Nano and Other Emerging Chemical Technologies Blog

Nano and Other Emerging Chemical Technologies Blog

Regulatory & legal developments involving nano and other emerging chemical technologies

Charles Geraci Receives NIOSH Director’s Distinguished Career Scientist Award

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

On April 27, 2017, Dr. Charles Geraci, Associate Director for Nanotechnology at the National Institute for Occupational Safety and Health (NIOSH), received the Director’s Distinguished Career Scientist Award.  Dr. Geraci provides overall strategic guidance to the nanotechnology research program at NIOSH and is recognized internationally for his leadership in the field.  Dr. Geraci has more than 40 years of industrial hygiene practice experience.  He brings to NIOSH a unique blend of skills that he developed through his public and private sector professional practice.  Dr. Geraci has made major contributions in the form of developing policy documents, refining research methods, developing field investigation strategies, and directly applying research outputs to effective worker health and safety approaches needed to develop emerging technologies responsibly.  He serves as a subject matter expert on various national and international panels and advisory boards, including representing NIOSH on the U.S. National Nanotechnology Initiative and the Sub-Committee on Advanced Manufacturing.  Dr. Geraci is also active on the International Organization for Standardization Technical Committee 229 on Nanotechnology, as well as the Organization for Economic Cooperation and Development (OECD) Working Party on Manufactured Nanomaterials, and serves on the executive committee of the American Industrial Hygiene Association Nanotechnology Working Group.  Speaking for all in the nano community, the honor is richly deserved as Dr. Geraci’s service to the community and his scholarship and leadership are without equal.

Nanosensor Manufacturing Workshop Will Be Held in June

Posted in Federal, United States

On June 13-14, 2017, a “Nanosensor Manufacturing Workshop:  Finding Better Paths to Products” will be held at the National Science Foundation in Arlington, Virginia.  The Workshop supports the goals of the National Nanotechnology Initiative’s (NNI) Nanotechnology Signature Initiative, “Nanotechnology for Sensors and Sensors for Nanotechnology.”  According to NNI, the Workshop will identify key elements needed to achieve production-scale manufacturing of nanotechnology-enabled sensors.  The first day of the Workshop will survey the ecosystem for taking a nanosensor from the research lab to production and examine important issues related to manufacturing, such as fabrication, testing, and product performance.  The second day will include an interactive “scrimmage” in which participants will walk through a hypothetical scenario, such as engaging a contract manufacturer to produce a sensor.  NNI states that “attendance will be limited to encourage robust discussion, and participants will be invited from a wide range of sectors and application areas.”  NNI will webcast the Workshop.  According to NNI, the Workshop will culminate in a publicly available report and may inform future research priorities for achieving scalable manufacturing and commercialization of nanosensors.

EC4safenano Conducts Survey on Demand and Supply of Services for Safe Use of Nanomaterials and Nanotechnology

Posted in International

The European Center for Risk Management and Safe Innovation in Nanomaterials and Nanotechnologies (EC4safenano) states that it wishes to develop a catalog of services matching the anticipated needs and service requirements to the supply of services from different organizations.  It has sent a survey to different stakeholders, including European Union (EU) Member States, the European Commission (EC) and EC agencies, industry, and bodies representing the general public.  Responses will influence the design of EC4safenano and ensure that issues important to stakeholders will be addressed; the catalog of services will be relevant; and services can be provided through EC4safenano.  EC4safenano will be developed over the next three years to bridge the gap between scientific knowledge and daily practice by providing services to help others to manage this new technology safely.  EC4safenano will anonymize and summarize the survey responses in a report that will be made available to all respondents.

NIOSH BSC Meeting Includes Presentation on Nanotoxicology

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

On April 12, 2017, the National Institute for Occupational Safety and Health (NIOSH) Board of Scientific Counselors (BSC) held its 68th meeting.  The BSC’s primary activity is to provide advice on NIOSH’s occupational safety and health research and prevention programs.  The BSC also advises on standards of scientific excellence, current needs in the field of occupational safety and health, and the applicability and dissemination of research findings.  Dr. Jenny Roberts, Nanotechnology Research Center (NTRC) Toxicology and Internal Dose Critical Area Coordinator, gave a presentation on the Nanotoxicology Program.  Roberts ended her presentation with the following questions and challenges regarding NTRC and nanotoxicology “version 2.0” — the second decade of research:

  • What is the next emerging material for investigation;
  • Who is using nanotechnology and nano-enabled materials, and how are they being used:
    • Advanced manufacturing and additive manufacturing; and
  • Entrenched in ‘omics — compiling all the data for use in predictive modeling (in vitro to in vivo, and mode of action) — determining the low effect and no effect dose levels.

