On October 11, 2019, the U.S. Environmental Protection Agency (EPA) published proposed significant new use rules (SNUR) for 31 chemical substances, including multiwalled carbon nanotubes (generic), that were the subject of premanufacture notices (PMN).  84 Fed. Reg. 54816.  EPA notes that eight of the chemical substances are subject to orders under the Toxic Substances Control Act (TSCA) issued by EPA.  The effective date of the TSCA Section 5(e) order for multiwalled carbon nanotubes (generic) was May 3, 2019.  According to EPA, the PMN states that multiwalled carbon nanotubes (generic) will be used in heat transfer, heat storage, thermal emission, and general temperature management in heat-generating systems, such as electronics, to improve mechanical properties or electrical conductivities of other materials or products and for light absorption properties.  The proposed SNUR states that EPA identified concerns for pulmonary toxicity based on carbon nanotube analogues and for aquatic toxicity when the substance is at low concentrations and in the presence of natural organic matter.  EPA issued the consent order under TSCA Sections 5(a)(3)(B)(ii)(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 substance may present an unreasonable risk of injury to human health and the environment.  To protect against these risks, the TSCA Section 5(e) order requires:

  1. Use of personal protective equipment by workers to prevent dermal exposure where there is potential dermal exposure;
  2. Use of a National Institute of Occupational Safety and Health (NIOSH) certified respirators with an Assigned Protection Factor (APF) of at least 50 workers to prevent inhalation exposure where there is potential inhalation exposure;
  3. Refrain from using the PMN in applications that generates a dust, vapor, mist, or aerosol, unless such application method occurs in an enclosed process;
  4. Process and use of the PMN substance only as described in the PMN;
  5. No release of the PMN substance to surface waters; and
  6. Disposal only by incineration or landfill.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.  Comments are due November 12, 2019.

On October 7, 2019, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion by Lise Bitsch, Governing Nanotechnologies through Societal Engagement (GoNano), entitled “Strengthening societal engagement with nanotechnologies.”  Bitsch presents several arguments for why actors in the research and innovation world of nanotechnologies and other key enabling technologies should care about societal engagement.  Bitsch also explains what societal engagement is by using the Horizon 2020 project GoNano as an example.

The European Chemicals Agency (ECHA) issued a press release on October 8, 2019, reminding companies that by January 1, 2020, companies must provide more information on nanomaterials on the European Union (EU) market under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation.  The new information requirements concern companies that manufacture or import nanoforms of substances that are subject to registration under REACH.  As reported in our December 4, 2018, blog item, the European Commission (EC) amended several REACH Annexes to introduce clarifications and new provisions for:

  • Characterization of nanoforms or sets of nanoforms covered by the registration (Annex VI);
  • The chemical safety assessment (Annex I);
  • Registration information requirements (Annexes III and VII-XI); and
  • Downstream user obligations (Annex XII).

ECHA states that the purpose is to ensure that companies provide enough information to demonstrate the safe use of their nanoforms for human health and the environment.  The amendments apply to all the new and existing registrations covering nanoforms.  ECHA states that it expects registrants to update their existing dossiers with nanoform-specific information by January 1, 2020.

ECHA notes that its new nano-specific guidance is intended to help companies comply with the changes in Annex VI.  In addition, ECHA is updating the guidance on read-across between nanoforms or sets of nanoforms to reflect the changes.  ECHA intends to have both documents ready by the end of 2019.  ECHA is also updating the 2017 ECHA guidance for human health and the environment.  According to ECHA, the Organization for Economic Cooperation and Development (OECD) is revising some of its existing test guidelines used under REACH to ensure that data generated on nanoforms is reliable and meets regulatory standards.  An overview of the revised REACH Annexes and the available test methods is available on the EU Observatory for Nanomaterials (EUON) website.

On October 30, 2019, the International Uniform Chemical Information Database (IUCLID) will be updated with new data fields for reporting the characteristics of nanoforms and sets of nanoforms.  Beginning October 30, 2019, registrants who intend to submit registrations covering substances in nanoform must provide complete characterization information on their nanoforms or sets of nanoforms.  According to ECHA, the completeness check will include a verification that the sets of nanoforms are accompanied by a justification for creating the set.  As before, the IUCLID tool will include the means to link these nanoforms or sets of nanoforms with the relevant data on their properties and hazards in the other parts of the dossier.  ECHA states that companies submitting information on nanoforms must use the new version of IUCLID because it is not possible to prepare a successful submission with previous versions.

