Ocular Toxicity Regulatory Considerations for Nondrug Food and Drug Administration (FDA) Products and the Environmental Protection Agency (EPA)

Abstract

The regulatory requirements for ocular toxicity of nondrug FDA products and the EPA are designed to identify the hazard of the material and ensure that labels have the proper use instructions and warnings. This is different from the Food, Drug, and Cosmetic Act (FDCA) process for drug development which is designed to determine the risk based on the exposure of the investigational drug. The regulatory guidance for cosmetics falls under the FDCA and is focused on ensuring that manufacturers produce safe products with proper use instructions and eye warnings. Other consumer products are regulated by the Consumer Product Safety Commission (CPSC) under the Federal Hazardous Substances Act (FHSA). The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) is responsible for registering pesticides and ensuring safe and proper use. Development of new industrial chemicals is regulated by the Toxic Substances Control Act (TSCA). The regulatory guidelines associated with these acts provide recommendations to use the Draize eye test for evaluation of ocular toxicity. However, each regulatory guidance for different substance categories has slightly different guidance for the Draize eye test methodology, the interpretation of the results, and conclusions based on the results. While the standard test to evaluate ocular toxicity has been the Draize eye test since the 1940s, significant efforts are currently under way to develop and validate alternative assays to identify ocular toxicity hazard, replace the Draize eye test, and modify the regulatory landscape.