterials on the European Union (EU) market, the details page of the database now includes information on the nanomaterial form characterization. According to ECHA, the results page also has an improved display, allowing better access to the data and improved user interaction options. Other improvements to the database include:

  • Properties of concern on infocards now link to more information on the origins of each property of concern;
  • Standard unified date formats in regulatory lists; and
  • All lists feeding the public activities coordination tool (PACT) have a first publication date, allowing the entry date of a substance in the PACT list to be shown.

The French Agency for Food, Environmental and Occupational Health and Safety (ANSES) has posted “important information” for the 2022 reporting period under R-Nano, France’s national reporting scheme for substances in nanoparticle form. ANSES states that it is asking providers to give an updated declaration number to their customers upon request, “even if they have no declaration to perform.” To do so, providers “must ‘duplicate’ the substance identity information entered in [fiscal year (FY)] 2021, without submitting it.” According to ANSES, this will create a declaration number that allows the client to import the substance identity data and declare their professional activity with the substance acquired in 2020. The declaration in “draft” status will not be considered in the database for FY 2022. ANSES has extended the declaration period to May 31, 2022. For producers and importers that have difficulties in characterization with one of the methods listed in the declaration form, ANSES suggests they follow the procedure detailed in the document published in the help section.

According to a May 9, 2022, news item published by the U.S. Environmental Protection Agency (EPA), “Advancing EPA’s Understanding of the Next Generation of Pesticides,” over the past decade, EPA “has received an increasing number of pesticide product applications that potentially contain nanomaterials.” The article notes that EPA’s current pesticide review method was not designed for nanomaterials, so each product is reviewed on a case-by-case basis. An EPA research team led by EPA scientist Dr. Chunming Su conducted an exhaustive search for patents and published literature related to nanopesticides to understand the state of the science. The item states that the team found and analyzed more than 36,000 patents and 500 peer-reviewed journal articles. The team established two general categories of nanopesticides to help inform EPA’s regulatory reviews: products with mostly metal-based nanomaterials as the active ingredient, like nanosilver and nanocopper oxide/hydroxide; and products that encapsulate and carry the active ingredient using nanomaterials (mostly carbon based) like graphene and carbon nanotubes. According to the item, the research team also developed a review framework “that includes a simple decision tree to determine what products should be classified and evaluated as a nanopesticide.” Products determined to contain nanomaterials are subject to additional assessment or data needs from the manufacturer. Dr. Andrew Byro of EPA’s Office of Pesticide Programs (OPP) states that the framework “represents a major steppingstone in the development of a method for identification of nanomaterials.” EPA will use this framework as a platform to help inform its data needs and future determinations regarding the evaluation of nanomaterials in antimicrobial pesticides.

EPA’s research team collected their findings related to the physical and chemical properties and efficacy of nanopesticides in a peer-reviewed journal article in Nature Nanotechnology, “Nano-enabled pesticides for sustainable agriculture and global food security.” According to EPA’s news item, the team “found that nano-enabled pesticides adhere better to plant surfaces and have a reduced impact on non-target organisms. Nanopesticides may also enhance plant resilience against stressors from heat or drought.” EPA states that these benefits “could lead to higher crop yield and provide more agricultural resilience to address climate change and weather extremes.” EPA notes that the research team’s findings “also highlight the data gaps and the need for additional research on potential adverse impacts of nanopesticides.”

The NanoHarmony and NANOMET projects are holding their first face-to-face joint workshop on the development of Organization for Economic Cooperation and Development (OECD) test guidelines (TG) for nanomaterials back-to-back with the OECD Working Party on Manufactured Nanomaterials (WPMN) at the OECD Conference Center in Paris on June 29-30, 2022. NanoHarmony aims to facilitate and improve the development process of TGs from the perspective of the developers, users, and harmonization body. NANOMET supports OECD to identify and develop standardized methods for nanomaterials.

During the workshop, participants will discuss the challenges and best practice approaches for the development of TGs. There will be a special focus on the use of TGs in regulation from an international point of view. NanoHarmony and NANOMET will inform participants about the different steps of the TG development process, potential process improvements, and ongoing TG developments for nanomaterials. The open discussions will be used to obtain input from stakeholders on the OECD process and to gather input on current OECD projects towards the development of TGs and guidance documents.

Places at the workshop may be limited, depending on any local restrictions that may be in force at the time, so registration does not guarantee a place at the workshop. Delegates will be selected to ensure a balanced representation between countries and stakeholder types. There will also be the possibility of participating at the meeting online and registrants can select this option on the order form. Registration will close June 8, 2022, at 15:00 (CEST) to ensure time for OECD to make relevant security checks.

