On February 19, 2020, the National Institute for Occupational Safety and Health (NIOSH) posted a Science Blog item entitled “Are There Nano- and Microplastics in the Workplace?” that reviews workplace exposure to microplastics (defined by NIOSH as “plastic particles smaller than 5 mm”) and nanoplastics (the nanoscale fraction of plastic particles).  NIOSH states that nano- and microplastic particles (NMPP) “can be formed through environmental and mechanical degradation (the top-down mechanism).  They can be also generated through condensation of molecular species, for example, during heating or burning of plastics (the bottom-up mechanism).”  NIOSH provides the following examples of inhalation exposure in the workplace:

  • Top-Down Mechanism:
    • During mechanical and environmental degradation of plastic goods, which can lead to potential exposures to nano- and microplastics among workers in the waste management and recycling operations;
    • Degradation of carpets and other synthetic fiber products that can produce airborne fibers considered NMPPs with potential for exposure among office/teleworkers and custodial staff;
    • Machining of polymer and plastic products generating dusts; and
  • Bottom-Up Mechanism:
    • During high-energy or high-heat processes (such as laser cutting or high-speed drilling), treatment of polymer composites, and during 3D printing from melting or fusing of plastics; and
    • Facilities hosting plastic processers and printers could expose workers to airborne NMPPs.

According to NIOSH, its Nanotechnology Research Center (NTRC) has developed approaches for exposure measurement, assessment and mitigation, and hazard characterization for nanomaterials, and many of these approaches would also be applicable to characterize and minimize risk of nano- and microplastics in the workplace.  NIOSH notes that presently there are no occupational exposure limits for nano- and microplastics.  In the absence of occupational exposure limits for nano- and microplastics, NIOSH states that workplace safety efforts should focus on minimizing potential exposure through appropriate engineering controls such as isolation cabinets, exhaust ventilation, and utilizing good industrial hygiene practices.

On January 28, 2020, the European Union (EU) published The NanoDefine Methods Manual, a collection of three Joint Research Center (JRC) reports developed within the NanoDefine project “Development of an integrated approach based on validated and standardized methods to support the implementation of the EC recommendation for a definition of nanomaterial.”  According to the Manual, the overall goal of the NanoDefine project was to support the implementation of the European Commission (EC) Recommendation on the definition of nanomaterial (2011/696/EU).  The Manual states that the project developed an integrated empirical approach that allows identifying a material as a nanomaterial according to the EC Recommendation.  The Manual consists of three parts:

  • Part 1: The NanoDefiner Framework and Tools, which covers the NanoDefiner framework, general information on measurement methods and performance criteria, and tools developed by NanoDefine such as a materials categorization system, a decision support flow scheme, and an e-tool;
  • Part 2: Evaluation of Methods, which discusses the outcome of the evaluation of the nanomaterials characterization methods for measuring size; and
  • Part 3: Standard Operating Procedures (SOP), which presents the 23 SOPs developed within the NanoDefine project.

In this combined document, the three parts are included as stand-alone reports, each having its own abstract; table of contents; page, table, and figure numbering; and references.

The U.S. Environmental Protection Agency (EPA) announced on February 12, 2020, that it is seeking public input on a proposal to incorporate a new nanosilver pesticide product into textiles to combat odors, discoloration, and other signs of wear.  The proposed registration decision is for NSPW Nanosilver, and the proposed pesticide product, Polyguard-NSPW Master Batch (Polyguard), will be incorporated into textiles to suppress bacteria, algae, fungus, mold, and mildew, which cause odors, discoloration, stains, and deterioration.  According to EPA, based on its human health and ecological risk assessment, it has preliminarily determined that the new active ingredient in Polyguard meets the regulatory standard under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) for use as a materials preservative in textiles.  EPA invites public comment on its proposal and preliminary findings.  Comments are due March 13, 2020.  More information is available in Docket ID EPA-HQ-OPP-2020-0043.

