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Guidance for Considering and Using Open Literature Toxicity Studies to Support Human Health Risk Assessment

Toxicological and metabolism data for pesticide chemicals (active and inert ingredients) are provided by the registrants as required in 40 CFR Part 158. Guidelines for conducting studies to meet these requirements are available on EPA's test guidelines website.

In addition to the information submitted by the registrants, effects data from studies published in the open literature may also be considered in risk assessments conducted in the Office of Pesticide Programs (OPP). The purpose of this document is to provide further information and clarification to assist in the selection and review of relevant publications available in the open literature (i.e., non-test guideline studies) for use in hazard and dose response assessment.

This guidance was developed to assist OPP scientists and is intended for use in OPP’s risk assessments. This guidance draws from OPP’s long standing experience and guidance for review of registrant-submitted studies submitted in response to the 40 CFR Part 158 data requirements. It is intended to ensure consistent consideration, use, and documentation of information in the open literature by OPP scientists and risk assessors when evaluating the potential adverse effects on human health. This document is also intended to make transparent how OPP judges the scientific quality of open literature publications of relevance and importance to human health risk assessment. Although this guidance focuses on mammalian in vivo toxicity studies, its general principles and criteria also apply to pharmacokinetic/metabolism, mechanism of toxicity and in vitro studies.

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