Nano and Other Emerging Chemical Technologies Blog

Nano and Other Emerging Chemical Technologies Blog

Regulatory & legal developments involving nano and other emerging chemical technologies

ECHA Announces Signed Agreement for EU Observatory for Nanomaterials

Posted in International, Legal/Regulatory Issues

On December 7, 2016, the European Chemicals Agency (ECHA) announced the signing of a delegation agreement between ECHA and the European Commission (EC) on the European Union Observatory for Nanomaterials (EU-ON).  According to ECHA, the information sources for the EU-ON will include data generated by various pieces of EU legislation regulating the safe use of nanomaterials (e.g., the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation, biocides, and cosmetics), as well as national inventories, research projects, and market studies.  ECHA states that in its first phase, the EU-ON “will only collect information that is already available and not generate any new data.”  ECHA will develop the EU-ON in three phases.  The first phase will explain what nanomaterials are and how they are used.  It will also address safety issues and contain links to research projects.  ECHA intends the first phase to go live in summer 2017.  Later phases include search functionalities and more detailed product information.  ECHA notes that the EC concluded that the EU-ON would be the best tool to increase transparency on nanomaterials on the EU market.  While the EC considered an EU-wide registry, the EC “considered that such a registry would be too costly for both industry and authorities.”

Obama’s Actions to Promote American Entrepreneurship Include Supporting Nanotechnology Industry

Posted in Federal, United States

On November 30, 2016, the White House published a blog item, “President Obama’s Top Ten Actions to Accelerate American Entrepreneurship,” and posted a fact sheet on President Obama’s entrepreneurship accomplishments.  The tenth action is “Unleashed entrepreneurship in the industries of the future, including clean energy, biotechnology, the commercial space industry, nanotechnology, drones, robotics, advanced manufacturing, and more.”  The fact sheet lists several National Nanotechnology Initiative (NNI) programs and states that the NNI invested over $150 million per year in user facilities at federal laboratories and universities that provide entrepreneurs low- or no-cost access to state-of-the-art instrumentation.  NNI also cumulatively funded more than $700 million of nanotechnology-related research by small businesses.  In addition, NNI catalyzed the creation of a Nano and Emerging Technology Student Network and annual conference with a specific goal of promoting entrepreneurship.

Registration Open for Webinar on “Water Sustainability through Nanotechnology: Increasing Water Availability”

Posted in Federal, United States

Registration is now open for a December 7, 2016, National Nanotechnology Initiative (NNI) webinar, “Water Sustainability through Nanotechnology:  Increasing Water Availability.”  NNI states that water demand in the U.S. is projected to increase over the next several decades.  In addition to increased demand, many U.S. aquifers are being depleted at unsustainable rates, which may lead to increased challenges in locating usable water sources in the future.  During the webinar, panelists Qilin Li (Rice University), Isabel Escobar (University of Kentucky), and David Mazyck (University of Florida) will describe current technologies and future opportunities related to water treatment and purification.  The speakers will address filtration and membrane separation systems, catalysis, and alternatives to reverse osmosis.  Webinar viewers will be able to submit questions for the panelists to answer during the question and answer period.  Submitted questions will be considered in the order received and may be posted on the NNI website.

Australian Draft National Standard for the Environmental Risk Management of Industrial Chemicals Addresses Nanomaterials

