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National Toxicology Program

National Toxicology Program

UPDATE NewsletterUPDATE NewsletterAugust 2019

The NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM)

By Catherine Sprankle

ICE Update Launched July 30

The Integrated Chemical Environment (ICE) is a publicly available, web-based resource that provides curated data and tools to facilitate safety assessment of chemicals. On July 30, NICEATM added the following to ICE:

  • Updates to Tox21 data
  • Predictions of endocrine activity using in silico models
  • Improved performance and output standardization for the In Vitro to In Vivo Extrapolation tool
  • Simplified outputs for the Machine Learning tool
  • Revised user guides

FDA to Present Update on Predictive Toxicology Roadmap September 18

On Wednesday, September 18, the U.S. Food and Drug Administration (FDA) will host a free public meeting to provide updates on implementation of its Predictive Toxicology Roadmap. Speakers from seven FDA centers will describe how predictive toxicology methods are being advanced for application to safety and risk assessments. The meeting will be held at FDA’s White Oak campus in Silver Spring, MD and webcast. Information about registration and a preliminary agenda are available on the FDA website. Those interested in attending or viewing the webcast should register by Monday, September 16.

Recent Workshop Reports

Three recently published reports of 2018 workshops have NICEATM coauthors.

NICEATM Deputy Director Nicole Kleinstreuer is a coauthor of the Report on the Ninth Berlin Workshop on Developmental Toxicity. Attendees considered the future of in vitro methods for developmental and reproductive toxicology, the potential relevance of alternative species in testing of developmental effects, and risk and hazard assessment of developmental and endocrine effects. Recommendations included the need for a harmonized terminology for classifying anomalies identified in laboratory animals in developmental toxicity studies for use in human health risk assessment.

NICEATM Director Warren Casey and David Allen, ILS (contractor supporting NICEATM) coauthored the report of the workshop “Implementing Nonanimal Approaches to Human and Veterinary Vaccine Testing: Achieving Scientific and Regulatory Success for Rabies and Beyond.” This workshop, organized by NICEATM and the International Alliance for Biological Standardization-North America, explored how to advance alternative methods for human and veterinary rabies virus vaccine potency testing. Workshop attendees agreed that a more suitable, scientifically based in vitro assay is needed as an alternative to the current in vivo challenge potency test. ELISA assays specific for rabies virus glycoprotein were identified as the most appropriate in vitro alternative test candidates for further development.

A report is available from the “Summit on Artificial Intelligence in Environmental Health Science and Decision Making”. The goal of the summit was to identify and prioritize environmental health sciences (EHS) research questions that might be investigated with artificial intelligence and machine learning (AI/ML) techniques. The summit described some early opportunities for the application of AI/ML in EHS. Participants also identified action items for advancing the field in the three areas of (1) data, research, and practice; (2) education and training; and (3) community and field development. NICEATM Deputy Director Nicole Kleinstreuer and Lyle Burgoon, U.S. Department of Defense, co-chair of the ICCVAM Ecotoxicology Workgroup, were among the presenters at the summit.

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The Update Newsletter is produced by NTP Office of Liaison, Policy, and Review. The text is not copyrighted and can be reprinted without permission. If you use parts of the Update Newsletter in your publication, we ask that you provide us with a copy for our records. We welcome your comments and suggestions.

Director of Office of Liaison, Policy, and Review and Editor-in-Chief: Mary Wolfe | Managing Editor: Anna Lee Mosley