EPA notes that NSPW Nanosilver was the active ingredient in a previous conditional registration that it granted in 2015, for use as a materials preservative in textiles and plastics.  As reported in our May 31, 2017, memorandum, that decision was challenged, and the U.S. Court of Appeals for the Ninth Circuit “vacated it on grounds that EPA’s public interest finding for granting the registration was without support in the record.”  EPA states that the currently proposed product “is solely for use in specified textiles; therefore, Polyguard will have a more limited use authorization than the previously vacated conditional registration.”  EPA notes that Polyguard will be formulated as a master batch, meaning that NSPW Nanosilver would be embedded within plastic beads or pellets, in contrast to the previous product registration, which was in the form of a liquid suspension.

On February 13, 2020, the Nanotechnology Industries Association (NIA) published a position paper entitled ‘Nanoplastics’:  Use of suitable terminology for representation in waste, degradation of plastics and presence in the environment.  In the paper, NIA and its members urge caution and clarity when referring to plastics as small particles or fragments.  NIA states that “nanoplastics” is a “non-specific and ambiguous term, and qualifiers should be considered for accurate presentation to all audiences.”  NIA notes that incidental “nanoplastics,” or more specifically incidental plastic nanoscale materials, can be formed by degradation of plastics or from wear.  Manufactured “nanoplastics” (i.e., plastic nanomaterials) are “intentionally produced at the nanoscale to allow for specific product characteristics.  The presence of manufactured ‘nanoplastics’ within the environment is expected to be very low as they are incorporated into products (i.e. bound in a matrix).”  According to the position paper, “[t]o NIA’s current knowledge there are very few intentionally produced nanoplastics, with use largely restricted to scientific research within laboratories.”  Bergeson & Campbell, P.C. is a proud NIA member.

The Scientific Committee on Consumer Safety (SCCS) announced on February 6, 2020, that the European Commission (EC) has requested scientific advice on the safety of nanomaterials in cosmetics.  The EC seeks advices on two questions:

  • The EC requests that SCCS determine the nanomaterials, as published in the recent catalogue of nanomaterials of 2019, for which specific concerns can be identified and justified to establish a priority list of nanomaterials for risk assessment (Article 16(4) Reg.1223/2009). The EC asks that SCCS provide a description of the specific concerns that have been identified.  According to the request, this process should be based on the currently available scientific literature and SCCS’s expert judgment.
  • For the nanomaterials with inconclusive SCCS opinions, the EC requests that SCCS assess if a potential risk can be identified according to Article 16(6) Reg.1223/2009. Such assessment, regardless of the data previously submitted by the respective applicants, should be based on the available scientific literature and SCCS’s expert judgment (i.e., systemic or local availability; harmful effects specifically related to nanoform; surface catalyzed reactions in nanoform, absorption (or potential absorption) from dermal and inhalation routes, or potential of nanoform to deliver ionic forms).  The inconclusive SCCS opinions specified in the request include Colloidal Silver (nano) (SCCS/1596/18), Styrene/Acrylates copolymer (nano) + Sodium styrene/Acrylates copolymer (nano) (SCCS/1595/18), and Silica, Hydrated Silica, and Silica Surface Modified with Alkyl Silylates (nanoform) (SCCS/1545/15).

To avoid conflicting opinions with other bodies, the EC invites SCCS to consult the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER).

The American Conference of Governmental Industrial Hygienists (ACGIH®) Threshold Limit Values for Chemical Substances (TLV®-CS) Committee has included carbon nanotubes on its 2020 list of chemical substances and other issues under study.  Being placed on the under study list indicates that the TLV®-CS Committee has selected carbon nanotubes for development of a threshold limit value (TLV®).  ACGIH® describes TLVs® as health-based values representing the opinion of the scientific community that exposure at or below the level of the TLV® does not create an unreasonable risk of disease or injury.  The TLV®-CS Committee seeks substantive data and comments, and will consider only those addressing issues of health and exposure, not economic or technical feasibility.  ACGIH® will update the under study list into a two-tier list by July 31, 2020:

  • Tier 1 entries indicate the chemical substances and physical agents that may move forward as a notice of intended change (NIC) or notice of intent to establish (NIE) in the upcoming year, based on their status in the development process; and
  • Tier 2 consists of those chemical substances and physical agents that will not move forward, but will either remain on, or be removed from, the under study list for the next year.