NanoMONITOR Demo Version Now Available Online

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

NanoMONITOR, a project partly funded by the European Commission Life+ with grant agreement LIFE14 ENV/ES/000662, is intended to develop a real-time information and monitoring system to support the risk assessment of nanomaterials under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation.  The overall objective of the NanoMONITOR project is to improve the use of environmental monitoring data to support the implementation of REACH and to promote the protection of human health and the environment.  On April 10, 2017, NanoMONITOR announced that a demo version of its web-based application, a distributed client-server system, is now available.  NanoMONITOR states:

The software application will support the import of “historical” monitoring data; the capture of monitoring data from sensors in real-time; real-time QA/QC for data imports, data storage including automatic incremental backup strategies, data  (basic descriptive statistics), graphical display, a range of analytical tools for exposure- and risk analysis,  and the prediction (simulation) of indoor- and ambient concentration (counts and mass based) values, together with data conversion- and export tools, and the management of associated META data (partly structured, partly as free (multi-media data for full text search) for the interpretation of all monitoring data holdings.

Swiss National Research Program Will Hold Closure Event in June

Posted in International, Legal/Regulatory Issues, Research

On June 2, 2017, the National Research Program “Opportunities and Risks of Nanomaterials” (NRP 64) will hold a closure event, parallel to the Swiss Nano Convention, which will be held June 1-2, 2017.  NRP 64 began its research work in December 2010 and has studied the development, use, behavior, and degradation of synthetic nanomaterials, as well as their impact on humans and the environment.  During the closure event, NRP 64 will present the most important findings and current state of the art in nanotechnology research.  NRP 64’s final brochure on the results, outcome, and perspectives provides an overview of the most important highlights, insights, and recommendations to industry and regulatory entities with regard to a “suitable handling of nanomaterials from the point of fabrication, to use in practice, right down to their disposal.”  The final brochure asks which of the two, opportunities or risks of nanomaterials, “wins.”  Peter Gehr, Professor Emeritus of Anatomy and Histology at the University of Berne, President of the NRP 64 Steering Committee, states:

Without a doubt the opportunities.  Synthetic nanomaterials have a scientific, an industrial and a medical-clinical potential that is second to none.  However, market-ready applications are only possible when we are on safe ground, this means we must always keep a keen eye on weighing up the risks.  Credit must be given to the NRP 64 for having enabled us to make this great stride forwards.  We now know where we need further scientific foundations and where further research potential exists.  And we are able to declare that the precautionary matrix put together by the Federal Office of Public Health, which allows industry and trade to weigh up the health and environmental risks of handling nanoproducts, is fit for its purpose at present, and that no further regulations in the sense of restricting application, are needed at present.

EU Addresses the Use of Nanomaterials in Medical Devices

Posted in International, Legal/Regulatory Issues

On April 5, 2017, the European Parliament (EP) approved a regulation on medical devices, as well as a regulation on in vitro diagnostic medical devices.  The EP’s April 5, 2017, press release states that the medical devices regulation is intended to ensure that medical devices are traceable and comply with European Union (EU) safety requirements.  The medical devices regulation addresses the use of nanomaterials in medical devices.  The European Commission’s April 5, 2017, fact sheet states that the critical factor in classifying devices incorporating or consisting of nanomaterials is the potential for nanomaterials to be in contact with membranes inside the body.  Those devices presenting a high or medium potential for such contact will be in the highest risk class and thus be subject to the most stringent conformity assessment procedures.  To allow manufacturers and authorities time to implement the regulations, the regulation on medical devices includes a three-year transition period, and the regulation on in vitro diagnostic medical devices includes a five-year transition period.

