Nano and Other Emerging Chemical Technologies Blog

Nano and Other Emerging Chemical Technologies Blog

Regulatory & legal developments involving nano and other emerging chemical technologies

EC Committee Includes Micro- and Nano-Plastic in the Environment and Nanoparticles Released from Building Materials and Construction Waste on List of Emerging Issues

Posted in International, Legal/Regulatory Issues

The European Commission’s (EC) Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) published on January 14, 2019, a statement and a position paper on emerging health and environmental issues.  SCHEER identified and prioritized 14 emerging issues to bring to the attention of the EC services, including:

  • Micro- and nano-plastic in the environment (priority is uncertain):
    • Source: Urban and industrial wastewater.  Agricultural soils treated with wastewater treatment plant (WWTP) sludge.  Macroplastic debris.  Tire debris.
    • Preliminary estimation of importance: Considering the amount of the emissions, the issue could be of high importance.  The available information on actual exposure in the different environmental compartments, as well as on the effects on living organisms, is still highly controversial, however.  The sampling methods for micro-plastic as well the analytical methods are not standardized and different procedures, providing different results, are used in monitoring studies.  Therefore, measured data in the aquatic environment reported in the literature are often difficult to compare.  As for the effect assessment, micro-plastic (arbitrarily defined as bigger than one microgram (µm)) should not cross cell membranes and, if ingested, should remain in the digestive system, producing only physical effects.  On the contrary, nano-plastics can probably enter the cells and, possibly, interact with cell metabolism.  To date, these are just hypotheses, however.  There is some evidence in the literature of the cellular uptake of nano-plastic, but the threshold below which this may occur is unknown, as well as the type of biological effects.

      These uncertainties point to the need for a better assessment of hazard and risk.  It is SCHEER’s opinion that the standardization of methods for assessing exposure, as well as the development of methods for assessing the different behavior in living organisms of micro- and nano-plastics, represent urgent priorities.

  • Nanoparticles released from building materials and construction waste to the environment (priority is high):
    • Sources: Nanomaterials are found in construction products, primarily in surface coatings, concrete, window glass, insulation, and steel.  Not all of them contain nanoparticles.  Some nanomaterials may be hazardous due to the presence of very small particles and the similarities observed between some nanomaterials and asbestos fibers, however.  The involved materials have potential impact on both human health and on the environment.  The most used are titanium dioxide, silicon dioxide, silver, copper oxide, and calcium carbonate.  Also, there are some nanomaterials in cement such as silicon dioxide, aluminum oxide, ferric oxide, zirconium dioxide, carbon nanotubes, and carbon nanofibers.  Titanium dioxide particles or antimicrobial silver nanoparticles or even carbon nanotubes provide concrete with self-cleaning properties, or antimicrobials or give it with improved strength and potentially electrical conductivity.
    • Preliminary estimation of importance: 3 (high).

The position paper on emerging issues and the role of SCHEER describes how SCHEER draws the attention of the EC services to emerging issues in the non-food area.

EUON Looks for Topic Suggestions for Future Studies on Nanomaterials

Posted in International, Research

The European Union (EU) Observatory for Nanomaterials (EUON) conducts up to three studies annually.  The studies are intended to address knowledge gaps relating to nanomaterials that are of interest to the general public and the research community.  EUON announced on January 14, 2019, that it is now looking for topic suggestions that could be addressed in its upcoming studies.  EUON is looking for studies that address:

  • Questions relating to the health and safety of nanomaterials, including hazard and risk assessment, exposure to nanomaterials, or worker safety and protection;
  • Specific issues surrounding the uses of nanomaterials by consumers or workers; or
  • Markets for nanomaterials, focusing on EU markets.

EUON states that the scope of the study can be on nanomaterials in general, a specific nanomaterial, or a defined group of nanomaterials.  It should be possible to execute the study within three to nine months.  The studies should be based on desk research and surveys, and they should not require experimental facilities, for example for conducting animal or other laboratory studies.  Proposals are due January 25, 2019.  The EUON secretariat will assess all proposals.  EUON’s existing framework contracts will carry out the selected proposals.  EUON will make the outcome and study reports publicly available on the EUON website.

