Assessment of the Effects of Antimicrobial Drug Residues From Food of Animal Origin on the Human Intestinal Flora; Availability

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The Food and Drug Administration (FDA) is announcing the availability for comment of draft guidance for industry entitled "Assessment of the Effects of Antimicrobial Drug Residues from Food of Animal Origin on the Human Intestinal Flora." This draft guidance is a revision of the guidance document no. 52 entitled "Microbiological Testing of Antimicrobial Drug Residues in Food," which was implemented in 1996. In this draft guidance, the agency recommends a pathway approach for assessing the microbiological safety of antimicrobial drug residues in food, rather than the approach described in the 1996 version of the guidance. The agency's decision to revise this guidance is based on new information available to the agency.