EPA guidelines and review

What you need to know about EPA's repellent guidelines

The Environmental Protection Agency of the United States has issued guidelines for the performance of personal insect repellents.

Currently under revision, the EPA “Product Performance Guidelines for Insect Repellents” describes the “Good Laboratory” and “Good Field” Practices that, when followed, ensure adequate testing while minimizing risks to participants.

The Practices have become the de facto minimum registration standards for product developers. As a registrant, it is valuable to understand these scientific guidelines to provide the data required for registration and marketing of any insect repellent. Carroll-Loye actively assists US EPA in formulating and refining the efficacy test guidelines.

Navigating the EPA Human Studies Review Board

Proposals to collect insect repellent efficacy data for registration purposes must first be reviewed by the US Environmental Protection Agency.

The purpose of this review is to ensure the rights and safety of human research subjects in repellent efficacy tests. Scientific merit and potential societal benefit are also evaluated, as balanced against risks. The agency is supported in the review by the Human Studies Review Board (HSRB), a Blue Ribbon Panel of academic Bioethicists and Biomedical Researchers. This 16 member Board convenes quarterly in the Washington DC area to review our protocols and study reports.

Since the advent of this augmented regulation in early 2006, Carroll-Loye has worked intensively with EPA staff to further refine our state-of-the-art protocols. The EPA has recommended our protocols and study reports to the HSRB, and the Board has reviewed them favorably. Under the EPA review system, Carroll-Loye is the only repellent science company to deliver successful results to sponsors for both field and laboratory efficacy studies.

More information about the HSRB may be found through the link below. For answers to specific questions, and additional insight into meeting EPA and HSRB requirements, please contact us.

HSRB on the US EPA web site