Nano and Other Emerging Chemical Technologies Blog

Nano and Other Emerging Chemical Technologies Blog

Regulatory & legal developments involving nano and other emerging chemical technologies

OECD Tour de Table Highlights International Developments on the Safety of Manufactured Nanomaterials

Posted in International, Legal/Regulatory Issues

On September 27, 2017, the Organization for Economic Cooperation and Development (OECD) published a corrected version of the Developments in Delegations on the Safety of Manufactured Nanomaterials — Tour De Table, which covers developments on the safety of manufactured nanomaterials that were provided by OECD delegations from March to August 2017.  It summarizes relevant information on activities related to manufactured nanomaterials, as well as other activities on nanotechnologies at the international level.  The reported activities include:

  • The French National Institute for Industrial Environment and Risks (INERIS) “has developed some preliminary guidance values on human toxicity (inhalation, ingestion) as well as for ecotoxicity for the case of [titanium dioxide] at the nanoform.”
  • Germany’s Federal Institute for Occupational Safety and Health (BAuA) and Federal Institute for Risk Assessment (BfR) have “decided on including investigations on nanofibers with special emphasis on fiber rigidity in their research program. The focus shall be on characterization, exposure assessment and inhalation toxicology.”
  • Korea’s Ministry of Environment (MOE) has added nanomaterials to the list for hazard evaluation prescribed in the Act on Registration and Evaluation, etc. of Chemical Substances (K-REACH):
    • Risk assessment decisions, including the type of: (a) nanomaterials assessed; (b) testing recommended; and (c) outcomes of the assessment;
    • Development related to exposure measurement and exposure mitigation;
    • Risk management approaches;
    • Any updates, including proposals or modifications to previous regulatory decisions; and/or
    • New regulatory challenge(s) with respect to any action for nanomaterials.

Based on the policy and research infrastructures developed from the first National Nano-Safety Master Plan (2012-2016) at interministerial levels (including MOE and the Ministries of Trade, Industry, and Energy, and Food and Drug Safety), the Korean government will establish the goal, vision, and implementation plan of the second Master Plan (2017-2021), and intended to make an official announcement by the first half of 2017.  MOE plans to introduce an effective safety management system of nanomaterials and nanoproducts distributed during the second period.  The secondary plan will include assessing the hazards of nanomaterials, and evaluating and managing safety assessments of nanomaterials in nanoproducts.

  • The European Commission (EC) intends to propose the adoption of possible revised Annexes to the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation addressing nanomaterials in the beginning of 2018, “with further transition arrangement regarding full application.”

EPA Issues Direct Final SNURs for Carbon Nanotube (Generic) and Nanocarbon (Generic)

Posted in Federal, Legal/Regulatory Issues, Occupational Health and Safety Issues, United States

The U.S. Environmental Protection Agency (EPA) promulgated on September 21, 2017, significant new use rules (SNUR) for 37 chemical substances that were the subject of premanufacture notices (PMN).  Six of the chemical substances, including carbon nanotube (generic) and nanocarbon (generic), are subject to consent orders issued by EPA under Section 4 of the Toxic Substances Control Act.  The SNURs require persons who intend to manufacture (defined by statute to include import) or process any of the 37 chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity.  The required notification initiates EPA’s evaluation of the intended use.  Manufacture and processing for the significant new use is unable to commence until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required with that determination.  The promulgated SNURs include:

  • Carbon nanotube (generic) (PMN Number P-15-672): The generic (non-confidential) use of the PMN substance will be in filtration media.  EPA identified concerns for pulmonary toxicity and oncogenicity, as well as environmental toxicity.  The consent order requires:
  1. Use of personal protective equipment involving impervious gloves and protective clothing (where there is a potential for dermal exposure) and a National Institute for Occupational Safety and Health (NIOSH)-certified respirator with N-100, P-100, or R-100 cartridges (where there is a potential for inhalation exposure);
  2. Processing and use of the PMN substance only for the use specified in the consent order;
  3. Processing and use of the PMN substance only as an aqueous slurry, wet form, or a contained dry form as described in the PMN; and
  4. No use of the PMN substance resulting in releases to surface waters and disposal of the PMN substance only by landfill or incineration.
  • Nanocarbon (generic) (PMN Number P-16-170): The substance will be used as an additive to composite materials.  EPA identified concerns for pulmonary toxicity and oncogenicity, as well as environmental toxicity.  The consent order requires:
  1. Use of personal protective equipment involving impervious gloves and protective clothing (where there is a potential for dermal exposure) and a NIOSH-certified respirator with N-100, P-100, or R-100 cartridges (where there is a potential for inhalation exposure);
  2. Submission of a dustiness test within six months of notice of commencement;
  3. Submission of a 90-day chronic inhalation study prior to exceeding the confidential production volume limit specified in the consent order;
  4. Processing and use of the PMN substance only for the use specified in the consent order, including no application method that generates a vapor, mist, or aerosol unless the application method occurs in an enclosed process; and
  5. No use of the PMN substance resulting in releases to surface waters and disposal of the PMN substance only by landfill or incineration.

