Advancing the science of EPA guidelines for sponsor-financed topical insect repellent efficacy studies

In 1999, the US Environmental Protection Agency (EPA) published guidelines for product performance testing of skin-applied insect repellents, which provide guidance for topical insect repellent efficacy studies. EPA subsequently uses these sponsor-financed studies in their evaluation of proposed label claims. This paper reviews some of the statistical flaws in the proposed revisions to these guidelines and suggests possible improvements. This review is important because EPA's revisions to the 1999 guidelines do not address these issues.