该NanoExplore项目，which is supported by the European Union’s (EU) LIFE program, aims at an integrated approach for exposure and health effects monitoring of engineered and incidental nanomaterials in occupational settings. The project is currently in its pilot phase. According to NanoExplore, the pilot study will take place following a two-step procedure over two field campaigns separated by a six- or nine-month interval. Each field campaign will last for four days, during which participants will be followed in their usual tasks to monitor a number of variables in the ambient air. Before and after starting this four-day period, participants will be asked to fill in a questionnaire, to perform a pulmonary function test, and to provide urine and exhaled air samples. NanoExplore states that the study and sample collection will be performed by experienced staff, and participants will have the possibility to discuss their results with a referent occupational physician. NanoExplore seeks employees of companies and organizations manufacturing and/or handling nanomaterials in their occupational settings or concerned with ultrafine particle exposure. Companies must be based in Spain, Italy, Switzerland, France, or Germany. To learn more and to participate in the study, NanoExplore can be contacted firstname.lastname@example.org。
该U.S. Food and Drug Administration (FDA) published a report entitledNanotechnology — Over a Decade of Progress and Innovation这凸显FDA在纳米技术领域的进步，因为它在2007年发布了其最后报告。报告还回顾了FDA在通过其涉及纳米技术的应用在其管辖范围内的产品监管推进公共健康的作用。据报道，FDA“将依托的地平线扫描活动相结合，以跟上新的发展和产品的应用，其中包括”：
- Participating in standards development;
- Continuing discussions with national and international counterparts;
- Monitoring scientific and trade literature;
- Performing prospective regulatory science on emerging technologies.
In addition, FDA states that its Emerging Sciences Working Group, a cross-agency, science-based forum established in 2016, continues to identify science and technology trends of relevance to FDA’s regulatory responsibilities, including those for nanotechnology products. FDA notes that its “science-based, product-focused regulatory framework is sufficiently flexible and robust to help ensure product safety (and effectiveness, as applicable) while supporting innovation for the development of beneficial nanotechnology products.”
OnAugust 13, 2020，FDA willhold a webinarto present the report. The webinar will include the basics of nanotechnology and will highlight the facilities, regulatory science research, guidance documents, standards, domestic and international collaborations, and emerging challenges in regulatory science. The speaker will be Anil K. Patri, Ph.D., Chair, Nanotechnology Task Force, Director, Nanocore, National Center for Toxicological Research (NCTR)/FDA.
该Australian Industrial Chemicals Introduction Scheme (AICIS) took effect on July 1, 2020. Under AICIS, companies that import or manufacture (including introduce) industrial chemicals, or products that release industrial chemicals, into Australia for commercial purposes should first check whether the industrial chemical islisted on the Inventory。If the chemical is on the Inventory and the introduction meets the terms of Inventory listing, the introduction is automatically categorized as a “listed” introduction. If the chemical is not listed, it must be categorized into one of five categories. On August 3, 2020, Australia publishedadditional guidance(和引入工业化学物质products that release industrial chemicals) with at least one external dimension in the nanoscale. Australia notes that if the chemical is a nano form of a chemical that is listed on the Inventory, “then it is only considered to be on our Inventory if the nano form has the same [Chemical Abstracts Service (CAS)] number as the bulk form of the chemical.” The guidance addresses what is a chemical at the nanoscale; whether the introduction is exempted, reported, or assessed; introductions of chemicals for use in research and development; introductions categorized using steps four through six of the categorization guide; and categorization outcomes.
该guidance states that nanoscale means the particle size range of one to 100 nanometers (nm). The introduction is a “specified class of introduction” if it is of a chemical that:
- Is introduced as a solid or is in a dispersion; and
- Consists of particles in an unbound state or as an aggregate or agglomerate, at least 50 percent (by number size distribution) of which have at least one external dimension in the nanoscale.
