EPA Guidance for Waiving of Toxicity Tests on Animal Skin

In December 2020, EPA published final guidance that will allow researchers to forego testing chemicals for acute systemic toxicity on animal skin in certain circumstances. The “Final Guidance for Waiving Acute Dermal Toxicity Tests for Pesticide Technical Chemicals and Supporting Retrospective Analysis” allows for data waivers for acute dermal systemic toxicity studies for single active ingredients used to develop end-use products other than fumigants and rodenticides. The document includes a policy statement to waive all acute lethality dermal studies for single active ingredients in many cases. 

This guidance supports EPA efforts to identify opportunities for test waivers that can reduce animal use for testing required for pesticide registration. It was based on a retrospective analysis conducted by EPA and collaborators, which concluded that such studies provide little to no added value in regulatory decision-making when an acute oral toxicity study has been conducted. This guidance is expected to save up to 750 test animals annually from unnecessary testing, as well as EPA, industry, and laboratory resources.