Nano and Other Emerging Chemical Technologies Blog

Nano and Other Emerging Chemical Technologies Blog

Regulatory & legal developments involving nano and other emerging chemical technologies

Presentations Available from ECHA Webinar on REACH Guidance for Nanomaterials

Posted in International, Legal/Regulatory Issues

On November 30, 2017, the European Chemicals Agency (ECHA) held a webinar to explain the support documentation available for registrants that cover nanoforms in their Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) registration dossier.  The main focus was on the registration and read-across of nanoforms, but the webinar also covered updates for information requirements for human health and the environment.  ECHA has posted the following presentations from the webinar:

WHO Publishes Guidelines on Protecting Workers from Potential Risks of Manufactured Nanomaterials

Posted in International, Occupational Health and Safety Issues

In December 2017, the World Health Organization (WHO) published WHO Guidelines on Protecting Workers from Potential Risks of Manufactured Nanomaterials.  WHO developed the Guidelines, which provide recommendations on how best to protect workers from the potential risks of manufactured nanomaterials (MNM).  According to WHO, its recommendations are intended to help policy-makers and professionals in the field of occupational health and safety in making decisions about the best protection against potential risks specific to MNMs in workplaces.  The Guideline Development Group (GDG) used a precautionary approach as one of its guiding principles, as well as the hierarchy of controls.  The GDG considers the following to be best practice in preventing the adverse health effects of MNMs:

  • Group nanomaterials into MNMs with specific toxicity, MNMs that are fibers, and MNMs that are granular biopersistent particles;
  • Educate and train workers in the specific health and safety issues of MNMs; and
  • Involve workers in all phases of risk assessment and control.

For all important issues, systematic reviews of the current state of the science were commissioned to inform the recommendations according to the process set out in the WHO Handbook for guideline development.  The recommendations were rated as “strong” or “conditional” depending on the quality of the scientific evidence, values and preferences, and costs related to the recommendation.  All recommendations were made based on consensus within the GDG.  The recommendations include:

  • Assess health hazard of MNMs;
  • Assess exposure to MNMs; and
  • Control exposure to MNMs.

The GDG states that it cannot make a recommendation for targeted MNM-specific health surveillance programs over existing health surveillance programs that are already in use owing to the lack of evidence.  According to the Guideline, the GDG considers training workers and worker involvement in health and safety issues to be best practice, but cannot recommend one form of training of workers over another, or one form of worker involvement over another, owing to the lack of studies available.  The Guideline states:  “It is expected that there will be considerable progress in validated measurement methods and risk assessment.  Therefore, the GDG proposes to update these guidelines in five years’ time, in 2022.”

ISO Publishes Standard on Aquatic Toxicity Assessment of Manufactured Nanomaterials in Saltwater Lakes

Posted in International, Research

In November 2017, the International Organization for Standardization (ISO) published standard ISO/TS 20787:2017, “Nanotechnologies — Aquatic toxicity assessment of manufactured nanomaterials in saltwater lakes using Artemia sp. Nauplii.”  ISO/TS 20787:2017 specifies a test method, aiming to maximize repeatability and reliability of testing, to determine whether manufactured nanomaterials are toxic to aquatic organisms, specifically Artemia sp. nauplius.  ISO states that ISO/TS 20787:2017 is intended to be used by ecotoxicological laboratories that are capable in the hatching and culturing of Artemia sp. and the evaluation of toxicity of nanomaterials using Artemia sp. nauplius.  The method uses Artemia sp. nauplii in a simulated environment, artificial seawater, to assess effects of nanomaterials.  ISO states that ISO/TS 20787:2017 is applicable to manufactured nanomaterials that consist of nano-objects such as nanoparticles, nanopowders, nanofibers, nanotubes, and nanowires, as well as aggregates and agglomerates of such manufactured nanomaterials.

