Nano and Other Emerging Chemical Technologies Blog

Nano and Other Emerging Chemical Technologies Blog

Regulatory & legal developments involving nano and other emerging chemical technologies

Safe Work Australia Guidance Includes Advice on Fine Dusts and Nanomaterials

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

In August 2018, Safe Work Australia (SWA) issued a national guide on classifying hazardous chemicals.  SWA intends the guidance for manufacturers and importers of substances, mixtures, and articles who have a duty under the Work Health and Safety (WHS) Act and Regulations to classify them.  SWA suggests that the guidance may also be useful for suppliers, persons undertaking business and undertakings, workers, and other persons involved with hazardous chemicals.  The guidance provides advice on specific situations, including fine dusts and nanomaterials.  The guidance states that particles in the “nano” scale (one billionth of a meter) may exhibit characteristics unlike similar materials examined at larger scales and must be appropriately classified.  According to the guidance, if the health hazards of nanoparticles are not fully characterized, it is recommended that an appropriate safety data sheet (SDS) be prepared and the container is labeled:

  • Contains engineered/manufactured nanomaterials. Caution:  Hazards unknown; or
  • Contains engineered/manufactured nanomaterials. Caution:  Hazards not fully characterized.

The guidance states that “[t]hese phrases are to be used on an interim basis only, as the manufacturer or importer has a duty to correctly classify the chemical and include information on known hazards on the label and within the SDS.”

OIRA Seeks Comment on How to Reduce Regulatory Differences between the U.S. and Canada, Including for Emerging Technologies Not Yet Regulated

Posted in Federal, Legal/Regulatory Issues, United States

The Office of Information and Regulatory Affairs (OIRA) published a request for information (RFI) on October 9, 2018, seeking comment on how the federal government, under the auspices of the Regulatory Cooperation Council (RCC), may reduce or eliminate unnecessary regulatory differences between the U.S. and Canada.  According to the RFI, this information may inform agencies’ development of regulatory reform proposals to modify or repeal existing agency requirements to increase efficiency related to economic activity with Canada, reduce or eliminate unnecessary or unjustified regulatory burdens, or simplify regulatory compliance, while continuing to meet agency missions and statutory requirements.  OIRA also seeks public comment to identify ongoing or emerging areas for which cooperation could reduce the risk of divergence between U.S. and Canadian regulations.  In 2012, Health Canada, Environment Canada, and the U.S. Environmental Protection Agency developed the Nanotechnology Work Plan, and RCC concluded its Nanotechnology Initiative in February 2014.  OIRA states in the RFI that it has identified some key topics on which stakeholder insights would be “most helpful,” although it welcomes input on opportunities for international regulatory cooperation beyond these topics, including particular sectors or issues for which the RCC should consider future regulatory cooperation or further regulatory alignment to reduce burden or other cost, including for emerging technologies that are not yet regulated.  Comments are due November 8, 2018.

EPA Posts Final Work Plan for Nanosilver Registration Review Process

Posted in Federal, Legal/Regulatory Issues, Research, United States

On October 19, 2018, the U.S. Environmental Protection Agency (EPA) posted the Final Work Plan (FWP) for the nanosilver registration review process under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The FWP explains what the Office of Pesticide Programs (OPP) “knows about nanosilver generally, highlighting anticipated data and assessment needs for each unique nanosilver chemistry, identifying the types of information that would be especially useful to the Agency in conducting the review, and providing an anticipated timeline for completing review of the nanosilver case.” According to the FWP, EPA has identified the following use patterns to date: swimming pool/spa treatments; and material preservative products for coatings, textiles, and plastics. The FWP states that people may be exposed to nanosilver through inhalation and dermal exposures while applying the products to swimming pools and from incidental oral exposures during swimming. Further exposures may come from material preservative uses either while applying or from nanosilver that leaches out when textiles and plastics are washed. Nontarget organisms can be exposed when swimming pool water is released or when nanosilver used as a material preservative leaches. The FWP includes the following anticipated registration review schedule:

Anticipated Activity Target Date* Completion Date
Phase 1: Opening the Docket
Open Docket and 60-Day Comment Period for Preliminary Work Plan 2012-06 2012-06-07
Close Public Comment Period 2012-08 2012-06-09
Phase 2: Case Development
Issue Final Work Plan 2018-09 2018-10
Issue Data Call-In (DCI) 2018-10
Receive Data to be Considered in Risk Assessment 2020-10
Open 60-Day Public Comment Period for Preliminary Risk Assessment(s) 2021-06
Close Public Comment Period 2021-08
Phase 3: Registration Review Decision and Implementation
Open 60-Day Public Comment Period for Proposed Decision 2022-01
Close Public Comment Period 2022-03
Issue Final Decision 2022-05
Begin Post-Decision Follow-up 2022
Total (years) 10

*The anticipated schedule will be revised as necessary (e.g., need arising under the Endocrine Disruptor Screening Program with respect to the active ingredients in this case).

According to the FWP, EPA “anticipates the need to require generation and submission of human health hazard and exposure data and to conduct a human health risk assessment for nanosilver during registration review.” The FWP states that EPA plans to conduct an environmental risk assessment for the nanosilver uses, “particularly focusing on materials preservative uses, such as plastics and textiles if the particular nanosilver chemistries are shown to leach, and swimming pool uses.” Any of the other use patterns may also be subject to ecological assessment if the fate and product chemistry profiles indicate the potential for environmental exposures. According to the FWP, the risk assessment integrates the environmental fate and effects data to determine if any uses pose risks to nontarget organisms. Potential risks to fish, aquatic invertebrates, aquatic plants, and birds and mammals will be assessed after the data gaps specified in the FWP are satisfied and the relevant data are available.

EPA invites any label amendments that could be considered to eliminate the anticipated need to require certain data, reduce the possibility that EPA’s planned risk assessments overestimate risk due to reliance on conservative assumptions, and/or improve label clarity. EPA anticipates issuing in 2018 a DCI requiring the data set out in Table 7 of the FWP, “Studies Anticipated as Needed for Nanosilver Registration Review.”

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: