Nano and Other Emerging Chemical Technologies Blog

Nano and Other Emerging Chemical Technologies Blog

Regulatory & legal developments involving nano and other emerging chemical technologies

Registration Opens for NNI Webinar on Nanotechnology-Related Standards

Posted in Federal, Research, United States

Registration has opened for the National Nanotechnology Initiative’s (NNI) July 9, 2019, webinar, “Nanotechnology-Related Standards: Availability and Applications.”  According to NNI, the development and use of nanotechnology-related standards is critical to ensuring validated measurements and methods to specify nanomaterial-containing products.  NNI states that standards are also necessary for comparative evaluation and assessment of the environmental, health, and safety effects of nanomaterials (nanoEHS).  The webinar will discuss existing and ongoing standards efforts and will highlight case studies from industry and government on how these standards are being applied and supporting nanoEHS research and safer product design.  The webinar will also discuss how interested stakeholders can engage in these efforts.  Dr. Ajit Jillavenkatesa, National Institute of Standards and Technology, will moderate.  Speakers will include:

  • Mark Ballentine, U.S. Army Corps of Engineers;
  • Scott Brown, The Chemours Company; and
  • Katherine Tyner, U.S. Food and Drug Administration (FDA).

EC JRC Contributes to OECD Test Guidelines for Nanomaterials

Posted in International, OECD, Research

The European Commission’s (EC) Joint Research Center (JRC) published a press release on June 6, 2019, regarding its contribution to the Organization for Economic Cooperation and Development’s (OECD) development of Test Guidelines for the safety assessment of nanomaterials.  According to the press release, scientists from JRC have actively participated in discussions of the OECD’s Working Party on Manufactured Nanomaterials (WPMN) since early on.  The press release states that the OECD Working Group of the National Coordinators of the Test Guidelines Program (WNT) is responsible for the final development, discussion, and adoption of Test Guidelines, and JRC “plays an important role as a link between WPMN and this group.”  JRC notes WPMN’s work regarding Test Guidelines includes:

  • Four new Test Guidelines and five guidance documents currently being developed that address the characterization of nanomaterials, their possible fate in the environment, and possible genotoxic effects;
  • Six more new proposals approved for development in April 2019 that will address environmental fate or possible sensitization effects; and
  • Discussion and preparation of eight additional proposals for Test Guidelines or guidance documents addressing possible effects on human health and the environment.

More information is available in an article in the June 2019 issue of Regulatory Toxicology and Pharmacology, “Developing OECD test guidelines for regulatory testing of nanomaterials to ensure mutual acceptance of test data.”

New York Further Delays Enforcement of Household Cleansing Product Information Disclosure Program

Posted in Legal/Regulatory Issues, State, United States

On June 12, 2019, the New York State Department of Environmental Conservation (NYSDEC) announced that it will delay enforcement of the Household Cleansing Product Information Disclosure Program (Disclosure Program) from July 1, 2019, to January 1, 2020. NYSDEC states in the June 12, 2019, Environmental Notice Bulletin that it will begin enforcing any violations of the required disclosure as of January 2, 2020. According to the notice, NYSDEC “will continue to work with any manufacturers on the design of their websites, or entertain any questions regarding compliance with website design or safety data sheets.” NYSDEC “remains committed to working with the manufacture[r]s to implement this program in the best manner possible.”

As reported in our January 23, 2019, blog item, NYSDEC previously announced a three-month delay in its enforcement of the Disclosure Program from July 1, 2019, to October 1, 2019. As reported in our June 8, 2018, blog item, the Disclosure Program requires manufacturers of cleaning products sold in New York to disclose chemical ingredients and identify any ingredients that appear on authoritative lists of chemicals of concern on their websites. According to the Disclosure Program Certification Form and Program Policy, for each ingredient that is a nanoscale material, a term describing the nanoscale material should be disclosed. For example, if the nanoscale material is carbon, the disclosure should use the term “nanoscale” carbon. NYSDEC’s Program Policy states that a nanoscale material “is a chemical substance that meets the [Toxic Substances Control Act (TSCA)] definition of a reportable chemical substance manufactured or processed at the nanoscale. That definition provides, in part, that a ‘reportable chemical substance is a chemical substance as defined in Section 3 of TSCA that is solid at 25° C and standard atmospheric pressure, that is manufactured or processed in a form where any particles, including aggregates and agglomerates, are in the size range of 1-100 nanometers in at least one dimension, and that is manufactured or processed to exhibit unique and novel properties because of its size. A reportable chemical substance does not include a chemical substance that is manufactured or processed in a form where less than 1% of any particles, including aggregates, and agglomerates, measured by weight are in the size range of 1-100 nanometers.’”

More information regarding the Disclosure Program and the previous enforcement delay is available in Bergeson & Campbell, P.C.’s January 14, 2019, memorandum, “NYDEC Delays for Three Months Enforcement of its Household Cleansing Product Information Disclosure Program.”

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.