Bridging the gap between regulatory acceptance and industry use of non-animal methods.

Amy Clippinger

doi:10.14573/altex.1601311

Abstract

Collaboration between industry and regulators resulted in the development of a decision tree approach using in vitro or ex vivo assays to replace animal tests when determining the eye irritation potential of antimicrobial cleaning products (AMCPs) under the United States Environmental Protection Agency (EPA) Office of Pesticide Programs' hazard classification and labeling system. A policy document issued by the EPA in 2013 and updated in 2015 describes the alternate testing framework that industry could apply to new registrations of AMCPs and, on a case-by-case basis, to conventional pesticide products. Despite the collaborative effort, the availability of relevant non-animal methods, and the EPA's change in policy, only a limited number of AMCPs have been registered using the framework. Companies continue to conduct animal tests when registering AMCPs due to various challenges surrounding adoption of the new testing framework; however, recent discussions between industry, regulators, and other interested parties have identified ways these challenges may be overcome. In this article we explore how use of the alternate framework could be expanded through efforts such as increasing international harmonization, more proactively publicizing the framework, and enhancing the training of regulatory reviewers. Not only can these strategies help to increase use of the EPA alternate eye irritation framework, they can also be applied to facilitate the uptake of other alternative approaches to animal testing in the future.

Highlights

In the United States, the majority of household cleaning products do not have to go through a registration process before they are marketed
Discussions on developing a non-animal approach to eye irritation testing began at the fall 2003 meeting of the Pesticide Program Dialog Committee (PPDC), an Environmental Protection Agency (EPA) federal advisory committee representing the pesticide industry, growers, the environmental and animal welfare communities, and other stakeholders
This led to collaboration between the EPA, seven antimicrobial cleaning products (AMCPs) companies, the Institute for In Vitro Sciences (IIVS), and the Accord Group in 2004

Summary

Introduction

In the United States, the majority of household cleaning products do not have to go through a registration process before they are marketed. Discussions on developing a non-animal approach (one that does not use live animals) to eye irritation testing began at the fall 2003 meeting of the Pesticide Program Dialog Committee (PPDC), an EPA federal advisory committee representing the pesticide industry, growers, the environmental and animal welfare communities, and other stakeholders. This led to collaboration between the EPA, seven AMCP companies, the Institute for In Vitro Sciences (IIVS), and the Accord Group in 2004. The protocols, prediction models for EPA labeling categories, applicability domains, and suggested integrated use of these assays were defined for this program and are described in the EPA policy document (U.S EPA OPP, 2015 (revised))

Results

Discussion

Conclusion