PRtf U.S. Environmental Protection Agency Office of Inspector General At a Glance 09-P-0952 May 27, 2009 Catalyst for Improving the Environment Why We Did This Review The Office of Inspector General (OIG) received a Hotline complaint that alleged that EPA is withholding information on product failures in the Antimicrobial Testing Program (ATP) from intended users. Background The EPA's Office of Pesticide Programs—Antimicrobials Division (OPP-AD) is responsible for all regulatory activities associated with antimicrobial pesticides. A key project of OPP-AD is the ATP, the post-registration testing program designed to evaluate the effectiveness of EPA-registered disinfectants. The focus of the ATP is on disinfectants most crucial to infection control: sterilants, tuberculocides, and hospital-level disinfectants. For further information, contact our Office of Congressional, I Public Affairs and Management at (202)566-2391. To view the full report, click on the following link: www.epa.gov/oig/reports/2009/ 20090527-09-P-0152.pdf Results of Hotline Complaint Review of EPA's Antimicrobial Testing Program What We Found We found that the allegation against EPA's ATP was unsubstantiated. The program policies and procedures require OPP to notify the Office of Enforcement and Compliance Assurance (OECA) and manufacturers when a product fails testing. OPP-AD is not withholding information on product failures from these intended users. As of February 2009, 325 of the 671 EPA registered disinfectant products had been tested under the ATP. ATP anticipates completing efficacy testing of all currently registered disinfectant products by 2011. The OPP-AD procedures specify what type of action is to be taken based on testing results. When a product fails, OPP-AD follows its Standard Operating Procedure (SOP) for product failures. OPP-AD decides whether a regulatory or enforcement action should be pursued for products that fail. OECA makes the final decision regarding any enforcement actions to be taken against manufacturers. The report does not contain any recommendations; however, we make several observations regarding OPP policies and practices that could be improved. OPP-AD could: • provide publicly-accessible information on effective hospital disinfectants and tuberculocidal products as it does with other disinfectants. • amend its SOPs to include products without a hospital disinfectant label claim. • develop a plan to sustain the program after testing is completed in 2011. ------- |