On September 15, 2020, the European Food Safety Authority (EFSA) called for grant proposals on the use of new approach methodologies (NAM) for the hazard assessment of cellulose nanofibers.  EFSA states that the use of cellulose at the nanoscale is increasing and requires an assessment.  According to EFSA, the main concern is that the nanoscale characteristics (e.g., length/shape of the fibers) may influence the toxicokinetic and hazardous properties of cellulose nanofibers.  The main objective of the call is to design and conduct a set of NAM-based studies for addressing the current data gaps and to offer a proposal for including the results in the regulatory hazard assessment of nanocellulose for consumers exposed via food.  The studies should cover the three main areas identified by EFSA:

  • Digestion or degradation, including surface modifications, of nanocellulose by the human microbiome;
  • Assessment of nanocellulose uptake in human intestinal epithelia; and
  • Assessment of local effects, including inflammation, of nanocellulose on the gastrointestinal epithelia.

All studies should be designed using NAMs, avoiding in vivo animal studies, and should specifically address the nanoscale properties.  EFSA states that the studies should also be designed for maximizing the use of the results in the regulatory context, including internal validation protocols and a detailed level of reporting, including access to the raw data for the verification of the results during the regulatory assessment.  The call includes two lots, and applicants may apply to one or both lots:

  • Lot 1 covers the adaptation and use of human cellular models and in vitro microbial gastrointestinal tract (GIT) digestion systems; and
  • Lot 2 focuses on the use of gut-on-a-chip models replicating GIT motility.

The call is restricted to the list of competent organizations established by EFSA’s Management Board.  Proposals are due November 3, 2020.  ECHA expects to notify applicants of the outcome of the call in December 2020.

This week’s All Things Chemical™ Podcast will be of interest to readers of the Nano and Other Emerging Chemical Technologies Blog.  A brief description of the episode written by Lynn L. Bergeson is below.

This week I sat down with Vincent Caprio, Founder and Executive Director of the NanoBusiness Commercialization Association (NanoBCA).  Vince has been on the forefront of nano innovations and optimizing opportunities for businesses to commercialize their nano creations for more than two decades.  In founding the NanoBCA, Vince has placed it at the center of nanotechnology commercialization, national policy, law, and business since the beginning of the public’s focus on nanotechnology.  NanoBCA has provided a much-needed spotlight on how nanotechnology has been a critical driver for the development of advanced materials, smart technology, innovations in chemistry, and a diverse range of other initiatives that have greatly benefited many economic sectors of the economy.  As Chair of the Environment, Health, and Safety (EHS) Committee of the NanoBCA, I have long admired Vince’s vision, organization-building skills, and his seemingly endless list of contacts — there is no one in Washington, D.C., or elsewhere, whom Vince does not know!

In our conversation, Vince shares a bit about the early days of nanotechnology, how NanoBCA helped frame critical EHS issues in a way that moved the technology forward, his relationship with and deep engagement in the activities of the National Nanotechnology Initiative (NNI), his engagement with key Senators and Representatives on nano matters, and what’s next for nanotechnology after the 2020 elections.

ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL  AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW.

According to the Summer 2020 edition of the National Nanotechnology Coordination Office (NNCO) Quarterly Newsletter, the 2020-2021 National Nanotechnology Initiative (NNI) nanomaterial environmental, health, and safety (nanoEHS) webinars will begin in November 2020.  According to the Newsletter, the Nanotechnology Environmental and Health Implications (NEHI) Working Group is planning nanoEHS webinars to present progress in the following areas:  nanomaterial measurement infrastructure; human exposure assessment; human health; environment; risk assessment and risk management methods; and informatics and modeling.  The Newsletter notes that these are the research areas identified in the NNI Environmental, Health, and Safety Research Strategy (NNI EHS Research Strategy).  The inaugural webinar will provide an overview of the research environment when the NNI EHS Research Strategy was developed, the major questions posed, and how collaborations and networks created a research infrastructure to address these questions.  NNI will post more information at https://www.nano.gov/publicwebinars as it becomes available.

The European Chemicals Agency (ECHA) has posted the German Federal Institute for Occupational Safety and Health’s (BAuA) substance evaluation conclusion document for multi-walled carbon nanotubes (MWCNT), synthetic graphite in tubular shape and tangled.  The conclusion provides a summary of how the information on the substance can be used for the purposes of regulatory risk management.