该guidance states that Australia has “an increased level of concern” for specified classes of introductions due to a greater potential for particular hazards or high levels of human or environmental exposure. According to the guidance, Australia’s increased level of concern for chemicals at the nanoscale “is because of uncertainty about the risks of some of these chemicals due to their potentially different properties, such as chemical reactivity, relative to the non-nanoscale forms of the chemicals.” This uncertainty requires either assessment by Australia or increased reporting or recordkeeping requirements. The guidance outlines the additional or different requirements arising from these concerns.
In July 2020, the German Environment Agency (UBA) published a report entitledAdvanced materials: Overview of the field and screening criteria for relevance assessment。该report describes activities within the project “Advanced materials — Thematic conferences: Assessment of needs to act on chemical safety” to provide discussion input on approaches to describe, cluster, and prioritize advanced materials. The aim of the report is to identify relevant advanced materials in regard to chemical safety. The report states that since the term advanced materials is not clearly defined, a major focus of the investigation is to characterize the use of the term to obtain a reasonable separation within the materials sector. According to the report, a set of criteria that could be applied to assess the relevance of advanced materials regarding chemical safety was developed and is provided for further discussion and refinement. In addition, a first description of identified advanced material clusters was performed.
As reported in our February 5, 2020,blog item中，American Conference of Governmental Industrial Hygienists (ACGIH®) Threshold Limit Values for Chemical Substances (TLV®-CS) Committee included carbon nanotubes on its 2020 list of chemical substances and other issues under study. Being placed on the under study list indicated that the TLV®-CS Committee had selected carbon nanotubes for development of a threshold limit value (TLV®). ACGIH®has now released itstwo-tier under study list。Tier 1 lists the chemical substances and physical agents that may move forward as a notice of intended change (NIC) or notice of intent to establish (NIE) in the upcoming year, based on their status in the development process. Tier 2 consists of those chemical substances and physical agents that will not move forward, but will either remain on or be removed from the under study list for the next year. Carbon nanotubes are included in Tier 2. If carbon nanotubes are included on the2021under study list, stakeholders will have an opportunity to submit substantive data and comments.
该Organization for Economic Cooperation and Development (OECD) recently published two guidance documents in its series on testing and assessment:
- Guidance Document on Aquatic and Sediment Toxicological Testing of Nanomaterials(317号):实践的指导性文件地址al aspects of carrying out valid tests with manufactured nanomaterials, as well as modifications or additions to OECD Test Guideline procedures intended to improve incrementally the accuracy, intra-laboratory repeatability, inter-laboratory reproducibility, and intra-laboratory reproducibility of test results. The guidance document considers initial characterization of test materials, preparation of test dispersion, monitoring the behavior of manufactured nanomaterials in the test dispersion throughout the duration of the test, and quantifying exposure and exposure-response. The focus of the guidance document is on measurements of worst-case hazard using traditional population level endpoints, including survival, growth, and reproduction, and does not provide guidance on making formal risk assessments. OECD states that since the focus is on the most conservative assessment of hazard, the guidance within involves efforts to disperse manufactured nanomaterials into laboratory media that may not always be realistic to environmental dispersal.
- 指导文件为溶出度的测试和纳米材料的分散稳定性和新的环境试验和评估策略的使用数据的betway官方网站（Excel) (No. 318): The guidance document provides guidance for the methods to address dissolution rate and dispersion stability for nanomaterials, with a focus on environmental aqueous media. OECD states that the guidance provided is relevant for solids in the nanoscale, as well as their aggregates and agglomerates, and it focuses on their fate and behavior in aqueous media. In particular, the guidance document presents the influence of various experimental conditions on the performance and outcomes of the discussed methods. In addition, the guidance document addresses modifications or additions to the methods and aims to give support for the interpretation of the test results.