Both SNURs would designate as a “significant new use” the absence of the specified protective measures.  The notice includes recommended testing for each substance.  The SNURs will take effect November 20, 2017.

EC Begins Consultation on Revising Recommendation on Definition of Nanomaterial

Posted in International, Legal/Regulatory Issues

On September 15, 2017, the European Commission (EC) began a public consultation on the revision of the 2011 EC Recommendation on the definition of nanomaterial.  The EC intended the definition to achieve consistent application of the term nanomaterial across all legislation.  The definition includes descriptors that the EC intended to review by December 2014 to ensure that the definition corresponds to the needs.  In particular, the review must examine issues where there was incomplete information at the time of adoption.  According to the Roadmap, the review generated the following interim findings:

  1.  While the uptake of the Recommendation in European Union (EU) regulation to date has taken place, it has not been as comprehensive as anticipated.  This is not due to the definition itself, however, but due to delays in the processes planned to include the definition, e.g., the possible amendment of Annexes of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation to address nanomaterials and the delay in the adoption of the novel food regulation, by which time the review was launched;
  2. There is general consensus on the adequacy of the main elements of the definition.  These are notably the neutral scope in terms of the origin of the materials and the definition’s focus on particles.  It is generally accepted that the definition uses the size of particles as the only defining parameter, applying to a 1-100 nanometer particle size range and bases the threshold for being a nanomaterial on a number concentration instead of mass;
  3. There are currently difficulties in directly applying the Recommendation in legislation.  For example, it includes a threshold that has a default value but is not fully defined in advance and might require an additional process to determine its value:  “In specific cases and where warranted by concerns for the environment, health, safety or competitiveness the number size distribution threshold of 50 % may be replaced by a threshold between 1 and 50 %.”  Also, application of the additional criteria based on the specific surface area by volume is considered ambiguous by some stakeholders.  These prevent the Recommendation from being referred to in full by different regulations and force individual selection of its elements during each regulatory uptake, which could eventually lead to inconsistencies;
  4. There is a need to clarify some terms in use and how the criteria are applied:  e.g., the definition of “particle,” the precise meaning of particle’s “external dimension” and the use of the concept of the “constituent particle” in respect to agglomerates and aggregates;
  5. There are issues of scope:  e.g., the present Recommendation in addition to the general criteria explicitly identifies three carbon-based materials (graphene flakes, single-wall carbon nanotubes, and fullerenes) as nanomaterials while very similar non-carbon materials are not included; and
  6. Implementation remains challenging; there is no single universally applicable measurement method, and refinement of existing measurement methods is still in progress.  In particular, to quantify “constituent particles” in all cases still poses a challenge.  No easy implementation routes are presently provided to determine quickly for certain when a material is or is not a nanomaterial.

According to the Roadmap, the intention now is to prepare a revised Recommendation to be adopted by the EC, accompanied by a Staff Working Document that will report on the review undertaken and the rationale for the modifications.  The Roadmap states that it is envisaged that the EC will then:

  • Promote the revised Recommendation within the EU and, as appropriate, in the international community;
  • Develop guidance (including technical requirements), sector-specific guidance, and implementation tools;
  • Support the uptake of the Recommendation in the relevant policy areas, such as chemicals, cosmetics, and food; and
  • Set up a system of continuous monitoring of implementation across sectors, facilitate quick dissemination and uptake of any relevant scientific/technical developments, and if considered appropriate, trigger actions to support quality assurance and control of the measurements and their application in the nanomaterial definition.

Comments on the Roadmap are due October 13, 2017.

