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NNI Holds Webinar on “What We Know about NanoEHS: Risk Assessment and Risk Management”

By Lynn L. Bergeson, Carla N. Hutton & Heidi M. Guenther on November 18, 2021
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The National Nanotechnology Initiative (NNI) held a webinar on November 16, 2021, entitled “What We Know about NanoEHS: Risk Assessment and Risk Management.” The webinar’s 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, Research Physical Scientist, Environmental Laboratory, U.S. Army Engineer 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, Division of Science Integration, National Institute for Occupational Safety and Health (NIOSH).

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

Schubauer-Berigan focused her presentation on the work that has been done in the past ten years on multi-walled and single-walled carbon nanotubes and carbon nanofibers. Schubauer-Berigan discussed studies that show biomarkers that may be able to help in exposure assessment and hazard identification. She discussed the variance in respiratory and dermal exposure in occupational workers, but noted that no one aspect of exposure was most relevant at this time. Future studies in occupational exposure settings will work to address these questions. Schubauer-Berigan did note that multi-walled carbon nanotubes have been listed for re-evaluation by IARC and that this was of particular concern for bulk materials. Future research will need to address risk assessments and evaluations involving bulk materials blended with multi-walled and single-walled carbon nanotubes and carbon nanofibers.

Canady shifted the discussion to the real-life applicability and everyday use of the research that has been produced. Canady spoke to how nanoEHS managers and regulatory bodies can move forward with this information to promote and protect worker safety. He noted that much of the data on exposure assessments is challenging to apply as the studies vary in particles, doses, concentrations, and potency values. He expressed concern that nanoparticle toxicity research can be too varied to assess threshold-based hazards. Canady’s proposed solution is to develop regulatory decision matrices and fund further research so as not to stifle agencies or industry innovation.

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

Photo of Lynn L. Bergeson Lynn L. Bergeson

Owner of Bergeson & Campbell, P.C. (B&C®), Lynn L. Bergeson has earned an international reputation for her deep and expansive understanding of the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), European Union Registration, Evaluation, Authorization…

Owner of Bergeson & Campbell, P.C. (B&C®), Lynn L. Bergeson has earned an international reputation for her deep and expansive understanding of the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), European Union Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), and especially how these regulatory programs pertain to nanotechnology, industrial biotechnology, synthetic biology, and other emerging transformative technologies. Her knowledge of and involvement in the policy process allows her to develop client-focused strategies whether advocating before Congress, the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), or other governance and standard-setting bodies.

Ms. Bergeson counsels corporations, trade associations, and business consortia on a wide range of issues pertaining to chemical hazard, exposure and risk assessment, risk communication, minimizing legal liability, and evolving regulatory and policy matters pertinent to conventional, biobased, and nanoscale chemicals, particularly with respect to TSCA, FIFRA, Food Quality Protection Act (FQPA), REACH and REACH-like programs, and Occupational Safety and Health Administration (OSHA) matters.

She served as chair of the American Bar Association Section of Environment, Energy, and Resources, and has served in many Section leadership positions. She has served on the Board of Directors of the Environmental Law Institute, the NanoBusiness Commercialization Association, and the Product Stewardship Society, among other business and law organizations, and lectures and writes frequently on legal, regulatory, and science policy issues. Ms. Bergeson is also President of The Acta Group (Acta®), B&C’s scientific and regulatory consulting arm, which assists chemical and product manufacturers in marketing and sustaining their products globally, and President of B&C Consortia Management, L.L.C., which helps the chemical industry leverage resources and maximize impact by forming consortia to achieve shared research, testing, regulatory, and access goals.

According to the Chambers USA Guide: “The universally highly regarded Lynn Bergeson of Bergeson & Campbell, P.C. has developed an enviable reputation in chemical and pesticide regulatory work, with particular expertise in nanotechnology. ‘She is probably the premier pesticide lawyer in DC,’ notes one impressed commentator. Peers predict that she is set to become ‘one of the most important lawyers in America.'”

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Photo of Carla N. Hutton Carla N. Hutton

Since 1996, Carla Hutton has monitored, researched, and written about regulatory and legislative issues that may potentially affect Bergeson & Campbell, P.C. (B&C®) clients. She is responsible for creating a number of monthly and quarterly regulatory updates for B&C’s clients, as…

Since 1996, Carla Hutton has monitored, researched, and written about regulatory and legislative issues that may potentially affect Bergeson & Campbell, P.C. (B&C®) clients. She is responsible for creating a number of monthly and quarterly regulatory updates for B&C’s clients, as well as other documents, such as chemical-specific global assessments of regulatory developments and trends. She authors memoranda for B&C clients on regulatory and legislative developments, providing information that is focused, timely and applicable to client initiatives. These tasks have proven invaluable to many clients, keeping them aware and abreast of developing issues so that they can respond in kind and prepare for the future of their business.

Ms. Hutton brings a wealth of experience and judgment to her work in federal, state, and international chemical regulatory and legislative issues, including green chemistry, nanotechnology, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Toxic Substances Control Act (TSCA), Proposition 65, and the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program.

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  • Posted in:
    Environmental and Climate
  • Blog:
    Nano and Other Emerging Chemical Technologies Blog
  • Organization:
    Bergeson & Campbell, PC

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