Reducing the need for animal testing while increasing efficiency in a pesticide regulatory setting: Lessons from the EPA Office of Pesticide Programs' Hazard and Science Policy Council

Abstract

As part of EPA's commitment to reducing animal testing, the Office of Pesticide Programs (OPP) created the Hazard and Science Policy Council (HASPOC). This group considers requests for waiving animal study requirements for human health risk assessments and makes recommendations based on a weight-of-the-evidence approach. Since its inception in 2012, the HASPOC has evaluated over one thousand requests to waive animal studies required by default for pesticide evaluation. Here, the number of studies waived, and the types of studies represented were analyzed to determine the impact of the HASPOC decisions in terms of animal and monetary savings. Overall, the waiving of studies by HASPOC resulted in over 200 thousand animals saved. There were also savings of over $300 million in study costs and over $6 million in study review costs as well as less time spent in study processing and review by EPA staff. Thus, the HASPOC has built significant efficiencies into the risk assessment process while continuing to protect human health.

Keywords: 3Rs; HASPOC; Pesticides; Risk assessment.

Fig. 1.. Decisions for animal study waiver requests presented to HASPOC.

Left: percentage of waivers granted or denied (i.e. required studies) by HASPOC using the WOE approach. Right: breakdown of waivers granted by study type.

Fig. 2.

Number of animals saved based on the type of studies recommended to be waived by HASPOC.

Fig. 3.. Savings to the regulated community in study costs.

Monetary amounts are in US dollars.

Fig. 4.. Savings to EPA in contractor costs.

Monetary amounts are in US dollars.