Concern(s) Subject to Evaluation

MWCNTs were originally selected for substance evaluation to clarify concerns about:

  • Wide spread use;
  • Consumer use;
  • Discrepancy in self-classification between different registrants of the joint submission(s);
  • Differences in physico-chemical properties that affect toxicity, e., number of different registered nanoforms and the choice of representative test material(s);
  • Suspected specific target organ toxicity – repeat exposure (STOT RE) (differing no observed adverse effect levels (NOAEL)/no observed adverse effect concentrations (NOAEC) in several animal studies using different forms of the same test material);
  • Suspected carcinogen;
  • Effects on environmental organisms;
  • Suspected environmental exposure;
  • Cumulative exposure; and
  • Suspected persistency.

During the evaluation, BAuA identified further concerns for most of the examined Human Health (HH) endpoints, precluding final conclusions with regard to the hazard assessment of the substance.

Overview of Other Processes/EU Legislation

There are no other ongoing or concluded processes at the EU level for the registered substance.  In 2019, the German Competent Authority (DE-CA) submitted to ECHA a harmonized classification and labeling (CLH) proposal for rigid MWCNT with World Health Organization (WHO) fiber dimensions.

Conclusion of Substance Evaluation

The evaluation of the available information on the substance has led Germany to the following conclusions, as summarized in the table below.

According to the report, in the framework of the substance evaluation, it was not possible to resolve the concerns described above.  The report states that based on ambiguities regarding the registered nanoforms, as well as based on the late updates of some of the dossiers at the very final stage of the substance evaluation, “it does not seem expedient to conclude on the substance evaluation with a decision on data requests at the present time.”

The report notes that 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.  In BAuA’s opinion, “these information requirements were not (adequately) addressed by the registrants yet.  Thus, further action is needed.”

According to the report, BAuA currently considers it necessary for ECHA to examine first if all information according to REACH Annex VI are available within the framework of a compliance check.  If information is missing, these data should be requested by respective decisions.  Once all data are available, it has to be decided if further information is needed to clarify a remaining concern and if this should be requested in the framework of a compliance check or a substance evaluation.

Apart from potential requests as consequences of a compliance check, the report urges registrants to update their dossiers and/or develop testing proposals to adhere to REACH requirements.

Conclusions Tick Box
Need for follow-up regulatory action at EU level
Harmonized Classification and Labeling
Identification as Substance of Very High Concern (SVHC) (authorization)
Restrictions
Other EU-wide measures
Currently no need for regulatory risk management follow-up action at EU level; outcome of compliance check needs to be awaited first

Currently No Follow-Up Foreseen at EU Level

Not possible for the time being.  Compliance check is needed first.

Tentative Plan for Follow-Up Actions (If Necessary)

Follow-Up Action Date for Intention Actor
Compliance check To be determined (TBD) ECHA
Potential inclusion to the Community Rolling Action Plan (CoRAP) for resuming substance evaluation TBD DE-CA

According to the report, the need for a re-opening of the substance evaluation process will be determined based on the outcome of the new information generated via the Compliance Check procedure.

On August 31, 2020, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion entitled “Nanosilver in healthcare — does the silver bullet exist?” by Dr. Dorota Napierska, Chemicals Policy and Projects Officer, Health Care Without Harm Europe (HCWH Europe).  Napierska examines how beneficial the properties of nanosilver are in clinical settings and the risks involved.  Napierska notes that a key point in assessing the toxicity of nanosilver is to adopt toxicological standardized assessment methods that are suitable for nanomaterials.  According to Napierska, “there are still significant uncertainties regarding required environmental risk assessment for nanomaterials.”  Napierska states that “[t]the nanotechnologies used in healthcare products need to be evaluated not only for their initial antiviral activity but also for their durability under conditions of use and how well they stand up to repeated cleaning and disinfection (i.e. assessed for leaching potential).”  Napierska urges that the application and commercialization of silver-related products and technologies be “critically reassessed for both safety and necessity.”

The U.S. Environmental Protection Agency (EPA) announced on August 27, 2020, that it submitted an information collection request (ICR), “Chemical-Specific Rules under the Toxic Substances Control Act Section 8(a); Certain Nanoscale Materials” to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (PRA).  85 Fed. Reg. 52995.  The ICR covers reporting and recordkeeping requirements for persons who manufacture or process chemical substances as nanoscale materials.  Under Section 8(a) of the Toxic Substances Control Act (TSCA), EPA requires reporting and recordkeeping for certain chemical substances as nanoscale materials.  Persons who manufacture or process these nanoscale materials must notify EPA of certain information, including production volume, methods of manufacture and processing, exposure and release information, and available health and safety information.  EPA states that the reporting of these activities will provide it “with an opportunity to evaluate the information and consider appropriate action under TSCA to reduce any risk to human health or the environment.”  EPA will use the reported information to inform its assessments of new chemical nanoscale materials submitted under TSCA Section 5.  EPA proposes to extend the ICR, which is currently approved through August 31, 2020.  Public comments were previously requested via the Federal Register on January 28, 2020, during a 60-day comment period.  Comments are due September 28, 2020.

