The Nanodatabase has posted a June 1, 2020, press release announcing that it has added product number 4,000 in its database. According to the press release, silver is still the nanomaterial most often reported, with titanium and titanium dioxide the second and third most common. The press release notes that for almost 3,000 products, the type of nanomaterial is unknown, however. The database includes categories for health and fitness (2,310 products, a little more than 800 are personal care products, and about 650 are sporting goods products) and home and garden (around 700 products, of which 330 are cleaning products). Other database categories include appliances, automotive, electronics and computers, food and beverage, goods for children, and “Impossible to categorize.” The press release states that the nanomaterial is suspended in liquid in 1,617 products, and in around 75 percent of those products, the nanomaterial is unknown, while titanium dioxide, silver, and silicon dioxide account for a little more than 15 percent of the products suspended in liquid. The Technical University of Denmark Department of Environmental Engineering (DTU Environment), the Danish Ecological Council, and the Danish Consumer Council developed the Nanodatabase.
On July 1, 2020, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion entitled “Polymer based nanocomposites – enabling innovation, resource efficiency and helping to fight climate change” by Dr. Sabine Lindner, Consumer and Environmental Affairs, PlasticsEurope Deutschland e.V. Dr. Lindner notes how the addition of nanoscale particles to plastic matrices can improve the properties of products such as plastic packaging for food. According to Dr. Lindner, PlasticsEurope and the European Chemical Industry Council (CEFIC) Food Contact Additives (FCA), the food additive sector group of CEFIC, collaborated with the Fraunhofer Institute for Process Engineering and Packaging (IVV) to examine whether nanoparticles can migrate from plastic packaging into the packaged foodstuff. Three plastic nanocomposites containing nanoscale silver, titanium nitride, and laponite were investigated for their potential to release nanoparticulates under stress conditions into food simulants. Dr. Lindner states: “In a nutshell, the studies demonstrated, that nanoparticles which are completely encapsulated in the host polymer matrix do not have a potential to migrate into food and therefore consumers will not be exposed to nanoparticles from food contact polymers when those are completely embedded in polymer and the contact surface is not altered by mechanical surface stress during application.”
Dr. Lindner describes the work that PlasticsEurope is doing with different stakeholders, such as the International Nano Authorities Dialogue, and its participation on the advisory board of RiskGONE, a project aimed “at providing solid procedures for science-based risk governance of nanomaterials, based on a clear understanding of risks and risk management practices.” According to Dr. Lindner, transferring knowledge about the safety of engineered nanomaterials is crucial “to implement a robust and reliable methodology for the risk assessment of engineered nanomaterials via decision-making tools that are applicable across different industrial sectors and facilitate risk communication to relevant stakeholders, including industry, regulators, insurance companies, civil society organisations and the general public.”
The U.S. Environmental Protection Agency (EPA) announced on July 2, 2020, that it registered NSPW Nanosilver as a new active ingredient that helps suppress odor-causing bacteria, and algae, fungus, mold, and mildew that can cause deterioration or staining in textiles. EPA notes that NSPW Nanosilver is registered only for use in specified textiles, including fabrics, sportswear, footwear, linens, and awnings. NSPW Nanosilver is the active ingredient in the pesticide product POLYGUARD-NSPW MASTER BATCH (Polyguard). According to EPA, Polyguard will be formulated as a master batch, meaning that NSPW Nanosilver will be embedded within plastic beads or pellets. EPA states that these beads or pellets “are polymeric materials similar to nylon or polyester which are incorporated/infused into textiles through a closed-loop manufacturing process called extrusion.” Once introduced into the process, no beads or pellets can escape into the environment. Available data indicate that the leach rate of nanosilver derived from NSPW Nanosilver-treated textiles is below the limit of detection; the potential for environmental exposure of the polymer is presumed to be negligible.
EPA notes that NSPW Nanosilver was the active ingredient in a previous conditional registration granted in 2015 for use as a materials preservative in textiles and plastics. As reported in our May 31, 2017, memorandum, that registration was challenged, however, 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 unsupported in the record. EPA states that the current action has a modified use pattern that is expected to limit exposures compared to the previous conditional registration. According to EPA, additional data were submitted and reviewed to update the risk assessment for NSPW Nanosilver, allowing for an unconditional registration.
