Nano and Other Emerging Chemical Technologies Blog

Nano and Other Emerging Chemical Technologies Blog

Regulatory & legal developments involving nano and other emerging chemical technologies

EUON Updates Website, Adds Two Searchable Databases

Posted in International, Legal/Regulatory Issues, Research

On June 11, 2018, the European Observatory for Nanomaterials (EUON) announced that its website now features the following two searchable databases, NanoData and eNanoMapper:

  • NanoData: Contains data on different products, research projects, publications, patents, and companies, and helps users to visualize statistics through built-in charts and graphs.  The data can also be filtered by different sectors and geographic location.  The database can be used for example by consumers interested in finding out about products that use nanotechnology.
  • eNanoMapper: Gives access to one of the largest data sources currently available on the toxicological properties of nanomaterials.  The data originates from several research projects, including the results of the European Union (EU)-funded NanoREG project.  The eNanoMapper can be used to find toxicological data on specific nanomaterials.

EUON states that it has also revamped its home page with more dynamic content, including the latest news on nanomaterials and nanotechnology from the web.  The update includes new information about nanomaterials within the EU regulatory framework, how they are used in different sectors, such as food, medicine, and environmental research, and how to use nanomaterials safely at work.

New York Household Cleansing Product Disclosure Program Will Require Disclosure of Nano Ingredients

Posted in Legal/Regulatory Issues, State

As reported in our June 7, 2018, memorandum, the New York State Department of Environmental Conservation (NYSDEC) on June 6, 2018, released its final policy and form for manufacturer disclosures under the Household Cleansing Product Information Disclosure Program.  The Household Cleansing Product Information 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 Household Cleansing Product Information 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.’”

According to the response to comments, a commenter suggested that NYSDEC delete the definition of nanomaterial, as “no unified determination of the definition of nanomaterial exists.”  NYSDEC responded that the U.S. Environmental Protection Agency (EPA) “requires disclosure of nanoscale materials under TSCA.  In doing so, they have created a definition for what is considered a nanoscale material.”  NYSDEC updated the Program Policy “to harmonize with this EPA definition.”  Another commenter stated that the requirement to disclose nanomaterials should be removed, and that NYSDEC should rely on TSCA/the Frank R. Lautenberg Chemical Safety for the 21st Century Act.  NYSDEC responded that “[t]he requirement to disclose nanoscale materials is important as the potential human health and environmental effects of such substances are not yet fully understood.  However, the disclosure of this information is subject to [confidential business information (CBI)] claims.”

NYSDEC has mischaracterized EPA’s one-time reporting rule as a disclosure program, and suggested that the definition used by EPA for the purposes of this one-time reporting rule applies to other TSCA regulations.  As noted in our memorandum, the scope of the New York Cleansing Products Disclosure Program may be just the beginning of many more product lines to be subject to disclosure.  That these “ingredient disclosure” programs are beginning to populate the commercial landscape is likely to be cause for concern by product manufacturers.  New York may simply be the first state to use the TSCA Section 8(a) reporting rule’s definition of a reportable chemical substance for its own purposes.

ISO Standard Analyzes Nano-Objects Using Asymmetrical-Flow and Centrifugal Field Flow Fractionation

Posted in International, Research

In June 2018, the International Standardization Organization (ISO) published standard ISO/TS 21362:2018, “Nanotechnologies — Analysis of nano-objects using asymmetrical-flow and centrifugal field-flow fractionation.”  The document identifies parameters and conditions, as part of an integrated measurement system, necessary to develop and validate methods for the application of asymmetrical-flow and centrifugal field-flow fractionation to the analysis of nano-objects and their aggregates and agglomerates dispersed in aqueous media.  According to ISO, in addition to constituent fractionation, analysis can include size, size distribution, concentration, and material identification using one or more suitable detectors.  The standard provides general guidelines and procedures for application, and specifies the minimal reporting requirements necessary to reproduce a method and to convey critical aspects.