On April 20, 2022, Germany’s Federal Institute for Risk Assessment (BfR) announced that the fourth joint symposium on nanotechnology will be held May 30-31, 2022. During the symposium, experts will present their findings on topics such as the use of nanotechnology in textiles and packaging, its application in agriculture, the effects of nanomaterials on the body, and future-oriented assessment approaches. BfR notes that with nanotechnology, consumer protection is expanding into new scientific realms in many areas. BfR is researching a variety of projects to elucidate the modes of action, to analyze complex samples, and to perform grouping approaches to advance health-related risk assessments of new materials. With the nanotechnology symposium, BfR will foster a regular, interdisciplinary, and interdepartmental exchange of knowledge. The symposium is open to the public. The registration deadline is May 20, 2022.

The U.S.  Food and Drug Administration (FDA) announced on April 22, 2022, the availability of a final guidance for industry entitled “Drug Products, Including Biological Products, that Contain Nanomaterials.” 87 Fed. Reg. 24169. FDA states that the guidance applies to human drug products, including those that are biological products, in which a nanomaterial is present in the finished dosage form. The guidance discusses both general principles and specific considerations for developing drug products containing nanomaterials through abbreviated pathways, as well as considerations for quality, nonclinical, and clinical studies as they relate to drug products containing nanomaterials throughout product development and production.

FDA issued a draft version of the guidance on December 18, 2017. According to FDA, it made two “noteworthy” changes from the draft version to the final guidance in response to stakeholder comments. First, the final guidance provides a glossary of terminology to assist in understanding how important terms are used in the document. Second, FDA made several revisions to reflect FDA’s current thinking with respect to abbreviated applications, including abbreviated new drug applications (ANDA), for products containing nanomaterials. In addition to changes in response to comments, FDA notes that it updated the final guidance document’s discussion regarding over-the-counter (OTC) monograph drugs for consistency with the enactment of OTC reform provisions of the Coronavirus Aid, Relief, and Economic Security Act (Pub. L. 116-136).

On May 4, 2022, NanoHarmony will hold a webinar in its series of webinars covering the different phases that an Organization for Economic Cooperation and Development (OECD) test guideline (TG) progresses through during its journey from a science-based initial idea through to use by industry to fulfill regulatory obligations. This webinar will cover phases 2 and 3 of the TG process, technical development and commenting and approval. Speakers will include:

  • Chair Claus Svendsen, United Kingdom Centre for Ecology and Hydrology (UKCEH);
  • Mar Gonzalez, OECD;
  • Thomas Kuhlbusch, Germany’s Federal Institute for Occupational Safety and Health (BAuA); and
  • Frank von der Kammer, University of Vienna.

The webinars are intended to be highly interactive, and attendees will have the opportunity to share their experiences, thoughts, and suggestions. NanoHarmony invites all stakeholders to attend to give their opinions and to help agree on the barriers and ways of improving the TG process that can be acted on as part of the legacy of the NanoHarmony project. Registration is now open.

The National Nanotechnology Initiative (NNI) announced on April 11, 2022, the release of a video documentary, NNI Retrospective Video: Creating a National Initiative, produced in cooperation with TV Worldwide. According to NNI, the video was made for the 20th NNI grantees conference at the National Science Foundation (NSF). Former President Clinton announced the creation of NNI in January 2000. NSF led the preparation of NNI together with other agencies, including the National Institutes of Health, the Department of Defense, the Department of Energy, the National Aeronautics and Space Administration, and the U.S. Environmental Protection Agency. Jim Murday was named the first Director of the National Nanotechnology Coordination Office to support the Nanoscale Science, Engineering, and Technology Subcommittee of the White House National Science and Technology Council. The scientific and societal success of NNI has been recognized in the professional communities, the National Academies of Sciences, Engineering, and Medicine, the President’s Council of Advisors on Science and Technology, and Congress. The interviews in the video explain why the creation of NNI was successful. Interviews focus on three questions: motivation and how NNI started; the process and reason for the success in creating NNI; and outcomes of NNI after 20 years and how the initial vision has been realized.