EPA states that based on its human health and ecological risk assessment, it has determined that the new active ingredient, NSPW Nanosilver, meets the regulatory standard under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) for use as a materials preservative in textiles in Polyguard. Although EPA includes a link to Docket ID EPA-HQ-OPP-2020-0043 to view the product registration and response to comments, those materials are not yet posted in the docket.
On June 26, 2020, the European Commission (EC) published a regulation in the Official Journal of the European Union that amends Annex II of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. Annex II describes the requirements for compiling safety data sheets (SDS). The EC notes that specific requirements for nanoforms of substances took effect on January 1, 2020, and that information related to those requirements is to be provided in SDSs. The Annex II amendments include the following provisions regarding nanoforms:
- If the SDS pertains to one or more nanoforms, or substances that include nanoforms, this must be indicated by using the word “nanoform”;
- If the substance is registered and it covers a nanoform, the particle characteristics that specify the nanoform, as described in Annex VI, must be indicated;
- If the substance is not registered, but the SDS covers nanoforms, the particle characteristics of which have impact on the safety of the substance, those characteristics must be indicated;
- If the substance as used in the mixture is in nanoform and is as such registered or addressed by the downstream user chemical safety report, the particle characteristics that specify the nanoform, as described in Annex VI, must be indicated. If the substance as used in the mixture is in nanoform but is not registered or addressed by the downstream user chemical safety report, the particle characteristics that impact the safety of the mixture must be provided;
- As regards nanoforms, the dissolution rate in water or in other relevant biological or environmental media must be indicated in addition to the water solubility; and
- As regards nanoforms of a substance for which the n-octanol/water partition coefficient does not apply, the dispersion stability in different media must be indicated.
Other Annex II amendments include aligning the SDS requirements with the sixth and seventh editions of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). The Annex II amendments will apply beginning January 1, 2021. SDSs not complying with the amended Annex II requirements may be used until December 31, 2022.
On June 25, 2020, the National Institute for Occupational Safety and Health (NIOSH) published a Nanotechnology Research Center (NTRC) Program Performance One-Pager (PPOP). NTRC conducts research to understand the potential effects on human health of exposure to engineered nanomaterials (ENM) and develops methods to control or eliminate exposures. According to the PPOP, NTRC’s accomplishments include conducting a survey to gather information about companies’ safety and health practices surrounding the use of ENMs to assess the impact of the NIOSH guidance. NTRC also expanded the focus of nanotechnology to include advanced materials and manufacturing. “What’s next” actions include:
- Publish the Current Intelligence Bulletin: Health Effects from Occupational Exposure to Silver Nanomaterials;
- Conduct an evaluation of biomarkers of exposure and disease using proteomic, metabolomics, and bioinformatics approaches;
- Work with industry leaders to develop practical, “real world” evaluation of hazard and risk represented by nanomaterials through their life cycles;
- Collaborate with international standards organizations, such as ASTM International, the Organization for Economic Cooperation and Development (OECD), and the International Organization for Standardization (ISO) Technical Committee (TC) 229, to develop international standards; and
- Provide a draft Technical Report: Approaches to Developing Occupational Exposure Limits or Bands for Engineered Nanomaterials for external peer review.
On June 30, 2020, from 9:00 a.m.-10:30 a.m. (EDT), the European Union (EU) NanoSafety Cluster will hold a webinar on “Immune response from occupational exposure to CNTs and nanofibres.” The following speakers will discuss work at the U.S. Centers for Disease Control and Prevention (CDC) National Institute for Occupational Safety and Health (NIOSH) on the association of occupational exposure with ex vivo functional immune response in workers handling carbon nanotubes and carbon nanofibers (CNT/F):
- Matthew Dahm — CNT/F exposure assessment;
- Aaron Erdely — Occupational exposure and immune effects; and
- Mary K. Schubauer-Berigan — Cross-sectional evaluation of CNT/F workers.
The objective was to evaluate the association between CNT/F and ex vivo responses of whole blood challenged with secondary stimulants in a cross-sectional study of 102 workers. The webinar description states that “CNT/F exposure metrics were significantly inversely associated with stimulant:null ratios of several individual biomarkers as well as PC1 and PC2, illustrating a reduced immune response. This approach may present a relatively sensitive method to evaluate human response to CNT/F or other occupational exposures.”
