Nano and Other Emerging Chemical Technologies Blog

Nano and Other Emerging Chemical Technologies Blog

Regulatory & legal developments involving nano and other emerging chemical technologies

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.

SCCS Issues Final Opinion on Additional Coatings for Titanium Dioxide (Nano Form) as UV-Filter in Dermally Applied Cosmetic Products

Posted in International

On March 7, 2017, the Scientific Committee on Consumer Safety (SCCS) issued a final opinion on additional coatings for titanium dioxide (nano form) coated with cetyl phosphate, manganese dioxide, or triethoxycaprylylsilane as an ultraviolet (UV)-filter in dermally applied cosmetics.  The conclusion states that given a general lack of dermal absorption and low general toxicity of nano-forms of titanium dioxide, SCCS considers 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 the ingredients used in some types of products (e.g., in lipsticks) may be incidentally ingested.  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.  The opinion 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).  SCCS states that if any new evidence emerges in the future to show that the titanium dioxide nanoparticles used in a sunscreen formulation can penetrate skin to reach viable cells, then it may consider revising this assessment.  SCCS notes that the opinion does not consider the potential ecotoxicological impacts of nano titanium dioxide when released into the environment.  As reported in our March 14, 2017, blog item, SCCS has begun a public consultation on its opinion on titanium dioxide (nano form) as UV-filter in sprays.  The public consultation will end May 14, 2017.

CRS Report on Science and Technology Issues in the 115th Congress Includes Nanotechnology and the NNI

Posted in Federal, Research, United States

The Congressional Research Service (CRS) prepared a March 14, 2017, report entitled Science and Technology Issues in the 115th Congress.  The report outlines science and technology policy issues that may come before the 115th Congress.  The report notes that, given the rapid pace of science and technology advancement and its importance in many diverse public policy issues, issues not discussed in this report may come before Congress.  The selected issues are grouped into nine categories.  The category Physical and Material Sciences includes the subcategory “Nanotechnology and the National Nanotechnology Initiative (NNI).”  The report states that development of this field has been fostered by “significant and sustained” public investments in nanotechnology research and development (R&D).  In 2001, President Clinton launched the NNI to accelerate and focus nanotechnology R&D to achieve scientific breakthroughs and to enable the development of new materials, tools, and products.  According to the report, more than 60 nations subsequently established programs similar to the NNI.  Through fiscal year (FY) 2016, Congress appropriated approximately $21.8 billion for nanotechnology R&D; the President requested $1.4 billion in FY 2017 funding.  In 2003, Congress enacted the 21st Century Nanotechnology Research and Development Act (P.L. 108-153), providing a legislative foundation for some of the activities of the NNI, establishing programs, assigning agency responsibilities, and setting authorization levels through FY 2008.  The report notes that although legislation has been introduced in successive Congresses to amend and reauthorize the Act, none has been enacted into law.  According to the report, Congress “has directed its attention primarily to three topics that may affect the realization of nanotechnology’s hoped-for potential:  R&D funding; U.S. competitiveness; and environmental, health, and safety (EHS) concerns.”

NIOSH Will Hold Public Meeting and Seeks Comments on Draft CIB on the Occupational Exposure Banding Process: Guidance for the Evaluation of Chemical Hazards

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

On March 15, 2017, the National Institute for Occupational Safety and Health (NIOSH) published a Federal Register notice announcing the availability of a draft Current Intelligence Bulletin (CIB) entitled The NIOSH Occupational Exposure Banding Process: Guidance for the Evaluation of Chemical Hazards for public comment.  Under occupational exposure banding, chemicals are assigned to specific categories or bands based on the chemical’s potency and the negative health outcomes associated with exposure to the chemical.  An occupational exposure band (OEB) corresponds to a range of exposure concentrations that is expected to be protective to worker health.  NIOSH states that it recently developed a process to apply the occupational exposure banding process to a broad spectrum of occupational settings.  The NIOSH process uses available, but often limited, toxicological data to determine a potential range of chemical exposure levels that can be used as targets for exposure controls to reduce risk among workers.

