On March 7, 2017, the Scientific Committee on Consumer Safety (SCCS) issued a final opinion on additional coatings for titanium dioxide (nano form) coated with cetyl phosphate, manganese dioxide, or triethoxycaprylylsilane as an ultraviolet (UV)-filter in dermally applied cosmetics. The conclusion states that given a general lack of dermal absorption and low general toxicity of nano-forms of titanium dioxide, SCCS considers that the use of the three titanium dioxide nanomaterials, coated with either cetyl phosphate, manganese dioxide, or triethoxycaprylylsilane, can be considered safe for use in cosmetic products intended for application on healthy, intact, or sunburned skin. SCCS notes that the ingredients used in some types of products (e.g., in lipsticks) may be incidentally ingested. The potential harmful effects of manganese dioxide should therefore be taken into account if the manganese dioxide-coated nanomaterials are to be used for applications that could lead to oral ingestion. The opinion does not apply to applications that might lead to exposure of the consumer’s lungs to the titanium dioxide nanoparticles through the inhalation route (such as powders or sprayable products). SCCS states that if any new evidence emerges in the future to show that the titanium dioxide nanoparticles used in a sunscreen formulation can penetrate skin to reach viable cells, then it may consider revising this assessment. SCCS notes that the opinion does not consider the potential ecotoxicological impacts of nano titanium dioxide when released into the environment. As reported in our March 14, 2017, blog item, SCCS has begun a public consultation on its opinion on titanium dioxide (nano form) as UV-filter in sprays. The public consultation will end May 14, 2017.
The Congressional Research Service (CRS) prepared a March 14, 2017, report entitled Science and Technology Issues in the 115th Congress. The report outlines science and technology policy issues that may come before the 115th Congress. The report notes that, given the rapid pace of science and technology advancement and its importance in many diverse public policy issues, issues not discussed in this report may come before Congress. The selected issues are grouped into nine categories. The category Physical and Material Sciences includes the subcategory “Nanotechnology and the National Nanotechnology Initiative (NNI).” The report states that development of this field has been fostered by “significant and sustained” public investments in nanotechnology research and development (R&D). In 2001, President Clinton launched the NNI to accelerate and focus nanotechnology R&D to achieve scientific breakthroughs and to enable the development of new materials, tools, and products. According to the report, more than 60 nations subsequently established programs similar to the NNI. Through fiscal year (FY) 2016, Congress appropriated approximately $21.8 billion for nanotechnology R&D; the President requested $1.4 billion in FY 2017 funding. In 2003, Congress enacted the 21st Century Nanotechnology Research and Development Act (P.L. 108-153), providing a legislative foundation for some of the activities of the NNI, establishing programs, assigning agency responsibilities, and setting authorization levels through FY 2008. The report notes that although legislation has been introduced in successive Congresses to amend and reauthorize the Act, none has been enacted into law. According to the report, Congress “has directed its attention primarily to three topics that may affect the realization of nanotechnology’s hoped-for potential: R&D funding; U.S. competitiveness; and environmental, health, and safety (EHS) concerns.”
On March 15, 2017, the National Institute for Occupational Safety and Health (NIOSH) published a Federal Register notice announcing the availability of a draft Current Intelligence Bulletin (CIB) entitled The NIOSH Occupational Exposure Banding Process: Guidance for the Evaluation of Chemical Hazards for public comment. Under occupational exposure banding, chemicals are assigned to specific categories or bands based on the chemical’s potency and the negative health outcomes associated with exposure to the chemical. An occupational exposure band (OEB) corresponds to a range of exposure concentrations that is expected to be protective to worker health. NIOSH states that it recently developed a process to apply the occupational exposure banding process to a broad spectrum of occupational settings. The NIOSH process uses available, but often limited, toxicological data to determine a potential range of chemical exposure levels that can be used as targets for exposure controls to reduce risk among workers.
Subchapter 3.15 of the draft CIB, “Consideration of Special Categories of Aerosols,” notes that some particles have unique physical characteristics that support modifications to the general occupational exposure banding process. According to the draft CIB, modification is necessary to address the observation that the total mass dose delivered does not always describe well the dose-response behavior for a single chemical across all particulate sizes and forms. Examples of particle categories include nanoscale solid-phase particles. For the purpose of the draft CIB, nanoscale particles are defined as those particles with primary particle diameters less than 100 nanometers. NIOSH recommends that the occupational exposure banding process — when applied to nanoparticles — be modified according to the following guidelines:
- Poorly-soluble nanoscale particles: If the toxicity data include no observed adverse effect levels that were developed specifically for the nanoscale form of the chemical, the NIOSH occupational exposure banding process can be used directly with no modifications. If data are only available for the microscale form of the chemical, the band assignment should be shifted to the next most potent band on the assumption that poorly soluble nanoscale agents will likely be an order of magnitude more toxic than their microscale equivalents.
