Nano and Other Emerging Chemical Technologies Blog

Nano and Other Emerging Chemical Technologies Blog

Regulatory & legal developments involving nano and other emerging chemical technologies

Austrian Academy of Sciences Publishes NanoTrust Dossier on the Safe-By-Design Concept

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

The Institute of Technology Assessment of the Austrian Academy of Sciences has published a NanoTrust Dossier entitled “Safe-by-Design — The Early Integration of Safety Aspects in Innovation Processes.”  The Dossier presents an overview of the concepts behind the idea of integrating health or environmental safety considerations in the design of materials, products, or processes, focusing on the nano-specific Safe-by-Design (SbD) concept.  SbD aims to take account of safety issues early on and throughout the entire product development process.  According to the Dossier, the nano-specific concepts of SbD are intended to address prevailing uncertainties about potential risks to the environment and human health at the beginning stages in the development of new nanomaterials and products.  The Dossier states that the basic assumption of the SbD concept is that risks can be reduced through the choice of materials, products, tools, and technologies, making them as safe as possible.  Particular attention is paid to the product development stage, when it is still possible to intervene to control the selection of these factors. In line with the precautionary principle, the early integration of safety in the innovation process is generally seen as desirable.  In recent years, according to the Dossier, many projects have been dedicated to the SbD concept and its practical implementation in industry.  Alongside the strengths of the concept, such as the early focus on safety-relevant issues, a number of challenges concerning practical applicability have been identified.  The Dossier notes that the voluntary nature of the use of SbD increases the users’ outlay in money and time without any visible added benefit for the enterprise.  Currently, therefore, “the nano-specific SbD concept must be considered as difficult to implement, although the effort to include safety as early as possible in the innovation process is generally very positively received.”  The Dossier includes a summary of projects at the European Union (EU) and national levels that have addressed or are addressing SbD in the nano-context.

EC Calls for Data on Certain Nano Ingredients Used in Cosmetic Products

Posted in International, Legal/Regulatory Issues

The European Commission (EC) published on June 11, 2019, a call for data on the following ingredients used in cosmetic products:  gold (nano); colloidal gold (nano); platinum (nano); colloidal platinum (nano); copper (nano); and colloidal copper (nano).  The EC states that it has concerns about the use of nano forms of gold, colloidal gold, platinum, colloidal platinum, copper, and colloidal copper “because of the potential of nanoparticles to enter cells through dermal absorption or across a mucous membrane.”  In addition, according to the EC, the data submitted by the applicants “seem to be insufficient” for the Scientific Committee on Consumer Safety (SCCS) to carry out a full risk assessment.  The EC has mandated SCCS to assess the safety of these nanomaterials.  Interested parties are invited to submit, in accordance with the requirements described in the call for data, any relevant scientific information on the safety of:

  • Gold (nano) and colloidal gold (nano) (CAS No. 7440-57-5, EC No. 231-165-9, with or without surface modifications, g., CAS No. 1360157-34-1);
  • Platinum (nano) and colloidal platinum (nano) (CAS No. 7440-06-4, EC No. 231-116-1, with or without surface modifications); and
  • Copper (nano) and colloidal copper (nano) (CAS No. 7440-50-8, EC No. 231-159-6) used in cosmetic products.

The EC seeks data on all physicochemical properties, toxicokinetics and toxicological end-points, assessment of exposure through consumer products, and/or an indication on the suggested safe concentration limits for these ingredients.  Submissions are due November 10, 2019.

ISO Guidance Specifies Characteristics and Measurement Methods for Antibacterial Silver Nanoparticles

Posted in International, Research

The International Organization for Standardization (ISO) has published standard ISO/TS 20660:2019, “Nanotechnologies — Antibacterial silver nanoparticles — Specification of characteristics and measurement methods.”  The standard provides guidance for the specification of characteristics and relevant measurement methods for silver nanoparticles in powder or colloidal forms that are intended for antibacterial applications in nanotechnology.  ISO states that the standard is intended to aid the producer in providing the physicochemical characteristics of silver nanoparticles that have an antibacterial effect to the buyer.  ISO notes that the standard does not cover considerations specific to health and safety issues either during manufacturing or use.

Stories from the NNI Podcast Series Includes Conversation with Vince Caprio, NanoBCA Founder and Executive Director

Posted in Federal, United States

The most recent episode of the National Nanotechnology Initiative’s (NNI) podcast series, Stories from the NNI, features Vince Caprio, Founder and Executive Director of the NanoBusiness Commercialization Association (NanoBCA).  Dr. Lisa Friedersdorf, Director of the National Nanotechnology Coordination Office (NNCO), speaks with Caprio about his memories of the early establishment of NNI, his thoughts on major advances in nanotechnology for the past 15 years, and NanoBCA’s role in advocating for NNI and enabling a better understanding and appreciation of nanotechnology by legislators and federal and state governments.  To celebrate the 15-year anniversary of the authorization of NNI, NNI is releasing a new podcast episode every Monday.  In each of the episodes, an expert from academia, government, or industry will share his or her perspectives on key research and development advances in nanotechnology and how NNI has changed the nanotechnology landscape.

