The National Nanotechnology Coordination Office (NNCO) is scheduled to publish on January 27, 2020, a Federal Register notice concerning public meetings under the National Nanotechnology Initiative (NNI).  According to the notice, the NNCO will hold one or more workshops, webinars, networks, and Community of Interest teleconferences between the publication date of the Federal Register notice and December 31, 2020.  Attendance information, including addresses, will be posted at https://www.nano.gov.  Information about upcoming workshops and webinars will be posted at https://www.nano.gov/events/meetings-workshops and https://www.nano.gov/PublicWebinars.  More information on the Communities of Interest is available at https://www.nano.gov/Communities.

We are pleased to announce that Lynn L. Bergeson will present at the 9th Nano Conference hosted by the Sustainable Nanotechnology Organization (SNO) and Nanotechnology, Occupational and Environmental Health (NanOEH) Committee.  Abstracts for the October 4-6, 2020, Conference are due March 6, 2020.  As reported in our December 9, 2019, blog item, the Conference will address:

  • Green/advanced synthetic materials and manufacturing;
  • Nanomedicine, nanodrugs, and pharmaceutical and medical applications;
  • Nanotoxicology related to humans;
  • Eco-toxicology;
  • Occupational and environmental exposure assessment;
  • Global challenges;
  • Sustainable water treatment and remediation;
  • Fate and transport;
  • Sustainable food and agriculture;
  • Sustainability and energy;
  • Devices and sensors;
  • Epidemiology;
  • Education panel; and
  • Regulation and policy.

The Conference will be held in Denver, Colorado.

As of January 1, 2020, companies must provide more information on nanomaterials on the European Union (EU) market under the updated Annexes to the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation.  ECHA organized a webinar on November 12, 2019, on the revised annexes and how companies can prepare to meet the new requirements.  ECHA states that the first part of the webinar explained what a nanoform is and how to build a set of similar nanoforms.  It also explained how to fulfill data requirements for the characterization of nanoforms.  The second part introduced new International Uniform Chemical Information Database (IUCLID) fields for reporting the characterization parameters of nanoforms and gave some practical examples on how to use the different fields.  During the webinar, participants had the chance to ask questions from ECHA experts.  In December 2019, ECHA published a questions and answers (Q&A) document that compiles and groups Q&As received during the webinar.  In the document, ECHA further elaborated on the replies and complemented them with additional advice intended to support registrants.  Topics addressed by the Q&A document include:

  • Support documentation;
  • Registration obligation;
  • Definition of a nanoform;
  • Set of similar nanoforms;
  • Particle size distribution;
  • Shape including aspect ratio and assembly structure;
  • Surface functionalization/treatment;
  • Specific surface area (SSA);
  • Reporting and submission;
  • Joint submission;
  • Annex VII-XI information requirements;
  • Chemical safety assessment and supply chain communication;
  • Inquiry; and
  • Challenges.

Bergeson & Campbell, P.C. (B&C®) and its consulting affiliate The Acta Group (Acta®) published on January 9, 2020, our “Forecast for U.S. Federal and International Chemical Regulatory Policy 2020.”  In this richly detailed and comprehensive document, the legal, scientific, and regulatory professionals of B&C and Acta distill key trends in U.S. and global chemical law and policy, and provide our best informed judgment as to the shape of key developments we are likely to see in the New Year.  The document includes a list of B&C speeches and writings, as well as a list of B&C webinars and podcasts available on demand.

On January 3, 2020, the National Nanotechnology Initiative (NNI) announced that it is expanding its podcast offerings in 2020.  The three podcast series will consist of interviews between Dr. Lisa Friedersdorf, Director of the National Nanotechnology Coordination Office (NNCO), and various experts, and will explore nanotechnology from three different perspectives:

  • Stories from the NNI, a series that began in 2019, features conversations with experts from the NNI community who share their perspective on advances that have been made and future prospects of nanotechnology;
  • Nano Matters episodes will explore specific nanotechnology topics for a broad audience; and
  • Nano Entrepreneurship Network episodes will highlight best practices, resources, and advice from nanotechnology entrepreneurs and those who support them.

Beginning January 6, 2020, NNI will release a new episode every Monday.

The European Food Safety Authority (EFSA) has announced a call for abstract submissions for oral presentations, posters, and poster pitches at its colloquium on “A coordinated approach to assess the human health risks of micro- and nanoplastics in food,” which will be held in Lisbon on June 8-9, 2020.  EFSA states that “[m]icroplastics are small particles of plastic less than 5mm in size; nanoplastics are even smaller, ranging from 1 to 100 nanometres (N.B. 1 nanometre equals one-millionth of a millimetre).”  In 2016, EFSA identified the need to generate more data on their occurrence levels in food and on their potential effects on human health following exposure.  According to EFSA, although international reports on microplastics and nanoplastics have been published recently, many of the food safety aspects remain unaddressed.  EFSA’s objectives are to:

  • Bring stakeholders together;
  • Understand the current state of play and ongoing research on this topic; and
  • Build possible synergies.