- Soluble nanoscale particles: Data support a role of increased total particle surface in the increased toxicity associated with poorly-soluble nanoscale particles, as discussed above. Thus, because the retained surface area is lower over time for soluble particles (due to dissolution), increased solubility would decrease the potency of particles if the adverse effects are due to the retained particle surface dose. On the other hand, higher solubility could result in increased potency (compared to poorly soluble particles) if the toxic effects are due to released ions. In the Agence nationale de sécurité sanitaire and International Standards Organization control banding schemes, soluble particles are addressed with regard to the toxicity of the solute, without consideration of nanoparticle-specific toxicity. The draft CIB states that acceptance of these general conclusions requires caution, however, because of limited data on which to evaluate their effectiveness. According to the draft CIB, it is recommended that in the absence of data to the contrary, all nanoscale particles should be treated in the same manner without regard to solubility. NIOSH recommends shifting the banding assignment to the next most potent band if data are only available for the microscale form of the agent.
- Nanoscale fibers (or tubes): Since the toxicity of nanoscale fibers and nanoscale tubes may differ significantly from other forms of the compound, the occupational exposure banding process may not fully and accurately capture the toxicity of these chemicals. Therefore, Tier 1 and Tier 2 should not be used. Instead, a Tier 3 assessment is required as described for other fibers.
The draft CIB states that these general recommendations are considered precautionary in nature. According to the draft CIB, limitations in the available scientific information include uncertainty in the mechanisms of potential potency differences in toxicity of nanoscale vs. microscale particles of various chemical composition, surface properties, shape, and degree of agglomeration. The draft CIB notes that the number of chemicals with adequate data for such size-based toxicity comparisons is small, preventing firm conclusions at this time about relative potencies among various particle types and sizes. NIOSH is currently evaluating the state of the science for deriving occupational exposure limits or OEBs for nanomaterials, and is also examining the process and data for developing hazard categories for nanomaterials based on biological mode of action and physical-chemical properties.
The public meeting will be held May 23, 2017, in Cincinnati, Ohio. Registration to attend the meeting in person or via remote participation is due April 21, 2017, and April 7, 2017, for non-U.S. citizens who wish to attend in person. Comments are due June 13, 2017.
On March 14, 2017, the National Institute for Occupational Safety and Health (NIOSH) extended the comment period on the proposed information collection entitled “Survey of Engineered Nanomaterial Occupational Safety and Health (OSH) Practices.” The goal of the project is to assess the relevance and impact of NIOSH’s contribution to guidelines and risk mitigation practices for safe handling of engineered nanomaterials in the workplace. NIOSH invites comment on:
- Whether the proposed collection of information is necessary for the proper performance of the functions of NIOSH, including whether the information shall have practical utility;
- The accuracy of NIOSH’s estimate of the burden of the proposed collection of information;
- Ways to enhance the quality, utility, and clarity of the information to be collected;
- Ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and
- Estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information.
According to NIOSH, because of an improper docket opening, the comment period is extended from April 11, 2017, to May 11, 2017. More information about the survey is available in our February 14, 2017, blog item, “NIOSH Seeks Comment on Proposed Survey of Engineered Nanomaterial OSH Practices.”
On March 10, 2017, the Scientific Committee on Consumer Safety (SCCS) began a public consultation on its opinion on titanium dioxide (nanoform) as an ultraviolet (UV)-filter in sprays. In July 2015, the European Commission (EC) received new data from industry to support the safe use of nano titanium dioxide when used as a UV-filter in sunscreens and personal care spray products at a concentration up to 5.5 percent. The EC asked SCCS whether, in light of the data provided, nano titanium dioxide is safe when used as a UV-filter in sunscreens and personal care spray products at a concentration up to 5.5 percent. SCCS concluded that, on the basis of the provided data, the information is insufficient to allow assessment of the safety of the use of nano titanium dioxide in sprayable applications. The opinion notes that exposure studies have not been conducted using representative sprayable products that may be intended for the European Union market. The submission also does not contain a toxicological evaluation for nano titanium dioxide via the inhalation route, which SCCS states would allow deriving a point of departure for risk assessment using worst-case conditions. SCCS emphasizes that compliance with the specifications from its previous opinion on nano titanium dioxide, SCCS/1516/13, will not imply absence of effects after inhalation exposure. That opinion addressed only the safety of nano forms of titanium dioxide in dermal applications and excluded sprayable products. The draft opinion states: “In fact, that [earlier] Opinion expressed concerns over the safety of TiO2 nanomaterial applications that could lead to inhalation exposure of the consumer to TiO2 nanoparticles.” The EC also asked whether SCCS had any further scientific concerns regarding the use of nano titanium dioxide when used as a UV-filter in sunscreens and personal care spray products. The draft opinion does not include a response from SCCS. Comments are due May 14, 2017.
