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National Toxicology Program

National Toxicology Program

UPDATE NewsletterUPDATE NewsletterNovember 2019

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

By Catherine Sprankle

Workshop considers key activities needed to predict acute toxicity

NICEATM and the Physicians Committee for Responsible Medicine held a workshop titled “Mind the Gaps: Prioritizing Activities to Meet Regulatory Needs for Acute Systemic Toxicity” on October 30-31 at the National Institutes of Health.

Acute systemic toxicity tests are the most commonly performed type of safety test worldwide. At this workshop, experts from government, industry, academia, and animal welfare organizations considered approaches available to assess acute lethality associated with chemicals and chemical mixtures, with the purpose of designing comprehensive strategies to predict toxicity while avoiding animal tests. Areas discussed included:

  • Defining how to calculate the LD50 of a chemical mixture/formulated product
  • Identifying gaps where model (or assay) development or optimization is needed
  • Understanding regulatory needs for model (or assay) outputs
  • Pinpointing the types of mechanistic information that would be useful
  • Establishing the feasibility of using artificial intelligence in model development

Group discussions focused on issues specific to particular classes of chemicals, mechanisms of acute toxicity, prioritization of activities, and recommending next steps. Follow-up actions include an analysis of variability in the in vivo test to establish confidence in toxicity predictions, a comprehensive assessment of an additivity equation for predicting mixtures toxicity, and exploring the addition of biological and mechanistic information to complement in silico predictions. Presentations from the workshop will be available soon on the NTP website.

NIEHS providing funding to develop in vitro models

NIEHS will provide funding for U.S. small businesses to develop novel, engineered 3D or organotypic in vitro systems using cells from experimental animal models typically used for toxicology testing. When developed and validated, these animal-derived in vitro systems will help predict toxicity of chemical and drug candidates, enable comparisons with existing in vivo animal toxicity data, and potentially reduce the numbers of animals used in toxicology testing.

The funding opportunity is open only to U.S. small businesses. NIEHS intends to fund six to eight awards totaling up to $4 million. Applications for renewals of existing grants are eligible. While this project is intended to facilitate comparisons to in vivo animal data, applicants should not include new in vivo animal studies in their research plan for initial development of these models. Letters of intent are due December 3, with applications due January 3, 2020.

EPA council achieves cost and animal savings for required testing

An article in Regulatory Toxicology and Pharmacology summarizes the activities of the U.S. Environmental Protection Agency’s (EPA) Hazard and Science Policy Council (HASPOC). HASPOC was established in 2012 by the EPA Office of Pesticide Programs to consider requests for waiving animal study requirements for human health risk assessments. Since its inception, HASPOC has evaluated over 1,000 requests to waive animal studies and granted waivers in response to nearly 90% of requests. These waivers have saved over 200,000 animals, $300 million in study costs, and $6 million in study review costs.

The Regulatory Toxicology and Pharmacology article was co-authored by Anna Lowit, PhD, co-chair of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). NICEATM provides scientific and operational support to ICCVAM.

Craig et al. 2019. Reducing the need for animal testing while increasing efficiency in a pesticide regulatory setting: lessons from the EPA Office of Pesticide Programs’ Hazard and Science Policy Council. Regulatory Toxicology and Pharmacology. https://doi.org/10.1016/j.yrtph.2019.104481

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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