NIA Will Hold Webinar on Commercialization of Nanomaterials

Posted in International

The Nanotechnology Industries Association (NIA) will hold a webinar on January 24, 2019, on “Nano in Business:  Commercialization of nanomaterials.”  This is the first webinar in NIA’s “Nano in Business” series, which is dedicated to the roadmap to commercial success for nanomaterials.  This includes not only the launch of companies, but also successfully bringing materials to market at a production volume that allows supply to match demand reliably.  The first webinar will focus on NIA members that produce nanomaterials, with support from NIA on the regulatory framework in which they must perform.  This webinar is open to all interested participants, including non-members, and will be recorded for public access.  Slides will be available to NIA members, and there will be a closed discussion session for members at the close of presentations.  Registration is now open.  Bergeson & Campbell, P.C. is a proud member of NIA.

B&C Publishes Forecast for U.S. Federal and International Chemical Regulatory Policy 2019

Posted in Federal, International, Legal/Regulatory Issues, Occupational Health and Safety Issues, United States

Bergeson & Campbell, P.C. (B&C®) and its consulting affiliate The Acta Group (Acta®) published on January 8, 2019, our “Forecast for U.S. Federal and International Chemical Regulatory Policy 2019.”  In this richly detailed document, the legal, scientific, and regulatory professionals of B&C and Acta distill key trends in U.S. and global chemical law and provide our best informed judgment as to the shape of key developments we are likely to see in 2019.  This edition contains new features — a detailed table of contents, more detail (the document is 70 pages), a glossary, the schedule of our complimentary webinars in 2019, links to key writings, and a summary of key presentations

Researchers Survey Nanosafety Research in the European Union and U.S.

Posted in International, Research, United States

The December 2018 issue of the Journal of Nanoparticle Research includes an article entitled “A survey on the state of nanosafety research in the European Union and the United States.”  According to the abstract, the authors surveyed researchers in the field of environmental safety and health of nanomaterials between September 2017 and January 2018 to obtain a snapshot on the state of investigations.  The data received from 84 respondents provide information on exposure pathways, methods, biologic and toxic effects, dose metrics and range, criteria for selecting benchmark materials, and problems that are considered urgent in the field.  The abstract states that the results can help guide research strategies and funding schemes related to nanosafety of nanoparticles.  The survey will be repeated every few years to follow developments in the field.

Transcript Available for NIOSH Webinar on Revised Draft CIB for Silver Nanomaterials

Posted in Federal, Legal/Regulatory Issues, Occupational Health and Safety Issues, United States

The National Institute for Occupational Safety and Health (NIOSH) has posted the transcript for the October 30, 2018, webinar on its revised draft document entitled Current Intelligence Bulletin:  Health Effects of Occupational Exposure to Silver Nanomaterials.  As reported in our September 19, 2018, blog item, the revised draft Current Intelligence Bulletin (CIB) provides an updated scientific literature review of information pertaining to occupational exposure to silver nanomaterials.  The literature review includes studies on the toxicological effects of exposure to silver nanomaterials in experimental animal and cellular systems, the effect of particle size and other properties on the toxicological effects of silver, and NIOSH recommendations on the measurement and control of occupational exposures to silver and silver nanomaterials.  Based on an assessment of these data, NIOSH developed a recommended exposure limit (REL) for silver nanoparticles (<100 nanometers (nm) primary particle size) of 0.9 micrograms per cubic meter (μg/m3) as an airborne respirable eight-hour time-weighted average (TWA) concentration.  The draft REL would apply to processes that produce or use silver nanomaterials.  In addition, NIOSH continues to recommend a REL of 10 μg/m3 for total silver (metal dust, fume, and soluble compounds, as Ag).  NIOSH further recommends the use of workplace exposure assessments, engineering controls, safe work procedures, training and education, and established medical surveillance approaches to prevent potential adverse health effects from exposure to silver nanomaterials.  Comments on the draft CIB were due November 30, 2018.