If the Committee decided to proceed with a proposed TLV® for carbon nanotubes, the ACGIH® Board of Directors would first ratify the proposed value, and it would be published as an NIE in the 2020 annual report of the TLV®-CS Committee.  The Committee included carbon nanotubes on its 2018 and 2019 lists of chemical substances and other issues under study.

On February 5, 2020, the Nanotechnology Entrepreneurship Network (NEN) will hold a webinar on insights from the U.S. Patent and Trademark Office (USPTO) from 12:00 p.m. to 1:00 p.m. (EST).  The National Nanotechnology Initiative (NNI) notes that a key stop on the technology development pathway is protecting the underlying intellectual property.  Entrepreneurs intending to commercialize an emerging technology, such as a nanomaterial or a nanomaterial-enabled product, need to be cognizant of pertinent intellectual property issues that will impact their business.  During the webinar, Elizabeth Dougherty, Eastern Regional Outreach Director for the USPTO, and Craig Morris, Managing Attorney for Trademark Educational Outreach for the USPTO, will discuss types of intellectual property, intellectual property strategies, the patent process, and issues related to trademarks.  Webinar participants will be able to submit questions for the panelists to answer.  Submitted questions will be considered in the order received and may be posted on the NNI website.  Registration is required.

As reported in our November 19, 2019, blog item, NEN brings new and seasoned entrepreneurs together with the people and resources available to support them.  NNI intends this emerging network to provide a forum for sharing best practices for advancing nanotechnology commercialization and the lessons learned along the technology development pathway.

The National Toxicology Program (NTP) published a Federal Register notice on January 31, 2020, announcing that the Board of Scientific Counselors (BSC) will meet on February 21, 2020.  During the meeting, BSC will review and provide advice on programmatic activities.  According to the preliminary agenda for the meeting, the meeting will include a presentation by Dr. Anil Patri, Food and Drug Administration, National Center for Toxicological Research, on “Understanding Human Exposure to Nanoplastics/Microplastics:  Novel Agents Bring Novel Challenges.”  The meeting will be held by webcast only and is open to the public.  Written comments will be accepted, and registration is required for oral comment and to access the webcast.  At this time, meeting materials have not yet been posted.

On February 24, 2020, the European Chemicals Agency (ECHA) will hold a webinar on “Registering nanoforms:  practical advice.”  As of January 1, 2020, companies must provide more information on nanomaterials on the European Union (EU) market under the updated Annexes to the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation.  Beyond this date, companies must have a registration compliant with these requirements to manufacture or import nanoforms of substances that fall within the scope of REACH.  ECHA invites stakeholders to join the webinar to hear about the registrations received so far, key lessons learned, and best practices.  Participants will have an opportunity to ask questions on how to prepare registration dossiers for their nanoforms and get practical advice from ECHA’s experts for successfully submitting registrations.

On January 24, 2020, the U.S. Environmental Protection Agency (EPA) posted a December 13, 2019, memorandum to Docket EPA-HQ-OPP-2011-0370, the nanosilver registration review docket.  The memorandum lists the 12 products for which EPA issued a generic data call-in (GDCI) as part of the nanosilver case (5042).  EPA issued the DCIs on August 31, 2019, and states that they can be accessed in the docket.

EPA Reg. Number PC Code Nano-Naming ID DCI Number
83587-3 072591 Nanosilver 001 GDCI-072591-1816
10324-18 072592 Nanosilver 002 GDCI-072592-1817
69681-35 072592 Nanosilver 002 GDCI-072592-1817
68161-1 072593 Nanosilver 003 GDCI-072593-1818
7124-101 072593 Nanosilver 003 GDCI-072593-1818
3432-64 072594 Nanosilver 004 GDCI-072594-1819
3432-71 072594 Nanosilver 004 GDCI-072594-1819
87396-1 072596 Nanosilver 006 GDCI-072596-1820
92760-1 072597 Nanosilver 007 GDCI-072597-1821
92760-3 072597 Nanosilver 007 GDCI-072597-1821
85249-1 072599 Silver nanoparticles GDCI-072599-1821
85249-2 072599 Silver nanoparticles GDCI-072599-1821

More information is available in our October 23, 2018, blog item on the final work plan for the nanosilver registration review process under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).