As reported in our September 27, 2019, blog item, ECHA is hosting a webinar on November 12, 2019, to introduce the guidance on identifying and reporting nanoforms and sets of nanoforms.  During the webinar, companies will have the opportunity to get advice directly from ECHA’s experts.  ECHA notes that its help desk is available to assist companies prepare for the new requirements.

We are pleased to announce that the Fall 2019 issue of The SciTech Lawyer, published by the American Bar Association’s (ABA) Section of Science and Technology Law, includes an article co-authored by Lynn L. Bergeson and Carla N. Hutton, “Nanotechnology and Regulatory Certainty Closer Now Than Ever.”  Nanoscale technologies and their resultant innovations have long captured the imaginations of scientists and inventors, the scrutiny of regulators, and the apprehension of nongovernmental organizations and consumer watchdogs.  Over the past decade or so, however, a compelling case can be made that the scientific and regulatory communities have done a credible job of allaying these initial concerns and thus can claim victory over nay-sayers who portended global calamity occasioned by the commercialization of nano-enabled products.  The article provides an overview of how the U.S. Environmental Protection Agency (EPA) and U.S. Food and Drug Administration (FDA) are using their existing authorities to ensure that nanomaterials do not pose a risk to human health and the environment.  The complete article is available only to Section members.

According to an item in the September 2019 issue of NIOSH eNews, the National Institute for Occupational Safety and Health (NIOSH) is working with RTI International to distribute a survey to companies that manufacture, distribute, fabricate, formulate, use, or provide services related to engineered nanomaterials.  The item states that the goal of the survey is to assess the impact of NIOSH’s contribution to guidelines and risk mitigation practices for the safe handling of engineered nanomaterials in the workplace.  NIOSH will use feedback from the survey to inform its research agenda, enhancing the relevance of guidance intended to manage nanomaterial workers’ safety and health.  The item notes that the survey takes only about 20 minutes to complete.  Adrienne Eastlake, aeastlake@cdc.gov, is the contact for any questions.

On November 12, 2019, the European Chemicals Agency (ECHA) will hold a webinar on the amended information requirements for nanoforms under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation.  As reported in our December 4, 2018, blog item, the European Commission (EC) announced on December 3, 2018, that it adopted amendments to several REACH Annexes to clarify the information requirements for nanomaterials.  The amended requirements will apply beginning January 1, 2020.  ECHA states that the updated Annexes introduce new concepts:  nanoform and a set of similar nanoforms.  The updated REACH Annex VI also defines specific characterization parameters for the nanoforms of substances.  The first part of the November 12, 2019, webinar will explain what a nanoform is and how to build a set of similar nanoforms.  It will also explain how to fulfil data requirements for the characterization of nanoforms.  The second part will introduce new International Uniform Chemical Information Database (IUCLID) fields for reporting the characterization parameters of nanoforms and give some practical examples on how to use the different fields.  Attendees will also have the chance to ask questions from ECHA’s experts.

On September 19, 2019, the European Union (EU) Observatory for Nanomaterials (EUON) announced the results of a study it commissioned to examine “next generation” nanomaterials and determine whether the current terminology used in the EU chemicals regulations, as well as the implementation of the current legal requirements for identifying nanomaterials, are likely to pose technical challenges.  The objectives of the study were to:

  • Collect existing definitions of generations of nanomaterials;
  • Refine these definitions to allow the sorting of different nanomaterials into different generations unambiguously;
  • Establish an inventory of second or higher generation nanomaterials on the market or close to the market; and
  • Assess the suitability of the terms “substance,” “mixture,” and “article” and of the identification and characterization parameters included in the revised Annex VI of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation to describe the next generation nanomaterials found.

According to EUON, the study findings “indicate that although the regulatory framework is well-equipped to handle these materials in the near future, further guidance would benefit companies registering nanomaterials” under REACH.  The study recommends further clarifications for some parameters characterizing both nanomaterials and their uses and that the guidelines on how to determine whether an object is an article under REACH could be complemented with specific examples of different nanomaterials, from simple nanoparticles to more complex assembly structures.  EUON states that the European Chemicals Agency (ECHA) is updating its guidance on the identification of nanomaterials following the amendments to the REACH Annexes.  The updated guidance is expected to be published later in 2019.

