The Swiss National Science Foundation issued a May 12, 2016, press release announcing that researchers from the National Research Program “Opportunities and Risks of Nanomaterials” have developed a new model to track the flow of the “most important nanomaterials in the environment.” To assess how man-made nanoparticles make their way into the air, earth, or water, researchers developed a computer model to determine the environmental accumulation of nanosilver, nanozinc, nano-titanium dioxide, and carbon nanotubes. The press release notes that knowing the degree of accumulation in the environment is only the first step in the risk assessment of nanomaterials. This data must be compared with ecotoxicological test results and the statutory thresholds. According to the press release, in the case of nanozinc, “its concentration in the environment is approaching the critical level.” The press release states that it “has to be given priority in future ecotoxicological studies — even though nanozinc is produced in smaller quantities than nano-titanium dioxide.” Furthermore, according to the press release, ecotoxicological tests have until now been carried out primarily with freshwater organisms. The researchers conclude that complementary investigations using soil-dwelling organisms are a priority.
According to an item in the Spring 2016 Regulatory Agenda, the U.S. Environmental Protection Agency (EPA) is “developing a final rule related to” its April 6, 2015, proposal to require reporting and recordkeeping requirements under Section 8(a) of the Toxic Substances Control Act (TSCA) for certain chemical substances when they are manufactured or processed at the nanoscale. EPA proposed to require persons that manufacture, import, or process, or intend to manufacture, import, or process these chemical substances to report to EPA certain information, including the specific chemical identity, production volume, methods of manufacture and processing, exposure and release information, and existing data concerning environmental and health effects. The proposal involves one-time reporting for existing nanoscale materials and one-time reporting for new discrete nanoscale materials before they are manufactured or processed. According to EPA, this information would facilitate its evaluation of the materials and a determination of whether further action, including additional information collection, is needed. EPA notes that, consistent with the President’s memorandum for Executive Departments and Agencies regarding Principles for Regulation and Oversight of Emerging Technologies, “this rule would facilitate assessment of risks and risk management, examination of the benefits and costs of further measures, and making future decisions based on available scientific evidence.” While the regulatory agenda item states that EPA intends to promulgate a final rule in October 2016, EPA has not indicated how it intends to address comments on the proposed rule. The Office of Management and Budget (OMB) took several years to review the proposed rule. OMB’s Office of Information and Regulatory Affairs (OIRA) issued a December 17, 2015, memorandum concerning “Regulatory Review at the End of the Administration,” which states that “agencies should strive to complete their highest priority rulemakings by the summer of 2016 to avoid an end-of-year scramble that has the potential to lower the quality of regulations that OIRA receives for review and to tax the resources available for interagency review.” EPA has not yet submitted a final rule to OMB for review.
On May 16, 2016, the U.S. Environmental Protection Agency (EPA) promulgated, through a direct final rule, significant new use rules (SNUR) for 55 chemical substances that were the subject of premanufacture notices (PMN), including functionalized carbon nanotubes (CNT) (generic). EPA states that it determined that any use of the functionalized CNTs without the use of impervious gloves, where there is potential for dermal exposure; manufacturing the PMN substance for use other than as a thin film for electronic device applications; manufacturing, processing, or using the PMN substance in a form other than a liquid; use of the PMN substance involving an application method that generates a mist, vapor, or aerosol except in a closed system; or any release of the PMN substance into surface waters or disposal other than by landfill or incineration may cause serious health effects or significant adverse environmental effects. EPA states that the following tests would help characterize the health and environmental effects of the PMN substance: “a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); an algal toxicity test (OCSPP Test Guideline 850.4500); a 90-day inhalation toxicity test (OPPTS 870.3465) with additional testing parameters beyond those noted at CFR 870.3465, for using the 90-day subchronic protocol for nanomaterial assessment; a two-year inhalation bioassay (OPPTS Test Guideline 870.4200); and a surface charge by electrophoresis (for example, using ASTM E2865-12 or NCL Method PCC-2 — Measuring the Zeta Potential of Nanoparticles).” The SNUR requires persons who intend to manufacture, import, or process any of the 55 chemical substances for an activity that is designated as a significant new use by the direct final rule to notify EPA at least 90 days before commencing that activity. The direct final rule will be effective July 15, 2016. If EPA receives written adverse or critical comments, or notice of intent to submit adverse or critical comments, on one or more of the SNURs before June 15, 2016, EPA will withdraw the relevant sections of the direct final rule before its effective date.
