Risk assessment and risk management


The National Nanotechnology Initiative (NNI) hosted a webinar on November 16, 2021, titled “What We Know About NanoEHS: Risk Assessment and Risk Management.” Webinar speakers explored the impact of advances in risk assessment and risk management on the safe and responsible development of nanotechnology. The panel included:

  • Rick Canady, Director and Founder, NeutralScience L3C;

  • Igor Linkov, Physical Science Researcher, Environmental Laboratory, US Army Engineers Research and Development Center (ERDC);

  • Mary Schubauer-Berigan, Deputy Director, Evidence Synthesis and Classification Branch, International Agency for Research on Cancer (IARC), World Health Organization (WHO); and

  • Paul Schulte, Director, Science Integration Division, National Institute for Occupational Safety and Health (NIOSH).

Schulte introduced the panel and provided the basis for discussing the historical evolution of the environmental, health, and safety aspects of nanomaterials (nanoEHS), what researchers have learned, and the direction of research. Schulte noted that the innovation of nanoparticles has led researchers to perform risk assessments and evaluate risk management by groups or categories, rather than by individual particles. Schulte highlighted the work that has been done in occupational safety and exposure studies, but said most of that research has been limited to extrapolating from animal studies to humans to develop safety limits. occupational exposure. Schulte said epidemiological studies in humans could help ensure that classification group data properly addresses particle overload and the effects of exposure to various combinations of nanoparticles in risk management policy.

Schubauer-Berigan focused his presentation on the work that has been done over the last ten years on carbon nanotubes and multi-walled and single-walled carbon nanofibers. Schubauer-Berigan discussed studies that show biomarkers that may be able to aid in exposure assessment and hazard identification. She discussed the variance of respiratory and dermal exposure among professional workers, but noted that no aspect of exposure was most relevant at this time. Future studies in occupational exposure contexts will help answer these questions. Schubauer-Berigan noted that multi-walled carbon nanotubes have been listed for re-evaluation by IARC and this is of particular concern for bulk materials. Future research should focus on risk assessments and evaluations involving bulk materials mixed with carbon nanotubes and multi-walled and single-walled carbon nanofibers.

Canady moved the discussion to the real-life applicability and everyday use of the research that was produced. Canady explained how nanoEHS managers and regulators can move forward with this information to promote and protect worker safety. He noted that much of the data on exposure assessments is difficult to apply because studies vary in terms of particles, doses, concentrations and power values. He expressed concern that research on nanoparticle toxicity may be too varied to assess hazards based on thresholds. The solution proposed by Canady is to develop regulatory decision matrices and fund further research so as not to stifle agency or industry innovation.

The day’s final panelist, Linkov, expanded on Canady’s proposal, comparing developments in nanotechnology research to developments in knowledge about COVID-19. Linkov asserted that past knowledge and lessons in conventional chemical risk assessment and management can be used to leverage emerging research in the nanoEHS field. He expressed concern that exposure and toxicity assessments may not adequately represent particle migration. Linkov argued for a regulatory approach similar to the regulatory approach for conventional chemicals. Linkov noted that no matter how good risk assessments are, there will always be a gap between risk assessment and the regulatory realm, as innovation will accelerate faster than the ability to acquire data. His solution to this shortcoming is to take known data and historical risk management techniques and apply them to new materials.

Heidi M. Guenther contributed to this article.

©2022 Bergeson & Campbell, CPNational Law Review, Volume XI, Number 322


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