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Volume XI, Number 337

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Comment Period Begins on Draft NIOSH Report on Approaches to Developing Occupational Exposure Limits or Bands for Engineered Nanomaterials

On July 13, 2021, the National Institute for Occupational Safety and Health (NIOSH) announced the availability of a draft technical report entitled Approaches to Developing Occupational Exposure Limits or Bands for Engineered Nanomaterials: User Guide and Technical Report86 Fed. Reg. 36748. NIOSH states that the draft report describes an evidence-based approach to evaluate the scientific information available to derive occupational exposure limits, or bands, for engineered nanomaterials. This draft report contains two main parts: (1) user guide; and (2) full technical report and appendixes. NIOSH seeks comments from individuals, including scientists and representatives from various government agencies, industry, labor, and other stakeholders, and also the public. NIOSH asks that comments note whether there are errors of fact, unsubstantiated claims, evidence of careless experimental work, inclusion of too much information already in the literature, or statements that are inaccurate. NIOSH requests that special emphasis be placed on technical review of the following issues:

  • Does the draft document adequately describe the process for gathering and evaluating the information available on occupational exposure limits or bands for engineered nanomaterials?

  • Does the draft document adequately describe the development of a framework for categorizing engineered nanomaterials by potential occupational health hazard from inhalation exposure?

  • Are the clustering and classification modeling methodologies reasonable for these data?

  • Is a revision to current occupational exposure banding guidance needed to incorporate a band F?

  • How useful and practical is the approach described in both the user guide and full technical report for deriving categorical occupational exposure limits, and what are the opportunities for improvement?

  • Are the current searches and collection of scientific data sufficient, and are there additional opportunities for obtaining data that were not included?

  • Would the methods used in the report also be appropriate for a future comprehensive dataset of experimental, toxicological, and physicochemical information for engineered nanomaterials?

Comments are due September 13, 2021.

©2021 Bergeson & Campbell, P.C.National Law Review, Volume XI, Number 194
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About this Author

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

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...

202-557-3801
Carla Hutto, Bergeson Campbell PC environmental law regulatory analyst,Toxic Substances Control Act law attorney
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...

202-557-3809
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