On January 12, 2017, the U.S. Environmental Protection Agency (EPA) is scheduled to publish in the Federal Register a Section 8(a) of the Toxic Substances Control Act (TSCA) rule establishing reporting and recordkeeping requirements for certain chemical substances when they are manufactured or processed at the nanoscale. According to a pre-publication version of the final rule, manufacturers and processers, or persons who intend to manufacture or process these chemical substances must report certain information to EPA. The information to be reported includes, insofar as known to or reasonably ascertainable by the person making the report, the specific chemical identity, production volume, methods of manufacture and processing, exposure and release information, and existing information concerning environmental and health effects. Persons who manufacture or process a discrete form of a reportable chemical substance at any time during the three years prior to the effective date of the final rule must report to EPA one year after the effective date of the final rule. There is also a standing one-time reporting requirement for persons who intend to manufacture or process a discrete form of a reportable chemical substance on or after the effective date of the rule. These persons must report to EPA at least 135 days before manufacture or processing of that discrete form. The final rule will be effective 120 days after publication in the Federal Register. The final rule states that EPA has prepared a detailed response to public comments that will be available in the rulemaking docket. More information on the final rule will be available in our forthcoming memorandum, which will be available on our website under the key phrase nanotechnology.
The National Nanotechnology Coordination Office (NNCO) periodically holds webinars to share information with the general public and the nanotechnology research and development community. Upcoming webinars include the following:
- On January 18, 2017, the National Nanotechnology Initiative (NNI) will hold a webinar on “Water Sustainability through Nanotechnology: Enabling Next-Generation Water Monitoring Systems.” In this webinar, panelists will discuss the current state of and future opportunities related to water monitoring. Justin Mattingly, Water Environment & Reuse Foundation, will describe water monitoring needs related to reuse, and this broad overview will be followed by two specific use cases: Nick Dokoozlian, E&J Gallo Winery, will describe his work with distributed sensors for improved grape yield and water use efficiency, and Daniel Barta, National Aeronautics and Space Administration, will speak in technical detail about the water monitoring needs aboard spacecraft. Webinar viewers will be able to submit questions for the panelists to answer during the question and answer period. Submitted questions will be considered in the order received and may be posted on the NNI website;
- On January 25, 2017, NNCO will hold a webinar on “The Utility of Alternative Testing Strategies in Nanotechnology Health and Safety Evaluations.” Andre Nel, Distinguished Professor of Medicine and Director of the National Science Foundation- and U.S. Environmental Protection Agency-funded Center for Environmental Implications of Nanotechnology, will review recent scientific advancements in developing alternative testing strategies. Dr. Nel’s presentation will describe how the connection between a molecular initiating event, tied to engineered nanomaterials’ physicochemical properties, and key intermediary responses can be linked to apical health outcomes. Dr. Nel will also address how data can be used for dose- and exposure-relevant tiered risk assessment, as well as data acquisition and submission for regulatory consideration. NNCO will soon post the link for registration on its website; and
- On a date to be announced, NNCO will hold a webinar on “Water Sustainability through Nanotechnology: Improving the Efficiency of Water Delivery and Use.”
The Committee on Hazardous Substances (AGS) of the Federal Institute for Occupational Safety and Health (BAuA) began a public consultation on its update to several technical rules. AGS seeks comment on Bekanntmachung zu Gefahrstoffen (BekGS) 527, “Hergestellte Nanomaterialien.” Although BAuA has published an English translation of Announcement 527, “Manufactured Nanomaterials,” BAuA notes that it is not up-to-date and is unofficial. The German documents are more recent and include a chart listing edits to the 2015 version. Comments are due March 31, 2017.
The American Innovation and Competitiveness Act (S. 3084) would amend the 21st Century Nanotechnology Research and Development Act (15 U.S.C. § 7501 et seq.) to change the frequency of National Nanotechnology Initiative (NNI) reports. The strategic plan would be released every five instead of every three years, and the triennial review would be renamed the quadrennial review and be prepared every four years instead of every three. The evaluation of the NNI, which is submitted to Congress, would be due every four instead of every three years. Under the amendments, the strategic plan will address how the NNI will “move results out of the laboratory and into application for the benefit of society”; its support for long-term funding for interdisciplinary research and development in nanotechnology; and the allocation of funding for interagency nanotechnology projects. The Senate passed the bill on December 10, 2016, and the House passed it on December 16, 2016. On December 28, 2016, the bill was presented to President Obama. President Obama is expected to sign the bill.
In November 2016, the Ministry of the Environment, Energy, and the Sea released its 2016 report, in French, Éléments issus des déclarations des substances à l’état nanoparticulaire. The report analyzes nanomaterial declarations received in 2016 for reporting year 2015. Under Decree No. 2012-232, companies that manufacture, import, and/or distribute a “substance with nanoparticle status” in an amount of at least 100 grams per year must submit an annual report with substance identity, quantity, and use information. According to the report, while the number of declarations received in 2016 decreased from 2015, the quantity of materials produced increased (350,487 tonnes vs. 300,822 tonnes in 2015), as well as the quantity imported (125,279 tonnes vs. 114,951 tonnes in 2015).
The fifth Nanosafe conference was held November 7-10, 2016, in Grenoble, France. The conference included panel discussions on responsible development with non-governmental organizations; urban particles mitigation: what is reasonably possible; and nanomedicine: benefit-risk. Topics addressed during the conference included:
- Measurement and characterization of nano objects;
- Manufactured nano objects:
- Release from nano-enabled products;
- Safer by design nanomaterials and process;
- Risk management;
- From nanoproducts to waste;
- Nano responsible developments; and
- Commercial equipment;
- Urban particles;
- Nano objects and health:
- Environmental interactions of nanomaterials; and
- Safe use of nano objects for medicine applications;
Presentations from the conference are now available.
