NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM)
Skin sensitization webinar December 8
The second webinar in a series on “Current Concepts in Quantitative Risk Assessment for Skin Sensitization” will be presented Wednesday, December 8, from 9:00-10:30 a.m. EST. Nicole Kleinstreuer of NICEATM and Denise Bloch of the German Federal Institute for Risk Assessment will speak on “Methods for Hazard and Exposure Assessment.” Registration for the webinar series is open; if you registered for the first webinar in the series, you do not need to register for subsequent webinars.
This webinar series will provide an overview of the current state of the science in the rapidly developing field of quantitative risk assessment of skin sensitizing chemicals. The webinars are intended as background for a planned workshop in 2022 on quantitative risk assessment of skin sensitizing pesticides but they are of interest to the broader scientific community as they are relying on the development of concepts and methods in other areas such as cosmetics, fragrances, and consumer products. The webinar series is organized by NICEATM, the Swiss Centre for Applied Human Toxicology, and the Swiss State Secretariat for Economic Affairs.
National Academies workshop on NAMs December 9
A workshop on “New Approach Methods (NAMs) for Human Health Risk Assessment” will be held Thursday, December 9, from 10:00 a.m. – 3:00 p.m. The workshop is being convened by an ad hoc committee of the National Academies of Sciences, Engineering, and Medicine and is open to the public.
Acting NICEATM Director Nicole Kleinstreuer and Elijah Petersen of the National Institute of Standards and Technology are among the members of the National Academies committee, which is conducting a consensus study on “Variability and Relevance of Current Laboratory Mammalian Toxicity Tests and Expectations for New Approach Methods (NAMs) for use in Human Health Risk Assessment.” Kleinstreuer and Petersen are both members of the Interagency Coordinating Committee on the Validation of Alternative Methods, which NICEATM supports. The goal of this study is to set data-driven and science-based expectations for NAMs based on the variability and relevance of the traditional toxicity testing models.
Free support offered for NIH small business grant applicants; apply by December 10
The National Institutes of Health (NIH) Applicant Assistance Program provides free support for companies that are planning to apply for a Phase I NIH Small Business Innovation Research or Small Business Technology Transfer award. The National Institute of Environmental Health Sciences participates in the Applicant Assistance Program and provides funding for development of improved methods for toxicity testing or computational approaches for predictive toxicology. Applications for the program must be submitted by December 10.
Publications available from KMD symposium
The kinetically derived maximum dose (KMD) refers to the dose at which a departure from dose proportionality or linear pharmacokinetics is observed. A September 2020 symposium organized by NICEATM, the U.S. Environmental Protection Agency Office of Pesticide Programs, and the Health and Environmental Sciences Institute reviewed the application of the KMD in toxicity testing. Symposium presentations summarized commonly raised technical and scientific issues related to the use of KMD as an approach to select doses in toxicology testing studies or to interpret dose-response study results.
Two publications developed following the symposium are now available in Regulatory Toxicology and Pharmacology:
- Lowe et al. 2021. Incorporating human exposure information in a weight of evidence approach to inform design of repeated dose animal studies. https://doi.org/10.1016/j.yrtph.2021.105073.
- Tan et al. 2021. Opportunities and challenges related to saturation of toxicokinetic processes: Implications for risk assessment. https://doi.org/10.1016/j.yrtph.2021.105070