Nano and Other Emerging Chemical Technologies Blog

Nano and Other Emerging Chemical Technologies Blog

Regulatory & legal developments involving nano and other emerging chemical technologies

NNI Publishes Key Takeaways and Transcript for Webinar on Technology Pathways Toward Commercializing Nanotechnology

Posted in Federal, Research, United States

The National Nanotechnology Initiative (NNI) has published key takeaways and a transcript for the September 19, 2018, webinar, “Technology Pathways Toward Commercializing Nanotechnology.”  The webinar focused on quality control in the manufacturing process and built on NNI’s November 2017 Technology Pathways workshop.  Webinar panelists Katherine Barton, Laboratory and Production Manager at Nano-C, and Doug Singer, Executive Vice President in Charge of Manufacturing, Development, and Commercialization at Cerion Advanced Materials, engaged in a dialogue about the criticality of and issues surrounding quality control in the production of nanomaterials.  Dr. Lisa Friedersdorf, Director of the National Nanotechnology Coordination Office (NNCO), moderated the discussion.  Panelists provided a brief overview of their experiences, successes, and challenges in ensuring the quality of manufactured nanomaterials, followed by a question and answer period.  The key takeaways from the webinar guests include:

  1. In nanomanufacturing: fail fast.  Have the mindset of fail fast, learn from it, loop back, and fix the problem;
  2. Expect that anywhere from 25 percent to the entire technical team of a small company will play a role in the quality control process; and
  3. Take advantage of the ecosystem in your geographic area: companies, research institutions, and government-supported infrastructure.  Engage the National Institute for Occupational Safety and Health (NIOSH) for access to environmental, health, and safety resources.

NanoReg2 Publishes Grouping and Read Across Article in Nanotechnology

Posted in International, Legal/Regulatory Issues

The Nanotechnology Industries Association (NIA) announced on October 5, 2018, that the NanoReg2 project, of which NIA is a partner, has published a comprehensive review of European Union (EU) legislation addressing chemical substances and the potential for grouping and read across in nanomaterials.  The article, “Insights into possibilities for grouping and read-across for nanomaterials in EU chemicals legislation,” considers both the overarching regulation of chemical substances under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation and the Classification, Labeling and Packaging of Substances and Mixtures (CLP) regulation, and the sector-specific pieces of legislation for cosmetic, plant protection, and biocidal products, and legislation addressing food, novel food, and food contact materials.  The review identifies and reviews the relevant supporting documents (e.g., guidance documents) regarding each piece of legislation, considering the relevant technical and scientific literature.  The review identifies prospective regulatory needs for implementing grouping in the assessment of nanomaterials, and answers whether each particular piece of legislation permits the use of grouping and read-across to address information gaps.

Berlin Declaration on Nanomaterials Submitted to Environment Council of the Council of the EU

Posted in International, Legal/Regulatory Issues

The Environment Council of the Council of the European Union (EU) met on October 9, 2018.  According to the outcome of the Council meeting, the items debated under any other business included the “Berlin Declaration” on nanomaterials, submitted by the German delegation and supported by the French and Luxembourg delegations.  The Berlin Declaration summarizes the conclusions and recommendations of the 12th International Nano-Authorities Dialogue of Germany, Liechtenstein, Luxembourg, Austria, and Switzerland, and was acknowledged by the environment ministers of those countries at their annual meeting in June 2018.  The Declaration “acknowledges the progress that has been made in the regulatory framework for nanomaterials in the last few years, and especially the European Commission’s Decision to adapt the annexes of the REACH Regulation to the requirements of nanomaterials.  It also sets out the needs identified for further activities in this field, most of which will have to be addressed at EU level.”  According to the Berlin Declaration, these needs include:

  • The adaptation of test methods within the context of the Organization for Economic Cooperation and Development (OECD);
  • A transversal definition of nanomaterials in all relevant regulatory contexts in the EU;
  • The approach to be taken to the emerging topic of “advanced materials”;
  • The continued support of research activities and the small- and medium-sized enterprises (SME) in the field of nanomaterials; and
  • Provisions to give the European Chemicals Agency (ECHA) a permanent mandate for the EU Observatory for Nanomaterials (EUON).

