Pesticides; Draft Guidance for Waiving Acute Dermal Toxicity Tests for Pesticide Technical Chemicals and Supporting Retrospective Analysis; Notice of Availability and Request for Comment

Résumé

The Environmental Protection Agency (EPA) is announcing the availability of and seeking public comment on a draft guidance document entitled "Guidance for Waiving Acute Dermal Toxicity Tests for Pesticide Technical Chemicals & Supporting Retrospective Analysis." Guidance documents are issued by the Office of Pesticide Programs (OPP) to inform pesticide registrants and other interested persons about important policies, procedures, and registration related decisions, and serve to provide guidance to pesticide registrants and OPP personnel. This draft guidance document provides information to pesticide registrants concerning the Agency's consideration to expand the potential for data waivers for acute dermal studies to single technical active ingredients (technical AIs) used to formulate end use products. The reasoning and analysis in this dermal waiver guidance for technical active ingredients is similar to what was presented in the 2016 guidance for end-use products. While more acute toxicity studies are submitted to OPP annually for formulated pesticide products than for technical AIS, there is still the potential for animal and resource savings from waivers for acute toxicity stud