NanoMONITOR’s first stakeholders’ day, April 4, 2017, will include a workshop on “Development of a real-time information and monitoring system to support the risk assessment of nanomaterials under REACH.” The overall aim of the NanoMONITOR project is to develop a prototype system to generate robust, accessible, comparable, and interoperable environmental and indoor air monitoring data to support the implementation of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. The workshop will provide a forum for researchers, industry, and regulators to present and discuss the use of measured data on the concentration of engineered nanomaterials to support the risk assessment of nanomaterials and the implementation of safe exposure scenarios. A first prototype monitoring station, as well as the main outcomes of the project concerning the concentration of engineered nanomaterials in workplaces and urban areas, will be presented. Workshop topics will include:
- Workplace and environmental exposure to engineered nanomaterials;
- Data acquisition and data sharing technologies;
- Air quality monitoring;
- Impact of nanotechnologies on human health and the environment; and
- Risk governance of nanotechnologies.
The registration deadline is March 24, 2017. Due to the capacity limitations of the venue, the maximum number of attendees to be accepted is limited to 70. Registration will be on a first-come, first-served basis.
On March 9, 2017, the NanoSafety Cluster published its 2017 Research Regulatory Roadmap. The purpose of the Roadmap is to identify both ongoing and complete activities associated with the development of regulations promoting the safety of nanomaterials. The Roadmap identifies research areas or priorities that need to be addressed further to facilitate this process. According to the Roadmap, there remain significant gaps in knowledge and procedures that need to be addressed to generate “appropriate and proportionate regulation for nanomaterials that is informed by a sound evidence base.” The Roadmap outlines the current regulatory landscape pertaining to nanomaterials and then identifies the additional major areas that need to be considered, noting relevant activities that have or are being conducted in relation to each, but highlighting those for which more work is needed. The key activities include not only research, but also standardization and regulation development. The Roadmap states that the rapid evolution of the field of nanotechnology means that the content may need updating with time, and the NanoSafety Cluster plans to combine the outputs of the Roadmap with other activities such as Closer to the Market Roadmap and to consider these reports in generating a NanoSafety Cluster Research Agenda.
On March 2, 2017, the European Chemicals Agency (ECHA) announced that its Board of Appeal issued its decision in Case A-011-2014, which concerns a Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) dossier evaluation for titanium dioxide. In its evaluation, ECHA considered only the substance identity information required and not the information requirements for human health and environmental effects. The Contested Decision required Huntsman P&A UK Ltd (formerly Tioxide Europe Limited), the lead registrant and one of the nine appellants, to provide detailed substance identity information on the crystal phases, nanoforms, and surface treatment of nanoforms covered by its registration. The appellants raised eight pleas in law in support of their appeal. The Board of Appeal first examined the appellants’ third plea, that ECHA acted outside its competence and breached REACH. The appellants argued that information on phases, nanoforms, and surface treatment of nanoforms is not information required for a registration under REACH Annex VI Section 2. According to the appellants, it is up to them to define the substance that they intend to register. It then falls to ECHA to perform a compliance check of the relevant registrations to determine whether the “hazard and risk data” required for a registration have been provided. The titanium dioxide registration dossier met the requirements of Section 2, which does not currently call for a more detailed identification of a registered substance if it is a nanomaterial. The appellants note that the legislator is considering amending the REACH Annexes to address nanomaterials specifically, and that there is no current requirement to provide more specific substance identity information on nanoforms than on other forms of a substance.
ECHA, and the French REACH Competent Authority, who intervened in support of ECHA, maintained that a registration must, in principle, separately address the toxicological and ecotoxicological properties of every crystal phase and/or nanoform covered by a registration dossier. Alternatively, a registrant can establish scientifically that differences in physical properties between different crystal phases and/or nanoforms do not result in different toxicological and ecotoxicological properties. ECHA, supported by the intervenor, argued that knowledge of the precise crystal phases and/or nanoforms covered by the registration “is therefore an implicit ‘prerequisite’ for assessing the hazards and risks posed by the Substance, regardless of whether a ‘form-by-form’ or a ‘grouping’ approach is adopted.” According to ECHA and the intervenor, a strictly literal interpretation of Annex VI Section 2 “would defeat the purpose of that provision, leading to the unacceptable consequence that manufacturers and importers of nanoforms of substances would not be required to assess the relevant hazards and risks.”
