On March 4, 2020, the National Institute for Occupational Safety and Health (NIOSH) published a Federal Register notice announcing the availability of its Current Intelligence Bulletin 69:  NIOSH Practices in Occupational Risk Assessment.  85 Fed. Reg. 12786.  The Current Intelligence Bulletin (CIB) describes the process and logic NIOSH uses to conduct risk assessments, including the following steps:

  • Determining what type of hazard is associated with a chemical or other agent;
  • Collating the scientific evidence indicating whether the chemical or other agent causes illness or injury;
  • Evaluating the scientific data and determining how much exposure to the chemical or other agent would be harmful to workers; and
  • Carefully considering all relevant evidence to make the best, scientifically supported decisions.

Appendix C of the CIB includes sections addressing nanomaterials risk assessment and alternative methods for nanomaterials.  The CIB states that “[g]iven the large and growing number of engineered nanomaterials (ENMs) with limited data, as for other emerging and existing substances produced or used in the workplace, alternative test strategies (i.e., toxicological approaches other than primary animal testing) such as high-throughput screening and in vitro exposures may help to fill the gaps by providing data that could be used in validated hazard and risk assessment models.”  The CIB section on nanomaterials risk assessment includes subsections on dose normalization in vitro and in vivo and correlation of in vitro and in vivo responses.  The section on alternative methods for nanomaterials includes subsections on comparative potency estimation, hazard classification/clustering, and validation.  The CIB notes that a key challenge to using alternative test strategies data is the development and application of validation criteria.

As reported in our February 13, 2020 blog item, 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.  According to a February 27, 2020, memorandum placed in Docket ID EPA-HQ-OPP-2020-0043, EPA received a request to extend the comment period 30 days to allow additional time to review the documentation contained in the docket.  The memorandum states that EPA “feels that 15 additional days should be sufficient to allow for adequate review of the Proposed Decision and supporting documentation.”  Comments are now due March 30, 2020.

 

The Federal Institute for Occupational Safety and Health (BAuA) issues Technical Rules for Hazardous Substances (TRGS), which reflect the state of technology, occupational safety and health, and occupational hygiene, as well as other verified scientific knowledge relating to activities involving hazardous substances, including their classification and labeling.  BAuA has published an English translation of TRGS 527:  “Activities with nanomaterials.”  TRGS 527 contains rules for protection of employees at the workplace during activities with substances, mixtures, and products consisting of or containing nanomaterials.  It includes provisions on:

  • The scope of application;
  • Definition of terms;
  • Identification of risks;
  • Risk assessment;
  • Protective measures;
  • Effectiveness testing; and
  • Working instructions and provision of information to employees, documentation.

TRGS 527 defines nanomaterials to include nanoforms of substances registered under the European Union (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation, as well as non-registered nanoforms according to Annex VI of Regulation (EC) No. 1907/2006, as amended by (EU) 2018/1881.  TRGS 527 notes that the European Commission (EC) does not distinguish between established and new materials.  It does not apply to:

  1. Natural nanomaterials if no activities are carried out with them;
  1. Nanomaterials created as a result of work processes (g., weld fumes, diesel particles) if they are not handled as products. For activities such as welding, cutting, and similar procedures involving metal materials, TRGS 528:  “Welding work” applies.  For activities in work areas in which diesel exhaust gases may occur, TRGS 554:  “Exhausts of diesel engines” applies; and
  1. TRGS 527 amends the rules for hazardous substances regarding the risks caused by nanomaterials and in particular TRGS 400: “Risk assessment for activities involving hazardous substances.”

TRGSs specify, within their scope of application, the requirements of the German Hazardous Substances Ordinance.  If an employer complies with TRGSs, that employer may assume that the relevant requirements of the Ordinance have been met.  If the employer chooses a different solution, that solution must achieve at least the same level of safety and health protection for employees.  BAuA notes that the English translation is an unofficial version.  Only the original German text has legal effect.

The European Chemicals Agency (ECHA) issued a press release on February 24, 2020, stating that it has received a low number of registration dossiers for nanomaterials.  ECHA states that it has received only 95 unique submissions for 36 substances covering nanoforms according to the updated Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation requirements.  ECHA expected to receive updated registrations for approximately 300 substances, based on data from the Belgian and French national inventories and the European Commission’s (EC) catalog of nanomaterials used in cosmetic products.  With the submission rate so low and half of the incoming dossiers failing the technical completeness check, ECHA notes that a webinar is available with practical advice for companies on how to prepare their registration dossiers for nanoforms.  According to the press release, ECHA is working closely with key industry associations and Member States to understand better the additional actions needed to raise awareness on the legal obligations.  ECHA states that it is also engaged in several short-term actions to help improve compliance, for example, by revising the Nanomaterials Expert Group’s mandate to allow more support for decision making and updating manuals, instructions, and guidance for human health and environmental endpoints.  Where validated test methods for meeting REACH Annexes VII and VIII information requirements are not yet available, ECHA has published a template to support registrants in documenting practical constraints and to help ensure they can show they have made all possible efforts to meet the information requirements.  ECHA reminds companies that without a valid registration, nanomaterials that fall within the scope of REACH are currently illegally on the market.

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.