On June 9, 2020, the National Academies of Sciences, Engineering, and Medicine (National Academies) held a briefing webinar featuring its report, A Quadrennial Review of the National Nanotechnology Initiative. During the webinar, members of the ad hoc National Academies committee discussed how U.S. nanotechnology programs compare to those in other nations, whether coordination under the National Nanotechnology Initiative (NNI) should continue, and how to improve the NNI’s research and development (R&D) strategy to enhance further U.S. economic prosperity and security. The National Academies has posted the public briefing video and public briefing slides.
The European Union (EU) Observatory for Nanomaterials (EUON) posted a Nanopinion on June 12, 2020, entitled “Pigments: The oldest nanomaterials in human history facing modern day challenges.” Dr. Heike Liewald, Managing Director, Eurocolour e.V., and Giuliana Beck, Advisor, German association of producers of pigments and fillers, describe how the introduction of nano-specific requirements in statutes has significantly increased the regulatory burden. The authors state that while many pigments have been produced in the same way over several decades without any safety concerns, the nano-specific requirements introduced more recently have increased the reporting and safety obligations, even though the product itself or information on its safety has not changed at all. The authors review the various nano-specific requirements, noting that the lack of harmonization among statutes means that the same pigment may be a nanomaterial under one regulation but not another. According to the authors, there is a divergence between the amended Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Annexes and the REACH guidance documents, leading to more confusion instead of more clarity. The authors state that the objective of the industry is to avoid unjustified restrictions or use bans, and they recommend that downstream legislation take into account whether pigments and fillers are tightly bound to a matrix or paste preventing direct contact with single nanoparticles.
On June 9, 2020, the French National Agency for Food, Environmental, and Occupational Health Safety (ANSES) issued a press release, in French, proposing an inventory of manufactured nanomaterials in food. According to ANSES, manufactured nanomaterials are used in food:
- As additives to improve the appearance and palatability of the product;
- As food contact materials to improve food packaging; and
- As nutrient-oriented ingredients that may be present at the nanoscale.
ANSES used data published in the scientific literature to identify 37 substances used as food additives or ingredients for which it considers that the presence of nanoparticles is proven (seven substances: calcium carbonate, titanium dioxide, iron oxides and hydroxides, calcium silicate, tricalcium phosphates, synthetic amorphous silicas, and organic and composite compounds) or suspected (30 substances, including: aluminum, silver, gold, magnesium phosphates, ferric ammonium citrate, sodium, potassium, and calcium salts of fatty acids). ANSES used food databases to identify nearly 900 food products that incorporate at least one additive or ingredient that meets the classification “substances for which the presence of manufactured nanomaterials is proven.” Based on its research, ANSES created an inventory of the use of nanomaterials in food. According to the press release, its next step will be to study the health risks that these substances could present for consumers. ANSES states that it intends to apply an approach allowing the use of the risk assessment most suitable, either a standard or nano-specific risk assessment. ANSES plans to apply this approach to a selection of substances and to propose a nano-specific risk assessment methodology. It expects the first results by early 2021.
The Nanotechnology Industries Association (NIA) began a survey on June 4, 2020, inviting commercial actors within the nanomaterials arena (producers, users, and professional providers) to contribute their organization’s perception and use of the term “Advanced Materials.” According to NIA, there is increasing policy focus on the term “Advanced Materials,” with national governments and international frameworks starting to discuss potential safety and regulatory implications. NIA states that “[t]his is a conversation that needs clear industrial input and must avoid the assumption that ‘Advanced Materials’ are already recognised by industry as a distinct category of materials and treated as such, with additional safety or regulatory needs beyond existing frameworks.”
The survey takes only five to six minutes to complete (ten questions in total). The survey closes on June 12, 2020. NIA will share a public anonymized report of survey responses, present this report at the Organization for Economic Cooperation and Development (OECD) meeting “Advanced materials — online conferences,” and create a position paper with NIA members to provide clear industrial input to longer term research, policy, and regulatory development. All responses are confidential, and any queries can be sent to email@example.com.
Bergeson & Campbell, P.C. is a proud NIA member.