On April 29, 2016, Australia’s National Industrial Chemicals Notification and Assessment Scheme (NICNAS) published the third consultation paper on its reform initiative. Under the reforms, the requirements to establish that a new chemical can be classified as being not hazardous to human health or the environment, and therefore falls in Hazard Band A, include consideration of several factors, including whether the chemical is a nanomaterial. The consultation paper states that the risk matrix applies to chemicals (and their nanoforms) that are not listed on the Australian Inventory of Chemical Substances (AICS). Chemicals used in controlled environments, such as contained import/export and research and development (R&D) situations (up to 100 kilograms introduction volume) would be categorized as Exempted. Contained import/export is where a new chemical is imported and then exported without any repackaging or processing (i.e., packaging remains intact). Because the packaging remains unopened and there is negligible exposure to humans or the environment, the consultation paper states that the risk is very low and categorization as an Exempted chemical is appropriate. The proposed definition of R&D excludes commercialization, and according to the consultation paper, these chemicals are used only in controlled environments by trained personnel. R&D facilities are regulated by the Australian State/Territory Work Health and Safety (WHS) regulations. According to the consultation paper, the WHS model adopts a precautionary approach to nanomaterials used in R&D settings, and recommends that safety data sheets (SDS) be provided to workers handling nanomaterials, even if they are not classified as hazardous substances under the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). Nanomaterials should be labeled as “caution: hazards unknown” or “caution: hazards not fully characterized.” Under the reforms, new chemicals that are nanoforms and do not qualify for the contained import/export or R&D exemption would be categorized within Hazard Bands D or E. Comments are due June 10, 2016. Stakeholder workshops will be held May 16, 2016, and May 18, 2016.
On April 19, 2016, the European Union (EU) NanoSafety Cluster announced the availability of the “Closer to the Market” Roadmap (CTTM). The NanoSafety Cluster states that the CTTM is a “multi-dimensional, stepwise plan targeting a framework to deliver safe nano-enabled products to the market.” The steps include: (1) building an inclusive collaboration network; (2) bringing together scientific and entrepreneurial experts; (3) strengthening dialog of all stakeholders to raise synergies and exchange safe resources; (4) implementing a novel risk assessment framework supported by regulatory initiatives and implemented by contract research organizations; and (5) building service provider platforms that function as consulting agencies assisting companies to bring their products towards market implementation. According to the CTTM, the first step is underway through a coordination and support action bringing together the nanosafety management platforms and institutes of the EU Member States. The CTTM states that joint calls will be implemented to pool national funding from Member States and third countries (e.g., the U.S.) to finance nanotechnology environmental, health, and safety (nanoEHS) research and market-oriented accompanying measures that are of common interest for the platforms. The timeline is to get the action operational by the end of 2016. The aim is to use this Coordination and Support Action (CSA) to develop further actions. According to the CTTM, the platforms provide services and support for stakeholders (e.g., industry, governments, and researchers) to create in a sustainable way marketable, societal approved products and goods. The CTTM will be part of the NanoSafety Cluster strategic research and innovation agenda that will be launched at the end of 2016.
On May 11, 2016, the National Nanotechnology Coordination Office (NNCO) will hold a webinar for small- and medium-sized enterprises (SME) that will focus on the experiences, successes, and challenges for SMEs working in nanotechnology and on issues of interest to the business community. The National Science Foundation’s Center for High-rate Nanomanufacturing, at Northeastern University’s College of Engineering in Boston, will host the webinar. Speakers include:
- Marcie Black: Chief Executive Officer (CEO) and co-founder of Advanced Silicon Group (ASG); and
- Viktor Vejins: President and CEO of Nano-C, Inc.
The speakers will begin the event by providing an overview of their experiences, successes, and challenges in the nanotechnology small business space. This will be followed by a question and answer (Q&A) segment with members of the public. Questions can be submitted through the end of the webinar at 3:00 p.m. (EDT) on May 11, 2016.
NNCO will launch its nanotechnology environmental, health, and safety (nanoEHS) webinar series with a May 18, 2016, webinar, “Applying a Lab Safety Culture to Nanotechnology: Educating the Next Generation of Nanoscientists.” The series is aimed at strategies for safe development and use of nanotechnology along the life cycle of nanomaterials and nanotechnology-enabled products. This first webinar will discuss how an effective culture of safety in the research laboratory facilitates safe and responsible nanomaterial research and supports the National Nanotechnology Initiative (NNI) goal of responsible development. Speakers will include:
- Charles L. Geraci, Jr.: Associate Director for Nanotechnology and Co-Manager of the Nanotechnology Research Center at the National Institute for Occupational Safety and Health (NIOSH);
- Larry Gibbs: Associate Vice Provost for Environmental Health and Safety (EHS) at Stanford University;
- Craig Merlic: Associate Professor of Chemistry and Executive Director for the University of California, Los Angeles (UCLA) Center for Laboratory Safety; and
- Lori Seiler: Associate Director for Global Research and Development EHS at Dow Chemical Company.