OECD Tour de Table Reports on Developments on Safety of Manufactured Nanomaterials

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

The Organization for Economic Cooperation and Development (OECD) published a May 17, 2018, document entitled Developments in Delegations on the Safety of Manufactured Nanomaterials — Tour de Table.  The document compiles information provided by delegations for the February 2018 OECD Working Party on Manufactured Nanomaterials (WPMN) meeting on current developments on the safety of manufactured nanomaterials.  It aims to summarize relevant information on activities related to manufactured nanomaterials, as well as other activities on nanotechnologies at the international level.  The reported developments include:

  • Canada is currently developing a risk assessment framework that will be used to guide environmental and human health risk assessment of prioritized nanomaterials in commerce. Expert consultations on the draft framework are planned for 2018;
  • As part of its evaluation of the Danish Nanoproduct Register, Denmark is checking how neighbor countries are following the use of nanomaterials on their national markets. The results of this study were expected to be publicly available in the beginning of 2018;
  • In 2018, the French National Institute for Industrial Environment and Risks (INERIS) will conduct studies on environmental toxicology guidance values for titanium dioxide, cerium oxide, and nano silver. The French Agency for Food, Environmental and Occupational Health and Safety (ANSES) intended to begin in March 2018 the substance evaluation process for titanium dioxide listed on the European Chemical Agency’s (ECHA) Community Rolling Action Plan (CoRAP);
  • In 2017, the German Environment Agency (UBA) and the German Federal Institute for risk assessment (BfR) started a substance evaluation of zinc oxide, in particular the nanoforms of zinc oxide, as listed on CoRAP;
  • The Dutch Ministry of Infrastructure and Water Management, in close collaboration with the Dutch National Institute for Public Health and the Environment (RIVM), will organize a policy conference to establish a common European Union (EU) agenda on how to create a future-proof approach to nanomaterials, based on the recommendations of the ProSafe White Paper and related to ongoing or new initiatives in the field of nanosafety with an emphasis on the regulatory context;
  • Under Section 5 of the Toxic Substances Control Act (TSCA), the U.S. Environmental Protection Agency (EPA) reviewed TSCA premanufacture notices for four quantum dots and a single-walled carbon nanotube. Based on potential risk findings to human health and the environment, EPA issued consent orders and/or significant new use rules (SNUR) for all of these materials.  EPA also reviewed low volume exemptions for five quantum dots and four nanodiamond substances.  EPA allowed the exemptions under conditions that limited human and environmental exposures to prevent unreasonable risks.  The deadline for reporting existing nanoscale materials in commerce is August 14, 2018;
  • In collaboration with the Thailand Industrial Standard Institute (TISI), Thailand proposes to initiate five additional industrial standardization manuals related to nanotechnology by 2021:
    • Guidance on voluntary labelling for consumer products containing manufactured nano-objects;
    • Standard guide for size measurement of nanoparticles using atomic force microscopy;
    • Preparation of material safety data sheets (MSDS) for nanomaterials;
    • Occupational risk management applied to engineered nanomaterials — Part 1: Principles and approaches; and
    • Occupational risk management applied to engineered nanomaterials — Part 2: Use of the control banding approach).

OECD Assesses Biodurability of Nanomaterials and Their Surface Ligands

Posted in International, OECD, Research

The Organization for Economic Cooperation and Development (OECD) has published a May 22, 2018, report entitled Assessment of Biodurability of Nanomaterials and their Surface ligands.  The purpose of the report was to compile the relevant information on the biodurability of the pristine and functionalized nanomaterials in biological and environmental media in vitro and in vivo, as well as describing methods for measuring the stability and halftimes of nanomaterials.  The report presents the in vitro and in vivo systems that are used to measure biodurability in biological and environmental systems for the pristine nanomaterials of the OECD Sponsorship Program.  In addition, the report describes the effect of the physicochemical properties of these nanomaterials and the properties of the biological and environmental media, as well as surface coating and ligands on their dissolution and biodegradation.  Nanomaterials with low dissolution rates include titanium dioxide and cerium oxide, and because of their primary genotoxicity, it was proposed that their responses after long-term exposure be further evaluated due to their accumulation in systemic organs.  Nanomaterials with high dissolution rates include zinc oxide, copper oxide, and quantum dots that release zinc, copper, or cadmium ions, respectively, and induce severe toxicity.  Those that have not yet been investigated for their biodurability either through dissolution or biodegradation include dendrimers, nanoclays, and aluminum oxide nanoparticles.  Those nanomaterials with dissolution rates are not biodurable and hence may cause short-term toxicity and health effects, as opposed to those with slow dissolution rates that are biodurable and hence may cause both short- and long-term health effects and show high environmental persistency.  The report recommends that the existing identified in vitro and in vivo standard techniques be validated in relation to their ability to predict the pathogenic potential and environmental persistence of nanomaterials to increase the predictive potential of these tests.