ISO Publishes Vocabulary Standard for Graphene and Related 2D Materials

Posted in International, Research

The International Organization for Standardization (ISO) has published standard ISO/TS 80004-13:2017, “Nanotechnologies — Vocabulary — Part 13:  Graphene and related two-dimensional (2D) materials.”  According to ISO, over the last decade, interest has arisen in graphene due to its “many exceptional properties.”  More recently, other materials with a similar structure have also shown promising properties, including monolayer and few-layer versions of hexagonal boron nitride, molybdenum disulphide, tungsten diselenide, silicene, germanene, and layered assemblies of mixtures of these materials.  The thickness of these materials is constrained within the nanoscale or smaller and consists of between one and several layers.  These materials are thus termed two-dimensional (2D) materials as they have one dimension at the nanoscale or smaller, with the other two dimensions generally at scales larger than the nanoscale.  ISO states that 2D materials are a significant subset of nanomaterials, and it is important to standardize the terminology for graphene, graphene-derived, and related 2D materials at the international level, as the number of publications, patents, and organizations rapidly increases.  According to ISO, these materials need an associated vocabulary as they become commercialized and sold throughout the world.  The standard lists terms and definitions for graphene and related 2D materials, and includes related terms naming production methods, properties, and their characterization.  ISO intends the standard to facilitate communication between organizations and individuals in research and industry, other interested parties, and those who interact with them.

TURI Publishes Nanomaterials Fact Sheet

Posted in Legal/Regulatory Issues, State, United States

In August 2017, the Toxics Use Reduction Institute (TURI), a research, education, and policy center established by the Massachusetts Toxics Use Reduction Act of 1989, published a nanomaterials fact sheet.  The fact sheet is part of a series of chemical and material fact sheets developed by TURI that are intended to help Massachusetts companies, community organizations, and residents understand the use of hazardous substances and their effects on human health and the environment.  The fact sheet also includes information on safer alternatives and safer use options.  According to the fact sheet, TURI researchers have started a blueprint for design rules for safer nanotechnology.  The design rules include five principles, which together follow the acronym SAFER, as shown below.  The principles focus on aspects such as modifying physical-chemical characteristics of the material to diminish the hazard, considering alternative materials, and enclosing the material within another, less hazardous, material.  The fact sheet notes that other researchers have proposed other more specific design rules, which include avoiding chemical compositions of engineered nanomaterials that contain known toxic elements, and avoiding nanomaterials with dimensions that are known to possess hazardous properties.

Design Principles for SAFER Nanotechnology

  1. Size, surface, and structure: Diminish or eliminate the hazard by changing the size, surface, or structure of the nanoparticle while preserving the functionality of the nanomaterial for the specific application;
  2. Alternative materials: Identify either nano or bulk safer alternatives that can be used to replace a hazardous nanoparticle;
  3. Functionalization: Add additional molecules (or atoms) to the nanomaterial to diminish or eliminate the hazard while preserving desired properties for a specific application;
  4. Encapsulation: Enclose a nanoparticle within another less hazardous material; and
  5. Reduce the quantity: In situations where the above design principles cannot be used to reduce or eliminate the hazard of a nanomaterial, and continued use is necessary, investigate opportunities to use smaller quantities while still maintaining product functionality.

The fact sheet provides a summary of regulations concerning nanomaterials.  Massachusetts currently has no regulations specifically governing the use or release of nanomaterials.  At the federal level, the U.S. Environmental Protection Agency (EPA) primarily regulates nanomaterials under the Toxic Substances Control Act.  The fact sheet notes that as of 2017, companies using or manufacturing nanomaterials that have not been subject to premanufacture notices or significant new use rules will be subject to a one-time reporting and recordkeeping rule.  More information regarding the rule and its final guidance is available in our August 14, 2017, blog item.

RIVM Announces Model to Calculate Concentrations of Nanoparticles in the Environment

Posted in International, Legal/Regulatory Issues, Research

The Netherlands National Institute for Public Health and the Environment (RIVM) announced on September 6, 2017, that an RIVM researcher, Joris Meesters, modified SimpleBox, a distribution model for chemicals, to create SimpleBox4nano, a model to calculate concentrations of nanoparticles in water, soil, and air.  SimpleBox4nano includes new processes that specifically apply to nanoparticles, such as the clustering of particles.  Meesters tested the model using three metal oxide nanoparticles:  titanium dioxide, zinc oxide, and cerium dioxide.  According to RIVM, the SimpleBox model results confirm the clumping of nanoparticles with the many natural particles in the environment (clay, sediment, organic matter).  The research shows that SimpleBox4nano can be used to estimate the distribution of nanoparticles in the environment.  RIVM describes SimpleBox4nano as a “major step forward in the environmental risk assessment of nanoparticles.”