The Occupational Safety and Health Administration (OSHA) released on December 20, 2016, a white paper entitled Sustainability in the Workplace: A New Approach for Advancing Worker Safety and Health. The paper highlights the importance of including worker safety and health in the growing movement toward sustainability and corporate responsibility. According to the paper, research on sustainability does not include occupational safety and health. The paper notes that sustainability research opportunities include nanotechnology:
Horizon Scanning: Emerging issues impacting workers (e.g., aging workforce, worker well-being, nanotechnology, green chemistry) are a potential path for integrated sustainability research. For example, climate change is one of the most talked about areas of sustainability and workers have been and will continue to be disproportionately impacted. It will be critical to recognize exposures, anticipate hazards and responses, and possible adaptation mechanisms for these responses (chemicals, pathogens, conflict, heat, etc.).
On February 7-9, 2017, a conference focused on new tools and approaches for nanomaterial safety assessment will be held in Malaga, Spain. The conference is jointly organized by five major Seventh Research Framework Program (FP7) projects: NANOSOLUTIONS, GUIDEnano, Sustainable Nanotechnologies (SUN), NanoMILE, and eNanoMapper. It will present the main results achieved in the course of the projects, fostering a discussion about their impact in the nanosafety field and possibilities for future research programs. Conference topics will include:
- Hazard assessment along the life cycle of nano-enabled products;
- Exposure assessment along the life cycle of nano-enabled products;
- Risk assessment and management;
- Systems biology approaches in nanosafety;
- Categorization and grouping of nanomaterials;
- Nanosafety infrastructure; and
- Safe by design.
The conference will conclude with a stakeholder workshop that will provide a platform for an open discussion with interested stakeholders that could guide the research needs addressed in future projects. The conference welcomes consortium partners from the organizing projects, as well as representatives from other European Union projects, industry and government, civil society, and media.
The European Chemicals Agency (ECHA) announced in its December 14, 2016, ECHA Weekly that the following drafts for updated ECHA guidance on the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation have moved to the next consultation step and been sent to the Member State Committee for review:
- Guidance on recommendations for nanomaterials for environmental endpoints:
- Appendix R7-1 Recommendations for nanomaterials applicable to Chapter R7a Endpoint specific guidance;
- Appendix R7-1 Recommendations for nanomaterials applicable to Chapter R7b Endpoint specific guidance; and
- Appendix R7-2 Recommendations for nanomaterials applicable to Chapter R7c Endpoint specific guidance; and
- Guidance on recommendations for nanomaterials for human health endpoints.
ECHA suggests that potential registrants for the 2018 deadline may be interested in viewing the revised draft documents. As reported in our June 9, 2016, blog item, “ECHA Consults PEGs on Nanomaterial Guidance Documents,” the draft guidance documents were first submitted to Partner Expert Groups (PEG) for consultation. ECHA has posted summaries of the comments received from the PEGs, as well as its responses. The final consultation on the guidance documents will be with the European Commission and the relevant Competent Authorities.
On November 15, 2016, the Federal Institute for Risk Assessment (BfR) published a report, in English, entitled Nanoview — Influencing factors on the perception of nanotechnology and target group-specific risk communication strategies. In 2007, BfR conducted a survey concerning the public perception of nanotechnology. Given the newness of nanotechnology and that large sections of the population did not have any definite opinions or knowledge of it, BfR conducted a follow-up survey, Nanoview, in 2012. Nanoview also included the additional question of which communication measures for conveying risk information regarding nanotechnology are best suited to reach the majority of the population. BfR developed two alternative concepts for the target group-oriented risk communication of nanotechnology in areas relevant to consumers on this basis. The report states that, given the findings from the 2007 representative survey, which confirmed gender-specific differences in the perception of nanotechnology, ideal-typical male and ideal-typical female concepts were developed. Focus groups then reviewed and optimized the conceptual considerations. According to the report, the ideal-typical male concept met the expectations of the male target groups (nano-types “supporters” and “cautious observers”). The report states that the concrete communication measures do not adequately achieve the objectives, however, because the measures are too specific and give the impression of being overly focused on technical fascination and not addressing potential risks to the desired degree. According to the report, the conceptual approach of the ideal-typical female concept met the expectations of the female target groups (nano-types “sceptics” and “cautious observers”), as well as catering to the information needs of some men (“cautious observers”). Of the concrete communication measures discussed, acceptance levels are particularly high for the online platform and the brochure, and these represent the most effective channels to provide basic information. The report states that when consumers are asked to draw up communication approaches, the main focus is on the interlinking of scientific aspects and everyday consumer aspects. The importance attached to the two different areas varies between target groups, however. With regard to the communication media, the surveyed men and women prefer a website that provides basic information presented in a stimulating format. The report concludes that, with regard to the central communication measure, creating an information portal on the Internet appears to be the most meaningful strategy. The information services and content should be prepared and presented to cater to the specific main gender-sensitive requirements and information needs. The report states: “The ideal-typical male concept is geared towards the provision of information on scientific, technical and application-related aspects of nanotechnology, for example. The ideal-typical female concept focuses on the provision of information on application-related aspects of nanotechnology and support for everyday (purchase) decisions.”