INRS 2016/2017 Brochure Includes Studies in Progress Concerning Manufactured Nanomaterials

Posted in EU Member State, International, Occupational Health and Safety Issues

On November 23, 2017, the French National Research and Safety Institute for the Prevention of Occupational Accidents and Diseases (INRS) published a report summarizing studies and research completed in 2016 and in progress in 2017.  According to the report, INRS action on manufactured nanomaterials has three objectives:  (1) making knowledge on hazards available to the working world; (2) designing tools for identifying, characterizing, and measuring occupational exposures; and (3) proposing risk prevention approaches and tools for firms and laboratories that produce or handle these materials.  In 2016, INRS completed a study entitled “Impact of sources and of the environment on confinement of nanoparticulate pollutants by collective protective equipment.”  The objective of the study was to develop the tools necessary for assessing the effectiveness of collective protection systems, based on ventilation, for protecting people from nanoparticle aerosols.  Three focuses for action were identified:  characterizing the sources of nanoparticle aerosols; studying the airflow factors in degradation of the confinement of ventilated enclosures; and developing models for numerically simulating the dispersion of nanoaerosols at workplaces (predictive ventilation).  According to INRS, the results made it possible to identify the main nanomaterial aerosol sources present in ventilated enclosures.  An experimental method of characterizing the generation flow rates of these sources that is applicable out in the field was then developed and validated.  A realistic predictive model for the variation in pollutant nanoaerosols in work atmospheres was designed.

Studies in progress in 2017 include:

  • Study of the effect of agglomeration on the respiratory toxicological properties and the toxicokinetics of inhaled titanium dioxide nanoparticles in rats (2013-2017);
  • Study of neuro-inflammation and of potential disruptions of the blood-brain barrier in adult and old rats exposed to nanoparticulate titanium dioxide by inhalation (2014-2017);
  • A common European approach for regulatory assessment of nanomaterials (NANOREG) (2013-2017);
  • Development of a smart experimental approach for assessing the hazard related to nanomaterials (European project SMARTNANOTOX) (2016-2020);
  • Performance of real-time exposure monitoring applied to nanoparticle aerosols (2014-2018);
  • Multiparametric characterization of metal ultrafine particles (2016-2019);
  • Optimizing methods of sampling ultrafine particles of metal aerosols using cascade impactors (2016-2020);
  • Assessment of exposure to nanometric titanium dioxide (2014-2017);
  • Standardization of activities concerning nanotechnologies and nanomaterials (NANOCEN) (2013-2018);
  • EXPROPNANO: Assessment of occupational exposure to nanometric particles (measurement strategy coupled with analysis of the activity) (2015-2017);
  • Nanomaterials and occupational exposure during operations implementing powders: study of the relationships between the physico-chemical properties of the powders and the characteristics of the aerosols emitted at workplaces (2016-2019); and
  • Performance of filtering and isolating respiratory protective devices in protecting from nanoparticles (2013-2017).

Sweden Announces Product Registration Requirement for Nanomaterials

Posted in EU Member State, International, Legal/Regulatory Issues

On December 5, 2017, the Swedish Chemicals Agency (KEMI) announced that it has amended the information requirements for the products register to require notifiers to provide information on nanomaterials contained in chemical products.  The announcement, available in Swedish, states that the requirement will enter into force on January 1, 2018, and the first reports will be due in February 2019.  According to KEMI, the purpose of the new notification requirements is to obtain information on the identity and quantity of the nanomaterials used in Sweden.  As reported in our June 13, 2017, blog item, on June 7, 2017, Sweden notified the draft regulation to the European Commission (EC).  Under the draft regulation, the requirement will apply to nanomaterials that have been intentionally added to the product, regardless of the concentration of the nanomaterials.  The definition of nanomaterial will reflect the EC’s recommended definition, except that nanomaterials that are natural or incidental shall not be notified to the product register.  Exemption from the notification obligation is proposed for nanopigments and for entities with an annual turnover of less than SEK 5 million.

UBA Report Summarizes Work to Develop New OECD Test Guideline on Dispersion Stability of Nanomaterials