On July 23, 2020, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion entitled “Material manufacturing from nano-scaled particles: moving forward using plants” by Dr. Blaise Tardy, Research Fellow, Bio-Based Colloids and Materials Research Group — Aalto University in Finland. Dr. Tardy notes that bio-based nanomaterials such as nanocellulose “have shown great promise in forming high performance materials, with the potential to replace plastics.” In addition to replacing hazardous synthetic materials such as single-use, disposable materials, these biomaterials could be used in car parts, 3D-printable bioinks, reflective coatings, adhesives, and high-strength filaments. According to Dr. Tardy, these bio-based nanoparticles offer the promise of large-scale nanomanufacturing using water-based systems. Dr. Tardy states that “[u]sing water as the solvent to assemble these fibers results in a myriad of material types, with increasingly versatile properties as associated with ongoing worldwide nanomaterials research and developments.” As the field of nanotechnology moves forward, integrating the use of green, bio-based nanoparticles will become increasingly beneficial, particularly for materials with a short service lifetime, such as packaging, single-use personal protective equipment, and disposable filters. Dr. Tardy concludes that “finding ways to facilitate nanomanufacturing will become as important as the development of these outstanding nanoparticles, which are essential for future developments in materials science.”
该July 2020 issueof the National Institute of Environmental Health Sciences (NIEHS)环境因素includes an item on anew database that facilitates nanomaterial research。According to the article, NIEHS grantees constructedPubVINAS”,一个大型数据库的结构、化学改过的y, and activity information on 705 nanomaterials, covering 11 material types.” The article states that the extensive data on each material “allows scientists to use the structures of new nanomaterials to predict their critical properties and potential toxicity.” PubVINAS “draws upon thousands of scientific papers and contains 705 unique nanomaterials, 1,365 physicochemical properties of those materials, and 2,386 data points related to their bioactivity, including whether the nanomaterials can be taken up by cells and lead to cell death. The nanostructures are stored as data files that can be downloaded by researchers worldwide.” The NIEHS article cites a自然通讯article, “Construction of a web-based nanomaterial database by big data curation and modeling friendly nanostructure annotations。”
该European Food Safety Authority (EFSA) has begun apublic consultation在题为文件草案“关于管制食品和饲料产品的应用，建立小颗粒，包括纳米颗粒存在技术要求欧洲食品安全局的指导。”该指南草案规定了信息要求在规定的食品和饲料产品领域，并建立标准，以评估小颗粒的一小部分存在的应用程序。欧洲食品安全局指出，这些要求适用于需要具体评估在传统材料的纳米级不符合工程纳米材料的定义，粒子设置了小说中的食品监管（EU）2283分之2015。betway官方网站该指南草案大纲的评价标准，在三节编组，以确认是否传统的风险评估应与nanospecific事项加以补充。所述第一组地址溶解度和溶出速率的关键的物理化学性质，以评估消费者是否将暴露于颗粒。第二组建立用于评估常规材料是否包含一小部分或由小的粒子，其特征的信息的要求。betway官方网站第三组描述要提出了现有的安全研究，以证明小颗粒，包括纳米级的颗粒的部分，已被正确评估的信息。此外，引导现有的安全性研究的评估，指导完成数据的差距，同时减少用于进行新的动物研究的必要性提出了建议草案。EFSA指出，指导意见草案补充了“纳米科学与技术指导意见” 2018年通过的欧洲食品安全局科学委员会建议其申请开展新的研究之前，征询指导性文件。评论是由于September 9, 2020。
OnAugust 19 and 20, 2020中，American National Standards Institute Nanotechnology Standards Panel (ANSI-NSP) will hold avirtual workshop on advanced materials。ANSI states that advanced materials are of growing interest as there is increasing recognition that size alone does not define the unique properties of a material. More and more, governments and organizations that originally focused on nanomaterials are now also focusing on advanced materials and emerging technologies. The workshop will focus on whether existing nanotechnology standards bodies should address advanced materials and how the gaps and needs relative to advanced materials standards can best be identified and prioritized. Panelists will include representatives from the National Nanotechnology Coordination Office (NNCO), the U.S. Environmental Protection Agency (EPA), the U.S. Consumer Product Safety Commission (CPSC), The Chemours Company, the Society of Toxicology, and the Organization for Economic Cooperation and Development (OECD). ANSI-NSP invites interested stakeholders, including industry, government representatives, representatives from non-governmental organizations, and academics, to participate. Online registration is now open.