Questions for the panel can be submitted from now through the end of the webinar at 3:00 p.m. (EDT) on May 18, 2016.
On April 26, 2016, a group of non-governmental organizations (NGO), consumer groups, and research organizations issued a press release expressing “disappointment with the European Commission’s [(EC)] continuing failure to propose adequate measures for the collection and publication of information about nanomaterials on the [European Union (EU)] market after a Commission meeting with stakeholders in Brussels on Monday.” The press release criticizes the EC for deciding against an EU-wide nanomaterial registry before completing the impact assessment process. Instead, according to the press release, the EC asked the European Chemicals Agency (ECHA) to develop a nanomaterial observatory as part of its 2015-18 nanomaterials work plan. The press release states that the April 25, 2016, meeting “was supposed to provide more details about this new mechanism, but in reality it provided little hope that the observatory will be able to address the pressing information gaps about nanomaterials on the market.”
The European Commission’s (EC) Scientific Committee on Occupational Exposure Limits (SCOEL) met on March 7-9, 2016. The meeting minutes include the following summary regarding SCOEL’s discussion of nanomaterials:
Several chemical agents proposed or envisaged to be addressed by SCOEL do concern or also concern the form as nanomaterial. SCOEL identified a group of scientists to organise a workshop or expert meeting in order to prepare for dealing with the subject in specific and take into account latest state-of-the-art. The lead is with MvT, who will organise the workshop/expert meeting in close collaboration with the Secretariat and the Board.
An update was provided. In view of the enhanced needs for cooperation with [the European Chemicals Agency] and the tight schedule, the nanomaterials and [occupational safety and health] workshop will be planned for 2017.
Registration is now open for the June 6-7, 2016, U.S.-European Union (EU) “Bridging NanoEHS Research Efforts” joint workshop. The workshop will bring together the U.S.-EU Communities of Research (COR), which serve as a platform for U.S. and EU scientists to share information on nanotechnology environmental, health, and safety (nanoEHS) research. The goal of the workshop is to publicize progress towards COR goals and objectives, clarify and communicate future plans, share best practices, and identify areas of cross-COR collaboration. The workshop will also feature a COR-led nanoEHS scrimmage in which the communities will collectively respond to a hypothetical spill of a nanotechnology-enabled product. The workshop is free and open to the public with registration on a first-come, first-served basis.
On April 18, 2016, the Silver Nanotechnology Working Group (SNWG) submitted comments on the National Institute for Occupational Safety and Health’s (NIOSH) draft NIOSH Current Intelligence Bulletin: Health Effects of Occupational Exposure to Silver Nanomaterials. The draft Current Intelligence Bulletin (CIB) includes a review and assessment of the currently available scientific literature on the toxicological effects of exposure to silver nanoparticles in experimental animal and cellular systems, and on the occupational exposures to silver dust and fume and the associated health effects. According to the draft CIB, “[a]lthough the experimental animal and cellular studies are useful for showing potential risks from exposure to silver nanomaterials, NIOSH considers the currently available data to be too limited to develop a [recommended exposure limit (REL)] for silver that is specific to particle size.” Instead, NIOSH recommends that effective risk management control practices be implemented so that worker exposures to silver nanomaterials do not exceed the NIOSH REL of ten micrograms per cubic meter (μg/m3) (eight-hour time-weighted average) for silver metal dust, fume, and soluble compounds, measured as a total airborne mass concentration. The SNWG states that, in general, it agrees with NIOSH’s recommendation and the evidence upon which the recommendation is based. The SNWG “recognizes the uncertainties that NIOSH has concerning the current data on nanosilver particles, but continues to maintain that the toxicity of nanosilver is not significantly different from bulk or dissolved silver (colloidal silver).” The SNWG states that it “confirms NIOSH’s recommendation that if companies manufacturing and making use of nanosilver particles implement effective risk management control practices so that worker exposures to all forms of silver, including silver nanomaterials,” do not exceed the NIOSH REL for silver metal dust, fume, and soluble compounds measured as a total airborne mass concentration, “their workers will be more than adequately protected from any potential harmful exposures to all forms of silver, including nanosilver.” Regarding the research needs discussed in Section 8 of the draft CIB, the SNWG states that one of its functions is to identify, gather, and consolidate industry data in an anonymous manner to protect confidential business information. If NIOSH needs such a mechanism to obtain any needed data, the SNWG has offered to serve in such a capacity.