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Alternate Testing Framework for Classification of Eye Irritation Potential of EPA-Regulated Pesticide Products
In May 2015, EPA released updated guidance for testing antimicrobial cleaning products for their potential to cause eye irritation.
This updated guidance document, effective immediately, describes a testing framework for assessing eye irritation potential of EPA-registered antimicrobial cleaning products using three in vitro/ex vivo assays (non-animal tests):
- Bovine Corneal Opacity and Permeability assay (BCOP).
- EpiOcular assay (EO).
- Cytosensor Microphysiometer (CM) assay.
The same testing approach is currently considered on a case-by-case basis for other classes of pesticides and pesticide products.
This updated guidance document replaces the 2013 version of this document.
Learn more about the 2015 eye irritation alternate testing framework for antimicrobial cleaning products:
What’s New in the 2015 Guidance
The testing framework in the updated guidance document expands the scope of the BCOP assay. Previously, the BCOP could be used to identify antimicrobial cleaning product Toxicity Category I and II eye irritants. EPA is now expanding the applicability of the BCOP assay for identifying toxicity category III eye irritants for antimicrobial cleaning products.
Scope of the Use of this Guidance
After additional analysis, the agency concluded that the testing approach in the 2015 guidance is acceptable for determining the eye hazard classification and labeling for antimicrobial cleaning products. Thus, the testing scheme can be used to satisfy the in vivo data requirement for eye irritation in 40 CFR Part 158W for antimicrobial cleaning products. See antimicrobial product data requirements.
For other pesticides, including conventional, biochemical, and other antimicrobial pesticides that do not include cleaning claims, the agency will consider alternative tests on a case-by-case basis. In these situations, the registrant is encouraged to consult with the EPA or submit the proposed test protocol to the EPA for review before conducting the study. EPA will determine the acceptability of test results on these other classes using a weight of evidence approach. That is, the results of the non-animal tests will be considered along with additional information on the chemical, including but not limited to structure-activity relationships and results of in vivo testing of the same or similar chemicals to support a classification under this testing scheme
In 2009, the agency initiated a pilot program through publication of a document entitled “Non-Animal Testing Approach to EPA Labeling for Eye Irritation.” This pilot encouraged antimicrobial pesticide registrants to submit studies on eye irritation for antimicrobial cleaning products using the in vitro and ex vivo testing methods mentioned above (BCOP, EO, and CM). The purpose of this pilot was to determine whether labeling decisions for eye irritation could be made using this approach.
As a result of this pilot program, and based on analyses conducted by the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), the agency established as science policy the use of this approach for antimicrobial cleaning products in general and for other classes of pesticides and pesticide products on a case-by-case basis.
The agency recently conducted additional analysis to determine whether the BCOP assay could be used to identify Toxicity Category III eye irritants. This use of the BCOP assay is supported and has been incorporated into the updated guidance document.