The National Nanotechnology Initiative will hold a webinar on October 8, 2019, on “Evaluating Worker and Consumer Exposure to Engineered Nanomaterials.”  The webinar, part of NNI’s 2019 series on the environmental, health, and safety effects of nanomaterials (nanoEHS), will examine the tools, techniques, and successes in assessing and managing potential effects of engineered nanomaterials (ENM) in the workplace and consumer environments.  According to NNI, the presentations will provide insights into the challenges, similarities, and key advances in understanding the potential effects of exposure to ENMs, including the development of biomarkers of exposure.  Dr. Paul Schulte, Director of the Division of Science Integration, National Institute for Occupational Safety and Health (NIOSH), and Dr. Joanna Matheson, Toxicologist, Directorate for Health Sciences, Consumer Product Safety Commission (CPSC), will speak.  Dr. John Howard, NIOSH Director, will moderate.  Webinar viewers will be able to submit questions for the panelists to answer during the question and answer period.  Submitted questions will be considered in the order received and may be posted on the NNI website.  Registration is required.

NNI will hold the final webinar in its 2019 nanoEHS series, “Global Harmonization of Nanoinformatics:  A Case Study in Convergence and Team Science,” on November 12, 2019.  The speakers will include Dr. Christine Hendren, Duke University, and Dr. Fred Klaessig, Pennsylvania Bio Nano Systems LLC.

The European Union (EU) Observatory for Nanomaterials (EUON) has created a Nanopinion section, where it invites views from different contributors ranging from policy-makers and authorities to industry and civil society on their work and priorities related to nanomaterials on the EU market.  The first item, posted on September 16, 2019, is “EUON:  past, present and future,” written by Bjorn Hansen, Executive Director of the European Chemicals Agency (ECHA).  As reported in our July 11, 2019, blog item, in July 2019, ECHA finished a mid-term review to assess where it has succeeded and where it can improve over the remaining years of the mandate that it host and maintain EUON.  Hansen notes that the review highlighted areas where EUON can improve, including the need to:

  • Enhance its communication;
  • Provide more detailed information on nanomaterials for experts; and
  • Provide more simplified information on nanomaterials to the public.

In addition to the incorporation of two databases to the EUON, NanoData (the nano-technology knowledge base) and the eNanoMapper (with data and tools for the risk assessment of nanomaterials), EUON also produces independent studies on different safety aspects with the aim of generating new data on topical issues and complementing already existing research.  According to Hansen, EUON is preparing in final a study on the next-generation nanomaterials and working on three new studies:

  • Critical review of the factors determining dermal absorption of nanomaterials and available tools for the assessment of dermal absorption;
  • Critical review of studies on the reproductive and developmental toxicity of nanomaterials; and
  • Perception of nanomaterials among the general public.

As reported in our July 8, 2019, blog item, EUON recently launched a search tool that combines data submitted by companies in their registration dossiers under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation, data collected about nanomaterials used as ingredients in cosmetic products under the Cosmetics Regulation, and data from the Belgian and French public national nanomaterial inventories.  Hansen predicts that the data available on nanomaterials “will see an exponential increase as of 2020 when new information requirements for REACH enter into force, feeding the EUON with more data for its various audiences.”  Industry will submit this new information via updates of their REACH registration dossiers.  EUON invites its stakeholders and partners to use Nanopinion “to share their views on anything and everything to do with nanomaterials, their safety and their benefits.”  Stakeholders who would like to contribute with a Nanopinion post of their own should contact EUON.

The September 10, 2019, issue of the U.S. Environmental Protection Agency’s (EPA) Science Matters newsletter includes an article entitled “Keeping up with 3D Printing:  EPA Researchers Build on New Plastic Emissions Study.”  According to the article, EPA scientists, through an agreement with the Consumer Products Safety Commission (CPSC), are investigating whether increased use of 3D printers can lead to unintended adverse impacts to human health.  EPA states that while there have been studies on the effects of volatile organic compounds (VOC) from 3D printing, none have considered how the emissions change when certain additives are introduced to the 3D printing filament.  The scientists studied a commonly available filament that is sold both with and without carbon nanotube inclusions to determine whether VOC emissions changed between the two types of product.  The scientists quantified and characterized VOC emissions from carbon nanotube filaments under a variety of conditions intended to simulate the different heating, melting, and forming of plastics that can occur during 3D printing.  The scientists concluded that:  (1) the filaments with carbon nanotubes emitted two new VOC gases that could potentially pose an inhalation hazard to users printing several kilograms of material; (2) increased print temperature had the most significant effect on increasing VOC emissions, followed by increased length of time heating the material; and (3) carbon nanotube filament may “trap” certain VOC gases in particulates of the printed plastic.  The article notes that EPA’s research to understand exposure to and the health effects of nanomaterials is conducted as part of the interagency National Nanotechnology Initiative (NNI).  Other NNI members conducting research on 3D printer nanomaterials include CPSC and the National Institute of Standards and Technology (NIST).