OECD Tour de Table Provides Updates on Developments on the Safety of Manufactured Nanomaterials

Posted in International, Legal/Regulatory Issues, OECD

As reported in our May 30, 2019, blog item, the Organization for Economic Cooperation and Development (OECD) recently published several reports in its Series on the Safety of Manufactured Nanomaterials, including Developments in Delegations on the Safety of Manufactured Nanomaterials — Tour de Table.  The Tour de Table compiles information provided by delegations on the occasion of the 19th meeting of the OECD Working Party on Manufactured Nanomaterials (WPMN) in February 2019.  Below are highlights from the Tour de Table:

  • Canada: Canada is currently developing a risk assessment framework that will be used to guide environmental and human health risk assessment of nanomaterials in commerce.  Canada expected to complete a generalized draft risk assessment framework by spring 2019.  In addition, Canada plans expert consultations on the high-level framework at a later date.
  • European Union (EU): Following the European Commission’s (EC) review of the Recommendation on the definition of nanomaterial (2011/696/EU), the EC anticipated “minor revision” of the Recommendation.  The EC planned a public consultation on the considered changes, “but its launch has been delayed.”  The public consultation may take place later in 2019, at which time more information will also be made available.  Until any change, the existing Recommendation should be used.
  • France: The French National Research and Safety Institute for the Prevention of Occupational Accidents and Diseases (INRS) has ongoing studies “dedicated to the prevention of occupational risks associated with manufactured nanomaterials”:
    • Five toxicological studies (mainly conducted by inhalation in animals);
    • Five studies on the characterization of occupational exposures; and
    • A study on collective protection devices (filtration).

In 2019, INRS is going to start a major epidemiological study of biomarkers of the early effects related to occupational exposure to amorphous nanostructured silicas.

  • Germany: In 2019, the Federal Environment Agency (UBA) intends to launch a new research project aiming to promote the knowledge on advanced materials on the European market and their relevance for the risk assessment in the context of chemical safety regulations.  Topic conferences are scheduled for fall/winter 2019, summer 2020, and spring 2021.  UBA also intends to launch a research project focusing on the development of a static and a dynamic standard method to determine solubility and dissolution rate of nanomaterials in environmental media.  Both methods are intended for inclusion in an OECD Test Guideline.  The project is intended to start in October 2019 with a duration of approximately three years.
  • Korea: With the enforcement of the Consumer Chemical Products and Biocides Safety Act (K-BPR) in January 2019, the Ministry of Environment (MOE) has prescribed in its Ordinance to submit evaluation reports on the impacts of nanomaterials contained in biocidal products on humans, animals, and the environment.  In case of biocidal products containing nanomaterials, the name of a substance should be labeled with the word “nano” in brackets before the name of a substance.
  • Thailand: The Thailand Food and Drug Agency (Thai FDA) “is starting to seriously look at product certification that have nanoparticles.”  It has sought the assistance of NANOTEC to implement awareness training for its staff on nanoparticles and labels.  Thai FDA has indicated that it would like to initiate a collaborative working agreement with NANOTEC to promote nanosafety awareness.
  • U.S.: The U.S. Environmental Protection Agency (EPA) completed review of low volume exemptions for five quantum dots and a metal oxide substance.  EPA “allowed the exemptions under conditions that limited human and environmental exposures to prevent unreasonable risks.”

OECD Publishes New Reports in Series on Safety of Manufactured Nanomaterials, Including Tour de Table

Posted in International, Legal/Regulatory Issues, OECD, Research

The Organization for Economic Cooperation and Development (OECD) has posted the following reports in its Series on the Safety of Manufactured Nanomaterials:

  • Developments in Delegations on the Safety of Manufactured Nanomaterials — Tour de Table: The Tour de Table compiles information provided by delegations on the occasion of the 19th meeting of the OECD Working Party on Manufactured Nanomaterials (WPMN) in February 2019.  It aims to summarize relevant information on activities related to manufactured nanomaterials, as well as other activities on nanotechnologies at the international level.  We will provide more detail in a forthcoming blog item on the regulatory developments reported by the delegations;
  • Physical-Chemical Decision Framework to Inform Decisions for Risk Assessment of Manufactured Nanomaterials: This document provides guidance on which test methods are appropriate to measure a given physico-chemical parameter considered key to characterization and identification for a given type of nanomaterial; and
  • Guiding Principles for Measurements and Reporting for Nanomaterials: Physical Chemical Parameters:  OECD intends this to aid in improving the conduction of the studies, in addition to promoting consistent data reporting (including reporting details on sample preparation and measurement protocols) to maximize utility and comparability of the data.  It provides a transparent approach that:  (1) aids communication of key purposes for data generation; (2) facilitates the identification of suitable methods; (3) pinpoints method limitations; and (4) highlights good reporting practices that address purposes related to the assessment of nanomaterials.