The Board of Appeal states that, in the present case, the registration dossier uses a very broad definition of titanium dioxide, including the bulk form and all nanoforms of various crystal phases of titanium dioxide, including rutile and anatase. To comply with REACH, the registration dossier must include toxicological and ecotoxicological information covering both the nanoforms and bulk forms of the rutile and anatase crystal phases of titanium dioxide. To reach a decision on the third plea, the Board of Appeal states that it must examine whether Annex VI Section 2 requires registrants to submit the information at issue when registering a substance. The Section 2 requirements “are worded with such technical precision and clarity that they leave no scope for doubt as to their meaning,” and “[n]one of these points mention the need to provide information on crystal phases and/or nanoforms.” The Board notes that Section 2 does not contain an openly worded information requirement such as a reference to “any other information necessary to identify the registered substance,” and the terms nanoforms and nanomaterials are not mentioned in REACH. The Board concluded that the wording of Section 2 is clear and “cannot be interpreted in the light of its purpose and context with regard to the information requests in the Contested Decision.”
According to the Board of Appeal, the procedures available to ECHA allow for information concerning the toxicological and ecotoxicological properties, and potentially other information, to be considered to ensure that sufficient information is available regarding the hazards and risks posed by the substance. In the present case, the literal interpretation of Section 2 does not endanger the protection of human health and the environment. The toxicological and ecotoxicological information in the registration dossier must satisfy the registration requirements set out in REACH with regard to all the bulk forms and crystal phases and/or nanoforms of titanium dioxide covered by the registration. The Board of Appeal concluded that a literal interpretation of the wording of Section 2 of Annex VI does not lead to an unreasonable result. The alleged contradiction in this case between the purpose and the wording of Section 2 does not stem from the wording of that provision. It derives, according to the Board, from the compliance check in the present case being limited to substance identity information only. The Board of Appeal annulled the requests for information on the crystal phases and/or nanoforms of titanium dioxide. As the requirement to submit information on nanoforms must be annulled, the Board states that there is no need to examine the requirement to submit information on the surface treatment of such nanoforms.
In January 2017, the International Organization for Standardization (ISO) published International Electrotechnical Commission (IEC)/Technical Specification (TS) 80004-9:2017, “Nanotechnologies — Vocabulary — Part 9: Nano-enabled electrotechnical products and systems.” IEC/TS 80004-9:2017 specifies terms and definitions for electrotechnical products and systems reliant on nanomaterials for their essential functionalities. ISO states that it is intended to facilitate communications between organizations and individuals in industry and those who interact with them. It includes sections on general terms related to nano-enabled electrotechnical products and systems; terms related to nano-enabled photovoltaics and thin-film organic electronics; and terms related to luminescent nanomaterials.
On February 23, 2017, the Center for International Environmental Law (CIEL) issued a press release announcing a new report, commissioned by CIEL, the European Environmental Citizens’ Organization for Standardization (ECOS), and the Oeko-Institute, that “shows that most of the information made available by the Sponsorship Testing Programme of the Organisation for Economic Co-operation and Development (OECD) is of little to no value for the regulatory risk assessment of nanomaterials.” CIEL states that the Institute of Occupational Medicine (IOM) screened 11,500 pages of raw data from the OECD dossiers on 11 nanomaterials, and analyzed all characterization and toxicity data on three specific nanomaterials — fullerenes, single-walled carbon nanotubes, and zinc oxide. According to CIEL, while OECD’s Working Party on Manufactured Nanomaterials has yet to draw conclusions on the data quality, some stakeholders participating in European Union (EU) policy-making — “notably the European Chemicals Agency (ECHA) and the European Commission’s Joint Research Centre” — have presented the dossiers as containing information on nano-specific human health and environmental impacts. CIEL states that industry associations and individual companies “have taken this a step further emphasizing that there is enough information available to discard most concerns about potential health or environmental risks of manufactured nanomaterials.” The report recommends the following options be considered:
- Expand the currently ongoing program to test systematically the appropriateness of the OECD Testing Guidelines, including how to identify and prevent artefacts;
- Develop Testing Guidelines for making nanomaterial preparations such as aerosols, dispersions, and feed;
- Define a minimum set of characteristics to be reported when testing nanomaterials following OECD Testing Guidelines;
- Support the build-up of widely accessible exposure registries and databases; and
- Fill the gaps of current dossiers.