On August 25, 2000, a Federal Register Notice (65 FR 51828-51830 - HBV) was issued which summarizes the Agency's policy guidance regarding a hepatitis B virus (HBV) testing alternative. As part of EPA's commitment to continue to advance scientific methodologies that will protect the public and also reduce animal testing, EPA has endorsed the in vitro (test tube) duck assay as the appropriate and preferred alternative to animal testing. The Agency's FIFRA Scientific Advisory Panel (SAP) has also endorsed and supported this approach. The in vitro duck assay uses duck hepatitis B virus as a surrogate for human hepatitis B virus. This method maintains the rigorous efficacy testing requirements to ensure public health protection. An additional benefit of this method is the potential for a significant reduction in the use of animals for such testing, while maintaining EPA's high standards for testing accuracy and reliability.
F.R. Notice (62 FR 71924-71925) - Announcement of the Availability and Request for Comments on Protocols for Testing the Efficacy of Disinfectants Used to Inactivate Hepatitis B Virus and Corresponding Label Claims
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