Antimicrobial Performance Evaluation Program (APEP)
EPA has developed a new draft strategy for selecting and testing hospital disinfectants to ensure these products continue to be effective after they enter the marketplace. While EPA ensures disinfectant products are effective before they can be sold, the new Antimicrobial Performance Evaluation Program (APEP) draft strategy goes a step further by laying out a risk-based approach for confirming hospital disinfectants remain effective and are used properly after they are registered.
Read and comment on the APEP draft strategy until January 2, 2020 in docket EPA-HQ-OPP-2018-0265.
Antimicrobial pesticides are designed to destroy or mitigate harmful bacteria, viruses and other microorganisms on inanimate objects and surfaces in hospitals and other settings. EPA evaluates the efficacy of disinfectant products with public health claims during the registration and reregistration processes.
Once finalized, the APEP will replace the Antimicrobial Testing Program (ATP), which EPA suspended in November 2017, consistent with recommendations from the Agency’s Office of Inspector General (OIG).
Understanding the Different Types of Disinfectants and EPA’s Role in Monitoring Them
EPA classifies disinfectants into the following three classes: hospital disinfectants, broad-spectrum (general) disinfectants, and limited disinfectants. EPA-registered hospital disinfectants must have demonstrated acceptable efficacy against two qualifying bacteria — Pseudomonas aeruginosa and Staphylococcus aureus.
Before registering a product, EPA evaluates product-specific data against predetermined performance standards and test methods. As stewards of public health, EPA previously monitored post-market hospital disinfectant product efficacy through the former ATP. The public should be assured that EPA monitors the efficacy of disinfectant products with public health claims under its registration and reregistration processes. The proposed APEP represents a more risk-based approach to prioritize product testing than the former ATP. It is important to note that disinfectants used in healthcare environments are part of a comprehensive, multi-tiered infection control paradigm, with disinfectants representing only a single element.
Next Steps
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Establishing a framework for periodic testing after registration;
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Defining a program that is responsive to current public health risks;
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Identifying risk factors for selecting products to test;
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Establishing a process to be used to obtain samples for testing; and
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Setting a date to begin risk-based post-registration testing.
The APEP draft strategy is available for public comment until January 2, 2020 in docket EPA-HQ-OPP-2018-0265. EPA sought input from the public as well as stakeholders from industry, healthcare, and state and federal government in preparing the APEP draft strategy. In 2018, EPA held webinar listening sessions, followed by a 30-day public comment period.
Due to the public health importance of this action, and to ensure transparency, EPA is seeking additional stakeholder input on the APEP draft strategy via a 60-day public comment period.
After reviewing comments received on the draft strategy, EPA expects to publish the APEP final strategy in 2020. Implementation is scheduled to begin in 2022.
For questions on the APEP, contact OPP APEP (opp_apep@epa.gov).
Background
In 1991, the Agency initiated the Antimicrobial Testing Program (ATP). EPA developed the ATP in response to a report from the Government Accountability Office (GAO) (PDF) (22pp, 5 MB, About PDF). The ATP targeted evaluation of the effectiveness of antimicrobial disinfectant products with hospital claims (claims against Staphylococcus aureus and Pseudomonas aeruginosa) and tuberculocidal claims (claims against Mycobacterium).
EPA’s OIG periodically evaluated the program and offered advice on implementing and improving it. In 2016, the OIG issued its latest report about the ATP. EPA’s OIG recommended that EPA develop a risk-based strategy to ensure the effectiveness of public health pesticides used in hospital settings post-registration.
Following the OIG’s recommendations, EPA suspended the ATP in November 2017 and developed the Antimicrobial Performance Evaluation Program (APEP): A (Draft) Risk-Based Strategy to Ensure the Effectiveness of Hospital-Level Disinfectant, released in August 2019, for public comment.
EPA has always conducted surveillance, monitoring and enforcement involving disinfectant products. The proposed APEP strategy will implement a risk-based approach to prioritize testing for hospital disinfectant products currently registered against specific healthcare associated microorganisms based on disease prevalence data, and/or hospital disinfectant products with novel technology and chemistry.
EPA values the lessons learned, data gathered, and results of products tested under the ATP. These study outcomes may be used to inform subsequent sampling and testing under the APEP.