In response to recommendations from the Office of Inspector General (OIG), EPA is suspending the active product sample collection and routine testing done by the Antimicrobial Testing Program (ATP). The OIG periodically evaluates the testing program and offers advice to assist in the implementation of and options for improving the program. In September 2016, the OIG recommended suspension of the Agency’s product testing program until EPA completes the re-registration process for antimicrobial pesticides and develops a risk-based strategy to ensure the effectiveness of public health pesticides used in hospital settings once products are in the marketplace. View the OIG Report: EPA Needs a Risk-Based Strategy to Assure Continued Effectiveness of Hospital-Level Disinfectants.

EPA implemented the ATP to ensure that EPA-approved hospital disinfectants, sterilants and tuberculocidal products in the marketplace would continue to meet stringent efficacy standards. Under the testing program, EPA’s Office of Pesticide Programs’ laboratories or state laboratories under contract to the Agency tested samples of EPA-registered hospital sterilants, disinfectants and tuberculocidal products. As a result of this program, products that did not meet the Agency’s efficacy performance standards were brought into compliance through regulatory or enforcement measures.

EPA will continue to review product specific disinfectant and tuberculocidal efficacy data and update the product status on the Antimicrobials Products Tested or Pending Testing list using two processes. Through the reregistration process, EPA is calling in and reviewing a combination of new product-specific studies and citations of contemporary studies that will increase the level of confidence in the efficacy of antimicrobial products including hospital disinfectants. In addition, EPA has requested the voluntary submission of data for liquid formulations using the 2013 version of the AOAC Use Dilution Method for Testing Disinfectants, as a follow-up to certain registration or enforcement actions.

EPA is in the process of developing a risk-based testing strategy in response to the OIG’s recommendations. This strategy will ensure the effectiveness of public health pesticides used in hospital settings by:

• establishing a framework for periodic testing after registration;
• defining a program that is responsive to current public health risks;
• identifying risk factors for selecting products to test;
• establishing a process to be used for obtaining samples for testing and;
• setting a date to begin risk-based post-registration testing.

EPA continues to work on developing a new, risk-based strategy and plans to release the draft strategy for public comment  in 2019 prior to implementation.

For questions on the Antimicrobial Testing Program, contact Ben Chambliss (chambliss.ben@epa.gov) or (703) 308-8174.

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