Summary: Pursuant to a congressional request, GAO reviewed the Environmental Protection Agency's (EPA) regulation of the efficacy of disinfectants, focusing on: (1) controversies regarding EPA-recommended methods and performance standards for testing disinfectant efficacy; (2) EPA efforts to obtain objective research to resolve the controversies; (3) EPA internal controls to ensure the quality and integrity of registrant-submitted efficacy data; (4) EPA and states' post-registration efforts to ensure disinfectant efficacy; and (5) the need and options for a laboratory to research and test disinfectant efficacy.
GAO found that: (1) EPA primarily relied on standard-setting organizations and the disinfectant industry to develop test methods and performance standards and generally accepted registrants' test methods and modifications without criteria or independent laboratory data to evaluate their validity; (2) EPA inadequately managed a cooperative agreement it had with a university to improve disinfectant test methods and subsequently made little progress in resolving controversies surrounding its acceptance of different methods and their differing results; (3) EPA reviewed registrant-submitted disinfectant data and performed laboratory inspections and data audits, but was not aware of most laboratories performing efficacy studies, and data reviewers and laboratory inspectors generally did not observe tests in progress and did not have access to physical evidence remaining from tests; (4) EPA did not enforce the efficacy claims of registered disinfectants; (5) EPA discontinued its limited enforcement testing program in 1982, primarily due to budget constraints; (6) although EPA relied on states, user groups, and the industry to enforce efficacy claims, few states and no user groups monitored efficacy due to cost concerns; and (7) EPA lacked a strategy to channel complaints about potentially ineffective disinfectants and to take appropriate action against ineffective disinfectants.
