New EPA Guidance for Testing Pesticides Will Reduce Animal Testing

Today, in an open letter to stakeholders the Environmental Protection Agency is announcing progress on its goal to significantly reduce the use of animals in acute effects testing, and is releasing two guidance documents in support of this goal.  Rapid advancements in science and new technologies allow us to evaluate more pesticides across a broader range of potential effects in less time, using fewer animals and reducing costs for everyone.  EPA is adopting alternative approaches to more traditional toxicity testing and using Integrated Approaches to Testing and Assessment (IATA) to enhance the quality of its risk assessments and risk management decisions.

First, EPA is releasing 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 transparent, stepwise 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.

Second, EPA is releasing for public comment draft guidance, “Retrospective Analysis & Guidance for Waiving Acute Dermal Toxicity Tests for Pesticide Formulations.” We expect this guidance will lead to more data waivers for acute dermal studies for formulated pesticide products. 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.

The agency used the analysis to support a draft policy to waive all acute lethality dermal studies for formulated pesticide products. EPA is accepting comments on the draft policy for 60 days, until May 16, 2016. Please submit any comments on the draft guidance to docket EPA-HQ-OPP-2016-0093.

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