; (B) in subparagraph (I), by inserting or at the end; and (C) by inserting after subparagraph (I) the following: (J) with respect to a medically important antimicrobial (as defined in subsection (q)), the applicant has failed to demonstrate that there is a reasonable certainty of no harm to human health due to the development of antimicrobial resistance that is attributable, in whole or in part, to the nontherapeutic use (as defined in subsection (q)) of the medically important antimicrobial or drug; ; and (2) in the second sentence, by striking (A) through (I) and inserting (A) through (J) . (b) Phased elimination of nontherapeutic use in animals of medically important antimicrobials Section 512 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360b ) is amended by adding at the end the following: (q) Phased elimination of nontherapeutic use in animals of medically important antimicrobials (1) Applicability This paragraph applies to the nontherapeutic use in a food-producing animal of a drug— (A) that is a medically important antimicrobial; or (B) (i) for which there is in effect an approval of an application or an exemption under subsection (b), (i), or (j) of section 505; or (ii) that is otherwise marketed for human use. (2) Withdrawal The Secretary shall withdraw the approval of a nontherapeutic use in food-producing animals of a drug described in paragraph (1) on the date that is 2 years after the date of enactment of this subsection unless— (A) before the date that is 2 years after the date of the enactment of this subsection, the Secretary makes a final written determination that the holder of the approved application has demonstrated that there is a reasonable certainty of no harm to human health due to the development of antimicrobial resistance that is attributable in whole or in part to the nontherapeutic use of the drug