November 19, 2018

November 19, 2018

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November 16, 2018

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OECD Report Presents Findings from Survey Aimed at Investigating Different Types of Risk Assessment

The Organization for Economic Cooperation and Development (OECD) published a July 4, 2018, report entitled Investigating the Different Types of Risk Assessments of Manufactured Nanomaterials:  Identifying Tools Available for Risk Management Measures and Uncertainties Driving Nano-Specific Data Needs.  The report presents the findings from a survey conducted in 2016 that aimed at investigating the different types of risk assessment.  The survey was conducted to gather the following information concerning risk assessments in different member countries:

  • Different types of risk assessment used by jurisdictions, such as:
    • Screening (e., risk and hazard prioritization) level versus a more detailed risk assessment;
    • Level of detail in the assessment; and
    • Jurisdictions that emphasize hazard more than risk/exposure;
  • Levels of uncertainties/assumptions used in these risk assessments;
  • Risk management measures and other outcomes of the assessment; and
  • Risk assessment process(es) used when evaluating manufactured nanomaterials, including uncertainties, data requirements, and characterization/identification.

OECD states that the outcome of the project is an increased understanding of the details and scope of different regulatory risk assessments for manufactured nanomaterials by comparing and contrasting the conditions, assumptions, and levels of uncertainties of approaches used in different jurisdictions.  Best practices could be identified that could be adopted by other countries.  A majority of survey participants identified the following recommendations:

  • There is further need for validated exposure/release scenarios and assessment for nanomaterials;
  • The utility of specific physical-chemical properties to predict environmental fate and hazard must be validated to agree to a set of required characterization parameters, which will likely be specific to the type of nanomaterial being assessed;
  • It is essential to improve the ability to use read-across/grouping/screening tests to assess nanomaterials; and
  • There needs to be continued development of validated test guidelines specific to nanomaterials.
©2018 Bergeson & Campbell, P.C.

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Lynn Bergeson, Campbell PC, Toxic Substances Control Act Attorney, federal insecticide lawyer, industrial biotechnology legal counsel, Food Drug Administration law
Managing Partner

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...

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Carla Hutton, Bergeson Campbell PC, global regulatory attorney, public health activists lawyer, metals industry legal counsel, Toxic Substances Control Act law
Regulatory Analyst

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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