EUON Reports on Nordic Information Campaign on REACH-Relevant Regulation for Nanomaterials

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

On May 23, 2018, the European Union Observatory for Nanomaterials (EUON) published an article entitled “Nordic information campaign on REACH-relevant regulation for nanomaterials.”  According to EUON, Norway, Sweden, Finland, and Denmark are coordinating an information campaign through the N-Nano project group of the Nordic Chemical Working Group of the Nordic Council of Ministers.  The goal of the campaign is to develop a web-based tool to provide information on European Union (EU) chemical legislation requirements for nanomaterials, such as preparing a Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) registration for nanomaterials.  The tool, which will be available in English, will focus on small- and medium-sized companies that may not have sufficient in-house expertise on regulations covering nanomaterials.  EUON states that the tool is mainly based on the current version of REACH and will include a summary of:

  • The definition of nanomaterials;
  • The types of nanomaterials;
  • An overview of nanomaterial-specific annexes to existing REACH guidance;
  • The chemical and physical characterization of nanomaterials;
  • Data and testing of nanomaterials; and
  • Exposure and risk.

The information campaign is expected to be completed by the end of 2018.

ECHA Interviews KEMI Regarding Nano Reporting Requirement

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

The May 2018 ECHA Newsletter includes an interview with Robert Johansson, Head of the Swedish Chemicals Agency’s (KEMI) Chemical Statistics and Registries Unit.  As reported in our December 7, 2017, blog item, KEMI has established a mandatory reporting scheme to obtain information on the quantities and types of nanomaterials used in Sweden, with the first reports due in February 2019.  According to Johansson, “[t]his information can then provide a basis for making changes to legislation or taking other measures regarding nanomaterials, in areas such as healthcare, the environment or workplace safety.”  The article provides the following list of actors required to notify if their products contain nanomaterials:

  • Professional manufacturers or importers of chemical products and biotechnical organisms;
  • Those who, in their own name, package, repackage, or change the names of chemical products or biotechnical organisms for further distribution;
  • Those who make mixtures of chemical products and biotechnical organisms for further distribution;
  • Manufacturers or importers of notifiable chemical pesticides; and
  • Third parties that report the products on behalf of the manufacturers or importers.

According to the article, Kemi expects to receive between 900 and 2,600 notifications.  The current reporting requirements include exemptions for nanomaterials that occur naturally or are accidentally produced, as well as nanomaterials used as pigments.  Johansson notes that these figures are somewhat uncertain and are based in part on a study made at the European Union (EU) level.  The article offers tips for other countries planning to establish a national registry.  Johansson suggested that when setting up a national registry, it should “be planned together with different stakeholders, taking into account their views and needs during the entire process.”

NICNAS Case Studies Provide Guide to Categorizing Chemicals under New Scheme

Posted in International, Legal/Regulatory Issues

On May 16, 2018, the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) announced the availability of six case studies intended to help stakeholders understand how the categorization process for new industrial chemicals will work under the new Australian Industrial Chemicals Introduction Scheme (AICIS).  The case studies cover typical scenarios for introducing cosmetic and non-cosmetic new chemicals, and show how introducers would categorize chemicals as exempted or reported under the new scheme.  The case studies include checklists of the information needed for categorization; a summary and walk through of the steps to categorize the chemical introduction; and an explanation of what happens next and a brief comparison for the same introduction under the current legislation.  NICNAS provides the following case studies:

  1. Low concentration (non cosmetic);
  2. High volume lower hazard (non cosmetic);
  3. High molecular weight polymer (non cosmetic);
  4. Very low volume, no hazard information available (cosmetic);
  5. Low concentration (cosmetic); and
  6. High volume surfactant (cosmetic).