Study Examines How to Reduce Nanoparticle Emissions during 3D Printing

Posted in Research

On August 30, 2017, Environmental Science & Technology, an American Chemical Society (ACS) publication, published a study entitled “Characterization and Control of Nanoparticle Emission during 3D Printing.” According to the abstract, the study aimed to evaluate particle emission characteristics and to evaluate several control methods used to reduce particle emissions during three-dimensional (3D) printing. Experiments for particle characterization measured particle number concentrations, emission rates, morphology, and chemical compositions under manufacturer-recommended and consistent-temperature conditions with seven different thermoplastic materials in an exposure chamber. Eight different combinations of the different control methods were tested, including an enclosure, an extruder suction fan, an enclosure ventilation fan, and several types of filter media. The nanoparticle emission rate was at least one order of magnitude higher for all seven filaments at the higher consistent extruder temperature than at the lower manufacturer-recommended temperature. The abstract states that among the eight control methods tested, the enclosure with a high-efficiency particulate air (HEPA) filter had the highest removal effectiveness (99.95 percent) of nanoparticles. The authors’ recommendations for reducing particle emissions include applying a low temperature, using low-emitting materials, and instituting control measures like using an enclosure around the printer in conjunction with an appropriate filter (e.g., HEPA filter) during 3D printing.

EC4SafeNano Survey on Demand and Supply of Services in Nanosafety Ends September 15

Posted in International

Responses to the European Center for Risk Management and Safe Innovation in Nanomaterials and Nanotechnologies (EC4SafeNano) survey on demand and supply of services in nanosafety are due September 15, 2017. EC4SafeNano notes that multiple responses from different departments and groups within a single organization are possible. As reported in our April 24, 2017, blog item, EC4SafeNano wishes to develop a catalog of services matching the anticipated needs and service requirements to the supply of services from different organizations. It has sent a survey to different stakeholders, including European Union (EU) Member States, the European Commission (EC) and EC agencies, industry, and bodies representing the general public. Responses will influence the design of EC4SafeNano and ensure that issues important to stakeholders will be addressed; the catalog of services will be relevant; and services can be provided through EC4SafeNano. EC4SafeNano will be developed over the next three years to bridge the gap between scientific knowledge and daily practice by providing services to help others to manage this new technology safely. EC4SafeNano will anonymize and summarize the survey responses in a report that will be made available to all respondents.

NIOSH Engineering Controls Program Protects Workers from Emerging Hazards

Posted in Federal, Legal/Regulatory Issues, Occupational Health and Safety Issues, United States

On September 6, 2017, the National Institute for Occupational Safety and Health (NIOSH) published a Program Performance One-Pager entitled NIOSH Engineering Controls Program.  The Program’s activities include providing engineering control recommendations to protect workers from emerging hazards in nanotechnology and advanced materials used in additive manufacturing/three-dimensional (3D) printing.  The Program is currently working to:

  • Complete laboratory evaluations of ultrafine particle emissions and engineering controls for 3D printing of materials that include carbon nanotubes and graphene in filaments;
  • Complete evaluations at advanced manufacturing workplaces and publish engineering control recommendations to reduce worker exposure to ultrafine particles; and
  • Publish three NIOSH engineering control workplace design solution documents to highlight effective engineering control approaches for the most common nano-manufacturing workplaces.

EC Environment DG Publishes Report on Assessing the Environmental Safety of Manufactured Nanomaterials

Posted in International, Legal/Regulatory Issues, Research

The European Commission (EC) Environment Directorate General (DG) published an August 2017 report entitled Assessing the environmental safety of manufactured nanomaterials.  The report “shows that, despite early fears, nano-sized particles are not inherently more toxic than larger particles; however, differences between them may be notable and new insights are still being provided by research.”  The report’s aim is “to present the most promising strategies and most significant challenges of nanomaterial characterisation, exposure, fate and behaviour, ecotoxicological hazard and risk assessment.”  It includes examples and case studies of both the scientific developments and the knowledge gaps.  According to the report, while research and development into the new properties and potential of nanomaterials is “fast-moving,” research supporting comprehensive risk assessments “is often lagging behind.”  The report notes that there is an “urgent need” for long-term exposure studies.  Although testing of each individual nanomaterial would “always be preferred,” the report states that “its feasibility is questionable, financially and ethically.”  The report states that there is growing interest in a safe-by-design approach, which would represent a further shift towards the burden of proof approach under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation.  Safe-by-design would require increased cooperation between researchers, designers, developers, distributers, potential end-users, and regulators.  The report suggests more incentives need to exist to publish and publicize negative results and that there is a need for platforms and networks, such as the European Observatory for Nanomaterials, “that will enable unprecedentedly accessible data and collaboration between businesses, researchers, decisionmakers and assessment experts.”