EPA Announces New Framework to Assess Eye Irritation in New Chemicals

Released January 8, 2024

Today, the U.S. Environmental Protection Agency (EPA) announced a new framework for identifying eye irritation and corrosion hazards for new chemicals reviewed under the Toxic Substances Control Act (TSCA). This framework will provide a standard approach for EPA to use when evaluating new chemicals for potential eye irritation or corrosion hazards leading to improved consistency across final risk assessments as well as improved transparency. This framework also supports EPA’s ongoing efforts to reduce the use of animal testing and make the Agency’s review of new chemicals more efficient, helping to bring new chemicals to market more quickly while protecting human health.

Under TSCA, EPA is required to review new chemicals within 30 or 90 days (depending on the type of submittal), assess the potential hazards to human health and the environment, and make risk determinations. When potential risks are identified, EPA must take action to mitigate those risks before the chemical can enter commerce. Assessing a new chemical’s potential to cause eye irritation or corrosion is one part of the Agency’s review.

Historically, traditional toxicity testing has used tests on living rabbits to determine if a chemical causes eye irritation or corrosion hazards. However, these tests do not provide consistent results, particularly for chemicals that cause mild to moderate irritation, raising questions about how applicable the test results are to humans.  With this new framework, EPA will place increased weight on data from non-animal test methods that are more reproducible and provide results more relevant to humans. This will streamline the decision-making process and increase efficiency through a standard process for EPA to use each time it evaluates eye irritation or corrosion hazards test data.    

The new framework supports EPA’s mandate under TSCA to promote the development and implementation of alternative test methods and strategies that can provide information on chemical hazards without animal testing. These alternatives, also known as New Approach Methodologies (NAMs), reduce, refine, or replace vertebrate animal testing and provide information of equivalent or better scientific quality and relevance for assessing risks of injury to health or the environment. By establishing this framework, EPA expects the decision-making process for identifying potential eye irritation and corrosion hazards concerns for new chemicals to be simplified and streamlined. Transitioning to NAMs can also decrease time and costs for stakeholders by eliminating the need for animal studies.

If you have any questions or would like to send EPA comments about the framework, please contact Renee Beardslee at beardslee.renee@epa.gov.

Read more about the Decision Framework for Hazard Identification of Eye Irritation and Corrosion