Germany asked the Environment Council to take note of the Declaration.

EU-OSHA Posts Info Sheet on Manufactured Nanomaterials in the Workplace

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

On October 3, 2018, the European Agency for Safety and Health at Work (EU-OSHA) published an info sheet on “Manufactured nanomaterials in the workplace.”  According to the info sheet, “[t]he requirements for managing nanomaterials in the workplace are the same as those for managing other hazardous chemicals, including the provision of information and training for workers, carrying out risk assessments and taking action to ensure a safe workplace.”  The prerequisites for fulfilling these demands are different for nanoparticles than for most other chemicals, however.  The info sheet notes that knowledge about the risks associated with nanomaterials is still limited, and “there are no occupational exposure limits (yet) for any nanomaterials, although reference values have been suggested.”  Therefore, the info sheet states, the precautionary principle needs to be applied to keep exposure at a level at which the risk can be expected to be under control, even if the nanomaterial should prove to be more hazardous than it is currently known to be.  The info sheet gives general, practical advice on how to apply the precautionary principle in managing nanomaterials.

Germany Publishes Study on Health Effects of Ultrafine Particles

Posted in EU Member State, International, Occupational Health and Safety Issues, Research

The German Environment Agency (UBA) in October 2018 published a study entitled Health Effects of Ultrafine Particles:  Systematic literature search and the potential transferability of the results to the German setting.  The study notes that ultrafine particles represent the smallest size fractions of particles with sizes from one to about 100 nanometers in aerodynamic diameter.  Their specific health effects are thus related to their physical capacity to reach diverse organ systems.  Prepared on behalf of UBA and the Swiss Federal Office for the Environment, the aims of the study were to review systematically the scientific literature on the health effects of ultrafine particles, to evaluate the quality of the selected studies, and to assess the transferability of the results to the situation in Germany.  The search strategy yielded 85 references of original articles.  Most of the included studies were conducted in North America (n=37) or Western Europe (n=27), investigating short-term effects (n=75).  The short-term studies are dominated by panel studies (n=32), scripted exposure studies (n=16), and time-series studies (n=11).  Ten studies investigated long-term associations using exposure estimates averaged over a period of months to years.  The study states that the evidence on health effects remains inconclusive or insufficient for most of the studied outcomes.  Specifically, while a number of studies have investigated mortality and emergency department/hospital admission outcomes, the relatively few studies with co-pollutant adjustment reveal mixed and, up to now, inconclusive evidence.  According to the study, in terms of number of studies, most available evidence is from studies investigating subclinical outcomes.  Within this group, cardiovascular outcomes and outcomes of pulmonary and systemic inflammation show the most consistent patterns with associations generally pointing in the direction of the adverse health outcome.  The study states that a future challenge is the development of enhanced spatiotemporal models that can contribute to a more precise exposure assessment across larger areas, as well as incorporating multipollutant models to become clear of independent effects.

EPA Publishes SNUR for Single-Walled Carbon Nanotubes

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

The U.S. Environmental Protection Agency (EPA) published on October 10, 2018, a direct final  rule promulgating significant new use rules (SNUR) for 28 chemical substances, including  single-walled carbon nanotubes, that were the subject of premanufacture notices (PMN).  The chemical substances are subject to orders issued by EPA pursuant to Section 5(e) of the Toxic Substances Control Act (TSCA).  The direct final rule requires persons who intend to manufacture (defined by statute to include import) or process any of the chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity.  The required notification will initiate EPA’s evaluation of the intended use within the applicable review period.  Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required with that determination.  The direct final rule will be effective December 10, 2018.  Written adverse comments on one or more of the SNURs must be received by November 9, 2018.  If EPA receives written adverse comments, it will withdraw the relevant sections of the direct final rule before its effective date.  In addition to the direct final rule, EPA published a proposed rule on October 10, 2018.  Comments on the proposed rule are due November 9, 2018.