According to the notice, the entities potentially affected by this ICR are nanomaterial manufacturers and nanomaterial processors.  EPA estimates that there will be 285 respondents per year and that the total estimated burden is 40,089 hours per year.  EPA states that there is a decrease of 106,766 hours in the total estimated respondent burden compared with the ICR currently approved by OMB.  According to EPA, the decrease reflects its expectation of decreased submissions.  In the previous ICR period, the rule required an initial one-time reporting on current nanomaterials, while the reporting covered in this period requires only the reporting of new nanomaterials.  EPA notes that furthermore, the burden estimates assume that the same manufacturers will report each year and, therefore, will have already undertaken rule familiarization in the previous ICR period.  More information on EPA’s TSCA Section 8(a) rule is available in our January 12, 2017, memorandum, “EPA Promulgates Final TSCA Reporting and Recordkeeping Rule for Nanoscale Materials.”

The U.S. National Nanotechnology Initiative (NNI) and European Commission (EC) have organized the ninth annual meeting of the environmental, health, and safety effects of nanomaterials (nanoEHS) Communities of Research (COR) as a virtual workshop on September 16-17, 2020.  According to NNI, as the nanoEHS research ecosystem continues to evolve, the workshop will identify future needs and opportunities.  Conversations will further address how the lessons learned from nanoEHS research can be applied to other areas such as emerging technologies and incidental nanomaterials.  NNI states that the workshop will foster high-level discussions of nanoEHS and related areas to explore connections and synergies that will drive responsible development into the coming decades.  The workshop will run for four hours each day.  Webcast plenaries will include a live question and answer portion.  Breakout sessions will feature interactive discussion.  The draft agenda is available.  Registration is free.

The European Union’s (EU) Horizon 2020 project GRACIOUS has launched its stakeholder engagement platform and started an open consultation on the GRACIOUS Framework.  The GRACIOUS project invites stakeholders from industry, regulators, policy makers, consultants, non-governmental organizations (NGO), and academia to use the platform to provide their opinions on the progress within the project, including whether the structure of the GRACIOUS Framework is “clear and appropriate” for all stakeholders.  The Framework is intended to streamline the process for assessing the risk of nanomaterials by logically grouping them, thereby allowing extrapolation between (read-across) nanomaterials and reducing the need to assess exposure to and toxicity on a case-by-case basis.  Comments are due August 31, 2020.  The project will use all feedback to refine the Framework further for its official launch in 2021.

The European Union (EU)-funded projects NanoHarmony and NANOMET-Organization for Economic Cooperation and Development (OECD) have jointly organized a September 16, 2020, webinar on “The Pathway to Test Guidelines:  from science to standards for nanomaterials.”  Participants will learn how OECD develops Test Guidelines, using case studies from the Test Guidelines that are supported through the projects for expansion into nanomaterials.  The webinar will explain how novel methodologies are developed and approved through expert committees, eventually becoming internationally accepted standard methods used by governments, industry, and independent laboratories to assess the safety of chemicals.  The webinar is relevant for any stakeholder interested in how chemicals are developed and demonstrated as safe for market within a global framework of countries.

The European Commission’s (EC) Joint Research Center (JRC) and the Directorate-General for Research and Innovation (RTD) will jointly organize a virtual “Workshop on Safe and Sustainable Smart Nanomaterials” on September 9-10, 2020.  The workshop is focused on smart (responsive, multi-functional) nanomaterials, as such or embedded in products, that are developed for application in industrial sectors such as agriculture, food, packaging, and cosmetics.  The program is structured in four sessions of presentations, each followed by a dedicated breakout session:

  • Session 1, “Designing Smart Nanomaterials,” will be entirely dedicated to developers;
  • Session 2, “From Safe-by-Design to Safe-and-Sustainable-by-Design,” will give the floor to experts on assessing safety and sustainability of nanotechnology, to illustrate and discuss challenges with smart nanomaterials;
  • In Session 3, “Regulatory Preparedness,” regulators will present the legislative context and some initiatives concerning smart nanomaterials; and
  • Session 4, “How to shift towards a more sustainable path? Implications of the Chemical Strategy for Sustainability,” will be dedicated to consult the priority areas of Sustainable-by-Design in view of Horizon Europe, the European Union’s (EU) next framework program for research and innovation.

The conference is open to experts from authorities, research organizations, and industry.  Registration is required.