The purpose of the OECD Series on the Safety of Manufactured Nanomaterials is to provide up-to-date information on the OECD activities related to human health and environmental safety.

SweNanoSafe Launches Free Web Tool to Help Register Nanomaterials under REACH

Posted in International, Legal/Regulatory Issues

On May 16, 2019, the Swedish National Platform for Nanosafety (SweNanoSafe) announced the availability of eREACHNano, “a new web tool focused on helping small and medium-sized companies that may lack sufficient in-house expertise on the regulation covering nanomaterials.”  The web tool explains the data requirements for nanoforms according to the guideline documents of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation, including:

  • Definition of nanomaterials;
  • Types of nanomaterials;
  • Overview of nanomaterial-specific annexes to existing REACH guidance;
  • Chemical and physical characterization of nanomaterials;
  • Testing of nanomaterials; and
  • Exposure and risk assessment of nanomaterials.

SweNanoSafe notes that the December 2018 amendments clarifying the information requirements for nanomaterials have not yet been included.  The information requirements will apply beginning January 1, 2020.  The information requirements will be included in a subsequent version of the web tool to be launched later in 2019.

Registration Opens for NNI Webinar on Measurements of Potential Ecotoxicological Risk

Posted in Federal, Occupational Health and Safety Issues, United States

Registration is now available for the National Nanotechnology Initiative’s (NNI) June 11, 2019, webinar on “Practical Applications of 15 Years of NanoEHS Research:  Measurements of Potential Ecotoxicological Risk.”  The speaker will be Dr. Elijah Petersen, National Institute of Standards and Technology (NIST), and Dr. Treye Thomas, U.S. Consumer Product Safety Commission (CPSC) and NNI Coordinator for Environmental, Health, and Safety (EHS) Research, will moderate.  The webinar will spotlight the progress in addressing the measurement challenges posed by the unique behaviors of engineered nanomaterials.  NNI states that modifications to typical toxicity assays are needed to account for these behaviors, avoid artifacts, and ensure accurate measurements.  Using several practical examples, Dr. Petersen will describe the different artifacts that can occur during measurements and the potential control experiments to assess these artifacts.  Dr. Petersen will also discuss the development of an Organization for Economic Cooperation and Development (OECD) guidance document on aquatic and sediment toxicological testing of nanomaterials.  According to NNI, the webinar will underscore the role of the collaborative U.S.-European Union (EU) Communities of Research in sharing information and best practices for measuring and studying nanomaterials in ecologically relevant scenarios.  Webinar viewers will be able to submit questions for the panelists to answer during the question and answer period.  Submitted questions may be posted on the NNI website.

NIOSH Activities at 2019 AIHce EXP Include Presentations on Nanomaterials

Posted in Federal, Occupational Health and Safety Issues, United States

On May 17, 2019, the National Institute for Occupational Safety and Health (NIOSH) announced that its presentations at the May 20-22, 2019, American Industrial Hygiene Conference & Expo (AIHce EXP) include:

  • 119 — An Evaluation of Engineered Nanomaterial Safety Data Sheets Post [Globally Harmonized System of Classification and Labeling of Chemicals (GHS)]
    Presenter:  Laura Hodson
    Type:  Poster 119, May 20, 2019; and
  • 348 — Comparison of Enhanced Darkfield Microscopy and Hyperspectral Mapping with Electron Microscopy for Analysis of Airborne Nanoparticulate Collected on Filter-based Media
    Presenter:  Adrienne Eastlake
    Type:  Poster 348, May 22, 2019.

NIOSH congratulates Dr. Charles Geraci, Ph.D., Associate Director for Advanced Manufacturing, on being awarded the Henry F. Smyth, Jr. Award for his outstanding ability to recognize technical or scientific challenges that, when solved, benefit the industrial hygiene profession.

Slides Available from ACS Webinar on Working Safely with Nanomaterials in the Laboratory

Posted in Federal, Occupational Health and Safety Issues, United States

The American Chemical Society (ACS) has posted the slides from its May 16, 2019, webinar on working safely with nanomaterials in the laboratory.  Chuck Geraci, Associate Director for Emerging Technologies at the National Institute for Occupational Safety and Health (NIOSH), moderated a panel including:

  • Ken Kretchman, Director of Environmental Health Safety, North Carolina State University;
  • Craig Merlic, Professor of Chemistry, University of California, Los Angeles (UCLA); and
  • Debbie Decker, Safety Manager, Department of Chemistry, University of California (UC), Davis.

The panel members discussed the importance of managing products containing nanomaterials by integrating them into an existing lab safety program.  They highlighted the importance of a strong safety culture that is created and maintained by bench scientists who champion appropriate safety practices.  Free resources for nanotechnology laboratory safety are available on the National Nanotechnology Initiative (NNI) website.