The first checklist, essential information requirements, includes whether the chemical is considered to be at the nanoscale and meets certain criteria.  In each of the six case studies, the answer is no.  The first step to categorizing the chemical is whether the introduction is a type that cannot be “exempted” or “reported.”  This includes the introduction of certain industrial chemicals at the nanoscale, and the introduction of such would likely be an assessed introduction.  Step three is whether the introduction is a type that is automatically “reported,” and this includes the introduction of an industrial chemical at the nanoscale that is solely for use in research and development.  The fourth case study, very low volume, no hazard information available (cosmetic), notes that under the current legislation, introduction of the chemical under the same circumstances would require a cosmetic ≤ 10 kilograms per year no unreasonable risk exemption that would include determining whether the chemical is a type of chemical that NICNAS advises is unsuitable for exemption such as a nanomaterial.  As reported in our March 26, 2018, blog item, NICNAS has begun a public consultation on several draft documents that, together with the Industrial Chemicals Bill 2017, will form the new AICIS.  NICNAS has extended the May 4, 2018, comment deadline to May 31, 2018.

Report Available on March 2018 EUON Stakeholder Dialogue Meeting

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

The European Union Observatory for Nanomaterials (EUON) has posted the workshop report from the March 9, 2018, Stakeholder Dialogue meeting.  According to the report, the annual meeting focused on providing an update on EUON and allowing stakeholders an opportunity to share their views on expectations on the future development of EUON.  During his welcome address, Jukka Malm, European Chemicals Agency (ECHA), acknowledged that some stakeholders preferred a mandatory register for nanomaterials instead of an observatory.  Malm reminded stakeholders that the meeting should “focus on how to best work together to make EUON more useful within existing limitations.”  According to Abdel Sumrein, ECHA, EUON intends to launch two databases in June 2018, eNanoMapper and NanoData.  Sumrein described the possible future integration of national inventories on nanomaterials to EUON.  Sumrein stated that studies on pigments and on EU markets are expected to be published in May 2018.  Georgios Katalagarianakis, European Commission (EC), RTD, explained EU nano safety research policy, highlighting the Nano Safety Cluster and stressing the importance for research to match with regulatory objectives.  Monique Groenewold, National Institute for Public Health and the Environment (RIVM), offered an EU Member State’s view of what EUON should deliver to regulators, including transparency, traceability, monitoring, knowledge of what is on the market, and user-friendly and easily accessible databases to understand the risks.  Groenewold stated that it is key to continue urging the EC to provide necessary preconditions such as an update to the Annexes of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation; a harmonized and unequivocal EU definition of nanomaterials; and future financial commitment of the EC.  Damien De Geeter, French Ministry for an Ecological and Solidary Transition, discussed the lessons learned from the French national register for nanomaterials.  According to De Geeter, limited access to the data in the register was given only to French regulatory and research agencies due to confidentiality concerns, and the data are being used for risk assessment and exposure on a national level.  Aida Ponce del Castillo, European Trade Union Institute (ETUI), gave a presentation outlining five key development proposals on the regulatory governance of nanomaterials:  make information about nanomaterials public and visible; prioritize nanoforms; establish mandatory safety data sheets (SDS) for nanoforms; include labeling of nanomaterials in the same way as for cosmetics; and compile and harmonize data from national registries and disseminate it through EUON.  Claire Skentelbery, Nanomaterials Industry Association (NIA), addressed industry expectations for EUON and how industry can contribute.  Skentelbery’s suggestions for further developing EUON to meet industry needs include case studies on nanomaterials and nano-enabled product development, nano safety assessment tools linked to databases, links to standards for nanomaterials assessments, and a calendar of events where EUON is present as an umbrella for nanotechnology forums or topics.

Lynn L. Bergeson Will Speak at 17th NanoBusiness Commercialization Association Conference

Posted in United States

The NanoBusiness Commercialization Association (NanoBCA) will hold its 17th annual conference on June 14, 2018, in Washington, D.C.  Speakers will include Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C., as well as:

  • Jim Phillips, Chairman and Chief Executive Officer (CEO), NanoMech Corporation;
  • Doyle Edwards, Director, Government Programs, Brewer Science;
  • Marco Curreli, Ph.D., Executive Director and Founder, Omni Nano;
  • Lisa Friedersdorf, Director, National Nanotechnology Coordination Office;
  • Penelope Salmons, President, Fibrtec Inc.;
  • Carleton JC Hsia, Ph.D., Chairman and CEO, AntiRadical Therapeutics LLC;
  • Anis Rahman, Ph.D., President/Chief Technology Officer CTO, Applied Research & Photonics, Inc.; and
  • A representative from the Federal Bureau of Investigation (FBI).

Registration is available online.