We are pleased to announced that Lynn L. Bergeson, Charles M. Auer, and Carla N. Hutton published an article, “Practitioner Insights: A Review and Analysis of TSCA Reform Provisions Pertinent to Manufacturers and Processors of Nanoscale Materials,” in the January 26, 2017, issue of Bloomberg BNA’s Daily Environment Report. The article reviews and analyzes the Toxic Substances Control Act (TSCA) as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, Pub. L. No. 114-182, and focuses narrowly on how new TSCA specifically impacts nanoscale materials. Although new TSCA dramatically changes how the U.S. Environmental Protection Agency (EPA) evaluates and manages industrial chemicals, including nanoscale chemicals, the absence of words or phrases such as nano or nanoscale materials means that there are no specific or additional requirements that apply explicitly to such materials. This was a significant shift from many of the earlier TSCA reform bills, which explicitly addressed nanoscale materials by proposing new definitions such as “substance characteristics” and “special substance characteristics” that included concepts such as size or size distribution; shape; surface structure; and reactivity. New TSCA is noticeably silent on this subject and does not distinguish nanoscale materials or treat such materials differently from other chemical substances regulated under TSCA. The article focuses on the key changes in new TSCA that could affect manufacturers and processors of nanoscale materials, and notes opportunities for stakeholders to engage in forthcoming rulemaking processes and other regulatory initiatives to ensure EPA is successful in implementing new TSCA.
The Swedish Chemicals Agency (KEMI) is in the process of consulting with stakeholders on a draft regulation that would require companies to provide information on nanomaterials in chemical products to the Swedish products register by February 28, 2019. According to KEMI, the proposal is the same as presented in its 2015 report. Although the report is in Swedish, it includes an English summary on page 8, which states:
The Swedish Chemicals Agency proposes that those who report chemical products to the products register shall, in addition to the information that is currently reported, also provide further information regarding any nanomaterials contained in the product. The proposal covers nanomaterials which have been intentionally added to the product, regardless of concentration. Nanomaterials are defined in accordance with the recommended definition of the European Commission. Although, this proposal does not cover nanomaterials that are naturally occurring or unintentionally produced.
Exemptions from the reporting requirements are proposed for companies with a turnover of less than SEK 5 million per year during a period of evaluation. These companies should only need to tick a box if they believe that their products contain nanomaterials. During the period of evaluation, the same exemption should also apply to nanomaterials in the form of pigment.
The product groups, which are already exempt from the reporting requirements in the Products Register, will remain exempt for any purposes of this proposal. Those product groups are waste, food and animal feed, pharmaceuticals, cosmetics and tattoo ink.
The report states that KEMI does not propose any reporting requirements for nanomaterials in articles. Comments are due March 24, 2017. KEMI will review the responses and consider whether any revisions are necessary. Once KEMI prepares a final draft, it will notify the European Commission of the regulation.
On January 13, 2017, the European Chemicals Agency (ECHA) sent the draft appendix on recommendations for nanomaterials applicable to the guidance on registration to the Forum, Member State Committee, and Risk Assessment Committee for consultation. The draft guidance outlines the minimum elements potential registrants need to consider when registering substances that fulfil the European Commission’s (EC) Recommendation for the definition of nanomaterial. The aim of the draft guidance is to define the term “nanoform,” the minimum criteria for distinguishing between different nanoforms, and the minimum set of elements that should be reported on the characterization of nanoforms. The draft guidance defines nanoform as a substance that meets the requirements of the EC’s Recommendation for the definition of nanomaterial and has a shape and a surface chemistry. The three minimum elements to characterize nanoforms are: (1) size; (2) shape; and (3) surface chemistry. The draft guidance notes that these are the minimum elements necessary to characterize registered nanoforms in a registration dossier, and additional elements and/or additional refinement of these elements may need to be reported. The draft guidance includes a hypothetical example of the minimum elements that would be needed to report a nanoform.
John Howard, M.D., Director of the National Institute for Occupational Safety and Health (NIOSH), authored a January 10, 2017, NIOSH blog item entitled “Occupational Health Issues in the USA.” Howard shares a recent editorial he wrote in Occupational Medicine, “Occupational health issues in the USA,” that highlights some of the occupational safety and health issues identified as needing attention by the industry sector groups of the National Occupational Research Agenda (NORA). The identified issues include nanotechnology, and the blog item states:
Risk characterization of a new technology to quickly determine if it raises safety and health issues for workers should be a priority for occupational health researchers and practitioners. Engineered nanomaterials and devices demonstrate novel size-dependent properties and behavior that hold great promise in many areas of benefit to society such as new lightweight but stronger materials, new pharmaceuticals, enhanced water filtration, and advances in regenerative medicine The challenge is 2-fold — does the nature of engineered nanomaterials present occupational safety and health hazards, and, if so, how can the benefits of nanomaterials be realized while proactively minimizing or eliminating the potential risks? Although the occupational health implications of advanced manufacturing involving nanomaterials are not yet clearly understood, it is prudent to take precautions to protect workers until the risks can be fully characterized.
According to the blog item, NIOSH “welcome[s] input on how to best protect workers in these areas in the comment section below.”
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.