ISO Publishes Specification for Developing Representative Test Materials Consisting of Nano-Objects in Dry Powder Form

Posted in International, Research

In December 2018, the International Standardization Organization (ISO) published standard SO/TS 16195:2018, “Nanotechnologies — Specification for developing representative test materials consisting of nano-objects in dry powder form.”  The standard specifies development of representative test materials consisting of nano-objects in dry powder form to enable test method development and improve comparability of data for nanotechnology applications.  The standard specifies that for dry powders of nano-objects, the following minimum information be gathered and provided in a verification report to qualify the material as a nanoscale representative test material:

  • Information describing the manufacturing process;
  • Information on the quality management of its manufacturing process;
  • Data from physico-chemical measurements representing the principal features of the representative test material; and
  • Data on the stability and homogeneity of the above parameters.

ISO states that conformity to the standard, expressed in the form of a verification report, “will provide a level of assurance that the representative test material is homogeneous, statistically representative of the manufacturing process, and has stability.”  This will increase the likelihood that measurements that are undertaken on the representative test material are comparable across testing laboratories, “even for properties for which methods are being developed and for which homogeneity and stability have not been quantitatively assessed.”

Canada’s Occupational Cancer Research Center Holds Seminar on Mitigating Exposures to Engineered Nanomaterials in the Workplace

Posted in International, Occupational Health and Safety Issues

On December 7, 2018, the Occupational Cancer Research Center (OCRC) held a seminar on “Perspectives on Mitigating Exposures to Engineered Nanomaterials in the Workplace.”  The seminar was part of the Occupational and Environmental Health seminar series supported by the Dalla Lana School of Public Health, Public Health Ontario, OCRC, and the Center for Research Expertise in Occupational Disease.  Pat Rasmussen, Health Canada/University of Ottawa, gave the presentation, addressing:

  • The unique properties of engineered nanomaterials (definitions);
  • Control banding approach: Selection of control measures based on hazard and exposure (Canadian Standards Association (CSA)/International Organization for Standardization (ISO));
  • Harmonized tiered approach: To assess potential exposures in workplaces (Organization for Economic Cooperation and Development (OECD));
  • How research feeds into CSA/ISO and OECD exposure measurement and mitigation efforts; and
  • Accessing nano workplace safety information in Ontario.

EPA Withdraws SNUR for Single-Walled Carbon Nanotubes

Posted in Federal, Legal/Regulatory Issues, United States

The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on December 7, 2018, withdrawing significant new use rules (SNUR) promulgated under the Toxic Substances Control Act (TSCA) for 28 chemical substances, including single-walled carbon nanotubes, that were the subject of premanufacture notices (PMN).  As reported in our October 10, 2018, blog item, EPA issued the SNURs through a direct final rule on October 10, 2018.  EPA states that it received adverse comments regarding the SNURs identified in the direct final rule, and is withdrawing them.  On October 10, 2018, EPA also issued proposed SNURs covering these 28 chemical substances.  EPA states that it will address all adverse public comments in a subsequent final rule, based on the proposed SNURs.

EC Amends REACH to Require Information on Nanomaterials

Posted in International, Legal/Regulatory Issues

The European Commission (EC) announced on December 3, 2018, that it adopted amendments to several Annexes of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation to clarify the information requirements for nanomaterials.  The EC notes that REACH “has always applied to nanomaterials, but did not contain specific provisions for them, which is why companies often did not know how to register these ‘substances in nanoform.’”  According to the EC, the modifications and new requirements will help close the knowledge gap concerning which nanomaterials are placed on the market and in what quantities.  The EC states that “[t]he new provisions will have to be implemented for all substances in nanoform that fall within the scope of REACH, from the already widely used and registered ‘legacy’ nanomaterials in all their product grades and variations to the specifically engineered nanomaterials placed on the market by the newly founded SMEs.”  The European Chemicals Agency’s (ECHA) December 3, 2018, press release states that nanoforms of substances are those covered by the EC’s recommendation for a definition of a nanomaterial.  ECHA “strongly encourages registrants of nanoform substances to familiarise themselves with the amendments and assess what action they need to take to comply.”  ECHA is currently assessing the need to update existing guidance or issue new guidance to help registrants comply with the new requirements.  The information requirements will apply beginning January 1, 2020.