Nanodatabase Adds 3,000th Product

Posted in International

The Nanodatabase, developed by the Technical University of Denmark Department of Environmental Engineering (DTU Environment), the Danish Ecological Council, and the Danish Consumer Council, announced on April 4, 2017, that it added product number 3,000.  According to The Nanodatabase, most products fall into the health and fitness category (1,845) while only about one-sixth of the products fall into the home and garden category (555).  Of the 1,845 products in the health and fitness category, a little more than 700 products are personal care products, about 400 are clothing, and approximately another 400 are sporting goods.  The Nanodatabase states that silver is the nanomaterial reported to be used in most products, but for 60 percent of the products, the identity of the nanomaterials was not reported.  The Nanodatabase includes instructions for reporting products.  Individuals should search shop shelves and find products where the word “Nano” appears on the packaging or on the product itself.  Individuals should then:

  1. Note down product name, manufacturer, address and website.
  2. Take a picture of the product.
  3. Check The Nanodatabase to see if the product you have found has already been reported to the Danish Consumer Council.
  4. Fill out the form below.

After The Nanodatabase receives the report, it will contact DTU Environment, which will examine the reported product and in turn authorize its addition.

AIHA Publishes Nanomaterial Stewardship Guidance

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

On March 29, 2017, the American Industrial Hygiene Association (AIHA) announced the availability of nanomaterial stewardship guidance sponsored by the AIHA Nanotechnology Working Group.  The guidance addresses stewardship considerations for nanomaterials and nanoproducts based on the evolving state of the science for human health hazard, exposure, and risk assessment.  The guidance promotes a life cycle approach and safer design principles for particles, production, and products; reviews the regulatory landscape; and provides practical suggestions to help determine the presence of nanoscale ingredients in raw materials from suppliers.  According to the guidance, a whole life cycle approach ensures that potential environmental, health, safety (EHS), and regulatory impacts are:

  1. Considered early in product and process design and development;
  2. Addressed in product design, raw material selection, manufacture (including distribution operations), use (including maintenance), re-use, recycle, and disposal; and
  3. Reassessed periodically and when new information becomes available.

The guidance recommends that product stewards and other EHS professionals:  (1) identify which regulations apply to nanomaterials and nanoproducts for which they are responsible, including state, local, and country regulations; (2) understand the requirements in detail; and (3) closely monitor the regulatory landscape for changes and new requirements potentially affecting commercialization.  The guidance describes challenges to consistent and meaningful hazard communication and understanding of exposure potential.  The guidance states that studies have indicated there is room for improvement regarding the quality and completeness of nanomaterial safety data sheets, including:

  1. Identifying which ingredient(s) is nanoscale, and including size/size range information;
  2. Including known physical-chemical properties, such as nanoparticle shape, density, and solubility; and
  3. Indicating implications if the hazard classification, toxicity data, or occupational exposure limit provided was not derived from nanoscale material.

The guidance includes literature references and links related to nanomaterial stewardship compiled by the authors.

IRSST Publishes Report for Project on Development and Validation of Methods for Sampling and Characterizing Engineered Nanomaterials in Air and on Workplace Surfaces

Posted in International, Occupational Health and Safety Issues, Research

On March 7, 2017, the Institut de recherche Robert-Sauvé en santé et en sécurité du travail (IRSST) published the final report for Project 2013-0059, “The Development and Validation of Methods for Sampling and Characterizing Engineered Nanomaterials in Air and on Workplace Surfaces.”  The report is available in French, but the abstract is available in English.  The main goal was to develop innovative methodological approaches for detailed qualitative and quantitative characterization of workplace exposure to engineered nanomaterials.  IRSST states that the workplace investigations covered a variety of industries (e.g., electronics, manufacturing, printing, construction, energy, and research and development) and included producers as well as users or integrators of engineered nanomaterials.  According to IRSST, it found nanometals or metal oxides, nanoclays, nanocellulose, and carbonaceous materials, including carbon nanofibers and carbon nanotubes.  IRSST states the project helped to advance its knowledge of workplace assessments of engineered nanomaterials by documenting specific tasks and industrial processes (e.g., printing and varnishing), as well as certain “little investigated” engineered nanomaterials, such as nanocellulose.  IRSST proposes a strategy for more accurate assessment of engineered nanomaterials exposure using methods that require a minimum of preanalytical handling:  (1) testing with different direct-reading instruments, as well as sample collection and subsequent microscopic analysis, to identify clearly the work tasks that generate engineered nanomaterials; and (2) once work exposure is confirmed, specific quantification of the engineered nanomaterials detected.