Posted in International, Legal/Regulatory Issues

On November 24, 2016, the Australian Department of the Environment and Energy began a public consultation on the Draft National Standard for the Environmental Risk Management of Industrial Chemicals and a supporting Draft Explanatory Document.  According to the Department, the primary purpose of the papers is to outline the design and operation of the National Standard.  The Draft National Standard contains risk management measures applicable for each Environment Schedule under the Standard.  The Draft Explanatory Document provides supporting information for the scheduling criteria and risk management measures and outlines the processes that will support decision-making under the Standard.  The National Standard will apply to all industrial chemicals, and is intended to fill a gap identified for the environmental management of industrial chemicals.  Therefore, the Draft National Standard does not explicitly manage risks to human health.  The Draft National Standard categorizes industrial chemicals into one of seven Environment Schedules depending on their level of concern to the environment.  Chemicals will be considered to be low, intermediate, or high concern to the environment, and management responses will be proportionate to this level of concern.  The Draft National Standard defines a nanomaterial as “a material intentionally produced, manufactured or engineered to have unique properties or specific composition at the nanoscale, that is a size range typically between 1 nm and 100 nm, and is either a nano-object (i.e. that is confined in one, two, or three dimensions at the nanoscale) or is nanostructured (i.e. having an internal or surface structure at the nanoscale).”  Chemicals of intermediate concern categorized into Schedule 3 (hazardous, moderate risk substances) would include substances that “have other characteristics that may result in adverse short or long term effects on the environment.”  A footnote states that these characteristics are “e.g. nanomaterials, persistent substances that may have adverse effects on the environment as they accumulate such as chemicals exhibiting endocrine activity but are not identified endocrine disruptors, or chemicals with Global Warming Potential.”  The Draft Explanatory Document includes an explanation of questions in the categorization decision trees.  Question 10 is whether there is evidence to suggest that the substance has other characteristics that may result in adverse short- or long-term effects on the environment.  The answer notes that, in some circumstances, substances may not be hazardous through toxicity or bioaccumulation, “but may have other characteristics that may result in short or long term effects on the environment.  These substances currently have unquantifiable risks, but there is evidence to suggest their presence in the environment may have possible adverse effects.”  The Draft Explanatory Document includes nanomaterials in this category.  According to the Draft Explanatory Document, substances in this category that are otherwise not identified as hazardous (at least harmful, bioaccumulative, perfluorinated, or endocrine-disrupting) will be recommended for inclusion in Environment Schedule 3.  The Document states:  “This will enable release to the environment to be managed appropriately and include the potential for a watching brief to ensure a change in circumstances is reported.  This category will also have the potential to be reviewed to include substances with emerging but yet unquantifiable risks to the environment.”  Comments on the Draft National Standard are due March 3, 2017.

Company Announces First REACH Registration of Single Wall Carbon Nanotubes

Posted in International

On October 13, 2016, OCSiAl announced that it is the first manufacturer of single wall carbon nanotubes (SWCNT) to complete Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) registration.  According to OCSiAl, the registration was successfully completed thanks to the collaboration between OCSiAl’s Health and Safety Department, Envigo, and Intertek, which jointly completed the work involved in demonstrating compliance with the standards and requirements of REACH.  Envigo’s press release states that scientists at OCSiAl, Envigo, and Intertek collaborated to research and test the potentially hazardous properties of SWCNTs.  These efforts resulted in a technical and highly detailed analysis of SWCNTs and their nature and potential risks, as well as specifications for particular methods of risk management.

 

ISO Standard Provides Overview of Frameworks for Developing OELs and OEBs for NOAAs

Posted in International, Occupational Health and Safety Issues

On November 21, 2016, the International Organization for Standardization (ISO) released ISO/TR 18637:2016, “Nanotechnologies — Overview of available frameworks for the development of occupational exposure limits and bands for nano-objects and their aggregates and agglomerates (NOAAs).”  ISO notes that occupational exposure limits (OEL) are generally substance-specific.  In some case, there is insufficient data to develop an OEL, especially for substances such as nano-objects and their aggregates and agglomerates (NOAA) used in emerging technologies.  Under hazard banding, substances are assigned to a hazard band based on limited toxicity data.  ISO states that to date, few OELs and occupational exposure bands (OEB) have been developed for specific NOAAs and none have been formally regulated by a government agency.  One of the goals of the document is to identify both the similarities and differences in the methods used to develop OELs.  ISO notes that the exposure assessment of nanomaterials, including carbon nanomaterials (such as fullerene, graphene, single-walled carbon nanotubes, and multi-walled carbon nanotubes), metal oxides (titanium dioxide, silicon dioxide, zinc oxide, iron oxide), and metals (silver and gold nanoparticles), remains a challenge in the field of occupational hygiene, as there have been relatively few studies on the characterization of workplace exposures to NOAA.  The primary target audience of the document is occupational safety and health professionals in government, industry, and academia, who have the expertise to develop OELs or OEBs based on the document’s guidance.

SCCS Opinion on Additional Coatings for Titanium Dioxide (Nano Form) as UV-Filter Available for Comment