According to the SNUR, the generic (non-confidential) use of the single-walled carbon nanotubes will be as an additive in composite materials for mechanical, thermal, and conductivity improvements.  According to the SNUR, based on analysis of analogous carbon nanotubes, EPA identified concerns for pulmonary toxicity, as well as potential toxicity to aquatic organisms if the PMN substance is released to water.  EPA issued an order under TSCA Sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the PMN substance may present an unreasonable risk of injury to human health and the environment.  The order requires:

  1. Submitting to EPA certain toxicity testing before manufacture (including import) by the times specified in the order;
  2. Providing personal protective equipment (PPE) to workers to prevent dermal exposure where there is a potential for dermal exposure;
  3. Providing National Institute for Occupational Safety and Health (NIOSH) certified respirators with an Assigned Protection Factor (APF) of at least 50 to workers to prevent inhalation exposure;
  4. No use of the PMN substance in application methods that generate a dust, vapor, mist, or aerosol;
  5. Use of the PMN substance only for industrial uses;
  6. Use of the PMN substance only for the confidential uses specified in the order;
  7. No release of the PMN substance to water; and
  8. Disposal of the PMN substance only via landfill or incineration.

The SNUR designates as a “significant new use” the absence of these protective measures.  EPA states that it has determined that “certain information about the environmental and health effects of the PMN substance may be potentially useful to characterize the effects of the PMN substance in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR.”  EPA notes that the submitter has agreed not to manufacture the PMN substance without performing specific physical property and pulmonary toxicity testing.  EPA states that it has also determined that the results of specific chronic aquatic toxicity testing would help characterize the potential environmental effects of the PMN substance.  Although the order does not require these tests, the order’s restrictions remain in effect until the order is modified or revoked by EPA based on submission of this or relevant information.

Slides Available from Scientific Workshop on Grouping of Nanomaterials

Posted in International, Legal/Regulatory Issues, OECD, Research

On September 12-13, 2018, the Organization for Economic Cooperation and Development (OECD), NanoReg2, and GRACIOUS hosted a “Scientific Workshop:  Grouping of Nanomaterials.”  The Workshop brought together 120 nanotechnology specialists from Europe, North America, and Asia to discuss a bottleneck in nanomaterials development and testing.  The agenda and the following slides from the workshop have been posted online:

EPA Will Publish SNUR for Carbon Nanomaterial (Generic)

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

The U.S. Environmental Protection Agency (EPA) is scheduled to publish on October 3, 2018, a direct final rule promulgating significant new use rules (SNUR) for 26 chemical substances, including carbon nanomaterial (generic), that were the subject of premanufacture notices (PMN).  The chemical substances are subject to orders issued by EPA pursuant to Sections 5(e) and 5(f) of the Toxic Substances Control Act (TSCA).  The direct final rule requires persons who intend to manufacture (defined by statute to include import) or process any of the chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity.  The required notification will initiate EPA’s evaluation of the intended use within the applicable review period.  Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required with that determination.  The direct final rule will be effective 60 days after publication in the Federal Register.  Written adverse comments on one or more of the SNURs must be received within 30 days of publication in the Federal Register.  If EPA receives written adverse comments, it will withdraw the relevant sections of the direct final rule before its effective date.  In addition to the direct final rule, EPA is scheduled to publish a proposed rule on October 3, 2018.  Comments on the proposed rule are due 30 days after publication in the Federal Register.

According to the SNUR, the generic (non-confidential) use of carbon nanomaterial (generic) will be in printing applications.  EPA states that it identified concerns for pulmonary toxicity and carcinogenicity based on analogy to carbon black.  EPA issued an order under TSCA Sections 5(e)(1)(A)(i), based on a finding that the available information is insufficient to permit a reasoned evaluation of the human health and environmental effects of the PMN substance, and 5(e)(l)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health and the environment.  The Order requires:

  1. Submission to EPA of certain health testing and material characterization data before exceeding a specified confidential production volume;
  2. Use of personal protective equipment (PPE) where there is a potential for dermal exposure;
  3. Use of a National Institute for Occupational Safety and Health (NIOSH) certified air purifying, tight-fitting full-face respirator equipped with N100, P-100, or R-100 filter with an Assigned Protection Factor (APF) of at least 50 where there is a potential for inhalation exposure;
  4. No release of the PMN substance to surface waters;
  5. Use of the PMN substance only for the confidential uses specified in the order;
  6. Limiting the manufacture, processing, and use of the PMN substance to industrial uses;
  7. No processing or use of the powder form of the PMN substance outside of the site of manufacture/processing; and
  8. No processing or use of the PMN substance in the liquid resin form using an application method that generates a vapor, mist, or aerosol.