On March 31, 2022, the National Nanotechnology Initiative (NNI) published a supplement to President Biden’s 2022 budget request. The supplement serves as NNI’s annual report. According to the supplement, NNI has made significant progress toward the five goals of NNI identified in the 2021 NNI Strategic Plan. Furthermore, the nanotechnology research community continues to leverage former NNI investments that established a strong foundation of understanding at the nanoscale to combat COVID-19 and prepare for future pandemics. The supplement provides examples of progress toward the five NNI goals:

  • Goal 1. Ensure that the United States remains a world leader in nanotechnology research and development (R&D): According to the supplement, at the heart of NNI is support for nanotechnology R&D, from the fundamental discoveries that expand the boundaries of knowledge to the applied and translational breakthroughs that enable new products and help address societal challenges. Individual NNI agencies use a variety of mechanisms to conduct and fund research that supports their respective missions, collectively supporting “a vibrant and dynamic nanotechnology R&D ecosystem that is making critical advances in areas as diverse as biomedicine, semiconductors, energy, agriculture, aerospace, and materials development.” Continued investments will enable future discoveries that build on the strong foundation developed over the course of NNI and ensure that the benefits to society and the economy are realized.
  • Goal 2. Promote commercialization of nanotechnology R&D: Federal investments in nanotechnology R&D have led to thousands of products in the marketplace, and today’s scientific discoveries serve as the foundation for the next generation of applications, from tissue regeneration to aerospace composites. According to the supplement, NNI fosters commercialization by sharing information, promoting access to user facilities, leveraging resources through public-private partnerships, and participating in international standards activities that are critical to commercialization. In addition to these mechanisms, the National Nanotechnology Coordination Office (NNCO) has a dedicated industry liaison staff member who engages with industry and the development community by conducting outreach, sharing best practices, and suggesting collaborations as appropriate.
  • Goal 3. Provide the infrastructure to sustainably support nanotechnology research, development, and deployment: Research infrastructure includes physical equipment, digital models, simulations, and data and is critical to all the NNI goals. The supplement states that the need for expensive, specialized tools remains a key requirement for much of nanotechnology R&D. User facilities that provide researchers and developers access to the critically enabling tools required to create, characterize, and understand nanomaterials and nanotechnology-enabled components, devices, and systems are one of the NNI hallmarks. NNI agencies support advances in tool development, establishment of facilities, and creation and dissemination of cyber resources through mechanisms such as individual grants, collaborative centers, and networks of user facilities. The NNI user facilities have adapted operations to prioritize pandemic response and improve remote options to continue serving the nanotechnology community.
  • Goal 4. Engage the public and expand the nanotechnology workforce: The United States’ position as a world leader in nanotechnology innovation relies on talent in science, technology, engineering, and mathematics (STEM) and a highly skilled workforce for every aspect of the R&D continuum. According to the supplement, NNI has supported outreach, education, and workforce development activities as part of its primary goals for the past 20 years. Fostering the growth of a globally competitive and diverse nanotechnology workforce is one of NNI’s strategic objectives, as outlined in the 2021 NNI Strategic Plan. In recognition of the importance of education, workforce development, and public engagement to the entire nanotechnology ecosystem, these efforts are now a stand-alone NNI goal.
  • Goal 5. Ensure the responsible development of nanotechnology: Since the beginning of NNI, responsible development has been an integral pillar of the initiative. The 2021 NNI Strategic Plan articulates an expanded framework for responsible development that includes long-standing considerations, such as understanding ethical, legal, and other societal implications (ELSI) and the environment, health, and safety implications of nanotechnology development. According to the supplement, this new framework further embraces additional concepts, including an emphasis on inclusion, diversity, equity, and access and the responsible conduct of research. These efforts support the other NNI goals by helping ensure the integrity of nanotechnology R&D and fostering public confidence and regulatory certainty.

The European Commission (EC) has begun a public consultation on how the Cosmetic Products Regulation could be improved to ensure human health and the functioning of the internal market. According to the EC, the identified shortcomings include “the lack of coherence between legislations on the definition of nanomaterials.” The EC notes that its October 2020 Chemicals Strategy for Sustainability outlines its goal to protect better the public and the environment against hazardous chemicals by encouraging innovation in developing safe and sustainable alternatives as part of the European Union (EU) Green Deal. The Chemicals Strategy calls for the EC to review the definition of nanomaterials and “ensure its coherent application across legislation using legally binding mechanisms.” The questionnaire asks whether the definition of nanomaterial in the Cosmetic Products Regulation should be updated and if the definition of nanomaterial in the Cosmetic Products Regulation should be consistent with the definition applicable to multiple sectors (i.e., a cross-sectoral definition). The public consultation is open to all stakeholders (experts and non-experts). The EC states that it welcomes contributions from citizens/consumers and professional users of cosmetic products, manufacturers, importers, distributors, and other businesses, including small- and medium-sized enterprises (SME); from industry and SME associations; from civil society organizations; and from EU member state authorities, including market surveillance authorities and customs authorities, as well as any other interested stakeholder. The public consultation will end June 21, 2022.