The program will include presentations and discussion groups exploring the following questions on microplastics and nanoplastics in food and feed:

  • Risk assessment: What data gaps need filling to allow risk assessments for health?
  • Society: What is driving public concerns, and what can help EFSA to understand people’s risk perceptions?

The deadline for submissions is January 31, 2020.

The National Institute for Occupational Safety and Health (NIOSH) published a Federal Register notice on December 17, 2019, requesting information on toxicological and physicochemical data of engineered nanomaterials (ENM) to evaluate in developing categorical occupational exposure limits (OEL).  84 Fed. Reg. 68935.  As reported in our December 16, 2019, blog item, NIOSH intends to develop categorical OELs based on the available scientific evidence regarding the hazard or safety of ENMs.  NIOSH seeks to obtain information, including published and unpublished reports and research findings, to evaluate the possible adverse health risks of occupational exposure to ENMs.  Information is due by February 18, 2020.  NIOSH will publish a Technical Report that describes the data, methods, and findings for the development of categorical OELs for ENMs, which may include relevant information submitted in response to this request.  NIOSH will make the draft Technical Report available for public comment in a subsequent Federal Register notice.

The National Institute for Occupational Safety and Health (NIOSH) is scheduled to publish a Federal Register notice on December 17, 2019, requesting information on toxicological and physicochemical data of engineered nanomaterials (ENM) to evaluate in developing categorical occupational exposure limits (OEL).  According to the notice, NIOSH intends to develop categorical OELs based on the available scientific evidence regarding the hazard or safety of ENMs.  NIOSH seeks to obtain information, including published and unpublished reports and research findings, to evaluate the possible adverse health risks of occupational exposure to ENMs.  Information will be due 60 days after the notice is published in the Federal Register.

NIOSH states that “development of an OEL for an individual chemical involves a critical review of the available scientific data in humans and animals to identify relevant studies and to characterize the various lines of evidence that can support the derivation of the OEL.”  NIOSH requests human, animal, and cellular toxicology data, including but not limited to:  acute, subchronic, or chronic data; the physicochemical characterization of those ENMs; and other information about the biological mechanisms and toxicological effects of ENMs.  NIOSH also seeks information on studies that evaluate the dose-response relationships between exposure to ENMs and the development of adverse lung effects including inflammation, fibrosis, or neoplasia.  According to the notice, NIOSH will publish a Technical Report that describes the data, methods, and findings for the development of categorical OELs for ENMs, which may include relevant information submitted in response to this request.  NIOSH will make the draft Technical Report available for public comment in a subsequent Federal Register notice.

The European Commission’s (EC) Joint Research Center (JRC) recently published a JRC Science for Policy Report entitled Identification of nanomaterials through measurements that is intended to support the implementation of the EC’s Recommendation on the definition of nanomaterials (2011/696/EU).  It is a follow-up of a previous JRC Science for Policy Report on concepts and terms used in the definition.  The present report addresses identification of nanomaterials by measurements and discusses options and points to consider when assessing whether a particulate material is a nanomaterial, according to the definition of nanomaterials.  According to JRC, the primary criterion against which particulate materials should be assessed is the median of the number-based distribution of the external dimensions of the particles.  The particles to be measured are the constituent particles of the material, regardless whether these particles appear separate from one another or are parts of aggregates or agglomerates.  JRC states that the main steps to identify nanomaterials by measurements are collecting information on the material, acquiring knowledge of the measurement method(s), matching method(s) and material, sample preparation, measurement/analysis, and decision (nanomaterial/no nanomaterial).  JRC notes that assessing particle size measurements requires specification of the measurand, the physical principle of the measurement technique, the applied sample preparation protocol, the covered size range, and the data analysis procedure to allow a reliable classification of a material according to the EC nanomaterial definition.  JRC provides examples and practical options for consideration, including a flowchart that can assist users with relevant technical knowledge in the identification of nanomaterials.

On December 11, 2019, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion entitled “The innovator, the regulator and the citizen — building public trust through transparent, empowered and safe innovation.”  Carlos Eduardo Lima da Cunha, the European Commission (EC), explains how the EU is supporting safe by design approaches to new technologies such as nanomaterials to deliver safer products to the market.  Lima da Cunha notes that the EU has monitored and funded the development of nanomaterials for more than 15 years, with a special focus on understanding their potential harm to human health and the environment.  According to Lima da Cunha, it is time to apply that knowledge to use and design nanomaterials in a safe and functional way.  Lima da Cunha states:  “In a society where economy, industry and society will be more closely integrated and the trend is to have an ever-increasing number of personalised products and services, the development of any new and advanced (nano)materials in Europe will rely heavily on work done in innovation testbeds using safe by design approaches to deliver faster and safer products to Europeans.”