Antimicrobial Cleaning Product Testing Strategy

In 2008, EPA submitted to NICEATM a non-animal testing strategy to assess the eye irritation potential of antimicrobial cleaning products (AMCPs). The proposed testing strategy used the bovine corneal opacity and permeability (BCOP), Cytosensor microphysiometer, and EpiOcular test methods to determine EPA hazard category and labeling requirements. In a test method evaluation report, ICCVAM reported the results of their evaluation of the proposed strategy and recommended further studies to characterize its usefulness and limitations.

In 2013, the EPA Office of Pesticide Programs established the use of an alternative testing approach to assess the eye irritation potential for AMCPs in general. They also stated that the approach could be used for other classes of pesticides and pesticide products on a case-by-case basis. This testing approach modified the 2008 proposal to consider the ICCVAM recommendations and studies submitted by product registrants. EPA updated the approach in 2015 to expland the applicability of the BCOP method. A guidance document is available on the EPA website.

Background on the AMCP Testing Strategy Evaluation

EPA collaborated with seven consumer product companies to develop the 2008 proposal. The Institute for In Vitro Sciences, Inc., (IIVS) coordinated the collaboration and prepared a background review document describing the final approach.

EPA and the consumer product companies requested that NICEATM and ICCVAM conduct a technical review of the scientific validity of the AMCP testing strategy. The goal of the review was to determine whether the testing strategy could be used to make appropriate hazard classification and labeling decisions for AMCPs.

NICEATM and ICCVAM used the IIVS background review document and additional data and information as the basis for a draft summary review document (SRD) and draft ICCVAM recommendations. Before finalizing its recommendations for federal agencies, ICCVAM considered the comments of an independent international scientific review panel as well as comments from the Scientific Advisory Committee on Alternative Toxicological Methods and the public.

The ICCVAM recommendations and ICCVAM-recommended protocols for the test methods are in the ICCVAM Test Method Evaluation Report: Current Validation Status of a Proposed In Vitro Testing Strategy for U.S. Environmental Protection Agency Ocular Hazard Classification and Labeling of Antimicrobial Cleaning Products (2010).

ICCVAM concluded that, at that time, there were insufficient data with which to adequately demonstrate that the proposed strategy could classify test substances to all four EPA ocular hazard categories. ICCVAM recommended future studies that could further characterize the usefulness and limitations of a testing strategy for AMCPs. These recommendations were considered in the final EPA strategy released in 2013 and updated in 2015.

Background on the ICCVAM Evaluation of the Low Volume Eye Test

As part of its evaluation of the AMCP testing strategy, ICCVAM also reviewed the validation status of the low volume eye test (LVET). The LVET is similar to the traditional in vivo rabbit eye test, but uses a smaller volume of test substance and a different application procedure. Data generated using the LVET were used as reference data to partially substantiate the validity of the in vitro test methods used in the AMCP testing strategy.

ICCVAM recommended that the LVET should not be used for future regulatory testing. The ICCVAM recommendations are included in the ICCVAM Test Method Evaluation Report: Recommendation to Discontinue Use of the Low Volume Eye Test for Ocular Safety Testing.

Recommendations and Agency Responses

The ICCVAM recommendations were communicated to federal agencies in letters from Linda Birnbaum, Ph.D., Director, NIEHS. The following list includes these letters and the responses received from federal agencies.