Posted in International, OECD, Research

In December 2017, Germany’s Federal Environment Agency (UBA) published a report entitled Clarification of methodical questions regarding the investigation of nanomaterials in the environment:  Development of a decision support tool for the investigation of nanomaterial’s environmental behaviour based on dispersion behaviour and dissolution in relation to various environmental parameters.  UBA states that for an adequate and valid interpretation of data regarding the environmental fate and behavior of nanomaterials, it is essential to describe parameters like dissolution, dispersibility, and dispersion stability.  The aim of the project was to develop a standardized test method to determine dispersibility and dispersion stability of nanomaterials in simulated environmental media as a new Organization for Economic Cooperation and Development (OECD) Test Guideline.  For this objective, both conceptual and experimental work was conducted, and an international round robin was initiated and executed to validate the proposed test setup regarding reliability and reproducibility.  According to UBA, two comprehensive expert commenting rounds of the OECD Test Guideline Program supported the refinement of the draft within this project.  The test method developed was submitted to OECD by UBA and published by OECD in October 2017 as a new “Test Guideline on dispersion stability of nanomaterials in simulated environmental media (OECD No. 318).”  The final report describes the considerations, experimental approaches, and obtained results that build the basis for the new OECD Test Guideline.  The report also contains a literature review of transformation reactions of nanomaterials in environmental media (up to 2015).

RIVM Takes Critical Look at EUON

Posted in International, Legal/Regulatory Issues

The Dutch National Institute for Public Health and the Environment (RIVM) published a brochure entitled “The European Union Observatory for Nanomaterials:  A step forward?” on November 30, 2017.  RIVM concludes that the European Union (EU) Observatory for Nanomaterials (EUON) will have a limited contribution to reducing the uncertainty regarding the safety of nanomaterials.  Although several EU Member States, including the Netherlands, supported a mandatory EU-wide registration system for nanomaterials, the European Commission (EC) created the EUON.  RIVM explores the consequences of this decision for the available knowledge regarding the use and safety of nanomaterials.  According to RIVM, for the Dutch government to protect humans and the environment, it is important to know which products contain nanomaterials and what the potential risks of these materials are for public health and the environment.  While the EUON contributes to this knowledge by collecting the available information in one central location, the quality of the information is also important.  RIVM states that one of the sources of information is the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation, but notes that “this risk assessment framework is not yet sufficiently suitable for nanomaterials.”  In addition, according to RIVM, the information is limited to broad categories of products and articles, and brand names are not specified.  RIVM concludes that “it will remain difficult for consumers, as well as others, to judge whether they are actually using a ‘nanoproduct’ and what the potential health consequences are of such use.  Accordingly, even though the EUON maintains a separate web portal for consumers, it appears most relevant for experts, competent authorities, and industry.”

NNI Publishes Supplement to President’s 2018 Budget Request

Posted in Federal, Research, United States

On November 30, 2017, the National Nanotechnology Initiative (NNI) published a supplement to the President’s 2018 budget.  The supplement also serves as NNI’s annual report and summarizes the progress made in achieving NNI’s goals, the research and development (R&D) activities and plans of the participating agencies, and the agency investments in each program component area.  The President’s 2018 Budget requests $1.2 billion for the NNI, “a continued investment in support of innovation promoting America’s competitiveness, economic growth, and national security.”  The NNI investments proposed for 2018 reflect an emphasis on broad, fundamental research in nanoscience to provide a continuing pipeline of new discoveries that will enable future transformative commercial products and services.  The supplement provides the following key points about the 2016-2018 NNI investments:

