US EPA’s New Framework Prioritises Non-Animal Methods for Eye Irritation Testing

The US Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT) issued a new decision framework, which discourages the use of the in vivo rabbit Draize test in favour of approaches using human cells and other non-animal methods that assess the range of severity of eye irritants from corrosive to non- or minimally irritating substances.

This framework was described in a poster coauthored by the EPA, PETA Science Consortium International e.V., the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), and the Institute for In Vitro Sciences (IIVS) that was presented at the Society of Toxicology 62nd Annual Meeting.

The framework references and aligns with the concepts described in a 2021 paper coauthored by the EPA, the Science Consortium, NICEATM, IIVS, and the European Commission Joint Research Centre, titled “Human-Relevant Approaches to Assess Eye Corrosion/Irritation Potential of Agrichemical Formulations”, showing that tests that do not use rabbits are more consistent and as or more reflective of human responses.

The Science Consortium and the EPA have collaborated for years on projects to identify the most reliable and relevant testing approaches to evaluate chemicals and best protect humans and the environment, including a long-standing collaboration to advance robust eye irritation tests that do not use live rabbits.

“The EPA’s new framework for assessing eye irritation and corrosion overcomes the multiple issues with the rabbit eye test,” says Science Consortium President Dr Amy Clippinger. “The ultimate goal of these tests is to protect the public’s health, and the way to ensure that is through wider adoption of modern, non-animal approaches that more effectively reflect human biology.”

This is the latest step in the EPA’s progress in adopting modern, non-animal methods that allow it to make better-informed decisions regarding the potential risks of chemical exposure to humans.

In 2019, the EPA released a Work Plan (which was updated in 2021) outlining concrete steps it would take to reduce toxicity testing on animals and prioritise robust non-animal testing methods. The same year, the agency also began hosting its own biennial conference devoted to understanding the state-of-the-science on the development and application of non-animal methods.

The agency also advances reliable and relevant non-animal testing through various cross-sector partnerships. For example, it collaborated with the Science Consortium on an analysis of 119 pesticides, resulting in a publication showing that the avian sub-acute dietary test does not typically contribute to regulatory decision-making or environmental protections. Based on the analyses in this publication, the EPA released guidance for waiving sub-acute dietary tests for pesticide registrations. The agency also collaborates with the Science Consortium and others on a webinar series that provides information on non-animal testing methods and how to use them.

Other recent progress includes an EPA policy on the use of non-animal approaches for skin sensitisation testing, as well as a policy that will save as many as 240 fish each year from being used in bioconcentration factor (BCF) studies for pesticide testing.

In order to highlight opportunities to reduce and replace the use of animals in tests and to track the reduction in the number of animals used, the EPA’s Office of Pesticide Programs developed a website that collates information about strategies to reduce and replace animal testing with equivalent or better non-animal methods.