Subchapter 3.15 of the draft CIB, “Consideration of Special Categories of Aerosols,” notes that some particles have unique physical characteristics that support modifications to the general occupational exposure banding process.  According to the draft CIB, modification is necessary to address the observation that the total mass dose delivered does not always describe well the dose-response behavior for a single chemical across all particulate sizes and forms.  Examples of particle categories include nanoscale solid-phase particles.  For the purpose of the draft CIB, nanoscale particles are defined as those particles with primary particle diameters less than 100 nanometers.  NIOSH recommends that the occupational exposure banding process — when applied to nanoparticles — be modified according to the following guidelines:

  • Poorly-soluble nanoscale particles: If the toxicity data include no observed adverse effect levels that were developed specifically for the nanoscale form of the chemical, the NIOSH occupational exposure banding process can be used directly with no modifications.  If data are only available for the microscale form of the chemical, the band assignment should be shifted to the next most potent band on the assumption that poorly soluble nanoscale agents will likely be an order of magnitude more toxic than their microscale equivalents.
  • Soluble nanoscale particles: Data support a role of increased total particle surface in the increased toxicity associated with poorly-soluble nanoscale particles, as discussed above.  Thus, because the retained surface area is lower over time for soluble particles (due to dissolution), increased solubility would decrease the potency of particles if the adverse effects are due to the retained particle surface dose.  On the other hand, higher solubility could result in increased potency (compared to poorly soluble particles) if the toxic effects are due to released ions.  In the Agence nationale de sécurité sanitaire and International Standards Organization control banding schemes, soluble particles are addressed with regard to the toxicity of the solute, without consideration of nanoparticle-specific toxicity.  The draft CIB states that acceptance of these general conclusions requires caution, however, because of limited data on which to evaluate their effectiveness.  According to the draft CIB, it is recommended that in the absence of data to the contrary, all nanoscale particles should be treated in the same manner without regard to solubility.  NIOSH recommends shifting the banding assignment to the next most potent band if data are only available for the microscale form of the agent.
  • Nanoscale fibers (or tubes): Since the toxicity of nanoscale fibers and nanoscale tubes may differ significantly from other forms of the compound, the occupational exposure banding process may not fully and accurately capture the toxicity of these chemicals.  Therefore, Tier 1 and Tier 2 should not be used.  Instead, a Tier 3 assessment is required as described for other fibers.

The draft CIB states that these general recommendations are considered precautionary in nature.  According to the draft CIB, limitations in the available scientific information include uncertainty in the mechanisms of potential potency differences in toxicity of nanoscale vs. microscale particles of various chemical composition, surface properties, shape, and degree of agglomeration.  The draft CIB notes that the number of chemicals with adequate data for such size-based toxicity comparisons is small, preventing firm conclusions at this time about relative potencies among various particle types and sizes.  NIOSH is currently evaluating the state of the science for deriving occupational exposure limits or OEBs for nanomaterials, and is also examining the process and data for developing hazard categories for nanomaterials based on biological mode of action and physical-chemical properties.

The public meeting will be held May 23, 2017, in Cincinnati, Ohio.  Registration to attend the meeting in person or via remote participation is due April 21, 2017, and April 7, 2017, for non-U.S. citizens who wish to attend in person.  Comments are due June 13, 2017.

NIOSH Extends Comment Period on Proposed Survey of Engineered Nanomaterial OSH Practices

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

On March 14, 2017, the National Institute for Occupational Safety and Health (NIOSH) extended the comment period on the proposed information collection entitled “Survey of Engineered Nanomaterial Occupational Safety and Health (OSH) Practices.”  The goal of the project is to assess the relevance and impact of NIOSH’s contribution to guidelines and risk mitigation practices for safe handling of engineered nanomaterials in the workplace.  NIOSH invites comment on:

  • Whether the proposed collection of information is necessary for the proper performance of the functions of NIOSH, including whether the information shall have practical utility;
  • The accuracy of NIOSH’s estimate of the burden of the proposed collection of information;
  • Ways to enhance the quality, utility, and clarity of the information to be collected;
  • Ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and
  • Estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information.

According to NIOSH, because of an improper docket opening, the comment period is extended from April 11, 2017, to May 11, 2017.  More information about the survey is available in our February 14, 2017, blog item, “NIOSH Seeks Comment on Proposed Survey of Engineered Nanomaterial OSH Practices.”