  • Reductions in overall NNI investments are consistent with the goal of the President’s 2018 budget to prioritize federal resources on areas that industry is not likely to support, over later-stage applied R&D that the private sector is better equipped to pursue;
  • The actual NNI investments reported by the participating agencies for 2016 ($1.56 billion) are significantly larger than 2016 estimated investments published in the 2017 budget ($1.43 billion) and 2016 requested investments published in the 2016 budget ($1.50 billion). This change is due largely to the fact that an increasing proportion of agencies’ nanotechnology investments are coming from “core” R&D programs, where the high success rate of nanotechnology-related proposals cannot be anticipated in advance;
  • Total funding for Program Component Area (PCA) 1, Nanotechnology Signature Initiatives and Grand Challenges, for 2018 (nearly $200 million, representing over 16 percent of the NNI total) reflects the emphasis on focused investments in R&D that advance interagency cooperation and public/private partnerships in support of national priorities, as a key part of the overall NNI funding strategy;
  • NNI’s Nanotechnology-Inspired Grand Challenge for Future Computing is a new investment category in the President’s 2018 budget, included for the first time under PCA 1. The challenge helps to address renewed international competition for U.S. leadership in semiconductor manufacturing and downstream information technology industries;
  • The increase in the percentage of total NNI investments in PCA 2, Foundational Research, reflects the budget’s focus on supporting early-stage R&D, and is consistent with calls by NNI advisory bodies to maintain a pipeline of basic research that will lead to the innovations of the future;
  • Proportional NNI investments in PCA 3, Nanotechnology-Enabled Applications, Devices, and Systems, hold steady at about 24 percent of the total NNI investments for 2016-2018, down slightly from 25 percent in 2015;
  • NNI agencies continue to provide consistent, proportional funding for PCA 4, Research Infrastructure and Instrumentation. The 2018 request includes sustained support for the National Science Foundation’s (NSF) National Nanotechnology Coordinated Infrastructure network of university-based nanotechnology user facilities.  The President’s 2018 budget for the Department of Energy (DOE) requests continued support for three of the original five Nanoscale Science Research Centers.  PCA 4 also includes research to develop novel or improved instrumentation, which is critical to continued progress in nanotechnology and to maintain U.S. competitiveness internationally;
  • PCA 5, Environment, Health, and Safety (EHS), investments are a key element of the NNI’s strategy to ensure responsible development of nanotechnology;
  • The return of the Department of Justice’s National Institute of Justice (NIJ) to the NNI budget crosscut in the President’s 2018 budget “is another example of where nanotechnology innovations initially funded by basic research agencies are now coming to fruition in R&D programs focused on applications, devices, and systems that directly contribute to national priorities”; and
  • Investments in Small Business Innovation Research (SBIR) and Small Business Technology Transfer Research (STTR) funding by the participating agencies play a critical role in transitioning nanotechnology innovations into products for commercial and public benefit.

NanoReg2 Begins Survey Concerning Knowledge of Risks from Nanomaterials and Concept of Safe-by-Design

Posted in International, Legal/Regulatory Issues, Occupational Health and Safety Issues

On behalf of its project partner, the Institute of Occupational Medicine, NanoReg2 seeks information from organizations that manufacture, make, use, distribute, or dispose of nanomaterials.  NanoReg2 states that, as part of the NanoReg2 Project, it is trying to find out what organizations know and understand about worker and end-user risk from nanomaterials and the concept of Safe-by-Design.  NanoReg2 encourages participation from individuals who are involved in product development, health and safety, production engineering, or risk management.  According to NanoReg2, the survey should take no longer than 15 minutes.  NanoReg2 “would be happy to stay in touch with you (if you provide your email) about the future results of NanoReg2.”  Survey responses are requested by December 15, 2017.

Germany Publishes Report on Relationship of Nanomaterial’s Physical-Chemical Properties and Aquatic Toxicity for the Purpose of Grouping

Posted in EU Member State, International, Legal/Regulatory Issues, Research

Germany’s Federal Environment Agency (UBA) published a November 2017 report entitled Considerations about the relationship of nanomaterial’s physical-chemical properties and aquatic toxicity for the purpose of grouping.  The report notes that, based on the variety of existing nanomaterials with numerous modifications, “the effort of investigating environmental fate and effects will be tremendous.”  As a result, it will be necessary to group nanomaterials that feature similar environmental fate and effects.  The project objective was to correlate physical-chemical data with ecotoxicological effects for selected nanomaterials and to define reference values that can serve as a basis for grouping.  The report presents the development of concepts for the grouping of nanomaterials with regard to their ecotoxicological effects, focusing on aquatic ecotoxicity.  The project was structured into five steps:

  1. Fourteen nanomaterials were selected according to pre-defined criteria.  The selected nanomaterials were different subtypes of silver, zinc oxide, titanium dioxide, cerium oxide, and copper;
  2. Their physico-chemical properties were determined in water and in all test media;
  3. Based on the results, hypotheses regarding the expected ecotoxicity were formulated;
  4. The hypotheses were verified by testing the selected nanomaterials in three ecotoxicological tests (acute aquatic toxicity with algae, daphnia, and fish embryo according to the Organization for Economic Cooperation and Development (OECD) Test Guidelines No. 201, 202 and 236); and
  5. A grouping concept was compiled based on the nanomaterials’ physico-chemical parameters that were identified as relevant for the emergence of a toxic effect in aquatic organisms.

The report includes recommendations intended to support the further identification of relevant correlations between physico-chemical properties and the ecotoxicity of nanomaterials and thus, the development of the grouping/read-across approach regarding ecotoxicity.