The SNUR designates as a “significant new use” the absence of these protective measures.  EPA states that it has determined that “certain information about the health effects of the PMN substance may be potentially useful to characterize the effects of the PMN substance in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR.”  EPA notes that the submitter has agreed not to exceed certain time limits without performing specific physical-chemical property tests and characterization and pulmonary effects testing.  According to EPA, it also determined that the results of a carcinogenicity study would help characterize the potential health effects caused by the PMN substance.  Although the order does not require this test, EPA states that the order’s restrictions “will remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.”

Nanotechnology Industries Association Will Hold Open Webinar on Regulatory Priorities

Posted in International, Legal/Regulatory Issues, OECD

The Nanotechnology Industries Association (NIA) published an open newsletter on September 19, 2018, that includes an invitation to NIA’s October 11, 2018, open webinar on regulatory priorities.  The open webinar will cover the latest news on the nanomaterials definition, amendments to the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Annexes, the Organization for Economic Cooperation and Development (OECD) Malta project, and the latest news on nanowaste management and transport.  The webinar is free and open to non-members.  Bergeson & Campbell, P.C. is a proud member of NIA.

OECD Publishes Case Study on Grouping and Read-Across for the Genotoxicity of Nano Titanium Dioxide

Posted in International, OECD, Research

On September 21, 2018, the Organization for Economic Cooperation and Development (OECD) announced four new case studies on integrated approaches for testing and assessment (IATA), including a Case Study on Grouping and Read-Across for Nanomaterials — Genotoxicity of Nano-TiO2.  The European Union (EU) Joint Research Center (JRC) developed the case study for the genotoxicity of nano-titanium dioxide (TiO2) for illustrating the practical use of IATA.  The case study applies the workflow for grouping and read-across proposed in the European Chemicals Agency’s (ECHA) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) guidance update for nanomaterials and explores the extent to which ECHA’s Read-Across Assessment Framework (RAAF) is applicable to nanoforms for identifying sources of uncertainty associated with the read-across.  According to the case study, the purpose of the read-across exercise was to determine the genotoxic hazard potential of two nano-TiO2 target substances based on the in vitro comet assay results from other TiO2 nanoforms.  Overall, the case study shows the practical application of the ECHA guidance for grouping and read-across of nanomaterials, which was slightly adapted for the case study.  Furthermore, the case study states, it demonstrates the usefulness of cheminformatics techniques to support the grouping hypothesis by identifying the differences between nanoforms and by supporting the weight of evidence.  JRC successfully applied the ECHA RAAF for evaluating the confidence in the read-across argumentation of nanomaterials.  According to the case study, some nanospecific issues were identified for further specification of the RAAF for nanomaterials, in particular the concept of similarity, which cannot be based only on structural similarity for nanomaterials.

OECD states that the objective of the IATA Case Studies Project is to increase experience with the use of IATA by developing case studies that constitute examples of predictions fit for regulatory use.  The aim is to create common understanding of using novel methodologies and the generation of considerations/guidance stemming from these case studies.  OECD published the following three case studies with the case study on nano-TiO2:

  1. Case Study on the Use of Integrated Approaches for Testing and Assessment (IATA) for Estrogenicity of the Substituted Phenols;
  2. Prioritisation of Chemicals Using the Integrated Approaches for Testing and Assessment (IATA)-Based Ecological Risk Classification; and
  3. A Case Study on the Use of Integrated Approaches for Testing and Assessment for Sub-Chronic Repeated-Dose Toxicity of Simple Aryl Alcohol Alkyl Carboxylic Esters: Read-Across.

OECD also published a considerations document summarizing the learnings and lessons of the review experience of the case studies, Report on Considerations from Case Studies on Integrated Approaches for Testing and Assessment (IATA) — Third Review Cycle (2017).