Posted in International

On November 22, 2016, the European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) began a public consultation on its opinion on additional coatings for titanium dioxide (nano form) as an ultraviolet (UV)-filter in dermally applied cosmetic products.  The EC asked if SCCS considered safe the use of cetyl phosphate, manganese dioxide, and triethoxycaprylylsilane as coatings for titanium dioxide (nano) used as a UV-filter in dermally-applied cosmetic products.  SCCS concluded that the use of the three titanium dioxide nanomaterials coated with either cetyl phosphate, manganese dioxide, or triethoxycaprylylsilane can be considered safe for use in cosmetic products intended for application on healthy, intact, or sunburned skin.  SCCS notes that this does not apply to applications that might lead to exposure of the consumer’s lungs to the titanium dioxide nanoparticles through the inhalation route (such as powders or sprayable products), however.  The EC also asked if SCCS has any further scientific concerns regarding the use of these coatings for titanium dioxide (nano) used as UV-filter in dermally-applied cosmetic products.  SCCS states that the ingredients used in some types of products (e.g., in lipsticks) may be incidentally ingested.  SCCS cautions that the potential harmful effects of manganese dioxide should, therefore, be taken into account if the manganese dioxide-coated nanomaterials are to be used for applications that could lead to oral ingestion.  SCCS may consider revising its assessment if new evidence emerges to show that titanium dioxide nanoparticles used in a sunscreen formulation can penetrate skin (healthy, compromised, or damaged skin) to reach viable cells.  SCCS notes that its opinion does not consider the potential ecotoxicological impacts of nanoscale titanium dioxide when released into the environment.  Comments on the opinion are due January 17, 2017.

FDA CDER Identifies Nanotechnology as Area of Interest for Site Visit Training Program for OPQ Staff

Posted in Federal, Legal/Regulatory Issues, United States

The Food and Drug Administration (FDA) published a Federal Register notice on November 16, 2016, announcing the 2017 Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Quality (OPQ) Staff Experiential Learning Site Visit Program.  According to the notice, “[a] critical part of the commitment by CDER to make safe and effective high-quality drugs available to the American public is gaining an understanding of all aspects of drug development and a drug’s commercial life cycle, including the variety of drug manufacturing operations.”  The Site Visit Program is intended to offer experiential and firsthand learning opportunities that will provide OPQ staff with a better understanding of the pharmaceutical industry and its operations, as well as of the challenges that impact a drug’s development program and commercial life cycle.  CDER invites pharmaceutical companies interested in participating in the Program to submit a site visit proposal.  The notice states that while observation of all aspects of drug development and production would be beneficial to OPQ staff, OPQ identified a number of areas of interest to its staff, including emerging technologies such as nanotechnology.  Selection of potential facilities will be based on the priorities developed for OPQ staff training, the facility’s current regulatory status with FDA, and on consultation with the appropriate FDA district office.  Proposals are due January 17, 2017.

Germany Publishes Action Plan Nanotechnology 2020

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

The Federal Ministry of Education and Research (BMBF) recently published an English version of its Action Plan Nanotechnology 2020.  Based on the success of the Action Plan Nanotechnology over the previous ten years, the federal government will continue the Action Plan Nanotechnology for the next five years.  Action Plan Nanotechnology 2020 is geared towards the priorities of the federal government’s new “High-Tech Strategy” (HTS), which has as its objective the solution of societal challenges by promoting research.  According to Action Plan Nanotechnology 2020, the results of a number of research projects “have shown that nanomaterials are not per se linked with a risk for people and the environment due to their nanoscale properties.”  Instead, this is influenced more by structure, chemical composition, and other factors, and is thus dependent on the respective material and its application.  Action Plan Nanotechnology 2020 states that the results from risk research “will be introduced into regulations in all relevant areas, such as occupational, consumer and environmental law.”  Germany will continue the work already begun on analytical verifiability of existing legal regulations concerning nanomaterials since standardized instrumental and analytical methods for exposure assessment and routine control are still largely lacking.  According to Action Plan Nanotechnology 2020, Germany is committed to continuing with the development and adaptation of the Organization for Economic Cooperation and Development (OECD) test guidelines to create the prerequisite for comparability of international research results.

ISO Publishes Measurement Technique Matrix for Characterization of Nano-Objects

Posted in Research

The International Organization for Standardization (ISO) recently published ISO/TR 18196:2016, “Nanotechnologies — Measurement technique matrix for the characterization of nano-objects.”  The document provides a matrix intended to guide users to commercially available techniques relevant to the measurements of common physiochemical parameters for nano-objects.  Some techniques are also applicable to nanostructured materials.  As scientific advances are made and additional commercial measurement techniques become available, ISO will periodically review and update the document to maintain its relevance.  ISO notes that many of the listed techniques have not been validated through round-robin testing or any other means for the measurement of nano-objects.  ISO states that the document “is intended as a starting point and resource to help identify potentially useful and relevant techniques; it is not an exhaustive or primary source.”  ISO recommends that once a technique has been identified, the reader refer to relevant international standards and conduct a literature search for similar or comparable applications.  Other sources of information include instrument manufacturer’s applications notes and technical literature.