title: Bridging the gap between regulatory acceptance and industry use of non-animal methods.
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.
authors.affiliation: People for the Ethical Treatment of Animals, Norfolk, VA, USA.
authors.forename: Amy J
authors.initials: AJ
authors.lastname: Clippinger
authors.affiliation: Institute for In Vitro Sciences, Inc., Gaithersburg, MD, USA.
authors.forename: Erin
authors.initials: E
authors.lastname: Hill
authors.affiliation: Institute for In Vitro Sciences, Inc., Gaithersburg, MD, USA.
authors.forename: Rodger
authors.initials: R
authors.lastname: Curren
authors.affiliation: People for the Ethical Treatment of Animals, Norfolk, VA, USA.
authors.forename: Patricia
authors.initials: P
authors.lastname: Bishop
mesh_terms: D000826:Animal Testing Alternatives / Q000331:legislation & jurisprudence* / Q000592:standards*; D000818:Animals; D003257:Consumer Product Safety / Q000331:legislation & jurisprudence; D005123:Eye / Q000187:drug effects; D015386:Hazardous Substances; D007509:Irritants / Q000633:toxicity; D007880:Legislation, Drug; D010573:Pesticide Residues; D010575:Pesticides; D018675:Toxicity Tests / Q000379:methods* / Q000592:standards*; D014481:United States; D014484:United States Environmental Protection Agency
chemical_list: D015386:Hazardous Substances; D007509:Irritants; D010573:Pesticide Residues; D010575:Pesticides
keywords:  EPA; antimicrobial cleaning products; eye hazard classification; non-animal testing strategy; pesticides