EPA has released a new guidance document, “Process for Establishing & Implementing Alternative Approaches to Traditional in Vivo Acute Toxicity Studies” to expand the use of alternative methods for acute toxicity testing. The guidance describes a process for evaluating and implementing alternative testing methods (not using live animals) for acute oral, dermal and inhalation toxicity, along with skin and eye irritation and skin sensitization. EPA has incorporated comments from stakeholders, other regulatory organizations, and the scientific community. The agency’s response to public comments is included in docket EPA-HQ-OPP-2016-0093.

EPA has also released for public comment draft guidance, “Retrospective Analysis & Guidance for Waiving Acute Dermal Toxicity Tests for Pesticide Formulations.” EPA and the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods conducted a retrospective analysis of oral and dermal acute lethality studies relevant to EPA’s regulation of pesticides. This analysis, including 593 formulations and 316 active ingredients across numerous classes representing conventional pesticides, antimicrobials, and biopesticides, examined the utility of the acute dermal toxicity study for formulations in pesticide labelling for end-use products.

Click here for more details about these actions.